This digest covers key virtual and digital health regulatory and public policy developments during January and early February 2026 from the United States (U.S.), United Kingdom (UK), and European Union (EU).
Continue Reading Virtual and Digital Health Digest – NewsletterOn 19 November 2025, the European Commission published two legislative proposals – the Digital Omnibus on AI Regulation Proposal and the broader Digital Omnibus Regulation Proposal (“Proposals”) – as part of a wider initiative to simplify and streamline the EU’s digital regulatory framework. Together, the Proposals introduce targeted but significant amendments across a broad range of instruments, including the EU AI Act (Regulation (EU) 2024/1689), the GDPR (Regulation (EU) 2016/679), the ePrivacy Directive (2002/58/EC), the NIS2 Directive ((EU) 2022/2555), and the EU Data Act (Regulation (EU) 2023/2854).
Continue Reading EU Digital Omnibus: What the Proposed Reforms Mean for Pharma and MedTechThe Prescription Medicines Code of Practice Authority (PMCPA) has published revised guidance on social media.
Social media has remained a significant focus for the PMCPA in recent years, with numerous companies found in breach of the ABPI Code (the Code) due to activity on social media by the companies themselves, their employees, or associated third parties. Compliance in this space is particularly challenging given the global reach of social media and its inherently public nature, especially when the promotion of prescription-only medicines (POMs) to the public is prohibited in the UK.
Continue Reading UK PMCPA publishes revised guidance for the use of social mediaToday, 16 February 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) opened an important consultation seeking views on proposed changes to the recognition of CE‑marked medical devices in Great Britain (GB). The initiative forms part of the UK’s ongoing efforts to refine its post‑Brexit regulatory landscape and ensure continued patient access to safe, effective medical technologies. The consultation invites feedback from a broad range of stakeholders, including manufacturers, distributors, clinicians, procurement bodies, trade associations, regulatory specialists, and patient organisations. It follows the UK government’s response in July 2025 to its consultation on routes to market for medical devices and IVDs, which outlined, among other initiatives, details of a future international reliance scheme – see our previous blog post on this for more information.
Continue Reading MHRA Launches Targeted Consultation on Indefinite Recognition of CE‑Marked Medical DevicesThe UK Department of Health and Social Care (DHSC) has proposed to set the repayment percentage on sales of branded “newer” prescription-only medicines to the NHS at 16.5% for 2026, a significant reduction on the current rate of 24.3%. The DHSC published the proposals in a consultation, which is open for comment until 21 April 2026.
The Statutory Scheme applies by default to suppliers of branded prescription-only medicines to the NHS who have not elected to be members of the equivalent voluntary scheme for controlling NHS expenditure on branded medicines, currently the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG).
Continue Reading UK government sets out 2026 branded medicines Statutory Scheme repayment rateThe Data (Use and Access) Act 2025 (“DUAA”) represents the UK’s first major reform of data protection law since leaving the EU. The Act aims to modernise the UK’s data protection framework by reducing administrative burdens on businesses, supporting innovation and maintaining high standards of data protection while enhancing the UK’s position as a competitive destination for data-driven industries.
As most of the data protection reforms introduced by the DUAA came into effect on 5 February 2026, life sciences companies should consider how the new framework reshapes their data protection compliance. While the DUAA introduces new rules, it also creates opportunities for the sector.
Continue Reading UK’s Data (Use and Access) Act: What Life Sciences Companies Need to KnowGlobal manufacturers placing medical devices or IVDs on the EU market are facing a pivotal moment. Our latest advisory sets out details on the most significant reforms to the EU framework since the MDR and IVDR took effect, with particular emphasis on what these mean for international companies. For companies headquartered outside the EU, who already face additional hurdles such as appointing an EU Authorised Representative, navigating EU‑specific labelling and language rules, and registering in EUDAMED, the Commission’s proposed changes represent both a long‑awaited easing of systemic pressures and a clear signal to reassess EU market‑entry strategies.
Continue Reading The EU Medical Device Shake‑Up: What International Companies Should Prepare ForThe Prescription Medicines Code of Practice Authority (PMCPA) has published new guidance to provide clarity on the disclosure obligations and commercial governance expected from companies in relation to package deals (Guidance). The Guidance responds to analysis conducted by PMCPA in 2025 which revealed “varying longstanding practices in relation to package deals among companies, particularly in relation to disclosure of transfers of value”.
Continue Reading UK PMCPA releases new guidance on Package Deals: key takeaways for industryThe Law Commission, an independent organisation established to keep the law of England & Wales under review and recommend reform, has announced a review of the law in relation to liability for defective products.
Continue Reading Is change on the horizon for the UK product liability regime? [Updated]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 December 2025 and early January 2026 from the the United Kingdom, and European Union.
Continue Reading Virtual and Digital Health Digest – December 2025