[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4077 Introduced in House (IH)]

103d CONGRESS
  2d Session
                                H. R. 4077

     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

                             March 17, 1994

Mr. Condit (for himself, Mr. Conyers, and Ms. Velazquez) introduced the 
    following bill; which was referred jointly to the Committees on 
     Government Operations, the Judiciary, and Energy and Commerce

_______________________________________________________________________

                                 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 1994''.
    (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 INFORMATION PRACTICES FOR PROTECTED HEALTH INFORMATION

         Subtitle A--Treatment of Protected Health Information

Sec. 101. Duties and authorities of health use trustees.
Sec. 102. Duties and authorities of public health trustees.
Sec. 103. Duties and authorities of special purpose trustees.
Sec. 104. Duties and authorities of affiliated persons.
   Subtitle B--Duties and Authorities of Health Information Trustees

             Part 1--Duties of Health Information Trustees

Sec. 111. Inspection of protected health information.
Sec. 112. Amendment of protected health information.
Sec. 113. Notice of information practices.
Sec. 114. Accounting for disclosures.
Sec. 115. Security.
       Part 2--Use and Disclosure of Protected Health Information

Sec. 121. General limitations on use and disclosure.
Sec. 122. Authorizations for disclosure of protected health 
                            information.
Sec. 123. Treatment, payment, and oversight.
Sec. 124. Next of kin and directory information.
Sec. 125. Public health.
Sec. 126. Emergency circumstances.
Sec. 127. Judicial, administrative, and other legal purposes.
Sec. 128. Health research.
Sec. 129. Law enforcement.
Sec. 130. Subpoenas, warrants, and search warrants.
           Subtitle C--Access Procedures and Challenge Rights

Sec. 141. Access procedures for law enforcement subpoenas, warrants, 
                            and search warrants.
Sec. 142. Challenge procedures for law enforcement subpoenas.
Sec. 143. Access and challenge procedures for other subpoenas.
Sec. 144. Construction of subtitle; suspension of statute of 
                            limitations.
Sec. 145. Responsibilities of Secretary.
                  Subtitle D--Miscellaneous Provisions

Sec. 151. Debit and credit card transactions.
Sec. 152. Access to protected health information outside of the United 
                            States.
Sec. 153. Standards for electronic documents and communications.
Sec. 154. Powers of attorney.
Sec. 155. Rights of incompetents.
Sec. 156. Rights of minors.
                        Subtitle E--Enforcement

Sec. 161. Civil actions.
Sec. 162. Civil money penalties.
Sec. 163. Alternative dispute resolution.
Sec. 164. 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; EFFECTIVE DATES; APPLICABILITY; AND 
                       RELATIONSHIP TO OTHER LAWS

