[House Hearing, 105 Congress]
[From the U.S. Government Publishing Office]



 
       H.R. 52, THE FAIR HEALTH INFORMATION PRACTICES ACT OF 1997
=======================================================================



                                HEARING

                               before the

                 SUBCOMMITTEE ON GOVERNMENT MANAGEMENT,
                      INFORMATION, AND TECHNOLOGY

                                 of the

                        COMMITTEE ON GOVERNMENT
                          REFORM AND OVERSIGHT
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED FIFTH CONGRESS

                             FIRST SESSION

                                   ON

                                H.R. 52

     TO ESTABLISH A CODE OF FAIR INFORMATION PRACTICES FOR HEALTH 
INFORMATION, TO AMEND SECTION 552A OF TITLE 5, UNITED STATES CODE, AND 
                           FOR OTHER PURPOSES

                               __________

                              JUNE 5, 1997

                               __________

                           Serial No. 105-58

                               __________

Printed for the use of the Committee on Government Reform and Oversight






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              COMMITTEE ON GOVERNMENT REFORM AND OVERSIGHT

                     DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York         HENRY A. WAXMAN, California
J. DENNIS HASTERT, Illinois          TOM LANTOS, California
CONSTANCE A. MORELLA, Maryland       ROBERT E. WISE, Jr., West Virginia
CHRISTOPHER SHAYS, Connecticut       MAJOR R. OWENS, New York
STEVEN SCHIFF, New Mexico            EDOLPHUS TOWNS, New York
CHRISTOPHER COX, California          PAUL E. KANJORSKI, Pennsylvania
ILEANA ROS-LEHTINEN, Florida         GARY A. CONDIT, California
JOHN M. McHUGH, New York             CAROLYN B. MALONEY, New York
STEPHEN HORN, California             THOMAS M. BARRETT, Wisconsin
JOHN L. MICA, Florida                ELEANOR HOLMES NORTON, Washington, 
THOMAS M. DAVIS, Virginia                DC
DAVID M. McINTOSH, Indiana           CHAKA FATTAH, Pennsylvania
MARK E. SOUDER, Indiana              ELIJAH E. CUMMINGS, Maryland
JOE SCARBOROUGH, Florida             DENNIS J. KUCINICH, Ohio
JOHN B. SHADEGG, Arizona             ROD R. BLAGOJEVICH, Illinois
STEVEN C. LaTOURETTE, Ohio           DANNY K. DAVIS, Illinois
MARSHALL ``MARK'' SANFORD, South     JOHN F. TIERNEY, Massachusetts
    Carolina                         JIM TURNER, Texas
JOHN E. SUNUNU, New Hampshire        THOMAS H. ALLEN, Maine
PETE SESSIONS, Texas                 HAROLD E. FORD, Jr., Tennessee
MICHAEL PAPPAS, New Jersey                       ------
VINCE SNOWBARGER, Kansas             BERNARD SANDERS, Vermont 
BOB BARR, Georgia                        (Independent)
ROB PORTMAN, Ohio
                      Kevin Binger, Staff Director
                 Daniel R. Moll, Deputy Staff Director
                       Judith McCoy, Chief Clerk
                 Phil Schiliro, Minority Staff Director
                                 ------                                

   Subcommittee on Government Management, Information, and Technology

                   STEPHEN HORN, California, Chairman
PETE SESSIONS, Texas                 CAROLYN B. MALONEY, New York
THOMAS DAVIS, Virginia               PAUL E. KANJORSKI, Pennsylvania
JOE SCARBOROUGH, Florida             MAJOR R. OWENS, New York
MARSHALL ``MARK'' SANFORD, South     ROD R. BLAGOJEVICH, Illinois
    Carolina                         DANNY K. DAVIS, Illinois
JOHN E. SUNUNU, New Hampshire
------ ------

                               Ex Officio

DAN BURTON, Indiana                  HENRY A. WAXMAN, California
          J. Russell George, Staff Director and Chief Counsel
                         Mark Uncapher, Counsel
                 John Hynes, Professional Staff Member
                          Andrea Miller, Clerk
           David McMillen, Minority Professional Staff Member













                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on June 5, 1997.....................................     1
    Text of H.R. 52..............................................     1
Statement of:
    Condit, Hon. Gary A., a Representative in Congress from the 
      State of California........................................    27
    Gabriel, Dr. Sherine, Department of Health Services Research, 
      Mayo Clinic, representing the Healthcare Leadership 
      Council; Dr. Elizabeth Andrews, Glaxo Wellcome Inc., 
      representing the Pharmaceutical Research and Manufacturers 
      Association; and Dr. Steven Kenny Hoge, chair, Council on 
      Psychiatry and Law of the American Psychiatric Association.    97
    Goldman, Janlori, visiting scholar, Georgetown University Law 
      Center, and affiliated with the Center for Democracy and 
      Technology; Dr. Donald J. Palmisano, member, Board of 
      Trustees, American Medical Association; and Merida L. 
      Johns, Ph.D., president, American Health Information 
      Management Association.....................................    53
    Stearns, Hon. Cliff, a Representative in Congress from the 
      State of Florida...........................................    32
Letters, statements, etc., submitted for the record by:
    Andrews, Dr. Elizabeth, Glaxo Wellcome Inc., representing the 
      Pharmaceutical Research and Manufacturers Association:
        Information concerning informed consent..................   158
        Prepared statement of....................................   116
    Condit, Hon. Gary A., a Representative in Congress from the 
      State of California, prepared statement of.................    29
    Gabriel, Dr. Sherine, Department of Health Services Research, 
      Mayo Clinic, representing the Healthcare Leadership 
      Council, prepared statement of.............................   100
    Hoge, Dr. Steven Kenny, chair, Council on Psychiatry and Law 
      of the American Psychiatric Association, prepared statement 
      of.........................................................   128
    Johns, Merida L., Ph.D., president, American Health 
      Information Management Association, prepared statement of..    67
    Maloney, Hon. Carolyn B., a Representative in Congress from 
      the State of New York, prepared statement of...............    49
    Palmisano, Dr. Donald J., member, Board of Trustees, American 
      Medical Association, prepared statement of.................    59
    Shays, Hon. Christopher, a Representative in Congress from 
      the State of Connecticut, prepared statement of............    41
    Slaughter, Hon. Louise M., a Representative in Congress from 
      the State of New York, prepared statement of...............    43
    Stearns, Hon. Cliff, a Representative in Congress from the 
      State of Florida, prepared statement of....................    34













       H.R. 52: THE FAIR HEALTH INFORMATION PRACTICES ACT OF 1997

                              ----------                              


                         THURSDAY, JUNE 5, 1997

                  House of Representatives,
Subcommittee on Government Management, Information, 
                                    and Technology,
              Committee on Government Reform and Oversight,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 9:32 a.m., in 
room 2154, Rayburn House Office Building, Hon. Stephen Horn 
(chairman of the subcommittee) presiding.
    Present: Representatives Horn, Sessions, and Maloney.
    Staff present: J. Russell George, staff director and chief 
counsel; Mark Uncapher, counsel; John Hynes, professional staff 
member; Andrea Miller, clerk; and David McMillen and Ron 
Stroman, minority professional staff members.
    Mr. Horn. The Subcommittee on Government Management, 
Information, and Technology will come to order.
    We are here today to consider the issue of medical records 
privacy and H.R. 52, the Fair Health Information Practices Act 
of 1997, introduced by Representative Condit of California.
    [The text of H.R. 52 follows:]

105th CONGRESS
1st Session
                                H.R. 52

     To establish a code of fair information practices for health 
information, to amend section 552a of title 5, United States Code, and 
                          for other purposes.

                                 ______
                                 

                    IN THE HOUSE OF REPRESENTATIVES

                            January 7, 1997

  Mr. Condit introduced the following bill; which was referred to the 
Committee on Commerce, and in addition to the Committees on Government 
      Reform and Oversight, and the Judiciary, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

                                 ______
                                 

                                 A BILL

     To establish a code of fair information practices for health 
information, to amend section 552a of title 5, United States Code, and 
                          for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Fair Health 
Information Practices Act of 1997''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings and purposes.
Sec. 3. Definitions.

               TITLE I--FAIR HEALTH INFORMATION PRACTICES

           Subtitle A--Duties of Health Information Trustees

Sec. 101. Inspection of protected health information.
Sec. 102. Amendment of protected health information.
Sec. 103. Notice of information practices.
Sec. 104. Disclosure history.
Sec. 105. Security.

     Subtitle B--Use and Disclosure of Protected Health Information

Sec. 111. General limitations on use and disclosure.
Sec. 112. Authorizations for disclosure of protected health 
    information.
Sec. 113. Treatment, payment, and oversight.
Sec. 114. Next of kin and directory information.
Sec. 115. Public health.
Sec. 116. Health research.
Sec. 117. Emergency circumstances.
Sec. 118. Judicial and administrative purposes.
Sec. 119. Law enforcement.
Sec. 120. Subpoenas, warrants, and search warrants.

           Subtitle C--Access Procedures and Challenge Rights

Sec. 131. Access procedures for law enforcement subpoenas, warrants, 
    and search warrants.
Sec. 132. Challenge procedures for law enforcement subpoenas.
Sec. 133. Access and challenge procedures for other subpoenas.
Sec. 134. Construction of subtitle; suspension of statute of 
    limitations.
Sec. 135. Responsibilities of Secretary.

                  Subtitle D--Miscellaneous Provisions

Sec. 141. Payment card and electronic payment transactions.
Sec. 142. Access to protected health information outside of the United 
    States.
Sec. 143. Standards for electronic documents and communications.
Sec. 144. Duties and authorities of affiliated persons.
Sec. 145. Agents and attorneys.
Sec. 146. Minors.
Sec. 147. Maintenance of certain protected health information.

                        Subtitle E--Enforcement

Sec. 151. Civil actions.
Sec. 152. Civil money penalties.
Sec. 153. Alternative dispute resolution.
Sec. 154. Amendments to criminal law.

          TITLE II--AMENDMENTS TO TITLE 5, UNITED STATES CODE

Sec. 201. Amendments to title 5, United States Code.

   TITLE III--REGULATIONS, RESEARCH, AND EDUCATION; EFFECTIVE DATES; 
             APPLICABILITY; AND RELATIONSHIP TO OTHER LAWS

Sec. 301. Regulations; research and education.
Sec. 302. Effective dates.
Sec. 303. Applicability.
Sec. 304. Relationship to other laws.

SEC. 2. FINDINGS AND PURPOSES.

    (a) Findings.--The Congress finds as follows:
            (1) The right to privacy is a personal and fundamental 
        right protected by the Constitution of the United States.
            (2) The improper use or disclosure of personally 
        identifiable health information about an individual may cause 
        significant harm to the interests of the individual in privacy 
        and health care, and may unfairly affect the ability of the 
        individual to obtain employment, education, insurance, credit, 
        and other necessities.
            (3) Current legal protections for health information vary 
        from State to State and are inadequate to meet the need for 
        fair information practices standards.
            (4) The movement of individuals and health information 
        across State lines, access to and exchange of health 
        information from automated data banks and networks, and the 
        emergence of multistate health care providers and payors create 
        a compelling need for uniform Federal law, rules, and 
        procedures governing the use, maintenance, and disclosure of 
        health information.
            (5) Uniform rules governing the use, maintenance, and 
        disclosure of health information are an essential part of 
        health care reform, are necessary to support the 
        computerization of health information, and can reduce the cost 
        of providing health services by making the necessary transfer 
        of health information more efficient.
            (6) An individual needs access to health information about 
        the individual as a matter of fairness, to enable the 
        individual to make informed decisions about health care, and to 
        correct inaccurate or incomplete information.
    (b) Purposes.--The purposes of this Act are as follows:
            (1) To define the rights of an individual with respect to 
        health information about the individual that is created or 
        maintained as part of the health treatment and payment process.
            (2) To define the rights and responsibilities of a person 
        who creates or maintains individually identifiable health 
        information that originates or is used in the health treatment 
        or payment process.
            (3) To establish effective mechanisms to enforce the rights 
        and responsibilities defined in this Act.

SEC. 3. DEFINITIONS.

    (a) Definitions Relating to Protected Health Information.--For 
purposes of this Act:
            (1) Disclose.--The term ``disclose'', when used with 
        respect to protected health information that is held by a 
        health information trustee, means to provide access to the 
        information, but only if such access is provided by the trustee 
        to a person other than--
                    (A) the trustee or an officer or employee of the 
                trustee;
                    (B) an affiliated person of the trustee; or
                    (C) a protected individual who is a subject of the 
                information.
            (2) Disclosure.--The term ``disclosure'' means the act or 
        an instance of disclosing.
            (3) Protected health information.--The term ``protected 
        health information'' means any information, whether oral or 
        recorded in any form or medium--
                    (A) that is created or received in a State by--
                            (i) a health care provider;
                            (ii) a health benefit plan sponsor;
                            (iii) a health oversight agency; or
                            (iv) a public health authority;
                    (B) that relates in any way to the past, present, 
                or future physical or mental health or condition or 
                functional status of a protected individual, the 
                provision of health care to a protected individual, or 
                payment for the provision of health care to a protected 
                individual; and
                    (C) that--
                            (i) identifies the individual; or
                            (ii) with respect to which there is a 
                        reasonable basis to believe that the 
                        information can be used to identify the 
                        individual.
            (4) Protected individual.--The term ``protected 
        individual'' means an individual who, with respect to a date--
                    (A) is living on the date; or
                    (B) has died within the 2-year period ending on the 
                date.
            (5) Use.--The term ``use'', when used with respect to 
        protected health information that is held by a health 
        information trustee, means--
                    (A) to use, or provide access to, the information 
                in any manner that does not constitute a disclosure; or
                    (B) any act or instance of using, or providing 
                access, described in subparagraph (A).
    (b) Definitions Relating to Health Information Trustees.--For 
purposes of this Act:
            (1) Carrier.--The term ``carrier'' means a licensed 
        insurance company, a hospital or medical service corporation 
        (including an existing Blue Cross or Blue Shield organization, 
        within the meaning of section 833(c)(2) of the Internal Revenue 
        Code of 1986), a health maintenance organization, or other 
        entity licensed or certified by a State to provide health 
        insurance or health benefits.
            (2) Health benefit plan.--The term ``health benefit plan'' 
        means--
                    (A) any contract of health insurance, including any 
                hospital or medical service policy or certificate, 
                hospital or medical service plan contract, or health 
                maintenance organization group contract, that is 
                provided by a carrier; and
                    (B) an employee welfare benefit plan or other 
                arrangement insofar as the plan or arrangement provides 
                health benefits and is funded in a manner other than 
                through the purchase of one or more policies or 
                contracts described in subparagraph (A).
            (3) Health benefit plan sponsor.--The term ``health benefit 
        plan sponsor'' means a person who, with respect to a specific 
        item of protected health information, receives, creates, uses, 
        maintains, or discloses the information while acting in whole 
        or in part in the capacity of--
                    (A) a carrier or other person providing a health 
                benefit plan, including any public entity that provides 
                payments for health care items and services under a 
                health benefit plan that are equivalent to payments 
                provided by a private person under such a plan; or
                    (B) an officer or employee of a person described in 
                subparagraph (A).
            (4) Health care provider.--The term ``health care 
        provider'' means a person who, with respect to a specific item 
        of protected health information, receives, creates, uses, 
        maintains, or discloses the information while acting in whole 
        or in part in the capacity of--
                    (A) a person who is licensed, certified, 
                registered, or otherwise authorized by law to provide 
                an item or service that constitutes health care in the 
                ordinary course of business or practice of a 
                profession;
                    (B) a Federal or State program that directly 
                provides items or services that constitute health care 
                to beneficiaries; or
                    (C) an officer or employee of a person described in 
                subparagraph (A) or (B).
            (5) Health information trustee.--The term ``health 
        information trustee'' means--
                    (A) a health care provider;
                    (B) a health oversight agency;
                    (C) a health benefit plan sponsor;
                    (D) a public health authority;
                    (E) a health researcher; or
                    (F) a person who, with respect to a specific item 
                of protected health information, is not described in 
                subparagraphs (A) through (E) but receives the 
                information--
                            (i) pursuant to--
                                    (I) section 117 (relating to 
                                emergency circumstances);
                                    (II) section 118 (relating to 
                                judicial and administrative purposes);
                                    (III) section 119 (relating to law 
                                enforcement); or
                                    (IV) section 120 (relating to 
                                subpoenas, warrants, and search 
                                warrants); or
                            (ii) while acting in whole or in part in 
                        the capacity of an officer or employee of a 
                        person described in clause (i).
            (6) Health oversight agency.--The term ``health oversight 
        agency'' means a person who, with respect to a specific item of 
        protected health information, receives, creates, uses, 
        maintains, or discloses the information while acting in whole 
        or in part in the capacity of--
                    (A) a person who performs or oversees the 
                performance of an assessment, evaluation, 
                determination, or investigation relating to the 
                licensing, accreditation, or certification of health 
                care providers;
                    (B) a person who--
                            (i) performs or oversees the performance of 
                        an audit, assessment, evaluation, 
                        determination, or investigation relating to the 
                        effectiveness of, compliance with, or 
                        applicability of, legal, fiscal, medical, or 
                        scientific standards or aspects of performance 
                        related to the delivery of, or payment for, 
                        health care; and
                            (ii) is a public agency, acting on behalf 
                        of a public agency, acting pursuant to a 
                        requirement of a public agency, or carrying out 
                        activities under a State or Federal statute 
                        regulating the assessment, evaluation, 
                        determination, or investigation; or
                    (C) an officer or employee of a person described in 
                subparagraph (A) or (B).
            (7) Health researcher.--The term ``health researcher'' 
        means a person who, with respect to a specific item of 
        protected health information, receives the information--
                    (A) pursuant to section 116 (relating to health 
                research); or
                    (B) while acting in whole or in part in the 
                capacity of an officer or employee of a person 
                described in subparagraph (A).
            (8) Public health authority.--The term ``public health 
        authority'' means a person who, with respect to a specific item 
        of protected health information, receives, creates, uses, 
        maintains, or discloses the information while acting in whole 
        or in part in the capacity of--
                    (A) an authority of the United States, a State, or 
                a political subdivision of a State that is responsible 
                for public health matters;
                    (B) a person acting under the direction of such an 
                authority; or
                    (C) an officer or employee of a person described in 
                subparagraph (A) or (B).
    (c) Other Definitions.--For purposes of this Act:
            (1) Affiliated person.--The term ``affiliated person'' 
        means a person who--
                    (A) is not a health information trustee;
                    (B) is a contractor, subcontractor, associate, or 
                subsidiary of a person who is a health information 
                trustee; and
                    (C) pursuant to an agreement or other relationship 
                with such trustee, receives, creates, uses, maintains, 
                or discloses protected health information.
            (2) Approved health research project.--The term ``approved 
        health research project'' means a biomedical, epidemiological, 
        or health services research or statistics project, or a 
        research project on behavioral and social factors affecting 
        health, that has been approved by a certified institutional 
        review board.
            (3) Certified institutional review board.--The term 
        ``certified institutional review board'' means a board--
                    (A) established by an entity to review research 
                involving protected health information and the rights 
                of protected individuals conducted at or supported by 
                the entity;
                    (B) established in accordance with regulations of 
                the Secretary under section 116(d)(1); and
                    (C) certified by the Secretary under section 
                116(d)(2).
            (4) Health care.--The term ``health care''--
                    (A) means--
                            (i) any preventive, diagnostic, 
                        therapeutic, rehabilitative, maintenance, or 
                        palliative care, counseling, service, or 
                        procedure--
                                    (I) with respect to the physical or 
                                mental condition, or functional status, 
                                of an individual; or
                                    (II) affecting the structure or 
                                function of the human body or any part 
                                of the human body, including banking of 
                                blood, sperm, organs, or any other 
                                tissue; or
                            (ii) any sale or dispensing of a drug, 
                        device, equipment, or other item to an 
                        individual, or for the use of an individual, 
                        pursuant to a prescription; but
                    (B) does not include any item or service that is 
                not furnished for the purpose of maintaining or 
                improving the health of an individual.
            (5) Law enforcement inquiry.--The term ``law enforcement 
        inquiry'' means a lawful investigation or official proceeding 
        inquiring into a violation of, or failure to comply with, any 
        criminal or civil statute or any regulation, rule, or order 
        issued pursuant to such a statute.
            (6) Person.--The term ``person'' includes an authority of 
        the United States, a State, or a political subdivision of a 
        State.
            (7) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
            (8) State.--The term ``State'' includes the District of 
        Columbia, Puerto Rico, the Virgin Islands, Guam, American 
        Samoa, and the Northern Mariana Islands.

               TITLE I--FAIR HEALTH INFORMATION PRACTICES

           Subtitle A--Duties of Health Information Trustees

SEC. 101. INSPECTION OF PROTECTED HEALTH INFORMATION.

    (a) In General.--Except as provided in subsection (b), a health 
information trustee described in subsection (g)--
            (1) shall permit a protected individual to inspect any 
        protected health information about the individual that the 
        trustee maintains, any record with respect to such information 
        required under section 104, and any copy of an authorization 
        required under section 112 that pertains to such information;
            (2) shall provide the protected individual with a copy of 
        the information, upon request by the individual and subject to 
        any conditions imposed by the trustee under subsection (d), in 
        any form or format requested by the individual, if the 
        information is readily reproducible by the trustee in such form 
        or format;
            (3) shall permit a person who has been designated in 
        writing by the protected individual to inspect the information 
        on behalf of the individual or to accompany the individual 
        during the inspection; and
            (4) may offer to explain or interpret information that is 
        inspected or copied under this subsection.
    (b) Exceptions.--A health information trustee is not required by 
this section to permit inspection or copying of protected health 
information by a protected individual if any of the following 
conditions apply:
            (1) Information about others.--The information relates to 
        an individual, other than the protected individual or a health 
        care provider, and the trustee determines in the exercise of 
        reasonable professional judgment that inspection or copying of 
        the information would cause sufficient harm to one or both of 
        the individuals so as to outweigh the desirability of 
        permitting access.
            (2) Endangerment to life or safety.--Inspection or copying 
        of the information could reasonably be expected to endanger the 
        life or physical safety of an individual.
            (3) Confidential source.--The information identifies or 
        could reasonably lead to the identification of an individual 
        (other than a health care provider) who provided information 
        under a promise of confidentiality to a health care provider 
        concerning a protected individual who is a subject of the 
        information.
            (4) Administrative purposes.--The information--
                    (A) is used by the trustee solely for 
                administrative purposes and not in the provision of 
                health care to a protected individual who is a subject 
                of the information; and
                    (B) is not disclosed by the trustee to any person.
            (5) Duplicative information.--The information duplicates 
        information available for inspection under subsection (a).
            (6) Information compiled in anticipation of litigation.--
        The information is compiled principally--
                    (A) in anticipation of a civil, criminal, or 
                administrative action or proceeding; or
                    (B) for use in such an action or proceeding.
    (c) Inspection and Copying of Segregable Portion.--A health 
information trustee shall permit inspection and copying under 
subsection (a) of any reasonably segregable portion of a record after 
deletion of any portion that is exempt under subsection (b).
    (d) Conditions.--A health information trustee may--
            (1) require a written request for the inspection and 
        copying of protected health information under this section; and
            (2) charge a reasonable cost-based fee for--
                    (A) permitting inspection of information under this 
                section; and
                    (B) providing a copy of protected health 
                information under this section.
    (e) Statement of Reasons for Denial.--If a health information 
trustee denies in whole or in part a request for inspection or copying 
under this section, the trustee shall provide the protected individual 
who made the request with a written statement of the reasons for the 
denial.
    (f) Deadline.--A health information trustee shall comply with or 
deny a request for inspection or copying of protected health 
information under this section within the 30-day period beginning on 
the date the trustee receives the request.
    (g) Applicability.--This section applies to a health information 
trustee who is--
            (1) a health benefit plan sponsor;
            (2) a health care provider;
            (3) a health oversight agency; or
            (4) a public health authority.

SEC. 102. AMENDMENT OF PROTECTED HEALTH INFORMATION.

    (a) In General.--A health information trustee described in 
subsection (f) shall, within the 45-day period beginning on the date 
the trustee receives from a protected individual about whom the trustee 
maintains protected health information a written request that the 
trustee correct or amend the information, complete the duties described 
in one of the following paragraphs:
            (1) Correction or amendment and notification.--The trustee 
        shall--
                    (A) make the correction or amendment requested;
                    (B) inform the protected individual of the 
                amendment or correction that has been made;
                    (C) make reasonable efforts to inform any person 
                who is identified by the protected individual, who is 
                not an employee of the trustee, and to whom the 
                uncorrected or unamended portion of the information was 
                previously disclosed of the correction or amendment 
                that has been made; and
                    (D) at the request of the individual, make 
                reasonable efforts to inform any known source of the 
                uncorrected or unamended portion of the information 
                about the correction or amendment that has been made.
            (2) Reasons for refusal and review procedures.--The trustee 
        shall inform the protected individual of--
                    (A) the reasons for the refusal of the trustee to 
                make the correction or amendment;
                    (B) any procedures for further review of the 
                refusal; and
                    (C) the individual's right to file with the trustee 
                a concise statement setting forth the requested 
                correction or amendment and the individual's reasons 
                for disagreeing with the refusal of the trustee.
    (b) Standards for Correction or Amendment.--A trustee shall correct 
or amend protected health information in accordance with a request made 
under subsection (a) if the trustee determines that the information is 
not accurate, relevant, timely, or complete for the purposes for which 
the information may be used or disclosed by the trustee.
    (c) Statement of Disagreement.--After a protected individual has 
filed a statement of disagreement under subsection (a)(2)(C), the 
trustee, in any subsequent disclosure of the disputed portion of the 
information, shall include a copy of the individual's statement and may 
include a concise statement of the trustee's reasons for not making the 
requested correction or amendment.
    (d) Construction.--This section may not be construed to require a 
health information trustee to conduct a hearing or proceeding 
concerning a request for a correction or amendment to protected health 
information the trustee maintains.
    (e) Correction.--For purposes of subsection (a), a correction is 
deemed to have been made to protected health information when--
            (1) information that is not timely, accurate, relevant, or 
        complete is clearly marked as incorrect; or
            (2) supplementary correct information is made part of the 
        information and adequately cross-referenced.
    (f) Applicability.--This section applies to a health information 
trustee who is--
            (1) a health benefit plan sponsor;
            (2) a health care provider;
            (3) a health oversight agency; or
            (4) a public health authority.

SEC. 103. NOTICE OF INFORMATION PRACTICES.

    (a) Preparation of Notice.--A health information trustee described 
in subsection (d) shall prepare a written notice of information 
practices describing the following:
            (1) The rights under this Act of a protected individual who 
        is the subject of protected health information, including the 
        right to inspect and copy such information and the right to 
        seek amendments to such information, and the procedures for 
        authorizing disclosures of protected health information and for 
        revoking such authorizations.
            (2) The procedures established by the trustee for the 
        exercise of such rights.
            (3) The uses and disclosures of protected health 
        information that are authorized under this Act.
    (b) Dissemination of Notice.--A health information trustee--
            (1) shall, upon request, provide any person with a copy of 
        the trustee's notice of information practices (described in 
        subsection (a)); and
            (2) shall make reasonable efforts to inform persons in a 
        clear and conspicuous manner of the existence and availability 
        of such notice.
    (c) Model Notices.--Not later than July 1, 1999, the Secretary, 
after notice and opportunity for public comment, shall develop and 
disseminate model notices of information practices for use by health 
information trustees under this section.
    (d) Applicability.--This section applies to a health information 
trustee who is--
            (1) a health benefit plan sponsor;
            (2) a health care provider; or
            (3) a health oversight agency.

SEC. 104. DISCLOSURE HISTORY.

