On May 1-2, Hogan Lovells is hosting its annual Health Care AI Law and Policy Summit, an informative and interactive program where our thought leaders and industry guests will address a variety of topics including new and emerging health care AI policies and regulatory considerations, implications for ethics and consumer safety, developments in the U.S., UK, and EU, and more. You can register for the Summit online here.

Impact of the Biden Administration’s Executive Order on AI

In October 2023, the Biden Administration issued an Executive Order (EO) on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence. The EO signals a clear interest in the impact of AI on the health care industry and stands to reshape AI use in the sector, as we have described here. The EO outlines dozens of actions, including many for which the U.S. Department of Health and Human Services (HHS) will be responsible. Additional agency activity to implement the EO will likely be forthcoming, with potential opportunities for stakeholder comment and involvement as the regulatory paradigms for AI continue to evolve.

For example, we expect that the HHS Office for Civil Rights (OCR) will finalize proposed rules which would expand the obligations for developers of AI tools under Section 1557 of the Affordable Care Act (which prohibits discrimination on the basis of race, color, national origin, age, disability, or sex in covered health programs or activities) to ensure that clinical algorithms do not have a discriminatory effect.

We also anticipate further agency educational efforts for providers and developers of the Health IT Certification Program regarding compliance with the HHS Office of the National Coordinator (ONC) final rule (HT-1) on transparency and risk mitigation activity reporting for certain AI systems. ONC’s goals in implementing the rule are to advance interoperability, improve transparency, and support the access, exchange, and use of electronic health information by requiring transparency requirements for AI and other predictive algorithms that are part of certified health IT.

In addition, a number of health care providers and IT companies have signed the White House’s voluntary commitment aimed at ensuring the safe development of AI, as we discussed here. Health care systems and others in the life sciences sector need to consider steps to incorporate the White House’s Executive Order on AI, among other existing artificial intelligence guidance.

Congressional activity

While members of Congress have expressed enthusiasm about the potential applications of AI in health care, they have also raised deep concerns regarding transparency, privacy, and bias, including AI potentially incorporating human biases and the safeguarding of patient information used to train AI models. We expect continued discussions around the incorporation of AI guardrails into existing data privacy legislation and discussion of appropriate Medicare coverage and payment for AI applications. While comprehensive legislation may be unlikely prior to the election, we expect AI to remain a top issue on Capitol Hill, including as part of upcoming appropriations bills.

Next steps

Health care systems and others in the life sciences sector need to pay attention. At the federal and state levels, now is the time for stakeholders to engage in policymaking processes given the breadth of their potential impact on life sciences companies and patients. Policymakers continue to face a steep learning curve and industry perspectives will be one important key to advancing appropriate regulations in this rapidly evolving area.