Sec. 301. Regulations.
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, means to provide 
        access to the information, but only if such access is provided 
        by a health information 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) the individual who is the 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, that--
                    (A) is created or received by a health use trustee 
                or a public health trustee in a State; and
                    (B) relates to the past, present, or future 
                physical or mental health of an individual, the 
                provision of health care to an individual, or payment 
                for the provision of health care to an individual and--
                            (i) identifies the individual; or
                            (ii) with respect to which there is a 
                        reasonable basis to believe that the 
                        information can be used readily to identify the 
                        individual.
    (b) Definitions Relating to Health Information Trustees.--For 
purposes of this Act:
            (1) Health benefit plan.--The term ``health benefit plan'' 
        means any public or private entity or program that provides 
        payments for health care--
                    (A) including--
                            (i) a group health plan (as defined in 
                        section 607 of the Employee Retirement Income 
                        Security Act of 1974) or a multiple employer 
                        welfare arrangement (as defined in section 
                        3(40) of such Act) providing health benefits; 
                        and
                            (ii) any other health insurance 
                        arrangement, including any arrangement 
                        consisting of a hospital or medical expense 
                        incurred policy or certificate, hospital or 
                        medical service plan contract, or health 
                        maintenance organization subscriber contract;
                    (B) but not including--
                            (i) an individual making payment on the 
                        individual's own behalf (or on behalf of a 
                        relative or other individual) for health care 
                        or for deductibles, coinsurance, copayments, 
                        items, or services not covered under a health 
                        insurance arrangement;
                            (ii) a plan sponsor (as defined in section 
                        3(16) of the Employee Retirement Income 
                        Security Act of 1974);
                            (iii) an employer of an employee covered 
                        under a multiple employer welfare arrangement;
                            (iv) an employee organization that sponsors 
                        a multiple employer welfare arrangement; or
                            (v) an organization, association, 
                        committee, joint board of trustees, or similar 
                        group of representatives of 2 or more employers 
                        described in clause (iii) or 2 or more employee 
                        organizations described in clause (iv).
            (2) Health care provider.--The term ``health care 
        provider'' means 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.
            (3) Health information trustee.--The term ``health 
        information trustee'' means a person who--
                    (A) creates or receives protected health 
                information that affects interstate commerce; and
                    (B) is a health use trustee, public health trustee, 
                or special purpose trustee.
            (4) Health oversight agency.--The term ``health oversight 
        agency'' means a person--
                    (A) 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) who--
                            (i) enters into agreements with health 
                        benefit plans that are offered to individuals 
                        residing in a specific geographic region in 
                        order to facilitate the enrollment of such 
                        individuals in such plans; 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 agreements; or
                    (C) who--
                            (i) performs or oversees the performance of 
                        an 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.
            (5) Health researcher.--The term ``health researcher'' 
        means a person who conducts a health research project.
            (6) Health use trustee.--The term ``health use trustee'' 
        means a person who, with respect to protected health 
        information, receives, creates, uses, maintains, or transmits 
        such information while acting in whole or in part in the 
        capacity of--
                    (A) a health care provider, health benefit plan, or 
                health oversight agency; or
                    (B) an officer or employee of a person described in 
                subparagraph (A).
            (7) Public health authority.--The term ``public health 
        authority'' means an authority of the United States, a State, 
        or a political subdivision of a State that--
                    (A) is responsible for public health matters; and
                    (B) is conducting--
                            (i) a disease or injury reporting program;
                            (ii) public health surveillance; or
                            (iii) a public health investigation.
            (8) Public health trustee.--The term ``public health 
        trustee'' means a person who, with respect to protected health 
        information, receives, creates, uses, maintains, or transmits 
        such information while acting in whole or in part in the 
        capacity of--
                    (A) a health researcher;
                    (B) a public health authority; or
                    (C) an officer or employee of a person described in 
                subparagraph (A) or (B).
            (9) Special purpose trustee.--The term ``special purpose 
        trustee'' means a person who, with respect to protected health 
        information--
                    (A) receives such information under section 126 
                (relating to emergency circumstances), 127 (relating to 
                judicial, administrative, and other legal purposes), 
                129 (relating to law enforcement), or 130 (relating to 
                subpoenas, warrants, and search warrants); or
                    (B) is acting in whole or in part in the capacity 
                of an officer or employee of a person described in 
                subparagraph (A) with respect to such information.
    (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, affiliate, 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 transmits protected health information in order to 
                conduct a legitimate business activity of the trustee.
            (2) 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 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.
            (3) Health research project.--The term ``health research 
        project'' means a biomedical, epidemiological, or health 
        services research project, or a health statistics project, that 
        has been approved by--
                    (A) an institutional review board for the 
                organization sponsoring the project;
                    (B) an institutional review board for each health 
                information trustee that maintains protected health 
                information intended to be used in the project; or
                    (C) an institutional review board established or 
                designated by the Secretary.
            (4) Institutional review board.--The term ``institutional 
        review board'' means--
                    (A) a board established in accordance with 
                regulations of the Secretary under section 491(a) of 
                the Public Health Service Act;
                    (B) a similar board established by the Secretary 
                for the protection of human subjects in research 
                conducted by the Secretary;
                    (C) a similar board established under regulations 
                of a Federal Government authority other than the 
                Secretary; or
                    (D) a similar board which meets such requirements 
                as the Secretary may specify.
            (5) Law enforcement inquiry.--The term ``law enforcement 
        inquiry'' means a lawful investigation or official proceeding 
        inquiring into a specific 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 INFORMATION PRACTICES FOR PROTECTED HEALTH INFORMATION

         Subtitle A--Treatment of Protected Health Information

SEC. 101. DUTIES AND AUTHORITIES OF HEALTH USE TRUSTEES.

    A health use trustee--
            (1) shall comply with sections 111 (relating to 
        inspection), 112 (relating to amendment), 113 (relating to 
        notice of information practices), 114 (relating to accounting 
        for disclosures), and 115 (relating to security);
            (2) may use protected health information if such use is in 
        accordance with section 121; and
            (3) may disclose such information if such disclosure is in 
        accordance with section 121 and 1 or more of the following 
        sections:
                    (A) Section 122 (relating to authorizations).
                    (B) Section 123 (relating to treatment, payment, 
                and oversight).
                    (C) Section 124 (relating to next of kin and 
                directory information).
                    (D) Section 125 (relating to public health).
                    (E) Section 126 (relating to emergency 
                circumstances).
                    (F) Section 127 (relating to judicial, 
                administrative, and other legal purposes).
                    (G) Section 128 (relating to health research).
                    (H) Section 129 (relating to law enforcement).
                    (I) Section 130 (relating to subpoenas, warrants, 
                and search warrants).

SEC. 102. DUTIES AND AUTHORITIES OF PUBLIC HEALTH TRUSTEES.