    (a) In General.--Except as provided in subsection (b) and section 
114, each health information trustee shall create and maintain, with 
respect to any protected health information the trustee discloses, a 
record of--
            (1) the date and purpose of the disclosure;
            (2) the name of the person to whom the disclosure was made;
            (3) the address of the person to whom the disclosure was 
        made or the location to which the disclosure was made; and
            (4) where practicable, a description of the information 
        disclosed.
    (b) Regulations.--Not later than July 1, 1999, the Secretary shall 
promulgate regulations that exempt a health information trustee from 
maintaining a record under subsection (a) with respect protected health 
information disclosed by the trustee for purposes of peer review, 
licensing, certification, accreditation, and similar activities.

SEC. 105. SECURITY.

    (a) In General.--Each health information trustee who receives or 
creates protected health information that is subject to this Act shall 
maintain reasonable and appropriate administrative, technical, and 
physical safeguards--
            (1) to ensure the integrity and confidentiality of the 
        information;
            (2) to protect against any reasonably anticipated--
                    (A) threats or hazards to the security or integrity 
                of the information; and
                    (B) unauthorized uses or disclosures of the 
                information; and
            (3) otherwise ensure compliance with this Act by the 
        trustee and the officers and employees of the trustee.
    (b) Guidelines.--Not later than July 1, 1999, the Secretary, after 
notice and opportunity for public comment, shall develop and 
disseminate guidelines for the implementation of this section. The 
guidelines shall take into account--
            (1) the technical capabilities of record systems used to 
        maintain protected health information;
            (2) the costs of security measures;
            (3) the need for training persons who have access to 
        protected health information; and
            (4) the value of audit trails in computerized record 
        systems.

     Subtitle B--Use and Disclosure of Protected Health Information

SEC. 111. GENERAL LIMITATIONS ON USE AND DISCLOSURE.

    (a) Use.--Except as otherwise provided under this Act, a health 
information trustee may use protected health information only for a 
purpose--
            (1) that is compatible with and directly related to the 
        purpose for which the information--
                    (A) was collected; or
                    (B) was received by the trustee; or
            (2) for which the trustee is authorized to disclose the 
        information under this Act.
    (b) Disclosure.--A health information trustee may disclose 
protected health information only as authorized under this Act.
    (c) Scope of Uses and Disclosures.--
            (1) In general.--A use or disclosure of protected health 
        information by a health information trustee shall be limited, 
        when practicable, to the minimum amount of information 
        necessary to accomplish the purpose for which the information 
        is used or disclosed.
            (2) Guidelines.--Not later than July 1, 1999, the 
        Secretary, after notice and opportunity for public comment, 
        shall issue guidelines to implement paragraph (1), which shall 
        take into account the technical capabilities of the record 
        systems used to maintain protected health information and the 
        costs of limiting use and disclosure.
    (d) Identification of Disclosed Information as Protected 
Information.--Except with respect to protected health information that 
is disclosed under section 114 (relating to next of kin and directory 
information), a health information trustee may disclose protected 
health information only if the recipient has been notified that the 
information is protected health information that is subject to this 
Act.
    (e) Agreement to Limit Use or Disclosure.--A health information 
trustee who receives protected health information from any person 
pursuant to a written agreement to restrict use or disclosure of the 
information to a greater extent than otherwise would be required under 
this Act shall comply with the terms of the agreement, except where use 
or disclosure of the information in violation of the agreement is 
required by law. A trustee who fails to comply with the preceding 
sentence shall be subject to section 151 (relating to civil actions) 
with respect to such failure.
    (f) No General Requirement to Disclose.--Nothing in this Act shall 
be construed to require a health information trustee to disclose 
protected health information not otherwise required to be disclosed by 
law.

SEC. 112. AUTHORIZATIONS FOR DISCLOSURE OF PROTECTED HEALTH 
                    INFORMATION.

    (a) Written Authorizations.--A health information trustee may 
disclose protected health information pursuant to an authorization 
executed by the protected individual who is the subject of the 
information, if each of the following requirements is satisfied:
            (1) Writing.--The authorization is in writing, signed by 
        the individual, and dated on the date of such signature.
            (2) Separate form.--The authorization is not on a form used 
        to authorize or facilitate the provision of, or payment for, 
        health care.
            (3) Trustee described.--The trustee is specifically named 
        or generically described in the authorization as authorized to 
        disclose such information.
            (4) Recipient described.--The person to whom the 
        information is to be disclosed is specifically named or 
        generically described in the authorization as a person to whom 
        such information may be disclosed.
            (5) Statement of intended uses and disclosures received.--
        The authorization contains an acknowledgment that the 
        individual has received a statement described in subsection (b) 
        from such person.
            (6) Information described.--The information to be disclosed 
        is described in the authorization.
            (7) Authorization timely received.--The authorization is 
        received by the trustee during a period described in subsection 
        (c)(1).
            (8) Disclosure timely made.--The disclosure occurs during a 
        period described in subsection (c)(2).
    (b) Statement of Intended Uses and Disclosures.--
            (1) In general.--A person who wishes to receive from a 
        health information trustee protected health information about a 
        protected individual pursuant to an authorization executed by 
        the individual shall supply the individual, in writing and on a 
        form that is distinct from the authorization, with a statement 
        of the uses for which the person intends the information and 
        the disclosures the person intends to make of the information. 
        Such statement shall be supplied before the authorization is 
        executed.
            (2) Enforcement.--If the person uses or discloses the 
        information in a manner that is inconsistent with such 
        statement, the person shall be subject to section 151 (relating 
        to civil actions) with respect to such failure, except where 
        such use or disclosure is required by law.
            (3) Model statements.--Not later than July 1, 1999, the 
        Secretary, after notice and opportunity for public comment, 
        shall develop and disseminate model statements of intended uses 
        and disclosures of the type described in paragraph (1).
    (c) Time Limitations on Authorizations.--
            (1) Receipt by trustee.--For purposes of subsection (a)(7), 
        an authorization is timely received if it is received by the 
        trustee during--
                    (A) the 1-year period beginning on the date that 
                the authorization is signed under subsection (a)(1), if 
                the authorization permits the disclosure of protected 
                health information to--
                            (i) a health benefit plan sponsor;
                            (ii) a health care provider;
                            (iii) a health oversight agency;
                            (iv) a public health authority;
                            (v) a health researcher; or
                            (vi) a person who provides counseling or 
                        social services to individuals; or
                    (B) the 30-day period beginning on the date that 
                the authorization is signed under subsection (a)(1), if 
                the authorization permits the disclosure of protected 
                health information to a person other than a person 
                described in subparagraph (A).
            (2) Disclosure by trustee.--For purposes of subsection 
        (a)(8), a disclosure is timely made if it occurs before--
                    (A) the date or event (if any) specified in the 
                authorization upon which the authorization expires; and
                    (B) the expiration of the 6-month period beginning 
                on the date the trustee receives the authorization.
    (d) Revocation or Amendment of Authorization.--
            (1) In general.--A protected individual in writing may 
        revoke or amend an authorization described in subsection (a), 
        in whole or in part, at any time, except insofar as--
                    (A) disclosure of protected health information has 
                been authorized to permit validation of expenditures 
                based on health condition by a government authority; or
                    (B) action has been taken in reliance on the 
                authorization.
            (2) Notice of revocation.--A health information trustee who 
        discloses protected health information in reliance on an 
        authorization that has been revoked shall not be subject to any 
        liability or penalty under this Act if--
                    (A) the reliance was in good faith;
                    (B) the trustee had no notice of the revocation; 
                and
                    (C) the disclosure was otherwise in accordance with 
                the requirements of this section.
    (e) Additional Requirements of Trustee.--A health information 
trustee may impose requirements for an authorization that are in 
addition to the requirements in this section.
    (f) Copy.--A health information trustee who discloses protected 
health information pursuant to an authorization under this section 
shall maintain a copy of the authorization.
    (g) Construction.--This section may not be construed--
            (1) to require a health information trustee to disclose 
        protected health information; or
            (2) to limit the right of a health information trustee to 
        charge a fee for the disclosure or reproduction of protected 
        health information.
    (h) Subpoenas, Warrants, and Search Warrants.--If a health 
information trustee discloses protected health information pursuant to 
an authorization in order to comply with an administrative subpoena or 
warrant or a judicial subpoena or search warrant, the authorization--
            (1) shall specifically authorize the disclosure for the 
        purpose of permitting the trustee to comply with the subpoena, 
        warrant, or search warrant; and
            (2) shall otherwise meet the requirements in this section.

SEC. 113. TREATMENT, PAYMENT, AND OVERSIGHT.

    (a) Disclosures by Plans, Providers, and Oversight Agencies.--A 
health information trustee described in subsection (d) may disclose 
protected health information to a health benefit plan sponsor, health 
care provider, or health oversight agency if the disclosure is--
            (1) for the purpose of providing health care and a 
        protected individual who is a subject of the information has 
        not previously objected to the disclosure in writing;
            (2) for the purpose of providing for the payment for health 
        care furnished to an individual; or
            (3) for use by a health oversight agency for a purpose that 
        is described in subparagraph (A) or (B)(i) of section 3(b)(6).
    (b) Disclosures by Certain Other Trustees.--A health information 
trustee may disclose protected health information to a health care 
provider if--
            (1) the disclosure is for the purpose described in 
        subsection (a)(1); and
            (2) the trustee--
                    (A) is a public health authority;
                    (B) received protected health information pursuant 
                to section 117 (relating to emergency circumstances); 
                or
                    (C) is an officer or employee of a trustee 
                described in subparagraph (B).
    (c) Use in Action Against Individual.--A person who receives 
protected health information about a protected individual through a 
disclosure under this section may not use or disclose the information 
in any administrative, civil, or criminal action or investigation 
directed against the individual, except an action or investigation 
arising out of and related to receipt of health care or payment for 
health care.
    (d) Applicability.--A health information trustee referred to in 
subsection (a) is any of the following:
            (1) A health benefit plan sponsor.
            (2) A health care provider.
            (3) A health oversight agency.

SEC. 114. NEXT OF KIN AND DIRECTORY INFORMATION.

    (a) Next of Kin.--A health information trustee who is a health care 
provider, who received protected health information pursuant to section 
117 (relating to emergency circumstances), or who is an officer or 
employee of such a recipient may orally disclose protected health 
information about a protected individual to the next of kin of the 
individual (as defined under State law), or to a person with whom the 
individual has a close personal relationship, if--
            (1) the trustee has no reason to believe that the 
        individual would consider the information especially sensitive;
            (2) the individual has not previously objected to the 
        disclosure;
            (3) the disclosure is consistent with good medical or other 
        professional practice; and
            (4) the information disclosed is limited to information 
        about health care that is being provided to the individual at 
        or about the time of the disclosure.
    (b) Directory Information.--
            (1) In general.--A health information trustee who is a 
        health care provider, who received protected health information 
        pursuant to section 117 (relating to emergency circumstances), 
        or who is an officer or employee of such a recipient may 
        disclose to any person the information described in paragraph 
        (2) if--
                    (A) a protected individual who is a subject of the 
                information has not objected in writing to the 
                disclosure;
                    (B) the disclosure is otherwise consistent with 
                good medical and other professional practice; and
                    (C) the information does not reveal specific 
                information about the physical or mental condition or 
                functional status of a protected individual or about 
                the health care provided to a protected individual.
            (2) Information described.--The information referred to in 
        paragraph (1) is the following:
                    (A) The name of an individual receiving health care 
                from a health care provider on a premises controlled by 
                the provider.
                    (B) The location of the individual on such 
                premises.
                    (C) The general health status of the individual, 
                described in terms of critical, poor, fair, stable, 
                satisfactory, or terms denoting similar conditions.
    (c) No Disclosure Record Required.--A health information trustee 
who discloses protected health information under this section is not 
required to create and maintain a record of the disclosure under 
section 104.
    (d) Recipients.--A person to whom protected health information is 
disclosed under this section shall not, by reason of such disclosure, 
be subject to any requirement under this Act.

SEC. 115. PUBLIC HEALTH.

    (a) In General.--A health information trustee who is a health care 
provider or a public health authority may disclose protected health 
information to--
            (1) a public health authority for use in legally 
        authorized--
                    (A) disease or injury reporting;
                    (B) public health surveillance; or
                    (C) public health investigation or intervention; or
            (2) an individual who is authorized by law to receive the 
        information in a public health intervention.
    (b) Use in Action Against Individual.--A public health authority 
who receives protected health information about a protected individual 
through a disclosure under this section may not use or disclose the 
information in any administrative, civil, or criminal action or 
investigation directed against the individual, except where the use or 
disclosure is authorized by law for protection of the public health.
    (c) Individual Recipients.--An individual to whom protected health 
information is disclosed under subsection (a)(2) shall not, by reason 
of such disclosure, be subject to any requirement under this Act.

SEC. 116. HEALTH RESEARCH.

    (a) In General.--A health information trustee described in 
subsection (c) may disclose protected health information to a person 
if--
            (1) the person is conducting an approved health research 
        project;
            (2) the information is to be used in the project; and
            (3) the project has been determined by a certified 
        institutional review board to be--
                    (A) of sufficient importance so as to outweigh the 
                intrusion into the privacy of the protected individual 
                who is the subject of the information that would result 
                from the disclosure; and
                    (B) impracticable to conduct without the 
                information.
    (b) Limitations on Use and Disclosure; Obligations of Recipient.--A 
health researcher who receives protected health information about a 
protected individual pursuant to subsection (a)--
            (1) may use the information solely for purposes of an 
        approved health research project;
            (2) may not use or disclose the information in any 
        administrative, civil, or criminal action or investigation 
        directed against the individual; and
            (3) shall remove or destroy, at the earliest opportunity 
        consistent with the purposes of the approved health research 
        project in connection with which the disclosure was made, 
        information that would enable an individual to be identified, 
        unless a certified institutional review board has determined 
        that there is a health or research justification for retention 
        of such identifiers and there is an adequate plan to protect 
        the identifiers from use and disclosure that is inconsistent 
        with this Act.
    (c) Applicability.--A health information trustee referred to in 
subsection (a) is any health information trustee other than a person 
who, with respect to the specific protected health information to be 
disclosed under such subsection, received the information--
            (1) pursuant to--
                    (A) section 118 (relating to judicial and 
                administrative purposes);
                    (B) paragraph (1), (2), (3), or (4) of section 
                119(a) (relating to law enforcement); or
                    (C) section 120 (relating to subpoenas, warrants, 
                and search warrants); or
            (2) while acting in whole or in part in the capacity of an 
        officer or employee of a person described in paragraph (1).
    (d) Requirements for Institutional Review Boards.--
            (1) Regulations.--Not later than July 1, 1999, the 
        Secretary, after opportunity for notice and comment, shall 
        promulgate regulations establishing requirements for certified 
        institutional review boards under this Act. The regulations 
        shall be based on regulations promulgated under section 491(a) 
        of the Public Health Service Act and shall ensure that 
        certified institutional review boards are qualified to assess 
        and protect the confidentiality of research subjects.
            (2) Certification.--The Secretary shall certify that an 
        institutional review board satisfies the requirements of the 
        regulations promulgated under paragraph (1).

SEC. 117. EMERGENCY CIRCUMSTANCES.

    (a) In General.--A health information trustee may disclose 
protected health information if the trustee believes, on reasonable 
grounds, that the disclosure is necessary to prevent or lessen a 
serious and imminent threat to the health or safety of an individual.
    (b) Use in Action Against Individual.--A person who receives 
protected health information about a protected individual through a 
disclosure under this section may not use or disclose the information 
in any administrative, civil, or criminal action or investigation 
directed against the individual, except an action or investigation 
arising out of and related to receipt of health care or payment for 
health care.

SEC. 118. JUDICIAL AND ADMINISTRATIVE PURPOSES.

    (a) In General.--A health information trustee described in 
subsection (d) may disclose protected health information--
            (1) pursuant to the Federal Rules of Civil Procedure, the 
        Federal Rules of Criminal Procedure, or comparable rules of 
        other courts or administrative agencies in connection with 
        litigation or proceedings to which a protected individual who 
        is a subject of the information is a party and in which the 
        individual has placed the individual's physical or mental 
        condition or functional status in issue;
            (2) if directed by a court in connection with a court-
        ordered examination of an individual; or
            (3) to assist in the identification of a dead individual.
    (b) Written Statement.--A person seeking protected health 
information about a protected individual held by health information 
trustee under--
            (1) subsection (a)(1)--
                    (A) shall notify the protected individual or the 
                attorney of the protected individual of the request for 
                the information;
                    (B) shall provide the trustee with a signed 
                document attesting--
                            (i) that the protected individual is a 
                        party to the litigation or proceedings for 
                        which the information is sought;
                            (ii) that the individual has placed the 
                        individual's physical or mental condition or 
                        functional status in issue; and
                            (iii) the date on which the protected 
                        individual or the attorney of the protected 
                        individual was notified under subparagraph (A); 
                        and
                    (C) shall not accept any requested protected health 
                information from the trustee until the termination of 
                the 10-day period beginning on the date notice was 
                given under subparagraph (A); or
            (2) subsection (a)(3) shall provide the trustee with a 
        written statement that the information is sought to assist in 
        the identification of a dead individual.
    (c) Use and Disclosure.--A person to whom protected health 
information is disclosed under this section may use and disclose the 
information only to accomplish the purpose for which the disclosure was 
made.
    (d) Applicability.--A health information trustee referred to in 
subsection (a) is any of the following:
            (1) A health benefit plan sponsor.
            (2) A health care provider.
            (3) A health oversight agency.
            (4) A person who, with respect to the specific protected 
        health information to be disclosed under such subsection, 
        received the information--
                    (A) pursuant to--
                            (i) section 117 (relating to emergency 
                        circumstances); or
                            (ii) section 120 (relating to subpoenas, 
                        warrants, and search warrants); or
                    (B) while acting in whole or in part in the 
                capacity of an officer or employee of a person 
                described in subparagraph (A).

SEC. 119. LAW ENFORCEMENT.

    (a) In General.--A health information trustee may disclose 
protected health information to a law enforcement agency, other than a 
health oversight agency--
            (1) if the information is disclosed for use in an 
        investigation or prosecution of a health information trustee;
            (2) in connection with criminal activity committed against 
        the trustee or an affiliated person of the trustee or on 
        premises controlled by the trustee; or
            (3) if the information is needed to determine whether a 
        crime has been committed and the nature of any crime that may 
        have been committed (other than a crime that may have been 
        committed by the protected individual who is the subject of the 
        information).
    (b) Additional Authority of Certain Trustees.--A health information 
trustee who is not a public health authority or a health researcher may 
disclose protected health information to a law enforcement agency 
(other than a health oversight agency)--
            (1) to assist in the identification or location of a 
        victim, fugitive, or witness in a law enforcement inquiry;
            (2) pursuant to a law requiring the reporting of specific 
        health care information to law enforcement authorities; or
            (3) if the information is specific health information 
        described in paragraph (2) and the trustee is operated by a 
        Federal agency;
    (c) Certification.--Where a law enforcement agency requests a 
health information trustee to disclose protected health information 
under subsection (a) or (b)(1), the agency shall provide the trustee 
with a written certification that--
            (1) is signed by a supervisory official of a rank 
        designated by the head of the agency;
            (2) specifies the information requested; and
            (3) states that the information is needed for a lawful 
        purpose under this section.
    (d) Restrictions on Disclosure and Use.--A person who receives 
protected health information about a protected individual through a 
disclosure under this section may not use or disclose the information--
            (1) in any administrative, civil, or criminal action or 
        investigation directed against the individual, except an action 
        or investigation arising out of and directly related to the 
        action or investigation for which the information was obtained; 
        and
            (2) otherwise unless the use or disclosure is necessary to 
        fulfill the purpose for which the information was obtained and 
        is not prohibited by any other provision of law.

SEC. 120. SUBPOENAS, WARRANTS, AND SEARCH WARRANTS.

    (a) In General.--A health information trustee described in 
subsection (g) may disclose protected health information if the 
disclosure is pursuant to any of the following:
            (1) A subpoena issued under the authority of a grand jury 
        and the trustee is provided a written certification by the 
        grand jury that the grand jury has complied with the applicable 
        access provisions of section 131.
            (2) An administrative subpoena or warrant or a judicial 
        subpoena or search warrant and the trustee is provided a 
        written certification by the person seeking the information 
        that the person has complied with the applicable access 
        provisions of section 131 or 133(a).
            (3) An administrative subpoena or warrant or a judicial 
        subpoena or search warrant and the disclosure otherwise meets 
        the conditions of one of sections 113 through 119.
    (b) Authority of All Trustees.--Any health information trustee may 
disclose protected health information if the disclosure is pursuant to 
subsection (a)(3).
    (c) Restrictions on Use and Disclosure.--Protected health 
information about a protected individual that is disclosed by a health 
information trustee pursuant to--
            (1) subsection (a)(2) may not be otherwise used or 
        disclosed by the recipient unless the use or disclosure is 
        necessary to fulfill the purpose for which the information was 
        obtained; and
            (2) subsection (a)(3) may not be used or disclosed by the 
        recipient unless the recipient complies with the conditions and 
        restrictions on use and disclosure with which the recipient 
        would have been required to comply if the disclosure by the 
        trustee had been made under the section referred to in 
        subsection (a)(3) the conditions of which were met by the 
        disclosure.
    (d) Restrictions on Grand Juries.--Protected health information 
that is disclosed by a health information trustee under subsection 
(a)(1)--
            (1) shall be returnable on a date when the grand jury is in 
        session and actually presented to the grand jury;
            (2) shall be used only for the purpose of considering 
        whether to issue an indictment or report by that grand jury, or 
        for the purpose of prosecuting a crime for which that 
        indictment or report is issued, or for a purpose authorized by 
        rule 6(e) of the Federal Rules of Criminal Procedure or a 
        comparable State rule;
            (3) shall be destroyed or returned to the trustee if not 
        used for one of the purposes specified in paragraph (2); and
            (4) shall not be maintained, or a description of the 
        contents of such information shall not be maintained, by any 
        government authority other than in the sealed records of the 
        grand jury, unless such information has been used in the 
        prosecution of a crime for which the grand jury issued an 
        indictment or presentment or for a purpose authorized by rule 
        6(e) of the Federal Rules of Criminal Procedure or a comparable 
        State rule.
    (e) Use in Action Against Individual.--A person who receives 
protected health information about a protected individual through a 
disclosure under this section may not use or disclose the information 
in any administrative, civil, or criminal action or investigation 
directed against the individual, except an action or investigation 
arising out of and directly related to the inquiry for which the 
information was obtained;
    (f) Construction.--Nothing in this section shall be construed as 
authority for a health information trustee to refuse to comply with a 
valid administrative subpoena or warrant or a valid judicial subpoena 
or search warrant that meets the requirements of this Act.
    (g) Applicability.--A health information trustee referred to in 
subsection (a) is any trustee other than the following:
            (1) A public health authority.
            (2) A health researcher.

           Subtitle C--Access Procedures and Challenge Rights

SEC. 131. ACCESS PROCEDURES FOR LAW ENFORCEMENT SUBPOENAS, WARRANTS, 
                    AND SEARCH WARRANTS.

    (a) Probable Cause Requirement.--A government authority may not 
obtain protected health information about a protected individual from a 
health information trustee under paragraph (1) or (2) of section 120(a) 
for use in a law enforcement inquiry unless there is probable cause to 
believe that the information is relevant to a legitimate law 
enforcement inquiry being conducted by the government authority.
    (b) Warrants and Search Warrants.--A government authority that 
obtains protected health information about a protected individual from 
a health information trustee under circumstances described in 
subsection (a) and pursuant to a warrant or search warrant shall, not 
later than 30 days after the date the warrant was served on the 
trustee, serve the individual with, or mail to the last known address 
of the individual, a copy of the warrant.
    (c) Subpoenas.--Except as provided in subsection (d), a government 
authority may not obtain protected health information about a protected 
individual from a health information trustee under circumstances 
described in subsection (a) and pursuant to a subpoena unless a copy of 
the subpoena has been served by hand delivery upon the individual, or 
mailed to the last known address of the individual, on or before the 
date on which the subpoena was served on the trustee, together with a 
notice (published by the Secretary under section 135(1)) of the 
individual's right to challenge the subpoena in accordance with section 
132, and--
            (1) 30 days have passed from the date of service, or 30 
        days have passed from the date of mailing, and within such time 
        period the individual has not initiated a challenge in 
        accordance with section 132; or
            (2) disclosure is ordered by a court under section 132.
    (d) Application for Delay.--
            (1) In general.--A government authority may apply to an 
        appropriate court to delay (for an initial period of not longer 
        than 90 days) serving a copy of a subpoena and a notice 
        otherwise required under subsection (c) with respect to a law 
        enforcement inquiry. The government authority may apply to the 
        court for extensions of the delay.
            (2) Reasons for delay.--An application for a delay, or 
        extension of a delay, under this subsection shall state, with 
        reasonable specificity, the reasons why the delay or extension 
        is being sought.
            (3) Ex parte order.--The court shall enter an ex parte 
        order delaying, or extending the delay of, the notice and an 
        order prohibiting the trustee from revealing the request for, 
        or the disclosure of, the protected health information being 
        sought if the court finds that--
                    (A) the inquiry being conducted is within the 
                lawful jurisdiction of the government authority seeking 
                the protected health information;
                    (B) there is probable cause to believe that the 
                protected health information being sought is relevant 
                to a legitimate law enforcement inquiry being conducted 
                by the government authority;
                    (C) the government authority's need for the 
                information outweighs the privacy interest of the 
                protected individual who is the subject of the 
                information; and
                    (D) there are reasonable grounds to believe that 
                receipt of a notice by the individual will result in--
                            (i) endangering the life or physical safety 
                        of any individual;
                            (ii) flight from prosecution;
                            (iii) destruction of or tampering with 
                        evidence or the information being sought; or
                            (iv) intimidation of potential witnesses.
            (4) Service of application on individual.--Upon the 
        expiration of a period of delay of notice under this 
        subsection, the government authority shall serve upon the 
        individual, with the service of the subpoena and the notice, a 
        copy of any applications filed and approved under this 
        subsection.

SEC. 132. CHALLENGE PROCEDURES FOR LAW ENFORCEMENT SUBPOENAS.

    (a) Motion to Quash Subpoena.--Within 30 days of the date of 
service, or 30 days of the date of mailing, of a subpoena of a 
government authority seeking protected health information about a 
protected individual from a health information trustee under paragraph 
(1) or (2) of section 120(a) (except a subpoena to which section 133 
applies), the individual may file (without filing fee) a motion to 
quash the subpoena--
            (1) in the case of a State judicial subpoena, in the court 
        which issued the subpoena;
            (2) in the case of a subpoena issued under the authority of 
        a State that is not a State judicial subpoena, in a court of 
        competent jurisdiction;
            (3) in the case of a subpoena issued under the authority of 
        a Federal court, in any court of the United States of competent 
        jurisdiction; or
            (4) in the case of any other subpoena issued under the 
        authority of the United States, in--
                    (A) the United States district court for the 
                district in which the individual resides or in which 
                the subpoena was issued; or
                    (B) another United States district court of 
                competent jurisdiction.
    (b) Copy.--A copy of the motion shall be served by the individual 
upon the government authority by delivery of registered or certified 
mail.
    (c) Affidavits and Sworn Documents.--The government authority may 
file with the court such affidavits and other sworn documents as 
sustain the validity of the subpoena. The individual may file with the 
court, within 5 days of the date of the authority's filing, affidavits 
and sworn documents in response to the authority's filing. The court, 
upon the request of the individual, the government authority, or both, 
may proceed in camera.
    (d) Proceedings and Decision on Motion.--The court may conduct such 
proceedings as it deems appropriate to rule on the motion. All such 
proceedings shall be completed, and the motion ruled on, within 10 
calendar days of the date of the government authority's filing.
    (e) Extension of Time Limits for Good Cause.--The court, for good 
cause shown, may at any time in its discretion enlarge the time limits 
established by subsections (c) and (d).
    (f) Standard for Decision.--A court may deny a motion under 
subsection (a) if it finds that there is probable cause to believe that 
the protected health information being sought is relevant to a 
legitimate law enforcement inquiry being conducted by the government 
authority, unless the court finds that the individual's privacy 
interest outweighs the government authority's need for the information. 
The individual shall have the burden of demonstrating that the 
individual's privacy interest outweighs the need established by the 
government authority for the information.
    (g) Specific Considerations With Respect to Privacy Interest.--In 
determining under subsection (f) whether an individual's privacy 
interest outweighs the government authority's need for the information, 
the court shall consider--
            (1) the particular purpose for which the information was 
        collected by the trustee;
            (2) the degree to which disclosure of the information will 
        embarrass, injure, or invade the privacy of the individual;
            (3) the effect of the disclosure on the individual's future 
        health care;
            (4) the importance of the inquiry being conducted by the 
        government authority, and the importance of the information to 
        that inquiry; and
            (5) any other factor deemed relevant by the court.
    (h) Attorney's Fees.--In the case of any motion brought under 
subsection (a) in which the individual has substantially prevailed, the 
court, in its discretion, may assess against a government authority a 
reasonable attorney's fee and other litigation costs (including expert 
fees) reasonably incurred.
    (i) No Interlocutory Appeal.--A court ruling denying a motion to 
quash under this section shall not be deemed a final order and no 
interlocutory appeal may be taken therefrom by the individual. An 
appeal of such a ruling may be taken by the individual within such 
period of time as is provided by law as part of any appeal from a final 
order in any legal proceeding initiated against the individual arising 
out of or based upon the protected health information disclosed.

