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
Regulatory Updates
The UK Medicines and Healthcare products Regulatory Agency Launches a Consultation on the Medical Device Regulations. The consultation seeks input on the development of a risk proportionate medical devices regime that is aligned with international best practice, while ensuring requirements on safety are met and that the UK continues to promote innovation. In particular, there are a number of proposals on the up-classification of software, similar to the EU regime. There are also provisions on the international reliance procedure for medical devices that includes a number of exclusions for software (see our May 2024 Blog). The consultation closes on January 5, 2025.
MedTech Europe Publishes Recommendations on the Future of Medical Technology Frameworks. The recommendations, prepared by the European trade association for the medical technology industry, MedTech Europe, alongside other industry associations, aim to create a sustainable regulatory environment that fosters safety and innovation in medical technology. This is part of the broader comments from stakeholders on amendments to the EU regime, as set out in our October 2024 Blog. MedTech's recommendations include: (1) short term measures that should be implemented without delay (including introducing accelerated pathways for breakthrough innovation or ensuring a harmonized interpretation and application of the EU Medical Devices Regulation and EU In Vitro Diagnostic Medical Devices Regulation) and (2) a mid-term measure of developing a unified governance structure for health technologies to address fragmentation and improve efficiency.
Consultation on Guidelines on the EU AI Act's Prohibitions and AI System Definition. Launched by the European Commission's AI Office, the consultation seeks input on the implementation of the EU AI Act's definition of AI systems and the prohibited AI practices under the EU AI Act that pose unacceptable risks. The feedback will inform the Commission's guidelines, expected in early 2025, aimed at assisting national authorities and AI providers to comply with the EU AI Act (which will apply from February 2, 2025). The consultation closed on December 11, 2024.
UK Government Publishes a Report on Assuring a Responsible Future for AI. The report sets out the actions that the government will take in order to mitigate risks and drive adoption of safe and responsible AI. The first action is to develop an AI Assurance Platform, which will provide information on AI assurance and resources to support startups and small- and medium-sized enterprises, and which will draw on existing AI-related standards and frameworks, including the EU AI Act. The government will also provide a roadmap in order to boost supply of third-party AI assurance and support research. Lastly, the government will develop a tool to enhance interoperability of AI assurance.
MHRA Publishes Information on the AI Airlock Pilot Cohort. The AI Airlock, as discussed in our June 2024 digest and our May 2024 Blog, is a regulatory sandbox for AI medical devices. The updated information from the MHRA sets out details of the five candidates that have been selected for the sandbox and provides an overview of the products.
Reimbursement Updates
Danish Health Applications Committee to Assess and Recommend Digital Health Applications. Following a meeting on November 6, 2024, the committee has determined the criteria by which health apps will be assessed, and published the application form. The assessment comprises four criteria, including evidence of clinical effectiveness (with guidance provided for CE marked and non-CE marked devices), usability (as the health app should meet the users' needs and expectations), price (which must be proportionate to the effect that the health app is expected to deliver), and value to society (as the health app is expected to contribute to solving health and social challenges). It is anticipated that the assessment will be adapted as technology advances and the health application market develops. Apps that are recommended by the committee will be listed on Sundhed.dk, a well-known Danish public health website. Organizations who offer the health app may apply through the online form, following which the committee will carry out their assessment, using external experts if required, and may request follow-up information before discussion at a board meeting.
The UK National Institute for Health and Care Excellence (NICE) Publishes Recommendations on the Implementation of a Sandbox Approach in Health Technology Assessments. NICE sets out the key recommendations for implementation of a sandbox approach in health technology assessments (HTA) in this Blog post, further to the paper published on November 4, 2024. A sandbox provides a controlled environment for new products and ideas to be explored in order to support HTA agencies in keeping up with technological developments. NICE recommends that HTA agencies use sandboxes to prepare for and anticipate future challenges, focusing on those challenges that are expected to have technical rather than, for example, ethical solutions. Digital health is identified as such an area, and NICE also points to its current HTA lab projects including AI in HTA discussed in our September 2024 digest.
Privacy and Cybersecurity Updates
MedTech Europe Publishes Recommendations on EU Health Care Cybersecurity Action. MedTech Europe and the European trade association representing medical imaging, radiotherapy, health information and communication technologies, and electromedical industries (known as COCIR), have prepared recommendations following the upcoming European action plan on the cybersecurity of hospitals and health care providers announced by the commission president. The recommendations aim to strengthen the cybersecurity resilience of Europe's health care systems by (1) increasing cybersecurity capacity and expertise in health care; (2) addressing risks posed by outdated medical technologies and software; (3) raising awareness and engaging stakeholders on cybersecurity in health care; (4) developing guidelines for the implementation of the NIS2 Directive in health care; (5) supporting a secure European cloud ecosystem for health care; and (6) integrating cybersecurity considerations in health care procurement.
IP Updates
UK Supreme Court Grants Leave to Appeal on Patentability of AI Inventions. Following the Court of Appeal decision mentioned in our September 2024 digest, it has been reported that the Supreme Court has granted Emotional Perception leave to appeal in Comptroller-General of Patents, Designs and Trade Marks v. Emotional Perception AI Limited [2024] EWCA Civ 825.
As reported in the December 2023 digest, the invention in question concerned an Artificial Neural Network (ANN), which the Intellectual Property Office of the United Kingdom (UKIPO) found was subject to the exclusion to patentability in the Patents Act 1977, concluding that an ANN was "a program for a computer ... as such." The High Court later overturned the UKIPO's decision, but the Court of Appeal subsequently reversed the High Court decision, finding that an ANN was a computer, and the weights and biases of the particular ANN in question constituted a computer program, excluding the invention from patentability as it lacked a technical contribution unrelated to the computer program.
Readers of the digest and digital health innovators considering filing patent applications for inventions involving ANNs should note that the law on the patentability of such inventions may be subject to change following the consideration of this case by the High Court. In the interim, the UKIPO guidance that "patent examiners should treat ANN implemented inventions like any other computer implemented invention" still stands. Future digests will report on any further updates in these proceedings in due course.
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