Evolving regulatory paradigms governing AI use in health care at the U.S. Food and Drug Administration (FDA) have set the pace for AI regulatory frameworks worldwide. Jodi Scott, partner in the Hogan Lovells medical device &...more
Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including data and privacy...more
Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including reimbursement issues...more
On May 22, 2025 the U.S. House of Representatives voted to pass a 10-year moratorium on the enforcement of state laws governing artificial intelligence (AI). If enacted, the AI moratorium would limit states’ ability to...more
U.S. Senate Artificial Intelligence Caucus co-chairs Mike Rounds (R-SD) and Martin Heinrich (D-NM) recently introduced S. 1399, the “Health Tech Investment Act,” which would establish a Medicare reimbursement pathway for...more
On February 6, 2025, the Trump Administration released published a Request for Information (RFI) on behalf of the White House Office of Science and Technology Policy (OSTP) concerning the development of an Artificial...more
Life sciences and health care companies are heavily regulated under the rigorous standards of the U.S. Food and Drug Administration to ensure high levels of quality and patient safety. However, companies seeking to advance...more
The U.S. Federal Trade Commission (FTC) staked out its role in policing the potential competition and consumer protection implications of generative AI technologies’ use of copyrighted materials in comments submitted in the...more
President Joe Biden signed a sweeping executive order on artificial intelligence (AI) spurring broad U.S. government action on AI safety, security, and trust and reinforcing Congressional interest in AI....more
The rapid growth of AI and its ramifications for nearly all aspects of society and the economy is placing increasing pressure on the U.S. and European governments to proactively set regulations and guardrails for this nascent...more
On April 11, the U.S. Department of Health & Human Services (HHS) Office of the National Coordinator (ONC) posted a proposed rule entitled, “Health Data, Technology, and Interoperability: Certification Program Updates,...more
The U.S. Food and Drug Administration (FDA) – in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) – recently hosted a one-day virtual public workshop entitled,...more
At our recent Health Care AI Law and Policy Summit, Hogan Lovells partner Melissa Bianchi moderated a panel discussion on the state of the health care AI industry. Joined by representatives from the American Medical...more
Hogan Lovells partners Kelliann H. Payne and John J. Smith, M.D., J.D. recently joined Richard Frank, MD, PhD, Chief Medical Officer, Siemens Healthineers, and other industry leaders in person and virtually at the Health Care...more