ABHI LEADERSHIP
AI is Not the Future, it is the Present
Regulation and Governance There is a huge buzz around AI in healthcare, some of that focused on how it can deliver improved efficiency and efficacy of health outcomes, and some of it focused on the concerns of how we ensure patients 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 public, patients and users and in identifying, assessing and signposting those technologies that meet safety, clinical and health economic criteria.
The Future is Here It is a truism that regulation lags innovation and whilst we do not have specific AI regulation 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 in the NHS for diverse applications with some of the key use cases including cancer diagnosis, back-office automation and population health analytics.
It is Not the Wild West However, it is not the case that AI is unregulated.
32 UKHEALTHCARE P A VILION. COM
Andrew Davies Digital Health Lead, ABHI
At a recent ABHI Digital Health Conference, it was highlighted that whilst not being AI specific, existing legislation and processes, such as the UK regulation concerning Software as a Medical Device (SaMD), already provides 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 those existing frameworks with AI specific standards, rather than layer on additional regulation. While not always having the clarity of regulation, industry generally favours this approach as it provides a more agile system, able to react more quickly in what is still an emerging use case within life sciences.
International Approach The UK has a desire to be a world leader in Artificial Intelligence, taking a global approach to how we do regulation and how we 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 International Medical Device Regulators Forum (IMDRF) classification from SaMD within the new UKCA mark.
To find out more about ABHI’s work, visit
www.abhi.org.uk
DUB AI 2023
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