2025 -- S 0767

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LC000556

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2025

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A N   A C T

RELATING TO COMMERCIAL LAW--GENERAL REGULATORY PROVISIONS --

GENETIC INFORMATION PRIVACY ACT

     Introduced By: Senators Zurier, Valverde, and Euer

     Date Introduced: March 14, 2025

     Referred To: Senate Commerce

     It is enacted by the General Assembly as follows:

     SECTION 1. Legislative findings and short title.

     (a) The general assembly finds and declares the following:

     (1) Direct-to-consumer genetic testing services are largely unregulated and could expose

personal and genetic information, and potentially create unintended security consequences and

increased risk.

     (2) There is growing concern in the scientific community that outside parties are exploiting

the use of genetic data for questionable purposes, including mass surveillance and the ability to

track individuals without their authorization.

     (3) Genomic data is highly distinguishable. There is a confirmation that a sequence of 30

to 80 single nucleotide polymorphisms could uniquely identify an individual. Genomic data is also

very stable. It undergoes little change over the lifetime of an individual and thus has a long-lived

value, as opposed to other biometric data such as blood tests, which have expiration dates.

     (4) The potential information hidden within genomic data is cause for significant concern.

As our knowledge in genomics evolves, so will our view on the sensitivity of genomic data.

     (b) Short title. This chapter shall be known, and may be cited, as the "Genetic Information

Privacy Act."

     SECTION 2. Title 6 of the General Laws entitled "COMMERCIAL LAW — GENERAL

REGULATORY PROVISIONS" is hereby amended by adding thereto the following chapter:

CHAPTER 61

GENETIC INFORMATION PRIVACY ACT

     6-61-1. Definitions.

     For purposes of this chapter, the following definitions apply:

     (1) “Affirmative authorization” means an action that demonstrates an intentional decision

by the consumer.

     (2) “Biological sample” means any material part of the human, discharge therefrom, or

derivative thereof, such as tissue, blood, urine, or saliva, known to contain deoxyribonucleic acid

(DNA).

     (3) “Consumer” means a natural person who is a Rhode Island resident.

     (4) “Dark pattern” means a user interface designed or manipulated with the substantial

effect of subverting or impairing user autonomy, decision making, or choice.

     (5) “Direct-to-consumer genetic testing company” means an entity that does any of the

following:

     (i) Sells, markets, interprets, or otherwise offers consumer-initiated genetic testing

products or services directly to consumers.

     (ii) Analyzes genetic data obtained from a consumer, except to the extent that the analysis

is performed by a person licensed in the healing arts for diagnosis or treatment of a medical

condition.

     (iii) Collects, uses, maintains, or discloses genetic data collected or derived from a direct-

to-consumer genetic testing product or service, or is directly provided by a consumer.

     (6) “Express consent” means a consumer’s affirmative authorization to grant permission in

response to a clear, meaningful, and prominent notice regarding the collection, use, maintenance,

or disclosure of genetic data for a specific purpose. The nature of the data collection, use,

maintenance, or disclosure shall be conveyed in clear and prominent terms in such a manner that

an ordinary consumer would notice and understand it. Express consent cannot be inferred from

inaction. Agreement obtained through use of dark patterns does not constitute consent.

     (7)(i) “Genetic data” means any data, regardless of its format, that results from the analysis

of a biological sample from a consumer, or from another element enabling equivalent information

to be obtained, and concerns genetic material. Genetic material includes, but is not limited to,

deoxyribonucleic acids (DNA), ribonucleic acids (RNA), genes, chromosomes, alleles, genomes,

alterations or modifications to DNA or RNA, single nucleotide polymorphisms (SNPs),

uninterpreted data that results from the analysis of the biological sample, and any information

extrapolated, derived, or inferred therefrom.

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     (ii) “Genetic data” does not include deidentified data. For purposes of this subsection,

“deidentified data” means data that cannot be used to infer information about, or otherwise be

linked to, a particular individual; provided that, the business that possesses the information does all

of the following:

     (A) Takes reasonable measures to ensure that the information cannot be associated with a

consumer or household;

     (B) Publicly commits to maintain and use the information only in deidentified form and

not to attempt to reidentify the information, except that the business may attempt to reidentify the

information solely for the purpose of determining whether its deidentification processes satisfy the

requirements of this subsection; provided that, the business does not use or disclose any information

reidentified in this process and destroys the reidentified information upon completion of that

assessment; and

     (C) Contractually obligates any recipients of the information to take reasonable measures

to ensure that the information cannot be associated with a consumer or household and to commit

to maintaining and using the information only in deidentified form and not to reidentify the

information;

     (iii) “Genetic data” does not include data or a biological sample to the extent that data or a

biological sample is collected, used, maintained, and disclosed exclusively for scientific research

conducted by an investigator with an institution that holds an assurance with the United States

Department of Health and Human Services pursuant to Part 46 (commencing with Section 46.101)

of Title 45 of the Code of Federal Regulations, in compliance with all applicable federal and state

laws and regulations for the protection of human subjects in research including, but not limited to,

the Common Rule pursuant to Part 46 (commencing with Section 46.101) of Title 45 of the Code

of Federal Regulations, United States Food and Drug Administration regulations pursuant to Parts

50 and 56 of Title 21 of the Code of Federal Regulations, and the federal Family Educational Rights

and Privacy Act (20 U.S.C. Sec. 1232g).

