[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 422 Introduced in Senate (IS)]







105th CONGRESS
  1st Session
                                 S. 422

 To define the circumstances under which DNA samples may be collected, 
stored, and analyzed, and genetic information may be collected, stored, 
   analyzed, and disclosed, to define the rights of individuals and 
      persons with respect to genetic information, to define the 
  responsibilities of persons with respect to genetic information, to 
   protect individuals and families from genetic discrimination, to 
establish uniform rules that protect individual genetic privacy, and to 
       establish effective mechanisms to enforce the rights and 
              responsibilities established under this Act.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 11, 1997

 Mr. Domenici (for himself, Mr. Jeffords, and Mr. Dodd) introduced the 
 following bill; which was read twice and referred to the Committee on 
                       Labor and Human Resources

_______________________________________________________________________

                                 A BILL


 
 To define the circumstances under which DNA samples may be collected, 
stored, and analyzed, and genetic information may be collected, stored, 
   analyzed, and disclosed, to define the rights of individuals and 
      persons with respect to genetic information, to define the 
  responsibilities of persons with respect to genetic information, to 
   protect individuals and families from genetic discrimination, to 
establish uniform rules that protect individual genetic privacy, and to 
       establish effective mechanisms to enforce the rights and 
              responsibilities established under this Act.

    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 ``Genetic 
Confidentiality and Nondiscrimination Act of 1997''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings and purposes.
Sec. 3. Definitions.
       TITLE I--COLLECTION, STORAGE, AND ANALYSIS OF DNA SAMPLES

Sec. 101. Collection of samples.
Sec. 102. Storage and genetic analysis of DNA samples.
      TITLE II--DISCLOSURE OF GENETIC INFORMATION TO THIRD PERSONS

Sec. 201. Disclosure of genetic information.
Sec. 202. Inspection and copying of clinical records containing genetic 
                            information.
Sec. 203. Amendment of records.
Sec. 204. Disclosures pursuant to compulsory process.
          TITLE III--AUTHORIZATION BY WRITTEN INFORMED CONSENT

Sec. 301. Authorization for collection and storage of DNA samples for 
                            genetic analysis.
Sec. 302. Authorization for disclosure of genetic information.
                  TITLE IV--DISCRIMINATION PROHIBITED

Sec. 401. Discrimination by employers or potential employers.
Sec. 402. Discrimination by health insurers.
                      TITLE V--RESEARCH ACTIVITIES

Sec. 501. Research involving genetic analysis.
Sec. 502. Disclosure of genetic information for research purposes.
Sec. 503. Exception for DNA samples collected prior to the effective 
                            date.
                   TITLE VI--MISCELLANEOUS PROVISIONS

Sec. 601. Notification of privacy obligations.
Sec. 602. Transfer of possession of DNA samples and genetic 
                            information; discontinuance of services.
                         TITLE VII--ENFORCEMENT

Sec. 701. Civil remedies.
Sec. 702. Civil penalties and injunctive relief.
 TITLE VIII--EFFECTIVE DATE; APPLICABILITY; AND RELATIONSHIP TO OTHER 
                                  LAWS

Sec. 801. Effective date.
Sec. 802. Applicability.
Sec. 803. Relationship to other laws.

SEC. 2. FINDINGS AND PURPOSES.

    (a) Findings.--Congress finds the following:
            (1) The DNA molecule contains the uniquely private and 
        personal genetic information of an individual. This information 
        is contained in a code that is rapidly being deciphered and 
        understood.
            (2) Research in human and medical genetics continues to 
        provide and to predict immense health benefits to individuals 
        and their families.
            (3) Improper use and unauthorized disclosure of genetic 
        information may cause significant social and psychological harm 
        to individuals, including stigmatization and discrimination.
            (4) Genetic analysis of the DNA of an individual provides 
        information about the individual, and may provide information 
        about the parents, siblings, and children of the individual.
            (5) Existing legal protections for genetic information are 
        inadequate to ensure genetic privacy and to prevent genetic 
        discrimination.
            (6) Uniform rules for the collection, storage, and use of 
        DNA samples and genetic information, and for the disclosure of 
        genetic information, will protect individual privacy, encourage 
        genetic research, and prevent genetic discrimination.
    (b) Purposes.--The purposes of this Act are--
            (1) to define the circumstances under which--
                    (A) DNA samples may be collected, stored, and 
                analyzed; and
                    (B) genetic information may be collected, stored, 
                analyzed, and disclosed;
            (2) to define the rights of individuals and persons with 
        respect to genetic information;
            (3) to define the responsibilities of persons with respect 
        to genetic information;
            (4) to protect individuals and families from genetic 
        discrimination;
            (5) to establish uniform rules that protect individual 
        genetic privacy; and
            (6) to establish effective mechanisms to enforce the rights 
        and responsibilities established under this Act.

SEC. 3. DEFINITIONS.

