This Bill Could Make It Legal for AI to Prescribe Medicine
A new legislative proposal, the Healthy Technology Act of 2025, has the potential to grant artificial intelligence (AI) the authority to prescribe medications, pending approval from Congress. This bill proposes an amendment to the Federal Food, Drug, and Cosmetic Act, allowing AI and machine learning technologies to qualify as practitioners authorized to prescribe drugs if sanctioned by the respective state and approved by the US Food and Drug Administration (FDA).
Current Landscape of AI in Healthcare
Many physicians are optimistic about the role of AI in enhancing healthcare delivery. Currently, AI is utilized to streamline processes such as clinical documentation and assist in decision-making. However, experts caution that extensive research is still required before AI can autonomously generate prescriptions.
Dr. Ravi B. Parikh, an associate professor at Emory University, pointed out that the legislation references a type of AI technology that is not yet available. The bill was introduced to the US House of Representatives on January 7 and is currently under review by the House Committee on Energy and Commerce.
AI’s Limitations in Prescription Writing
As of now, AI does not possess the capability to independently write prescriptions. Researchers are working on developing AI tools that assist physicians in making informed prescribing decisions. For instance, predictive tools analyze a patient’s electronic health records to assess the likelihood of treatment efficacy.
Additionally, AI is being developed to create digital twins of patients, enabling simulations to determine the most effective medication options. Despite these advancements, there remains a significant gap between AI’s current capabilities and the level of trust required for it to take over prescribing duties.
Concerns Regarding AI Prescribers
Experts have expressed concerns about the accuracy and reliability of AI in clinical settings. Past incidents, such as an AI scribe incorrectly diagnosing a patient based on incomplete data, highlight the potential risks associated with AI-enabled prescriptions. Dr. Matthew DeCamp emphasized that AI’s performance in real-time clinical environments remains unproven, and it cannot replicate the nuanced decision-making that human physicians engage in when prescribing medications.
Furthermore, issues surrounding bias in AI training data could lead to skewed recommendations, particularly if the data used to train these systems is incomplete or unrepresentative of diverse patient populations.
Regulatory Challenges
The proposed act raises critical questions about the regulation of AI prescribers. Under the Healthy Technology Act, AI prescribing tools would be required to meet state authorization and FDA approval, yet existing regulatory standards may not be adequate for the complexities of AI technologies.
Dr. Parikh cautioned that the regulatory landscape for AI devices is currently less stringent than for traditional medications, which could lead to premature adoption of AI in prescribing without sufficient evidence of its efficacy.
Future Prospects of AI in Prescribing
For the Healthy Technology Act of 2025 to be enacted, it must navigate through Congress successfully. Historical attempts to introduce similar legislation have stalled in committee, making the future uncertain.
Should the bill pass, there is speculation about how AI could eventually play a role in prescribing protocols, perhaps by assisting in low-risk scenarios while ensuring a human physician remains involved in the decision-making process.
In conclusion, while the potential for AI to enhance healthcare is significant, the implications of allowing AI to prescribe medications necessitate careful consideration of regulatory frameworks, ethical standards, and ongoing oversight to ensure patient safety and efficacy.