    (a) In General.--Except as provided in subsections (b) and (c), a 
public health trustee--
            (1) shall comply with sections 111 (relating to 
        inspection), 114 (relating to accounting for disclosures), and 
        115 (relating to security);
            (2) may use protected health information if such use is in 
        accordance with section 121; and
            (3) may disclose such information if--
                    (A) such disclosure is essential to fulfill a 
                public health purpose; or
                    (B) such disclosure is in accordance with section 
                121 and 1 or more of the following sections:
                            (i) Section 122 (relating to 
                        authorizations).
                            (ii) Section 125 (relating to public 
                        health).
                            (iii) Section 126 (relating to emergency 
                        circumstances).
                            (iv) Section 128 (relating to health 
                        research).
                            (v) Section 129 (relating to law 
                        enforcement) (except section 129(a)(2)).
    (b) Determinations by Public Health Trustees Specific to an 
Individual.--A public health trustee who makes a decision concerning a 
right, benefit, or privilege of a individual using protected health 
information about the individual shall be considered to be a health use 
trustee with respect to such information and is subject to section 101 
(and not this section) with respect to such information.
    (c) Overlap With Health Use Trustee.--A person who is a public 
health trustee and a health use trustee with respect to the same 
protected health information is subject to section 101 and is not 
subject to this section with respect to such information.

SEC. 103. DUTIES AND AUTHORITIES OF SPECIAL PURPOSE TRUSTEES.

    (a) In General.--A special purpose trustee--
            (1) shall comply with sections 114 (relating to accounting 
        for disclosures) and 115 (relating to security);
            (2) may use protected health information if such use is in 
        accordance with section 121; and
            (3) may disclose such information if such disclosure is in 
        accordance with section 121 and one or more of the following 
        sections:
                    (A) Section 122 (relating to authorizations).
                    (B) Section 126 (relating to emergency 
                circumstances).
                    (C) Section 128 (relating to health research).
                    (D) Section 129 (relating to law enforcement).
                    (E) Section 130 (relating to subpoenas, warrants, 
                and search warrants).
    (b) Overlap With Health Use and Public Health Trustees.--A person 
who is a health use trustee and a special purpose trustee with respect 
to the same protected health information is subject to section 101 and 
is not subject to this section with respect to such information. A 
person who is a public health trustee and a special purpose trustee 
with respect to the same protected health information is subject to 
section 102 and is not subject to this section with respect to such 
information.

SEC. 104. DUTIES AND AUTHORITIES OF AFFILIATED PERSONS.

    (a) Duties of Affiliated Persons.--
            (1) In general.--An affiliated person is required to 
        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 
        described in section 3(c)(1)(C) does not relieve a health 
        information trustee of any duty or liability under this Act.
    (b) Authorities.--
            (1) In general.--An affiliated person may exercise any 
        authority under this Act that the health information trustee 
        with whom the person has an agreement or relationship described 
        in section 3(c)(1)(C) may exercise and that the person has been 
        given pursuant to such agreement. 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 
        described in section 3(c)(1)(C) does not affect the authority 
        of a health information trustee under this Act.

   Subtitle B--Duties and Authorities of Health Information Trustees

             PART 1--DUTIES OF HEALTH INFORMATION TRUSTEES

SEC. 111. INSPECTION OF PROTECTED HEALTH INFORMATION.

    (a) In General.--Except as provided in subsection (b), a health 
information trustee who is required by subtitle A to comply with this 
section--
            (1) shall permit an individual to inspect any protected 
        health information about the individual that the trustee 
        maintains;
            (2) shall permit the individual to have a copy of the 
        information;
            (3) shall permit a person who has been designated in 
        writing by the individual to inspect, or to have a copy of, 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 if any of the following conditions apply:
            (1) Mental health treatment notes.--The information 
        consists of psychiatric, psychological, or mental health 
        treatment notes, the trustee determines in the exercise of 
        reasonable medical judgment that inspection or copying of the 
        notes would cause sufficient harm to the individual who is the 
        subject of the notes so as to outweigh the desirability of 
        permitting access, and the trustee does not disclose the notes 
        to any person not directly engaged in treating the individual, 
        except with the authorization of the individual or under 
        compulsion of law.
            (2) Information about others.--The information relates to 
        an individual other than the individual seeking to inspect or 
        have a copy of the information and the trustee determines in 
        the exercise of reasonable medical 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.
            (3) Endangerment to life or safety.--Disclosure of the 
        information could reasonably be expected to endanger the life 
        or physical safety of an individual.
            (4) 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 the individual who is the subject of the 
        information.
            (5) Administrative purposes.--The information--
                    (A) is used by the trustee solely for 
                administrative purposes and not in the provision of 
                health care to the individual who is the subject of the 
                information; and
                    (B) is not disclosed by the trustee to any person.
            (6) Duplicative information.--The information duplicates 
        information available for inspection under subsection (a).
            (7) Information compiled in anticipation of litigation.--
        The information is compiled principally--
                    (A) in reasonable anticipation of a civil action or 
                proceeding; or
                    (B) for use in such an action or proceeding.
    (c) Inspection and Copying of Segregable Portion.--A health 
information trustee who is required by subtitle A to comply with this 
section 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 fee (not greater than the actual 
        cost) 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 a request for inspection or copying under this section, 
the trustee shall provide the individual who made the request (or the 
individual's designated representative) 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.

SEC. 112. AMENDMENT OF PROTECTED HEALTH INFORMATION.

