AI Could Prescribe Without Human Oversight and Be ‘Licensed by Law’ If This Bill Passes

A new bill introduced in the U.S. House of Representatives aims to pave the way for artificial intelligence (AI) and machine learning technologies to prescribe FDA-approved drugs autonomously. The proposed legislation, known as the Health Technology Act of 2025 (H.R. 238), seeks to amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to classify AI systems as "practitioners licensed by law" capable of prescribing medications.

Introduced by Representative David Schweikert (R-AZ) on January 7, 2025, this bill represents a significant step toward integrating AI into healthcare practice. If enacted, it could potentially revolutionize the way medications are prescribed and address ongoing challenges in the healthcare system.

Key Provisions of the Health Technology Act

The core of H.R. 238 lies in its proposal to expand the definition of who - or what - can prescribe medications. The bill seeks to amend the FFDCA to include AI and machine learning technologies as eligible practitioners for drug prescription, provided they meet certain criteria.

Key Highlights:
AI as a Licensed Practitioner – The bill expands the definition of a "practitioner licensed by law" to include AI and ML technologies.

State and Federal Authorization Required – AI-driven prescribing systems must be:

• Approved by the state government where they operate.
• Cleared by the FDA under existing regulatory pathways (such as 510(k), 513, 515, or 564).

Regulatory Oversight – The bill ensures that AI prescribing tools adhere to FDA approval standards before being implemented.

Notable Quotes from the Bill:

• “The term ‘practitioner licensed by law to administer such drug’ includes artificial intelligence and machine learning technology...”
• “Artificial intelligence and machine learning technology authorized pursuant to a statute of the State involved to prescribe the drug involved...”
• “ approved, cleared, or authorized under section 510(k), 513, 515, or 564.”

This bill signals a groundbreaking shift in healthcare technology, potentially revolutionizing telemedicine and automated care. If passed, it could streamline prescription processes, reduce human error, and expand access to medical services—especially in underserved areas. However, it also raises ethical and regulatory concerns, including safety, liability, and patient trust in AI-driven healthcare decisions.

Next Steps

As of now, H.R. 238 has been referred to the House Committee on Energy and Commerce for further consideration. The bill's journey through the legislative process is likely to be complex, given the groundbreaking nature of its proposals and the ongoing debates surrounding AI in healthcare.

Regardless of the bill's ultimate fate, it has already succeeded in sparking an important conversation about the future of healthcare and the role of artificial intelligence in medical practice. As technology continues to advance, similar proposals are likely to emerge, making it essential for healthcare professionals, policymakers, and the public to engage in informed discussions about the benefits and risks of AI in healthcare.

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