    As used in this Act:
            (1) Collect.--The term ``collect'' means to obtain a DNA 
        sample.
            (2) Compulsory disclosure.--The term ``compulsory 
        disclosure'' means any disclosure of genetic information 
        required by Federal or State law for a judicial, legislative, 
        or administrative proceeding.
            (3) Disclose.--The term ``disclose'', when used with 
        respect to the genetic information of an individual, means to 
        convey, or provide access to, the genetic information, to a 
        person other than the individual.
            (4) DNA.--The term ``DNA'' means deoxyribonucleic acid, 
        which is a genetic material that is composed of a sequence of 4 
        kinds of molecular building blocks, called nucleotides, that 
        encode genetic information.
            (5) DNA matching.--The term ``DNA matching'' means a 
        scientifically and statistically reliable process for 
        characterizing and comparing DNA samples, to determine if the 
        DNA samples match and may therefore be presumed to originate 
        from the same individual.
            (6) DNA sample.--The term ``DNA sample'' means a human 
        tissue sample from which DNA is intended to be extracted, or 
        DNA extracted from such tissue sample. The term ``DNA sample'' 
        does not include a tissue sample that is taken--
                    (A) as a biopsy or an autopsy specimen, or as a 
                clinical specimen solely for the purpose of conducting 
                an immediate clinical or diagnostic test that is not a 
                DNA test;
                    (B) as a blood sample solely for blood banking; or
                    (C) as a newborn screening specimen solely for 
                determination of disease in the newborn, as required by 
                law.
            (7) Employer.--The term ``employer'' has the meaning given 
        such term under section 3(5) of the Employee Retirement Income 
        Security Act of 1974, except that such term shall include only 
        employers of two or more employees.
            (8) Family.--The term ``family'' means the biological and 
        legal relatives of an individual who may have a material 
        interest in the genetic information of the individual.
            (9) Genetic analysis.--The term ``genetic analysis'' means 
        the process of characterizing genetic information from a human 
        tissue sample.
            (10) Genetic information.--The term ``genetic information'' 
        means information from a human DNA sample about molecular 
        genotype, information from mutation analysis, or information 
        about nucleotide sequence of a gene.
            (11) Individual.--The term ``individual'' means the source 
        of a human tissue sample from which DNA is extracted or 
        molecular genetic information is characterized. The term 
        ``individual'' includes a subject of genetic research, and 
        where appropriate includes the parent, guardian or legal 
        representative of the individual.
            (12) Individual identifier.--The term ``individual 
        identifier'' means any information by which the identity of the 
        individual can be ascertained. The term does not include codes 
        that cannot be used singly to identify an individual.
            (13) Institutional review board.--The term ``Institutional 
        Review Board'' means a board established in accordance with 
        section 46.102(g) of title 45, Code of Federal Regulations (or 
        any corresponding similar regulation or ruling).
            (14) Insurer.--
                    (A) In general.--The term ``insurer'' means an 
                insurance company, insurance service, or insurance 
                organization (including a health maintenance 
                organization, as defined in subparagraph (B)) which is 
                licensed to engage in the business of insurance in a 
                State and which is subject to State law which regulates 
                insurance (within the meaning of section 514(b)(2) of 
                the Employee Retirement Income Security Act of 1974). 
                Such term does not include a group health plan.
                    (B) Health maintenance organization.--The term 
                ``health maintenance organization'' means--
                            (i) a Federally qualified health 
                        maintenance organization (as defined in section 
                        1301(a));
                            (ii) an organization recognized under State 
                        law as a health maintenance organization; or
                            (iii) a similar organization regulated 
                        under State law for solvency in the same manner 
                        and to the same extent as such a health 
                        maintenance organization.
            (15) Person.--The term ``person'' includes a family, 
        corporation, partnership, association, joint venture, 
        government, governmental subdivision or agency, and any other 
        legal or commercial entity. The term ``person'', used with 
respect to a human tissue sample, does not include the individual who 
is the source of the tissue sample.
            (16) Research.--The term ``research'' means scientific 
        investigation that includes systematic development and testing 
        of hypotheses for the purpose of increasing knowledge.
            (17) Researcher.--The term ``researcher'' means a person 
        who conducts research.
            (18) Retain.--The term ``retain'' means to store a DNA 
        sample or genetic information characterized from such a sample 
        for an extended period of time after the initial testing 
        conducted on the sample.
            (19) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
            (20) Subject.--The term ``subject'', when used with respect 
        to genetic research, means the source of a human tissue sample 
        collected for molecular genetic analysis.

       TITLE I--COLLECTION, STORAGE, AND ANALYSIS OF DNA SAMPLES

SEC. 101. COLLECTION OF SAMPLES.

