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 March and early April 2025 from the United States, United Kingdom, and
Arnold & Porter Kaye Scholer LLP
With nearly 1,000 attorneys, Arnold & Porter provides sophisticated litigation to the life sciences and financial services industries across the globe. Their lawyers cover more than 30 practice areas including corporate finance, intellectual property, litigation, real estate, tax, and bankruptcy. With over 100 years of history, the firm offers clients forward-looking and client driven services to resolve their legal needs.
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Arnold & Porter Kaye Scholer LLP Blogs
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Recent updates on reform of UK clinical trial landscape
On 11 April 2025, the MHRA announced that the much anticipated changes to the clinical trial rules in the UK, the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 (the new Regulations), have been signed into law.
In January, we…
European Data Protection Board publishes study on secondary use of personal health data for scientific research
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…
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…
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…
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…
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…
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…
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…
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,…