    (a) In General.--A health information trustee who is required by 
subtitle A to comply with this section shall, within the 45-day period 
beginning on the date the trustee receives from an individual about 
whom the trustee maintains protected health information a written 
request that the trustee correct or amend the information, either--
            (1) make the correction or amendment requested, inform the 
        individual of the correction or amendment that has been made, 
        and inform any person who is identified by the 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; or
            (2) inform the 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) Bases for Request To Correct or Amend.--An individual may 
request correction or amendment of protected health information about 
the individual under subsection (a) if the information is not timely, 
accurate, relevant, or complete.
    (c) Statement of Disagreement.--After an 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 shall not be construed to require a 
health information trustee to conduct a formal, informal, or other 
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 where 
information that is not timely, accurate, relevant, or complete is 
clearly marked as incorrect or where supplementary correct information 
is made part of the information.

SEC. 113. NOTICE OF INFORMATION PRACTICES.

    (a) Preparation of Written Notice.--A health information trustee 
who is required by subtitle A of this title to comply with this section 
shall prepare a written notice of information practices describing the 
following:
            (1) Rights of individuals.--The rights under this title of 
        an 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) Procedures of trustee.--The procedures established by 
        the trustee for the exercise of such rights.
            (3) Authorized disclosures.--The disclosures of protected 
        health information that are authorized under this Act.
    (b) Dissemination of Notice.--A health information trustee who is 
required by subtitle A to comply with this section--
            (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 Notice.--Not later than July 1, 1996, the Secretary, 
after notice and opportunity for public comment, shall develop and 
disseminate a model notice of information practices for use by health 
information trustees under this section.

SEC. 114. ACCOUNTING FOR DISCLOSURES.

    (a) In General.--A health information trustee who is required by 
subtitle A to comply with this section 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) the information disclosed, but only where the recording 
        of the information disclosed is practicable, taking into 
        account the technical capabilities of the system used to 
        maintain the record and the costs of such maintenance.
    (b) Disclosure Record Part of Information.--A record created and 
maintained under subsection (a) shall be maintained as part of the 
protected health information to which the record pertains.

SEC. 115. SECURITY.

    (a) In General.--A health information trustee who is required by 
subtitle A to comply with this section shall maintain reasonable and 
appropriate administrative, technical, and physical safeguards--
            (1) to ensure the integrity and confidentiality of 
        protected health information created or received by the 
        trustee;
            (2) to protect against any anticipated threats or hazards 
        to the security or integrity of, improper disclosures of, or 
        unauthorized uses of, such information; and
            (3) otherwise ensure compliance with this Act by the 
        trustee and the officers and employees of the trustee.
    (b) Specific Security Measures.--A health information trustee who 
is required by subtitle A to comply with this section shall ensure 
that--
            (1) officers, employees, and affiliated persons of the 
        trustee who have access to protected health information created 
        or received by the trustee are regularly trained in the 
        requirements governing such information;
            (2) audit trails are maintained, but only where the 
        maintenance of such trails is practicable, taking into account 
        the technical capabilities of the system used to maintain 
        protected health information and the costs of such maintenance; 
        and
            (3) appropriate signs and warnings are posted to advise 
        persons described in paragraph (1) regarding the need to secure 
        protected health information.

       PART 2--USE AND DISCLOSURE OF PROTECTED HEALTH INFORMATION

SEC. 121. GENERAL LIMITATIONS ON USE AND DISCLOSURE.

    (a) Use.--A health information trustee may use protected health 
information only for a purpose that is compatible with and related to 
the purpose for which the information--
            (1) was collected; or
            (2) was received by the trustee.
    (b) Disclosure.--A health information trustee may disclose 
protected health information only for a purpose that is 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, 1996, 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 111 (relating to inspection) or 124 
(relating to next of kin and directory information), and except as 
provided in subsection (e), a health information trustee may disclose 
protected health information only if such information is clearly 
identified as protected health information that is subject to this Act.
    (e) Routine Disclosures Subject to Written Agreement.--A health 
information trustee who routinely discloses protected health 
information to a person may satisfy the identification requirement in 
subsection (d) through the conclusion of a written agreement between 
the trustee and the person with respect to the identification of 
protected health information.
    (f) 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 would otherwise 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 161 (relating to civil actions) 
with respect to such failure.
    (f) No General Requirement to Disclose.--Except as provided in 
section 111, 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. 122. AUTHORIZATIONS FOR DISCLOSURE OF PROTECTED HEALTH 
              INFORMATION.

