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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

Following the implementation of the Windsor Agreement, a new framework is coming into effect in the new year affecting the UK licensing regime for medicinal products, giving the Medicines and Healthcare products Regulatory Agency (MHRA) the exclusive authority to licence medicines across the whole of the UK.  The changes to the UK licensing regime will have knock-on effects on the Supplementary Protection Certificate (SPC) framework. To accommodate for this, The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (the Windsor Framework SPC Regulations) were laid before Parliament on 31 October 2024 to come into force on 1 January 2025. This will amend the existing assimilated Regulation (EC) No 469/2009 as it applies in the UK.

Although the UK SPC application process will eventually be simplified, the Windsor Framework SPC Regulations insert new definitions and additional provisions, as well as an Annex setting out transitional arrangements to address issues relating to territorial scope, validity, duration, expiry and paediatric extensions.Continue Reading Windsor Agreement changes to UK Assimilated SPC Regulation

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

A version of this article was first published in Life Sciences IP Review

There is currently no specific legislation in the UK that governs AI, or its use in healthcare. Instead, a number of general-purpose laws apply that have to be adapted to specific AI technologies. As a step towards a more coherent approach, the government recently published its response to its consultation on regulating AI in the UK.  This maintains the government’s “pro-innovation” framework of principles, to be set out in guidance rather than legislation, which will then be implemented by regulatory authorities in their respective sectors, such as by the MHRA for medicines.  The MHRA has already started this process and signalled itself as an early-adopter of the UK government’s approach. The hope is that this will lead to investment in the UK by life science companies as the UK is seen as a first-launch country for innovative technologies.Continue Reading The UK’s pro-innovation approach to AI: What does this mean for life science companies?

The end of 2023 featured two significant judgments concerning AI inventions: (i) a highly awaited decision from the Supreme Court in Thaler on the ability of AI systems to be named inventors of patents; and (ii) a decision from the High Court in Emotional Perception considering the application of the computer program exclusion in the UK, leading to prompt changes in patent examination practices by the UKIPO. The Thaler decision was unsurprising and consistent with decisions in other jurisdictions. Consequently, this article focuses on the second of these judgments, especially as Emotional Perception could have ramifications for life sciences companies utilising artificial neural networks (ANN); inventions using ANNs will no longer be excluded from patentability on the basis that it engages the computer program exclusion to patentability in the UK.Continue Reading Landmark UK High Court decision makes it easier to patent AI-related inventions that utilise ANNs