17 DIGITALIZATION IN MEDICAL DEVICES


systems and factors that affect data quality. Collaboration and co-production between


developers, healthcare providers, academia, patients, governments and statutory bodies across the AI lifecycle is also seen as an important factor for maximizing the deployment of AI. One of the recommendations is therefore,


to develop a closer relationship with a number of stakeholder organizations, particularly the International Medical Device Regulators Forum (IMDRF). This is a group of 12 global regulators that come together to build common procedures. The aim would be to agree language and terminology and provide guidance and good regulatory practices through this forum, using existing standards as a basis. “New standards normally develop over


three years through to publication,” said Rob. “With the speed that AI is developing, we need to be able to keep updating and putting new content out quickly and in an agile way. “We have existing standards that provide


requirements for regulatory conformity, such as ISO 14971, and we would look to develop guidance for AI around these, rather than set up completely new standards,” said Rob. “We also recognize that any new terminology standards for AI in healthcare should be aligned to current international work under development in ISO/DIS 81001-1, which will lay down foundational principles, concepts and terms for health software and health IT systems. This could be used to establish a common language between traditional health software and AI communities which would be hugely beneficial.”


“Existing standards can be developed to align with and support existing regulatory frameworks while keeping pace with evolving technologies”


With the report now published and


informing debate around AI in medical devices, Rob believes that there is a much clearer direction and greater stakeholder awareness. “Standardization can help address challenges relating to deployment of any new technology quickly and responsively.


Existing standards can be developed to align with and support existing regulatory frameworks, while keeping pace with evolving technologies. “We want to stay at the forefront of


regulation of AI. Working with our US partners we can create a position of leading knowledge in this space and remain there.”


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