    (a) Statement of Intended Uses and Disclosures.--
            (1) In general.--A person who wishes to receive from a 
        health information trustee protected health information about 
        an 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 on or before the date on which 
        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 161 (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, 1996, 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).
    (b) Written Authorizations.--A health information trustee who is 
authorized by subtitle A to disclose protected health information under 
this section may disclose such information pursuant to an authorization 
executed by the individual who is the subject of the information, if 
each of the following requirements is met:
            (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 (a) 
        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 
        (d)(1).
            (8) Disclosure timely made.--The disclosure occurs during a 
        period described in subsection (d)(2).
    (c) Authorizations Requested in Connection With Provision of Health 
Care.--
            (1) In general.--A health use trustee or a public health 
        trustee may not request that an individual provide to any 
        person an authorization described in subsection (b) on a day on 
        which--
                    (A) the trustee provides health care to the 
                individual; or
                    (B) in the case of a trustee that is a health 
                facility, the individual is admitted into the facility 
                as a resident or inpatient in order to receive health 
                care.
            (2) Exception.--Paragraph (1) does not apply if a health 
        use trustee or a public health trustee requests that an 
        individual provide an authorization described in subsection (b) 
        for the purpose of assisting the individual in obtaining 
        counseling or social services from a person other than the 
        trustee.
    (d) Time Limitations on Authorizations.--
            (1) Receipt by trustee.--For purposes of subsection (b)(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 (b)(1), if 
                the authorization permits the disclosure of protected 
                health information to a health use trustee, public 
                health trustee, or 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 (b)(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 
        (b)(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.
    (e) Revocation or Amendment of Authorization.--
            (1) In general.--An individual in writing may revoke or 
        amend an authorization described in subsection (b), in whole or 
        in part, at any time, except when--
                    (A) disclosure of protected health information has 
                been authorized to permit validation of expenditures 
                for health care, or 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 pursuant to 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 Act.
    (f) Effect of Authorization on Privileges.--The execution by an 
individual of an authorization that meets the requirements of this 
section for the purpose of receiving health care or providing for the 
payment for health care shall not be construed as affecting any 
privilege that the individual may have under common or statutory law in 
a court of a State or the United States.
    (g) Additional Requirements of Trustee.--A health information 
trustee may impose requirements for an authorization that are in 
addition to the requirements in this section.
    (h) Copy.--A health information trustee who discloses protected 
health information pursuant to an authorization under this section 
shall maintain a copy of the authorization as part of the information.
    (i) Construction.--This section shall 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.
    (j) 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. 123. TREATMENT, PAYMENT, AND OVERSIGHT.

    (a) In General.--A health information trustee who is authorized by 
subtitle A to disclose protected health information under this section 
may disclose such information to a health use trustee if the disclosure 
is--
            (1) for the purpose of providing health care to an 
        individual and the individual who is the 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 
        authorized by law.
    (b) Use in Action Against Individual.--Protected health information 
about an individual that is disclosed under this section may not be 
used in, or disclosed to any person for use 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 receipt of health care or payment for health care.

SEC. 124. NEXT OF KIN AND DIRECTORY INFORMATION.

    (a) Next of Kin.--A health information trustee who is authorized by 
subtitle A to disclose protected health information under this section 
may disclose such information to the next of kin or legal 
representative (as defined under State law) of the individual who is 
the subject of the information, or to a person with whom the individual 
has a personal relationship, if--
            (1) the individual has not previously objected to the 
        disclosure;
            (2) the disclosure is consistent with accepted medical 
        practice; and
            (3) the information disclosed relates to the ongoing 
        provision of health care to the individual.
    (b) Directory Information.--A health information trustee who is 
authorized by subtitle A to disclose protected health information under 
this section may disclose such information to any person, if--
            (1) the information does not reveal specific information 
        about the physical or mental condition of the individual or 
        health care provided to the individual;
            (2) the individual who is the subject of the information 
        has not objected in writing to the disclosure;
            (3) the disclosure is consistent with accepted medical 
        practice; and
            (4) the information consists only of 1 or more of the 
        following items:
                    (A) The name of the individual.
                    (B) If the individual is receiving health care from 
                a health care provider on a premises controlled by the 
                provider, the location of the individual on such 
                premises.
                    (C) If the individual is receiving health care from 
                a health care provider on a premises controlled by the 
                provider, the general health status of the individual, 
                described in terms of critical, poor, fair, stable, 
                satisfactory, or terms denoting similar conditions.
    (c) 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. 125. PUBLIC HEALTH.

    (a) In General.--A health information trustee who is authorized by 
subtitle A to disclose protected health information under this section 
may disclose such information to a public health trustee for use in 
legally authorized--
            (1) disease or injury reporting;
            (2) public health surveillance; or
            (3) public health investigation.
    (b) Use in Action Against Individual.--Protected health information 
about an individual that is disclosed under this section may not be 
used in, or disclosed to any person for use 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.

SEC. 126. EMERGENCY CIRCUMSTANCES.

    A health information trustee who is authorized by subtitle A to 
disclose protected health information under this section may disclose 
such information to alleviate emergency circumstances affecting the 
health or safety of an individual.

SEC. 127. JUDICIAL, ADMINISTRATIVE, AND OTHER LEGAL PURPOSES.

