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AI Health Law & Policy: Health Tech Investment Act would create AI-enabled device Medicare payment pathway

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

Technology policy’s next big challenge: Divergent approaches to regulating AI

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

HHS ONC proposes new AI / ML requirements for certified Health IT

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

FDA M-CERSI AI workshop highlights future FDA comment period on AI in drug development

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

Panelists sum up state of health care AI regulation, standards, and data challenges

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

Evolution of FDA regulation of AI-based technology

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

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