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News

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...

News

Proof in Trial: Appellate Edition: Integra Med Analytics LLC et al. v. Providence Health & Services et al.

What happens when a company is unfairly accused of defrauding the U.S. government? In this case, a medical record software company was caught in the crosshairs of a business created for the ...

Published Works

A reimbursement framework for artificial intelligence in healthcare npj Digital Medicine

Responsible adoption of healthcare artificial intelligence (AI) requires that AI systems which benefit patients and populations, including autonomous AI systems, are incentivized...

News

The Federal Trade Commission rattles off two more hospital merger challenges

On the heels of two successful hospital merger challenges in the last year, the FTC announced on Thursday that it is bringing two new cases seeking to block proposed hospital transactions:...

News

Key legal concerns for advanced therapy medicinal product (ATMP) sponsors in Europe

In recent years we have seen more and more gene and cell therapies coming successfully to market – but many more such candidates have not made it to market, or been unable to obtain...

News

Cell and gene therapy transactions carry unique risks for both licensor and licensee

Cell and gene therapy transactions have increased dramatically over the last few years, in both number and complexity, and have given rise to a number of issues that merit further...

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D.C. District Court rules for PhRMA in PBM accumulator programs Final Rule litigation

On Tuesday, May 17, 2022, the U.S. District Court for the District of Columbia issued a decision granting the Pharmaceutical Research and Manufacturers of America’s (PhRMA)’s...

News

Demy-Colton panel explains how to make your market access strategy real ahead of Phase III trials

Hogan Lovells has teamed up with Demy-Colton to host a special three-part webinar series focused on U.S. market access for life sciences firms, providing companies that are new to the U.S....

News

Demy-Colton panel explains importance of U.S. market access planning ahead of Phase III trials

Hogan Lovells has teamed up with Demy-Colton to host a special three-part webinar series focused on U.S. market access for life sciences firms, providing companies that are new to the U.S....

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