    (a) In General.--A health information trustee who is authorized by 
subtitle A to disclose protected health information under this section 
may disclose such 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 the individual who is the 
        subject of the information is a party and in which the 
        individual has placed the individual's physical or mental 
        condition in issue;
            (2) pursuant to a law requiring the reporting of specific 
        medical information to law enforcement authorities;
            (3) if the disclosure is of information described in 
        paragraph (2) and the trustee is operated by a Federal agency;
            (4) if directed by a court in connection with a court-
        ordered examination of an individual; or
            (5) to assist in the identification of a dead individual.
    (b) Written Statement.--A person seeking protected health 
information about an individual maintained by health information 
trustee under--
            (1) subsection (a)(1) shall provide the trustee with a 
        written statement that the individual is a party to the 
        litigation or proceedings for which the information is sought; 
        or
            (2) subsection (a)(5) 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 under a condition described in subsection (a).

SEC. 128. HEALTH RESEARCH.

    (a) In General.--A health information trustee who is authorized by 
subtitle A to disclose protected health information under this section 
may disclose such information to a public health trustee if the 
disclosure is for use in a health research project that has been 
determined by an institutional review board to be--
            (1) of sufficient importance so as to outweigh the 
        intrusion into the privacy of the individual who is the subject 
        of the information that would result from the disclosure; and
            (2) reasonably impracticable to conduct without such 
        information.
    (b) Obligations of Recipient.--A person who receives protected 
health information pursuant to subsection (a) shall remove or destroy, 
at the earliest opportunity consistent with the purposes of the 
project, information that would enable 1 or more individuals to be 
identified, unless an 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.

SEC. 129. LAW ENFORCEMENT.

    (a) In General.--A health information trustee who is authorized by 
subtitle A to disclose protected health information under this section 
may disclose such information to a law enforcement agency (other than a 
health oversight agency) if the information is--
            (1) for use in an investigation or prosecution of a health 
        information trustee;
            (2) to assist in the identification or location of a 
        suspect, fugitive, or witness in a law enforcement inquiry;
            (3) in connection with criminal activity committed against 
        the trustee or an affiliated person of the trustee or on 
        premises controlled by the trustee; or
            (4) 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 individual who 
        is the subject of the information).
    (b) Certification.--Where a law enforcement agency requests a 
health information trustee to disclose protected health information 
under this section, 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.
    (c) Restrictions on Disclosure and Use.--Protected health 
information about an individual that is disclosed by a health 
information trustee to a law enforcement agency under this section--
            (1) may not be disclosed for, or used in, any 
        administrative, civil, or criminal action or investigation 
        against the individual, except in an action or investigation 
        arising out of and directly related to the action or 
        investigation for which the information was obtained; and
            (2) may not be otherwise used or disclosed by the agency, 
        unless the use or disclosure is necessary to fulfill the 
        purpose for which the information was obtained and is not 
        otherwise prohibited by law.

SEC. 130. SUBPOENAS, WARRANTS, AND SEARCH WARRANTS.

    (a) In General.--A health information trustee who is authorized by 
subtitle A to disclose protected health information under this section 
may disclose such 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 seeking the information that the grand jury has 
        complied with the applicable access provisions of section 141 
        or 143(a).
            (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 141 or 143(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 123 through 129.
    (b) Restrictions on Use and Disclosure.--Protected health 
information about an individual that is disclosed by a health 
information trustee under--
            (1) subsection (a) may not be disclosed for, or used in, 
        any administrative, civil, or criminal action or investigation 
        against the individual, except in an action or investigation 
        arising out of and directly related to the inquiry for which 
        the information was obtained;
            (2) 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
            (3) 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.
    (c) 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.
    (d) Copy As Part of Protected Information.--A health information 
trustee who discloses protected health information under this section 
shall maintain a copy of the applicable subpoena, warrant, or search 
warrant as part of the information.
    (e) Construction.--Nothing in this section shall be construed as 
authority for a health information trustee to refuse to comply with an 
administrative subpoena or warrant or a judicial subpoena or search 
warrant that meets the requirements of this Act.

           Subtitle C--Access Procedures and Challenge Rights

SEC. 141. ACCESS PROCEDURES FOR LAW ENFORCEMENT SUBPOENAS, WARRANTS, 
              AND SEARCH WARRANTS.

    (a) Probable Cause Requirement.--A government authority may not 
obtain protected health information about an individual from a health 
information trustee under paragraph (1) or (2) of section 130(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 an 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 an 
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 145(1)) of the 
individual's right to challenge the subpoena in accordance with section 
142, 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 142; or
            (2) disclosure is ordered by a court under section 142.
    (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 
                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. 142. 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 an 
individual from a health information trustee under paragraph (1) or (2) 
of section 130(a) (except a subpoena issued in compliance with the 
provisions of section 143(a)), 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 an individual's timely 
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 protect health information disclosed.

SEC. 143. ACCESS AND CHALLENGE PROCEDURES FOR OTHER SUBPOENAS.

    (a) In General.--A person (other than a government authority under 
section 141) may not obtain protected health information about an 
individual from a health information trustee pursuant to a subpoena 
under section 130(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 145(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 an 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 
timely 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. 144. 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 requests for protected health 
information. Nothing in this subtitle shall entitle an individual who 
is the subject of such information 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 Act which has the effect of delaying the access of a government 
authority to such information, any applicable statute of limitations is 
deemed to be tolled for the period beginning on the date such motion 
was filed and ending on the date on which the motion is decided.