     (8) “Genetic testing” means any laboratory test of a biological sample from a consumer for

the purpose of determining information concerning genetic material contained within the biological

sample, or any information extrapolated, derived, or inferred therefrom.

     (9) “Person” means an individual, partnership, corporation, association, business, business

trust, or legal representative of an organization.

     (10) “Service provider” means a sole proprietorship, partnership, limited liability company,

corporation, association, or other legal entity that is organized or operated for the profit or financial

benefit of its shareholders or other owners, that is involved in the collection, transportation, and

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analysis of the consumer’s biological sample or extracted genetic material on behalf of the direct-

to-consumer genetic testing company, or on behalf of any other company that collects, uses,

maintains, or discloses genetic data collected or derived from a direct-to-consumer genetic testing

product or service, or is directly provided by a consumer, or the delivery of the results of the

analysis of the biological sample or genetic material. The contract between the company and the

service provider shall prohibit the service provider from retaining, using, or disclosing the

biological sample, extracted genetic material, genetic data, or any information regarding the

identity of the consumer, including whether that consumer has solicited or received genetic testing,

as applicable, for any purpose other than for the specific purpose of performing the services

specified in the contract for the business, including both of the following:

     (i) A provision prohibiting the service provider from retaining, using, or disclosing the

biological sample, extracted genetic material, genetic data, or any information regarding the

identity of the consumer, including whether that consumer has solicited or received genetic testing,

as applicable, for a commercial purpose other than providing the services specified in the contract

with the business; and

     (ii) A provision prohibiting the service provider from associating or combining the

biological sample, extracted genetic material, genetic data, or any information regarding the

identity of the consumer, including whether that consumer has solicited or received genetic testing,

as applicable, with information the service provider has received from or on behalf of another

person or persons, or has collected from its own interaction with consumers or as required by law.

     6-61-2. Privacy of genetic data.

     (a) To safeguard the privacy, confidentiality, security, and integrity of a consumer’s genetic

data, a direct-to-consumer genetic testing company shall do both of the following:

     (1) Provide clear and complete information regarding the company’s policies and

procedures for the collection, use, maintenance, and disclosure, as applicable, of genetic data by

making available to a consumer all of the following:

     (i) A summary of its privacy practices, written in plain language, that includes information

about the company’s collection, use, maintenance, and disclosure, as applicable, of genetic data;

     (ii) A prominent and easily accessible privacy notice that includes, at a minimum, complete

information about the company’s data collection, consent, use, access, disclosure, maintenance,

transfer, security, and retention and deletion practices, and information that clearly describes how

to file a complaint alleging a violation of this chapter; and

     (iii) A notice that the consumer’s deidentified genetic or phenotypic information may be

shared with or disclosed to third parties for research purposes in accordance with Part 46

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(commencing with Section 46.101) of Title 45 of the Code of Federal Regulations.

     (2) Obtain a consumer’s express consent for collection, use, and disclosure of the

consumer’s genetic data, including, at a minimum, separate and express consent for each of the

following:

     (i) The use of the genetic data collected through the genetic testing product or service

offered to the consumer, including who has access to genetic data, and how genetic data may be

shared, and the specific purposes for which it will be collected, used, and disclosed;

     (ii) The storage of a consumer’s biological sample after the initial testing requested by the

consumer has been fulfilled;

     (iii) Each use of genetic data or the biological sample beyond the primary purpose of the

genetic testing or service and inherent contextual uses;

     (iv) Each transfer or disclosure of the consumer’s genetic data or biological sample to a

third party other than to a service provider, including the name of the third party to which the

consumer’s genetic data or biological sample will be transferred or disclosed;

     (v)(A) The marketing or facilitation of marketing to a consumer based on the consumer’s

genetic data or the marketing or facilitation of marketing by a third party based upon the consumer

having ordered, purchased, received, or used a genetic testing product or service;

