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Machine Learning Health Technology Food and Drug Administration (FDA)

Hogan Lovells

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

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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

Polsinelli

Generative Artificial Intelligence Leveraged to Deliver Healthcare - Legal Risks and Issues

Polsinelli on

With daily media reports citing to the explosion of interest in Artificial Intelligence (“AI”), AI start-ups have attracted a huge capital influx. During the last fiscal quarter of 2024 ending on December 31st, investors...more

Nelson Mullins Riley & Scarborough LLP

Bipartisan House Task Force Report Outlines Key Areas of AI Focus for Health Care

As the New Year begins, questions surrounding how recent election results will impact technology regulation across industries loom large. It’s hardly a bold prediction that artificial intelligence (“AI”) and the regulation...more

Sheppard Mullin Richter & Hampton LLP

Healthy AI: 2024 Year in Review

On October 30, 2023, President Biden signed Executive Order 14110, laying the groundwork for the ethical and secure deployment of AI across industries, including healthcare. This comprehensive directive outlines policy goals...more

Akin Gump Strauss Hauer & Feld LLP

AdvaMed, Releases AI White Paper

AdvaMed, the world’s largest medical technology association representing device, diagnostics and digital technology companies, released a white paper that reviews the current landscape of artificial intelligence (AI)-based...more

Mintz - Health Care Viewpoints

FDA Needs a New Approach to AI/ML-Enabled Medical Devices

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more

Gardner Law

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

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FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

Wilson Sonsini Goodrich & Rosati

[Ongoing Program] 2023 Medical Device Digital Health Conference - June 16th, San Francisco, CA

Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more

Wilson Sonsini Goodrich & Rosati

[Ongoing Program] MDC 2023 Reception & Dinner Women’s Networking Event & Program - June 15th, Menlo Park, CA

Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more

Hogan Lovells

Evolution of FDA regulation of AI-based technology

Hogan Lovells on

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

MoFo Life Sciences

FDA’S Plan For AI/ML-Based Software As Medical Devices: Progress And Concerns

MoFo Life Sciences on

U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory...more

McDermott Will & Emery

Reviewing Key Principles from FDA's Artificial Intelligence White Paper

McDermott Will & Emery on

In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more

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