SEC. 133. ACCESS AND CHALLENGE PROCEDURES FOR OTHER SUBPOENAS.

    (a) In General.--A person (other than a government authority 
seeking protected health information under circumstances described in 
section 131(a)) may not obtain protected health information about a 
protected individual from a health information trustee pursuant to a 
subpoena under section 120(a)(2) unless--
            (1) a copy of the subpoena has been served upon the 
        individual or mailed to the last known address of the 
        individual on or before the date on which the subpoena was 
        served on the trustee, together with a notice (published by the 
        Secretary under section 135(2)) of the individual's right to 
        challenge the subpoena, in accordance with subsection (b); and
            (2) either--
                    (A) 30 days have passed from the date of service or 
                30 days have passed from the date of the mailing and 
                within such time period the individual has not 
                initiated a challenge in accordance with subsection 
                (b); or
                    (B) disclosure is ordered by a court under such 
                subsection.
    (b) Motion to Quash.--Within 30 days of the date of service or 30 
days of the date of mailing of a subpoena seeking protected health 
information about a protected individual from a health information 
trustee under subsection (a), the individual may file (without filing 
fee) in any court of competent jurisdiction, a motion to quash the 
subpoena, with a copy served on the person seeking the information. The 
individual may oppose, or seek to limit, the subpoena on any grounds 
that would otherwise be available if the individual were in possession 
of the information.
    (c) Standard for Decision.--The court shall grant an individual's 
motion under subsection (b) if the person seeking the information has 
not sustained the burden of demonstrating that--
            (1) there are reasonable grounds to believe that the 
        information will be relevant to a lawsuit or other judicial or 
        administrative proceeding; and
            (2) the need of the person for the information outweighs 
        the privacy interest of the individual.
    (d) Specific Considerations With Respect to Privacy Interest.--In 
determining under subsection (c) whether the need of the person for the 
information outweighs the privacy interest of the individual, the court 
shall consider--
            (1) the particular purpose for which the information was 
        collected by the trustee;
            (2) the degree to which disclosure of the information will 
        embarrass, injure, or invade the privacy of the individual;
            (3) the effect of the disclosure on the individual's future 
        health care;
            (4) the importance of the information to the lawsuit or 
        proceeding; and
            (5) any other factor deemed relevant by the court.
    (e) Attorney's Fees.--In the case of any motion brought under 
subsection (b) by an individual against a person in which the 
individual has substantially prevailed, the court, in its discretion, 
may assess against the person a reasonable attorney's fee and other 
litigation costs (including expert fees) reasonably incurred.

SEC. 134. CONSTRUCTION OF SUBTITLE; SUSPENSION OF STATUTE OF 
                    LIMITATIONS.

    (a) In General.--Nothing in this subtitle shall affect the right of 
a health information trustee to challenge a request for protected 
health information. Nothing in this subtitle shall entitle a protected 
individual to assert the rights of a health information trustee.
    (b) Effect of Motion on Statute of Limitations.--If an individual 
who is the subject of protected health information files a motion under 
this subtitle which has the effect of delaying the access of a 
government authority to such information, the period beginning on the 
date such motion was filed and ending on the date on which the motion 
is decided shall be excluded in computing any period of limitations 
within which the government authority may commence any civil or 
criminal action in connection with which the access is sought.

SEC. 135. RESPONSIBILITIES OF SECRETARY.

    Not later than July 1, 1999, the Secretary, after notice and 
opportunity for public comment, shall develop and disseminate brief, 
clear, and easily understood model notices--
            (1) for use under subsection (c) of section 131, detailing 
        the rights of a protected individual who wishes to challenge, 
        under section 132, the disclosure of protected health 
        information about the individual under such subsection; and
            (2) for use under subsection (a) of section 133, detailing 
        the rights of a protected individual who wishes to challenge, 
        under subsection (b) of such section, the disclosure of 
        protected health information about the individual under such 
        section.

                  Subtitle D--Miscellaneous Provisions

SEC. 141. PAYMENT CARD AND ELECTRONIC PAYMENT TRANSACTIONS.

    (a) Payment for Health Care Through Card or Electronic Means.--If a 
protected individual pays a health information trustee for health care 
by presenting a debit, credit, or other payment card or account number, 
or by any other electronic payment means, the trustee may disclose to a 
person described in subsection (b) only such protected health 
information about the individual as is necessary for the processing of 
the payment transaction or the billing or collection of amounts charged 
to, debited from, or otherwise paid by, the individual using the card, 
number, or other electronic payment means.
    (b) Transaction Processing.--A person who is a debit, credit, or 
other payment card issuer, is otherwise directly involved in the 
processing of payment transactions involving such cards or other 
electronic payment transactions, or is otherwise directly involved in 
the billing or collection of amounts paid through such means, may only 
use or disclose protected health information about a protected 
individual that has been disclosed in accordance with subsection (a) 
when necessary for--
            (1) the authorization, settlement, billing or collection of 
        amounts charged to, debited from, or otherwise paid by, the 
        individual using a debit, credit, or other payment card or 
        account number, or by other electronic payment means;
            (2) the transfer of receivables, accounts, or interest 
        therein;
            (3) the audit of the credit, debit, or other payment card 
        account information;
            (4) compliance with Federal, State, or local law; or
            (5) a properly authorized civil, criminal, or regulatory 
        investigation by Federal, State, or local authorities.

SEC. 142. ACCESS TO PROTECTED HEALTH INFORMATION OUTSIDE OF THE UNITED 
                    STATES.

    (a) In General.--Notwithstanding the provisions of subtitle B, and 
except as provided in subsection (b), a health information trustee may 
not permit any person who is not in a State to have access to protected 
health information about a protected individual unless one or more of 
the following conditions exist:
            (1) Specific authorization.--The individual has 
        specifically consented to the provision of such access outside 
        of the United States in an authorization that meets the 
        requirements of section 112.
            (2) Equivalent protection.--The provision of such access is 
        authorized under this Act and the Secretary has determined that 
        there are fair information practices for protected health 
        information in the jurisdiction where the access will be 
        provided that provide protections for individuals and protected 
        health information that are equivalent to the protections 
        provided for by this Act.
            (3) Access required by law.--The provision of such access 
        is required under--
                    (A) a Federal statute; or
                    (B) a treaty or other international agreement 
                applicable to the United States.
    (b) Exceptions.--Subsection (a) does not apply where the provision 
of access to protected health information--
            (1) is to a foreign public health authority;
            (2) is authorized under section 114 (relating to next of 
        kin and directory information), 116 (relating to health 
        research), or 117 (relating to emergency circumstances); or
            (3) is necessary for the purpose of providing for payment 
        for health care that has been provided to an individual.

SEC. 143. STANDARDS FOR ELECTRONIC DOCUMENTS AND COMMUNICATIONS.

    (a) Standards.--Not later than July 1, 1999, the Secretary, after 
notice and opportunity for public comment and in consultation with 
appropriate private standard-setting organizations and other interested 
parties, shall establish standards with respect to the 
creation,transmission, receipt, and maintenance, in electronic and 
magnetic form, of each type of written document specifically required 
or authorized under this Act. Where a signature is required under any 
other provision of this Act, such standards shall provide for an 
electronic or magnetic substitute that serves the functional equivalent 
of a signature.
    (b) Treatment of Complying Documents and Communications.--An 
electronic or magnetic document or communication that satisfies the 
standards established under subsection (a) with respect to such 
document or communication shall be treated as satisfying the 
requirements of this Act that apply to an equivalent written document.

SEC. 144. DUTIES AND AUTHORITIES OF AFFILIATED PERSONS.

    (a) Requirements on Trustees.--
            (1) Provision of information.--A health information trustee 
        may provide protected health information to a person who, with 
        respect to the trustee, is an affiliated person and may permit 
        the affiliated person to use such information, only for the 
        purpose of conducting, supporting, or facilitating an activity 
        that the trustee is authorized to undertake.
            (2) Notice to affiliated person.--A health information 
        trustee shall notify a person who, with respect to the trustee, 
        is an affiliated person of any duties under this Act that the 
        affiliated person is required to fulfill and of any authorities 
        under this Act that the affiliated person is authorized to 
        exercise.
    (b) Duties of Affiliated Persons.--
            (1) In general.--An affiliated person shall fulfill any 
        duty under this Act that--
                    (A) the health information trustee with whom the 
                person has an agreement or relationship described in 
                section 3(c)(1)(C) is required to fulfill; and
                    (B) the person has undertaken to fulfill pursuant 
                to such agreement or relationship.
            (2) Construction of other subtitles.--With respect to a 
        duty described in paragraph (1) that an affiliated person is 
        required to fulfill, the person shall be considered a health 
        information trustee for purposes of this Act. The person shall 
        be subject to subtitle E (relating to enforcement) with respect 
        to any such duty that the person fails to fulfill.
            (3) Effect on trustee.--An agreement or relationship with 
        an affiliated person does not relieve a health information 
        trustee of any duty or liability under this Act.
    (b) Authorities of Affiliated Persons.--
            (1) In general.--An affiliated person may only exercise an 
        authority under this Act that the health information trustee 
        with whom the person is affiliated may exercise and that the 
        person has been given by the trustee pursuant to an agreement 
        or relationship described in section 3(c)(1)(C). With respect 
        to any such authority, the person shall be considered a health 
        information trustee for purposes of this Act. The person shall 
        be subject to subtitle E (relating to enforcement) with respect 
        to any act that exceeds such authority.
            (2) Effect on trustee.--An agreement or relationship with 
        an affiliated person does not affect the authority of a health 
        information trustee under this Act.

SEC. 145. AGENTS AND ATTORNEYS.

    (a) In General.--Except as provided in subsections (b) and (c), a 
person who is authorized by law (on grounds other than an individual's 
minority), or by an instrument recognized under law, to act as an 
agent, attorney, proxy, or other legal representative for a protected 
individual or the estate of a protected individual, or otherwise to 
exercise the rights of the individual or estate, may, to the extent 
authorized, exercise and discharge the rights of the individual or 
estate under this Act.
    (b) Health Care Power of Attorney.--A person who is authorized by 
law (on grounds other than an individual's minority), or by an 
instrument recognized under law, to make decisions about the provision 
of health care to an individual who is incapacitated may exercise and 
discharge the rights of the individual under this Act to the extent 
necessary to effectuate the terms or purposes of the grant of 
authority.
    (c) No Court Declaration.--If a health care provider determines 
that an individual, who has not been declared to be legally 
incompetent, suffers from a medical condition that prevents the 
individual from acting knowingly or effectively on the individual's own 
behalf, the right of the individual to authorize disclosure under 
section 112 may be exercised and discharged in the best interest of the 
individual by--
            (1) a person described in subsection (b) with respect to 
        the individual;
            (2) a person described in subsection (a) with respect to 
        the individual, but only if a person described in paragraph (1) 
        cannot be contacted after a reasonable effort;
            (3) the next of kin of the individual, but only if a person 
        described in paragraph (1) or (2) cannot be contacted after a 
        reasonable effort; or
            (4) the health care provider, but only if a person 
        described in paragraph (1), (2), or (3) cannot be contacted 
        after a reasonable effort.

SEC. 146. MINORS.

    (a) Individuals Who Are 18 or Legally Capable.--In the case of an 
individual--
            (1) who is 18 years of age or older, all rights of the 
        individual shall be exercised by the individual, except as 
        provided in section 145; or
            (2) who, acting alone, has the legal capacity to apply for 
        and obtain health care and has sought such care, the individual 
        shall exercise all rights of an individual under this Act with 
        respect to protected health information relating to such care.
    (b) Individuals Under 18.--Except as provided in subsection (a)(2), 
in the case of an individual who is--
            (1) under 14 years of age, all the individual's rights 
        under this Act shall be exercised through the parent or legal 
        guardian of the individual; or
            (2) 14, 15, 16, or 17 years of age, the right of inspection 
        (under section 101), the right of amendment (under section 
        102), and the right to authorize disclosure of protected health 
        information (under section 112) of the individual may be 
        exercised either by the individual or by the parent or legal 
        guardian of the individual.

SEC. 147. MAINTENANCE OF CERTAIN PROTECTED HEALTH INFORMATION.

    (a) In General.--A State shall establish a process under which the 
protected health information described in subsection (b) that is 
maintained by a person described in subsection (c) is delivered to, and 
maintained by, the State or an individual or entity designated by the 
State.
    (b) Information Described.--The protected health information 
referred to in subsection (a) is protected health information that--
            (1) is recorded in any form or medium;
            (2) is created by--
                    (A) a health care provider; or
                    (B) a health benefit plan sponsor that provides 
                benefits in the form of items and services to enrollees 
                and not in the form of reimbursement for items and 
                services; and
            (3) relates in any way to the past, present, or future 
        physical or mental health or condition or functional status of 
        a protected individual or the provision of health care to a 
        protected individual.
    (c) Persons Described.--A person referred to in subsection (a) is 
any of the following:
            (1) A health care facility previously located in the State 
        that has closed.
            (2) A professional practice previously operated by a health 
        care provider in the State that has closed.
            (3) A health benefit plan sponsor that--
                    (A) previously provided benefits in the form of 
                items and services to enrollees in the State; and
                    (B) has ceased to do business.

                        Subtitle E--Enforcement

SEC. 151. CIVIL ACTIONS.

    (a) In General.--Any individual whose right under this Act has been 
knowingly or negligently violated--
            (1) by a health information trustee, or any other person, 
        who is not described in paragraph (2), (3), (4), or (5) may 
        maintain a civil action for actual damages and for equitable 
        relief against the health information trustee or other person;
            (2) by an officer or employee of the United States while 
        the officer or employee was acting within the scope of the 
        office or employment may maintain a civil action for actual 
        damages and for equitable relief against the United States;
            (3) by an officer or employee of any government authority 
        of a State that has waived its sovereign immunity to a claim 
        for damages resulting from a violation of this Act while the 
        officer or employee was acting within the scope of the office 
        or employment may maintain a civil action for actual damages 
        and for equitable relief against the State government;
            (4) by an officer or employee of a government of a State 
        that is not described in paragraph (3) may maintain a civil 
        action for actual damages and for equitable relief against the 
        officer or employee; or
            (5) by an officer or employee of a government authority 
        while the officer or employee was not acting within the scope 
        of the office or employment may maintain a civil action for 
        actual damages and for equitable relief against the officer or 
        employee.
    (b) Knowing Violations.--Any individual entitled to recover actual 
damages under this section because of a knowing violation of a 
provision of this Act (other than subsection (c) or (d) of section 111) 
shall be entitled to recover the amount of the actual damages 
demonstrated or $5000, whichever is greater.
    (c) Actual Damages.--For purposes of this section, the term 
``actual damages'' includes damages paid to compensate an individual 
for nonpecuniary losses such as physical and mental injury as well as 
damages paid to compensate for pecuniary losses.
    (d) Punitive Damages; Attorney's Fees.--In any action brought under 
this section in which the complainant has prevailed because of a 
knowing violation of a provision of this Act (other than subsection (c) 
or (d) of section 111), the court may, in addition to any relief 
awarded under subsections (a) and (b), award such punitive damages as 
may be warranted. In such an action, the court, in its discretion, may 
allow the prevailing party a reasonable attorney's fee (including 
expert fees) as part of the costs, and the United States shall be 
liable for costs the same as a private person.
    (e) Limitation.--A civil action under this section may not be 
commenced more than 2 years after the date on which the aggrieved 
individual discovered the violation or the date on which the aggrieved 
individual had a reasonable opportunity to discover the violation, 
whichever occurs first.
    (f) Inspection and Amendment.--If a health information trustee has 
established a formal internal procedure that allows an individual who 
has been denied inspection or amendment of protected health information 
to appeal the denial, the individual may not maintain a civil action in 
connection with the denial until the earlier of--
            (1) the date the appeal procedure has been exhausted; or
            (2) the date that is 4 months after the date on which the 
        appeal procedure was initiated.
    (g) No Liability for Permissible Disclosures.--A health information 
trustee who makes a disclosure of protected health information about a 
protected individual that is permitted by this Act and not otherwise 
prohibited by State or Federal statute shall not be liable to the 
individual for the disclosure under common law.
    (h) No Liability for Institutional Review Board Determinations.--If 
the members of a certified institutional review board have in good 
faith determined that an approved health research project is of 
sufficient importance so as to outweigh the intrusion into the privacy 
of an individual pursuant to section 116(a)(1), the members, the board, 
and the parent institution of the boardshall not be liable to the 
individual as a result of such determination.
    (i) Good Faith Reliance on Certification.--A health information 
trustee who relies in good faith on a certification by a government 
authority or other person and discloses protected health information 
about an individual in accordance with this Act shall not be liable to 
the individual for such disclosure.

SEC. 152. CIVIL MONEY PENALTIES.

    (a) Violation.--Any health information trustee who the Secretary 
determines has demonstrated a pattern or practice of failure to comply 
with the provisions of this Act shall be subject, in addition to any 
other penalties that may be prescribed by law, to a civil money penalty 
of not more than $10,000 for each such failure. In determining the 
amount of any penalty to be assessed under the procedures established 
under subsection (b), the Secretary shall take into account the 
previous record of compliance of the person being assessed with the 
applicable requirements of this Act and the gravity of the violation.
    (b) Procedures for Imposition of Penalties.--The provisions of 
section 1128A of the Social Security Act (other than subsections (a) 
and (b)) shall apply to the imposition of a civil monetary penalty 
under this section in the same manner as such provisions apply with 
respect to the imposition of a penalty under section 1128A of such Act.

SEC. 153. ALTERNATIVE DISPUTE RESOLUTION.

    (a) In General.--Not later than July 1, 1999, the Secretary shall, 
by regulation, develop alternative dispute resolution methods for use 
by individuals, health information trustees, and other persons in 
resolving claims under section 151.
    (b) Effect on Initiation of Civil Actions.--
            (1) In general.--Subject to paragraph (2), the regulations 
        established under subsection (a) may provide that an individual 
        alleging that a right of the individual under this Act has been 
        violated shall pursue at least one alternative dispute 
        resolution method developed under such subsection as a 
        condition precedent to commencing a civil action under section 
        151.
            (2) Limitation.--Such regulations may not require an 
        individual to refrain from commencing a civil action to pursue 
        one or more alternative dispute resolution method for a period 
        that is greater than 6 months.
            (3) Suspension of statute of limitations.--The regulations 
        established by the Secretary under subsection (a) may provide 
        that a period in which an individual described in paragraph (1) 
        pursues (as defined by the Secretary) an alternative dispute 
        resolution method under this section shall be excluded in 
        computing the period of limitations under section 151(e).
    (c) Methods.--The methods under subsection (a) shall include at 
least the following:
            (1) Arbitration.--The use of arbitration.
            (2) Mediation.--The use of mediation.
            (3) Early offers of settlement.--The use of a process under 
        which parties make early offers of settlement.
    (d) Standards for Establishing Methods.--In developing alternative 
dispute resolution methods under subsection (a), the Secretary shall 
ensure that the methods promote the resolution of claims in a manner 
that--
            (1) is affordable for the parties involved;
            (2) provides for timely and fair resolution of claims; and
            (3) provides for reasonably convenient access to dispute 
        resolution for individuals.

SEC. 154. AMENDMENTS TO CRIMINAL LAW.

    (a) In General.--Title 18, United States Code, is amended by 
inserting after chapter 73 the following:

          ``CHAPTER 74--OBTAINING PROTECTED HEALTH INFORMATION

``Sec.
``1531. Definitions.
``1532. Obtaining protected health information under false pretenses.
``1533. Monetary gain from obtaining protected health information under 
    false pretenses.
``1534. Knowing and unlawful obtaining of protected health information.
``1535. Monetary gain from knowing and unlawful obtaining of protected 
    health information.
``1536. Knowing and unlawful use or disclosure of protected health 
    information.
``1537. Monetary gain from knowing and unlawful sale, transfer, or use 
    of protected health information.

``Sec. 1531. Definitions

    ``As used in this chapter--
            ``(1) the term `health information trustee' has the meaning 
        given such term in section 3(b)(5) of the Fair Health 
        Information Practices Act of 1997;
            ``(2) the term `protected health information' has the 
        meaning given such term in section 3(a)(3) of such Act; and
            ``(3) the term `protected individual' has the meaning given 
        such term in section 3(a)(4) of such Act.

``Sec. 1532. Obtaining protected health information under false 
                    pretenses

    ``Whoever under false pretenses--
            ``(1) requests or obtains protected health information from 
        a health information trustee; or
            ``(2) obtains from a protected individual an authorization 
        for the disclosure of protected health information about the 
        individual maintained by a health information trustee;
shall be fined under this title or imprisoned not more than 5 years, or 
both.

``Sec. 1533. Monetary gain from obtaining protected health information 
                    under false pretenses

    ``Whoever under false pretenses--
            ``(1) requests or obtains protected health information from 
        a health information trustee with the intent to sell, transfer, 
        or use such information for profit or monetary gain; or
            ``(2) obtains from a protected individual an authorization 
        for the disclosure of protected health information about the 
        individual maintained by a health information trustee with the 
        intent to sell, transfer, or use such authorization for profit 
        or monetary gain;
and knowingly sells, transfers, or uses such information or 
authorization for profit or monetary gain shall be fined under this 
title or imprisoned not more than 10 years, or both.

``Sec. 1534. Knowing and unlawful obtaining of protected health 
                    information

    ``Whoever knowingly obtains protected health information from a 
health information trustee in violation ofthe Fair Health Information 
Practices Act of 1997, knowing that such obtaining is unlawful, shall 
be fined under this title or imprisoned not more than 5 years, or both.

``Sec. 1535. Monetary gain from knowing and unlawful obtaining of 
                    protected health information

    ``Whoever knowingly--
            ``(1) obtains protected health information from a health 
        information trustee in violation of the Fair Health Information 
        Practices Act of 1997, knowing that such obtaining is unlawful 
        and with the intent to sell, transfer, or use such information 
        for profit or monetary gain; and
            ``(2) knowingly sells, transfers, or uses such information 
        for profit or monetary gain;
shall be fined under this title or imprisoned not more than 10 years, 
or both.

``Sec. 1536. Knowing and unlawful use or disclosure of protected health 
                    information

    ``Whoever knowingly uses or discloses protected health information 
in violation of the Fair Health Information Practices Act of 1997, 
knowing that such use or disclosure is unlawful, shall be fined under 
this title or imprisoned not more than 5 years, or both.

``Sec. 1537. Monetary gain from knowing and unlawful sale, transfer, or 
                    use of protected health information

    ``Whoever knowingly sells, transfers, or uses protected health 
information in violation of the Fair Health Information Practices Act 
of 1997, knowing that such sale, transfer, or use is unlawful, shall be 
fined under this title or imprisoned not more than 10 years, or 
both.''.
    (b) Clerical Amendment.--The table of chapters for part I of title 
18, United States Code, is amended by inserting after the item relating 
to chapter 73 the following:

``74. Obtaining protected health information.....................1531''.

          TITLE II--AMENDMENTS TO TITLE 5, UNITED STATES CODE

SEC. 201. AMENDMENTS TO TITLE 5, UNITED STATES CODE.

    (a) New Subsection.--Section 552a of title 5, United States Code, 
is amended by adding at the end the following:

    ``(w) Medical Exemptions.--The head of an agency that is a health 
information trustee (as defined in section 3(b)(5) of the Fair Health 
Information Practices Act of 1997) shall promulgate rules, in 
accordance with the requirements (including general notice) of 
subsections (b)(1), (b)(2), (b)(3), (c), and (e) of section 553 of this 
title, to exempt a system of records within the agency, to the extent 
that the system of records contains protected health information (as 
defined in section 3(a)(3) of such Act), from all provisions of this 
section except subsections (e)(1), (e)(2), subparagraphs (A) through 
(C) and (E) through (I) of subsection (e)(4), and subsections (e)(5), 
(e)(6), (e)(9), (e)(12), (l), (n), (o), (p), (q), (r), and (u).''.
    (b) Repeal.--Section 552a(f)(3) of title 5, United States Code, is 
amended by striking ``pertaining to him,'' and all that follows through 
the semicolon and inserting ``pertaining to the individual;''.

   TITLE III--REGULATIONS, RESEARCH, AND EDUCATION; EFFECTIVE DATES; 
             APPLICABILITY; AND RELATIONSHIP TO OTHER LAWS

SEC. 301. REGULATIONS; RESEARCH AND EDUCATION.

    (a) Regulations.--Not later than July 1, 1999, the Secretary shall 
prescribe regulations to carry out this Act.
    (b) Research and Technical Support.--The Secretary may sponsor--
            (1) research relating to the privacy and security of 
        protected health information;
            (2) the development of consent forms governing disclosure 
        of such information; and
            (3) the development of technology to implement standards 
        regarding such information.
    (c) Education.--The Secretary shall establish education and 
awareness programs--
            (1) to foster adequate security practices by health 
        information trustees;
            (2) to train personnel of health information trustees 
        respecting the duties of such personnel with respect to 
        protected health information; and
            (3) to inform individuals and employers who purchase health 
        care respecting their rights with respect to such information.
    (d) Office of Information Privacy.--
            (1) Establishment.--There is established in the Department 
        of Health and Human Services, within the Office of the 
        Secretary, an Office of Information Privacy. The Office of 
        Information Privacy shall be headed by a Director, who shall 
        also be the Privacy Adviser of the Department of Health and 
        Human Services. The Director shall be the principal adviser to 
        the Secretary on the effect of the use and disclosure of 
        personally-identifiable information on the privacy of 
        individuals.
            (2) Duties.--The Director of the Office of Information 
        Privacy shall--
                    (A) monitor and participate in the development of 
                regulations under this Act;
                    (B) monitor the implementation of this Act within 
                the Department of Health and Human Services;
                    (C) advise the Secretary of the effects of current 
                activities and proposed statutory, regulatory, 
                administrative, and budgetary actions on the 
                information privacy of individuals;
                    (D) monitor the implementation within the 
                Department of Health and Human Services of laws and 
                policies affecting the confidentiality of personally-
                identifiable health information or other personally-
                identifiable information;
                    (E) advise the Secretary on the implications for 
                privacy of automated systems for the collection, 
                storage, analysis, or transfer of personally-
                identifiable health information or other personally-
                identifiable information;
                    (F) engage in, or commission, research and 
                technical studies on the implications of policies and 
                practices for information privacy promulgated by the 
                Secretary;
                    (G) serve as a point of contact within the 
                Department of Health and Human Services for persons, 
                such as other agencies of the Federal Government, 
                States, foreign governments, international 
                organizations, privacy and consumer advocacy 
                organizations, businesses, nonprofit organizations, and 
                individuals, interested in the effects on privacy of 
                the collection, maintenance, use, and disclosure of 
                personally-identifiable health information or other 
                personally-identifiable information; and
                    (H) report from time to time to the Secretary, the 
                Congress, and the public on privacy matters.

