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Articles

International Comparative Legal Guide to Digital Health 2024

By Global Legal Group

This guide provides corporate counsel and international practitioners with comprehensive jurisdiction-by-jurisdiction guidance to digital health laws and regulations around the world.

Topics covered include digital health technologies, data use, data sharing, intellectual property, commercial agreements, AI and machine learning, and liability.

Articles

FDA’s New Guidance Proposes Flexible Use of AI in Medical Devices

By Jessa Boubker, Kyle Y. Faget, Nathan A. Beaver, Monica R. Chmielewski (Foley & Lardner LLP)

This article discusses the U.S. Food and Drug Administration's draft guidance on artificial intelligence/machine learning (AI/ML)-enabled devices.

The draft guidance — "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions" — was issued on April 3, 2023. 

Articles

HHS Updates Pixels and Trackers Guidance for HIPAA Regulated Entities

By Aaron T. Maguregui and Jennifer J. Hennessy, Foley & Lardner LLP

Pixels, cookies, and trackers continue to be front of mind for HIPAA regulated entities seeking clarity on their ability to advertise, market, and engage with existing and prospective patients. On March 18, 2024, the U.S. Department of Health and Human Services (HHS) issued updated guidance on the topic.

Articles

Retraining the Acquisition Model: How to Approach the Risks and Rewards of Deals With Artificial Intelligence Targets

By Natasha Allen, David W. Kantaros, Shabbi S. Khan, Avi B. Ginsberg, Graham P. MacEwan

In recent years, companies specializing in artificial intelligence (AI) technologies have been increasingly coveted acquisition targets. Foley & Lardner have provided insight into the AI field transforming our approaches to key issues. Accordingly, it is no surprise that AI has emerged as a prime sector for M&A activity. This guide helps breakdown how to approach risks and rewards in dealing with the rising importance of Artificial Intelligence.

Articles

Remote Therapeutic Monitoring: What You Need to Know About CMS’ Proposed Changes

By Thomas B. Ferrante, Nathaniel M. Lacktman, Rachel B. Goodman, Foley & Lardner

On July 7, 2022, the Centers for Medicare & Medicaid Services (CMS) proposed five new changes to Remote Therapeutic Monitoring (RTM) services under the Medicare program. The changes are part of the proposed 2023 Medicare Physician Fee Schedule rule. To learn more check out this Foley & Lardner article.

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