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
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
In the wake of the biggest American political comeback in more than 100 years, stakeholders in the health industry are asking themselves: What does this portend for health policy—patients, providers, manufacturers, and...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
On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant drug pricing-related provisions. The bill generally revives many of the drug pricing provisions...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
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: FDA warns...more