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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 April and early May 2025 from the United States, United Kingdom, and European Union.

Cybersecurity is a hot topic in the UK and EU this month. In both, cybersecurity plans are developing, with the European Commission conducting a consultation on the EU Action Plan to strengthen cybersecurity within hospitals and health care providers, and the UK Cyber Security and Resilience Bill being published, introduced partly because of cyberattacks on UK hospitals. This is clearly an important area for developers of digital products and services, who should watch the progress of these policies closely.Continue Reading Virtual and Digital Health Digest – May 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

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 2025 from the United States, United Kingdom, and European Union.

Artificial intelligence (AI) has been the focus this month, with certain aspects of the EU AI Act now in force and key guidance being published by the European Commission. In addition, the much criticized AI Liability Directive has been withdrawn by the European Commission. In the UK, the UK government published its AI Action Plan setting out its proportionate, flexible regulatory approach towards AI, and the Medicines and Healthcare products Regulatory Agency (MHRA) hosted an Innovation Showcase demonstrating how it is using digital technologies and AI throughout the regulatory lifecycle. Continue Reading Virtual and Digital Health Digest – March 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 January and early February 2025 from the United States, United Kingdom, and European Union.

In this issue, we discuss some useful international guidance documents from the International Medical Device Regulators Forum (IMDRF). These include Guiding Principles on Good Machine Learning Practices (GMLP) that build on the principles previously set out by the U.S. Food and Drug Administration (FDA), UK Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada, and guidance on characterization and risks of medical device software. The continued development of international guidance in this area highlights the importance of coordination between regulatory authorities and standardized guidance for these products. There have also been important developments in ongoing litigation relating to digital technologies, although whether these developments provide clear guidance to manufacturers remains to be seen.Continue Reading Virtual and Digital Health Digest – February 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 2024 and early January 2025 from the United Kingdom, and European Union.

In this issue, we feature the emerging trends in digital health in 2024 that have been highlighted in IQVIA’s recent report. The IQIVA report is a yearly summary of digital health trends and gives a good snapshot of the market. The latest report notes that Germany continues to lead in its approval and reimbursement of digital therapeutics, followed by the United States and UK.Continue Reading Virtual and Digital Health Digest – January 2025

Welcome to the last 2024 installment of Arnold & Porter’s Virtual and Digital Health Digest! This digest covers key virtual and digital health regulatory and public policy developments during November and early December 2024 from the United Kingdom and European Union.

Of note, health authorities in the EU continue to develop methods to assess and recommend health apps. The latest is in Denmark, where new guidance has been published on how health apps will be assessed by the Board for Health Apps. The assessment criteria includes evidence of clinical effectiveness, usability, price, and value to society. This guidance is another important step to ensure greater access to health apps across the EU.

It has been a busy year in digital health and the impact to care delivery is only just beginning. We hope you will continue to follow the digest in 2025 as we track what we expect to be an even busier year.   

Wishing you the best for the new year! 
The Arnold & Porter Team Continue Reading Virtual and Digital Health Digest – December 2024

This digest covers key virtual and digital health regulatory and public policy developments during October and early November 2024 from the United Kingdom and European Union.

Regulatory and legislative reform is on the horizon in both the UK and in the EU, which will impact software and artificial intelligence (AI) medical devices. The UK government recently published the new medical devices post-market surveillance rules, which could be in place by summer 2025. Further, the Medicines and Healthcare products Regulatory Agency’s (MHRA) priorities until spring 2025 are focused on the draft pre-market rules for devices, the in vitro diagnostics (IVD) roadmap, and guidance on AI development and deployment. In the EU, industry should watch the potential upcoming reform of the Medical Devices and In-Vitro Medical Devices Regulations, with increasingly urgent calls for reform from key stakeholders gaining traction with the institutions.Continue Reading Virtual and Digital Health Digest – November 2024

On 14 October 2024, the day of the International Investment Summit, the UK government published its green paper ‘Invest 2035: The UK’s Modern Industrial Strategy’, a ten-year plan designed to promote growth in the UK, with a focus on growth-driving sectors, including the Life Sciences and the Digital and Technologies sectors.

The Industrial Strategy will be informed by the new Industrial Strategy Advisory Council, which is to be chaired by Clare Barclay, CEO of Microsoft UK. The green paper explains that the Advisory Council will be led by evidence and “empowered to advise, make recommendations, and monitor Industrial Strategy policy”. The creation of the Advisory Council is intended to prevent frequent policy changes and ensure “stability and long-termism” and the government has committed to making it a permanent and independent statutory body.

This green paper comes less than a week after the UK Government announced the launch of the Regulatory Innovation Office noting that more plans for boosting growth were to be expected.Continue Reading UK government launches new Industrial Strategy and Advisory Council to boost economic growth

This digest covers key virtual and digital health regulatory and public policy developments during September and early October 2024 from the United Kingdom and European Union.

Guidance on AI continues to be published. In the EU, the European Medicines Agency (EMA) has published its Reflection Paper on the use of AI throughout the medicines life cycle. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) opened applications for its AI Airlock, a regulatory sandbox for AI as Medical Devices. And over 100 companies have signed up to join the EU AI Pact, a voluntary initiative to encourage companies to comply with the AI Act before the statutory deadlines. These guidance documents and initiatives provide companies with much greater clarity on how the authorities will regulate the use of AI in health care.Continue Reading Virtual and Digital Health Digest – October 2024

On 8 October 2024, the UK government launched the new Regulatory Innovation Office (RIO), which aims to “reduce the burden of red tape” faced by businesses when bringing innovations to market, including artificial intelligence (AI) healthcare technologies and engineering biology products such as vaccines and cultivated meat.

The RIO, established within the Department of Science, Innovation and Technology, will seek to reshape regulatory landscapes by working with existing regulators to accelerate approvals, bring regulations up to date and facilitate inter-regulator collaboration. The creation of the RIO is a key manifesto commitment, as part of the government’s wider mission to kickstart economic growth, aiming to provide regulatory certainty and reduce unnecessary delays.Continue Reading UK government launches new Regulatory Innovation Office to reduce red tape