In recent developments concerning digital health regulations within the United Kingdom and the European Union, significant steps have been taken to enhance the assessment and implementation of health technologies, especially in the context of artificial intelligence (AI) and digital health applications. The latest edition of Arnold & Porter's Virtual and Digital Health Digest highlights these trends following key events from November to early December 2024.
A crucial aspect of this evolution has been the ongoing efforts of health authorities in developing standards for assessing health applications. In Denmark, a new guidance document has been released by the Board for Health Apps, outlining the criteria for health apps evaluation. This includes parameters such as clinical effectiveness, usability, price, and societal value, reflecting a comprehensive strategy aimed at ensuring broader access to health technologies across the EU.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has also initiated a public consultation regarding medical device regulations, inviting input until January 5, 2025. This consultation seeks to develop a risk-proportionate regime that aligns with international best practices while fostering innovation in medical technologies. Among the proposals under consideration are the up-classification of software and provisions regarding an international reliance procedure that includes exclusions for certain software applications.
Meanwhile, MedTech Europe, the European trade association for medical technologies, has released recommendations aimed at shaping the future regulatory landscape for medical technology. These recommendations call for immediate measures such as the introduction of accelerated pathways for innovative solutions and the establishment of a unified governance structure for health technologies, addressing the current fragmentation in the regulatory environment.
Another development is the European Commission's ongoing consultation on the EU AI Act. This initiative aims to define AI systems and identify prohibited AI practices that pose unacceptable risks. Closing on December 11, 2024, the feedback obtained will be instrumental in shaping guidelines to assist national authorities and AI providers, with a full implementation of the EU AI Act anticipated by February 2, 2025.
In the UK, the government is pursuing a report delineating actions to ensure responsible AI adoption. A core initiative within this framework is the establishment of an AI Assurance Platform. This platform aims to provide resources and information on AI assurance to support startups and small- to medium-sized enterprises, while also creating a roadmap to boost the supply of third-party AI assurance services.
Furthermore, the MHRA provided updates on its AI Airlock Pilot Cohort, a regulatory sandbox intended for AI medical devices. The selection of five candidates for this initiative marks a significant advancement in testing and evaluating innovative health technologies within a controlled environment.
On the reimbursement front, the Danish Health Applications Committee has set criteria for evaluating digital health applications, which will be documented on the public health portal Sundhed.dk if recommended. This assessment includes rigorous criteria concerning clinical effectiveness, usability, price, and societal impact.
In addition, the UK National Institute for Health and Care Excellence (NICE) has recommended the incorporation of a sandbox approach in health technology assessments, thereby enabling HTA agencies to keep pace with rapid technological advancements, particularly in digital health.
Cybersecurity remains a pressing concern within this evolving landscape, with MedTech Europe publishing recommendations aimed at enhancing the cybersecurity resilience of healthcare systems across Europe. These recommendations focus on increasing cybersecurity expertise, addressing risks of outdated technologies, and fostering a secure cloud ecosystem for health data management.
Finally, the UK Supreme Court has granted leave to appeal in a noteworthy case concerning the patentability of AI inventions. The case involves Emotional Perception AI Limited and the outcome may influence how patents for artificial neural networks are treated under current law, which was previously deemed to exclude such technologies under the Patents Act 1977.
These developments collectively highlight a decisive shift towards a well-regulated framework for digital and AI technologies in health, reflecting the industry's proactive approach to innovation while addressing pressing concerns related to safety, efficacy, and privacy. The impact of these changes is expected to shape business practices significantly in the healthcare sector moving forward.
Source: Noah Wire Services