II

A BILL

To protect the genetic privacy of individuals.

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

Sec. 1. SHORT TITLE; TABLE OF CONTENTS
(a) SHORT TITLE. -- This act may be cited as the "Genetic Privacy Act."
(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.

PART A - - COLLECTION AND ANALYSIS OF DNA SAMPLES
Sec. 101. Collection of DNA samples.
Sec. 102. Analysis of DNA samples.
Sec. 103. Authorization for collection and storage of individually identifiable DNA samples for genetic analysis.
Sec. 104. Ownership and destruction of DNA samples.
Sec. 105. Notice of rights and assurances.

PART B - - DISCLOSURE OF PRIVATE GENETIC INFORMATION
Sec. 111. Disclosure of private genetic information.
Sec. 112. Authorization for disclosure of private genetic information.
Sec. 113. Inspection and copying of records containing private genetic information.
Sec. 114. Amendment of records.
Sec. 115. Disclosures pursuant to compulsory process.

PART C - - EXCEPTIONS FOR IDENTIFICATION AND COURT-ORDERED GENETIC ANALYSIS

Sec. 121. Identification of dead bodies.
Sec. 122. Identification for law enforcement purposes.
Sec. 123. Collection and analysis of DNA samples pursuant to court ordered analysis.

PART D - - RESEARCH ACTIVITIES
Sec. 131. Research involving genetic analysis.
Sec. 132. Disclosure of private genetic information for research purposes.
Sec. 133. Exceptions for DNA samples collected from deceased persons.
PART E - - MINORS AND INCOMPETENT PERSONS
Sec. 141. Authorization for collection and analysis of DNA from minors.
Sec. 142. Authorization for disclosure of private genetic information about individuals age 16 and 17.
Sec. 143. Authorization for collection and analysis of DNA samples from incompetent persons.
Sec. 144. Authorization for private genetic information about incompetent persons.

PART F - - PREGNANT WOMEN, FETUSES, AND EXTRACORPOREAL EMBRYOS
Sec. 151. Authorization for collection and analysis of DNA from pregnant women and fetuses.
Sec. 152. Authorization for disclosure of private genetic information about pregnant women and fetuses.
Sec. 153. Authorization for collection and analysis of DNA samples from extracorporeal embryos.

PART G - - MISCELLANEOUS PROVISIONS
Sec. 161 Notification of privacy provisions.
Sec. 162 Transfer of ownership, discontinuation of services.

PART H - - ENFORCEMENT
Sec. 171 Civil remedies.
Sec. 172 Civil penalties and injunctive relief.

PART I - - EFFECTIVE DATE; APPLICABILITY; AND RELATIONSHIP TO OTHER LAWS
Sec. 181 Effective Date.
Sec. 182 Applicability.
Sec. 183 Relationship to other laws.

Sec. 2. FINDINGS AND PURPOSES

(a) FINDINGS. -- The Congress finds as follows:

(1) The DNA molecule contains information about one's probable medical future, and this information is written in a code that is currently being broken at a rapid pace.

(2) Genetic information has a history of being used by governments to harm individuals.

(3) Genetic information is uniquely private and personal information that should not be collected or disclosed without the individual's authorization.

(4) The improper use and disclosure of genetic information can lead to significant harm to the individual, including stigmatization and discrimination in areas such as employment, education, health care, and insurance.

(5) An analysis of an individual's DNA provides information not only about an individual, but also about that individual's parents, siblings and children, thus implicating family privacy.

(6) Genetic information is uniquely tied to reproductive decisions which are among the most private and intimate decisions that an individual can make.

(7) Current legal protections for medical information, tissue samples, and DNA samples are inadequate to protect genetic privacy.

(8) Uniform rules for the collection, storage and use of identifiable DNA samples and private genetic information obtained from them are needed both to protect individual privacy and to permit legitimate genetic research.

(b) PURPOSES. -- The purposes of this Act are as follows:

(1) To define the circumstances under which DNA samples may be collected, stored and analyzed.

(2) To define the circumstance under which private genetic information may be created, stored and disclosed.

(3) To define the rights of individuals whose DNA samples are collected, stored, and analyzed.

(4) To define the rights of individuals whose genetic information is stored and disclosed.

(5) To define the responsibilities of persons who collect, analyze and use DNA samples and the genetic information derived from them.

(6) To establish effective mechanisms to enforce the rights and responsibilities defined in this Act.

