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.

Regulatory Updates

New Post-Market Surveillance (PMS) Legislation Could Be Introduced in the UK by Summer 2025. On October 21, 2024, the UK government laid before Parliament the draft statutory instrument setting out proposed new PMS requirements for medical devices in Great Britain. The amendments will bring PMS requirements in Great Britain broadly into alignment with those in the EU Medical Devices Regulation 2017/745 (MDR) and the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). Further, the new PMS requirements will apply to all medical devices placed on the market in Great Britain, including devices CE marked under the EU regimes and made available in Great Britain under transitional arrangements. Read more in our Blog post.

MHRA Sets Out Key Points To Expect From Its Regulatory Reforms to Medical Devices in 2024 and 2025. In a recent blog post, the MHRA sets out its priorities for the reform of the rules for medical devices over the next year. The industry can expect an early draft of the pre-market legislation by the end of the year, and the full text by spring 2025. In addition, the MHRA expects to publish draft guidance on AI development and deployment, as well as a revised IVD roadmap by spring. The MHRA also reminds readers about the transition timelines that will be included in the regulations that are being developed, noting that next year will not be a regulatory “cliff edge.”

European Parliament Calls on the European Commission To Revise the MDR and IVDR. On October 23, 2024, the European Parliament adopted a resolution on the urgent need to revise the MDR and IVDR. Given implementation difficulties, delays, and lack of harmonization across the EU, the Parliament calls on the European Commission and notified bodies to take various actions to ensure advances in digital health, AI diagnostics, and personalized medicine. However, as the Parliament cannot initiate amendments to the MDR or IVDR itself, we will need to wait for the European Commission’s response before the full impact of this resolution is known. You can read more in our Blog post.

EFPIA Recommendations on Use of AI in Medicines Lifecycle. The European Federation of Pharmaceutical Industries and Associations (EFPIA) published its position on the use of AI in the medicinal product lifecycle, and proposed six recommendations: (1) leveraging EU regulations and guidance for AI in medicines; (2) entrusting the European Medicines Agency (EMA) with the regulatory oversight of AI in medicine development; (3) clarifying EMA’s risk-based approach to AI within the regulatory framework; (4) having AI policies that balance transparency and innovation protection when sharing AI models and datasets; (5) aligning global regulatory approaches through collaboration to foster safe innovation; and (6) building trust and capabilities in AI use through collaboration with industry, regulators, patients, and stakeholders. These recommendations were published shortly after the EMA reflection paper on the use of AI, which you can read about in our Blog post.

A UK National Quantum Facility Has Opened to Further Research in AI and Health Care. The newly opened National Quantum Computing Centre will house state-of-the-art quantum computers that will be harnessed to fuel advancements in areas such as AI, drug discovery, energy, and climate prediction, and help cement the UK’s position as a global leader in quantum technology.

Reimbursement Updates

UK National Institute for Health and Care Excellence (NICE) Consults on Recommendations for Four Different AI Tools for Examination of X-Rays. Missed fractures are one of the most common errors in the emergency department. The hope is that using AI, along with the assessment of a health care professional, will reduce the number of undetected fractures at initial presentation and promote an equal standard of care across the country. Clinical evidence suggests that the AI technologies may improve fracture detection on X-rays in urgent care, compared with a professional reviewing on their own, without increasing the risk of incorrect diagnoses. NICE has issued draft guidance for consultation recommending the use of four AI technologies to help professionals detect fractures in urgent care settings.

NICE Recommends Remote-Monitoring Technologies Shown To Reduce Hospitalizations by Half. The new technologies can detect signs of heart failure by monitoring individuals’ general activity, heart rate variability, and heart sounds. Data can be sent in real time to hospital staff who can provide care over the phone and determine if hospitalization is required.

Privacy Updates

ICO Publishes Report on the Use of Personal Data in Quantum Technologies. Quantum technology is a broad term for a range of technologies that deploy principles of quantum mechanics in computing, sensing, timing, and imaging, among others. Future uses of quantum technologies within medicine are being explored by researchers, such as simulating novel chemicals and complex modelling in the context of drug discovery and personalized medicine. The Information Commissioner’s Office (ICO) report considers the impact of these technologies on personal data, and individuals’ privacy and information rights. It calls for responsible innovation and for the early consideration of privacy and data protection implications.

Data Use and Access Bill Laid Before UK Parliament. The new bill aims to enhance data access in order to support economic growth. Among the draft provisions are proposals to enable the transfer of patient data across the National Health Service to promote faster and higher quality care. The ICO has published a response which highlights that the bill provides positive reform while maintaining high data protection standards.