    (a) Requirement of Written Authorization.--Except as otherwise 
provided by law, a person may collect a DNA sample from an individual 
for genetic analysis only if the person--
            (1) obtains the written authorization of the individual, as 
        described in section 301;
            (2) provides the information described in subsection (b) 
        and the notice described in subsection (c); and
            (3) collects the sample in accordance with the 
        authorization and notice.
    (b) Required Information.--Prior to the collection of a DNA sample 
from an individual for genetic analysis, the person who collects the 
sample shall inform the individual, in language understandable to the 
individual--
            (1) that consent to the collection of the DNA sample is 
        voluntary;
            (2) about the genetic information that can reasonably be 
        expected to be derived from the genetic analysis;
            (3) about the implications of genetic information derived 
        from the genetic analysis, for the individual and the family 
        members of the individual;
            (4) about the ways in which the genetic information derived 
        from the genetic analysis will be used;
            (5) about the information that the individual can expect to 
        receive on completion of the genetic analysis;
            (6) about the extent of the right of the individual to have 
        the DNA sample removed from a research study and, if possible, 
        to have the genetic information characterized from the DNA 
        sample destroyed;
            (7) about the right of the individual to revoke consent to 
        the genetic analysis at any time prior to the commencement of 
        the genetic analysis;
            (8) that revocation of consent for genetic analysis does 
        not absolve the individual of responsibility for all relevant 
        costs of a clinical, diagnostic test;
            (9) that the genetic analysis may yield information that 
        should be communicated to a family member of the individual;
            (10) about the existence of, and protections afforded by, 
        this Act; and
            (11) about the availability, or the lack of availability, 
        of optional genetic counseling.
    (c) Notice of Rights and Assurances.--The person who collects the 
DNA sample for genetic analysis shall provide the individual, prior to 
the collection of the DNA sample, and any other person upon request, 
with a written notice of rights and assurances that contains the 
following information and assurances:
            (1) That the DNA sample will be used only as authorized in 
        the written authorization, as described in section 301.
            (2) That the individual has the right to order the 
        destruction of an identifiable DNA sample at any time.
            (3) That the DNA sample will be destroyed upon the 
        completion of the genetic analysis or the genetic test, unless 
        the individual has consented in writing to further use of the 
        sample in accordance with section 301(a)(6).
            (4) That the individual may designate another person as the 
        person authorized to make decisions regarding disposition of 
        the DNA sample after the death of the individual, and, if any 
        person is so designated, that the individual should notify the 
        facility in which the DNA sample is stored.
            (5) That the individual has the right to examine clinical 
        records containing genetic information, to obtain copies of 
        such records, and to request amendment of such records.
            (6) That researchers may be granted access to a DNA sample 
        only as specified in the written authorization of the 
        individual, in accordance with section 301(a)(6)(A).
            (7) That the collection, storage, and analysis of the DNA 
        sample and the genetic information characterized from the 
        sample are protected by this Act, and that an individual whose 
        rights under this Act are violated may seek civil remedies, 
        including damages and attorney's fees, as provided for in this 
        Act.
            (8) That optional genetic counseling is, or is not, 
        available as part of a research program.

SEC. 102. STORAGE AND GENETIC ANALYSIS OF DNA SAMPLES.

    Except as otherwise required by Federal or State law, a person may 
store or conduct a genetic analysis of a DNA sample from an individual 
only if the person--
            (1) confirms that the written authorization of the 
        individual as described in section 301 has been obtained and 
        the notice described in section 101(c) has been provided; and
            (2) stores or conducts the analysis of the DNA sample in 
        accordance with such authorization and notice.

      TITLE II--DISCLOSURE OF GENETIC INFORMATION TO THIRD PERSONS

SEC. 201. DISCLOSURE OF GENETIC INFORMATION.

    (a) Requirement of Written Authorization.--Except as otherwise 
required by Federal or State law, a person may disclose genetic 
information characterized from the DNA sample of an individual only 
with the written authorization of the individual, as described in 
section 302.
    (b) Redisclosure Prohibited.--Except to the extent reasonable in 
the exercise of judgment for professional medical consultation for the 
direct benefit of a patient, a person to whom genetic information has 
been disclosed may disclose the information only with the written 
authorization of the individual, as described in section 302.

SEC. 202. INSPECTION AND COPYING OF CLINICAL RECORDS CONTAINING GENETIC 
              INFORMATION.

    (a) Inspection of Clinical Records.--A person who retains the 
genetic information of an individual in clinical records shall, on 
written request, permit the individual to inspect the records 
containing the genetic information and shall provide a copy of any such 
records to the individual.
    (b) Response to Request for Examination and Copying of 
Information.--A person described in subsection (a) who receives a 
written request from an individual to inspect or copy clinical records 
shall, not later than 20 business days after receiving the request, 
make the information available to the individual. The person may make 
the information available by permitting the individual to inspect the 
records at the storage site during regular business hours, or by 
delivering a copy of the records to the individual, using the mail or a 
private interstate document carrier.
    (c) Explanation of Terms and Codes.--A person shall provide a 
nontechnical explanation of terms, and any codes or abbreviations, used 
in the records of the individual requesting the records.
    (d) Fee.--The person may charge an individual (except an individual 
who participates as a subject in a research project) a reasonable fee, 
for copies of records that are provided under this section. The fee 
shall not exceed the actual duplication costs, including administrative 
costs, to the person providing the copies.

SEC. 203. AMENDMENT OF RECORDS.

