HR 5045
HEALTH AI Act
TL;DR
Rep. Ted Lieu (D-CA) introduced the HEALTH AI Act, which would establish federal oversight of artificial intelligence used in healthcare settings like clinical decision-making, diagnostics, and patient care. The bill is currently in the House Energy and Commerce Committee and aims to set safety, transparency, and validation standards for medical AI tools.
How This Might Impact Your Business
Healthcare providers using AI diagnostic tools would face new federal validation and safety standards before deploying them on patients.
Medical device makers and health tech vendors selling AI software (radiology tools, clinical decision support, triage algorithms) would likely need to meet transparency requirements about how their models were trained and tested.
Hospitals and health systems would need documentation showing AI tools have been vetted for accuracy and bias, similar to how they vet drugs and devices today.
Health insurers using AI for claims processing, prior authorization, or coverage decisions could face scrutiny over algorithmic denials.
Digital health startups and telehealth platforms selling AI features would need to budget for compliance testing and audits.
The bill is early stage (committee referral only), so specific penalties, thresholds, and deadlines are not yet finalized.
Small clinics and independent practices may be indirectly affected if their EHR vendors pass compliance costs downstream.
What Should You Do
Inventory every AI tool currently in use across clinical, administrative, and billing functions, including vendor-supplied features you may not have flagged as 'AI.'
Ask AI vendors for documentation on training data, validation studies, bias testing, and FDA status now, so you are not scrambling if this bill or similar rules advance.
Have legal and compliance teams track HR 5045 through the House Energy and Commerce Committee and flag related FDA and HHS guidance that may move faster than the bill itself.
Assign an executive owner (Chief Medical Officer, Chief Compliance Officer, or CIO) for healthcare AI governance if you have not already.
Review any AI-driven prior authorization or claims tools for documented accuracy rates and appeal pathways, as these are likely first targets for enforcement.
Who It Affects
Sponsors
Status Timeline
committee
Referred to the House Committee on Energy and Commerce.
August 26, 2025