On October 30, 2023, President Biden issued an Executive Order on the Safe, Secure and Trustworthy Development and Use of Artificial Intelligence (the “Executive Order”). The Executive Order outlines several steps that the Biden Administration will take with respect to the regulation of artificial intelligence (“AI”) technologies and tools across various industry sectors and previews a more heavily regulated landscape for developers and users of AI-enabled technologies and tools in the health care industry.
Guiding Principles for Governing the Development and Use of AI
The Executive Order outlines the following eight guiding principles that executive departments and agencies should adhere to when making decisions and implementing policies regarding AI.
Directives to HHS for Regulating AI in Health Care
The Executive Order charges the U.S. Department of Health and Human Services (“HHS”) (in conjunction with other agencies when appropriate) with establishing guidelines, regulations and best practices for the development, commercialization, deployment and use of AI in the health care sector. These directives to HHS are outlined below.
Establishment of an HHS AI Task Force
Within 90 days, the Secretary of HHS will, in consultation with the U.S. Secretary of Defense and U.S. Secretary for Veterans Affairs, establish an HHS AI Task Force (the “Task Force”). The Task Force will, no later than one year after its establishment, be responsible for developing a strategic plan for policies and regulatory action with respect to the responsible deployment of AI and AI-enabled technologies in the health care sector (including research and discovery, drug and device safety, health care delivery and financing and public health). The Task Force’s recommended guidance will address:
Development of Strategies for AI Quality Assurance and Use of AI in Drug Development
Within 180 days, the Secretary of HHS must direct HHS components to develop a strategy to determine whether AI-enabled technologies in the health care sector maintain appropriate levels of quality, including the development of an AI assurance policy to evaluate the important aspects of AI-enabled health care tools and addressing infrastructure needs for enabling pre-market assessment and post-market oversight of AI-enabled technology algorithmic performance against real-world data.
Advancement of Federal Non-Discrimination Laws as Related to AI
Within 180 days, the Secretary of HHS will take appropriate actions to advance the understanding of and compliance with federal nondiscrimination laws by health care providers that receive federal financial assistance and how those laws relate to AI technologies. Such actions may include:
Establishment of an AI Safety Program
Within one year, the Secretary of HHS will also, in partnership with voluntary federally-listed patient safety organizations, establish an AI safety program that:
Key Takeaways
Stakeholders in the health care sector planning to use, develop, commercialize or deploy AI‑enabled technologies and tools should prepare to face closer regulation and monitoring from HHS and other federal agencies. As the Biden Administration increases its emphasis on AI, organizations should assess their current practices and policies regarding AI and keep in mind the unique quality, safety, privacy and security considerations surrounding AI in the health care setting.