Sec. 3. DEFINITIONS

For purposes of this Act:

(a) COMPULSORY DISCLOSURE. -- The term "compulsory disclosure" means any disclosure of private genetic information mandated or required by federal or state law in connection with a judicial, legislative, or administrative proceeding, including but not limited to, disclosure required by subpoena, subpoena duces tecum, request or notice to produce, court order, or any other method of requiring a person maintaining private genetic information to produce private genetic information under the criminal or civil discovery laws of any state or the federal law.

(b) DISCLOSE. -- The term "disclose", when used with respect to private genetic information, means to provide access to the information, or the verification of the information, but only if such access or verification is provided to a person other than the sample source or the sample source's representative.

(c) DISCLOSURE. -- The term "disclosure" means the act or an instance of disclosing.

(d) DNA. -- The term "DNA" means deoxyribonucleic acid.

(e) DNA SAMPLE. -- The term "DNA sample" means any human biological specimen from which DNA can be extracted, or DNA extracted from such specimen.

(f) DNA TYPING. -- The term "DNA typing" means a scientifically reliable method for characterizing and comparing sequences of DNA, and applying a statistical analysis of population frequency to determine that if the DNA sequences match, the probability that the match occurs by chance.

(g) IDENTIFIABLE INDIVIDUAL. -- The term "identifiable individual" means any individual whose name, address, Social Security number, health insurance identification number, or similar identifying information is known, available, or can be determined with reasonable accuracy either directly or by reference to other available information.

(h) INDIVIDUAL IDENTIFIER. -- The term "individual identifier" means a name, address, Social Security number, health insurance identification number, or similar information by which the identity of a sample source can be determined with reasonable accuracy, either directly or by reference to other available information. The term does not include characters, numbers, or codes assigned to an individual or a DNA sample which cannot be used to determine the identity of a sample source.

(i) INDIVIDUALLY IDENTIFIABLE DNA SAMPLE. -- The term "individually identifiable DNA sample" means any DNA sample linked to an individual identifier.

(j) INDIVIDUALLY IDENTIFIABLE RECORD. -- The term "individually identifiable record" means any record that contains private genetic information linked to an individual identifier.

(k) INSTITUTIONAL REVIEW BOARD. -- The term "Institutional Review Board" means a board established in accordance with 45 CFR 46.102(g)(1992) as such regulation may be amended.

(l) PERSON. -- The term "person" shall include an individual, a corporation, partnership, association, joint venture, government, governmental subdivision or agency, and other legal or commercial entity.

(m) PRIVATE GENETIC INFORMATION. -- The term "private genetic information" means any information about an identifiable individual that is derived from the presence, absence, alteration, or mutation of a gene or genes, or the presence or absence of a specific DNA marker or markers, and which has been obtained:

(1) from an analysis of the individual's DNA; or

(2) from an analysis of the DNA of a person to whom the individual is related.

(n) SAMPLE SOURCE. -- The term "sample source" means the individual from whose body the DNA sample originated.

(o) SAMPLE SOURCE'S REPRESENTATIVE. -- The term "sample source's representative" means any person who has the legal authority to make health care decisions concerning a minor or an incompetent person, or the administrator or executor of a deceased person's estate, if any, otherwise the next of kin of a deceased person.

PART A - - COLLECTION AND ANALYSIS OF DNA SAMPLES

Sec. 101. COLLECTION OF DNA SAMPLES

(a) REQUIREMENT OF WRITTEN AUTHORIZATION. -- Except as otherwise provided in sections 121, 122, and 123, no person may collect or cause to be collected an individually identifiable DNA sample for genetic analysis without the written authorization of the sample source or the sample source's representative.

(b) REQUIRED INFORMATION. -- Prior to the collection of a DNA sample from a sample source for genetic analysis, the person collecting the sample or causing the sample to be collected shall verbally inform the sample source or the sample source's representative:

(1) that consent to the collection or taking of the DNA sample is voluntary;

(2) that consent to the genetic analysis is voluntary;

(3) of the information that can reasonably be expected to be derived from the genetic analysis;

(4) of the use, if any, that the sample source or the sample source's representative will be able to make of the information derived from the genetic analysis;

(5) of the right to inspect records that contain information derived from the genetic analysis;

(6) of the right to have the DNA sample destroyed;

(7) of the right to revoke consent to the genetic analysis at any time prior to the completion of the analysis;

(8) that the genetic analysis may result in information about the sample source's genetic relatives which may not be known to such relatives but could be important, and if so the sample source will have to decide whether or not to share that information with relatives;

(9) that in the future someone else may ask if the sample source has obtained genetic testing or analysis and condition a benefit on the disclosure of information regarding such testing or analysis;

(10) that the collection and analysis of the DNA sample, and the private genetic information derived from the analysis is protected by this Act; and

(11) of the availability of genetic counseling.

