Title 42, The Public Health and WelfareRelease 119-110

§1320d–9 Application of Hipaa Regulations to Genetic Information

Title 42 › CHAPTER 7 — SOCIAL SECURITY › SUBCHAPTER XI — GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE SIMPLIFICATION › Part C — Administrative Simplification › § 1320d–9

Last updated Sep 23, 2026|Official source

Summary

The Secretary must change the HIPAA privacy rules so genetic information is treated like health information. Group health plans, health insurers, and issuers of Medicare supplemental (Medigap) policies may not use or share a person’s genetic information for underwriting. Underwriting means deciding who can enroll or stay enrolled, calculating premiums or contributions, applying pre‑existing condition exclusions, and other actions tied to creating, renewing, or replacing health coverage. The law uses the meanings of “genetic information,” “genetic test,” and “family member” from section 300gg–91, and the meanings of “group health plan” and “health insurance coverage” from the same place, and “medicare supplemental policy” from section 1395ss(g). The rule change had to be published in the Federal Register no later than 60 days after May 21, 2008, and took effect when published without prior public comment, though it can be revised later after comment. Plans or insurers who violate the rule face the penalties in sections 1320d-5 and 1320d-6.

Full Legal Text

Title 42, §1320d–9

The Public Health and Welfare, Source: USLM XML via OLRC

(a)In general
The Secretary shall revise the HIPAA privacy regulation (as defined in subsection (b)) so it is consistent with the following:
(1)Genetic information shall be treated as health information described in section 1320d(4)(B) of this title.
(2)The use or disclosure by a covered entity that is a group health plan, health insurance issuer that issues health insurance coverage, or issuer of a medicare supplemental policy of protected health information that is genetic information about an individual for underwriting purposes under the group health plan, health insurance coverage, or medicare supplemental policy shall not be a permitted use or disclosure.
(b)Definitions
For purposes of this section: (1) Genetic information; genetic test; family member
(2)Group health plan; health insurance coverage; medicare supplemental policy
The terms “group health plan” and “health insurance coverage” have the meanings given such terms under section 300gg–91 of this title, and the term “medicare supplemental policy” has the meaning given such term in section 1395ss(g) of this title.
(3)HIPAA privacy regulation
The term “HIPAA privacy regulation” means the regulations promulgated by the Secretary under this part and section 264 of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note).
(4)Underwriting purposes
The term “underwriting purposes” means, with respect to a group health plan, health insurance coverage, or a medicare supplemental policy—
(A)rules for, or determination of, eligibility (including enrollment and continued eligibility) for, or determination of, benefits under the plan, coverage, or policy;
(B)the computation of premium or contribution amounts under the plan, coverage, or policy;
(C)the application of any pre-existing condition exclusion under the plan, coverage, or policy; and
(D)other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits.
(c)Procedure
The revisions under subsection (a) shall be made by notice in the Federal Register published not later than 60 days after May 21, 2008, and shall be effective upon publication, without opportunity for any prior public comment, but may be revised, consistent with this section, after opportunity for public comment.
(d)Enforcement
In addition to any other sanctions or remedies that may be available under law, a covered entity that is a group health plan, health insurance issuer, or issuer of a medicare supplemental policy and that violates the HIPAA privacy regulation (as revised under subsection (a) or otherwise) with respect to the use or disclosure of genetic information shall be subject to the penalties described in section 1320d–5 and 1320d–6 of this title in the same manner and to the same extent that such penalties apply to violations of this part.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Genetic Information Nondiscrimination Act of 2007, referred to in subsec. (b)(1), probably means the Genetic Information Nondiscrimination Act of 2008, Pub. L. 110–233, May 21, 2008, 122 Stat. 881. For complete classification of this Act to the Code, see

Short Title

note set out under section 2000ff of this title and Tables. section 264 of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (b)(3), is section 264 of Pub. L. 104–191, which is set out as a note under section 1320d–2 of this title.

Statutory Notes and Related Subsidiaries

Effective Date

Pub. L. 110–233, title I, § 105(b)(2),
May 21, 2008, 122 Stat. 905, provided that: “The amendment made by subsection (a) [enacting this section] shall take effect on the date that is 1 year after the date of the enactment of this Act [
May 21, 2008].”

Regulations

Pub. L. 110–233, title I, § 105(b)(1),
May 21, 2008, 122 Stat. 905, provided that: “Not later than 12 months after the date of the enactment of this Act [
May 21, 2008], the Secretary of Health and Human Services shall issue final

Regulations

to carry out the revision required by section 1180(a) of the Social Security Act [42 U.S.C. 1320d–9(a)], as added by subsection (a). The Secretary has the sole authority to promulgate such

Regulations

, but shall promulgate such

Regulations

in consultation with the Secretaries of Labor and the Treasury.”

Reference

Citations & Metadata

Citation

42 U.S.C. § 1320d–9

Title 42, The Public Health and Welfare

Last Updated

Sep 23, 2026

Release point: 119-110