SEC. 302. EFFECTIVE DATES.

    (a) In General.--Except as provided in subsection (b), this Act, 
and the amendments made by this Act, shall take effect on January 1, 
2000.
    (b) Provisions Effective Immediately.--
            (1) In general.--A provision of this Act shall take effect 
        on the date of the enactment of this Act if the provision--
                    (A) imposes a duty on the Secretary to develop, 
                establish, or promulgate regulations, guidelines, 
                notices, statements, or education and awareness 
                programs; or
                    (B) authorizes the Secretary to sponsor research or 
                the development of forms or technology.
            (2) Office of information privacy.--Section 301(d) 
        (relating to the Office of Information Privacy) shall take 
        effect on the date of the enactment of this Act.

SEC. 303. APPLICABILITY.

    (a) Protected Health Information.--Except as provided in 
subsections (b) and (c), the provisions of this Act shall apply to any 
protected health information that is received, created, used, 
maintained, or disclosed by a health information trustee in a State on 
or after January 1, 2000, regardless of whether the information existed 
or was disclosed prior to such date.
    (b) Exception.--
            (1) In general.--The provisions of this Act shall not apply 
        to a trustee described in paragraph (2), except with respect to 
        protected health information that is received by the trustee on 
        or after January 1, 2000.
            (2) Applicability.--A trustee referred to in paragraph (1) 
        is--
                    (A) a health researcher; or
                    (B) a person who, with respect to specific 
                protected health information, received the 
                information--
                            (i) pursuant to--
                                    (I) section 117 (relating to 
                                emergency circumstances);
                                    (II) section 118 (relating to 
                                judicial and administrative purposes);
                                    (III) section 119 (relating to law 
                                enforcement); or
                                    (IV) section 120 (relating to 
                                subpoenas, warrants, and search 
                                warrants); or
                            (ii) while acting in whole or in part in 
                        the capacity of an officer or employee of a 
                        person described in clause (i).
    (c) Authorizations for Disclosures.--An authorization for the 
disclosure of protected health information about a protected individual 
that is executed by the individual before January 1, 2000, and is 
recognized and valid under State law on December 31, 1999, shall remain 
valid and shall not be subject to the requirements of section 112 until 
January 1, 2001, or the occurrence of the date or event (if any) 
specified in the authorization upon which the authorization expires, 
whichever occurs earlier.

SEC. 304. RELATIONSHIP TO OTHER LAWS.

    (a) State Law.--Except as otherwise provided in subsections (b), 
(c), (d), (e), and (g), a State may not establish, continue in effect, 
or enforce any State law to the extent that the law is inconsistent 
with, or imposes additional requirements with respect to, any of the 
following:
            (1) A duty of a health information trustee under this Act.
            (2) An authority of a health information trustee under this 
        Act to disclose protected health information.
            (3) A provision of subtitle C (relating to access 
        procedures and challenge rights), subtitle D (miscellaneous 
        provisions), or subtitle E (relating to enforcement).
    (b) Laws Relating to Public Health and Mental Health.--This Act 
does not preempt, supersede, or modify the operation of any State law 
regarding public health or mental health to the extent that the law 
prohibits or regulates a disclosure of protected health information 
that is permitted under this Act.
    (c) Criminal Penalties.--A State may establish and enforce criminal 
penalties with respect to a failure to comply with a provision of this 
Act.
    (d) Requirements on State Agencies.--A State may establish, 
continue in effect, and enforce any State law to the extent that the 
law imposes on a judicial, legislative, or executive agency of the 
State a requirement, limitation, or procedure with respect to the use 
or disclosure of protected health information that is in addition to 
the requirements, limitations, and procedures imposed under this Act.
    (e) Privileges.--A privilege that a person has under law in a court 
of a State or the United States or under the rules of any agency of a 
State or the United States may not be diminished, waived, or otherwise 
affected by--
            (1) the execution by a protected individual of an 
        authorization for disclosure of protected health information 
        under this Act, if the authorization is executed for the 
        purpose of receiving health care or providing for the payment 
        for health care; or
            (2) any provision of this Act that authorizes the 
        disclosure of protected health information for the purpose of 
        receiving health care or providing for the payment for health 
        care.
    (f) Department of Veterans Affairs.--The limitations on use and 
disclosure of protected health information under this Act shall not be 
construed to prevent any exchange of such information within and among 
components of the Department of Veterans Affairs that determine 
eligibility for or entitlement to, or that provide, benefits under laws 
administered by the Secretary of Veterans Affairs.
    (g) Certain Duties Under State or Federal Law.--This Act shall not 
be construed to preempt, supersede, or modify the operation of any of 
the following:
            (1) Any law that provides for the reporting of vital 
        statistics such as birth or death information.
            (2) Any law requiring the reporting of abuse or neglect 
        information about any individual.
            (3) Subpart II of part E of title XXVI of the Public Health 
        Service Act (relating to notifications of emergency response 
        employees of possible exposure to infectious diseases).
            (4) The Americans with Disabilities Act of 1990.
            (5) Any Federal or State statute that establishes a 
        privilege for records used in health professional peer review 
        activities.
    (h) Secretarial Authority.--
            (1) Secretary of health and human services.--A provision of 
        this Act does not preempt, supersede, or modify the operation 
        of section 543 of the Public Health Service Act, except to the 
        extent that the Secretary of Health and Human Services 
        determines through regulations promulgated by such Secretary 
        that the provision provides greater protection for protected 
        health information, and the rights of protected individuals, 
        than is provided under such section 543.
            (2) Secretary of veterans affairs.--A provision of this Act 
        does not preempt, supersede, or modify the operation of section 
        7332 of title 38, United States Code, except to the extent that 
        the Secretary of Veterans Affairs determines through 
        regulations promulgated by such Secretary that the provision 
        provides greater protection for protected health information, 
        and the rights of protected individuals, than is provided under 
        such section 7332.

    Mr. Horn. No one will make the mistake of thinking that 
medical privacy is a new issue. It is worth recalling the words 
of Hippocrates. His oath included the following pledge: ``All 
that may come to my knowledge in the exercise of my profession, 
which ought not to be spread abroad, I will keep secret and 
will never reveal.''
    Patient information acquired by medical experts is deeply 
personal and should be kept private. The challenge we now face 
is to protect the timeless value of confidentiality, the 
privacy between doctor and patient, in a rapidly changing 
health care environment. We face an enormous conflict between 
an old value, the right to personal privacy, and the increasing 
need of our health care system to exchange intimate information 
about each of us. Managed health care systems must be able to 
exchange information between doctors, insurers, and others. We 
need to set the rules of the road.
    At stake are the quality and the value of our health care. 
The increasing use of information technology and the increasing 
complexity of provider arrangements are inevitable. The 
exchange of patient health care information is an integral part 
of the existing health care system. Claims payments require 
diagnostic information. Communications between primary care 
providers and other providers, such as specialists or 
hospitals, require patient information to be shared. Pharmacies 
maintain data bases of past prescriptions.
    Despite this highly fluid environment for exchanging health 
care information, no uniform national standard currently exists 
to protect the confidentiality of this information. Moreover, 
there is little uniformity among State statutes regarding the 
confidentiality of health care information. Most of the States' 
laws lack penalties for misuse or misappropriation. Protections 
vary according to both the holder and the type of information.
    Under last year's Kassebaum-Kennedy act, the Secretary of 
Health and Human Services is required to recommend privacy 
standards for health care information to Congress by September 
1997. If Congress does not enact health care privacy 
legislation by August 1999, the Secretary of Health and Human 
Services is required to promulgate such privacy regulations. In 
effect, the Kassebaum-Kennedy act gave Congress a 3-year window 
of opportunity to enact major health care privacy legislation.
    An illustration of the difficulties we face is the 
revolution in the science of genetics, with the mapping of the 
human genome. Incredibly sensitive, precise genetic tests have 
been developed, genetic screening has become commonplace, and 
an extraordinary array of genetic interventions are being 
explored.
    Genetics privacy issues inevitably accompany the scientific 
advances. Do genetic data differ fundamentally from other 
health data? Genetic data could be used prejudicially, such as 
ineligibility for employment, financial credit, or life or 
health insurance.
    Issues associated with genetic privacy and possible 
discrimination based on genetic information have received 
heightened attention. The House Committee on Commerce has 
established a task force on health records and genetic privacy 
chaired by Representative Stearns and Green. Any substantial 
legislation on the issue of medical records privacy will 
involve establishing uniform national rules on the collection 
and protection of personally identifiable health data, 
affirming the rights of patients, setting criteria and 
procedures for disclosure, their use and security of health 
care information, focusing responsibilities for ensuring proper 
protection and use of health care information and establishing 
penalties for wrongful use of the data.
    The legislation before us today is H.R. 52, the Fair Health 
Information Practices Act of 1997. Under this bill, medical 
records created or used during the process of treatment become 
protected health information. Furthermore, health care 
providers are required to maintain appropriate administrative, 
technical, and physical safeguards to protect the integrity and 
privacy of health care information. H.R. 52 would allow 
patients to review their medical records and correct inaccurate 
information. It would also place restriction on the release of 
information relating to the treatment of patients and on the 
payment for health care services.
    Three Members of Congress who have taken the lead on 
medical records privacy issues will testify today as part of 
our first panel. They are Representative Condit, who is author 
of H.R. 52, as well as Representatives Slaughter and Stearns.
    Representatives of privacy advocates, health care providers 
and records management organizations will testify on panel II. 
The witnesses are Ms. Janlori Goldman, visiting scholar at 
Georgetown University Law Center, who is also affiliated with 
the Center for Democracy and Technology; Dr. Donald J. 
Palmisano, who is a member of the Board of Trustees, American 
Medical Association; and Dr. Merida Johns, who is president of 
the American Health Information Management Association.
    Representatives of medical researchers will testify on 
panel III. Witnesses are Dr. Sherine Gabriel of the Department 
of Health Services Research, Mayo Clinic, representing the 
Health Care Leadership Council; Dr. Elizabeth Andrews of Glaxo 
Wellcome, representing the Pharmaceutical Research and 
Manufacturers Association; and Dr. Steven Kenny Hoge, who 
serves as chair of the Council on Psychiatry and Law at the 
American Psychiatric Association.
    We welcome all of today's witnesses.
    I have just learned that Mrs. Slaughter will not be here. 
She asks for her comments to be submitted for the record and 
without objection, they will be. We are delighted to have the 
author of this legislation with us, Mr. Condit, and it is all 
yours.

STATEMENT OF HON. GARY A. CONDIT, A REPRESENTATIVE IN CONGRESS 
                  FROM THE STATE OF CALIFORNIA

    Mr. Condit. Thank you, Mr. Chairman. First of all, let me 
commend you, Mr. Chairman, for gathering us here today to 
discuss the privacy of medical records. This is an extremely 
important step in addressing the anxiety of many patients and 
citizens across this country. The time has come for us in 
reforming the way we handle medical records; and this is a very 
sensitive issue, and it is time for us to take a look at how we 
have been doing this.
    As more and more medical records are computerized, a 
patient's confidentiality is put at risk, and we have examples 
of that throughout our review of this issue. For this reason, I 
have introduced the Fair Health Information Practices Act; and 
you have been kind enough to work with us on that, Mr. Chairman 
and I appreciate that very much.
    Our guiding principle in drafting this bill is to protect 
the confidential information contained in medical records and 
protecting this information once it leaves the physician's 
office. Under the bill, medical information is protected by 
establishing uniform Federal rules for handling medical 
records; holding those who handle this information accountable 
for the security and privacy of the medical records.
    Today, you will hear testimony from a number of people who 
have expertise in this area, and I look forward to their 
testimony. We have heard them speak before, over the last 
couple of years, on this issue. You know, last year, with the 
Kennedy-Kassebaum bill, we were given a target date, 1999, to 
enact something. We think this is a good step in the right 
direction, and I hope we can put something together.
    Mr. Chairman, I have an extensive statement and some 
background information that I would like to submit for the 
record, and I would be available here for a few minutes to 
respond to any comments or questions; and with that, I will 
yield back.
    Mr. Horn. Well, we appreciate you coming and your statement 
will be, without objection, part of the record at this point.
    Mr. Condit. Thank you.
    [The prepared statement of Hon. Gary A. Condit follows:] 
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    Mr. Horn. We now have the distinguished Member from 
Florida, Mr. Stearns.

 STATEMENT OF HON. CLIFF STEARNS, A REPRESENTATIVE IN CONGRESS 
                   FROM THE STATE OF FLORIDA

    Mr. Stearns. Good morning, Mr. Chairman. I am delighted to 
be here and want to compliment you on your leadership in having 
this hearing. While the scope of your hearing today covers 
medical records in general, I would like to restrict my 
comments to why I believe we must provide safeguards to prevent 
discrimination based on a person's genetic profile.
    The question of confidentiality of one's medical record is 
something that should concern us all. The reason I am here 
today is to discuss how we can find a way to ensure that 
technological advances in genetic testing proceed while 
protecting the interests of the individual.
    Let me state, technology is good, research must be allowed. 
It is the means and applications of this technology and 
research that concerns us all. I believe genetic testing may 
become, in fact, a civil rights issue. It could be the civil 
rights issue of the 21st century. Should an insurance company 
be able to deny children medical coverage because their mother 
died of an inherited heart defect? Even if children may or may 
not carry the defect this is a dilemma faced by a father in 
California who could not get family medical coverage under his 
group plan as a result of his wife's death.
    In another case, a man lost his auto insurance coverage 
because he had a genetic condition which affected his muscles. 
Although he had a clean driving record stretching back 20 
years, genetic information was used to cancel his policy.
    One young woman was hired as a social worker, and for 8 
months, she received promotions and positive performance 
reviews. However, while conducting a training program on caring 
for patients with Huntington's disease, she mentioned that she 
had family members with that condition. She was soon fired and 
informed by another colleague that it was due to a concern that 
she might develop Huntington's disease.
    As these cases show, access to genetic information can 
result in being denied health insurance, cancellation of auto 
insurance, and even the loss of a job. These people were 
discriminated against based upon their genes. You might be 
amazed to know how many of us here in this committee room carry 
mutated genes. The fact is, we all do. Fortunately, most 
genetic mutations are silent, exhibiting no significant 
consequences.
    The National Institutes for Health is home to the Human 
Genome Project. This project is a 15-year study scheduled for 
completion in the year 2005. The discoveries made from mapping 
out the entire human genome will mean better early detection, 
treatment of disease, and even their prevention. These are the 
up sides of genetic research.
    The examples I provided earlier show genetic information 
can also be used to discriminate against people. That is where 
Congress should take action to ensure continued progress in 
genetic research while also protecting people from the misuse 
of genetic information. This issue is moving very quickly, and 
we need to make some sound public policy decisions now.
    In the last Congress, I introduced the Genetic Privacy and 
Nondiscrimination Act, H.R. 2690, to establish guidelines 
concerning the disclosure and use of genetic information. My 
goal was to protect the health privacy of the American people 
while not disrupting genetic research efforts. I am currently 
drafting a similar piece of legislation for the 105th Congress.
    Last year, I was able to, with the help of others, insert 
language into the Health Care Coverage and Affordability Act 
while the measure was in the Commerce Committee, on which I 
sit. As you know, we passed this measure and the President 
signed it. One provision of this bill prohibits insurance 
companies from denying coverage to an employee or beneficiary 
on the basis of health status. Health status was defined as an 
individual's medical condition, claims, experience, receipt of 
health care, medical history, evidence of insurability, or 
disability. The two words that I inserted in the commerce bill 
were, quote, genetic information. These two words made a good 
bill better, but additional protection and guidelines are still 
needed. That is one of my priorities in the 105th Congress.
    Chairman Tom Bliley of the Commerce Committee asked me to 
take a leading role in establishing policy on these issues by 
chairing the task force on health records and genetic privacy. 
This bipartisan task force will consider these questions in a 
series of briefings, meetings, and public hearings.
    The job of the task force is to answer a number of 
questions which certainly pertain to medical records and 
privacy; and some of these are, Mr. Chairman, one, how will we 
protect the health records of persons with genetic deficiencies 
and still allow scientific research to go forward unimpeded? 
Additionally, the whole area of, quote, informed consent, end 
quote, must be clarified as it pertains to genetic privacy. How 
will the thousands of available genetic tests created as a 
result of the Human Genome Project affect our citizens? And 
three, what issues are raised by the potential misuse of 
genetic and other information about an individual?
    Genetic information is personal, powerful, permanent, and 
sensitive. It not only affects the individual, but it also has 
an impact on offspring and other blood relatives. Genetic 
privacy must be protected. On the other hand, it is a key to 
the treatment, cure and prevention of disease, so genetic 
research must continue. I see our job is to meet these goals as 
best we can; it is also an issue of fairness.
    In conclusion, Mr. Chairman, think about those two little 
boys in California who were denied insurance coverage because 
of an error in a genetic script. This is something that they 
could not control and did not choose. As I noted, we all have 
errors in our genetic blueprints. For most of us, it does not 
harm us, but for many, the onset of disease is devastating. We 
owe them a level of privacy and the hope for treatment and 
cure. That is the central mission of my task force and 
legislation.
    Thank you, Mr. Chairman.
    Mr. Horn. I thank you for that very fine statement.
    [The prepared statement of Hon. Cliff Stearns follows:] 
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    Mr. Horn. Let me just put in the record, without objection, 
the comments of Representative Shays, who is chairman of the 
Human Resources Subcommittee of our full committee and the 
comments of Representative Slaughter, who is the author of H.R. 
306, the Genetic Information Nondiscrimination and Health 
Insurance Act. Any other remarks as Members arrive, those 
opening statements will be put in the record.
    [The prepared statements of Hon. Christopher Shays and Hon. 
Louise M. Slaughter follow:] 
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    Mr. Horn. Let us now, in your limited time, ask a few 
questions. Given the situation on genetic information in those 
cases, Representative Stearns, that you cited, are truly 
important because I happen to have a college classmate whose 
child had exactly that heart situation. No one thought the 
child would live past 8, and that child is now in his late 30's 
or early 40's. So genetic information doesn't always have an 
inevitable consequence.
    And I think the one question here is, should we separate 
the genetic information aspect from the other privacy aspects 
in the Condit bill, or should we just work on both in one 
piece? What is your feeling on that?
    Mr. Stearns. Well, I think what Gary is doing is important, 
and I think separating them temporarily until we know enough 
about it--because as you just pointed out, if a doctor sits 
down with me and says, Cliff, you have a predisposition because 
of your gene for X, Y, Z, what does that mean in terms of 
probability theory? Does the environment, the fact I don't 
drink or smoke or perhaps that I exercise, perhaps where I 
live, how does that tie in? And what does that predisposition 
mean? We just don't know.
    We can say, in some genes, it means you are going to die at 
a definite date. But for a lot of this, there is going to be a 
high level of probability that we have to work out and we 
should not have the health records impeded while we try to 
understand the whole impact of this, in the legal aspect, in 
terms of punitive--allowing research to go ahead, in terms of 
counseling people. I mean, the issues just open up like 
Pandora's box.
    So I think the whole area of genetics is an issue unto 
itself in how we deal with it, much like we are trying to deal 
with cloning. And as you know, the President's Commission, I 
think is going to reveal its recommendations this week or next. 
And so this whole area is something that is staggering in terms 
of implication.
    Mr. Condit. May I respond?
    As you know, you and I have had discussions, we are looking 
for a comprehensive approach to medical records and the 
confidentiality, and so we would like to eventually see 
everything sort of on an even keel here. But I do acknowledge 
that what Mr. Stearns has brought up here is sort of in a 
special category. At this time, we don't have a lot of 
information about it, so I do think that there is a time period 
where we may want to do as he said, take a special look at it 
and see whether or not it fits under this category. But we 
probably could work to accommodate it either way, but I think 
he makes a very good point and one we would probably agree 
with.
    I also, Mr. Chairman--if I may, I apologize to you; you 
have been very kind to hold this hearing today, and I know you 
are going to get a lot of good information. I have another 
obligation I need to get to, but I do have a stack of 
information I would like to leave for the record, if I may.
    Mr. Horn. Without objection, it will be inserted at this 
point.
    I just have one question, if you have got a second.
    On H.R. 52, as put in this year, is there an impact on law 
enforcement investigations? I recall that some law enforcement 
officials, representatives of the Department of Justice, in 
particular, expressed concern about your previous legislation, 
H.R. 435, and its effect on law enforcement investigations. Do 
you know of any similar concerns?
    Mr. Condit. That is a good point, and I am glad you brought 
it up.
    It is certainly not my intent to exclude law enforcement 
from having access to information that is crucial to them, 
maybe in a criminal case. So last session when we worked on 
this issue, we spent a lot of time working with the law 
enforcement industry, and I think we clarified, to their 
satisfaction, language that they can accept. And I think they 
are protected under this bill, and we have not received, to my 
knowledge, any objection from them on this particular language. 
They do have access to records when they need them.
    Mr. Horn. Thank you very much.
    Mr. Stearns, when I listened to your examples on genetics 
and how insurance companies were doing this and that, it came 
to my mind that the whole reason we have insurance is not just 
to insure well people, but to insure a group of people, and 
that is what the actuarial tables, it seems to me, are based 
upon; and to deny an individual, just because science has 
progressed, it bothers me a lot, and we have to do something to 
figure out how to solve that one.
    Do you have any other comments you want to make? I don't 
want to hold you here. I know you have a lot of things to do.
    Mr. Stearns. Well, Mr. Chairman, in the area of law 
enforcement, also in the area of military, that is another area 
that health records--in determining availability, access for 
military people, military doctors, putting people in combat; 
and with genetic predisposition, how does that work out if a 
person has strong allergies or a person has some other problems 
that would become apparent under stress or would become 
apparent under certain conditions? How does that work out, and 
how is the individual protected, and what does it mean? That is 
an area that we need to have the wisdom of Solomon to figure 
out how to protect health records and at the same time allow 
the military, the law enforcement and research--most 
importantly, research--to have access to the records.
    So, I mean, it is something I commend you and others for 
doing, and I am delighted to be here.
    Mr. Horn. Let me just ask if Mr. Sessions has any questions 
he would like to ask you before you leave.
    Mr. Sessions. I really have no questions. I would just say 
that I was unprepared before I walked in today. I knew the 
general subject. I have a little boy with Down's Syndrome, so I 
have had to ask a lot of these same questions, not only of 
myself in dealing with him, but also of my son, and how we are 
going to deal with him as he progresses.
    So these are very thought-provoking issues, and I am very 
interested in your comments today and those of Congressman 
Condit.
    Mr. Stearns. Dr. Collins, who heads up the Genome Project 
out at the National Institutes of Health--I went out there and 
toured the facility, and I urge all Members to go out there and 
to actually meet with Dr. Collins and hear his presentation on 
the future with genetic engineering. It is exciting.
    For example, with your son and other children that many 
Americans will have, the hope some day is we can actually go 
back into your DNA and correct things and make things new 
again, and that is a spectacular kind of thought. But at the 
same time, for many Americans who have mutated genes, we need 
to make sure that they have a full life and are not 
discriminated against because of anything that medicine finds.
    Mr. Sessions. What is interesting to me, since we are on 
the subject--and I know you need to go--I struggle and I have 
struggled in dealing with my child. Many people, in dealing 
with all sorts of gene and genetic problems, as Down's Syndrome 
is one of those, I am of a firm belief that God gave us baby 
Alex the way he is, and we are simply trying to take him as far 
as we can; and a lot of changes, I would not want to make to 
him. We are trying to take him as far as he can go as he was 
given to us.
    And a lot of people do things with exercise or their facial 
muscles so that the disability that this child has is not 
recognizable. And so my wife and I have taken the perspective 
in dealing with this that we want to massage him, we want to do 
those things that help his facial muscles, that help him to be 
able to speak and help him to do those things, but he should 
not become unrecognizable for what he is to this world. He 
could, at some point, be 25 years old on a street corner, be 
lost, and a person would look at him and maybe not know what 
they are looking at.
    So I have found that I like baby Alex the way he is, and he 
was a gift to us; and I would not go back and alter one single 
thing, even if I knew he were Down's from the very beginning. 
So there are a lot of things that come to us that may not be 
exactly the way you and I think are perfect, but is in reality 
a wonderful creation.
    Mr. Stearns. Well, that is an inspiring attitude toward it, 
and I think all of us should have that attitude on many things. 
So I commend you for that attitude, and I think that is an 
inspiration for many of us.
    Mr. Sessions. Thank you.
    Mr. Horn. I agree with the gentleman. When you mentioned 
allergies, the thought crossed my mind that no one on Capitol 
Hill would be able to get insurance. As I walk down the hall, 
everybody seems to have allergies. And when our class arrived 
in the fall of 1992, somebody said, you know, ``Why we all have 
allergies?'' We apparently have one of every tree in America on 
Capitol Hill. I don't know if it is true, but it is an 
interesting source for what the problem is around here.
    Would the gentlewoman from New York care to ask any 
questions?
    Mrs. Maloney. I would like to have my opening comments put 
into the record as read.
    Mr. Horn. That has automatically been done already.
    [The prepared statement of Hon. Carolyn B. Maloney 
follows:] 
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    Mrs. Maloney. I am sorry Mr. Condit has already left. We 
wouldn't be as far along as we are on this issue if it had not 
been for the work he did in the 103d Congress.
    I wanted to ask him, but maybe Mr. Stearns can answer, in 
one of his bills, he had exempted mental health, and yet now he 
dropped from his bill the exception for mental health 
treatment, and I wanted to ask him why. Are you working with 
him on his bill?
    Mr. Stearns. No, I am not and it would not be fair for me 
to comment on his bill. Gary is very knowledgeable.
    Mrs. Maloney. Do you think the provisions in Congresswoman 
Slaughter's bill are adequate or would you add to them?
    Mr. Stearns. Well, this is a bill that we dropped pretty 
much like we dropped last year. Senator Mack and Senator 
Hatfield dropped it on the Senate side.
    The bill we are going to drop this year is going to be a 
little different, and we think that our bill is going to be 
more specific and tailored. And we are seeking the 
administration's help, because we think the administration has 
some concern about certain things; and since we are trying to 
get something passed, we are trying to work with them.
    She has also been very active, and I admire her for her 
leadership and her activities on this, and welcome the work 
that she has done and working with her.
    Mrs. Maloney. OK. Thank you very much.
    Mr. Horn. Thank you for coming. We appreciate you having 
shared your knowledge on the subject. When will that task force 
of yours report, basically?
    Mr. Stearns. Mr. Chairman, Gene Green of Texas represents 
Houston. We are hoping to have some hearings at some of the 
universities. University of Florida has a lot of research on 
this and we are hoping to have a hearing in July, in which we 
try to define where in this enormous panoramic subject that we 
could go and get the most bang for the buck. We would seek your 
advice and the members of this committee too.
    Mr. Horn. Well, we thank you for the hard work you have 
dedicated to this issue. It is very important.
    We will now call forth the second panel, and that will be 
Ms. Goldman, Mr. Palmisano, and Ms. Johns.
    If you stand and raise your right hands, we have a 
tradition that witnesses other than Members of Congress take 
the oath.
    [Witnesses sworn.]
    Mr. Horn. All three witnesses affirmed, and we will start 
with Ms. Goldman.

