News & Analysis as of August 12, 2025

Digital Health

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Follow this channel for updates and analysis on all aspects of the European Union's General Data Protection Regulation, a reform of EU's data protection rules that impacts... more +

Follow this channel for updates and analysis on all aspects of the European Union's General Data Protection Regulation, a reform of EU's data protection rules that impacts individuals throughout the Union and all businesses operating therein. less -

European Health Data Space Regulation enters into force

McDermott Will & Schulte on 3/27/2025

March 26, 2025, marked a pivotal moment in the EU with the European Health Data Space Regulation, (EU) 2025/327 (“EHDS Regulation”), coming into force. The EHDS represents a transformative initiative by the European Union...more

EU moves closer to a unified digital health system with the European Health Data Space Regulation (EHDS)

Hogan Lovells on 6/11/2024

The European Health Data Space (EHDS) Regulation seeks to overcome significant obstacles in digital health by creating a comprehensive framework for sharing electronic health data. It aims to establish clear rules, common...more

Navigating the FemTech regulatory landscape: which rules apply and what are the enforcement priorities?

BCLP on 5/17/2024

Security, scale or functionality – pick two. This computer science principle coined by the late Professor Anderson is particularly relevant to the FemTech industry. Anderson’s Rule states that for a system to provide high...more

2018 Digital Health Data Developments – Navigating Change in 2019

McDermott Will & Schulte on 2/5/2019

Data privacy and security legislation and enforcement saw significant activity in 2018 and early 2019. McDermott’s 2018 Digital Health Year in Review: Focus on Data report – the first in a four-part series – highlights...more

K&L Gates Triage: Triage in 2019: Health Care Topics to Watch in the New Year

K&L Gates LLP on 1/31/2019

As K&L Gates begins its third season of Triage: Rapid Legal Lessons for Busy Health Care Professionals, Hilary Bowman previews several topics that the health care practice group anticipates will have a significant impact on...more

2018 Digital Health Year in Review: Focus on Data

McDermott Will & Schulte on 1/29/2019

Introduction - The past year was an active one for data privacy and security legislation and enforcement. Protection for certain personal data was enhanced internationally by the EU General Data Protection Regulation...more

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on 12/13/2018

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

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