The European Data Protection Body (EDPB) has published a study on how personal health data is and/or can be reused for scientific research in the EU under the EU General Data Protection Regulation (GDPR). The study highlights the related practical challenges due to divergent interpretations of the GDPR and national rules across EU Member States.
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Arnold & Porter Kaye Scholer LLP Blogs
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LDTs Are Not Devices Under the FDCA: Eastern District of Texas Vacates FDA Final Rule on LDTs
In our blog in December 2024, we provided an update on the U.S. Food and Drug Administration (FDA) final rule, revising the regulatory definition of an in vitro diagnostic (IVD) to explicitly capture IVDs manufactured by laboratories (known as laboratory developed tests or LDTs). We noted that two cases had been filed challenging the…
ABPI calls for changes to “unsustainable” medicines pricing scheme
The Association of the British Pharmaceutical Industry (ABPI) has published a report (the Report) setting out its members’ concerns regarding the operation of the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG).
VPAG is an agreement between the Department of Health and Social Care (DHSC), NHS England and ABPI, which came into…
UK Public Procurement Landscape Transformed: What Does It Mean for Medicines?
By Jackie Mulryne & Heba Jalil
On February 24, 2025, new rules came into force in the UK transforming the public procurement landscape. The new regime aims to provide a simplified and flexible framework for contracting authorities when conducting procurement processes, including the purchase of medicinal products by the National Health Service (NHS).
Under the new Act, a number of elements…
Virtual and Digital Health Digest – March 2025
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during February and early March 2025 from the United States, United Kingdom, and European Union.
Artificial intelligence (AI) has been the focus this month, with certain aspects of…
EU Medical Devices Legislation: What You Need To Know Given Latest Developments and Ongoing Challenges
We recently published this Advisory for our US clients, but thought it may be a useful reminder for UK and EU teams given the number of updates in this area.
We are sure that you are aware that the European Union (EU) medical devices framework has been subject to significant changes over recent years. However,…
UK Prime Minister Announces that NHS England will be abolished
UK Prime Minister Kier Starmer announced yesterday that NHS England will be abolished to “cut bureaucracy” and bring management of England’s health service “back into democratic control”. NHS England will be brought back into the Department of Health and Social Care (DHSC) over the next two years.
The Government aims to remove a “burdensome layer…
UK ICO Announces Cookies Compliance Review of the UK’s Top 1,000 Websites
The ICO recently announced its plan to bring the UK’s top 1,000 websites into compliance with applicable data protection law, in relation to their use of cookies. At the time of the announcement, the ICO had already checked 200 websites, and communicated its concerns to 134 of their operators. This suggests a prevalence of non-compliant…
European Commission Publishes Proposal for EU Critical Medicines Act
On 11 March 2025, the European Commission published a proposal for a Critical Medicines Act (CMA).
The CMA introduces measures to improve the security of supply chains and availability of critical medicinal products and medicinal products of common interest in the European Union (EU). Some of the proposed measures directly affect Life Sciences companies, while…
EU announces pilot coordinated assessment for clinical investigations of medical devices
On 6 February 2025, EU Member States announced the launch of a new pilot scheme for coordinated assessment of clinical investigations of medical devices (CI) and performance studies for in vitro diagnostic (IVD) medical devices (PS). Supported by the European Commission, the pilot allows sponsors to submit a single CI or PS application for review…