Report finds AI-based medical products should be regulated similarly to drugs

A report commissioned by NHS Digital has found that AI-based products should be regulated like drugs. It is reported that this is likely under the remit of the Medicines and Healthcare products Regulatory Agency (MHRA).

The report, published by the Academy of Medical Royal Colleges, gave seven recommendations for politicians, policy makers and services providers to consider.

These include:

  1. Politicians and policymakers should avoid thinking that AI is going to solve all the problems
    the health and care systems across the UK are facing. Artificial intelligence in everyday life is
    still in its infancy. In health and care it has hardly started – despite the claims of some high profile
    players
  2. As with traditional clinical activity, patient safety must remain paramount and AI must be
    developed in a regulated way in partnership between clinicians and computer scientists.
    However, regulation cannot be allowed to stifle innovation
  3. Clinicians can and must be part of the change that will accompany the development and use
    of AI. This will require changes in behaviour and attitude including rethinking many aspects of
    doctors’ education and careers. More doctors will be needed who are as well versed in data
    science as they are in medicine
  4. For those who meet information handling and governance standards, data should be made
    more easily available across the private and public sectors. It should be certified for accuracy
    and quality. It is for Government to decide how widely that data is shared with non-domestic
    users
  5. Joined up regulation is key to make sure that AI is introduced safely, as currently there is too
    much uncertainty about accountability, responsibility and the wider legal implications of the
    use of this technology
  6. External critical appraisal and transparency of tech companies is necessary for clinicians to
    be confident that the tools they are providing are safe to use. In many respects, AI developers in
    healthcare are no different from pharmaceutical companies who have a similar arms-length
    relationship with care providers. This is a useful parallel and could serve as a template. As with
    the pharmaceutical industry, licensing and post-market surveillance are critical and methods
    should be developed to remove unsafe systems
  7. Artificial intelligence should be used to reduce, not increase, health inequality – geographically,
    economically and socially.

– Artificial Intelligence in Healthcare

This report follows the NHS Long Term Plan and announcements from Secretary of State Matt Hancock about how the NHS will seek to utilise digital technology in the future.

MAP will continue to monitor these developments and publish further insights when information becomes available.

Tagged with

Published 12. February 2019 in News UK