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.
Regulatory Updates
EMA Reflection Paper on the Use of AI in the Medicine
Life Cycle. On September 30, 2024, the EMA published its Reflection Paper on the use
of AI in the medicines life cycle, from medicine discovery to
post-authorization. The paper underscores the utility of AI in
digital transformation, while urging developers to take a
risk-based approach to ensure patient safety and data integrity.
You can read more in our October 2024 BioSlice blog.
MHRA Opens Applications for AI Airlock Pilot. As
reported in our June Digest, the MHRA recently launched the AI
Airlock, a new regulatory sandbox for AI as Medical Devices
(AIaMDs). It is intended to act as a platform for the relevant
stakeholders to collaborate to understand and mitigate novel risks
associated with AIaMDs. On September 23, 2024, the MHRA opened applications to take part in the
AI Airlock. Certain eligibility criteria must be met, including
that the product is innovative, presents a regulatory challenge,
and that the proposal is ready to be trialed. The call for
applications closed on October 7, 2024. You can read more in
our May 2024 BioSlice blog.
Companies Join EU AI Pact to Encourage Compliance With EU
AI Act. Over one hundred companies have recently joined
the EU AI Pact. The EU AI Pact is a voluntary
initiative aimed at encouraging companies to begin implementing the
requirements in the AI Act. You can read more in our August 2024 BioSlice blog.
Draghi Report on the Future of European
Competitiveness. On September 9, 2024, the European
Commission published a report on The Future of
European Competitiveness, prepared by former European Central Bank
President Mario Draghi. Regarding pharmaceuticals, the report
proposes policy recommendations such as maximizing the EU Health
Data Space (EHDS) by improving access to and sharing of electronic
health records, increasing efforts to standardize existing health
data sources to a common data model, and leveraging the DARWIN EU
network (i.e., the network created by the EMA to deliver real-world
evidence (RWE) to generate evidence for innovation. It also calls
for the use of AI to support policy and clinical decision-making,
as well as scale up genome sequencing capacities. Though
non-binding, the proposals could influence future EU
policies.
The MHRA Sets Out Its Data Strategy for 2024-2027.
On September 18, 2024, the MHRA published its Data Strategy for 2024-2027,
which addresses data, digital technology, and RWE focusing on five
key themes. For example, supporting data-driven innovation, early
access, and interdisciplinary data science to underpin the
regulatory framework, and enabling effective, timely, and
proportionate regulatory decision-making through RWE.
MHRA Provides a Progress Update on Roadmap for Future
Regulation of Medical Devices. As previously reported in
our February Digest, the MHRA published a roadmap
for the future regulation of medical devices in the UK. The MHRA now reports that some details and
timelines will be changed. The intention to update the Medical
Devices Regulations 2002 through statutory instruments (SI)
remains, beginning with an SI clarifying the rules on Post Market
Surveillance, which the government intends to lay before Parliament
by the end of the year.
The Innovative Health Initiative Launches a Project
Targeting Synthetic Data Generation. The collaborative
project, SYNTHIA, involves both industry and academia.
The aim is to provide validated, reliable tools and methods to
support the generation of synthetic data. SYNTHIA's tools
span multiple areas, including lab results, clinical notes,
genomics, imaging, and mobile health data. The output will be made
available to the research community.
Reimbursement Updates
Belgian Parliament Calls for Enhanced Accessibility and Affordability of Digital Health Applications. On September 3, 2024, the Belgian Parliament adopted a resolution calling for the Belgian government to advance digital health solutions. In particular, it calls for:
- Enhancing accessibility, affordability, and quality of digital health applications, with a special focus on vulnerable groups
- Encouraging KCE, the Belgian health care research institute, to conduct research on the implementation of digital health, particularly on digital health apps
- Defining a growth trajectory for increased federal investment in digital health, emphasizing research, innovation, and practical implementation
- Creating a legal framework for digital health apps
- Developing a system to expedite the approval and reimbursement of health apps with unproven socioeconomic value
NICE Recommends Digital Mental Health Technologies in an Effort to Improve Access to Mental Health Services. The UK National Institute for health and Care Excellence (NICE) conducted rapid assessments to recommend seven digital health technologies for the treatment of depression, post-traumatic stress disorder, social anxiety, body dysmorphic disorder, and generalized anxiety. The assessments compared the digital technology to face-to-face therapy.
Privacy Updates
ICO and NCA Will Enhance Collaboration on
Cybersecurity. The Information Commissioner's Office
(ICO) has agreed to a Memorandum of
Understanding with the National Crime Agency (NCA) for
deeper collaboration regarding cybersecurity. This includes the ICO
sharing more information about cyber incidents with the NCA on a
systemic, anonymized, and aggregated basis, and where suitable,
also on an organization-specific basis, in order to enhance the
NCA's visibility. Further, it encourages organizations to
engage with the NCA on security matters, including in relation to
cybercrime.
New EFPIA Anonymization Gradient. On September 10,
2024, the European Federation of Pharmaceutical Industries and
Associations (EFPIA) introduced the Anonymization Gradient, a
visual tool to help EU and Member State bodies understand the
balance between preserving data utility and patient privacy. It
outlines various controls and degrees of data redaction, showing
the transition from personal to anonymized data. EFPIA believes the
tool will be particularly relevant for implementing anonymization
in the EHDS and national research programs.
IP Updates
European Patent Office Rejects Reinforcement Learning Patent for Lack of Technical Effect. The Board of Appeal of the European Patent Office (the Board) issued a decision against granting a patent with a claim including a machine learning system due to lack of inventive step. In case T 1952/21, the Board considered the “starting point” for assessing the technical character of reinforcement learning to be that simulation models are not themselves technical but may contribute to technicality if they:
- Are a reason for adapting the computer (at base of the claim) or its functionality
- Form the basis for further technical use of the outcomes of the simulation
In this case, the Board held that the computer was not adapted and no further technical use was claimed. Advantages in reinforcement learning were argued by the appellant, but the Board did not agree that these advantages were to be acknowledged — neither by experiments or theoretical considerations could it be concluded that a technical effect was present over the full breadth of the claim. Therefore, the appeal was refused.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
