News & Analysis as of

Artificial Intelligence Digital Health Risk Management

Rothwell, Figg, Ernst & Manbeck, P.C.

From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more

Ropes & Gray LLP

The Biden Administration’s Swan Song on Digital Health: Two FDA Guidances on Artificial Intelligence and FDA’s Defense of its...

Ropes & Gray LLP on

In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more

Foley & Lardner LLP

AI Drug Development: FDA Releases Draft Guidance

Foley & Lardner LLP on

On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more

Hogan Lovells

FDA’s first Digital Health AdComm meeting mulls promises & perils of Generative AI

Hogan Lovells on

Amid continued rapid development of novel software products that present new opportunities in the health care space, FDA has yet to grant marketing authorization to a medical device incorporating artificial intelligence (AI)...more

Fenwick & West LLP

Key Takeaways from Digital Health Counsel 2024 AI Summit

Fenwick & West LLP on

Walking away from Digital Health Counsel 2024 AI Summit, the stunning impact that AI and data-powered innovation are making on healthcare is undeniable. Organized by Ogden Murphy Wallace and sponsored by Fenwick, the summit...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - July 2024 #3

News Briefs - Joint Employer Rule Withdrawn by National Labor Relations Board - The National Labor Relations Board withdrew its appeal of a district court ruling that enjoined its "joint employer" final rule....more

Society of Corporate Compliance and Ethics...

[Event] Regional Compliance & Ethics Conference - March 8th, Washington, DC

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Health Care Compliance Association (HCCA)

[Event] Regional Compliance & Ethics Conference - March 8th, Washington, DC

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

McDermott Will & Emery

[Webinar] AI Risk Management 101 - June 29th, 12:00 pm - 1:00 pm ET

McDermott Will & Emery on

Healthcare is rapidly changing, with artificial intelligence (AI) and algorithmic models leading the transformation. In recent years, big data and machine learning algorithms have revolutionized our ability to predict...more

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