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Regulatory activity in the EU and UK over the past month has focused on accelerating the alignment of digital, AI, and life sciences regulatory frameworks, alongside increasing scrutiny of data governance and market readiness for emerging technologies. At the EU level, work to simplify and streamline EU AI-related legislation has advanced, with the Council of the European Union and European Parliament having adopted their positions on the European Commission’s (EC) Digital Omnibus reforms, and now entering trilogue negotiations on the final text. In parallel, MedTech Europe published its response to the EC consultation on the simplification of the EU AI rules as part of the Digital Omnibus, calling for clearer integration between the AI Act and other sectoral legislation, as well as extended implementation timelines. Separately, the European Data Protection Board (EDPB) and European Data Protection Supervisor (EDPS) issued a joint opinion on the proposed European Biotech Act, emphasizing the need for clearer safeguards, harmonized legal bases for processing clinical data, and strong protections when health and genetic data are used in biotech and AI contexts. In the UK, developments have focused on the role of AI-enabled innovation within the health care system. A new parliamentary inquiry into personalized medicine and AI will examine ongoing challenges and barriers to National Health Service (NHS) adoption of new technologies, including procurement, digital infrastructure limitations, and system fragmentation. At the same time, the Medicines and Healthcare products Regulatory Agency (MHRA) has secured multi year funding to expand its AI Airlock Program to support the development of more ambitious AI medical devices. These initiatives signal a continued policy commitment to embedding digital and AI driven innovation into health care delivery and to strengthening the regulatory environment required to support safe deployment at scale.…

Continue Reading Virtual and Digital Health Digest – April 2026

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 2026 from the the United Kingdom, and European Union.

February 2026 saw a period of substantial regulatory activity across both the UK and EU, particularly in relation to AI governance, medical technologies, and data protection. In the UK, the policy landscape continued to evolve with initiatives affecting the regulation of medical devices, clinical research, and AI deployment. Key developments included the Medicines and Healthcare products Regulatory Agency’s (MHRA) consultation on the indefinite recognition of CE-marked medical devices, record levels of medical device testing, and the Prescription Medicines Code of Practice Authority’s (PMCPA) revised guidance on the use of social media. AI remained a major focus in the UK, with the UK government’s response to the consultation on the AI Management Essentials tool, increased industry involvement in the UK AI Security Institute’s alignment program, and feedback relating to governmental research on AI adoption across UK businesses. Additional international collaboration efforts included UK engagement at the India AI Impact Summit and an expanded science and technology partnership with Japan, as well as the launch of the first-ever AI Strategy for UK Research and Innovation.

Continue Reading Virtual and Digital Health Digest – February 2026

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.

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 proposed amendments to the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), proposals to strengthen the EU Cybersecurity Act, and important data protection interventions. In parallel, UK and EU regulators continued to focus on the safe deployment of digital tools in healthcare, including new Medicines and Healthcare products Regulatory Agency (MHRA) guidance on mental health technologies and ongoing work to refine AI governance. These updates, alongside developments in Intellectual Property (IP) and product liability, signal a rapidly evolving regulatory environment that will help to shape digital innovation and compliance expectations throughout 2026.

Continue Reading Virtual and Digital Health Digest – January 2026

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 accelerate the adoption of new technologies.

The previous guidance, dating back to 2002, was designed for a pre-digital era and struggled to accommodate modern technologies such as AI and machine learning. As a result, innovators and NHS partners often faced prolonged negotiations and unclear ownership rules, delaying patient access to life-changing solutions. In some cases, promising collaborations collapsed after years of legal uncertainty, highlighting the urgent need for reform.

Continue Reading Updated NHS IP Guidance: Unlocking Healthcare Innovation

Answers to Some Common Questions

After many years of debate, negotiations and work, the Unified Patent Court (UPC) and the unitary patent system were finally launched on 1 June 2023. In this publication, we demystify confusing terminology and misconceptions by providing answers to common questions on the UPC and the unitary patent system.

Continue Reading Demystifying the UPC and the Unitary Patent