  STATEMENTS OF JANLORI GOLDMAN, VISITING SCHOLAR, GEORGETOWN 
   UNIVERSITY LAW CENTER, AND AFFILIATED WITH THE CENTER FOR 
  DEMOCRACY AND TECHNOLOGY; DR. DONALD J. PALMISANO, MEMBER, 
BOARD OF TRUSTEES, AMERICAN MEDICAL ASSOCIATION; AND MERIDA L. 
JOHNS, Ph.D., PRESIDENT, AMERICAN HEALTH INFORMATION MANAGEMENT 
                          ASSOCIATION

    Ms. Goldman. Good morning, and thank you very much for 
inviting me to testify today. I not only appreciate your 
invitation, I appreciate this subcommittee's continued 
commitment to this issue. I think this might be the third or 
fourth hearing on this subject you have held in the last few 
years, and I think it has advanced the policy discussions quite 
a bit.
    What I would like to do, since this has been an issue that 
has been very well discussed and documented--there is quite a 
record that this subcommittee alone has created--is just talk a 
little bit about what has changed since the last hearing, which 
was almost a year ago today. Congress passed the Health 
Information Portability Act, the Kassebaum-Kennedy bill that 
now--really what Congress did, in place of passing mandatory 
privacy rules, was give itself a time limit and say, we must 
act to pass legislation in the next few years on privacy of 
health records, or else the Secretary of HHS will promulgate 
regulations. So one way or another we are going to have a law 
on enforceable regulations in the next few years.
    It was, I think, a serious failing in the Kassebaum-Kennedy 
law that the administrative simplification provisions did pass, 
which require standard uniform format of health information, 
essentially a computerized patient record in the next few 
years, without saying at the outset what the privacy rules 
should be.
    What it means is that as the Secretary and as the computer 
industry and the health information industry is moving to 
computerize and standardize personal medical records, they are 
doing so without knowing what privacy and security rules to put 
in place. So when Congress does act or the Secretary acts, they 
are going to have to go back and retrofit those systems.
    It is expensive. I think it is a problem. I would urge the 
Congress not to wait until the time limit it has been given, 
but to act more swiftly so that people who are in those 
offices, in those industries, that are working with health 
information, know what to do at the outset.
    In that law though that did pass, instead of passing the 
rules, what Congress did do was say, we need to address the 
privacy issues. A committee was created, the National Committee 
on Vital and Health Statistics. It has held hearings on the 
issue and created an even more extensive public record about 
the need for health privacy legislation. The Secretary is going 
to issue a report this summer.
    In addition, since last year, the National Research Council 
issued a report for the record, very detailed report about the 
need for security in computerized health information systems. 
They went around the country, they did case studies and they 
found that even with the best of intentions, there was a lack 
of strong privacy and security safeguards in place. And again 
we have horror stories about people who acted with malice and 
used information without permission, sold it to the press. We 
have information about carelessness, we have horror stories, 
but I think for the vast majority of people in this country who 
want to do the right thing, they don't know where to start and 
they are seeking Congress' guidance.
    As well, the National Action Plan on Breast Cancer and the 
Human Genome Project, which we have talked a little bit about, 
is holding a series of workshops on privacy and genetic 
information, because they are wrestling with the need to push 
forward in genetic research. But the fear that so many 
individuals who are participants in these studies are going to 
have, is fear that they will be discriminated against in 
insurance, even in employment. Even though the ADA should 
protect them against that, they do not trust the research and 
public health community to protect their confidentiality.
    I don't think it is an overstatement to say we are rapidly, 
and have been for years, approaching a crisis in health care 
because of the lack of privacy rules. Fundamental critical 
health care services are at risk of being undermined.
    This is not a case of privacy practices being a barrier to 
research and to public health and to managed care; that is 
often how the issue is formulated in the press and by some in 
the industry who say, ``privacy will be a barrier to us, if we 
have to protect privacy, we are not going to get the 
information we need because people won't consent to these 
uses.''
    I would actually say we have quite the opposite scenario. 
We will have substantial barriers to treatment, research, and 
public health if people do not believe that their privacy is 
protected and that they don't have the following principles 
guaranteed.
    One is, they must have access to their own records. Half 
the States in this country give people the right to see their 
own medical records. It is a sham.
    The other thing people must have is control over their own 
records. When they go to a doctor, they should be able to 
determine who else gets to see the record and under what 
circumstances. Right now people sign blanket waivers, and even 
where doctors want to maintain confidentiality and want to have 
kind of the old-fashioned doctor-patient relationship, they are 
unable to do so because of requirements on the part of payers, 
insurance companies, sometimes researchers with whom they have 
relationships, to disclose that information.
    The other thing people must have are strong enforceable 
remedies, individual remedies where they can pursue a lawsuit 
against someone who has harmed them. There should be civil 
penalties and criminal penalties. Most of the legislation that 
has been introduced in both the House and the Senate has very 
strong penalties.
    Very quickly, on some of the issues raised, my view--and, I 
think, the view of a number of people in the research community 
at NIH in the Human Genome Project--is that we should treat 
genetic information as health information and not treat it 
separately and not isolate it as a separate, special 
circumstance. In fact, H.R. 52, Congressman Condit's bill, does 
incorporate genetic information now under the definition of 
personal health information. It talks about past, present, or 
future information, as do a number of the Senate proposals. 
That is genetic information. It refers to information about 
others who are not necessarily the record subject. That is also 
genetic information.
    As well, I think that the law enforcement provisions, which 
I know and, Mr. Chairman, you raised in your questions, I 
really believe that the law enforcement sections in a health 
privacy law must be consistent with other law enforcement 
provisions and privacy laws that we currently have at the 
Federal level.
    The Video Privacy Protection Act, better known as the Bork 
bill by some, the Right to Financial Privacy Act, the Education 
Privacy Act, all have law enforcement provisions that require a 
warrant before access; and I think that we should have at least 
the same level of protection for medical records that we have 
for video rental records.
    In addition, the pre-emption section which is in H.R. 52 is 
different than some of the provisions on the Senate side, but I 
think also needs some looking. Right now, we can't do any worse 
than we currently have since there is no Federal standard.
    Again let's look at the very serious consequences. Without 
privacy protections, people are going to withhold information 
from their doctors because they are going to be afraid the 
doctor will have to convey it to somebody else, and they know 
the protections aren't in place. They will withhold information 
or they may lie to their doctors; they may give inaccurate 
information, which will undermine the ability of the doctor to 
give an accurate diagnosis. The other problem is that doctors 
may actually lie in submitting the claim forms, and I don't 
mean to suggest doctors are doing ill here, but they are trying 
to protect their patients, so they often put inaccurate 
diagnoses on the claim forms.
    Or I think the more horrible consequence is that people 
will not seek health care. They will stay away from health care 
altogether because of fear, and we see it in the HIV area and 
reproductive health; people are afraid of going to the doctor 
at all in terms of discrimination and employment and insurance, 
that their families may find out, reporters, marketers. The 
personal consequences are very real, but I think the societal 
consequences are even more startling and one that we tend to 
overlook, which is that public health will be undermined if we 
don't have accurate information; and research will be 
undermined if we don't have accurate and reliable information.
    So while the public health people and researchers often say 
we are worried about how privacy rules will affect our work in 
improving health care, we really need to look at the cost of 
not protecting privacy. Privacy, I believe, is a necessary, 
vital partner in other health care goals. It is not a barrier, 
it is not an impediment, but it is a partner in achieving other 
health care goals.
    I appreciate your holding this hearing. Thank you.
    Mr. Horn. We thank you for the most helpful statement.
    [Note.--A copy of the report entitled, ``Privacy and Health 
Information Systems: A Guide to Protecting Patient 
Confidentiality,'' can be found in subcommittee files, and may 
be obtained by calling (206) 682-2811.]
    Mr. Horn. Dr. Palmisano, member of the Board of Trustees of 
the American Medical Association.
    Dr. Palmisano. Thank you Mr. Chairman and members of the 
committee. My name is Donald Palmisano, and I am here 
representing the American Medical Association and some 300,000 
physicians and medical student members. I also bring to the 
discussion today my 26 years' experience as a surgeon 
practicing in New Orleans. We appreciate the time and energy 
the subcommittee is devoting to this important issue.
    Let me begin by stating medicine's underlying premise in 
all of the discussions of patient confidentiality. The patient-
physician relationship is first built on trust. Confidentiality 
of communications within this relationship is the cornerstone 
of good medical practice and good medical care. Patients must 
feel safe in disclosing to their physicians personal and 
sometimes embarrassing facts and information that they do not 
want others to know. We, as physicians, need this information 
to provide the best and most appropriate medical care. Without 
such assurances, patients may not provide the information 
necessary for proper diagnosis and treatment. The cost of 
medical care can increase when physicians do not have such 
information.
    Our professional and ethical responsibility is outlined in 
our AMA Code of Medical Ethics and it is to keep our patients' 
confidences, and it is no different because the medical records 
are stored electronically rather than on paper. But the 
evolution of electronic medical data has intensified our 
existing concerns about access to and, now, even commerce in 
patients' confidential medical information.
    The growing number of third parties demanding information 
has eroded our patients' confidence that information that they 
share with their doctor is going to help in their individual 
care. Any number of parties will give you arguments for a vast 
array of supposedly compelling health and public safety reasons 
as to why they need to know such private information.
    But a need is not a right, and I would like to emphasize 
that, a need is not a right. And because it may be happening 
now, doesn't make it right.
    AMA policy clearly states that conflicts between a 
patient's right to privacy and a third party's need to know 
should be resolved in favor of the patient except where that 
would result in serious health hazard or harm to the patient, 
or others; and we would suggest that all bills studied in the 
Congress use that guideline so that the patient is the primary 
protector of his or her own medical information, and not 
someone else's right, desire, or belief in their right to get 
that information.
    We believe that patients have a basic right of privacy of 
their medical information and records. We believe that the 
patient's privacy should be honored, unless the patient waives 
it in a meaningful way or in rare instances of strongly 
countervailing public interests. And by ``meaningful,'' we mean 
informed and not coerced.
    We believe that you should limit the information disclosed 
to that part of the medical record or abstract necessary to 
fulfill the immediate and specific purpose--that is, no fishing 
expeditions.
    While you have our written statement, which goes into more 
detail, I would like to highlight a few points. First, we 
cannot forget that the primary purpose of the medical record is 
to provide a reliable tool and to provide clinical diagnosis 
and treatment for patients. Patients should generally have 
access to information from their medical record. There are few 
exceptions to protect the mental or physical safety of the 
patient, but the physical record is the property of the 
physician or provider, and this is where control of most 
disclosures should emanate.
    Second, on the issue of consent, a patient's first consent, 
generally for treatment or payment, should not automatically 
apply to subsequent disclosures unless the patient specifically 
and freely waives defined rights. Insurers, of course, need 
basic information to pay claims and have legitimate need for 
information to conduct utilization review and quality assurance 
and to monitor for fraud and abuse. The AMA cautions against 
categorizing these activities as payment for treatment purposes 
when they do not go directly to paying for a specific 
individual's treatment.
    Patients generally believe that their signature releases 
personal information for their direct and specific benefit, 
overly broad and legislative definitions should not exploit 
patients' lack of knowledge regarding complex information 
systems. For consent to be truly voluntary, it must be knowing 
and that includes a patient knowing for what purpose their 
records are being sought. Patients should not be coerced into 
divulging any and all medical records, either their own or 
their families by way of a nonspecific consent signed upon 
enrolling in a plan as a condition of insurance payment, nor 
should physicians have to sign agreements with insurers to 
produce records without that patient's consent.
    Third, exceptions to the requirement for patient consent to 
disclosure should be minimally and narrowly drawn.
    Last, whenever possible, medical information used for 
research purposes should have all identifying information 
removed, unless the patient specifically consents to the use of 
his or her personally identifiable information.
    In conclusion, the fact that we have vastly improved 
technology to collect, sort and analyze patients' medical data 
does not diminish our ethical obligation to protect our 
patients' privacy. We all hear seemingly compelling arguments 
for efficiency and technological potential, but we cannot allow 
the vigorous standards of confidentiality required by the 
medical profession's ethical code to be subverted once the 
record gets into others' hands. We have to work to fit the goal 
of efficiency within the larger framework of patient privacy, 
not the other way around.
    Thank you again for inviting the American Medical 
Association to testify. I am happy to discuss our testimony in 
more detail, and the AMA is happy to work with the subcommittee 
to address concerns. Thank you very much, sir.
    Mr. Horn. We thank you. That is a very well developed 
statement, as I read it earlier.
    [The prepared statement of Dr. Palmisano follows:] 
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    Mr. Horn. Dr. Johns is President of the American Health 
Information Management Association, a rather large 
organization. Give us a little bit about its history. I know 
you mentioned the numbers in your second paragraph, but I think 
you could educate most of us about the extent of your 
membership.
    Ms. Johns. I will be happy to, Mr. Chairman.
    Thank you, Mr. Chairman and members of the subcommittee. 
AHIMA appreciates the opportunity to appear before the 
subcommittee today in support of the Fair Health Information 
Practices Act. AHIMA is an organization that was established 69 
years ago and a professional organization that represents 
37,000 credentialed health information managers. We have over 
200 educational programs throughout the country, in colleges 
and universities which prepare accredited record technicians 
and record administrators.
    Our organization, a professional organization, was 
originally established for the purpose of managing, storing, 
and protecting health information, and we have a long tradition 
with the issues regarding confidentiality and privacy, and a 
principal goal in the mission of our organization, since 1929, 
for protection of health information. So certainly, we are not 
new to the issues that are being posed today.
    We are the credentialed specialists who manage and protect 
patient health information. We work in a variety of health care 
institutions and health-related organizations, and we are the 
professionals that are responsible for handling requests for 
information from third-party payers, from employers, from 
researchers, attorneys, other health care providers, local, 
State, and Federal agencies. Our members ensure that 
information is disclosed pursuant to valid authorizations and 
pursuant to statutes, regulations, and court orders. Our 
efforts, however, to protect health information have been 
complicated by a lack of Federal pre-emptive confidentiality 
legislation.
    Assuring confidentiality is important because it makes 
patients feel comfortable enough to communicate openly with 
their health care providers. Assuring confidentiality is also 
important because it makes patients feel comfortable that the 
information they are providing health care providers is going 
to be protected. Unfortunately, current regulations and the 
physician-patient privilege do not offer patients real 
protection. Therefore, AHIMA believes H.R. 52 is a solution to 
this dilemma, first, because the bill establishes a code of 
fair information practices, and, second, because it provides a 
uniform national health standard for the use and the disclosure 
of individually identifiable health information.
    It is true that some States have enacted confidentiality 
legislation, but there is little uniformity with their 
approaches. Most statutes do not even address the issue of 
redisclosure of health information, and penalties for its 
misuse are lacking. Protections also vary according to the 
holder of the information, and for different types of 
information.
    For instance, several States have recently enacted genetic 
privacy legislation. Segregating and creating special 
protections for specific types of information, such as mental 
health or genetic information could result in inadvertent 
breaches of confidentiality. For that reason, AHIMA recommends 
that comprehensive confidentiality legislation cover all types 
of health information.
    One of the greatest threats to patient privacy is the 
increasing and growing demand for data, and while there are 
Federal regulations that offer strong protections, they are 
limited in their applicability. For example, the Federal 
Privacy Act of 1974 was designed to provide citizens some 
control over the information collected on them by the Federal 
Government. However, this law does not apply to the private 
sector. There are also Federal regulations in regard to alcohol 
and substance abuse, but these only apply to Federal or 
federally funded facilities that offer treatment for alcohol or 
substance abuse.
    As a result of the ongoing public policy debate, during the 
past several years, Congress and the general public have come 
to a consensus there is a need for Federal confidentiality 
legislation. Reports of the Institutes of Medicine and from the 
Office of Technology Assessment and, most recently, the 
National Research Council have all underscored the need for 
Federal action.
    In order to address the need for Federal legislation, AHIMA 
in 1993 drafted model legislative language that outlined a code 
of fair health information practices. This language was 
published in the Office of Technology Assessment report, 
protecting privacy in computerized medical information as a 
model code, and was used in drafting the Fair Health 
Information Practices Act.
    There are a number of key provisions in the model language 
that are essential to any legislation governing the collection, 
use and disclosure of health information. These include, first, 
a patient's right to know and access his or her own health 
information; the provision--providing provisions for 
restrictions on information used and provisions for criminal 
and civil penalties to protect the misuse of information. We 
are pleased to note that H.R. 52 covers all of these key 
provisions.
    We are also pleased to note that H.R. 52, in sections 101 
and 102, provides individuals with the right to access and copy 
the personal health information and also to amend errors as 
well. Currently, only 28 States allow patients access to their 
health information, and even within these particular statutes, 
they are not uniform.
    We note, however, one principal concern with sections 101 
and 102. These require health information trustees such as 
health benefit plan sponsors, health care providers, health 
oversight agencies and public health authorities to permit 
patients to inspect and copy their records. They also require 
that these trustees correct or amend protected health 
information upon request, or take certain actions if they 
refuse to make such changes.
    Because medical records are the physician's or health care 
facility's legal record, they are an important element of 
patient care, and we urge that the language be amended that 
only providers be permitted to correct health information. In 
other words, information should be corrected at its source.
    AHIMA believes that the passage of pre-emptive 
confidentiality legislation is imperative, and we thank the 
subcommittee for holding this very important hearing. We 
sincerely hope that our testimony will prove helpful. In 
addition to the points we have made here today, we would be 
more than willing to offer our technical comments to you, as 
you continue to discuss the provisions of the Fair Health 
Information Practices Act.
    [The prepared statement of Ms. Johns follows:] 
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    Mr. Horn. Well, we appreciate that very thorough statement, 
and we will take you and others up on that because this is a 
continuing dialog. We don't claim to know it all up here. That 
is why we have hearings, and in hearings we try to bring out 
what are the similarities and differences.
    Let's start with you, Ms. Goldman. From what you heard from 
two of your colleagues, where do you differ from them?
    Ms. Goldman. Well, I wouldn't want to pass up the 
opportunity to find differences with my colleagues, but in 
truth, I am extremely heartened by how much agreement we all 
have. It has been the true history of this issue that all of us 
at this table, representing the various organizations, have 
worked closely together and believe that we must have health 
privacy legislation. On the broad principles, it seems to me 
that we have very strong agreement and we have worked together 
over the years to try to fashion some kind of a consensus. I am 
not sure there is vast disagreement or even significant 
disagreement at this time.
    Mr. Horn. So you are OK on the principles, but it is the 
nitty-gritty that sometimes brings the Congress to a halt. Does 
any of the nitty-gritty bother you?
    Ms. Goldman. There are probably some vast differences among 
folks who are not at this table, but I think if it were left to 
the three of us we could probably come up with something----
    Mr. Horn. The next panel is going to join us, and we asked 
you all to stay here to get a dialog between the six of you; 
but I thought we would do some of it first so we could have a 
few things that are strictly in your testimony.
    Ms. Goldman. I think what is remarkable about this issue 
is, you have organizations such as the American Medical 
Association and the American Civil Liberties Union and the 
Center for Democracy and Technology. You have such a broad 
range of groups who are involved in various aspects of the 
health care system who realize, from a very first-hand 
knowledge, how important it is to have enforceable rules.
    Mr. Horn. Dr. Palmisano, how about the AMA? Where do you 
agree and where do you disagree about what you have heard by 
the fine witnesses on either side of you?
    Dr. Palmisano. Well, I would second what we just heard. I 
think we are in basic agreement.
    What I would like to emphasize is, I think the patient 
rights need to be superior to the Government's need to know or 
some other third parties need to know and we should follow 
established procedure. Certainly nothing less than probable 
cause to get into the medical record, and we must always 
protect that right; and we think very strongly the code of 
medical ethics is something that we rely on very heavily and it 
states very clearly that the patients' rights are primary. I 
believe our society is a society that has decided we go to the 
patient first. It is a philosophical base where the patient has 
the right to make a decision, even if it is the wrong decision, 
as opposed to teleological society, where we do what we think 
is right for the patient and the patients' desires become 
secondary. So I think we are all in sync on these issues.
    We are concerned about some aspects in the bill. We are 
concerned about the definition of ``health oversight agency'' 
seems overly broad. We understand there may be some agencies 
that look at this with proper credentials, but maybe there are 
agencies like XYZ that is a for-profit corporation that gets a 
hold of this information.
    We are very concerned about anything that would allow 
people who don't have the knowledge and the ethical base to 
protect the patients' rights having control of these records. 
We are concerned about anything that would link to Social 
Security numbers, where someone could get in. We are concerned 
about crackers or perhaps hackers getting in this information, 
if it is a clearinghouse. We see the Central Intelligence 
Agency, recently in the news, reports where some hacker--
cracker, I am not sure what the right term is.
    Mr. Horn. You can use both, if you want.
    Dr. Palmisano. The evil people that get in without our 
permission--and they said the Central Stupidity Agency; and we 
think that is one of our most secure and secret agencies, if 
people can get through their fire walls, that is what bothers 
us. And once people know this information is available in 
electronic form on a central data base, we think there will be 
great incentives. Right now they are just people doing it to 
show they can, quote, ``beat the system,'' perhaps, but there 
will be people selling this information.
    So we are very concerned. We appreciate the opportunity, 
and I will be happy to deal with any specific questions. Thank 
you.
    Mr. Horn. Dr. Johns, what is your feeling based on the 
testimony your two colleagues have given? Any agreement, any 
disagreement?
    Ms. Johns. Very much agreement, Mr. Chairman, and I think 
as a result of the ongoing policy debate, which occurred over 
the past several years, we have come as a group to a consensus 
about the need for this type of Federal confidentiality 
legislation.
    Mr. Horn. Let me ask a few questions before we go to the 
next panel.
    Ms. Goldman, some patients may be willing to volunteer 
information about themselves or even waive their right of 