SEC. 145. RESPONSIBILITIES OF SECRETARY.

    Not later than July 1, 1996, the Secretary, after notice and 
opportunity for public comment, shall develop and disseminate a brief, 
clear, and easily understood notice--
            (1) for use under subsection (c) of section 141, detailing 
        the rights of an individual who wishes to challenge, under 
        section 142, the disclosure of protected health information 
        about the individual under such subsection; and
            (2) for use under subsection (a) of section 143, detailing 
        the rights of an 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. 151. DEBIT AND CREDIT CARD TRANSACTIONS.

    (a) Payment for Health Care Through Debit or Credit Card.--If an 
individual pays a health information trustee for health care by 
presenting a debit or credit card or card number, the trustee may use 
or disclose such protected health information about the individual as 
is necessary for the processing of the debit or credit card transaction 
or the billing or collection of amounts charged or debited to the 
individual using the card or number.
    (b) Transaction Processing By Card Issuers.--A person who is a 
debit or credit card issuer or is otherwise directly involved in the 
processing of credit or debit transactions or the billing or collection 
of amounts charged or debited thereto may only use or disclose 
protected health information about an individual--
            (1) that has been disclosed in accordance with subsection 
        (a); and
            (2) when necessary for--
                    (A) the billing or collection of amounts charged or 
                debited to the individual using a debit or credit card;
                    (B) the transfer of receivables, accounts, or 
                interest therein;
                    (C) the audit of the credit or debit card account 
                information;
                    (D) compliance with Federal, State, or local law; 
                and
                    (E) a properly authorized civil, criminal, or 
                regulatory investigation by Federal, State, or local 
                authorities.

SEC. 152. ACCESS TO PROTECTED HEALTH INFORMATION OUTSIDE OF THE UNITED 
              STATES.

    (a) In General.--Except as provided in subsection (b), 
notwithstanding the provisions of subtitle A and part 2 of subtitle B, 
a health information trustee may not permit any person who is not in a 
State to have access to protected health information about an 
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 122.
            (2) Equivalent information practices.--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 country where the access 
        will be provided that are equivalent to the fair information 
        practices 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 126; or
            (3) is necessary for the purpose of providing for payment 
        for health care that has been provided to an individual.

SEC. 153. STANDARDS FOR ELECTRONIC DOCUMENTS AND COMMUNICATIONS.

    (a) Standards.--Not later than July 1, 1996, the Secretary, after 
notice and opportunity for public comment, shall promulgate standards 
with respect to the creation, transmission, receipt, and maintenance, 
in electronic form, of each written document required or authorized 
under this Act. Where a signature is required with respect to a written 
document under any other provision of this Act, such standards shall 
provide for an electronic substitute that serves the functional 
equivalent of a signature.
    (b) Treatment of Complying Documents and Communications.--An 
electronic document or communication that satisfies the standards 
promulgated 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. 154. POWERS OF ATTORNEY.

    In the case of an individual who has executed a power of attorney, 
recognized under State law, authorizing a person to act as agent or 
attorney for the individual for one or more purposes, the person may 
exercise any right of the individual under this title that the person 
is authorized to exercise by the power of attorney, if--
            (1) any condition precedent to the exercise of such right 
        that is set forth in the power of attorney has been satisfied; 
        and
            (2) the power of attorney specifically references or 
        describes the rights under this title that may be exercised by 
        the person.

SEC. 155. RIGHTS OF INCOMPETENTS.

    (a) Effect of Declaration of Incompetence.--Except as provided in 
section 154, if an individual has been declared to be incompetent by a 
court of competent jurisdiction, the rights of the individual under 
this title shall be exercised and discharged in the best interests of 
the individual through an authorized legal representative of the 
individual.
    (b) No Court Declaration.--Except as provided in section 154, if a 
health care provider determines that an individual, who has not been 
declared to be incompetent by a court of competent jurisdiction, 
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 122 may 
be exercised and discharged in the best interest of the individual by 
the individual's next of kin.

SEC. 156. RIGHTS OF 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 sections 154 and 155; or
            (2) who, acting alone, has the legal capacity to apply for 
        and obtain a type of medical examination, care, or treatment 
        and who has sought such examination, care, or treatment, the 
        individual shall exercise all rights of an individual under 
        this title with respect to protected health information 
        relating to such examination, care, or treatment.
    (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 title 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 111), the right of amendment (under section 
        112), and the right to authorize disclosure of protected health 
        information (under section 122) of the individual may be 
        exercised either by the individual or by the parent or legal 
        guardian of the individual.

                        Subtitle E--Enforcement

SEC. 161. CIVIL ACTIONS.