Sec. 102. ANALYSIS OF DNA SAMPLES

(a) ANALYSIS PROHIBITED WITHOUT AUTHORIZATION. -- Except as otherwise provided in sections 121, 122, and 123, genetic analysis of an individually identifiable DNA sample is prohibited unless specifically authorized in writing by the sample source or the sample source's representative.

(b) ASCERTAINMENT OF AUTHORIZATION. -- No person may analyze an individually identifiable DNA sample without ascertaining that written authorization for the analysis has been obtained.

Sec. 103. AUTHORIZATION FOR COLLECTION AND STORAGE OF INDIVIDUALLY IDENTIFIABLE DNA SAMPLES FOR GENETIC ANALYSIS

(a) WRITTEN AUTHORIZATION. -- To be valid, the authorization required by sections 101 and 102 must satisfy each of the following requirements:

(1) WRITING. -- The authorization must be in writing, signed by the sample source or the sample source's representative, and dated on the date of such signature;

(2) COLLECTOR IDENTIFIED. -- The authorization must identify the person who collects the DNA sample or causes the DNA sample to be collected;

(3) ANALYZER IDENTIFIED. -- The authorization must identify the facility in which the analysis will be performed;

(4) STORAGE FACILITY IDENTIFIED. -- The authorization must identify the facility in which the DNA sample will be stored;

(5) COLLECTION DESCRIBED. -- The authorization must state the manner in which the sample is to be collected;

(6) AUTHORIZED USE. -- The authorization must include a description of all authorized uses of the DNA sample;

(7) STATEMENT REGARDING STORAGE AFTER COMPLETION OF ANALYSIS. -- The authorization must indicate whether or not the sample source permits the sample to be maintained or stored in an identifiable form after the analysis is completed;

(8) STATEMENT REGARDING USE OF UNIDENTIFIABLE DNA SAMPLES FOR RESEARCH OR COMMERCIAL PURPOSES. -- The authorization form must include a provision that enables the sample source or the sample source's representative to prohibit the use of the DNA sample for research or commercial purposes even if the sample is not in an individually identifiable form.

(b) RETENTION OF AUTHORIZATION. -- The authorization for the collection and analysis of an individually identifiable DNA sample shall be retained at least as long as the DNA sample is retained.

(c) COPY. -- A copy of the authorization shall be provided to the sample source or the sample source's representative.

Sec. 104. OWNERSHIP AND DESTRUCTION OF DNA SAMPLES

(a) OWNERSHIP OF THE DNA SAMPLE. -- An individually identifiable DNA sample is the property of the sample source.

(b) RIGHT TO ORDER DESTRUCTION OF THE DNA SAMPLE. -- Except when a DNA sample has been collected pursuant to section 122 or 123 of this Act, the sample source or the sample source's representative shall have the right to order the destruction of the DNA sample.

(c) ROUTINE DESTRUCTION OF SAMPLES OR IDENTIFIERS. -- An individually identifiable DNA sample must be destroyed on completion of genetic analysis unless:

(1) the sample source or the sample source's representative, has directed otherwise in writing, or

(2) all individual identifiers linking the sample to the sample source are destroyed.

Sec. 105. NOTICE OF RIGHTS AND ASSURANCES

A person who collects or stores DNA samples for genetic analysis shall provide a sample source or a sample source's representative prior to the collection, storage, or analysis of a DNA sample, and any other person upon request, with a notice of rights and assurances that contains the following information and assurances that:

(a) a DNA sample will only be used as authorized in the written authorization;

(b) an individually identifiable DNA sample is the property of the sample source;

(c) unless specifically prohibited by the sample source or sample source's representative, researchers may be granted access to DNA samples that cannot be linked to individual identifiers;

(d) the sample source or the sample source's representative has the right to order the destruction of the individually identifiable DNA sample at any time;

(e) the individually identifiable DNA sample will be destroyed on the completion of the analysis unless the sample source or the sample source's representative has previously directed otherwise in writing;

(f) the sample source can designate another individual as the person authorized to make decisions regarding the individually identifiable DNA sample after the death of the sample source; and if any person is so designated, the sample source should notify the facility in which the DNA sample is stored;

(g) the sample source or the sample source's representative has the right to examine the records containing private genetic information, to obtain copies of such records and to request correction or amendment of them;

(h) private genetic information may be disclosed to researchers who qualify for such access under this Act;

(i) the collection and analysis of the DNA sample and the private genetic information derived from the analysis is protected by this Act, and anyone whose rights under this Act have been violated can seek civil remedies, including damages, as provided in this Act; and

(j) genetic counseling is available.

