*EH1521.1* April 4, 2025 ENGROSSED HOUSE BILL No. 1521 _____ DIGEST OF HB 1521 (Updated April 3, 2025 11:22 am - DI 119) Citations Affected: IC 22-9; IC 24-4. Synopsis: Consumer genetic testing providers. Provides that a person may not discriminate against an individual on the basis of the individual's solicitation and use of consumer genetic testing services or on the basis of the results of genetic testing performed by a provider of consumer genetic testing services (provider). Requires a provider to disclose specified information to an individual who submits biological material to the provider for genetic testing. Prohibits a provider that performs, or causes to be performed, genetic testing on an individual's biological material from: (1) taking specified actions with regard to: (A) the biological material; or (B) data resulting from genetic testing performed on the biological material; unless the provider has solicited (Continued next page) Effective: Upon passage. Pierce K, Morris, Commons (SENATE SPONSORS — HUNLEY, JOHNSON T, BUCHANAN, KOCH, FORD J.D., SPENCER) January 21, 2025, read first time and referred to Committee on Commerce, Small Business and Economic Development. February 6, 2025, amended, reported — Do Pass. February 10, 2025, read second time, ordered engrossed. February 11, 2025, engrossed. Read third time, passed. Yeas 91, nays 0. SENATE ACTION March 3, 2025, read first time and referred to Committee on Commerce and Technology. April 3, 2025, amended, reported favorably — Do Pass. EH 1521—LS 7089/DI 119 Digest Continued and received the individual's consent to the action; or (2) providing data, other than deidentified data, resulting from genetic testing performed on the individual's biological material to: (A) an insurer; (B) a business that provides information or data to insurers for the purposes of underwriting or rating of risks; or (C) the individual's employer. Imposes requirements on a provider with respect to: (1) controlling access to an individual's biological material and data; (2) complying with the individual's revocation of consent with regard to the individual's biological material and data; and (3) marketing or advertising sent to the individual as a result of the individual's solicitation and use of the provider's genetic testing services or use of a website or other remote or virtual service associated with the provider's genetic testing services. Provides that a provider may not charge a fee for the provision of biological material or data resulting from genetic testing performed on biological material: (1) to a law enforcement agency on the basis of a search warrant; or (2) as required by a court order; that is more than the provider's actual cost of providing the material or data. Provides for enforcement of the bill's provisions by the attorney general. EH 1521—LS 7089/DI 119EH 1521—LS 7089/DI 119 April 4, 2025 First Regular Session of the 124th General Assembly (2025) PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana Constitution) is being amended, the text of the existing provision will appear in this style type, additions will appear in this style type, and deletions will appear in this style type. Additions: Whenever a new statutory provision is being enacted (or a new constitutional provision adopted), the text of the new provision will appear in this style type. Also, the word NEW will appear in that style type in the introductory clause of each SECTION that adds a new provision to the Indiana Code or the Indiana Constitution. Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts between statutes enacted by the 2024 Regular Session of the General Assembly. ENGROSSED HOUSE BILL No. 1521 A BILL FOR AN ACT to amend the Indiana Code concerning trade regulation. Be it enacted by the General Assembly of the State of Indiana: 1 SECTION 1. IC 22-9-14 IS ADDED TO THE INDIANA CODE AS 2 A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE UPON 3 PASSAGE]: 4 Chapter 14. Genetic Discrimination 5 Sec. 1. The definitions in IC 24-4-24 apply throughout this 6 chapter. 7 Sec. 2. A person may not discriminate against an individual on 8 the basis of the individual's solicitation and use of consumer 9 genetic testing services or on the basis of the results of genetic 10 testing performed by a consumer genetic testing provider, 11 including by discriminating against the individual in any of the 12 following ways: 13 (1) Denying the individual access to the person's goods or 14 services. 15 (2) Charging the individual a different rate for the person's 16 goods or services. 