     (B) This subsection does not require a direct-to-consumer genetic testing company to

obtain a consumer’s express consent to market to the consumer on the company’s own website or

mobile application based upon the consumer having ordered, purchased, received, or used a genetic

testing product or service from that company if the content of the advertisement does not depend

upon any information specific to that consumer, except for the product or service that the consumer

ordered, purchased, received, or used, and the placement of the advertisement is not intended to

result in disparate exposure to advertising content. Nothing in this subsection alters, limits, or

negates the requirements of any other antidiscrimination law or targeted advertising law;

     (C) Any advertisement of a third-party product or service presented to a consumer shall be

prominently labeled as advertising content and be accompanied by the name of any third party that

has contributed to the placement of the advertising. If applicable, the advertisement also shall

clearly indicate that the advertised product or service, and any associated claims, have not been

vetted or endorsed by the direct-to-consumer genetic testing company;

     (D) For the purpose of this section, “third party” does not include a public or private

nonprofit postsecondary educational institution to the extent that the consumer’s genetic data or

biological sample is disclosed to a public or private nonprofit postsecondary educational institution

for the purpose of scientific research or educational activities as described in § 6-61-5. A company

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that is subject to the requirements described in this section shall provide effective mechanisms,

without any unnecessary steps, for a consumer to revoke their consent after it is given, at least one

of which utilizes the primary medium through which the company communicates with consumers.

     (b) If a consumer revokes the consent that they provided pursuant to this section, the

company shall honor the consumer’s consent revocation as soon as practicable, but not later than

thirty (30) days after the individual revokes consent, in accordance with both of the following:

     (1) Revocation of consent under this section shall comply with Part 46 of Title 45 of the

Code of Federal Regulations; and

     (2) The company shall destroy a consumer’s biological sample within thirty (30) days of

receipt of revocation of consent to store the sample.

     (c) The direct-to-consumer genetic testing company shall do both of the following:

     (1) Implement and maintain reasonable security procedures and practices to protect a

consumer’s genetic data against unauthorized access, destruction, use, modification, or disclosure;

and

     (2) Develop procedures and practices to enable a consumer to easily do any of the

following;

     (i) Access the consumer’s genetic data;

     (ii) Delete the consumer’s account and genetic data, except for genetic data that is required

to be retained by the company to comply with applicable legal and regulatory requirements; or

     (iii) Have the consumer’s biological sample destroyed.

     (d) A person or public entity shall not discriminate against a consumer because the

consumer exercised any of the consumer’s rights under this chapter by doing any of the following

including, but not limited to:

     (1) Denying goods, services, or benefits to the customer;

     (2) Charging different prices or rates for goods or services, including through the use of

discounts or other incentives or imposing penalties;

     (3) Providing a different level or quality of goods, services, or benefits to the consumer;

     (4) Suggesting that the consumer will receive a different price or rate for goods, services,

or benefits, or a different level or quality of goods, services, or benefits;

     (5) Considering the consumer’s exercise of rights under this chapter as a basis for suspicion

of criminal wrongdoing or unlawful conduct.

     (e)(1) Notwithstanding any other provision in this section, and except as provided in

subsection (e)(2) of this section, a direct-to-consumer genetic testing company shall not disclose a

consumer’s genetic data to any entity that is responsible for administering or making decisions

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regarding health insurance, life insurance, long-term care insurance, disability insurance, or

employment or to any entity that provides advice to an entity that is responsible for performing

those functions;

     (2) A direct-to-consumer genetic testing company may disclose a consumer’s genetic data

or biological sample to an entity described in subsection (e)(1) of this section if all of the following

are true:

     (i) The entity is not primarily engaged in administering health insurance, life insurance,

long-term care insurance, disability insurance, or employment;

     (ii) The consumer’s genetic data or biological sample is not disclosed to the entity in that

entity’s capacity as a party that is responsible for administering, advising, or making decisions

regarding health insurance, life insurance, long-term care insurance, disability insurance, or

employment; and

     (iii) Any agent or division of the entity that is involved in administering, advising, or

making decisions regarding health insurance, life insurance, long-term care insurance, disability

insurance, or employment is prohibited from accessing the consumer’s genetic data or biological

sample.

     6-61-3. Penalties.

     (a) Any person who negligently violates this chapter shall be assessed a civil penalty in an

amount not to exceed one thousand dollars ($1,000) plus court costs, as determined by the court.

     (b) Any person who willfully violates this chapter shall be assessed a civil penalty in an

amount not less than one thousand dollars ($1,000) and not more than ten thousand dollars

($10,000) plus court costs, as determined by the court.

     (c) Actions for relief pursuant to this chapter shall be prosecuted exclusively in a court of

competent jurisdiction by the attorney general.

     (d) Court costs recovered pursuant to this section shall be paid to the party or parties that

prosecuted the violation. Penalties recovered pursuant to this section shall be paid to the individual

to whom the genetic data at issue pertains.