    (a) In General.--Not later than 20 business days after receiving a 
written request by an individual to amend any clinical records 
containing genetic information, a person who retains the information in 
the records shall agree or refuse to add the written amendment to the 
clinical record. The person shall agree to make the amendment if such 
information is not accurate or complete for the purposes for which such 
information may be used or disclosed by the person.
    (b) Agreement.--If the person retaining the information agrees to 
make an amendment under subsection (a), the person shall, not later 
than 20 business days after such receipt--
            (1) make the amendment requested;
            (2) inform the individual that the amendment has been made; 
        and
            (3) make reasonable efforts to inform any other person to 
        whom the information was previously disclosed of the amendment.
    (c) Reasons for Refusal and Review Procedures.--If the person 
retaining the information refuses to make an amendment under subsection 
(a), the person shall inform the individual in writing of--
            (1) the reasons for the refusal of the person to make the 
        amendment;
            (2) the procedures for further review of the refusal; and
            (3) the right of the individual to file with the person a 
        concise written statement setting forth the requested amendment 
        and the reasons of the individual for disagreeing with the 
        refusal of the person to make the amendment.
    (d) Statement of Disagreement.--After an individual has filed a 
statement of disagreement under subsection (c)(3), the person storing 
the records--
            (1) shall make the statement part of the records of the 
        individual; and
            (2) in any subsequent disclosure of the disputed portion of 
        the information, shall include a copy of the statement and may 
        include a statement of the reasons for not making the requested 
        amendment.

SEC. 204. DISCLOSURES PURSUANT TO COMPULSORY PROCESS.

    (a) Proceedings in Which Available.--A person who stores genetic 
information in records may be compelled to disclose such information 
pursuant to a request for compulsory disclosure in any judicial, 
legislative, or administrative proceeding if--
            (1) the request for compulsory disclosure is in accordance 
        with Federal or State law requiring such disclosure;
            (2) the individual whose genetic information is requested 
        is a party to the proceeding and the content of the information 
        is at issue; or
            (3) the genetic information is requested for use in a law 
        enforcement proceeding or investigation and the person storing 
        the information is the subject of or a party to the proceeding 
        or investigation.
    (b) Notice.--A person requesting compulsory disclosure of genetic 
information under paragraph (2) or (3) of subsection (a) shall serve on 
the person storing the genetic information, and on the individual or 
the legal representative of the individual, the original or a copy of 
the compulsory disclosure request at least 30 days prior to the date on 
which the compulsory disclosure is requested. The request shall include 
a statement of the right of the individual, and of the person storing 
the genetic information, to have any objections to such compulsory 
disclosure heard by the court or governmental agency considering the 
request prior to the issuance of an order for compulsory disclosure, 
and a description of the procedure to be followed to have any such 
objections heard. Such service shall be made by certified mail, return 
receipt requested, or by hand delivery, in addition to any form of 
service required by applicable Federal or State law.
    (c) Certification.--Service of compulsory disclosure (including 
discovery) requests on the person storing the genetic information shall 
be accompanied by a written certificate that--
            (1) is signed by the person requesting disclosure of the 
        genetic information or the authorized representative of the 
        person;
            (2) identifies the provision of subsection (a) under which 
        the compulsory disclosure (including discovery) is being 
        requested; and
            (3) if disclosure of genetic information is requested under 
        paragraph (2) or (3) of subsection (a), states that the 
        requirements for notice under subsection (b) have been 
        fulfilled.
The signature of a person on the certification shall be considered to 
be valid only if the person, at the time of signing, reasonably 
believed that the provision of subsection (a) that is identified in the 
certification provides an appropriate basis for compulsory disclosure 
(including discovery). The person shall store a copy of the written 
certification as a permanent part of the records containing the genetic 
information.
    (d) Standard for Issuance of Order.--An order may only be entered 
under this section by a court or agency of competent jurisdiction after 
a hearing and determination that good cause exists for compulsory 
disclosure of genetic information. In making such a determination, the 
court or agency shall determine whether--
            (1) other ways of obtaining the genetic information are 
        available and would be effective; and
            (2) there is a compelling need for the genetic information 
        that outweighs the potential harm to the privacy interest of 
        the individual whose genetic information is requested.
    (e) Content of Order.--An order entered under this section that 
authorizes disclosure of genetic information shall--
            (1) limit disclosure to the parts of records that contain 
        the information and that are essential to fulfill the objective 
        of the order;
            (2) limit disclosure to the person whose need for the 
        information is the basis of the order;
            (3) require the deletion of individual identifiers from any 
        documents that may be made available to the public; and
            (4) include such other measures as are necessary to limit 
        disclosure for the protection of the individual whose genetic 
        information is requested, including sealing from public 
        scrutiny the record or any portion of the record of any 
        proceeding for which disclosure of the information has been 
        ordered.

          TITLE III--AUTHORIZATION BY WRITTEN INFORMED CONSENT

SEC. 301. AUTHORIZATION FOR COLLECTION AND STORAGE OF DNA SAMPLES FOR 
              GENETIC ANALYSIS.