17 (3) Suggesting that the individual will be subject to any of the EH 1521—LS 7089/DI 119 2 1 measures described in subdivisions (1) through (2). 2 SECTION 2. IC 24-4-24 IS ADDED TO THE INDIANA CODE AS 3 A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE UPON 4 PASSAGE]: 5 Chapter 24. Consumer Genetic Testing Providers 6 Sec. 1. (a) As used in this chapter, "consumer genetic testing" 7 means a service in which a person: 8 (1) provides an individual with a means of submitting a 9 sample of the individual's biological material directly to the 10 person; 11 (2) performs, or causes to be performed, genetic testing on the 12 submitted biological material; and 13 (3) returns the results of the genetic testing directly to the 14 individual. 15 (b) The term does not include genetic testing: 16 (1) of biological material of a patient of a health care provider 17 (as defined in IC 16-18-2-163(a)), the collection and testing of 18 which is: 19 (A) performed at the request or direction of the health care 20 provider for the purpose of the diagnosis, cure, mitigation, 21 treatment, or prevention of a physical or mental illness, 22 injury, disease, disorder, or disability; and 23 (B) subject to the Health Insurance Portability and 24 Accountability Act (HIPAA) (P.L. 104-191); 25 (2) performed as required by a court order; 26 (3) performed for purposes of a law enforcement investigation 27 at the request or direction of a law enforcement agency; 28 (4) performed at the request or direction of a coroner or 29 medical examiner for purposes of investigating the cause of an 30 individual's death; or 31 (5) performed for purposes of research (as defined in 45 CFR 32 164.501) that is subject to: 33 (A) 21 CFR 50 and 21 CFR 56; or 34 (B) 45 CFR 46. 35 Sec. 2. As used in this chapter, "consumer genetic testing 36 provider" or "provider" means a person that, in the ordinary 37 course of the person's business: 38 (1) offers consumer genetic testing; or 39 (2) collects, uses, or analyzes genetic data that: 40 (A) results from a consumer genetic testing product or 41 service; and 42 (B) is provided to the person by a consumer; EH 1521—LS 7089/DI 119 3 1 in exchange for consideration. 2 Sec. 3. As used in this chapter, "deidentified data" means data 3 that cannot reasonably be used to infer information about, or 4 otherwise be linked to, an identifiable consumer and that: 5 (1) is subject to: 6 (A) administrative and technical measures to ensure that 7 the data cannot be associated with a particular consumer; 8 (B) public commitment by the holder of the data to: 9 (i) maintain and use the data in deidentified form; and 10 (ii) not attempt to reidentify the data; and 11 (C) legally enforceable contractual obligations that 12 prohibit any recipients of the data from attempting to 13 reidentify the data; or 14 (2) meets requirements for deidentification of the data set 15 forth in 45 CFR 164.514. 16 Sec. 4. As used in this chapter, "DNA" has the meaning set forth 17 in IC 10-13-6-2. 18 Sec. 5. As used in this chapter, "genetic data" means any data, 19 regardless of format, that: 20 (1) results from the analysis of an individual's biological 21 material, including analysis of: 22 (A) the complete DNA; 23 (B) regions of the DNA; 24 (C) chromosomes; 25 (D) genes; or 26 (E) gene products; and 27 (2) concerns an individual's genetic characteristics. 28 The term does not include deidentified data. 29 Sec. 6. As used in this chapter, "genetic testing" means analysis 30 of genetic data. 31 Sec. 7. As used in this chapter, "insurer" has the meaning set 32 forth in IC 27-1-2-3. 33 Sec. 8. (a) A consumer genetic testing provider may not 34 perform, or cause to be performed, genetic testing on an 35 individual's biological material unless the provider has provided 36 the individual with a written disclosure of the provider's privacy 37 policy, including the provider's policies and procedures regarding 38 the provider's collection, maintenance, security, retention, and use 39 of both biological material sent to the provider and data resulting 40 from genetic testing performed on the biological material. 41 (b) The disclosure under subsection (a) must include complete 42 information regarding the following: EH 1521—LS 7089/DI 119 4 1 (1) The identity of any third party that may perform genetic 2 testing on biological material sent to the third party by the 3 provider. 4 (2) The manner in which: 5 (A) biological material sent to the provider; and 6 (B) data resulting from genetic testing performed on 7 biological material sent to the provider; 8 is stored, transferred, and secured. 