record confidentiality if the waiver is incorporated into an 
offer from a health care marketer to provide free samples or 
coupons that might fit the patients' needs. Is a purpose of 
H.R. 52 to discourage that activity, and should it or shouldn't 
it?
    Ms. Goldman. I think you raise one of the critical issues 
in privacy legislation, which is consent. It's usually the 
cornerstone of any piece of privacy legislation, as you may not 
use the information in an unrelated way, without the 
individual's consent.
    And as we heard from other testimony, consent is a big 
term, but it doesn't mean anything if it is not voluntary, if 
it is not informed. It is not meaningful if it doesn't have 
those qualities to it. And I think the way to ensure consent is 
meaningful and informed and voluntary is to make sure that 
obtaining that consent is not a condition of receiving certain 
benefits and services.
    I should be able to go to a doctor and say, I do not want 
you to release this information to a researcher, or I don't 
want this information to be released to another doctor without 
my knowledge; and I should still be able to receive treatment 
even if, as Dr. Palmisano said, it may not be in the patient's 
best medical interest. That is a decision he or she should be 
able to make without suffering the consequence of not getting 
care.
    Most people who sign the broad waivers, when they go to get 
health care, the broad waivers that say this information may be 
released for any purpose to anybody under any circumstances--
and I have signed many of them recently since I had surgery on 
my foot a few months ago, and you sign them because you know 
that it is not a choice. These are not real choices people are 
making; and what we should do is build in a way of removing the 
authorization process or consent process from the receiving of 
certain benefits and services, and then I think we will see.
    In fact, the Video Privacy Act, which I keep raising as an 
example of what we can do when there is consensus in the 
Congress, says you may not disclose without permission and you 
may not request that authorization as a condition of giving 
someone a video, so can't we do the same thing here?
    Mr. Horn. Any comments either of you have on that question?
    Dr. Palmisano. Mr. Chairman, I would just agree with that. 
In my personal practice over the years, it is not uncommon to 
get a request about treatment I have given to a patient that 
may be unrelated to the treatment I just gave, and they make a 
photocopy of this blanket consent. It is our policy and has 
been ever since I started medical practice 26 or 27 years ago 
to always call the patient, and if the patient is not 
immediately available, I have my staff continue to try and say 
this information they want is really not related.
    I want you to know what is in your medical record. If you 
have questions, you are welcome to come by and look at it, but 
you did confide to me some information that has a bearing on 
why you might have this ulcer, because of the stress, the 
family problems at home, and I don't believe that is anybody's 
business, unless you want it to be somebody's business.
    So patients feel rather intimidated. They are afraid they 
are going to lose their insurance, and now in this era of 
managed care, they could really have additional pressure put on 
them. They feel rather intimidated, so I think what we have 
advocated today and what you all are very wisely looking into 
is in the patients' best interest.
    Thank you.
    Mr. Horn. Dr. Johns, any comments?
    Ms. Johns. We fully agree with the statements that have 
been previously stated.
    Mr. Horn. OK. Let's move to the disclosure to spouses. I 
understand physicians are often faced with difficult choices in 
sharing that information about the condition and care of a 
patient with spouses and family members. Assuming a patient had 
not previously authorized disclosure nor prohibited it, how 
would H.R. 52 affect the ability of a health care provider, 
such as physician, to share information with a spouse, and what 
is your feeling on that, any one of the three of you?
    Ms. Goldman. Spouses are not necessarily treated 
differently from others who are requesting information. The one 
area where there may be slightly different treatment is called 
the next-of-kin provision, which allows a doctor to disclose to 
the next-of-kin, which could be a spouse, it could be a cousin, 
it could be someone with whom the individual has a significant 
relationship. It allows the physician to disclose to that 
person, for instance, after surgery, unless the individual has 
objected and said, I don't want you to talk to my spouse about 
my condition or about the results of my surgery, and so the 
spouse still has that option.
    I assume you would be able to talk with more knowledge 
about how it works in the real world, but there is usually a 
more comfortable relationship there unless the individuals 
suggest they don't want that shared. I think H.R. 52 deals with 
that pretty well.
    Dr. Palmisano. Well, I think this is a balancing act and 
something we face all the time. If I am examining a patient--
let's say, a woman and she requires an operation--and she says, 
``please allow my husband to come into the room during this 
discussion,'' then I know that she wants her husband to know 
everything and would want him to know everything in the 
immediate postoperative period, perhaps, and so on, so there is 
no problem.
    But if someone comes to me, man or woman, and I treat the 
individual, and someone calls up from another State and says, 
``Hi, I am the spouse,'' or whatever, I don't give that 
information out. There has to be identification, and I have to 
find out from the patient, ``Do you want me to release this 
information?'' Sometimes we find people are judicially 
separated, for instance; we don't really know they are 
judicially separated, and they are in the midst of a battle 
that would affect the division of their assets and so on, so I 
always go back to the patient.
    Basically, our reading of the next-of-kin provision on page 
35 is that they would be basically granted the right to give 
that information, unless the patient objected to that; and that 
is a balancing act that needs to be decided. So I don't know 
what is the correct answer to that.
    We always go back to the patient, and if the patient is 
unconscious, comes in from an automobile accident, for 
instance, in our State in Louisiana, there are provisions that 
state you can release the information to a next-of-kin. If 
someone is in a terminal, irreversible coma and hasn't made out 
a living will, we have a provision in many of the State laws 
that says the next-of-kin, if not judicially separated, is the 
individual that can make the decision whether or not to 
continue life-sustaining treatments if imminent death is there.
    Mr. Horn. Suppose it is a transmittable disease that could 
lead to death; does the spouse have a right to know?
    Dr. Palmisano. Well, of course that is under State law. In 
almost every State there is a reporting requirement. Some 
States require you name the individual; other States, they say 
you give the information immediately to the health officer, and 
if it looks like it could be something that could affect, for 
instance, someone with tuberculosis, with a productive cough 
that has the actual bacteria that causes tuberculosis, if that 
is being spread around, they need to know the name of the 
individual and so on. Our medical ethics say that you release 
the information if someone could do grievous harm to someone 
else.
    So you have to then make a decision. You advise the 
individual that it is best for you to disclose this, if you are 
talking about a sexually transmitted disease, such as AIDS, 
which usually is considered fatal, but now we have some drugs 
that may change our perspective on that. Then if the individual 
says, ``no, I am going to continue to do this,'' I think the 
physician has an ethical obligation to take the next step and 
decide whether or not you will transmit the information.
    First of all, you have to do it to the health officer, 
usually, in your State and call the individual. It is one of 
those ethical dilemmas that the physician needs to make sure 
that he or she really has all the facts. If someone had a 
plague that was transmittable by just exhaling and so on, we 
would need to isolate that individual; and if the individual 
says, I am out of here, it would be the physician's obligation 
to notify not only the next-of-kin, but the health authorities, 
so we wouldn't have a plague throughout the Nation.
    Mr. Horn. Dr. Johns, any comments?
    Ms. Johns. No, basically the comments and the sections 
within H.R. 52 that have been already been elaborated on, we 
feel comfortable with.
    Mr. Horn. Let me move to another area then on correcting 
patient records. Dr. Palmisano, H.R. 52, subtitle (a) permits 
patients to inspect their health care records to make 
corrections. With what frequency do patients currently ask you, 
or other doctors, to see their records and attempt to make 
corrections? And to what degree does that even occur?
    Dr. Palmisano. Mr. Chairman, that is a rarity. It is not 
unusual for people to request a copy of the records because 
they may be moving to another State, but it is a rarity for 
someone to come in and say--in fact, in 26 years of private 
practice, I have never had anybody come in and say they wanted 
to change the record. They see me do the record for the office 
visit right in the office, because after I do the history and 
physical examination, I usually start writing in front of the 
patient and ask if they have additional questions, and I tell 
them of their lab reports and so on, and offer a copy to them.
    So I have had people ask for copies of the records, and we 
give them that information. And in the field I am in, in 
surgery, it would be rare for me to have something in there 
that might affect the health of the individual, their mental 
health, such as psychiatrists might have. There might be 
information that if the patient got that information 
immediately--and Dr. Hoge can address that better--but the 
patient may get even more depressed and commit suicide. So it 
is a rarity in actual practice, but there is no hesitation on 
our part for the patient to get a copy of the record.
    We believe that the record is the record of the physician, 
and certainly we wouldn't want to give the original record and 
have them start changing, and mark out things and so on. But if 
they want to give me additional information--it is not 
uncommon, they would say, Doctor, I would like this medicine 
listed that I have here put in my record; I would say, 
certainly, and we will photocopy it and give them a copy back, 
and we will keep the copy, the original or the copy, whatever 
they prefer, in the record.
    It is a rarity that someone would want to take my records 
and change what is in my record.
    Mr. Horn. What State do you practice in?
    Dr. Palmisano. I am in the State of Louisiana.
    Mr. Horn. Does Louisiana have a law that relates to this 
type of situation, or do you follow an AMA protocol, or how do 
doctors sort of make up their minds how to handle the 
questions, rare though the question might be?
    Dr. Palmisano. Specifically, we follow the AMA ethical 
guidelines throughout the Nation, the people who are members of 
the AMA and many physicians who are not members also follow, 
whether or not they have sent their dues in. This seems to be 
the bible of what is the right thing to do.
    In Louisiana, on that specific issue--I don't recall if 
there is any--well, I take that back. We have a statute, in 
fact, patients have the right to get their record at any time. 
They can come in and ask for the record, and the record would 
be given to the patient. If an attorney sends a subpoena in 
Louisiana--and this law changes every year, but now it will 
change every other year, because Louisiana now will have a 
fiscal session 1 year and everything else the other year. But 
between the medical association, the trial lawyers and 
everybody else, there is a battle on how to get the record. 
What we have is a very rigid way of getting the medical record. 
A patient can come, request the record, sign for the record and 
get a copy of the record.
    If an attorney wants the record through subpoena, that 
attorney is obligated to send a notification to the patient, if 
it is an adverse attorney, to the patient or the patient's 
attorney; and after 10 days to 15 days--it changes from year to 
year--if there is no protest at the court level, then the 
physician is allowed to give the record out. But you cannot 
give the record out until that number of days have passed and 
you also have this notification; it is an affidavit that the 
attorney must submit.
    So we are very cautious about who can get the record.
    Mr. Horn. Do you, in your own practice, or do doctors you 
know, have they ever refused to grant a patient's request to 
access to the record; and if so, what is the policy of the AMA 
on that?
    Dr. Palmisano. No, I don't personally know anyone who has 
refused to grant access of the patients to the record. I have 
seen situations where a patient said, don't give that record; 
and a subpoena came for the record, and the doctor says, what 
am I supposed to do; and they will usually call the legal 
counsel or the medical society or their professional liability 
carrier, and they all get together and try to work something 
out. They usually end up going to the judge and trying to 
explain the situation.
    But there is no problem in giving that information, and it 
is the policy of the AMA that the patient has a right to 
inspect his or her records, unless there is some overriding 
reason that might, as I said, in a psychiatric situation--my 
counsel here just pointed out that the patient has access 
unless in the professional judgment of the medical doctor it 
would harm the patient--then it goes to some designee, for 
instance. And this usually occurs in a psychiatric situation, 
and it is not only in our policy, but it is also in our code of 
medical ethics book and the patient has a right to that 
information.
    We deal with informed consent, Mr. Chairman, all the time, 
and it is a very strict law of informed consent that has 
evolved throughout the Nation and especially in Louisiana.
    Mr. Horn. If we use an analogy to an audit report of an 
organization, often when an auditor makes a statement--let's 
say it is a Government auditor--the agency would be given the 
right to respond to that statement; but both items would remain 
in the record, in other words, the audit initiation and the 
agency response.
    Now, in terms of using medical information--and we talk 
about the patient's right to correct the record--would that 
mean we simply add, as you suggested earlier, another sheet of 
paper to the record, that this is the patient's view of this 
record, or would there have to be integration in what is 
presumably your record on the patient?
    Dr. Palmisano. Well, the original record is never changed 
unless there is an error in the record. For instance, if the 
physician wrote down the patient was on XYZ medication and, in 
reality, the physician did not hear that correctly and the 
patient says, gee, I looked at my record and I am not on that 
medication, then we don't want to go back and alter the record 
incorrectly. We want to do it in the approved methodology and 
make a new note, put an asterisk or some note saying, this is 
an error up above, put a line through it, date it, initial it; 
and then go down to the next area for writing and say, this 
area was corrected, the patient brought it to my attention, the 
patient is on this medication and not what we wrote. You would 
then, just move on and that would be the way to correct it.
    Now, on the other hand, if what the physician found was 
absolutely correct, such as the physician did an abdominal 
palpation and found a pulsating mass or suspected it to be an 
abdominal aneurysm, that was the physician's impression, based 
on the history and the physical examination at that time, the 
symptoms in the physical examination. So if the patient came in 
and said, ``I want that changed, I don't want that on my record 
because I am going to such and such--I am applying for new 
insurance,'' the physician could not ethically or medically or 
legally do that. That would be wrong.
    And if the patient wanted to insert that in there, I 
personally would have no objection; I don't think it would be 
in the patient's best interest, but I would put it in the 
record and say, I will make an attachment page. If the patient 
came in and wanted the record changed, I don't believe that is 
the appropriate thing to do.
    Here is the patient's statement and put it in there.
    Mr. Horn. Any comments on this aspect of record changing, 
correction or revision?
    Ms. Johns. The general practice, just as Dr. Palmisano has 
stated, where there is an error in the record, it is corrected 
by putting a line through the error, indicating that there is 
an error, and writing a correct entry for that; and the issue 
of the amendment to the record is common practice. Good 
information practice is to include the amendment to the record, 
if the patient and the health care provider are in 
disagreement.
    Mr. Horn. Is that practice sort of the basic code of your 
organization, and is that actually carried out in most State 
laws with which you are familiar?
    Ms. Johns. It is a practice. Our best practice--our 
association puts out practice briefs, and that procedure that I 
have just stated is included as best practice. Whether or not 
it is carried out in each State would be another issue, but as 
far as our credentialed, certified people, this is what we 
would expect.
    Mr. Horn. Did you have a comment on that?
    Ms. Goldman. Just a small comment.
    While I appreciate what the code of ethics is and how, in 
particular, Dr. Palmisano operates in his practice, my recent 
experience has been a little disconcerting.
    I was in a surgeon's office recently where the patient in 
front of me requested a copy of her medical record and she 
said, ``May I get a copy of my medical records, please?'' And 
the person behind the desk said, ``To whom should we send the 
record?'' And she said, ``I would like a copy for myself.'' And 
she said, ``I can't release the record to you, but if you would 
like to tell us who you would like us to send them to, we will 
make sure the doctor gets the record.''
    She went through a huge struggle, and I then couldn't help 
myself and suggested there was a law in the District of 
Columbia that required that she get a copy of her record. And 
the nurse was furious and said, ``That is not our policy in 
this office, we don't release records to the patients;'' and my 
understanding, in talking to the nurse later on and the 
doctor--who, by the way, I chose for his surgical ability and 
not his adherence to privacy principles--I was really surprised 
to find that at least in the District, there is something that 
is considered to be common practice which is not to give the 
record directly to the individual, even though there is a law 
that requires it.
    So I think that, at least in my little experience, there 
may be a real disjuncture between what the code of ethics is 
and how people practice.
    Mr. Horn. On, quote, the record, unquote, what about a 
xerox of the record? Are they worried about the complete loss 
of the record? That is a legitimate worry for a doctor.
    Ms. Goldman. I assume so.
    Mr. Horn. I assume they would make a xerox to send it even 
to another doctor, rather than lose that record. I would never 
release a record like that.
    Ms. Goldman. The issue, at least in the circumstances I am 
giving, is not so much whether it was xeroxed or not xeroxed, 
but that the practice, the policy of that office was not to 
release directly to the patient.
    Mr. Horn. I understand that; and I think the law is right 
and the doctor's office was wrong, that the patient ought to 
have a right to know, even if they can't translate the doctor's 
handwriting and even if they don't know what some of the words 
mean.
    Let me ask you, Dr. Johns, about audit tracing. Many 
information technology systems can incorporate these records, 
handling audit trails that maintain a log of each instance--
when each individual is looking at an electronic file. We have 
that argument in Government as to who had access to these 
files. This makes it possible to generate a list of each time 
and each individual who has looked at a patient's electronic 
record.
    How prevalent are such tracing procedures in existing 
health care information systems? Do they have that type of 
situation?
    Ms. Johns. With electronic information systems, there are 
usually provisions or functions for audit trails, and audit 
trails are used in various ways. It is not that they are 
included with the patient's medical record, but they are used 
as one mechanism in a total security policy; and I think that 
is important, to recognize that audit trails or tracings are 
one avenue by which you can protect or identify breaches of 
confidentiality or at least identify breaches of access into 
the record.
    A total security policy should include good policies, good 
procedures, very good employee education and training, in 
addition to being able to select various types of technical 
types of mechanisms that can protect information in an 
electronic environment.
    Mr. Horn. I think one thing that worries a lot of us--and I 
remember the testimony very clearly when Mr. Condit chaired the 
subcommittee under the Democratic Congress, one of our 
colleagues from New York had had her records stolen, and 
entered into her political campaign. In other words, her 
records were used against her.
    That was a very serious situation, and I think all of us 
worry about the person who has access to those records in a 
doctor's office, in a hospital, in an insurance company, 
whatever the case may be. You could have a disgruntled employee 
who decides to take copies of the records of the mayor of the 
city and the biggest developer in town. They would be subjected 
to blackmail are subjected to revelation of an embarrassing 
situation by sending the information to the local newspaper.
    Now, what kind of audit system do we have in one's office 
to say, who has access to these files? As I go into offices, 
what I see are rows and rows of paper folders. And often when I 
go in, there is nobody behind the desk; if it is the noon hour 
or whatever, somebody could walk through and say, that is an 
interesting folder, I think I heard her on TV the other night. 
So what do we do about that?
    Ms. Johns. In relationship to access to paper records, 
normal practice is that when records are released, there is a 
log that is kept as to who has requested that information and 
for what purpose. This would be occurring in hospital medical 
records departments.
    In regards to the instance that you were giving, as far as 
like an employee who might want to access records, if they felt 
they were going to be terminated, another good practice is that 
individuals who are going to be terminated, their access 
rights, in addition to audit trails, need to be terminated 
prior to them being informed of their termination, or at the 
same time, so that you have dual types of counterbalances, as 
far as protecting that information.
    Audit trails, too, can have intelligence built into them so 
that flags are set as to identifying potentially suspicious 
types of activity. For instance, if an employee of the health 
care facility was being treated in the hospital, any accesses 
to that record would be monitored and flagged, if it would be a 
health care provider that would be looking at the record who 
didn't have the direct patient contact relationship, or if it 
would be an employee within the institution someplace, where 
they should not have access.
    So I think an important consideration with audit trails, as 
well, or tracings, is that there is some mechanism by which 
potentially suspicious activities can be identified.
    Mr. Horn. Should hospitals, insurers, doctors, and other 
health care providers be required to incorporate such tracking 
procedures in all the information systems?
    Ms. Johns. I think that is an issue you have to look at in 
context, and again, as I mentioned, audit trails are only one 
technical aspect of a security program. You have other aspects, 
such as passwords, access levels, audit trails, certainly, and 
policies and procedures, as well as employee education and 
training.
    So, I think you really need to look at the specific 
application--how large the institution is, for instance--in a 
smaller physician's office practice, the need for audit trails 
when you have three people working in an office may really not 
make much sense, as opposed to an institution where you have 
5,000 individuals working and more people who have access, and 
clearly all of them would not be involved with the direct 
patient care.
    So I think it needs to be done, all of the guidelines need 
to be presented, and then a mechanism of procedure for a whole 
security program needs to be developed. I think that is going 
to be varied from institution to institution.
    Mr. Horn. One last question before we move to the next 
panel concerns administrative simplification.
    One of the objectives of the Kassebaum-Kennedy bill, which 
was enacted into law, as I mentioned in my opening statement, 
was to foster administrative simplification. This includes 
creating common definitions for data elements and coding 
practices.
    Three weeks ago, this subcommittee heard testimony on the 
medical transaction system of the Medicare operation, and the 
Department of Health and Human Services and their efforts to 
develop a common provider identification number. Are we making 
progress toward streamlining health care administration 
practices and what barriers continue to exist? What do you see 
happening in that area, Dr. Johns?
    Ms. Johns. As far as barriers in electronic patient 
records?
    Mr. Horn. Yes, and just how far are we from it.
    Are we getting into standardization based on software of a 
particular vendor, or is that software related to the best 
practices of your organization, the AMA and others?
    Ms. Johns. I think one very large barrier--and it has been 
cited by other reports--the Institutes of Medicine and their 
computer-based patient record report even back in 1991 cited 
one of the biggest barriers is lack of standard, and a barrier 
we certainly are experiencing is the barrier in regards to 
confidentiality and having Federal legislation in regards to a 
standard, uniform practice. And so, without some standard, 
uniform practice, it makes it very difficult to either transfer 
information--we have problems with standards in vocabularies 
which, of course, agencies or groups like the National Library 
of Medicine are certainly working on, other groups like HL-7 
and ASTM standard organizations are working on. I think that, 
because HIPA requires the Secretary of Health and Human 
Services to adopt standards for national providers, 
identification, payers, and patients by February 1998.
    We feel that this is a very good first step in helping us 
get the standards that we need to build a national information 
infrastructure, and I believe the NCVHS is currently holding 
hearings on these issues, and additional information will be 
available later this year, which certainly we will comment on 
at that time.
    Mr. Horn. Well, we thank you for your comments on this 
series of questions.
    We are now going to ask panel III to come forward and sit 
with you. You can relax for a while and then we have some 
comments, questions for both panels II and III. So if Dr. 
Gabriel, Drs. Andrews and Hoge will come forward, we will 
appreciate it. If the new witnesses will stand and raise their 
right hands.
    [Witnesses sworn.].
    Mr. Horn. All three witnesses have affirmed.
    Let's just go down the line, the way the agenda is.
    Dr. Sherine Gabriel, Department of Health Services 
Research, Mayo Clinic, representing the Healthcare Leadership 
Council, is first.