PART B - - DISCLOSURE OF PRIVATE GENETIC INFORMATION

Sec. 111. DISCLOSURE OF PRIVATE GENETIC INFORMATION

(a) REQUIREMENT OF WRITTEN AUTHORIZATION. -- Except as provided in section 115 and section 132(b) no person who, in the ordinary course of business, practice of a profession, or rendering of a service, creates, stores, receives or furnishes private genetic information may by any means of communication disclose private genetic information except in accordance with a written authorization as provided for in section 112.

(b) REDISCLOSURE PROHIBITED. -- Redisclosure of private genetic information which has been disclosed to any person pursuant to a valid written authorization is prohibited.

Sec. 112. AUTHORIZATION FOR DISCLOSURE OF PRIVATE GENETIC INFORMATION

(a) WRITTEN AUTHORIZATIONS. -- To be valid, an authorization for disclosure of private genetic information must satisfy each of the following requirements:

(1) WRITING. -- The authorization must be in writing, signed by the sample source or the sample source's representative and dated on the date of such signature;

(2) SAMPLE SOURCE OR REPRESENTATIVE IDENTIFIED. -- The authorization must identify the individual granting authorization and the individual's relationship to the sample source;

(3) PERSON MAKING DISCLOSURE IDENTIFIED. -- The authorization must identify the person permitted to make the disclosure;

(4) INFORMATION DESCRIBED. -- The authorization must describe the specific genetic information to be disclosed;

(5) RECIPIENT IDENTIFIED. -- The authorization must identify the person to whom the information is to be disclosed;

(6) PURPOSE DESCRIBED. -- The authorization must describe the purpose for which the disclosure is being made;

(7) EXPIRATION DATE. -- The authorization must state the date upon which the authorization will expire, which in no event shall be longer than 30 days after the date of the authorization; and

(8) REVOCATION STATEMENT. -- The authorization must include a statement that the authorization is subject to revocation at any time before the disclosure is actually made.

(b) COPY. -- A copy of the authorization shall be provided to the person making the authorization.

(c) REVOCATION OR AMENDMENT OF AUTHORIZATION. -- A sample source or the sample source's representative may revoke or amend the authorization, in whole or in part, at any time.

(d) NOTICE OF REVOCATION. -- A sample source may not maintain an action against a person for disclosure of private genetic information made in good faith reliance on a valid authorization if the person had no notice of the revocation of the authorization at the time the disclosure was made.

(e) IDENTIFICATION OF INFORMATION AS PROTECTED BY LAW. -- Each disclosure made with the written authorization described in subsection (a) must be accompanied by the following written statement:

"This information has been disclosed to you from confidential records protected under the Genetic Privacy Act and any further disclosure of the information without specific authorization is prohibited."

(f) 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 as an authorization for disclosure of private genetic information.

Sec. 113. INSPECTION AND COPYING OF RECORDS CONTAINING PRIVATE GENETIC INFORMATION

(a) INSPECTION OF RECORDS. -- Except as otherwise provided in section 131(c)(2) and 131(f), a person who maintains private genetic information shall upon written request permit the sample source or the sample source's representative to inspect records containing private genetic information and shall provide a copy of any such records upon request by the sample source or the sample source's representative.

(b) RESPONSE TO REQUEST EXAMINATION AND COPYING OF INFORMATION. -- Upon receipt of a written request from a sample source or the sample source's representative to inspect or copy all or part of records containing private genetic information, a person as promptly as required under the circumstances but no later than 30 business days after receiving the request, shall make the information available to the sample source or the sample source's representative for inspection during regular business hours or provide a copy, if requested, to the individual.

(c) EXPLANATION OF TERMS AND CODES. -- A person shall provide an explanation of terms and any code or abbreviations used in records containing the private genetic information upon request of the sample source or the sample source's representative.

(d) FEE. -- A person may charge a reasonable fee, not to exceed the person's actual duplication cost, for copies of records which are provided.

