From improving diagnosis accuracy and alleviating burdens on health care providers to helping along the creation of new, lifesaving drugs and expanding patient access to care, the integration of artificial intelligence has the potential to transform health care. 

The Biden Administration and Congress, however, are considering regulations that could stifle AI innovation in health care. We need lawmakers to carefully weigh the trade-offs between regulation and medical advancement.

The following principles for any government regulatory action concerning AI in health care are urged by a group of federal and state policy experts, including Washington Policy Center. (See the full letter and organizations on board here.)

1. No new regulatory agency: We advocate against creating a dedicated AI regulatory agency in healthcare. Instead, existing regulatory bodies should adapt their current authorities, such as the FDA’s approval and certification of AI-driven medical products, to accommodate AI innovations. Congress should ensure that these agencies avoid regulatory overreach and, instead, focus on developing modern and agile regulatory approaches.

2. Safeguarding American sovereignty and intellectual capital: While international collaboration can be beneficial, maintaining regulatory independence is vital to protect national sovereignty. Robust intellectual property (IP) frameworks for AI should spur research and investments in healthcare advancements and bolster investment while safeguarding American intellectual capital.

3. Cost-saving and resource efficiency: Government-deployed AI systems in healthcare agencies and programs should prioritize cost reduction, operational efficiency, and the elimination of duplicative activities. Targeting waste, fraud, and abuse in taxpayer-funded healthcare delivery and administration can yield significant resource savings. 

4. Prohibition of government authority to dictate results or limit ideas and scientific debate: Governments should not have the authority to dictate AI-generated outcomes in healthcare. To combat bias, comprehensive datasets are vastly preferable to governmental intervention in algorithmic decision-making. AI should not be used to stifle intellectual freedom, hinder scientific discourse, or suppress dissenting opinions. The ultimate authority for medical decisions should remain in the domain of the practice of medicine, upholding the principle of medical autonomy. 

5. Regulatory clarity and simplicity for fostering innovation: Modern and agile AI regulations in healthcare should prioritize clarity and simplicity. They should support innovation and AI technology development while providing for patient safety, privacy, and ethical standards. These regulations should resist the influence of large market incumbents and avoid creating artificial barriers to entry. 

6. Embrace innovation in healthcare: The integration of AI in healthcare has the potential to create a dynamic and patient-centered experience. It harnesses AI technologies to expand healthcare access, enhance outcomes, improve the patient experience, reduce costs, alleviate the burdens on our healthcare providers, and drive advancements in medicine. To achieve these goals, lawmakers and policymakers should meticulously assess the boundaries of regulatory action, weigh the trade-offs between regulation and medical advancement, and consider the consequences of stifling innovation, which would further limit healthcare access. 

Congressional and state policymakers need to find constructive solutions to concerns over new technologies in health care. If regulation is deemed necessary, it should be limited in scope, protecting patient safety and privacy while promoting competition and medical innovation that can make people’s lives better. Patient-centered health care needs to be front and center.