    STATEMENTS OF DR. SHERINE GABRIEL, DEPARTMENT OF HEALTH 
  SERVICES RESEARCH, MAYO CLINIC, REPRESENTING THE HEALTHCARE 
LEADERSHIP COUNCIL; DR. ELIZABETH ANDREWS, GLAXO WELLCOME INC., 
  REPRESENTING THE PHARMACEUTICAL RESEARCH AND MANUFACTURERS 
   ASSOCIATION; AND DR. STEVEN KENNY HOGE, CHAIR, COUNCIL ON 
   PSYCHIATRY AND LAW OF THE AMERICAN PSYCHIATRIC ASSOCIATION

    Dr. Gabriel. Mr. Chairman, members of the committee, I am 
Dr. Sherine Gabriel, a physician and researcher at the Mayo 
Clinic. Thank you for the opportunity to testify before you 
today regarding the issue of medical records confidentiality.
    I am here this morning, as you just heard, on behalf of the 
Healthcare Leadership Council. My testimony, however, will 
reflect my own perspectives as a health care researcher. I will 
address two fundamental questions: What is the importance of 
medical records-based research to the public, and what is the 
impact of legislation restricting access to medical records on 
such research?
    I am privileged to work at a world-renowned medical 
institution. Mayo Clinic's international reputation is a center 
of excellence in medicine, which grew out of the commitment of 
our founders, Drs. Will and Charlie Mayo, to integrate medical 
research and education with clinical practice.
    The Mayo brothers perceived a duty to use the information 
from medical records to answer important public health 
questions, and in 1907, pioneered the concept of the unit 
medical record, where medical data on each patient is stored in 
one self-contained packet and kept in perpetuity. This led to 
the formation of the Rochester Epidemiology Project, the unique 
national research resource which has been funded by the 
National Institutes of Health for over three decades. It has 
resulted in approximately 1,000 scientific publications, 
analyzing thousands of diseases and medical conditions, and was 
ranked in the top 1 percent of all NIH proposals when it was 
last reviewed in 1995. The central element of the REP is access 
to the complete medical records of all residents within a 
geographically defined population.
    Medical records research is vital to maintaining and 
improving the health of the American public. Virtually every 
health hazard we know of today and countless medical advances 
have been identified using information from medical records. 
For example, if researchers had not been allowed to study the 
medical records of patients with unusual immune deficiency 
problems in the late 1970's, the characterization of the AIDS 
epidemic would have been delayed at a huge cost to the public's 
health. Similarly, characterization of Lyme disease required 
collation of information from the medical records of the 
children who presented with this condition in Lyme, CT.
    Other examples include examining the benefits and risks of 
estrogen treatment, the health risks of smoking, of dietary 
fats, obesity, certain occupations, studies leading to the 
development of vaccines for polio and measles, and studies 
showing the benefits of breast cancer screening. Without 
medical records research, problems such as the Thalidomide 
tragedy and the role of prostate specific antigens, the 
controversial tests for prostate cancer, could not have been 
resolved to the extent they are.
    You may have read in the newspapers last year that an 
outbreak of flesh-eating strep was identified at Mayo in 1995. 
Without access to the medical records of patients with these 
unusual infections, characterization of this syndrome and 
isolation of this deadly bacterial strain would have been 
delayed and over 100 school children, which our research showed 
were the unwitting carriers of this deadly germ in their 
throats, would have gone untreated.
    Let's now turn to the second question: What is the impact 
of legislation which restricts access to medical records? Such 
legislation, in my opinion, threatens the very existence of 
this entire category of medical research. This is because 
people who do not consent are systematically different in 
important ways from people who do.
    For example, people who don't consent may have had worse 
outcomes, or they may be less satisfied with their care. 
Studies which exclude these people would be biased; they would 
simply give the wrong answer.
    Moreover, while research is clear on the point that people 
who do not consent are systematically different from those who 
do, the direction and magnitude of those differences are 
completely unpredictable from study to study. So not only will 
such research result in the wrong answers, but it will be 
impossible to determine how wrong they are or in what 
direction. Thus, the reliability and validity of the findings 
from such research will be weakened.
    Inclusion of all qualifying individuals is the only way to 
ensure that accurate conclusions are drawn in public health 
medical records-based research. Of course, such research--and 
we recognize this--must be done while taking appropriate 
measures for maintaining patient confidentiality, including 
careful review and oversight by institutional review boards and 
strict adherence to procedures restricting access to patients' 
specific medical information.
    In closing, I want to comment briefly on what I believe is 
an important driving force behind all of this, which is the 
desire to keep personal medical information between the patient 
and his or her physician, the old Hippocratic idea. As a 
physician, a patient and a mother, I understand why this idea 
is so appealing; however, in a complex health care environment, 
it is an unattainable ideal.
    For example, in an average medical visit, the following 
individuals and groups must have access to the patient's 
medical record in order to best serve the patient: the 
appointment office; the registration desk; all physicians, 
physician assistants and nurses who provide care for the 
patients, as well as receptionists and secretaries; medical, 
nursing and other students and their mentors; all laboratory, 
EKG, x-ray technicians who perform the necessary tests; 
infection control officers who regularly survey medical records 
for reportable diseases; continuous improvements staff who 
strive to improve our health care processes; members of the 
marketing department who seek to ensure patient satisfaction; 
the business office for billing, the legal department, 
insurers, and third-party payers.
    After all of this is taken care of, a qualified nurse 
researcher, bound by the rules of the IRB and strict patient 
confidentiality regulations could be abstracting clinical data 
from the medical record which, after being stripped of patient 
identifiers, will be combined with similar data from hundreds 
of other patients to answer a specific public health question. 
The type of legislation we currently have in Minnesota 
influences only that nurse's access to the medical record and 
has no impact on any of the other points of access.
    Mr. Chairman, legislation must be carefully crafted, such 
that it ensures privacy of medical information, a very 
important goal, and does not hinder medical scientific 
research, as such interference will put the public's health and 
well-being at risk for serious harm.
    Thank you for your attention.
    Mr. Horn. Well, thank you. You have raised some very 
interesting questions that we are all going to have to grapple 
with.
    [The prepared statement of Dr. Gabriel follows:] 
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    Mr. Horn. Our next witness is Dr. Elizabeth Andrews--I hope 
I am pronouncing this right--Glaxo Wellcome Inc., representing 
the Pharmaceutical Research and Manufacturers Association.
    Dr. Andrews. Thank you, Mr. Chairman, and thank you for the 
opportunity to present our information. My name is Elizabeth 
Andrews and I am director of Worldwide Epidemiology at Glaxo 
Wellcome. I appear before the committee on behalf of the 
Pharmaceutical Research and Manufacturers of America, or PhRMA, 
to discuss our industry's views on data privacy in general and 
H.R. 52 in particular. I will summarize our full statement, 
which will be provided for the record.
    It is clear that patients deserve to have medical 
information kept in strictest confidence by those to whom they 
entrust it. PhRMA companies honor that trust. Patients also 
deserve answers to their unmet medical needs.
    This past year, the research conducted by our companies 
yielded 53 new FDA-approved medicines, new weapons in the war 
against 40 diseases, including AIDS, cancer, heart ailments, 
and mental illness. Our continued progress depends on 
aggressive, multifaceted research, including basic science that 
allows us to understand disease processes, practical research 
and development that enables us to discover and develop drugs 
to treat disease. Clinical trials that demonstrate project 
safety and efficacy, epidemiologic research that helps us to 
know how drugs perform in the real world, identifying and 
characterizing rare side effects or unsuspected benefits and 
health services research that leads toward improvements and the 
quality and cost-effectiveness of patient care. Federal policy 
must accomplish twin objectives, protecting the privacy of 
individual patients, while also protecting the continued 
viability of research that promotes improved health care for 
all persons.
    We believe these objectives can best be met by establishing 
uniform national requirements for the handling of medical 
information, defined to include genetic information. PhRMA has 
three primary suggestions that should be included in Federal 
requirements, but need specifically to be addressed in H.R. 52.
    First, the bill should recognize the process already in 
place under regulations adopted by FDA and 16 other Federal 
agencies to protect patient identifiable information used in 
biomedical research. Second, any new legislation or regulations 
should preserve researchers' access to the full range of 
potentially useful information about the incidence, prevalence, 
and outcomes of illness, as long as individual privacy is 
properly safeguarded. Only those data sources that directly 
identify individuals need to be kept confidential.
    Third, uniform national requirements should provide 
effective Federal pre-emption of State statutes. One of the 
compelling reasons for establishing Federal requirements is to 
provide a uniform set of rules that can be applied consistently 
from State to State for research. With respect to clinical 
trials, the current controls regulating FDA-monitored trials 
are quite strict.
    Through standard operating procedures, companies ensure, 
under Federal Rules, that personally identifiable information 
remains secure in the offices of individual health care 
practitioners who serve as the study investigators. The 
sponsoring company has access only to the information that 
needs to report to FDA, to verify results and to protect 
patient safety. We are concerned that H.R. 52 does not 
recognize the existing safeguards, the regulatory processes and 
oversight mechanisms that exist. The National Institutes of 
Health and the President's National Bioethics Advisory 
Commission are already charged with examining the IRB process 
and will develop recommendations for any improvements that are 
deemed necessary.
    PhRMA is also concerned that H.R. 52 would restrict access 
to certain data bases if they could be linked by codes to data 
sources that identify individuals. These data bases contain 
crypted identifiers and only through the use of a secure and 
confidential key can specific patients be identified. In some 
studies, it is necessary to use this key to link to other 
sources of information about the patients to create a richer 
more scientifically informed set of data. These type of studies 
need special precautions to ensure confidentiality of patient 
information, but these studies are not concerned with the 
identity of the patient, only with the scientific content, that 
a patient's information can contribute to a study.
    A wide range of health-related data could be affected by 
the provisions of H.R. 52, from Medicare, Medicaid and private 
insurance claims data, to State-collected vital and health 
statistics. Access to these data is important to generate 
answers to many of today's pressing health issues that cannot 
be answered through other mechanisms. Analyses of such data 
have contributed to demonstrating the higher risk of hip 
fracture in the elderly among those taking psychotropic drugs, 
quantifying the risks and benefits of hormone replacement 
therapy, documenting the underuse of beta blockers following 
heart attacks and the resulting increase in mortality and 
morbidity.
    Under H.R. 52, access to these data bases could be 
construed to require for each reanalysis of the data, either 
specific consent of each of the subjects whose medical 
information is contained in the data base or the approval of a 
certified IRB. Current regulations exempt such data from IRB 
review and informed consent requirements. Such requirements are 
unnecessary and do nothing to protect human research subjects, 
whose identity is not revealed in such data bases. Instead, we 
can protect patients' privacy without impeding research, 
through careful encryption of data, effective security for the 
key to encrypted data, tight security safeguards whenever 
confidential information is accessed directly, and guarantees 
of confidentiality by each individual who obtains confidential 
information.
    In conclusion, the research-based pharmaceutical industry 
respects the privacy of patients and the confidentiality of 
information about them. We could not conduct our research if we 
did not do so. We urge that any changes in Federal 
confidentiality requirements be drafted with great care to 
ensure that medical research can continue to yield new remedies 
and better ways of caring for patients. Thank you.
    [The prepared statement of Dr. Andrews follows:] 
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    Mr. Horn. Well, thank you very much. We appreciate that 
testimony. We now have Dr. Steven Kenny Hoge, the chair of the 
Council on Psychiatry and Law of the American Psychiatric 
Association.
    Dr. Hoge. Thank you. Mr. Chairman, I am Dr. Ken Hoge. I am 
testifying on behalf of the American Psychiatric Association, a 
medical specialty society representing more than 40,000 
psychiatric physicians nationwide. We are pleased to have the 
opportunity to discuss with you privacy protections for medical 
records.
    Patients come to physicians and entrust them with 
sensitive, private, personal, and sometimes embarrassing 
information because they believe that it will be used to help 
them. Physicians acting in the interests of their patients have 
controlled access to this information. As the guardian of 
confidential medical record information, physicians have 
protected patients' privacy. When third parties inappropriately 
demand access to medical records, physicians refuse. When the 
third party's right to access is uncertain, physicians have 
acted as sentinels, alerting patients that others are trying to 
seek the records.
    Physicians may take steps to protect records even in the 
face of legal pressures. Physicians have guided patients so 
that even voluntary disclosures of medical information minimize 
privacy intrusions. The physician's role as guardian of the 
medical record has been recognized in professional standards, 
impressed upon physicians in their training and acknowledged as 
legitimate by the courts.
    Recently, the traditional role of the physician as guardian 
of patient privacy has come under serious attack. Medical 
information has increasingly been put to uses that are not 
intended to serve patient interests. Third party demands for 
access have increased with attended risks to patient privacy. 
Electronic storage of medical information raises serious 
privacy concerns, since these systems, by design, facilitate 
access, transmission, and duplication of medical records.
    In our written statement, we have submitted several 
principles that are important to maintaining the privacy of 
medical records. Let me emphasize the following now. Medical 
data is generated for the care and treatment of patients and 
should be used to serve their interests. This can only be done 
if physicians continue to play an active role as guardians of 
the medical record.
    New information technologies should not be employed to 
stretch the limits of appropriate access that have been 
established in professional custom and law. Third, legal and 
ethical sanctions for violations of patient privacy should keep 
pace with developments in technology. Existing legal sanctions, 
such as breach of fiduciary duties, malpractice, breach of 
implied contract, all help to protect confidentiality and 
provider patient relationships. These protections, which have 
been established in professional standards, statutes and case 
law, should not be undermined.
    Appropriate legal sanctions need to be developed to cover 
insurers, managed-care entities, and medical record data banks 
that handle and store sensitive medical information but do not 
have the
tradition of the physician/patient relationship. Throughout 
your deliberations, please remember that patient privacy is 
fragile, and that once it is lost, it cannot be regained and 
its loss cannot be truly compensated. I will be happy to answer 
your questions.
    [The prepared statement of Dr. Hoge follows:] 
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    Mr. Horn. We thank you very much for that statement and I 
am going to put in the record the comments of the Health 
Insurance Association of America. They were invited to testify, 
but they were not able to make it, so their statement, without 
objection, will go in the record at this particular point. They 
raise some interesting questions, which we might get into 
during the question period here.
    Let me just ask all of you here, what type of penalties are 
appropriate for individual medical privacy rights and if 
someone violates them, what do you suggest? Let's just go right 
down the line.
    Ms. Goldman.
    Ms. Goldman. Thank you. Well, I certainly believe----
    Mr. Horn. You did the right thing. You pulled the 
microphone toward you. All those microphones need to be pulled 
toward you. This was built in the 1960's, but they use the 
1890's sound system, so we have a problem.
    Ms. Goldman. I certainly believe that any Federal law 
should incorporate a variety of remedies. One remedy is not 
going to be sufficient. There should be a private right of 
action that gives an individual the ability to come in and 
bring a lawsuit against someone who has harmed them. Also, I 
think that an appropriate Federal agency, such as HHS, should 
be able to assess a civil penalty, so if the individual can't 
afford a lawyer, the Government can come in and say you have 
done wrong. And I also think, under very egregious 
circumstances, there should be criminal penalties as well.
    Mr. Horn. Well, if there is a criminal penalty, what should 
it be? I mean, is it a misdemeanor or is it a felony, let us 
start there.
    Ms. Goldman. Well, I think that by the time you reach the 
level at which you would be liable for criminal penalty, I 
think you should be looking at a felony. A criminal penalty, 
particularly under a number of the proposals that are out 
there, would be where there has been intentional, malicious 
disclosure of personal information, where there is a course of 
conduct over a period of time, the person----
    Mr. Horn. Pattern and practice.
    Ms. Goldman. Pattern and practice, flagrant violator, 
should certainly be a felony.
    Mr. Horn. What is your feeling, Dr. Palmisano?
    Dr. Palmisano. Thank you, Mr. Chairman. The American 
Medical Association believes penalties and sanctions for 
unintentional disclosures of identifiable patient information, 
where the disclosure does not result in demonstrable harm to 
the subject of the disclosure should be commensurate with the 
violation. Repeated such unintentional disclosure should 
receive stronger penalties if they indicate a negligent 
business practice.
    Penalties and sanctions related to improper disclosure for 
commercial purposes, profit malicious purposes or where there 
is significant patient harm should be more stringent. In 
addition to monetary sanctions, legislation could include the 
loss by a data base company, for example, of its privilege to 
hold or transmit protected medical information, thus reducing 
the potential for companies to accept the monetary penalties 
for improper, intentional disclosures, as a cost of doing 
business.
    In other words, we don't want them to say, well, gee, there 
is this little penalty. We will just pay it because we are 
making so much money here, but they would lose the right to 
function in that capacity in the future.
    Mr. Horn. Has your association considered the thought of 
compulsory arbitration, rather than going through the court 
system? Some associations do this. I mean, the patient would 
sign either mediation, which is not compulsory or a compulsory 
arbitration agreement. Rather than going into court on some of 
these, they would sign that if something happens to the record, 
let's say, you would have compulsory arbitration, and that 
would be, perhaps, an arbitrator picked by the patient, one 
picked by whoever, the doctor or hospital, whatever the 
violation source is, and the two usually pick a third.
    Dr. Palmisano. The American Medical Association for years 
has been in favor of alternative resolution mechanisms to the 
current court system. We believe it is expensive and very 
inefficient and that does not serve both sides very well, in 
our opinion. In this situation, I guess there would be two 
issues. The first issue would be how would you resolve the 
issue and we certainly have been in favor, as an association, 
of voluntary binding arbitration?
    For instance, in Louisiana, we have that as an alternative 
to the court system, if both sides agree prior to the event 
occurring, and there is a period of time, a cooling off period 
where you can change your mind, but after that, it is a binding 
arbitration. So in general, we are in favor of that. The next 
issue goes to the penalty phase of it. Would the arbitrator 
have available to him or her certain penalties that would be 
mandated to follow, based on how egregious the act was and so 
on?
    Mr. Horn. That would be the civil side of it, certainly. 
Obviously, they wouldn't be getting into the criminal side. But 
you also have the sort of rent-a-judge approach in many 
jurisdictions where X judges regularly decide very difficult 
disputes and both parties agree and it gets it out of waiting 1 
or 2 or 3 years to come up in some court systems.
    Dr. Palmisano. In general, the AMA has been in favor of 
such methods, where we could have alternative ways to resolve 
that. We just want to make sure there is fairness, due process 
and so on.
    Mr. Horn. Dr. Johns, any feelings on this?
    Ms. Johns. Mr. Chairman, part of our model legislative 
language and key provisions for national regulations in regard 
to this included civil and criminal penalties. Now, as far as 
distinguishing felony and when that should occur and so forth, 
I don't believe that we had gotten into that particular detail. 
I do feel comfortable in testifying, however, that the 
provisions, as they are stated in H.R. 52, is something that 
our association supports.
    Mr. Horn. Dr. Gabriel, do you have any thoughts on that?
    Dr. Gabriel. Not really. I would agree with what has been 
said before. I think it really depends a lot on the type of 
abuse, the motivation for it, whether the abuse is for 
commercial reasons, whether there has been patient harm, and I 
can tell you that in our own institution and I know in many 
others, even the mildest level of abuse results in termination 
of employment. So I think there has to be that and that the IRB 
has an important role in monitoring it and making sure those 
abuses do not occur.
    Mr. Horn. Dr. Andrews.
    Dr. Andrews. Well, first tight controls over data within 
the research setting are effective in preventing these types of 
violations. However, we do also concur that there should be 
penalties and that those penalties should be commensurate with 
the disclosures. PhRMA has developed no specific 
recommendations about penalties.
    Mr. Horn. Dr. Hoge.
    Dr. Hoge. I think the only thing I would add, I think it is 
important for all of us to keep in mind confidentiality is sort 
of a tricky thing to regulate, that once privacy has been 
breached, suing someone doesn't do you much good. The fact they 
are punished may not do you much good. Internally, in a 
hospital, terminating an employee, I think obviously makes a 
lot of sense, but what we see over and over again is that the 
result of bringing a lawsuit or seeking some kind of legal 
redress would be wider dissemination of the information that 
the person wanted to keep confidential in the first place. So 
there is a little difficulty here.
    At the APA, we have seen criminal penalties wax and wane in 
various versions of the bills. No penalty is too severe if the 
transgression is severe, assuming the underlying rules are set 
appropriately.
    I do want to add one other comment. You asked the earlier 
panelists if they had any disagreements. I think the biggest 
fault line I perceive in this issue over the last 3\1/2\ years 
pertains to the pre-emption issue. I think it is--my view is it 
is beyond a doubt, the APA has spent countless, hundreds of 
thousands, if not millions of dollars over the last generation, 
developing case law, statutes in States all over the country.
    We were instrumental in the Jaffey v. Rudman case. It is 
cited prominently in your draft bill. I think it is not correct 
to say that privacy is not protected in this country or that 
the States aren't doing an adequate job. Many States and many 
courts are doing a very adequate job. So I think the pre-
emption issue is an issue, and I think to put the whole moose 
on the table, that the people who are interested in pre-emption 
are interested in the efficiencies that pre-emption would 
provide, not in privacy protection.
    I think it is clear if a State wants to come along and 
raise the bar from any Federal law that might be passed, that 
that can only help patient privacy. I don't see any logical way 
of getting around that conclusion. So I think we need to 
understand now we are talking about privacy versus efficiency, 
and obviously the APA is going to come down on the side of 
patient privacy.
    Mr. Horn. I note in the Health Insurance Association of 
America testimony, this is the last time I will cite it, but it 
is relevant to this question. They say under Subtitle E, 
enforcement of the Condit bill: ``We find it troublesome that 
the act creates a private right of action and the right to 
obtain punitive damages. Such provisions raise the potential 
for a large increase in frivolous litigation. Regulating health 
information does not require creating a new cause of action. We 
suggest that broad exceptions should exist for inadvertent 
disclosures and those made in good faith and plaintiffs should 
be required to show specific harm.''
    Are there any reactions, anybody, to that? It is a little 
different than some of your testimony, so I thought I would 
throw that in for the record.
    Dr. Palmisano. Mr. Chairman, just one comment about 
frivolous actions. The American Medical Association is on 
record repeatedly that we are in favor of anything that 
discourages frivolous actions and certainly in the Health Care 
Quality Improvement Act, which created certain protections for 
peer review and also created the National Practitioner Data 
Bank.
    There is a provision in there that if someone files a claim 
without merit, and so on, that the individual can be 
sanctioned. And certainly I think in any legislation that we 
need to look at situations for people who don't really have a 
basis for it, and do this just to harass. So we would be in 
favor of something of that nature.
    Mr. Horn. That is a serious problem, without question, in 
some types of litigation. I think I said a year ago, when we 
were able to override the President's veto, when he was sort of 
defending that, 1 or 2 years ago, I guess it was, the fact is 
the American Bar Association, if it wants to be a professional 
organization, ought to be dealing with these matters. That is 
what professions are supposed to do, regulate their members. We 
haven't seen it yet. Maybe some day they will decide they are a 
profession and do something about it. It is despicable, some of 
the filings, absolute blackmail. And that is what has Congress 
upset in this area.
    For those where you have a true pattern and practice, that 
is something else. However, where you simply have somebody 
fishing around, trying to, in essence--and I went through this 
as a university executive and president. They filed suits and 
they figure you will buy them off at $10,000 a month or 
something, and if you got 50 suits filed, that is a pretty good 
income. So that is serious, how we deal with this and try to 
get the people that are really violating the law, versus the 
sort of snooping expeditions or whatever we call it, where we 
just have that kind of conduct by a small handful, less than 1 
percent or one-tenth of 1 percent, but enough to be annoying. 
So let us see here.
    All the panel has really taken a look at this one. Under 
H.R. 52, Secretary of Health and Human Services would be 
required to develop standards for maintaining the 
confidentiality of patient health records. Health care is 
provided in a wide diversity of settings in the country and 
they are pretty well represented here. We could have had 
another panel there 50 feet long and health care is provided in 
these settings, ranging from single practitioners in rural 
areas who provide care at multiple locations to large 
centralized hospitals. Can we expect a single records 
maintenance standard to be appropriate in all these different 
settings? If not, how should we take the differences into 
account?
    Any feelings on that? Let's start with Dr. Hoge.
    Dr. Hoge. Are you asking me about my feelings because I am 
a psychiatrist?
    Mr. Horn. Sure, that is what I hear psychiatrists ask 
about. My one course in psychology taught me that.
    Dr. Hoge. I have some thoughts on that. I think it is 
extremely difficult to regulate the use of medical information 
in all the various contexts.
    You mentioned going from research to data base to provision 
of health care, and I think that is one way in which many of 
the draft bills have gone off course. We know a lot about how 
to regulate physicians because we have had physicians and 
patients for as long as we can remember, and we have had case 
law and profession--we have had professional standards and 
professional training now for, again, as long as we can 
remember, as long as our grandfathers can remember. So we know 
a lot about that.
    And the bills kind of take an outline from how we think 
about doctors and try to make everyone else fit into that 
outline. I don't think it does a very good job. I think this is 
a strange way to make a law. I think it would make a lot more 
sense, if we need a Federal bill concerning physicians and it 
doesn't undermine existing State laws and case laws of 
malpractice, so be it.
    I think what is really needed in 1997 and in the future are 
laws that regulate data banks, managed care companies, 
insurers, and all of the entities now that have come to hold 
medical information that 30 or 40 or 50 years ago no one had 
even heard of these entities. I think it is particularly 
important because of the march on information technology. If 
you think up an information technology journal, you will see 
that some people believe that the insurance record and the 
medical record will be the same thing when we have all the 
computers up and running and software available. I find that a 
frightening Orwellian future. So I think what we need is some 
sort of regulation that starts to look at these other entities.
    I think we also need to keep in mind, like the various 
panelists earlier acknowledged, the physician should be the 
only one to change the record. They know the patients. They 
know what they are worried about, their privacy concerns, and 
their health care problems.
    Our professional standard requires that physicians look out 
after the best interest of patients. That is not true of any of 
the other entities that I have mentioned. So we need to have--
just like the physician should have certain prerogatives in 
that setting, with regard to that question--certain 
prerogatives with regard to the use, disclosure and 
dissemination of all health care records. Data banks should be 
relatively restricted and tightly regulated ways in which they 
can use health care information.
    Mr. Horn. You mentioned Orwell. Do you see physicians sort 
of using their own personal code in some of their records so if 
they did get misused by one of their staff or any of the food 
chain along the way, so to speak, that it would be very 
difficult to know what that number or that letter meant unless 
you had a subpoena and you were a witness in court where you 
were asked to translate it, something like that? But the 
average person who wants to make trouble in the publicity sense 
would not know what that means.
    Dr. Hoge. Well, of course we spend 4 years in medical 
school learning terms that no one else can understand.
    Mr. Horn. That is the making of a profession.
    Dr. Hoge. Right, make up your own language.
    But the serious answer to that I think would be this: I 
hear psychiatrists increasingly tell me I have changed the way 
I write my notes now, changed the way I keep records, because I 
don't know who is going to see it. When the insurance people 
come in and review the charts, I don't know if the insurance 
reviewer is really a friend, a neighbor of the patient. Some of 
that gets entered into various data banks. I don't know who is 
going to see that. So we have a number of things.
    We have patients who say, I have insurance and it does 
cover some mental health care, but I don't want to use it 
because I know it is going to go and the records are going to 
be reviewed by--it may make its way back to my corporation 
because we have our own in-house review of insurance payments. 
So I don't want to use it. I want to pay out-of-pocket.
    Of course, it is a sorry state of affairs in this country 
that we don't have mental health coverage on par with many 
other countries, however even when we do, people feel they 
can't use it. Prominent politicians, on occasion they have many 
ways they can be hurt by mental health treatment records.
    Then I have physicians telling me, psychiatrists telling me 
I don't put very much in the record now. So if I want to go 
back now and look 5 years ago, my records are very detailed. 
But 5 years from now, if I want to look at my record, I am not 
going to have exactly the same kind of information. It's going 
to take more reconstruction to get to that.
    So what we are seeing, because of this march of technology, 
the lack of regulation of insurance companies and other people, 
I think we are seeing an erosion of the quality of medical 
recordkeeping in this country already.
    Mr. Horn. Let me throw another question into it, and maybe 
you can all just go down the line and answer two of them, 
because it is relevant here.
    That question is, should a Federal medical privacy law such 
as we are considering, not necessarily the one we are 
considering but a law, pre-empt all State laws, or should we--
and a lot of Californians feel this way when it gets to air 
pollution and control of frozen chicken and other hearings we 
have held around here--if the State has a stricter standard, to 
let the State standard apply if it is stricter than the Federal 
standard?
    And I would also like to hear from all of you some time 
today, is there a State law that you think is the best law in 
this area right now? And of course States, as you know, have a 
system, if we have got a good law, trying to get the uniform 
code activity of other States with that model statute across 
the country.
    So we face the problem of what is that relationship if we 
do do something in Federal law and we have sort of given the 
HHS Secretary an anointment which maybe she shouldn't have, and 
maybe Congress ought to battle these things out. Because they 
don't have to listen to people. We do have to listen to people.
    That is where we are on that one, and I would just like to 
know what your feelings are in that whole jumble: What is the 
best State law and should there be Federal pre-emption, et 
cetera?
    Dr. Hoge. On what is the best State law, I think that is 
difficult to sort out, because much of the law is incorporated 
in either State laws or it is instilled in professional case 
law and practice, and that may vary somewhat from jurisdiction 
to jurisdiction. But, increasingly, physicians are held to a 
single national standard. So I think finding out where the best 
practices are and the best regulation will be a very, very 
difficult thing to sort out.
    Regarding pre-emption, as I alluded to earlier, I think 
that is the major fault line in this legislation. Because many 
of the bills that I have seen I think would erode existing 
privacy protections in this country, with regard to physician/patient relationships and the systems that physician control, 
which are held to, I think, a fairly stringent standard under 
malpractice law and existing case law.
    I think we need to keep in mind that the only arguments for 
pre-emption are arguments of efficiency and ease of 
transmission of information. There is no way to justify, if you 
do come out with a law which sets the bar at a certain level, 
if a State wants to raise the bar, that can only be protective 
of privacy. I don't see any privacy argument against a nonpre-
emptive Federal law.
    Mr. Horn. Dr. Andrews.
    Dr. Andrews. Yes. First, I would like to respond to your 
earlier question about different controls in different 
settings.
    There are certain universal principles about data 
protection such as the need of safeguards for personally 
identifiable data and penalties for severe breaches as we 
discussed. But the specifics are very different, as you 
mentioned earlier today, and in writing the legislation, the 
devil really will be in the detail; and we should be extremely 
careful in those details should they be put in the legislation 
so that those details do not inadvertently create barriers to 
research that will ultimately benefit the public in the long 
run.
    Regarding specific State legislation, first of all, let's 
not use Minnesota as an example of model legislation. I think 
that was probably very carefully crafted legislation and yet, 
as you have already heard, the Mayo Clinic has an incredible 
record of some of the most distinguished, productive, and 
tightly controlled research; and we have already seen that the 
Minnesota law creates some impediments to future research using 
that valuable resource.
    Regarding pre-emption, one of the compelling reasons for 
Federal requirements is to provide a uniform set of rules; and 
if individual States are permitted to add additional 
requirements, then the benefits of those uniform rules may be 
lost and researchers will again be faced with an inconsistent 
patchwork of requirements that may impede research and hurt 
patients. We need to remember that much research today does not 
know geographic boundaries and involves multiple States and 
multiple countries.
    Mr. Horn. Dr. Gabriel, how about it, in terms of the single 
records maintenance standard appropriate in all settings? And 
do you agree that the Minnesota law has those major problems 
you have heard about from yourself and others?
    Dr. Gabriel. I absolutely agree. In response to both of 
your questions, one size does not fit all. Integrated health 
care delivery systems like Mayo are different. A patient can 
access the system at 100 different points, can see numerous 
providers. There are dozens of, referrals going on all the 
time. It is hard to even define what constitutes a point of 
access. So I don't think the same rules can apply to an 
individual provider as to integrated health care delivery 
systems like Mayo.
    There really has to be a way to facilitate the appropriate 
flow of information, because that is our strength, is that we 
can do all of this, that the lines are going in all different 
directions to the benefit of the patient.
    In fact, with our recent experience with the Minnesota law, 
we have a partner in Rochester, a much smaller center, who have 
had far fewer problems. Because everyone comes in the same 
front door, and their system is basically sticking a red sticky 
on the chart, and if you see a red sticky, don't read the 
record. But we have to have a very complicated information 
management system that is constantly updated, and we are always 
looking at where the patients are going, so it is an entirely 
different kettle of fish.
    We favor pre-emption to the State law, again, for the same 
reason. Mayo operates in five different States. Our patients go 
back and forth from one State to another. Our research covers 
more than one State. So it just makes a whole lot of sense to 
have uniformity.
    Mr. Horn. If Minnesota law doesn't meet the test of your 
particular standards, are you aware of any State law that comes 
closer than Minnesota?
    Dr. Gabriel. I am not.
    Mr. Horn. OK. Well, I would say to all of you when you go 
back on the plane or train or bus or whatever and have some 
thoughts in this area, please write us. We will put it in the 
record at this point and others. Because what we are interested 
in is the best thinking in this area that is going on. 
Obviously, six people don't represent all of the best thinking 
in America, but it is a start.
    For your professional associations and their high-paid 
staff, we would certainly welcome actual line-by-line criticism 
of the bill. That might not be the bill, but that is a start--
or the Slaughter bill or whatever you want. And we would like 
your specific criticisms so we can get the total picture.
    We don't enter into this with a lot of preset ideas, except 
maybe on frivolous lawsuits. But we would like your thinking 
line-by-line. If you have a thought, don't be bashful.
    So lets ask Dr. Johns. How do you feel on the diversity of 
the setting? Do you think we can do a law that has the basic 
standard that can cover all that diversity? And if you know of 
a State law that does this well, we would like to hear about 
it. And do you think there ought to be Federal pre-emption?
    Ms. Johns. First of all, HIMA is in favor of pre-emption. 
And I think when we look at the issue of confidentiality we 
also have to separate issues of confidentiality and security 
practice.
    In regards to the confidentiality in H.R. 52, we are 
looking at inclusions of key provisions in regards to health 
