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Health Technology Regulatory Agenda

Arnall Golden Gregory LLP

AGG Talks: Healthcare Insights Podcast - Episode 8: What Healthcare Companies Need to Know When the Government Comes Knocking

In this episode, AGG Healthcare Litigation co-chair Jason Bring is joined by AGG Healthcare Litigation and Government Investigations partner Kara Silverman to discuss best practices for healthcare companies facing a...more

Akin Gump Strauss Hauer & Feld LLP

ONC Steps into AI Regulation by Imposing Requirements for ‘Predictive Decision Support Interventions’; Also Updates Information...

On December 13, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a wide-ranging final rule, Health Data, Technology, and...more

Gardner Law

Artificial Intelligence: Engaging FDA

Gardner Law on

Nathan Downing presented on artificial intelligence in medical products and strategies for partnering with FDA at a recent CLE program that Gardner Law and Fieldfisher hosted in Huntington Beach, California. If you do not...more

Foley & Lardner LLP

AI in Health Care: Regulatory Landscape & Risk Mitigation

Foley & Lardner LLP on

Health care, like most industries, is grappling with the proliferation of artificial intelligence (AI) and the novel risks and benefits it presents. Balancing these risks and benefits can be especially challenging for...more

Hogan Lovells

STeP’ing up: FDA advances expedited device review program, set to begin in March

Hogan Lovells on

On January 6, 2021, the U.S. Food and Drug Administration (FDA) published a final guidance outlining the Safer Technologies Program (STeP) for Medical Devices: a voluntary program for medical devices and device-led...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - October 2019

In this month's edition of our Privacy & Cybersecurity Update, we examine the California attorney general's draft regulations on the California Consumer Privacy Act, the CJEU's clarified rulings on the use of cookies, the...more

Stinson LLP

FDA Proposes Pathway for Artificial Intelligence/Machine Learning Software

Stinson LLP on

Last week, the FDA published a discussion paper outlining a proposed regulatory framework for artificial intelligence/machine learning software as a medical device (AI/ML SaMD)....more

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