9 (3) Any: 10 (A) testing or analysis that the provider performs or causes 11 to be performed on; or 12 (B) other purpose for which the provider uses; 13 biological material sent by an individual to the provider that 14 is in addition to the genetic testing requested by the 15 individual. 16 (4) The: 17 (A) identity of any third party to which the provider 18 provides access to: 19 (i) biological material sent to the provider; or 20 (ii) data resulting from genetic testing performed on 21 biological material sent to the provider; and 22 (B) purpose for which the third party uses the biological 23 material or data. 24 (c) A consumer genetic testing provider shall: 25 (1) publish the disclosure described in subsection (a) on the 26 provider's website; and 27 (2) include on the provider's website prominent directions and 28 hyperlinks to the location of the disclosure on the provider's 29 website. 30 Sec. 9. (a) A consumer genetic testing provider that performs, 31 or causes to be performed, genetic testing on an individual's 32 biological material may not take any of the following actions unless 33 the provider has solicited and received the individual's freely given, 34 specific, informed, and unambiguous consent to the action: 35 (1) Perform, or cause to be performed, any testing or analysis 36 of the individual's biological material that is not requested by 37 the individual except as required to comply with state and 38 federal law. 39 (2) Use the individual's biological material for any use other 40 than the genetic testing requested by the individual. 41 (3) Subject to section 10(b) of this chapter, provide access by 42 a third party to: EH 1521—LS 7089/DI 119 5 1 (A) the individual's biological material; or 2 (B) data, other than deidentified data, resulting from 3 genetic testing performed on the individual's biological 4 material. 5 (4) Retain the individual's biological material for more than 6 thirty (30) days after the performance of the genetic testing 7 requested by the individual, except as required to comply with 8 state or federal law. 9 (5) Retain data, other than deidentified data, resulting from 10 genetic testing performed on the individual's biological 11 material for more than thirty (30) days after the completion 12 of the service except as required to comply with state and 13 federal law. 14 (6) Disseminate advertising or marketing communications to 15 the individual based on the individual's genetic testing results. 16 (7) Provide information regarding the individual's: 17 (A) solicitation and use of the provider's genetic testing 18 services; or 19 (B) use of the provider's: 20 (i) website; or 21 (ii) other remote or virtual services; 22 associated with the provider's genetic testing services; 23 to a third party to enable the third party to disseminate 24 advertising or marketing communications to the individual. 25 (b) A provider's solicitation of an individual's consent to an 26 action described in subsection (a) must: 27 (1) describe the action in terms that are sufficiently clear and 28 concise as to be reasonably understandable by a person of 29 ordinary intelligence; and 30 (2) solicit the individual's consent to the action separately 31 from a solicitation of the individual's consent to any other 32 action described in subsection (a). 33 (c) Consent to an action under subsection (a) is not freely given, 34 specific, informed, and unambiguous if the consent is provided by 35 any of the following means: 36 (1) The individual's inaction. 37 (2) The individual's acceptance of: 38 (A) general or broad terms of service; or 39 (B) any other document requiring agreement by an 40 individual using the provider's services; 41 containing information unrelated to the action under 42 subsection (a). EH 1521—LS 7089/DI 119 6 1 (3) The individual closing, muting, pausing, or hovering a 2 computer cursor over a piece of content. 3 (4) The individual's communication of consent through an 4 Internet user interface that is designed or manipulated with 5 the substantial effect of subverting or impairing user 6 autonomy, decision making, or choice. 7 Sec. 10. (a) A consumer genetic testing provider that performs, 8 or causes to be performed, genetic testing on an individual's 9 biological material shall do the following: 10 (1) Implement commercially reasonable security measures to 11 protect: 12 (A) the individual's biological material; and 13 (B) data resulting from genetic testing performed on the 14 individual's biological material; 15 from unauthorized access, destruction, use, modification, or 16 disclosure. 17 (2) Allow the individual access to any data resulting from 18 genetic testing performed on the individual's biological 19 material. 