Regulatory Horizons Council makes recommendations to UK government for the regulation of AI as a medical device

The Regulatory Horizons Council (RHC), an independent expert committee that identifies the implications of technological innovation and provides government with impartial advice on regulatory reform, has published an independent report on artificial intelligence (AI) as a medical device (AIaMD). The report analyses the current regulatory framework of AIaMD and highlights the challenges and regulatory gaps. The RHC has provided a number of recommendations on developing a regulatory framework in order to "bridge the gaps" in the regulation of AIaMD in a bid to "unlock the benefits of these technologies".

The publication of this report follows closely on from the Medicines and Healthcare products Regulatory Agency's (MHRA) "Software and AI as a Medical Device Change Programme Roadmap", which the RHC has said it has taken into consideration within this report. Read our previous Insight on the roadmap for more. 

The RHC recommendations will no doubt be a useful tool for the government as to how it can amend the regulatory framework to fit with this expanding sector. 

Increase regulatory capacity, capability and agility 

To meet the growing needs of the AIaMD sector, RHC recommends an increase in regulatory capacity and capability: including investing in training in AIaMD within the MHRA, strengthening expertise in known and emerging issues within AIaMD and ensuring the wider government recognises the importance of software as a medical device (SaMD)/AIaMD as a driver for UK innovation. 

With the MHRA's roadmap signposting the reforms it intends to make in relation to SaMD/AIaMD, this nudge from the RHC should highlight to the MHRA that this area of technology is expanding rapidly and in order to align with this, it needs to start taking action sooner rather than later. 

Create a regulatory framework that considers the whole product life-cycle 

Emphasis for using standards and guidance for AIaMD is detailed in the RHC's second recommendation, where it notes that the UK should adopt a "legislatively-light" regulatory approach. The reasoning is that these documents can be updated more frequently compared to legislation, and allow for the fast-paced advance of this technology. While noting that there are risks to this approach, in that the interpretation of legal requirements set out in guidance can lead to disputes, the RHC has said it welcomes the government's position of regulating AIaMD within the regulation of SaMD, which will sit within medical devices regulation.  

Pre-market considerations for manufacturers are also included in this recommendation, in particular on the issue of AI bias. Here it recommends that manufacturers should "as a minimum provide evidence that the AIaMD is expected to perform safely across the diversity of its target population as described within the intended use." It also recommends that manufacturers should be required to show evidence of efforts to improve performance in those groups and what they are doing to towards achieving equity of performance.

The RHC has also provided a number of other considerations (both pre- and post-market): examples include proactive safety monitoring by manufacturers of their devices and model updates once they are on the market. The running theme is that obligations should be placed on manufacturers to show how their AIaMD will perform before and after it is placed on the market. 

This level of vigilance echoes both the requirements set out in the EU's Medical Devices Regulations 2017 and the MHRA's proposals on the future regulation of medical devices in the UK and should not be a surprise to manufacturers and producers. 

Open and transparent regulatory process

The third recommendation revolves around ensuring an open and transparent regulatory process. This includes increasing the involvement of patients and public, and improving the clarity of communication between regulators, manufacturers and users. An example of improving this communication is the RHC's recommendation of setting up a public register of approved devices to bolster the public's confidence in AIaMD. The report also states that doing this would require a number of key regulators and gatekeepers (MHRA, the National Institute for Health and Care Excellent (NICE), the Care Quality Commission, and health institutions) developing public explainers of regulatory guidance and documentation. 

The RHC emphasises the need to enhance public trust and the need for the MHRA and other bodies to take progressive steps to ensure the public, patients and the healthcare community are willing to put their trust into these technologies. These points also reflect some of the fundamental principles that have been driving reform in both the EU and UK. 

UK to demonstrate leadership in innovation and patient safety 

The report's conclusion looks at ensuring rapid innovation within the UK, as well as international collaboration and harmonisation of the regulation of AIaMD. The RHC picks up on the fact the MHRA has a new role as a full member of the International Medical Devices Regulators Forum programme, and should take advantage of this. 

Additionally it suggests that the MHRA should ensure there is appropriate alignment with other jurisdictions, such as the EU and US, to alleviate "friction" on medical device imports. If this recommendation is followed, it will be welcome news to manufacturers who place devices on multiple markets as it will mean more certainty and consistency in approach. 

Osborne Clarke comment 

This report, along with the MHRA's roadmap, shows that there is a need for significant changes to be made to the regulatory framework of AIaMD in order to keep up with this fast-moving technology.  

Much of the report's content and recommendations mirrors what is already in place in the EU for medical devices and echoes the sentiments of the MHRA's own roadmap which suggests that  regulatory alignment with the EU should be considered. Additionally, it puts more public pressure on the government to ensure there is a concerted focus on AIaMD as part of its Innovation Strategy and Innovation, Growth and Regulatory Reform proposals. 

It will ultimately be for the government to decide how to align these proposals with its own post-Brexit strategy but we expect that industry will welcome the RHC's focus on these issues.

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This article was produced with the assistance of Charlie Hennig, Knowledge Executive