In a groundbreaking move, Representative David Schweikert (R-AZ-1) has introduced HR 238, a bill designed to adapt federal regulations to the rapidly evolving landscape of artificial intelligence (AI) and machine learning in healthcare. The proposed legislation seeks to amend the Federal Food, Drug, and Cosmetic Act, clarifying that AI and machine learning technologies can qualify as practitioners eligible to prescribe drugs, provided they meet specific criteria.
Key Provisions of HR 238
The bill outlines several important conditions under which AI technologies could operate as prescribers:
1. State Authorization: AI systems must be explicitly authorized by the state where they are implemented.
2. FDA Approval: Such technologies must be approved, cleared, or authorized by the Food and Drug Administration (FDA) to ensure their safety and efficacy.
3. Human Oversight: While not explicitly mentioned in the bill’s summary, this legislative framework is likely to necessitate robust oversight mechanisms to ensure AI does not operate without proper safeguards.
Implications for Healthcare
If enacted, HR 238 could revolutionize the healthcare sector by leveraging AI’s efficiency to address prescription bottlenecks and expand access to care, particularly in underserved areas. AI technologies, when integrated responsibly, have the potential to reduce human error, streamline administrative processes, and offer timely interventions.
However, the legislation also raises important questions about patient safety, accountability, and ethical considerations. Critics may voice concerns over the potential risks of delegating such a critical role to AI, emphasizing the need for stringent safeguards and human oversight to prevent misuse or errors.
Legislative Journey
On January 6, 2025, the bill was introduced in the House of Representatives and referred to the House Committee on Energy and Commerce for review. This committee will play a pivotal role in determining whether the bill advances to a vote. Given the rapid advancements in AI, the proposal could spark significant debate among lawmakers, healthcare professionals, and technology experts.
A Step Toward AI-Driven Innovation
HR 238 signals Congress’s growing recognition of AI’s transformative potential in various sectors, including healthcare. As the bill moves through the legislative process, it will likely serve as a focal point for discussions about the role of emerging technologies in modernizing regulatory frameworks.
Whether HR 238 becomes law or inspires future legislation, it marks an important step in addressing the intersection of technology and public health policy.