Andrew Davies
Digital Health Lead, Association of British HealthTech Industries (ABHI)
Having an appropriate regulatory regime will support the UK’s ambition to be a leading market for AI in healthcare.
There is a huge buzz around artificial intelligence (AI) in healthcare. Some focused on how it can deliver improved efficiency and efficacy of health outcomes, and some focused on the concerns of how we ensure patient safety and guard against inequalities. In both cases, it is clear that the regulatory regime — in its broadest sense — has a critical role in building trust with the public, patients and users as well as in identifying, assessing and signposting those technologies that meet safety, clinical and health economic criteria.
Artificial intelligence in the NHS
Regulation lags innovation, and while we do not have specific AI regulations in place for medical devices, we are already seeing many deployments of AI within the health system. Research conducted for Health Education England has identified 240 AI technologies which are ready — or almost ready — for deployment. Many of these technologies are already in use by the NHS for diverse applications with some of the key use cases including cancer diagnosis, back-office automation and population health analytics.
The UK has the desire to be a world
leader in artificial intelligence.
Applying AI to existing frameworks
However, it is not the case that AI is unregulated. At a recent ABHI Digital Health Conference, it was highlighted that while not being AI-specific, existing legislation and processes — such as the UK regulation concerning Software as a Medical Device (SaMD) — already provide a framework that can be applied to this area.
There is also a growing consensus that the best approach to govern AI is to supplement existing frameworks with AI-specific standards, rather than layer on additional regulation. While not always having the clarity of regulation, the industry generally favours this approach as it provides a more agile system that can react more quickly in what is still an emerging use case within life sciences.
International approach
The UK has the desire to be a world leader in artificial intelligence. Taking a global approach to how we do regulation and align with other key jurisdictions is an important element of this. We are already seeing this being put into practice with joint work between MHRA, FDA and Health Canada, as well as proposals to use IMDRF classification from SAMD within the new UKCA mark.