The Medicines and Healthcare Products Regulatory Agency (‘MHRA’), which is responsible for regulating medicines, medical devices and blood components for transfusion in the UK, is set to update and clarify the regulations that apply to software and artificial intelligence (‘AI’) as medical devices.   The UK now wishes to update the regulation of software and AI as medical devices to help “drive innovation in healthcare and improve patient outcomes”.

AI can be used to identify ailments, monitor conditions, and facilitate treatment within the healthcare sector. With the ever-increasing growth of such technology, we can expect to see the range of AI used as a medical device to increase. This increase is being facilitated by schemes such as the Artificial Intelligence in Health and Care Award which seeks to award financial backing to promising AI technologies to be used in healthcare. For example, UK researchers recently secured funding through this award to study the use of AI for breast cancer screening in NHS hospitals.

In light of this, the MHRA is set to update regulations to ensure that such advances are not implemented at the expense of patient safety.  The MHRA has developed an extensive work programme to inform regulatory change (see: Software and AI as a Medical Device Change Programme). It has three key areas of focus which are designed to ensure that the requirements for AI and software as a medical device:  

  • provide a high degree of assurance that devices are safe and function as intended;
  • are clear and supported by clarificatory guidance and streamlined processes; and
  • are aligned with the requirements of other bodies including the National Institute for Health and Care Excellence (‘NICE’) and NHSX.

The programme contains work packages that fall into two core streams. The first stream makes reforms across the ‘software as a medical device’ lifecycle, including areas such as qualification, classification, and pre- and post- market objectives. The second stream focuses specifically on AI and seeks to address key concerns about its use. The work packages within this stream focus on safety, effectiveness, interpretability and adaptivity.

The MHRA has also launched a public consultation on the future regulation of medical devices, which remains open until 25 November 2021.   The MHRA anticipates that the reforms will not take the form of secondary legislation, but instead will be clarificatory.  It plans to deliver key elements of the work packages between this Autumn and Summer 2023.  Further details of the packages and timelines for proposals will be available in the coming months.

To find out more about the UK Government’s AI strategy, and where healthcare fits into this see here: National AI Strategy. And of course, those involved in this area within the EU will also need to keep a close eye on the EU’s new proposed laws planned to regulate AI.  See Proposed EU AI laws.