    (a) Written Authorization.--To be valid, the authorization by an 
individual required by sections 101 (for collection of a DNA sample) 
and 102 (for storage and genetic analysis of a DNA sample) shall comply 
with each of the following:
            (1) Writing.--The authorization shall be in writing, signed 
        by the individual, and dated on the date of the signature.
            (2) Identification of collector.--The authorization shall 
        identify the person authorized to collect the DNA sample.
            (3) Description of collection.--The authorization shall 
        state the tissue to be collected and the method of collection.
            (4) Authorized use.--The authorization shall include a 
        description of all authorized uses of the DNA sample.
            (5) Statement regarding storage after completion of 
        analysis.--The authorization shall indicate whether the 
        individual permits the sample to be retained after the analysis 
        is completed.
            (6) Statement regarding uses of dna samples for research or 
        commercial purposes.--The authorization shall include 
        provisions that permit the individual to consent to--
                    (A) use of the DNA sample for research;
                    (B) commercial use of the DNA sample, with a waiver 
                of, or a provision for, economic benefit to the 
                individual;
                    (C) if the individual consents to use under 
                subparagraph (A) or (B), use without identifiers, or 
                use with individual identifiers or codes retained, of 
                the DNA sample; and
                    (D) notification, if individual identifiers or 
                codes are retained, about information resulting from 
                such use that may have implications for the individual 
                or a family member of the individual.
            (7) Additional laws.--The authorization shall comply with 
        additional provisions of Federal or State law requiring 
        informed consent by human subjects in research, including the 
        provisions of part 46 of title 45, Code of Federal Regulations 
        (or any corresponding similar regulation or ruling).
    (b) Retention of Authorization.--The authorization shall be 
retained for the period during which the DNA sample is stored.
    (c) Copy.--A copy of the completed authorization shall be provided 
to the individual.

SEC. 302. AUTHORIZATION FOR DISCLOSURE OF GENETIC INFORMATION.

    (a) Written Authorizations.--To be valid the authorization by an 
individual required by section 201 (for disclosure of genetic 
information) shall comply with each of the following:
            (1) Writing.--The authorization shall be in writing, signed 
        by the individual, and dated on the date of the signature.
            (2) Identification of person making disclosure.--The 
        authorization shall identify the person authorized to make the 
        disclosure.
            (3) Description of genetic information.--The authorization 
        shall describe the specific genetic information to be 
        disclosed.
            (4) Recipient identified.--The authorization shall identify 
        the person to whom the genetic information is to be disclosed.
            (5) Purpose described.--The authorization shall describe 
        the purpose for which the disclosure is being made.
            (6) Expiration date.--The authorization shall state the 
        date upon which the authorization will expire.
            (7) Revocation or amendment statement.--The authorization 
        shall include a statement that the authorization for disclosure 
        of genetic information may be revoked or amended at any time 
        prior to the disclosure.
    (b) Copy.--A copy of the authorization shall be provided to the 
individual.
    (c) Revocation or Amendment of Authorization.--An individual may 
revoke or amend the authorization at any time prior to the disclosure. 
The revocation or amendment shall be in writing and addressed to the 
person who stores the genetic information.
    (d) Identification of Information as Protected by Law.--Each 
disclosure made pursuant to the authorization shall be accompanied by 
the following written statement:
    ``This information is obtained from the DNA sample of an individual 
and has been disclosed to you from confidential records protected under 
the Genetic Confidentiality and Nondiscrimination Act of 1997. Any 
further disclosure of the information without specific written 
authorization of the individual is prohibited and is punishable under 
the provisions of title VII of such Act.''.
    (e) Effect of General Authorization for Release of Medical 
Records.--A general authorization for the release of medical records or 
medical information shall not be construed to be an authorization for 
disclosure of genetic information about the molecular genotype of an 
individual with respect to any genetic trait. With respect to medical 
records that contain genetic information, the requirements for 
disclosure of genetic information that are described in this section 
shall be fulfilled prior to disclosure of the information.

                  TITLE IV--DISCRIMINATION PROHIBITED

SEC. 401. DISCRIMINATION BY EMPLOYERS OR POTENTIAL EMPLOYERS.

    (a) In General.--An employer shall not request, require, or use the 
genetic information of an employee or a prospective employee for the 
purpose of restricting any right or benefit otherwise due or available 
to the employee or the prospective employee. An employer may request or 
require or use the genetic information of an employee for the purpose 
of--
            (1) permitting a genetically susceptible employee to avoid 
        occupational exposure to substances with a mutagenic or 
        teratogenic effect; or
            (2) determining a genotype that is otherwise directly 
        related to the work and is consistent with business necessity.
    (b) Enforcement.--This section may be enforced in accordance with 
title VII.

SEC. 402. DISCRIMINATION BY HEALTH INSURERS.

