The Biden administration’s executive order issued on October 30, 2023, includes a number of initiatives relating to the development and use of artificial intelligence (AI), including in healthcare. As AI becomes a pivotal point of innovation for the healthcare industry, digital health healthcare technology developers, private equity sponsors, and other key industry stakeholders should track the regulatory frameworks certain to be developed following this executive order to better inform strategies for developing drugs and devices and assessing deals involving AI.
The executive order establishes a new White House AI Council tasked with coordinating agency activities to implement the AI-related initiatives mandated under the executive order. Accordingly, the executive order designates key Cabinet members, including the Secretary of the Department of Health and Human Services (HHS), as members of the White House AI Council. Along with each agency, HHS will create and appoint a Chief AI Officer within 60 days of the executive order.
The Chief AI Officer of HHS will be charged with coordinating HHS’ use of AI, promoting AI innovation within HHS, and managing risks of HHS use of AI. The executive order also calls on the Secretary of HHS to create an HHS AI Task Force within the next three months. Further, within a year of its establishment, the HHS AI Task Force should develop policies and frameworks on the use of AI in research and discovery, drug and device safety, healthcare delivery and financing, and public health, according to the executive order. With respect to FDA regulated products and technologies, this will presumably build on significant work already undertaken by the agency to develop an approach to AI.
The Biden administration calls on the HHS AI Task Force to focus on the following in forthcoming guidance for the responsible deployment of AI in healthcare:
- leveraging predictive and generative AI-enabled technologies in healthcare delivery and financing, such as quality measurement, performance improvement, program integrity, benefits administration, and patient experience
- ensuring long-term safety and real-world performance monitoring of AI-enabled technologies in healthcare for clinically relevant or significant modifications and performance across population groups, with a means to communicate product updates to regulators, developers, and users
- utilizing equity principles in AI-enabled technologies by using disaggregated data on affected populations and representative population data sets when developing new models, monitoring algorithmic performance against discrimination and bias in existing models, and helping to identity and mitigate discrimination and bias in current systems
The executive order also outlines several specific initiatives aimed at ensuring AI’s safe and responsible use in healthcare:
- AI Assurance Policy. The HHS Secretary should develop an AI assurance policy by April 2024 to determine whether AI-enabled technologies in healthcare maintain appropriate levels of quality by the premarket assessment and postmarket oversight of these technologies against real-world data.
- Compliance With Federal Nondiscrimination Laws. The HHS Secretary should consider appropriate actions to ensure the use of AI by healthcare providers that received federal financial assistance complies with federal nondiscrimination laws. This may include issuing guidance or taking action upon receipt of complaints of reports of noncompliance.
- AI Safety Program. The HHS Secretary will establish an AI safety program in partnership with federally listed patient safety organizations through which clinical errors from AI-technologies can be reported and best practices can be formulated.
- Regulating Use of AI in Drug Development. The executive order calls on the HHS Secretary to develop a strategy for regulating the use of AI or AI-enabled tools in drug-development processes.
- Prioritize Grantmaking That Supports Responsible AI Innovation. The Secretary of HHS will collaborate with private sector actors through HHS programs that may support the advancement of AI-enabled tools that develop personalized immune-response profiles for patients; allocating awards and grants to initiatives that explore ways to improve healthcare data quality to support the responsible development of AI tools for clinical care, real-world-evidence programs, population health, public health, and related research.
Another key area to monitor in the coming months lies in biological sequencing. The executive order directs efforts toward assessing how AI may increase or reduce biosecurity risks within the nucleic synthesis industry and developing a framework for providers and manufacturers on the procurement and use of nucleic acid synthesis.
In addition, the executive order opens the door to federal agency use of generative AI by discouraging blanket bans on the technology and directing the Office of Management and Budget and other agencies to develop procurement frameworks.
Finally, as noted above, FDA has already undertaken significant effort to develop its approach to use of AI, and the health-focused aspects of the executive order will presumably build on FDA’s existing policy efforts in this area. For example, FDA has been focusing on use of AI-enabled software as a medical device (SaMD) and use of AI in product development, manufacturing, and postmarket safety vigilance. For example, FDA has authorized a large number of AI-enabled medical devices and recognized that AI has been used in a large number of regulatory submissions for drug and biological products. In addition, FDA recently issued two discussion papers on use of AI in development of drug and biological products and in drug manufacturing.
Industry stakeholders should continue to monitor for HHS, FDA, and other sub-HHS agency guidance on these issues, with the potential for rapid regulatory developments in the coming months.
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