20 (3) Provide the following: 21 (A) A procedure by which the individual can revoke any 22 consent provided by the individual under section 9 of this 23 chapter. The procedure must enable the individual to 24 communicate the revocation: 25 (i) directly to the provider; and 26 (ii) through one (1) or more means, at least one (1) of 27 which must be the primary means by which the provider 28 communicates with the individual. 29 (B) Both: 30 (i) notice of the existence of; and 31 (ii) instructions regarding the use of; 32 the procedure under clause (A) that are sufficiently clear 33 and concise as to be reasonably understandable by a 34 person of ordinary intelligence. 35 (4) Comply with a revocation of consent by the individual not 36 later than thirty (30) days after the individual communicates 37 the revocation to the provider, including by: 38 (A) destroying the individual's biological material not later 39 than thirty (30) days after the individual revokes the 40 individual's consent to the provider's retention of the 41 biological material under section 9(a)(4) of this chapter; 42 and EH 1521—LS 7089/DI 119 7 1 (B) destroying any data resulting from genetic testing 2 performed on the individual's biological material not later 3 than thirty (30) days after the individual revokes the 4 individual's consent to the provider's retention of the data 5 under section 9(a)(5) of this chapter. 6 (5) Provide a third party with access to the individual's 7 biological material, or to data resulting from genetic testing 8 performed on the individual's biological material, only under 9 contractual terms that prohibit the third party from: 10 (A) using the biological material or data for any use to 11 which the individual has not consented under section 9 of 12 this chapter; 13 (B) providing another party with access to the biological 14 material or data; or 15 (C) retaining the biological material or data longer than 16 the provider is authorized to retain the biological material 17 or data under this chapter. 18 (6) Ensure that: 19 (A) any advertising or marketing communications sent to 20 the individual as a result of the individual's: 21 (i) solicitation and use of the provider's services; or 22 (ii) use of the provider's website or other remote or 23 virtual services; 24 are clearly and prominently denoted as advertising or 25 marketing materials; and 26 (B) advertising or marketing communications described in 27 clause (A) that are sent by a third party clearly and 28 prominently: 29 (i) identify the third party; and 30 (ii) notify the individual that any claims made in the 31 advertising or marketing communications have not been 32 evaluated by the provider. 33 (b) A consumer genetic testing provider may not provide data, 34 other than deidentified data, resulting from genetic testing 35 performed on an individual's biological material to: 36 (1) an insurer; 37 (2) a person that, in the ordinary course of the person's 38 business, provides information or data to insurers for the 39 purposes of underwriting or rating of risks; or 40 (3) a person that employs the individual; 41 regardless of whether the individual has consented to the provider 42 providing third parties with access to the data under section 9(a)(3) EH 1521—LS 7089/DI 119 8 1 of this chapter. 2 (c) A consumer genetic testing provider may not charge a fee for 3 the provision of biological material or for the provision of data 4 resulting from genetic testing performed on biological material: 5 (1) to a law enforcement agency on the basis of a search 6 warrant; or 7 (2) as required by a court order; 8 that is more than the actual cost, not including labor costs or 9 overhead costs, to the consumer genetic testing provider of 10 providing the material or data. 11 Sec. 11. (a) The attorney general has exclusive authority to 12 enforce the provisions of this chapter. 13 (b) The attorney general may initiate an action in the name of 14 the state and may seek an injunction to restrain any violations of 15 this chapter and a civil penalty not to exceed seven thousand five 16 hundred dollars ($7,500) for each violation under this chapter. 17 (c) The attorney general may recover reasonable expenses 18 incurred in investigating and preparing the case, including 19 attorney's fees, in any action initiated under this section. 