    (a) In General.--An insurer offering health insurance coverage 
shall not--
            (1) terminate, restrict, limit, refuse to renew, or 
        otherwise apply conditions to the coverage of an individual or 
        family member under the health policy or plan involved, or 
        restrict the sale of the health policy or plan to an individual 
        or family member;
            (2) deny coverage or exclude an individual or family member 
        under the health policy or plan;
            (3) impose a rider that excludes coverage for certain 
        benefits or services under the health policy or plan for an 
        individual or family member;
            (4) establish differentials in premium rates or cost-
        sharing for coverage under the health policy or plan for an 
        individual or family member; or
            (5) otherwise discriminate against an individual or family 
        member in the provision of health insurance coverage;
on the basis of any molecular genetic information about a healthy 
individual or a healthy family member, or on the basis of a request for 
or receipt of genetic services by an individual or family member.
    (b) Prohibition on Testing or Questioning.--An insurer shall not 
require an applicant for health insurance coverage, or an individual or 
family member who is enrolled under a health insurance coverage policy 
or plan, to be subjected to a genetic test or to be questioned about 
genetic information.
    (c) Disclosure.--An insurer shall, in the application or enrollment 
information provided by the insurer concerning health insurance 
coverage, provide the applicant or enrollee with a written statement 
disclosing the rights of the applicant or enrollee under this Act. Such 
statement shall be in a form and manner that is noticeable and 
understandable to an average applicant or enrollee.
    (d) Enforcement.--
            (1) Plans other than employee welfare benefit plans.--The 
        requirements established under subsections (a), (b), and (c) 
        shall be enforced by the State insurance commissioner for the 
        State involved or the official designated by the State, except 
        that in no case shall a State enforce such requirements as the 
        requirements relate to employee welfare benefit plans (as 
        defined in section 3 of the Employee Retirement Income Security 
        Act of 1974 (29 U.S.C. 1002)).
            (2) Employee welfare benefit plans.--With respect to such 
        employee welfare benefit plans, the Secretary shall enforce the 
        requirements established under subsections (a), (b), and (c) in 
        the same manner as the Secretary enforces requirements of the 
        Employee Retirement Income Security Act of 1974 (29 U.S.C. 1001 
        et seq.) under sections 502, 504, 506, and 510 of the Employee 
Retirement Income Security Act of 1974 (29 U.S.C. 1132, 1134, 1136, and 
1140).
    (e) Health Insurance Coverage.--In this section, the term ``health 
insurance coverage'' means benefits consisting of medical care 
(provided directly, through insurance or reimbursement, or otherwise 
and including items and services paid for as medical care) under any 
hospital or medical service policy or certificate, hospital or medical 
service plan contract, or health maintenance organization contract 
offered by an insurer.

                      TITLE V--RESEARCH ACTIVITIES

SEC. 501. RESEARCH INVOLVING GENETIC ANALYSIS.

    (a) Conditions for Genetic Analysis.--Except as provided in section 
802(a), a DNA sample may be analyzed as part of a research project only 
if an Institutional Review Board, or similar board in the research 
industry, has determined that--
            (1) use of DNA samples is essential to the research 
        project;
            (2) the potential benefit of the research project to 
        society outweighs the potential risks to the research subjects, 
        including psychosocial risks and intrusion into the privacy of 
        the subjects that would result from genetic analysis of DNA 
        samples; and
            (3) the research protocol--
                    (A) contains adequate safeguards to protect against 
                disclosure of genetic information that is generated by 
                the research;
                    (B) requires that research subjects will be given 
                the applicable information required under section 101;
                    (C) requires informed consent by the subjects, as 
                provided in part 46 of title 45, Code of Federal 
                Regulations (or any corresponding similar regulation or 
                ruling);
                    (D) requires the written authorization of the 
                subjects, that complies with the applicable 
                requirements of section 301, and that describes the 
                protocol and the intended uses of the DNA samples;
                    (E) prohibits inclusion of specific molecular 
                genetic genotype information in clinical records unless 
                the subjects authorize such inclusion in writing;
                    (F) with respect to protocols involving the use of 
                DNA samples from subjects deceased prior to the 
                effective date of this Act--
                            (i) provides a reasonable method for 
                        disclosing to the family members of a subject, 
                        the risks that--
                                    (I) are associated with genetic 
                                information of the subject that is 
                                generated by the research; and
                                    (II) in reasonable medical judgment 
                                can be effectively ameliorated, 
                                prevented, or treated; and
                            (ii) takes into account the right of family 
                        members to refuse learning about the genetic 
                        information; and
                    (G) describes the availability, or lack of 
                availability, of genetic counseling related to the 
                research project.
    (b) Safeguards Against Disclosures of Genetic Information.--For 
purposes of subsection (a)(3)(A), adequate safeguards against 
disclosure of genetic information, at a minimum, include--
            (1) obtaining an authorization from the Secretary as 
        provided for in section 301(d) of the Public Health Service Act 
        (42 U.S.C. 241(d));
            (2) ensuring that research subjects will not be 
        identifiable in any report or publication that results from the 
        research; and
            (3) having procedures to remove or destroy any individual 
        identifiers at the earliest opportunity, consistent with the 
        purposes of the project and the terms of the consent of the 
        subjects involved.
    (c) Destruction of DNA Samples of Identifiers.--If the DNA sample 
of a subject is collected, stored, or analyzed in connection with a 
research project, the researcher shall ensure the destruction of the 
DNA sample on the date of completion of the project or withdrawal of 
the subject from the project, whichever occurs first, unless the 
researcher obtains a specific authorization of the subject, as 
described in section 301, to store the sample after such date.
    (d) Pedigree Analysis and Family Linkage Studies.--If a research 
project includes genetic analysis of family members of a subject for 
pedigree analysis or linkage analysis--
            (1) the Institutional Review Board, in addition to making 
        the determinations required in subsection (a), shall also 
        require that genotype records be stored in strict 
        confidentiality; and
            (2) the process for obtaining the informed consent and 
        authorization of the subject, as described in subsection 
        (a)(3)(C) and sections 301 and 302, shall include information 
        about--
                    (A) the possibility that family members of the 
                subject may learn genetic information about the subject 
                as a result of a project;
                    (B) the possibility that the project may determine 
                that some family members are not genetic relatives; and
                    (C) the disposition of records and data generated 
                during the project.
    (e) Right of Subject To Obtain Information.--A person who analyzes 
DNA samples as part of a research project described in subsection (d) 
shall provide a subject or family member with genetic information about 
another family member only with the written authorization of the 
subject or the other family member.

