The ambition of the UK’s current government is for the UK to become the world leader in Artificial Intelligence, including in the medtech sector. Recognising this, it recently published a number of important updates focused on regulating AI in medical devices.
Of course, in a General Election year things may change, and it remains to be seen how a new government may approach future regulation of medical devices, both generally and more specifically in respect of Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD). Nevertheless, it is helpful to take stock of the current proposals as they stand at the moment, and to look to the future.
This article provides a summary of the key developments in relation to the proposals for a future regulatory framework for medical devices, with particular reference to the five key principles that the UK government currently applies to regulation of AI.
The current approach to regulation of AI in the UK healthcare sector
The government’s sector-specific approach to regulation of AI in the UK stands in contrast to other governmental approaches as evidenced most recently through the EU AI Act.
There are signs this approach may have been about to change, including the introduction of the UK AI (Regulation) Bill, a private members’ bill. However, for now the government’s white paper published in 2023 remains the guide to the current UK government’s approach. For medical devices, this has been reiterated in the MHRA’s strategic approach to regulating AI, which identified the five key principles for regulating AI:
• Appropriate transparency and explainability
• Safety, security and robustness
• Fairness
• Accountability and governance
• Contestability and redress
What has the government published recently in relation to medical devices?
The government’s recent publications fall within the overarching scope of its plans for the introduction of new regulations for medical devices in the UK, as confirmed in the MHRA’s Roadmap for the future regulatory framework for medical devices (the Roadmap) published in January 2024 as updated recently, and the wider government medtech strategy as updated in The medical technology strategy: one year on.
Two recent publications of note are:
- Announcement by the MHRA of the AI Airlock: the regulatory sandbox for AIaMD
- A press release detailing its plan to make the UK a world leader in tackling ethnic and other biases in medical devices, after an independent report was released which identified the current biases in medical devices (March 2024).
The five key principles
Appropriate transparency and explainability
The MHRA’s Roadmap set out the MHRA’s process for regulatory reform. It outlined the MHRA’s intention to be transparent, with stakeholder discussions taking place during the first half of 2024 focusing on a wide range of topics, including, but not limited to:
- Scope and classification;
- Essential requirements;
- Approved Bodies;
- Exempted devices;
- Clinical investigations; and
- Unique device identification.
The MHRA also intended a public consultation to be held on future enhancement regulation in the latter months of 2024.
The MHRA’s intention to increase explainability is also exemplified by the Roadmap, setting out the aim to publish an in vitro diagnostic (IVD) devices roadmap during the first half of 2024, as well as Software as a Medical Device (SaMD) guidance on:
- Good machine learning practice for medical device development mapping
- Data-driven SaMD research, development and governance, and
- AI as a Medical Device (AIaMD) development and deployment best practice.
The latter (the MHRA’s strategic approach to artificial intelligence on the regulation of medical products) was published in April 2024, and is explained in further detail below.
Safety, security and robustness
Regulatory Approach
The response from the MHRA to the letter sent to the UK regulators by Lord Evans outlined the approach of the MHRA in assessing and ensuring safety. As set out in the Roadmap, the MHRA is reforming many regulations, including those concerning AI as a Medical Device. This is being informed by the ‘Software and AI as a Medical Device Change Programme’, ensuring the regulatory requirements are clear, patients are protected and safeguards are implemented to detect and mitigate data within the lifecycle of a device.
The MHRA explained that its regulatory approach is focused on:
- premarket assessment and post-market surveillance
- inspection of the pharmaceutical industry and approved body activities
- drawing on the shared knowledge of its international and national collaborations with regulatory bodies and pharmaceutical industry.
As part of the MHRA’s strategic approach for the regulation of AI, the MHRA is also developing an MHRA data strategy which will have a focus on safety and also responsibly applying advanced analytics and AI within the agency.
The MHRA has also recently launched a four-week consultation to support the improved safety for certain high risk IVD devices.
AI Airlock
Additionally, the AI Airlock project was launched on 9 May 2024, as part of the MHRA’s strategic approach. In summary:
- The AI Airlock is intended to assist in the safe development and deployment of AI medical devices, assisting the MHRA to identify and address the challenges for regulating standalone AI medical devices.
