News & Analysis as of May 16, 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 & Emery 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

Vital Signs: Digital Health Law Update | Spring 2024

Jones Day on 7/22/2024

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...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

2018 Digital Health Data Developments – Navigating Change in 2019

McDermott Will & Emery 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

2018 Digital Health Year in Review: Focus on Data

McDermott Will & Emery 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

Digital health: Understanding the new responsibilities facing life sciences companies related to collecting and processing...

Hogan Lovells on 7/13/2018

In May 2018, the General Data Protection Regulation (GDPR) entered into effect in EU member states, replacing a longstanding and less rigorous data and e-privacy directive. ...more

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