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.

Regulatory Updates

MHRA Publishes a Revised MedTech Roadmap. The roadmap highlights policy areas that the Medicines and Healthcare products Regulatory Agency (MHRA) would like to develop, including in relation to Software as a Medical Device and AI. In relation to new regulations for post-market surveillance, the roadmap states that this is targeted to come into force around July 2025, with guidance being published in June.

The roadmap also sets out that the focus for the new regulations on pre-market requirements in the first quarter of 2025 will be on publishing responses to assimilated EU law, laying down the Statutory Instrument and bringing this into law, as well as publishing responses to the consultations. The Parliamentary debates are expected to occur at the end of the year, with the new regulation entering into force early 2026.

Further, in the first half of 2025, the MHRA aims to publish separate guidance regarding Good Machine Learning Practice, AI development and deployment, Software as a Medical Device for Cybersecurity, and digital mental health technologies.

UK National Health Service Using AI to Assist in Ensuring Patients Receive Help at an Earlier Stage. This program aims at identifying individuals who are frequent users of emergency services to assess why they are presenting for care so frequently and to help resolve the situation by offering immediate preventative care. The AI-powered prediction software uses routinely collected hospital data to identify patients who require immediate preventative support to avoid future, unplanned visits to the hospital.

Reimbursement Updates

IQVIA Publishes Report Outlining the Digital Health Trends of 2024. The report examines key trends in digital health, including in relation to digital therapeutics (DTx). It found that DTx are offered as standalone products in some countries, whereas in others there is a preference for digital care solutions. Germany is leading globally in the approval and reimbursement of prescription DTx as standalone products. In the UK, digital care solutions seem to be preferred as a blended therapy, several of which have been endorsed by the National Institute for Health and Care Excellence (NICE). DTx have, for example, been applied in relation to weight management programs alongside obesity medication, and digital care programs have been used to reduce waiting lists for traditional care for obesity by distributing patients to various levels of care.

In relation to digital tools for disease assessment, risk screening tools are expected to have the greatest impact in enabling a faster diagnosis as they have potential to reach large numbers of patients. NICE has recommended AI-based tools for detecting skin cancers in primary care to assess whether referral to a specialist is appropriate. NICE found that AI has a proven track record of improving accuracy in detecting melanoma compared to the standard of care. At the same time, it recognizes that more real-world practical testing and further data in relation to minority groups is needed. Remote monitoring tools have grown significantly, and have proven valuable for health providers to remotely track chronic and high risk condition patients, and personalize their care. This increase has led to developing accelerated reimbursement pathways for remote monitoring tools in Germany and France.

The report also examines trends in consumer health apps, sensor-based digital measures, digital diagnostics and health assessment tools, and uptake of digital health technologies.

Privacy and Cybersecurity Updates

UK’s Information Commissioner’s Office (ICO) Publishes Report Based on Responses to Its Consultations on Generative AI. The report primarily focuses on the ICO’s policy positions in relation to the legal basis for data scraping on the web in order to train generative AI models and the integration of data subjects’ rights into generative AI models. The ICO revised its position regarding legitimate interest as a legal basis for web scraping when training generative AI, emphasizing the need for transparency by AI developers. Any Terms of Use with deployers of AI will need to contain effective data protection measures and must demonstrate that these measures are met. Further, the ICO updated its stance on how individual’s rights are integrated into generative AI, including that organizations relying on Article 11 of UK’s General Data Protection Regulation regarding processing that does not require identification, will need to justify that this is appropriate, and demonstrate that people cannot in fact be identified. People must also be given the chance to provide further information in order to enable identification.

Seven Sites Have Been Selected To Host the First European AI Factories. The selection of the sites was made by the European High Performance Computing Joint Undertaking, a joint initiative between the EU, EU countries, and private partners. Set to be deployed during 2025, the AI factories are expected to drive innovation by fostering new industrial applications of AI in sectors such as health care. They will also provide industry access to AI-optimized high-performance computing resources, experimental platforms, and other advanced AI tools.

IP Updates

Unified Patent Court Revokes Third Dexcom Patent in Ongoing Continuous Glucose Monitoring Dispute. On December 11, 2024, the Paris Local Division of the Unified Patent Court (UPC) dismissed Dexcom Inc.’s infringement claim against Abbott, revoking Dexcom’s patent EP3831282, titled “Remote Monitoring of Analyte Measurements.” The court found the patent obvious and rejected auxiliary amendment requests for added matter. Adopting a “whole-content approach,” the court assessed whether a skilled person would find new technical information beyond what was directly and unambiguously derivable from the original application. It concluded that amended claim 1 extended beyond the earlier application. This marks the third Dexcom patent revoked in the global continuous glucose monitoring dispute with Abbott, showcasing the UPC’s growing influence on medical device patent litigation strategies. This dispute, which we reported on in our July 2024 and September 2024 digests, highlights the emerging role of the UPC in reshaping global patent litigation strategy for medical device patents.

UK Government Launches Consultation on Copyright and AI. The UK government has launched a consultation for views on how to deliver a copyright and AI framework solution that balances AI developer’s access to copyright content with rights holders’ protections. Proposals will be evaluated on their ability to: (1) give rights holders control, (2) enable lawful AI development, and (3) improve trust and transparency between AI sector and rightsholders. This consultation is significant for industries using AI in health care, including diagnostics, patient management, and drug discovery. The consultation will run until February 25, 2025.

European Patent Office (EPO) Publishes Patent Insight Report on Assistive Robotics. On December 3, 2024, the International Day of Persons with Disabilities, EPO published a report analyzing trends in assistive robotics patents for individuals with special needs. Based on over 25,000 inventions filed in over 80 countries, the report highlights a 20-fold growth in patent filings since 2000, far outpacing other technical fields.