- It applies the regulatory sandbox model, a recognised mechanism to help address novel regulatory challenges, and applies this to healthcare.
- The MHRA will be working collaboratively with the NHS AI Lab and the Department of Health and Social Care for this pilot project, with the aim that the AI Airlock will ‘accelerate solutions to novel regulatory challenges, ultimately improving the experience of patients’.
Fairness
The MHRA recognised the ‘biases’ within healthcare in its response to the letter sent to the UK regulators by Lord Evans. The MHRA stated it was working alongside the ‘STANDING Together’ team, as well as other academic partners, to ensure adequately represented data supports AI healthcare technologies.
In the MHRA’s response to the publication of Dame Margaret Whitehead’s Equity in Medical Devices: Independent Review, the MHRA acknowledged that more work is required to address inequities in the regulation of medical devices. The MHRA intended to:
- provide strengthened guidance in relation to improving diversity in testing, investigating and development of medical devices, aimed at both developers and manufacturers.
- continue to strengthen its vigilance role by engaging with patients and the public and ensure the regulatory programme for devices takes into account the diversity of users of AI by engaging in the Software and AI as a Medical Device Change Programme.
- continue to collaborate with the government and other stakeholders to address and overcome healthcare inequalities.
Accountability and governance
Non-Statutory Approach
The consultation outcome ‘A pro-innovation approach to AI regulation’ confirmed that there will remain a non-statutory approach to the regulatory regime, arguing that such a regime provides the adaptability that is important at this time. The government response made it clear that they would continue to keep this under review, as it is likely that legislative action will be required once understanding of risk has matured in order to ensure public safety and address potential AI-related harms.
New Central Function
Recognising the limits of regulators to identify opportunities and risks of AI technologies when acting within isolation, the government also proposed a new central function within government to monitor such risks and support coordination between regulators. They had already started to develop this central function, and the intention was for it to:
- undertake cross-sectoral risk monitoring
- work with regulators and governmental departments to identify potential gaps in existing regulatory powers
- support regulatory coordination
- fund a pilot multi-agency advisory service delivered by the DRCF, and
- support work on assurance technologies and technical standards to improve public trust.
The government also outlined its intention to establish a steering committee by spring 2024. This committee will consist of government representatives and key regulators, such as the MHRA, and will aim to support knowledge exchange and coordination on AI governance.
Datasets
Additionally, the MHRA’s strategic approach highlighted the importance of accountability and governance of the datasets used in the creation of AI models and its collaboration with partners in the US Food and Drug Administration (FDA) and Health Canada, which has enabled it to publish guidance on principles of Predetermined Change Control Plans (PCCP).
This guidance is intended for manufacturers to enable traceability and accountability. The MHRA also intends to include PCCPs in the future core regulations, which it hopes are in force by 2025.
Contestability and redress
The introduction of PCCPs in the future core regulations and the ability to monitor AI as a Medical Device products will also assist with improving contestability and redress.
MHRA’s strategic approach also highlighted the importance of the MHRA Yellow Card Scheme in relation to contestability and redress. Under the scheme, anyone can report concerns about devices or medicines to the MHRA and the MHRA collates reports of suspected adverse reactions. Additionally, the current regulations in relation to reporting incidents will be strengthened by introducing a legal requirement for manufacturers to report incidents to the MHRA for medical devices.
Conclusion
The current government proposals for regulating medical devices are focused on maintaining flexibility and adaptability to encourage innovation, while also ensuring the safety, efficacy and transparency of medical devices.
The Labour Party also recognises the importance of medtech, with Wes Streeting, Labour’s Shadow Health Secretary having said that “there is a revolution in medical technology taking place before our eyes.” Although Labour have released little information of their intentions, it appears their aim is to increase funding, break down the barriers to access, improve the regulatory framework and encourage an innovative and collaborative approach. Labour’s manifesto is yet to be published however, so their approach to regulation of medical devices remains to be seen.
It is also worth noting that NHS England and NICE, including with input from the MHRA, has recently announced a consultation on fast-tracking access to NHS funding for medtech developers, including for medical devices. Feedback can be submitted here.
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