By Victoria Barahona, Policy Associate and Matt Dennis, Partner
One of the most rapidly evolving policy areas for 2024 is artificial intelligence (AI) technology and its implications for health care. Specific use cases for AI in healthcare have the potential to transform delivery and accessibility of care and improve administrative efficiency. But policymakers and regulators in Washington, DC are also sinking their teeth into potential ethical and legal considerations, looking for ways to protect patients and the public from unintended consequences.
CRD Associates is closely monitoring how Congress, the White House, and federal agencies will respond to the challenges and opportunities posed by the development and application of AI.
Seeking to respond quickly to this emerging field, House and Senate committees have already held hearings to explore the broader implications of AI usage for health care delivery, such as data privacy, liability, workforce, and equity issues. The Senate Health, Education, Labor, and Pensions (HELP) Committee and the House Energy and Commerce (E&C) Subcommittee on Health both convened hearings in November to hear from experts on how AI can improve diagnosis and treatment, and to highlight the need for collaboration and coordination among federal agencies, industry, and academia to foster innovation and trust.
Last year, President Joe Biden signed an executive order requiring federal departments to establish regulatory framework around AI tools—including those in health care. As reported by the White House, the Department of Health and Human Services (HHS) is setting up a task force to create AI regulation policy, which will be responsible for developing policy around regulating the emerging technology. Top officials from a wide range of federal departments are expected to sit on the White House AI Council. By April, HHS must devise ways to assess AI fairness, legal compliance, and oversight.
In the Administration, the U.S. Food and Drug Administration (FDA) has issued a discussion paper and an action plan to propose a framework for AI-based software as a medical device (SaMD), but more guidance and oversight are needed to ensure the safety and effectiveness of these products. Interest groups and stakeholders have begun expressing concerns over FDA’s ability to consider approval or clearance of individual medical algorithms, preferring the FDA look to medical and health care professionals to identify practical use cases for autonomous AI and ensure resources are directed at in-demand solutions.
Without preconceived partisan battle lines, AI is a topic ripe for bipartisan collaboration on legislation and regulation, both of which remain in their infancy. And thirsty for technical expertise, policymakers and regulators will look to the health care industry, patient advocates, and academia to help shape the rules of the road and ensure safety, transparency, privacy, and human oversight over autonomies technologies.
CRD Associates will continue to follow this issue closely as Congress and the Administration seek to foster innovation, protect patient safety, and promote public health. For more information, reach out to us at [email protected].
