HR 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.
Creates new compliance requirements or restricts common AI uses. Action needed.
TL;DR
Rep. David Schweikert (R-AZ) introduced a bill requiring mammography facilities that use AI systems to meet new FDA quality standards and undergo additional inspections. The bill would mandate that facilities using AI for breast cancer screening disclose this to patients and maintain specific documentation about their AI tools.
How This Might Impact Your Business
Healthcare facilities using AI in mammography must comply with new FDA quality standards within 18 months of enactment
Facilities must provide written disclosure to patients when AI assists in reading mammograms, including accuracy data and FDA approval status
Annual inspections required for facilities using AI systems, beyond standard mammography facility inspections
Documentation requirements include maintaining AI algorithm version histories, performance metrics, and staff training records
Penalties include facility certification suspension and fines up to $10,000 per violation
Exempts facilities using AI solely for administrative purposes (scheduling, billing) rather than clinical interpretation
What Should You Do
Inventory all AI tools currently used in mammography departments and document their FDA approval status
Review patient consent forms and add required AI disclosure language if using AI-assisted mammography
Schedule meeting with radiology department heads to assess compliance gaps and timeline for meeting new standards
Monitor bill progress through House Energy and Commerce Committee (no hearing date scheduled yet)
Budget for potential annual inspection fees and system documentation requirements
Who It Affects
Sponsors
Status Timeline
committee
Referred to the House Committee on Energy and Commerce.
April 27, 2026
AI-generated analysis for informational purposes only. Not legal advice. Always consult a qualified attorney for legal guidance.
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