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Food and Drug Administration (FDA) New Regulations Digital Health

Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

DLA Piper

New Federal Initiatives Signal Digital Health Access as a Key Priority

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Recent activity among lawmakers and federal agencies signal that the government may be poised to undertake meaningful legislative and administrative efforts to harness the potential of digital health innovation and to expand...more

Foley & Lardner LLP

Regulation of Digital Health Products by FDA

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Industry insiders can all agree that the U.S. Food & Drug Administration (FDA) regulates the use of medical devices. Most insiders agree that a medical device is any instrument, apparatus, implement, machine, contrivance,...more

Jones Day

JONES DAY PRESENTS® Digital Health and Clinical Research: Understanding Regulatory Regimes

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Jones Day partner Maureen Bennett talks about how advancements in digital technology and their clinical trial applications have introduced additional regulatory regimes in the United States and the European Union, and...more

Holland & Knight LLP

Digital Health: FDA Announces New Policy for Genetic Testing Regulation

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In another example of the FDA's revision of regulatory policies for digital health products, Commissioner Scott Gottlieb announced on Nov. 6, 2017, that the agency is extending its precertification model to low-risk...more

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