Sec. 114. AMENDMENT OF RECORDS

(a) IN GENERAL. -- Within 45 days of receipt of a written request by a sample source or a sample source's representative to correct or amend in whole or in part any record containing private genetic information, a person who maintains records containing private genetic information shall:

(1) make the correction or amendment requested;

(2) inform the individual that the correction or amendment has been made;

(3) make reasonable efforts to inform any person to whom the uncorrected or unamended portion of the information was previously disclosed of the correction or amendment that has been made; and

(4) at the request of the individual, make reasonable efforts to inform any known source of the uncorrected or unamended portion of the information about the correction or amendment that has been made.

(b) REASONS FOR REFUSAL AND REVIEW PROCEDURES. -- If correction or amendment is refused, the person maintaining the records shall inform the sample source or the sample source's representative of:

(1) the reasons for the refusal of the person to make corrections or amendment;

(2) any procedures for further review of such refusal; and

(3) the individual's right to file with the person a concise statement setting forth the requested correction or amendment and the individual's reasons for disagreeing with the refusal of the person to make the correction or amendment.

(c) STANDARDS FOR CORRECTION OR AMENDMENT. -- A person maintaining records containing private genetic information shall correct or amend information in accordance with a request made under subsection (a) if the information is not accurate or complete for the purposes for which the information may be used or disclosed by the person.

(d) STATEMENT OF DISAGREEMENT. -- After a sample source or a sample source's representative has filed a statement of disagreement under subsection (b)(3), the person, in any subsequent disclosure of the disputed portion of the information, shall include a copy of the individual's statement and may include a statement of the reasons for not making the requested correction or amendment.

Sec. 115. DISCLOSURES PURSUANT TO COMPULSORY PROCESS

(a) PROCEEDINGS IN WHICH AVAILABLE. -- No person who maintains private genetic information may be compelled to disclose such information pursuant to a request for compulsory disclosure in any judicial, legislative, or administrative proceeding, unless:

(1) The person maintaining the genetic information has received the authorization of the sample source or the sample source's representative to release the information in response to such request for compulsory disclosure;

(2) The sample source or the sample source's representative is a party to the proceeding and the private genetic information is at issue; or

(3) The genetic information is for use in a law enforcement proceeding or investigation in which the person maintaining the information is the subject or party;

(b) NOTICE. -- If genetic information is sought under subparagraph (2) of subsection (a), or in a proceeding or investigation pursuant to subparagraph (3) of subsection (a), the person requesting compulsory disclosure shall serve upon the person maintaining the genetic information, and upon the sample source, the sample source's representative, or on the sample source's attorney, the original or a copy of the compulsory disclosure request at least thirty days in advance of the date on which compulsory disclosure is requested, and a statement of the right of the sample source or sample source's representative, and of the person maintaining the genetic information, to have any objections to such compulsory disclosure heard by such court or governmental agency prior to the issuance of an order for such compulsory disclosure, and 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 state or federal law.

(c) CERTIFICATION. -- Service of compulsory process or discovery requests upon a person maintaining private genetic information must be accompanied by a written certification, signed by the person seeking to obtain the private genetic information or his or her authorized representative, identifying at least one subparagraph of subsection (a) under which compulsory process or discovery is being sought. The certification must also state, in the case of information sought under subparagraphs (2) or (3) of subsection (a), that the requirements under subsection (b) for notice have been met. A person may sign the certification only if the person reasonably believes that the subparagraph of subsection (a) identified in the certification provides an appropriate basis for the use of discovery or compulsory process. A copy of the written certification shall be maintained as a permanent part of the records of private genetic information.

(d) STANDARD FOR ISSUANCE OF ORDER. -- An order under this section may only be entered by a court of competent jurisdiction after a hearing and determination that good cause exists. To make this determination the court must find that:

(1) other ways of obtaining the private genetic information are not available or would not be effective; and

(2) there is a compelling need for the private genetic information which outweighs the potential harm to the privacy interest of the subject of the information.

(e) CONTENT OF ORDER. -- An order under this section which authorizes disclosure of private genetic information must:

(1) limit disclosure to those parts of records containing such information which are essential to fulfill the objective of the order;

(2) limit disclosure to those persons whose need for the information is the basis of the order;

(3) require the deletion of individual identifiers from any documents made available to the public; and

(4) include such other measures as are necessary to limit disclosure for the protection of the subject of the information including, but not be limited to, sealing from public scrutiny the record or any portion of the record of any proceeding for which disclosure of the information has been ordered.

Proceed to next section.

File posted May 1995.

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