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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 2026 from the United Kingdom and European Union.

May 2026 saw continued momentum across the European Union (EU) and United Kingdom (UK) toward modernizing and streamlining the regulatory landscape for digital health, with a particular focus on accommodating AI-enabled technologies while reducing unnecessary complexity. A central development was the provisional agreement on the Digital Omnibus package, which seeks to simplify the application of the EU AI Act by clarifying overlaps with sector-specific legislation, deferring key obligations, and introducing more proportionate requirements.

In parallel, regulators on both sides of the Channel are advancing reforms to ensure that medical device frameworks remain fit for purpose in an increasingly software-driven and data-centric environment. In the EU, the activation of key European Database on Medical Devices (EUDAMED) modules marks a major step toward enhanced transparency and traceability, while ongoing discussions on the Medical Devices Regulation 2017/745 (MDR)/In Vitro Diagnostic Regulation 2017/746 (IVDR) revisions highlight a strong policy drive toward simplification and better integration of AI. In the UK, the Medicines and Healthcare products Regulatory Agency’s (MHRA) proposed pre-market reforms and broader thinking on AI regulation signal a shift toward more flexible, lifecycle-based oversight, with greater emphasis on post-market monitoring and innovation support.

Data governance and cybersecurity also remain high on the agenda. Industry and regulators alike are emphasizing the need for coherent, proportionate frameworks that avoid duplication while enabling innovation, particularly in light of expanding AI use cases and global supply chains. Together, these developments reflect a broader trend toward risk-based, innovation-friendly regulation, coupled with increasing expectations around transparency, accountability, and data protection in digital health.

Continue Reading Virtual and Digital Health Digest – June 2026

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 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 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 industry

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

On 10 October 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) announced the early launch of the “Aligned Pathway”. This is a joint initiative designed to streamline  the scheduling of the regulatory approval and health technology assessment processes in order to reduce the time before a new medicine is available on the NHS following the grant of the marketing authorisation (MA). The pathway supports the UK Government’s ambitions outlined in the 10-Year Health Plan for England and the Life Sciences Sector Plan to accelerate access to medicines and reduce regulatory burden, as discussed in our blog here.

Continue Reading MHRA and NICE launch aligned approvals pathway

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 31 July 2025, the UK government published a statement of policy intent, setting out its initial thinking on an Early Access Service (EAS) for innovative medical devices. The intention is for this to first focus on innovative diagnostic devices, particularly those supporting the NHS’s most urgent needs and financial sustainability in the NHS.  It is hoped this will lead to quick market access of such devices, by addressing challenges associated with generating sufficient evidence to obtain regulatory approval.

Continue Reading UK proposes Early Access Service for innovative medical devices

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

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 European Union.

The biggest change this month is that as of March 25, 2025, the European Health Data Space Regulation (EHDS Regulation) is now in force. This means that, as it is gradually implemented, companies will be able to request access to electronic health data for health care purposes, including for use in scientific research, and may be required to share certain health data that they hold. The implementation of the EHDS Regulation is likely to raise a number of questions, which future European Commission implementing regulations or guidelines may clarify.

Continue Reading Virtual and Digital Health Digest – April 2025