January 2026 saw significant activity as UK and EU authorities advanced major initiatives affecting the use of AI, digital technologies, data governance, and cybersecurity in healthcare and life sciences. Notable developments include EMA’s and FDA joint principles on the use of AI across the medicinal product lifecycle, the European Commission’s call for evidence on the
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EU Digital Omnibus: What the Proposed Reforms Mean for Pharma and MedTech
On 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…
Virtual and Digital Health Digest – December 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 December 2025 and early January 2026 from the the United Kingdom, and European Union.…
From complexity to clarity: How the EU Commission plans to overhaul the MDR and IVDR
Introduction
The European Commission has published its proposals on the amendment of the Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR) (“the proposals”). This marks a pivotal moment for the EU healthcare and MedTech landscape, following a public consultation by the Commission in early 2025 (see our blog here) and…
Updated NHS IP Guidance: Unlocking Healthcare Innovation
The UK government has published its first major update to the NHS Intellectual Property (IP) guidance in over two decades. Developed by the Department of Health and Social Care (DHSC) and NHS England with support from the National Institute for Health and Care Research (NIHR), the framework aims to remove long-standing barriers to innovation and…
Virtual and Digital Health Digest – November 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 October and early November 2025 from the the United Kingdom, and European Union.…
Digital Omnibus: The European Commission published its proposal to amend the GDPR, AI Act, Data Act and other related frameworks
The EU Commission has published its proposal for the “Digital Omnibus” aimed to simplify and streamline the EU rules governing artificial intelligence, data protection, cybersecurity, and data use more broadly. The proposal seeks to amend several cornerstone EU regulations, including Regulation (EU) 2016/679 (GDPR), Regulation (EU) 2024/1689 (AI Act), Regulation (EU) 2023/2854 (Data Act), Directive…
Rewriting the Rulebook: MHRA’s Vision for Rare Disease Therapies
A new policy paper released on 2 November 2025 sets out the MHRA’s proposals on overhauling and transforming the UK regulation of rare therapies.
The intention is for a “bold new rulebook for rare therapies” to be published in 2026. Rare therapies is defined as medicinal products intended to treat rare diseases, specifically, conditions with a…
Virtual and Digital Health Digest – October 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 September and early October 2025 from the the United Kingdom, and European Union.
This month, the EU and UK have been actively processing the future of AI development…
Virtual and Digital Health Digest – August 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 July and early August 2025 from the the United Kingdom, and European Union.
The UK government has published a number of initiatives and responses to consultations this month…