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AI Summit panelists weigh emerging data & privacy risks for novel technology

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

HHS finalizes changes to Section 1557 regulations strengthening anti-discrimination protections

On April 26, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the Centers for Medicare & Medicaid Services (CMS) finalized updates to regulations implementing Section 1557 of the...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

When being a little bit square is a good thing: CMS AppliedVR decision shows how innovative technology can secure a payment...

While the Medicare statute provides access to healthcare services for our nation’s elderly and disabled populations, it also can serve to foreclose access for those populations when an item or service does not fall within one...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

MEDCAC Coverage with Evidence Development meeting offers CMS guidance on CED study requirements

On February 13-14, 2023, the Centers for Medicare & Medicaid Services (CMS) convened a virtual panel of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) to evaluate changes to the criteria for clinical...more

Senate Passes Drug Pricing Legislation

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

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

Panelists discuss present & future reimbursement mechanisms for AI health care products

At our recent Health Care AI Law and Policy Summit, Hogan Lovells partner Stuart Langbein moderated a panel discussion on AI policy and reimbursement issues. Joined by representatives from CMS Medicare Administrative...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

U.S. House passes drug pricing legislation

This morning, the U.S. House passed drug pricing legislation as part of the Build Back Better Act (BBBA) (specifically the Rules Committee version available here and the manager’s amendments available here). In prelude to...more

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