    (a) In General.--Any individual whose rights under this title have 
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 title 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 title (other than subsection (c) or (d) of section 
121) 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 title (other than subsection 
(c) or (d) of section 121), 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) Inspection and Amendment.--If a health information trustee has 
established a written 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) 3 months after the date the original request for 
        inspection or amendment was made.
    (f) No Liability for Permissible Disclosures.--A health information 
trustee who makes a disclosure of protected health information about an 
individual that is permitted by this title and not otherwise prohibited 
by State or Federal statute shall not be liable to the individual for 
the disclosure under common law.
    (g) No Liability for Institutional Review Board Determinations.--If 
the members of an institutional review board have in good faith 
determined that a health research project is of sufficient importance 
so as to outweigh the intrusion into the privacy of an individual 
pursuant to section 128(a)(1), the members, the board, and the parent 
institution of the board shall not be liable to the individual as a 
result of such determination.
    (h) 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 title shall not be liable 
to the individual for such disclosure.

SEC. 162. CIVIL MONEY PENALTIES.

    (a) Violation.--Any health information trustee who the Secretary 
determines has substantially failed 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 violation.
    (b) Procedures for Imposition of Penalties.--The provisions of 
section 1128A of the Social Security Act (other than subsections (a) 
and (b) and the second sentence of subsection (f)) 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. 163. ALTERNATIVE DISPUTE RESOLUTION.

    (a) In General.--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 161.
    (b) 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.
    (c) 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 resolution of claims;
            (3) provides for the consistent and fair resolution of 
        claims; and
            (4) provides for reasonably convenient access to dispute 
        resolution for individuals.

SEC. 164. AMENDMENTS TO CRIMINAL LAW.

    (a) In General.--Title 18, United States Code, is amended by 
inserting after chapter 89 the following:

               ``CHAPTER 90--PROTECTED HEALTH INFORMATION

``Sec.
``1831. Definitions.
``1832. Obtaining protected health information under false pretenses.
``1833. Monetary gain from obtaining protected health information under 
                            false pretenses.
``1834. Knowing and unlawful obtaining of protected health information.
``1835. Monetary gain from knowing and unlawful obtaining of protected 
                            health information.
``1836. Knowing and unlawful use or disclosure of protected health 
                            information.
``1837. Monetary gain from knowing and unlawful sale, transfer, or use 
                            of protected health information.
``Sec. 1831. Definitions
    ``As used in this chapter--
            ``(1) the term `health information trustee' has the meaning 
        given such term in section 3(b)(3) of the Fair Health 
        Information Practices Act of 1994; and
            ``(2) the term `protected health information has the 
        meaning given such term in section 3(a)(3) of such Act.
``Sec. 1832. 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 an 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. 1833. 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 an 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. 1834. Knowing and unlawful obtaining of protected health 
              information
    ``Whoever knowingly obtains protected health information from a 
health information trustee in violation of the Fair Health Information 
Practices Act of 1994, knowing that such obtaining is unlawful, shall 
be fined under this title or imprisoned not more than 5 years, or both.
``Sec. 1835. 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 1994, 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. 1836. 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 1994, 
knowing that such use or disclosure is unlawful, shall be fined under 
this title or imprisoned not more than 5 years, or both.
``Sec. 1837. 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 1994, 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 89 the following:

``90. Protected health information..........................    1831''.

          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)(3) of the Fair Health 
Information Practices Act of 1994) 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), (m), (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; EFFECTIVE DATES; APPLICABILITY; AND 
                       RELATIONSHIP TO OTHER LAWS

SEC. 301. REGULATIONS.

    Not later than July 1, 1996, the Secretary shall prescribe 
regulations to carry out this Act.

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, 
1997.
    (b) Provisions Effective Immediately.--Any provision of this Act 
that imposes a duty on the Secretary 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 exists in a State on or after January 
1, 1997, regardless of whether the information existed or was disclosed 
prior to such date.
    (b) Special Purpose Trustees.--The provisions of this Act shall not 
apply to any special purpose trustee, except with respect to protected 
health information that is received by such a trustee on or after 
January 1, 1997.
    (c) Authorizations for Disclosures.--An authorization for the 
disclosure of protected health information about an individual that is 
executed by the individual before January 1, 1997, and is recognized 
and valid under State law on December 31, 1996, shall remain valid and 
shall not be subject to the requirements of section 122 until July 1, 
1998, 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 provided in subsections (b) and (c), this 
Act shall prevent the establishment, continuing in effect, or 
enforcement of State law to the extent such law is inconsistent with a 
provision of this Act, but nothing in this Act shall be construed to 
indicate an intent on the part of Congress to occupy the field in which 
its provisions operate to the exclusion of the laws of any State on the 
same subject matter.
    (b) Privileges.--This Act does not preempt or modify State common 
or statutory law to the extent such law concerns a privilege of a 
witness or person in a court of the State. This Act does not supersede 
or modify Federal common or statutory law to the extent such law 
concerns a privilege of a witness or person in a court of the United 
States.
    (c) Certain Duties Under State or Federal Law.--This Act shall not 
be construed to preempt, supersede, or modify the operation of--
            (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; or
            (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).

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