Federal · House Bill · 119th Congress, 2nd Session
HR8526
H.R. 8526 — To amend the Public Health Service Act to update quality standards for mammography facilities for the use of AI systems, and for other purposes

Status ● Introduced Effective N/A Passage Likelihood L

How Is This Bill Enforced

Enforcement Authority
Enforcement falls under the existing Mammography Quality Standards Act (MQSA) framework administered by the Secretary of Health and Human Services through the Food and Drug Administration. No new enforcement mechanism is created by this bill.
Private Right of Action
No private right of action. Enforcement is exclusive to the designated authority.
Penalties
No new penalties or remedies are created by this bill. Existing MQSA enforcement mechanisms (facility certification, sanctions) apply.

What This Bill Requires

Verbatim statutory text on the left; plain-language analysis and a per-section checklist on the right. Numbered markers cross-link to the matching checklist row.

Statutory Text
Analysis & Obligations
42 U.S.C. § 263b(f)(1)
Updating quality standards for mammography facilities for use of AI systems

(1)(A) in subparagraph (D)— (A) in the matter preceding clause (i), by striking ''physician who'' and inserting ''physician, or a machine-learning or artificial intelligence system, that'';

(1)(B) on clause (ii), by striking ''who'' and inserting ''that'';

(2) in subparagraph (G)(ii)(I), by striking ''signed by the interpreting physician''.

This section makes three targeted amendments to the Mammography Quality Standards Act to accommodate AI and machine-learning systems in mammography interpretation. The amendments expand the category of permissible mammogram interpreters from physicians only to include machine-learning or artificial intelligence systems, update pronoun references accordingly, and remove the requirement that mammography communications be signed by the interpreting physician — a requirement that is nonsensical when interpretation is performed by an AI system.

These are permissive amendments to an existing regulatory framework rather than new affirmative compliance obligations. The bill does not define what qualifies as a machine-learning or artificial intelligence system, nor does it impose any AI-specific safety, testing, or transparency requirements. Facilities using AI for mammogram interpretation would remain subject to existing MQSA quality standards and FDA oversight.

Passage Likelihood

Low
Status Introduced
Chamber No passage
Committee No action
Majority party (No data)
Bipartisan No
Prior session None

Legislative History

2026-04-27 Introduced in House
2026-04-27 Referred to the House Committee on Energy and Commerce.

Entry Last Reviewed

2026-05-20
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