News & Analysis as of

Artificial Intelligence Clinical Trials Digital Health

American Conference Institute (ACI)

[Event] 2nd Annual Life Sciences AI Summit - February 20th - 21st, New York, NY

Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more

Foley & Lardner LLP

AI Drug Development: FDA Releases Draft Guidance

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On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more

Jones Day

Vital Signs: Digital Health Law Update | Fall-Winter 2024

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We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more

Goodwin

In the Metaverse, Existing Healthcare Rules Apply

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Providers and platforms should know that healthcare in the metaverse — which may involve telepresence, digital twinning, and blockchain — is subject to ‘real life’ regulations. The metaverse uses technologies such as...more

Mintz - Health Care Viewpoints

FDA’s Review of Pulse Oximeter Performance Continues a Trend in Addressing Biases in Digital Health Technologies

The U.S. Food and Drug Administration (FDA) will schedule a public meeting of the Medical Devices Advisory Committee later this year to discuss study results, real-world data, and other evidence concerning the accuracy and...more

Jones Day

Vital Signs: Digital Health Law Update | Summer 2021

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NOTE FROM THE EDITORS - The "dog days of summer" certainly provide a welcome, if brief, break in the extremely rapid pace of statutory, regulatory, and various other policy and industry efforts applicable to digital health....more

Wiley Rein LLP

Full Speed Ahead – FDA’s Digital Health Center of Excellence to Host Listening Sessions

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On September 22, 2020, the U.S. Food and Drug Administration (FDA) announced the establishment of the Digital Health Center of Excellence (DHCE) within FDA’s Center for Devices and Radiological Health (CDRH). Bakul Patel will...more

Mayer Brown Free Writings + Perspectives

Update on Healthcare Financings in 2019

In a recent briefing, CB Insights reported increased funding in the healthcare sector for the first half of 2019 with $26.9 billion invested in healthcare companies across 2,258 deals globally. While promising, funding for...more

Fenwick & West Life Sciences Group

Takeaways from Fenwick’s 2018 Digital Health Investor Summit

The Seventh Annual Fenwick & West Digital Health Investor Summit profiled a sector that continues to attract record levels in investment, further matures and consolidates, and that is leveraging the newest technologies in...more

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