Consumer Genetic Testing Providers
IN Consumer Genetic Testing
Genetic
Enacted by HEA 1521 (2025) and effective on passage, this chapter regulates direct-to-consumer genetic testing companies. Before testing, they must give a written privacy disclosure. They need separate, specific consent for extra testing, secondary uses, third-party access, retention beyond 30 days, and genetics-based marketing, and they may never give identifiable genetic data to insurers or employers.
- Where
- Indiana
- Citation
- Ind. Code ch. 24-4-24 (IC 24-4-24-1 to 24-4-24-11)
- Status
- In force
- In force since
- 2025-05-06
- Enforced by
- Indiana Attorney General (exclusive authority, IC 24-4-24-11(a))
- People can sue
- No
- Penalties
- Injunction and a civil penalty of up to $7,500 per violation plus investigative costs and attorney's fees, after a 30-day written notice and cure opportunity (IC 24-4-24-11(b)-(e)).
- Applies to
- Consumer genetic testing providers: persons that, in the ordinary course of business and for consideration, offer direct-to-consumer genetic testing or collect, use, or analyze consumer-provided genetic data from such testing (IC 24-4-24-2)
- Excludes testing ordered by a health care provider and subject to HIPAA, court-ordered testing, law enforcement testing, coroner testing, and research under the Common Rule or FDA human-subjects rules (IC 24-4-24-1(b))
What a privacy notice must say
- Before testing, give the individual a written privacy policy disclosure covering collection, storage, security, retention, and use of samples and data, plus the identity of any third-party labs and recipients.IC 24-4-24-8
Rights it gives people
- Give individuals access to their genetic data and a clear process to revoke consent; honor a revocation within 30 days, including destroying samples and data.IC 24-4-24-10(a)(2)-(4)
Practices it requires
- Obtain freely given, specific, informed, and unambiguous consent, solicited separately for each action, before unrequested testing, other uses of the sample, third-party access to samples or identifiable data, retention beyond 30 days, or marketing based on results.IC 24-4-24-9(a)-(b)
- Consent obtained through inaction, broad terms of service, hovering or closing content, or a manipulative interface (dark pattern) is invalid.IC 24-4-24-9(c)
- Clearly label marketing sent because of the use of testing services, and make third-party marketers identify themselves.IC 24-4-24-10(a)(6)
- Share samples or data with third parties only under contracts barring unconsented use, onward sharing, and over-retention.IC 24-4-24-10(a)(5)
- Never provide non-deidentified genetic data to insurers, underwriting data suppliers, or the individual's employer, even with consent.IC 24-4-24-10(b)
Security duties
- Implement commercially reasonable security measures for biological material and genetic testing data.IC 24-4-24-10(a)(1)
Sources
- Official text
- Indiana Code 2026, Title 24, Chapter 4-24 (Indiana General Assembly)
- HEA 1521 (2025), P.L.233-2025: SECTION 2 effective upon passage; signed by the Governor May 6, 2025
Checked against these sources on 2026-09-25 by research agent (Claude), primary sources.
Unverified: The effective date assumes 'effective upon passage' means the Governor's signature date (May 6, 2025), per the bill actions.
Research reference, not legal advice.