20 (d) Before initiating an action under this section, the attorney 21 general shall provide a provider thirty (30) days written notice 22 identifying the specific provisions of this chapter that the attorney 23 general alleges have been or are being violated. If, within the thirty 24 (30) day period set forth in this subsection, the provider: 25 (1) cures the alleged violation; and 26 (2) provides the attorney general an express written statement 27 that: 28 (A) the alleged violation has been cured; and 29 (B) actions have been taken to ensure no further such 30 violations will occur; 31 the attorney general shall not initiate an action against the 32 provider. 33 (e) If a provider: 34 (1) continues an alleged violation following the thirty (30) day 35 period set forth in subsection (d); or 36 (2) breaches an express written statement provided to the 37 attorney general under subsection (d)(2); 38 the attorney general may initiate an action against the provider 39 under subsection (b). 40 (f) Nothing in this section may be construed as providing the 41 basis for a private right of action for violations of this chapter or 42 any other law. EH 1521—LS 7089/DI 119 9 1 SECTION 3. An emergency is declared for this act. EH 1521—LS 7089/DI 119 10 COMMITTEE REPORT Mr. Speaker: Your Committee on Commerce, Small Business and Economic Development, to which was referred House Bill 1521, has had the same under consideration and begs leave to report the same back to the House with the recommendation that said bill be amended as follows: Page 8, after line 24, begin a new paragraph and insert: "SECTION 2. IC 35-45-19-1.5, AS ADDED BY P.L.47-2019, SECTION 3, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2025]: Sec. 1.5. As used in this chapter, "human remains" means any part of the body of a deceased human being: (1) in any: (A) stage of decomposition; or (B) state of preservation; or (2) that indicate unique deoxyribonucleic acid (DNA). SECTION 3. IC 35-45-19-3, AS AMENDED BY P.L.47-2019, SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2025]: Sec. 3. A person who: (1) observes, discovers, or handles human remains when it appears the deceased person died: (A) by violence, suicide, or accident; (B) suddenly, while in apparent good health; (C) while unattended; (D) from poisoning or an overdose of drugs; (E) as the result of a disease that may constitute a threat to public health; (F) as the result of: (i) a disease; (ii) an injury; (iii) a toxic effect; or (iv) unusual exertion; incurred within the scope of the deceased person's employment; (G) due to sudden infant death syndrome; (H) as the result of a diagnostic or therapeutic procedure; or (I) under any other suspicious or unusual circumstances; and (2) knowingly or intentionally fails to report the observation, discovery, or handling of the human remains to a: (A) public safety officer; (B) coroner; (C) funeral director; EH 1521—LS 7089/DI 119 11 (D) physician; or (E) 911 telephone call center; within three (3) hours after finding the human remains; commits failure to report the observation, discovery, or handling of human remains, a Class A misdemeanor.". and when so amended that said bill do pass. (Reference is to HB 1521 as introduced.) MORRIS Committee Vote: yeas 9, nays 0. _____ COMMITTEE REPORT Mr. President: The Senate Committee on Commerce and Technology, to which was referred Engrossed House Bill No. 1521, has had the same under consideration and begs leave to report the same back to the Senate with the recommendation that said bill be AMENDED as follows: Page 1, between the enacting clause and line 1, begin a new paragraph and insert: "SECTION 1. IC 22-9-14 IS ADDED TO THE INDIANA CODE AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE UPON PASSAGE]: Chapter 14. Genetic Discrimination Sec. 1. The definitions in IC 24-4-24 apply throughout this chapter. Sec. 2. A person may not discriminate against an individual on the basis of the individual's solicitation and use of consumer genetic testing services or on the basis of the results of genetic testing performed by a consumer genetic testing provider, including by discriminating against the individual in any of the following ways: (1) Denying the individual access to the person's goods or services. (2) Charging the individual a different rate for the person's goods or services. (3) Suggesting that the individual will be subject to any of the measures described in subdivisions (1) through (2).". Page 1, line 2, delete "JULY" and insert "UPON PASSAGE]:". EH 1521—LS 7089/DI 119 12 Page 1, delete line 3. Page 8, delete lines 25 through 42, begin a new paragraph and insert: "SECTION 3. An emergency is declared for this act.". Delete page 9. Renumber all SECTIONS consecutively. and when so amended that said bill do pass. (Reference is to HB 1521 as printed February 6, 2025.) BUCHANAN, Chairperson Committee Vote: Yeas 10, Nays 1. EH 1521—LS 7089/DI 119