SEC. 502. DISCLOSURE OF GENETIC INFORMATION FOR RESEARCH PURPOSES.

    (a) In General.--Any person who stores molecular genetic 
information of a subject may allow access to such information to 
researchers only--
            (1) if an Institutional Review Board has approved the 
        protocol of the research project; and
            (2) with the written authorization of the subject, as 
        described in section 302.
Such information shall be provided with individual identifiers, or 
codes, or no identifiers, according to the written authorization of the 
subject.
    (b) Limited Access for Statistical Use.--Notwithstanding subsection 
(a), a person who stores genetic information may grant access to such 
information solely for the purpose of inspection or review of the 
records containing the information if--
            (1) the inspection or review is for the purpose of 
        compiling data for statistical or epidemiological studies and 
        genetic information that contains personal identifiers is not 
        copied, removed from the records, or redisclosed in any way; 
        and
            (2) the person conducting the inspection or review 
        certifies in writing--
                    (A) that the limitations in paragraph (1) will be 
                complied with;
                    (B) that the person has complied with this Act; and
                    (C) to knowledge of liability for violations of 
                this Act.

SEC. 503. EXCEPTION FOR DNA SAMPLES COLLECTED PRIOR TO THE EFFECTIVE 
              DATE.

    (a) In General.--A DNA sample collected prior to the effective date 
of this Act may be analyzed as part of a research project under a 
protocol approved by the Institutional Review Board, unless the 
individual involved, within 3 years of the effective date of this Act, 
submits a written request that such sample be withdrawn or destroyed; 
and
    (b) Disclosure.--Except as provided under section 502, genetic 
information collected as part of a research project described in 
subsection (a) may be disclosed only with the authorization of the 
individual involved or the individual's legal representative.

                   TITLE VI--MISCELLANEOUS PROVISIONS

SEC. 601. NOTIFICATION OF PRIVACY OBLIGATIONS.

    Every person who collects, stores, or analyzes DNA samples or 
genetic information shall not less than annually notify the employees 
of the person of their responsibilities under this Act and of the 
penalties for violating the provisions of this Act.

SEC. 602. TRANSFER OF POSSESSION OF DNA SAMPLES AND GENETIC 
              INFORMATION; DISCONTINUANCE OF SERVICES.

    (a) Activities Involving DNA Samples and Genetic Information.--Any 
person in possession of DNA samples and genetic information, who 
intends to transfer control of, or discontinue, activities or services 
related to the analysis of DNA samples, shall inform the individual 
that the individual has the right to--
            (1) consent to the transfer of the samples or records 
        containing the genetic information;
            (2) order that the samples or records be returned to the 
        individual; or
            (3) order that the samples or records be destroyed.
    (b) No Response.--If, within a period of 3 months after 
notification, the person identified in subsection (a) receives no 
response from the individual, the person--
            (1) shall destroy the samples or the records if the 
        activities or services are discontinued;
            (2) may place the samples and research records, without 
        personal identifiers, in a tissue sample archive, according to 
        prior instructions of the individual; or
            (3) may proceed with the intended transfer of the samples 
        and records.

                         TITLE VII--ENFORCEMENT

SEC. 701. CIVIL REMEDIES.

