Learn more about Software and Artificial Intelligence as a Medical device in UK
Software and Artificial Intelligence as a medical device (SaMD/AIaMD) is a face paced, yet challenging sector. The opportunities to have significant impact on healthcare options and delivery are endless, but how can we be assured of safety and performance of these products?
‘Traditional’ regulation is no longer able to take on the challenges this area poses, it calls for new ways of thinking, new principles and new approaches. The UK, guided by the MHRA are looking to lead the way in looking at how best to regulate this sector and how to support the sector – to make sure that SaMD and AIaMD is safe and delivers on its potential.
The consultation response demonstrates that the MHRA are not seeking to be overly prescriptive, they are considering what is beneficial and will add value to the regulation of SaMD and AIaMD. The work on the legislative text is being built upon with the MHRA’s Software and AI as a Medical Device Change Programme – Roadmap. Click here for MHRA’s document
This programme seeks to ensure:
- There is assurance that these devices are acceptable safe and perform as intended.
- Requirements are clear, with guidance and efficient processes that work for software
- Cross sector collaboration to ensure duplication is minimise when meeting various requirements such as NICE, MHRA or NHS England.
There are 11 work packages – 8 looking at reforms across the SaMD lifecycle and 3 looking at AIaMD and the challenges it brings.
The work packages cover a wide range of topics:
- What qualifies as SaMD?
- Classification rules to ensure the scrutiny applied is appropriate for the risk posed to patients
- Pre-market requirements, seeking to ensure these products have adequate data before being placed on the market and ensuring the requirements are proportionate to risk.
- Post-Market requirements, adapting the system so that signals are clearly received. Allowing for stronger vigilance by manufacturers and to detect and mitigate the risk of patient safety incidents.
- Cyber secure medical devices, looking at how cyber security issues translate to SaMD issues and that it is reflected in the requirements in post market surveillance requirements.
- AI Rigour, outlineing technical methods to test AIaMD, ensuring devices are acceptably safe and effective
- Project Glass box, this looks how opacity of AIaMD translates in safety, effectiveness or quality concerns, guidance regarding interpretability to ensure transparency and usability.
- Project Ship of Theseus will look at setting out the problems f fit with medical device regulation for adaptive AIaMD, distinguishing between models that are locked, batch-trained or continuous learning on streaming data, looking at existing change manage processes and looking at the need for guidance around adaptive AIaMD that does not fit these processes.
It is ambitious but really does set the course the UK looking SaMD and AIaMD differently, pushing the boundaries of traditional regulation and seeking to create a system that acknowledges the challenges and looks to address them, ensuring public health and supporting industry.