News & Analysis as of July 23, 2025

European Union › Health Information Technologies

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The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -

AI Transparency in Healthcare: Navigating a Changing Regulatory Landscape

MoFo Life Sciences on 4/29/2025

Transparency of artificial intelligence (AI) systems in healthcare is quickly becoming a central concern for regulators due to potential impacts on patient safety, healthcare quality, bias mitigation, and public trust. To...more

Council of Europe approves the European Health Data Space: a shift towards the digital regulation of health data across the EU

Hogan Lovells on 1/30/2025

The Council of Europe has formally adopted the EHDS, marking a significant milestone in the development of a unified framework for health data exchange across Member States. This initiative aims to enhance healthcare...more

Investment Opportunities in 2024

McDermott Will & Emery on 1/22/2024

In November, McDermott Will & Emery was pleased to host our annual European Health & Life Sciences Symposium in Paris. Welcoming a large crowd of healthcare professionals, investors and dealmakers for a programme of...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

Health Data in the EU and UK – Regulatory Trends and Developments

McDermott Will & Emery on 3/3/2023

In light of the increasing number of enforcement incidents under the General Data Protection Regulation (GDPR), organisations active in the Health and Life Sciences sectors in the United Kingdom, the European Union (EU) and...more

New Doctrine of the French National Authority for Health

Hogan Lovells on 2/11/2021

In line with its Action Plan for Innovative Medicines outlined in early 2020, the French National Authority for Health has updated its doctrine for the health technology assessment of medicines. Following its Action Plan for...more

The EC publishes an inception impact assessment for the proposal of a European Health Data Space

Hogan Lovells on 1/19/2021

The European Commission has published an inception impact assessment for a potential legislative proposal establishing a European Health Data Space. In its document, the European Commission identifies the problems currently...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

Highlights from the DigiHealth Leaders Conference: interoperability, reimbursement, patient centricity, and forging effective...

Hogan Lovells on 11/25/2019

Digital health offers huge potential for improving care and alleviating the increasing burden on our over-stretched healthcare systems. However, its uptake remains slow and varies significantly across the EU....more

International Life Sciences Data Transfers After Schrems

Morgan Lewis on 10/12/2015

With the recent ruling that the Safe Harbor programme is invalid under European law, life sciences companies will need to review their strategies when exporting patient data to the United States....more

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European Union › Health Information Technologies

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