    (a) Private Right of Action.--Any individual whose rights under 
this Act (other than section 402) have been violated may maintain a 
civil action for damages or equitable relief, as provided for in this 
section.
    (b) Jurisdiction.--The action may be brought under this section in 
a district court of the United States or a State court of competent 
jurisdiction.
    (c) Relief.--In any action brought under this section, a court may 
order a person to comply with the provisions of this Act and may order 
any other appropriate equitable relief.
    (d) Liability for Negligent Violations.--Any person who negligently 
collects, stores, or analyzes a DNA sample of an individual in 
violation of this Act, negligently discloses genetic information in 
violation of this Act, or negligently induces another person to conduct 
such collection, storage, analysis, or disclosure, shall be liable to 
the individual for each such violation in an amount equal to--
            (1) any actual damages sustained as a result of the 
        collection, storage, analysis, or disclosure, or $50,000, 
        whichever is greater;
            (2) in any case in which such violation has resulted in 
        profit or monetary gain, treble damages; and
            (3) in the case of a successful action under this section, 
        the costs of the action and reasonable attorneys' fees as 
        determined by the court.
    (e) Liability for Willful Violations.--Any person who willfully 
collects, stores, or analyzes a DNA sample of an individual in 
violation of this Act, willfully discloses genetic information of an 
individual in violation of this Act, or willfully induces another 
person to conduct such collection, storage, analysis, or disclosure, 
shall be liable to the individual for each such violation in an amount 
equal to--
            (1) any actual damages sustained as a result of the 
        collection, storage, analysis, or disclosure, or $100,000, 
        whichever is greater;
            (2) such punitive damages as the court may allow; and
            (3) in the case of a successful action under this section, 
        the costs of the action and reasonable attorneys' fees as 
        determined by the court.
    (f) Liability for Employment Discrimination.--Any person who 
violates the rights of an individual under section 401 shall be liable 
to the individual for each such violation in an amount equal to--
            (1) any actual damages sustained as a result of the 
        violation, or $50,000, whichever is greater;
            (2) in any case in which such violation has resulted in 
        profit or monetary gain, treble damages; and
            (3) in the case of a successful action under this section, 
        the costs of the action and reasonable attorney's fees as 
        determined by the court.
    (g) Statute of Limitations.--Except with respect to subsection (h), 
any action under this section shall be brought within 6 years after the 
date that the alleged violation was or should have been discovered.
    (h) Tolling of Limitations.--If the person entitled to maintain an 
action under this section is unable to maintain the action because the 
individual is a minor, or is incapacitated by reason of mental illness, 
when the right to bring an action first occurs, the action may be 
commenced up to 10 years after the disability is removed.

SEC. 702. CIVIL PENALTIES AND INJUNCTIVE RELIEF.

    (a) In General.--If the Attorney General believes that any person 
is violating or is about to violate the provisions of this Act, and 
that proceedings would be in the public interest, the Attorney General 
may bring an action against such person to restrain the person by 
temporary restraining order or preliminary or permanent injunction from 
such violation.
    (b) Jurisdiction.--The action may be brought in the district court 
of the jurisdiction in which the person resides or has a principal 
place of business.
    (c) Relief.--The court may issue temporary restraining orders or 
preliminary or permanent injunctions and issue such other orders or 
judgments as may be necessary to prevent harm or to remedy harm 
suffered by any individual as a result of a violation of this Act.
    (d) Civil Penalty.--If the court finds that a person knew or should 
have known that the person was violating this Act, the court may 
require such person to pay a civil penalty of not more than $50,000 for 
each such violation and may also require such person to pay reasonable 
costs of investigation and litigation of such violation, including 
reasonable attorney's fees.

 TITLE VIII--EFFECTIVE DATE; APPLICABILITY; AND RELATIONSHIP TO OTHER 
                                  LAWS

SEC. 801. EFFECTIVE DATE.

    This Act shall take effect on January 1, 1999.

SEC. 802. APPLICABILITY.

    (a) Research on DNA Samples Collected Prior to Effective Date.--
Notwithstanding the provisions of section 501, a DNA sample that was 
collected prior to the effective date of this Act may be analyzed as 
part of a research project under a protocol approved by the 
Institutional Review Board, if the researcher--
            (1) withdraws or destroys the DNA sample if the subject 
        makes a written request not later than 3 years after the 
        effective date of this Act; and
            (2) except as provided under section 502, discloses genetic 
        information only with the written authorization of the subject 
        or the legal representative of the subject, as described in 
        section 302.
    (b) Authorizations for Disclosures.--An authorization for the 
disclosure of genetic information that is executed before January 1, 
1999, and that does not meet the requirements of section 302, but which 
is valid under State law on January 1, 1998, shall remain valid until 
the expiration date specified in the authorization.

SEC. 803. RELATIONSHIP TO OTHER LAWS.

    (a) In General.--Nothing in this Act shall be construed to preempt 
any provision of State law or any privilege, whether derived from 
statute or common law, that--
            (1) more completely protects the confidentiality or privacy 
        of an individual with respect to genetic information about the 
        individual than does this Act; or
            (2) provides a greater right of access to genetic 
        information to a subject of the information than does this Act.
    (b) Disclosure.--No State may establish or enforce any law 
(including a regulation) concerning the disclosure of genetic 
information except to the extent that such law, conforms to the 
limitations contained in this Act.
    (c) Construction.--Nothing in this Act shall be construed as 
limiting or prohibiting the pursuit of any other remedies available 
under common or statutory law in regard to the collection, storage, 
analysis of DNA samples, and the disclosure of genetic information.
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