News & Analysis as of August 23, 2025

European Union

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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

EU legislative proposals to impose additional obligations on medical device companies

A&O Shearman on 4/26/2023

Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...more

Re-use of health data to train algorithms: European Union EDHS Proposal

Hogan Lovells on 4/19/2023

The European Health Data Space Regulation (still a proposal) will bring huge changes to the handling and possibilities of electronic health records in the European Union. It will create a common environment, with...more

European Health Data Space: a revolution for electronic health records

Hogan Lovells on 1/5/2023

Health care providers (both private and public) store and make use of electronic health records ("EHRs") in the context of providing health care services. However, the configuration of such EHRs by health providers in the EU...more

The European Health Data Space - Panacea or Poison Pill?

Latham & Watkins LLP on 11/2/2022

On 3 May 2022, the European Commission launched its proposal for a Regulation for the European Health Data Space to “unleash the full potential of health data”. However, questions arise as to whether this proposal is a...more

Italy Becomes Latest Country to Pass Sunshine Act

Pietragallo Gordon Alfano Bosick & Raspanti,... on 7/21/2022

Takeaway: Although the enactment of the Italian Sunshine Act furthers the global expansion of healthcare transparency, the implied consent provision may not comply with the GDPR....more

International News: Focus on Global Privacy and Cybersecurity - September 2020

McDermott Will & Schulte on 9/15/2020

Generally, contact tracing refers to an effort by public health officials to identify individuals with whom a patient who has tested positive for an infectious disease has been in close proximity. Public health officials will...more

Privacy, HIPAA, Security and GDPR – COVID-19 Considerations

McDermott Will & Schulte on 3/13/2020

PRIVACY, HIPAA, SECURITY AND GDPR - The introduction and spread of COVID-19 to communities across the globe has created numerous privacy and security compliance questions and challenges. Below, we address several frequently...more

Privacy and Data Security Alert l March 2020

Shook, Hardy & Bacon L.L.P. on 3/10/2020

Shook Weighs in on Updated CCPA Regulations - In response to extensive public comment, the California Attorney General’s office released modified draft regulations under the CCPA on February 7. Shook has provided initial...more

Cybersecurity 2020 — The Year in Preview: Changes in Health Data Privacy Legislation

Foley Hoag LLP - Security, Privacy and the... on 12/19/2019

Editors’ Note: This is the fourth in our fourth-annual end-of-year series examining important trends in data privacy and cybersecurity in the coming year. Our previous entry discussed the CCPA, energy, and Brexit. Up next:...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

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

Weekly Trends Report – 1/23/2019 Insights

Association of Certified E-Discovery... on 1/24/2019

Insight into where e-discovery, information governance cybersecurity, and digital transformation are heading – who is doing what now or in the future, what works and what doesn’t, and what people wish they could do but can’t...more

U.S. hospitals will continue to grapple with GDPR compliance in 2019

Bricker Graydon LLP on 1/10/2019

When the European Union’s General Data Protection Regulation (GDPR) became effective on May 25, 2018, many US-based hospitals struggled to determine whether they were subject to the GDPR and, if so, what they must do to...more

Does GDPR Regulate Clinical Care Delivery by US Health Care Providers?

McDermott Will & Schulte on 2/27/2018

The General Data Protection Regulation establishes protections for the privacy and security of personal data about individuals in the European Economic Area countries, and potentially affects the medical tourism programs and...more

Practical GDPR Steps for US-Headquartered Life Sciences Companies

Mintz - Privacy & Cybersecurity Viewpoints on 2/13/2018

In case you had not heard, the European Union is replacing its current privacy laws with a new, comprehensive General Data Protection Regulation (GDPR), which takes effect May 25, 2018. The essential principles of the EU’s...more

International News: Focus on Health Care - Fall 2017

McDermott Will & Schulte on 9/5/2017

Nationalism and Cross-Border M&A: Navigating Populist Politics in Deal Making - More than half of the G20 countries voted-in campaigns that focused on harming foreign, outside interests as a means to strengthen domestic...more

General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part One)

Foley Hoag LLP - Security, Privacy and the... on 8/25/2017

The clock is ticking: on May 25, 2018, in less than a year from now, the General Data Protection Regulation (“the GDPR”) will apply in all Member States of the European Union (“EU”) and will replace the Directive 95/46/CE...more

General Data Protection Regulation: What It Means For US Healthcare/Life Science Companies (Part Two)

Foley Hoag LLP - Security, Privacy and the... on 8/25/2017

New General Features of the GDPR - Some of the GDPR general features may be of particular interest for companies in the healthcare/life science sectors....more

An Opportunity to Shape Compliance with GDPR

Hogan Lovells on 4/24/2017

A close observer of the GDPR will have noticed that, in several places, individual EU Member States can implement derogations from the GDPR requirements. Of course, as a regulation under EU law there is less scope for local...more

Health Company Fined by UK’s Information Commissioner Office

Hogan Lovells on 3/8/2017

Last week, the UK’s Information Commissioner’s Office (ICO) published a monetary penalty notice which fined a private healthcare company, HCA International, £200,000 for its failure to keep sensitive data secure....more

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General Data Protection Regulation (GDPR) › Health Care Providers › European Union

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