     (e) Any provision of a contract or agreement between a consumer and a person governed

by this chapter that has, or would have, the effect of delaying or limiting access to a legal remedy

for a violation of this chapter shall not apply to the exercise of rights or enforcement pursuant to

this chapter.

     (f) Each violation of this chapter is a separate and actionable violation.

     6-61-4. Conflicts of law.

     (a) The provisions of this chapter shall not reduce a direct-to-consumer genetic testing

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company’s duties, obligations, requirements, or standards under any applicable state and federal

laws for the protection of privacy and security.

     (b) In the event of a conflict between the provisions of this chapter and any other law, the

provisions of the law that afford the greatest protection for the right of privacy for consumers shall

control.

     6-61-5. Exclusions.

     (a) This chapter shall not apply to any of the following:

     (1) Medical information governed by chapter 37.3 of title 5, (“confidentiality of medical

information act”) or to protected health information that is collected, maintained, used, or disclosed

by a covered entity or business associate governed by the privacy, security, and breach notification

rules issued by the United States Department of Health and Human Services, Parts 160 and 164 of

Title 45 of the Code of Federal Regulations established pursuant to the federal Health Insurance

Portability and Accountability Act of 1996 (Public Law 104-191) and the federal Health

Information Technology for Economic and Clinical Health Act (Public Law 111-5);

     (2) A provider of health care governed by chapter 37.3 of title 5, or a covered entity

governed by the privacy, security, and breach notification rules issued by the United States

Department of Health and Human Services, Parts 160 and 164 of Title 45 of the Code of Federal

Regulations, established pursuant to the Health Insurance Portability and Accountability Act of

1996 (Public Law 104-191) and the federal Health Information Technology for Economic and

Clinical Health Act, Title XIII of the federal American Recovery and Reinvestment Act of 2009

(Public Law 111-5), to the extent that the provider or covered entity maintains, uses, and discloses

genetic information in the same manner as medical information or protected health information, as

described in subsection (a)(1) of this section;

     (3) A business associate of a covered entity governed by the privacy, security, and data

breach notification rules issued by the United States Department of Health and Human Services,

Parts 160 and 164 of Title 45 of the Code of Federal Regulations, established pursuant to the federal

Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191) and the federal

Health Information Technology for Economic and Clinical Health Act, Title XIII of the federal

American Recovery and Reinvestment Act of 2009 (Public Law 111-5), to the extent that the

business associate maintains, uses, and discloses genetic information in the same manner as medical

information or protected health information, as described in subsection (a)(1) of this section;

     (4) Scientific research or educational activities conducted by a public or private nonprofit

postsecondary educational institution that holds an assurance with the United States Department of

Health and Human Services pursuant to Part 46 of Title 45 of the Code of Federal Regulations, to

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the extent that the scientific research and educational activities conducted by that institution comply

with all applicable federal and state laws and regulations for the protection of human subjects in

research including, but not limited to, the Common Rule pursuant to Part 46 (commencing with

Section 46.101) of Title 45 of the Code of Federal Regulations, United States Food and Drug

Administration regulations pursuant to Parts 50 and 56 of Title 21 of the Code of Federal

Regulations, the federal Family Educational Rights and Privacy Act (20 U.S.C. Sec. 1232g);

     (5) The provisions of the newborn screening program pursuant to § 23-13-14;

     (6) Tests conducted exclusively to diagnose whether an individual has a specific disease,

to the extent that all persons involved in the conduct of the test maintain, use, and disclose genetic

information in the same manner as medical information or protected health information, as

described in subsection (a)(1) of this section; or

     (7) Genetic data used or maintained by an employer, or disclosed by an employee to an

employer, to the extent that the use, maintenance, or disclosure of that data is necessary to comply

with a local, state, or federal workplace health and safety ordinance, law, or regulation.

     (b) Nothing in this chapter shall be construed to affect access to information made available

to the public by the consumer.

     6-61-6. Severability.

     The provisions of this chapter are severable. If any provision of this chapter or its

application is held invalid, that invalidity shall not affect other provisions or applications that can

be given effect without the invalid provision or application.

     SECTION 3. This act shall take effect upon passage.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO COMMERCIAL LAW--GENERAL REGULATORY PROVISIONS --

GENETIC INFORMATION PRIVACY ACT

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     This act would establish the Genetic Information Privacy Act, which would require a

direct-to-consumer genetic testing company, as defined, to provide a consumer with certain

information regarding the company’s policies and procedures for the collection, use, maintenance,

and disclosure, as applicable, of genetic data, and to obtain a consumer’s express consent for

collection, use, or disclosure of the consumer’s genetic data, as specified.

     This act would take effect upon passage.

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