Ana Gonzalez-Lamuno

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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 – 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.Continue Reading Virtual and Digital Health Digest – December 2025

On 11 December, after overnight interinstitutional negotiations between the European Parliament and the Council of the European Union (“Council”) and the European Commission, the institutions reached a provisional political agreement on the reform of the European Union (“EU”) pharmaceutical legislation.

This agreement concludes months of trilogue discussions and follows a much longer legislative process that began with the European Commission’s  proposal adopted in April 2023, the European Parliament’s position adopted on 10 April 2024, and the Council’s position adopted on 4 June 2025 (see our detailed advisory on the Commission’s proposal and our BioSlice blog posts on the Parliament’s and Council’s positions here and here).

The provisional agreement must now be formally adopted by both the Parliament and the Council.Continue Reading European institutions agree on the reform to the EU Regulatory Framework for Medicinal Products

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.Continue Reading 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 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 and regulation in life sciences and health care through a combination of legislative initiatives, opportunities for stakeholder engagement, and investment in infrastructure. In the EU, the European Commission has published draft guidance on reporting serious AI incidents under the AI Act, and the European Medicines Agency has initiated a stakeholder survey to define AI priorities in medicines regulation. In the UK, the UK government has announced a National Commission on the Regulation of AI in Healthcare and a new AIR-SP cloud platform. These developments signal a shift from theoretical regulation to practical implementation. There have also been two important decisions from the Court of Justice of the European Union refining the legal boundaries of digital health services and data protection.Continue Reading Virtual and Digital Health Digest – October 2025

The European Commission has published new Guidelines on the details of the various categories of variations (to the terms of marketing authorisations (“MA”) for medicinal products) (“Variations Guidelines”).

The new 2025 Variations Guidelines replace the older 2013 Variation Guidelines, and support the implementation of the amended Regulation (EC) No 1234/2008 (“Variations Regulation”) (see our BioSlice blog post), which entered into force in January 2025. The Variations Guidelines provide detailed guidance for marketing authorisation holders (“MAH”) on modifying and updating their MAs, the procedures to follow and the related requirements.

Overall, the new Guidelines provide greater flexibility and clarity in certain aspects of the variation procedures. At the same time, they introduce new obligations for MAHs that should be taken into account by pharmaceutical companies going forward.

In this blog, we highlight some of the key changes introduced by the Variations Guidelines.Continue Reading European Commission Publishes New Variation Guidelines for Medicines

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 that have included important proposals for devices and digital health. The 10 Year Health Plan and Life Sciences Sector Plan both refer to integration of digital health into the National Health Service. Further, the Medicines and Healthcare products Regulatory Agency’s statement on the future regulation of devices makes some key changes relevant to software, including that the proposed international reliance pathways will include software. There has also been some useful guidance on synthetic data, and on reporting adverse events for software devices. These initiatives continue to demonstrate that digital technologies are seen as a growth area and are important for delivering the government’s long-term healthcare plans. Continue Reading Virtual and Digital Health Digest – August 2025

On 2 July, 2025, the European Commission published its EU Life Sciences Strategy (the ‘Strategy’), setting out a roadmap to position the European Union (EU) as a global leader in life sciences by 2030.

For pharmaceutical, MedTech, and biotech companies, the Strategy may, at least in theory, represent a positive shift towards a more innovation-driven environment for research and development (R&D) and market access in life sciences. This will, however, depend, to a great extent, on the practical impact and implementation of the other policy and legislative initiatives in the EU (e.g., the reform of the EU pharmaceutical legislation (see our latest blog), Biotech Act, Critical Medicines Act (see our blog)).

The Strategy presents concrete EU level actions to address long-standing challenges in life sciences in the EU, such as regulatory fragmentation across EU Member States, as well as the barriers to multi-country clinical trials and to the market access of advanced therapies and novel technologies.

A new Life Science Coordination Group within the European Commission will oversee the implementation of the Strategy and ensure that EU policies are consistent and supportive of innovation.

This blog highlights key elements of the Strategy of relevance to pharmaceutical, MedTech, and biotech companies.Continue Reading The European Commission Publishes an EU Life Sciences Strategy

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 June and early July 2025 from the United Kingdom and European Union.

There has been a flurry of new guidance from the Medical Device Coordination Group this month, including guidance on classification of medical device software, on supply of software apps through online platform such as the App Store and Google Play, and on the interaction between the Medical Device Regulation and the EU AI Act. These are welcome guidance documents to provide important clarification for manufacturers as they develop software medical devices, although the guidance documents inevitably cannot cover every situation and leave some questions unanswered. Continue Reading Virtual and Digital Health Digest – July 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 May and early June 2025 from the United Kingdom and European Union.

There has been a lot of focus on AI this month. The European Commission has launched a consultation on high-risk AI systems, which includes medical devices and is therefore highly relevant for digital health companies. The European Medicines Agency has published a workplan on data and AI use, which sets out how the European Medicines Regulatory Network plans to leverage large volumes of regulatory and health data to support regulatory decision-making for better medicines. There has also been international guidance published on the use of AI in pharmacovigilance. However, there has also been controversy as the UK Data Use and Access Bill continues through the parliamentary process, as there is disagreement on its treatment of copyright-protected material in the development of AI systems. As uses of AI continue and authorities seek to put in place relevant legislation and guidance to match the speed of development, expect this focus to continue.Continue Reading Virtual and Digital Health Digest – June 2025