Congress quietly opens door to AI prescribing without liability rules
H.R. 238 — Healthy Technology Act of 2025 · Filed by David Schweikert (R-AZ) · Introduced Jan 7, 2025 · Referred to committee
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What it does
This bill amends federal drug law to allow artificial intelligence and machine learning systems to legally prescribe drugs, provided they are authorized by state law and approved by the FDA through its standard medical device pathways (510(k) clearance, premarket approval, or emergency authorization). The bill redefines 'practitioner' in the Federal Food, Drug, and Cosmetic Act to include AI/ML technologies meeting these conditions.
Why we flagged it
The bill's core function is to expand prescribing authority from licensed human practitioners to AI/ML systems, contingent on state authorization and FDA approval. This is a regulatory redefinition that opens a new category of prescriber, not a traditional medical practice reform.
What the text implies
- The bill does not specify liability allocation: if an AI system prescribes a drug that harms a patient, it is unclear whether the AI developer, the healthcare provider deploying it, the state that authorized it, or the patient bears legal responsibility. This creates a liability vacuum.
- State authorization is the only gate before FDA approval—states may authorize AI prescribing with minimal safeguards, and the bill does not require states to establish standards for AI training data, bias testing, or human oversight.
The full analysis lists 5 implications of this text.
Who stands to gain
AI/machine learning software companies developing prescribing systems; healthcare technology vendors; telehealth platforms integrating AI prescribing