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Medium urgency

US-CONGRESS BILLS-119s5345is: To provide for the delivery of artificial intelligence functional bills of materials, and for other purposes.

Detected August 13, 2026 · in Healthcare AI Regulation (FDA / ONC)

A new Senate bill (S. 5345) proposes requiring AI developers to provide a functional bill of materials (FBOM) for AI systems, including those used in healthcare, to improve transparency and accountability.

Aforeworn detected this change in the Healthcare AI Regulation (FDA / ONC) space on August 13, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Medium urgency. AI developers, healthcare AI vendors, medical device manufacturers, health systems using AI, and digital health startups. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Not specified; the bill is in early legislative stages.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Healthcare AI Regulation (FDA / ONC) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.

What changed

The bill introduces a requirement to deliver an AI functional bill of materials (FBOM) for AI systems, which would document components, data, and algorithms. It is currently proposed legislation, not yet law.

Who it affects

AI developers, healthcare AI vendors, medical device manufacturers, health systems using AI, and digital health startups.

What you must do

Monitor the bill's progress and prepare to document AI system components, data sources, and algorithms if it becomes law.

Deadline

Not specified; the bill is in early legislative stages.

Source: https://www.govinfo.gov/app/details/BILLS-119s5345is

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