Proposed Legislation to Allow AI to Prescribe FDA-Approved Drugs Autonomously
Recently, a new bill has been introduced in the U.S. House of Representatives that could potentially revolutionize the healthcare industry. The proposed legislation, known as H.R.238 or the Prescription of Drugs by Artificial Intelligence or Machine Learning Technologies Act of 2025, aims to amend the Federal Food, Drug, and Cosmetic Act to allow AI and machine learning technology to autonomously prescribe drugs approved by the FDA.
Key Points of the Bill
- The bill would clarify that AI and machine learning technologies can qualify as practitioners eligible to prescribe drugs if authorized by the state and approved by the FDA.
- Rep. David Schweikert (R -Az.) is the sponsor of the bill, which has been referred to the Committee on Energy and Commerce.
- If approved, AI would be recognized as a licensed practitioner to administer drugs under certain conditions.
The Larger Trend of AI in Healthcare
AI has already made significant strides in healthcare, with applications ranging from radiological detection to drug discovery. However, concerns have been raised about the readiness of AI to be used in certain aspects of care.
Challenges of AI Integration
Recent studies have shown that while AI models like GPT-4V may outperform human physicians in certain tasks, they still have limitations when it comes to providing accurate rationales for their decisions. Flawed rationales, especially in image comprehension, could lead to potential risks for patients.
High-Value and High-Risk Use Cases
Experts like Harjinder Sandhu from Microsoft emphasize the importance of evaluating AI systems thoroughly before integrating them into clinical workflows. The potential for AI to hallucinate information or omit crucial details could have catastrophic consequences for patients.
Overall, the proposed legislation to allow AI to prescribe FDA-approved drugs autonomously represents a significant step forward in the integration of technology within healthcare. However, careful consideration and evaluation of AI systems are essential to ensure patient safety and quality of care.