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US-CONGRESS HR2385: CREATE AI Act of 2025

Detected August 18, 2026 · in Healthcare AI Regulation (FDA / ONC)

The CREATE AI Act of 2025 has been amended and reported out of committee with unanimous support, signaling likely passage. It will impose new FDA oversight and bias audit requirements on AI in healthcare.

Aforeworn detected this change in the Healthcare AI Regulation (FDA / ONC) space on August 18, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated High urgency. Health systems, medical device companies, health tech startups, and digital health compliance teams developing or deploying AI/ML in clinical settings. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Not specified in the excerpt; bill is still in legislative process.. 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, as amended, introduces a regulatory framework for AI in healthcare, including FDA oversight for AI-based medical devices and mandatory bias audits for clinical decision support systems.

Who it affects

Health systems, medical device companies, health tech startups, and digital health compliance teams developing or deploying AI/ML in clinical settings.

What you must do

Monitor the bill's progress and begin preparing for compliance by reviewing current AI products against anticipated FDA requirements and planning for bias audits.

Deadline

Not specified in the excerpt; bill is still in legislative process.

Source: https://www.congress.gov/bill/119th-congress/house-bill/2385

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