information, as opposed to carving out regulations for specific 
types of entities.
    New entities in the health care industry arrive on almost a 
daily basis, so to regulate individual entities does not, in 
our minds, seem to be either feasible or reasonable. However, 
focusing directly on the health information that can be within 
any type of entity is the important part of H.R. 52; and we 
have key provisions such as access, such as disclosure, such as 
limiting information in order to--for specific use to perform a 
specific responsibility, and also provisions on redisclosure. 
So from that aspect, looking at it from that perspective as 
opposed to separate entities we think is very, very important.
    We also feel, as I mentioned, that we need a national 
standard. We don't have that now. And we need to--it is so 
imperative that we begin to address this issue on a national 
standard.
    Also, data does cross State lines. Integrated delivery 
systems themselves may have facilities in two, three, four, 
five, and many more States. So the issues regarding the health 
information need to be standardized across the country.
    Another point that was made by Dr. Hoge is the issue of 
patients feeling comfortable with being able to confide in 
their health care providers. And certainly previously I pointed 
that out in our testimony, that one of the mainstays of 
confidentiality is this confidence that the patient has in 
being able to share information.
    The kinds of situations that we are encountering today 
where patients withhold information and providers are not as 
specific with regards to their documentation result from not 
having general pre-emptive legislation that ensures all of us 
that we will have confidentiality and privacy.
    In regards to identifying a specific bill throughout the 
country and the State, I am not aware of that; and I am not 
prepared to provide that information at this time.
    Mr. Horn. Well, we would certainly welcome any thoughts 
your organization has. You have got a vast group out there. Or 
complaints where--please don't take this portion of law; it 
doesn't work.
    Ms. Johns. We would be happy to provide that.
    Mr. Horn. Dr. Palmisano.
    Dr. Palmisano. Thank you, Mr. Chairman.
    Regarding pre-emption, the American Medical Association is 
of the opinion that without a showing that the proposed Federal 
standard would be properly protective of patient privacy, any 
Federal law should provide a floor rather than a ceiling when 
applied to patient confidentiality protections. It is 
understood that there are many who believe that there should be 
a uniform Federal standard to facilitate electronic data 
interchange.
    The AMA is concerned, however, that heightened standards 
will be lost to Federal legislation. If, however, the law is 
high enough to secure protection of patient information in the 
Federal language, the AMA would revisit the pre-emption issue.
    I think Dr. Hoge's comments are issues we share concerns 
about. We think there are many concerns in States, and tomorrow 
they may pass a new law in a State that is ideal, and it is 
perhaps quicker to go through a State if we see a problem with 
confidentiality and raise a standard at a State level. So we 
think at the present time it should be a floor, not a ceiling.
    Regarding the uniform coding issue, we don't have a 
problem--for simplification, we don't have a problem with the 
provider identification number. For instance, the American 
Medical Association has an identification number for 
physicians. We would like that to be considered as a number 
that would be appropriate for physicians.
    Regarding a patient identification number for 
simplification, we are very much concerned about that; and we 
continue to study that. Our testimony in the past and continues 
to be at the present time, we are opposed to a unique patient 
identifier because it can too easily be linked up with Social 
Security numbers and other mechanisms that would allow someone 
who doesn't have the right to get there to gather a lot of 
information about the patient. We have a lot of concern about 
that.
    The other issue on uniform coding and so on, we certainly 
think that the current procedural terminology that is in place, 
CPT coding system, it is in common use; and we hope that the 
choice of coding system will allow for the CPT to compete 
fairly with any other system that is being considered.
    Regarding the wide range of practices throughout the United 
States, from clinics to small practitioner, I certainly don't 
want us to forget the small practitioner who may be a family 
practitioner in a small town, and this individual finds the 
administrative burdens continue to increase. Managed care has 
drastically affected the practice of medicine throughout the 
United States, and any other burdens might cause that 
practitioner to say it is not any fun, I can't do for my 
patients what I need to do for my patients, and we will see 
physicians retiring earlier, leaving communities, and that is a 
problem.
    So any law that would eventually be passed by Congress, we 
would hope that it would not create burdens on individuals who 
elect not to get involved in that methodology. If they are 
working just in their area and not transmitting the data, it 
would be on a voluntary basis. So someone doesn't say, now I 
have to buy a very expensive computer system; I have to bring 
in consultants. And many times, after that is over with, the 
physicians find out after they have spent a lot of money and 
they are not any better off. In fact, they are worse off 
because nobody understands the system.
    So we want to make sure that those who elect not to be 
involved in transmission of data to central data bases, they 
don't have to do that. And whatever comes out of Congress we 
are concerned about some clearinghouse in the sky where all of 
this data is going to be there. We are concerned about someone 
getting in and cracking into that information; and, as you have 
heard multiple times today, privacy has to take the No. 1 
position over efficiency.
    Mr. Horn. Since I grew up in rural America, I am very 
sympathetic with the type of examples you have cited and 
others.
    Now it seems to me the AMA, as a professional association, 
may sponsor workshops in which physicians or their office 
administrators could be educated and trained and specialized 
software. Do you develop software that can be used nationwide 
that would solve a lot of these problems? We do not want to 
drive that poor individual physician who was taught to do good 
in medical school out of serving rural America.
    Dr. Palmisano. Yes, sir, we have extensive programs at the 
State level and the American Medical Association level.
    And I know I will hear this--I am in practice before the 
colleagues, and when I get back and sort of give them a recap 
on how we are participating, our great civics lesson, in 
America, the greatest land in the world, how through democracy 
we can give our voice. And then my partner, who is my mentor in 
training, he just always looks at me and says, come back to the 
real world here. Do you realize what we have to do here? Do you 
realize the administrative burden? Why I don't leave here until 
8 at night even though I have an office manager. We have to 
hire consultants to come in.
    He is as sophisticated as anyone I ever met with computers, 
with the methodology to make sure everything is kept proper. 
But he says it is a tremendous burden.
    So I always listen sympathetically and say, ``well, I know, 
but we just want to make it simple and make sure our voice is 
heard.''
    And he says, ``we already know how to do it. The problem is 
the rules keep changing.''
    For instance, when the fraud alert two came out, I had 
occasion to be treating a very prominent member of our 
community. His wife and he had some connection with the 
judicial system, and he was upset because I was an hour late. I 
sent word because there was an emergency I had to run into the 
operating room and lend a hand with a very critical patient, 
and when I got there he started to lecture me as he often does.
    And I like him a lot, and I listened, and I said, ``Sir, if 
you would sit down and help me understand an alert I just got 
from our Federal Government about fraud alert two, which had to 
do with if you write off the balance of a patient, that is 
considered a crime.'' I said I don't quite understand that. It 
looks like it says that in English. And he said that just can't 
be so.
    So I went and treated his wife and came back, and he says, 
``I just can't believe that.'' I said, ``That is part of the 
administrative burden.'' We have patients that come up. I don't 
want to do means testing on my patients when they say, 
``Doctor, can you just accept the assignment?'' Sure, I will 
accept the assignment, but now I have to do means testing.
    Those are the many, many little things that keep coming up; 
and one little thing doesn't sound like a lot, but if you add 
another thing and another thing and another thing, that gets to 
be a lot.
    I am trying to treat the sick and help people. When I can't 
cure them, I want to comfort them. But I am just getting 
overwhelmed by the burden. And no matter what comes out, 
whatever we call it--we can call it simplification, call it 
privacy, but we don't want to create a burden that is more 
burdensome. We don't want to create a system that allows 
someone--like in other countries that kick down the door in the 
middle of the night and say I am just here to inspect and make 
sure there is no fraud going on in this home. This is the land 
of America. So that is our plea.
    Thank you.
    Mr. Horn. Well, I know a lot of doctors in my urban 
community that completely agree with you about the burdens that 
have been placed on the private physician; and, as you suggest, 
some of them are being driven out of the profession by simply 
the water treatment harassment that they are getting. Whereas 
one or two drops wouldn't bother you, but when it adds up to 
Niagara Falls coming in your direction, you worry a little bit.
    Ms. Goldman.
    Ms. Goldman. The position that I am taking on pre-emption 
in this Congress is slightly different than the one I took last 
Congress, and I would like to just lay out how I have arrived 
here.
    I have come to believe that pre-emption of State law in the 
privacy area is not the right approach to take. First of all, 
the States that currently have laws on the books that deal with 
access to records and allow people to limit disclosure of their 
own records are being complied with right now by the people 
sitting at this table who say it would be unworkable to have a 
Federal law that allowed for States to pass those. Right now, 
we have 50 different States with 50 different approaches, and 
people are not only managing to comply with those different 
laws, they are flourishing and doing quite well.
    The second thing is that, with the passage of a Federal 
privacy law, regardless of where the floor was, most States, I 
think, would feel that the issue had been addressed. The States 
that have been extremely active right now in passing 
legislation are doing so because there is a vacuum, because 
there is a serious need, either because there has been a story 
in their State or a problem in their State and they have to 
address it.
    And the States that have been particularly active are your 
home State, Mr. Chairman--California--Minnesota, New York, and 
Massachusetts. Where they have active consumer groups, the 
States' attorneys general have been active in those States; and 
while they may have passed laws that are imperfect from the 
perspective of the pharmaceutical industry and the health 
information industry, they are fulfilling a need.
    So I would say in this area we cannot only create a floor 
which is a high floor so those States that are weaker or 
problematic are, in effect, pre-empted, because the State law 
must meet that floor, but it would discourage other States that 
would say ``finally Congress has addressed the issue, we don't 
need to be tinkering with it.'' And I think it would allay a 
lot of concerns that the pro-pre-emption folks have been 
pressing, which is how would we comply with a few variations in 
the Federal law, when right now they are dealing with 50 
variations.
    The only other point I want to make is to pick up on 
something Dr. Gabriel said, that one size doesn't fit all. One 
size probably doesn't fit all, that if we do create a Federal 
flaw--floor--excuse my New York accent----
    Mr. Horn. It is either a Freudian or Jungian slip.
    Ms. Goldman. No, it is my accent. If we do create a floor 
which is a high one, I think then only States where there have 
been very serious, egregious violations and States with 
particular instances they want to address will enact 
legislation. The context is very important as well.
    I have worked in the privacy and civil rights area for a 
decade, and there is no other Federal privacy law or Federal 
civil rights law that pre-empts State law, and I think it would 
be a dangerous precedent to set. Those laws recognize that the 
privacy law is meant to do something good, to protect an 
interest that is considered vital to a national interest; and 
if a State finds it is important to go above that floor, they 
should be free to do so. I think particularly in this instance 
it would be wrong to constrain the States.
    Mr. Horn. OK. Any other comments you have heard your 
colleagues on that you would like to correct now that we are 
down to number 6?
    Dr. Hoge. No corrections.
    I might bring to your attention Senator Leahy's draft bill 
which is, I think, going to be introduced in the next couple of 
weeks which I think provides a reasonable platform on many of 
these issues.
    Mr. Horn. We are in contact with the Senator's staff on 
that, and we have worked with Senator Leahy on various 
occasions.
    Let me get back to fraud detection. One criticism leveled 
at H.R. 52 by the insurance community is that it would inhibit 
antifraud activities. Insurance companies would be limited in 
the claims investigations they would perform. Should there be a 
specific exemption for claims investigation and antifraud 
investigations? Anybody have a strong view on that?
    Dr. Hoge. Yes, I do. It is not clear to me why the 
insurance industry would say that. There are many countries 
that have national health care systems that don't intrude on 
patients' privacy the way they are proposing. There are many 
ways of detecting fraud and abuse through billing patterns, 
number of billings today, without getting access to 
identifiable, protected, sensitive health care information.
    It is just being done throughout the world in other ways, 
including Canada which has a society not so different from 
ours, again by looking at patterns of billing rather than 
specific, identifiable information.
    So I think once they have justification----
    Mr. Horn. Let me stop you right there. Let me be sure I 
understand you.
    Often what we are talking about is some software has been 
developed that when a certain type of operation is performed, 
lets say, there are certain things that relate to that; and one 
can look through the bill in a systematic way and even by 
software that would say, well, gee, I wonder why this was done. 
That isn't normal or usual with this particular operation.
    To give you a real horrible example, a woman, not in my 
district, but in a neighboring district, wrote about going to a 
hospital, having a particular type of operation she went in 
for. In the process of being there, they also did a mastectomy, 
claimed the bill. She thought that was strange since she had 
had a mastectomy 10 years before.
    So, obviously, there are some things thrown on these bills 
by unscrupulous hospitals and unscrupulous physicians and 
unscrupulous HMOs, whatever. There are a few bad apples we 
always find somewhere, and that is sort of what we are 
confronted with. I don't see how you deal with that operation 
without knowing the name of the patient.
    Dr. Hoge. Well, I think the example you gave probably would 
be sufficient to get a court order to get access to the records 
or maybe it is the first step to ask the hospital or doctor 
whether there was an error or whether they wanted to correct 
this or so on.
    Maybe I jumped too early. Because the law enforcement, the 
insurance company, they would love to have access--relatively 
free, unfettered access to records and look for lots of things. 
I think the question is how much access to allow people to have 
without having any demonstrable cause.
    Dr. Palmisano a minute ago talked about kicking down the 
doors. Once you have things on-line, we are talking about the 
computer equivalent of kicking down doors when law enforcement 
and insurance companies have unfettered access.
    I think the standard that is common in this country in 
almost every State that I am familiar with is if there is 
probable cause, a reasonable demonstration that records have to 
be accessed and that can be proven to a judge, that you get a 
court order; and sometimes you have to make accommodations to 
patient privacy.
    There are a couple of Federal cases that you should be 
aware of. The Ariyoshi case----
    Mr. Horn. Do you want to spell that for the record?
    Dr. Hoge. I think it's A-R-I-Y-O-S-H-I. It is a Hawaii 
State--State of Hawaii or Attorney General of Hawaii v. 
Ariyoshi, I believe, where the Medicare fraud investigation 
unit came in and grabbed a psychologist's records, snapped them 
all up. They were sealed by the judge. There was a court case 
that ultimately ensued, and the resolution was the court said 
you do have reasonable basis for looking at certain parts of 
this information, the billing aspects and so on, but you don't 
have a right to look at their private information, what the 
psychologist wrote about their fantasies or their fears or 
their personal life.
    So judicial supervision of access to records or access to 
private information I think is ingrained in our society. We 
don't allow the police, even if they think there might be a 
crack house somewhere if the neighborhood, to go door to door 
and look in every house looking for it; and that may deter--may 
lead to some decrement in law enforcement. I am not pro-crack 
house, but I think we have to protect privacy, and the result 
of that is we have some decrement in law enforcement and fraud 
and abuse investigation.
    Mr. Horn. Any comment you want to make on that, Dr. 
Palmisano?
    Dr. Palmisano. Yes, sir. The American Medical Association 
certainly is against fraud, but we do not want the standard for 
investigation lowered beyond probable cause.
    The example you gave, if someone had a mastectomy 10 years 
ago and is being billed for it now, that should be corrected. 
If it was a clerical error, to determine if it's a clerical 
error or knowingly and intentionally done to defraud, those 
have to be investigated.
    But when you have a reasonable belief and evidence to show 
that there probably is more than likely fraud going on, you can 
get that order to go search that information; and it ought to 
be limited to the information you need to search and not go 
through all the other information.
    When individuals have the power to invade your office 
records or hospital records at will with a very low standard, 
not only is it--it is unAmerican in our opinion, but also it is 
very expensive. Because you have the finances of the Federal 
Government basically funding this, your taxpayers' money 
funding this. You are paying all these different lawyers to 
come in to advise you what to do, and it gets extremely 
expensive.
    Mr. Horn. Well, this example, in fact, was on the 
information company where the doctor is sending forth the bill, 
lets say, where the patient has given them their health care 
information as to what insurance company and then the insurance 
company's attempt to apply whatever antifraud standard is the 
usual procedure with that company, and the degree to which they 
are saying that companies would be limited in the claims 
investigations they could perform under H.R. 52. I don't know 
if they are right on that or not. Obviously, we are going to 
explore it.
    And the question was, should there be a specific exception 
for claims investigations and antifraud investigation from the 
privacy standard which might be very high. But the whole reason 
you take insurance, presumably, is to get the payment. But it 
ought to be the accurate, truthful payment that justifies that.
    Dr. Palmisano. Well, we don't think there ought to be an 
exemption.
    The American Medical Association, first, we are against 
fraud. We have helped the FBI to help root out fraud, so we are 
on record for that. But we think the standard ought to be kept 
high so they are not fishing expeditions.
    Also, the approach that would solve a lot of so-called 
fraud problems is the approach that the American Medical 
Association put forward on the Worldwide Web site called Saving 
Medicare. It has been distributed to Congress. Basically, let 
the patient get more involved, let the patient get back in the 
driver's seat, let the patient be a fraud investigator so the 
patient has some responsibility in looking at the bill. The 
patient will know she didn't have a mastectomy and know right 
off the bat that is an error.
    The fact of getting rid of controlling prices, get down to 
letting the doctors set their own conversion factors and 
publicize that. Then the patients and the physicians get 
involved and we get back to a society with less regulations. It 
is impossible to write regulations to cover all possible 
situations.
    I think in terms of the heroic American effort when we were 
involved in the Normandy invasion after the people on the beach 
were killed--at Omaha beach. Ninety percent of the people that 
hit the beaches that day from the 116th, from Virginia, they 
were killed on the spot. Their ship was sunk, and they swam to 
shore and had to get up.
    The reason we were able to get up there and knock out the 
machine guns--the reason we were able to knock out those big 
guns is because Americans were resourceful. If they had to 
follow some little rule book and regulation--now, if the German 
Army does this--they would have all been killed that day. In 
fact, Colonel Rudder couldn't lead the attack. The General 
said, ``Colonel Rudder, don't do this attack;'' and he said, 
``I am going to have to disobey you, sir. I have got to lead 
the men. Otherwise, it won't get done.'' And he did it.
    That is why they say Hitler's Youth Crew lost out to the 
American Boy Scouts. The Boy Scouts were very resourceful.
    Every time we come up with more harassment on physicians 
and patients, we end with a system that really doesn't work. It 
becomes more burdensome. So we would hope that would remain on 
the forefront.
    Today we are talking about privacy and confidentiality, and 
we want to enhance that, protect that. But, on the other hand, 
we don't want to have rules and regulations that end up 
creating more burden and don't protect that.
    Mr. Horn. Ms. Goldman.
    Ms. Goldman. My only comment to add to the ones that have 
been made is I think it is really important that we recognize 
that there should be fourth-amendment-type limits on Government 
access to certainly health information. H.R. 52 and the other 
bills that have been discussed do that. We do it to varying 
degrees, and the Justice Department has expressed concern about 
those provisions, and I am not aware that they have signed off 
on any of them.
    I think it is a natural response on the Justice 
Department's part to say we now have unfettered access to 
personal health information. Please don't make us be bound by 
the fourth amendment. That is an understandable response, but 
it is certainly not the right one.
    The fourth amendment is not an absolute bar to law 
enforcement access to records. What it says is, you must meet 
the standards, probable cause or clear and convincing standard 
before you can get access; and it is a protection on the 
individual. It is certainly not an absolute bar. And it is one, 
again, we see in the privacy laws we already have at the 
Federal level and ones that should be built into this Federal 
policy as well.
    Mr. Horn. I must state one of the goofier implementations 
of privacy law in my field of education was when the Department 
of Education--and I happened to head a national coalition to 
create it, so I favored the Department--that we had strict 
rules written into that law that you could not impose curricula 
on States, et cetera. But they visited Pennsylvania State 
University and later California State University at Long Beach; 
and they said, oh, you can't display the thesis of a student in 
the library without the signed exception to the Buckley Act--of 
the privacy right.
    Now only an idiot would make that kind of ruling. 
Unfortunately, it went up the high hierarchy. And the 
Secretary, when the complaint was given to him, stuck by that 
stupid policy.
    Now the whole purpose of the dissertation and thesis is to 
be examined by the outside world. So here we have the case of a 
Federal law being used where the thesis writer could have 
massive plagiarism. The professors might have missed it. You 
can't keep up on everything in every field. That thesis is 
signed off, and it is normally deposited everywhere in America 
in the university library or the microfilm operation for 
dissertations in Michigan.
    There is an example of people going haywire with a, quote, 
privacy right, unquote. There is no privacy right, it seems to 
me; and yet they could get away with it. They could have 
plagiarized; and under the Department of Education's great 
interpretation, they can be free because no one will ever see 
it. It is not on the library shelf. I don't know if they are 
still doing it, but they were doing that several years ago.
    Ms. Goldman. I would agree with you. That is an unfortunate 
application of a privacy law.
    My experience has been a little bit different in that what 
I tend to see is underenforcement of existing privacy laws or 
weak construction of the existing privacy laws and not 
overzealous application. But it would be interesting to see if 
that is still the interpretation, because I agree with you that 
what is a public record ought to be available.
    Mr. Horn. All right. Let us move to the next series of 
questions, and H.R. 52 requires health researchers to receive 
approval from a certified institutional review board in order 
to review patient records. Is that acceptable to most of you or 
how do you feel on that? Are there any problems with that 
section, which is 152 of the bill?
    Ms. Goldman. Well, what is interesting is that the approach 
taken by H.R. 52 and the one taken in last year's bill 
introduced by Senators Leahy and Bennett is one that at least 
recognizes there are Federal regulations right now that require 
all federally funded researchers to get the informed consent of 
individuals whose information may be the subject of research. 
So, as Dr. Gabriel said earlier, there are already requirements 
on federally funded researchers to have to get the informed 
consent, unless the IRB agrees that a waiver is appropriate and 
there is a standard for the waiver.
    The Senate approach basically said, lets codify those 
regulations so that all researchers--not just federally funded 
researchers but all researchers will have to comply with 
informed consent. I think the pharmaceutical industry last year 
had concerns about that, but that has a fair amount of 
unanimity that that is a pretty good start.
    I think H.R. 52, again, tries to bring in the Institutional 
Review Board and create another level of hierarchy, which I 
don't think is a bad idea, to say someone should be watching 
the IRBs. Because even though there has been some studies 
commissioned in recent months, there is no record, no factual 
basis to know how IRBs work as a whole, how we look at the 
consent mechanism, when and where they approve waiver 
applications. So we know little about how IRBs work. We do know 
they adhere to privacy issues, consider them in the application 
for research.
    Mr. Horn. Now is there any type of research that does not 
require such approval?
    Ms. Goldman. The research that does not require approval 
are ones that do not involve identifiable data. And I would 
agree, if you are not using identifiable data, you should not 
have to get the consent of the records covered, because it is 
not within the privacy scope. Nonidentifiable data has to be 
clearly nonidentifiable data, and there is discussion about 
what that means. But I would agree that nonidentifiable data is 
outside the scope of a privacy bill.
    Dr. Andrews. I would like to make a couple of comments.
    First, relating to IRB review and approval----
    Mr. Horn. It is Institutional Review Boards. I just want 
the audience to know what we are talking about.
    Dr. Andrews [continuing]. The regulations are quite strict 
on IRBs. There is currently a commission that is looking at the 
IRB process and that, I assume, will also be looking at not 
only the protection of patients against medical risk but also 
privacy risks. There seems to be no need for additional 
legislation on this point which might pre-empt or prematurely 
set some legislation in place to pre-empt the outcome of that 
commission's reports.
    Regarding what information is considered identifiable, I 
think that is a key point; and we feel that the language in the 
current H.R. 52 is a little too broad in identifying what would 
be considered personally identifiable data. For studies that 
use data bases that contain a key or an encrypted code that 
could potentially be used to link back to medical records, 
those studies currently do not require IRB approval or patient-
informed consent. They generally are considered to fall below 
the level of minimal risk that would determine the need to have 
informed consent.
    In addition, as you have also heard from Dr. Gabriel, 
informed consent is frequently not feasible in these 
circumstances in using very large data bases answering 
questions that may arise many years after the information was 
collected, because there is difficulty locating patients in our 
highly mobile society, getting consent itself may introduce a 
bias, and because contacting patients may also constitute a 
violation of patient privacy.
    In addition, as you have also already heard, if you use 
only the patient data from those who have been located and 
provided consent, you may introduce a bias in the study which 
may invalidate the study findings.
    Mr. Horn. Dr. Hoge has a comment.
    Dr. Hoge. Actually, yes, and maybe in the way of a 
question. I am a little unclear if a doctor enters in the data 
base that you are talking about has a code, could be stripped 
of that code.
    I guess the point I am asking, it seems it would be 
reasonable to ask IRB approval if there is going to be the 
future capacity to relink that code to the person's actual 
identity, because now you have got a privacy concern that 
someone should be overseeing. But if you are going to take the 
information, strip it, it doesn't seem to be a problem, but 
maybe I am misunderstanding.
    Dr. Andrews. I think there is something in between that. I 
believe that data bases totally stripped of identifiers should 
be excluded. Then there are data bases that have an encrypted 
code that could be linked back, and we also feel those should 
be exempted.
    I think the actual relinking, which I think is what you are 
referring to--someone is taking the code, relinking, 
identifying patients and abstracting additional information to 
supplement the original study; and those do need very tight 
security over the relinking and may need and usually are, I 
believe, covered by IRB review and approval at the moment.
    Dr. Hoge. If I might--but, again, if there is a potential 
to relink through the code, that means you either have the plan 
or some expectation of relinking it; and, therefore, there is 
some privacy risk--I don't understand. It seems a little 
disingenuous. If you are not planning on relinking, why don't 
you just strip it? And if you are planning to relink it, it 
seems to me you are back at a point where you have got to get 
IRB.
    Mr. Horn. Do you want to respond to that, Dr. Andrews?
    Dr. Andrews. The reality is these data bases often have 
been so carefully developed that this encrypted code is 
available for the researcher. The researcher cannot by 
themselves identify the patient, and they have no interest in 
doing so. They are interested in the aggregate data. It is the 
local physician or a third party that would be able to take 
that encrypted code and link back.
    Mr. Horn. Dr. Gabriel.
    Dr. Gabriel. I just wanted to make the point that all of 
the research that I mentioned in my statement is already 
covered by the IRB. In fact, at our IRB we apply the 
regulations to everything, federally funded or not. So I would 
endorse having the IRB approval for all of these studies.
    Mr. Horn. Dr. Palmisano.
    Dr. Palmisano. Thank you, Mr. Chairman.
    I just wanted to emphasize that when we put in the 
statement--both oral statement and written statement--that 
medical information used for research purposes should have all 
identifying information removed unless a patient specifically 
consents to the use of his or her personally identifiable 
information; and on the subject of research it can be a 
troublesome category of exceptions to the general requirement 
for patient consent. Although in conclusion, we are generally 
satisfied that the IRB patient protections are adequate, we 
believe that a scientist should be able to pursue legitimate 
research without unreasonable barriers and that it is possible 
to do this while still protecting patients' privacy. What we 
don't want to see is the term research applied to a whole 
spectrum of economic analysis that solely benefits shareholders 
rather than patients.
    I guess I would like to pose a question back on H.R. 52. On 
page 39, it states that the project has been determined by a 
certified Institutional Review Board to be of sufficient 
importance to outweigh the intrusion into the privacy of the 
protected individual who is the subject of the information that 
will result from the disclosure. So it appears from this 
reading that privacy will be invaded, and the IRB is saying 
that the research is of sufficient importance. So it is not 
being treated as an IRB study.
    Consultation is being obtained with the IRB to decide 
whether or not it is of sufficient merit to invade privacy, and 
what we say is that medical information used for research 
purposes should have all identifying information removed unless 
a patient voluntarily and knowingly and willingly consents to 
that information.
    So it is right to go through the Institutional Review 
Board. We think--a lot of them we hold in high regard.
    On the other hand, we don't know that this is going to 
protect the privacy--it goes back to the philosophical 
discussion, is the teleological approach to the philosophical 
base whereby you say, well, the end justifies the means, so we 
are going to invade privacy to do this research and find out 
these potentially good things. We think the patient's privacy 
must be paramount.
    Thank you.
    Mr. Horn. Dr. Gabriel.
    Dr. Gabriel. I wanted to respond to that a little bit.
    As we said before, the researcher is not aware that this is 
Mrs. Jones' data. The only place that privacy might be 
invaded--there has to be a point somewhere where you collect 
the data from the medical records, put it in a data base, strip 
the identifiers, and that is where the analysis happens.
    So I have a question. How do you define nonidentifiable 
data? There has to be--so the point, at least in the way we do 
things, we have usually a nurse administrator abstract a piece 
of information from a medical record and then that is put in a 
data base with hundreds of other people's data and then the 
information or the patient identifiers are removed. So when you 
were reading that I was thinking maybe that was what they were 
referring to.
    Dr. Palmisano. Mr. Chairman, it is just a question. I am 
not sure what is being referred to. I think it is vague as 
written here. It may be because of my ignorance, I don't know, 
but I would like it clarified.
    I certainly understand how I could see a scenario. I don't 
consider myself a computer wizard, but I would see where you 
could send someone who understood confidentiality and taken an 
oath, could go to medical records and say, all names will be 
removed and codes will go in there and these codes don't 
necessarily link up, but it identifies whatever you need to 
identify without identifying the individual and that would be 
given to the researcher. It appears from what I have heard that 
would satisfy the researcher.
    So I think that could be done from a technological basis, 
and those who are much smarter than I am in computer 
methodology could come up with an even better way than that. 
But it appears that the information could be interpreted by a 
reasonable individual to say that we are going to allow the 
name to be kept with this record because the research is of 
such moment that the IRB, they agree, is really of great 
moment. So they have this invasion of privacy without the 
individual knowing; and the individual may say, no, I did not 
want you to allow that. I did not want to take the risk, 
however small, 10th of 1 percent that it would be discovered by 
someone else.
    Mr. Horn. Perhaps we should have staff talk to the National 
Institutes of Health. Because you could have a project that 
takes 5 to 10 years, maybe, to come to some conclusion; and the 
question is, if you do discover something that relates to that 
sample or you want a later subsample of that, is there a way 
you can tie that back to the good of the patient?
    Yes, Dr. Andrews.
    Dr. Andrews. Let me address this question of relinkage.
    While I may strip a data set, there are some circumstances 
where you would want to have the ability to go back and relink; 
for example, if you are doing a study on the safety of a 
particular kind of drug and you may follow patients for 6 
months. If you obtain a signal that this drug may be causing 
cancer and the latency period is longer than 6 months, then you 
might want to use that same cohort of patients, extended for a 
longer period of time, in which case you need to take the data 
set back to its origin, relink through a very careful time-
limited linkage, and gather the information that would then go 
into the data base that would no longer have the identity. It 
would be that linkage process that would need to be carefully 
safeguarded, rather than the whole data base. So I think we are 
all saying the same thing.
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    Ms. Goldman. I have to add one thing on the research.
    I think there is a fair amount of agreement the vast amount 
of research that is done in this country is done with the 
deidentified data, out the personal identifiers. For that small 
group of research that is done with identifiers, I again say 
that it is very important that informed consent of patients be 
obtained. Because, as a few people have testified, there is a 
concern about there being a bias, that those that opt out would 
create a bias. At least it is a known bias.
    You know, there are a small group of people who say, I am 
uncomfortable being a part of this research project because I 
am concerned with confidentiality or I am concerned about 
losing my job or whatever it is, which are real concerns on the 
part of the individual.
    The current situation we have, where identifiable data is 
used in research without individuals' consents, the bias in 
those research projects involve people who give inaccurate 
information because they are afraid of the lack of privacy. 
People who lie, people who don't seek treatment, those create 
biases; but we don't know about them. We can't quantify them. 
At least--if they opt out and the information is asked for and 
it is withheld, at least you know who is saying I do not want 
to be a part of this research project.
    Mr. Horn. Well, that leads to the next question. If some 
patients are willing to give general waivers at the outset of 
their treatment permitting future disclosures of records to 
providers, researchers and others, should H.R. 52 prevent that 
or should each research project require informed consent of the 
patient to be sampled at that particular time?
    Ms. Goldman. The way H.R. 52 is written is in authorization 
there has to be an identification of who the recipients would 
be and what the information would be used for.
    If the authorization is written broadly enough--and, again, 
getting that authorization does not then condition whether or 
not you deliver benefits or services. If people want to be part 
of ongoing research and that research is specified, it is not 
my judgment to make. I think these are individual judgments 
that people should make.
    The beauty of the privacy law that is crafted like this, it 
lets people make those choices. It lets doctors talk to the 
patients and say, I would like you to be involved with this; I 
think it would benefit you. It allows researchers to come in 
and have contact with people and talk to them about the 
benefits and risk. That is what is allowed here. It allows 
people to make their own choices and not myself or anyone else 
in this room to say here is the standard, here is what should 
apply.
    Mr. Horn. OK. We are going to wind this up.
    Anything any of you have on your mind that we haven't asked 
about in this hearing record?
    Dr. Hoge. I think you were a born therapist.
    Mr. Horn. We don't get those wages--sorry--salary, 
whatever, bills paid.
    OK, I want to thank you all very much for coming. You have 
all raised some new questions, as any good hearing does; and we 
will be following up. Just like your comments, as we go, if 
there is a new draft bill put together, we will send them to 
you. We would like your comments. Those of your association 
would be very helpful.
    With that, this hearing is adjourned.
    Oh, let me just put the staff on the record. I want to 
thank the following people that worked on this.
    J. Russell George, the staff director and chief counsel; 
and Mark Uncapher, who is on my left, your right, the counsel 
for this hearing; John Hynes, professional staff member; Andrea 
Miller, clerk. David McMillen, professional staff member for 
the minority; Ron Strohman, professional staff member for the 
minority; Jean Gosa, clerk for the minority; and Sheridan 
Parker, minority research assistant.
    We have had interns with this particular hearing: Mike 
Pressicci, Grant Newman, Melissa Holder; and our court 
reporters are Katrina Wright and Tracy Petty.
    Now we are adjourned.
    [Whereupon, at 12:30 p.m., the subcommittee was adjourned.]
    [Additional information submitted for the hearing record 
follows:] 

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