UK Medicines and Healthcare products Regulatory Agency unveils artificial intelligence strategy – Osborne Clarke

The MHRA has published its response on compliance with the principles set out in its Artificial Intelligence Regulation White Paper

As requested in the government’s response to the ‘Innovative approach to regulating artificial intelligence’ white paper, the Medicines and Healthcare products Regulatory Agency (MHRA) has published its strategic approach to artificial intelligence. The strategy sets out how the MHRA implements and will implement the principles set out in the white paper: safety, security and soundness; appropriate transparency and explainability; honesty; responsibility and management; and the ability to challenge and redress.

The MHRA’s AI strategy focuses on three perspectives: as a regulator of AI products, as a public service organization making time-critical decisions, and as an organization making evidence-based decisions that impact public safety and patient safety.

The MHRA recognizes the opportunities that AI offers and the regulatory reform needed to ensure safety while harnessing the benefits of AI, for example by launching the AI ​​Airlock this week.

Regulation of AI products

The MHRA’s strategy focuses on regulating artificial intelligence as a medical device (AIaMD). Although the UK Medical Devices Regulations 2002 already apply to software and its subset artificial intelligence, the MHRA understands that these regulations need to be updated to take account of advances in artificial intelligence technology.

Current regulations include a risk-based classification system, but many AI products are currently in lower risk categories and can be placed on the market without an independent compliance assessment. The MHRA in its reform (due in 2025) will aim to ensure a proportionate approach to regulating AIaMD, taking into account the unique challenges of each product and assessing risks accordingly.

In addition to legislative changes, the MHRA’s strategy also includes a number of guidance documents that manufacturers may have and will publish in the near future. Recognizing the importance of security, the MHRA will publish guidance in spring 2025 on the cybersecurity risks associated with AIaMD. To ensure transparency and explainability, the MHRA draws attention to guidance it has published to support manufacturers in meeting labeling and information requirements for AIaMD products.

AI lock

Another MHRA initiative mentioned in the strategy is the AI ​​airlock, which was launched on a pilot basis on May 9. AI Airlock aims to identify and address regulatory challenges for AIaMD and is a collaborative project involving key partners such as UK Approved Bodies, the NHS and other regulatory bodies.

This sandbox will help businesses navigate the regulatory environment and help them remain compliant with the regulatory framework while supporting innovation. In addition to its national approach, the MHRA also ensures that it is at the forefront of international best practice by working with the International Forum of Medical Device Regulators.

By addressing these regulatory aspects, the MHRA aims to provide a balanced approach to regulating AIaMD, promoting innovation while protecting patient safety and cybersecurity.

Provision of regulatory services

The MHRA recognizes the opportunities that AI offers to improve the efficiency of services across a range of regulatory functions, from market access and post-market surveillance. Using artificial intelligence, the MHRA aims to improve the timeliness of patient access to healthcare products in the UK. This will enable the MHRA to allocate resources more effectively, focusing on priority activities such as innovation and patient engagement.

In addition, the MHRA intends to expand the use of artificial intelligence, machine learning and advanced analytics to improve the way regulatory decisions are made in the future. The MHRA will ensure that these decisions remain transparent and understandable and will ensure that security, including cybersecurity, is at the heart of their operation.

Evidence-based decisions

As a regulator, the MHRA relies heavily on evidence provided by manufacturers and other third parties. With the increasing use of artificial intelligence to generate evidence, the MHRA recognizes the need to understand the impact of artificial intelligence on evidence production and regulation. For example, the impact this may have on clinical trial design and precision medicine. In addition, working with international regulators and industry partners, the MHRA aims to develop best practice in the use of artificial intelligence and avoiding unnecessary burdens.

Commentary by Osborne Clarke

For companies looking to bring AIaMD to the UK market, a rules-based regulatory approach provides flexibility and opportunities for innovation. The MHRA regulatory sandbox also provides stakeholders with a unique opportunity to engage with the regulator and address the challenges of bringing AIaMD to market.

Compared to the EU regulatory framework under the new Artificial Intelligence Act, the UK approach may be more attractive to businesses as it avoids undue obstacles and potential market access issues. However, it is crucial to address the risks associated with AI in healthcare, such as bias and misdiagnosis, as well as patient data issues that can negatively impact patient safety and healthcare delivery. Therefore, the requirement for a regulatory framework to manage AI-related risks is to some extent necessary without stifling innovation.

The MHRA’s strategy aims to achieve a balance in risk management by ensuring proportionate regulation, as evidenced by the current 2002 reform of medical device regulation, while also demonstrating readiness for the adoption of artificial intelligence. How the MHRA balances the competing demands of innovation and safety in AIaMD will become much clearer when new medical device regulations are introduced next year.

An additional factor is the MHRA’s cooperation with other international regulatory bodies in this field, combined with the recently launched international recognition process. This could have an impact on the life sciences and healthcare sectors if these established countries begin to approve precision medicines based on AIaMD or an AI platform. An example of this is the U.S. Food and Drug Administration’s consideration of how to deal with precision vaccines generated by an artificial intelligence platform (although its plans have not yet been formalized).

If these recognized international regulators begin to authorize new AI-based products on the market, this could prompt the UK regulator to do the same, including adopting similar regulatory review processes. Indeed, the MHRA noted that it is working with international regulators to develop best practice in the use of artificial intelligence and with a view to international adaptation to reduce burdens on both industry and regulators.

As the MHRA implements its strategy, AIaMD manufacturers should engage with the regulator to help shape the UK regulatory framework. As AI continues to develop, its use across a range of sectors, including life sciences and healthcare, will inevitably grow, and collaboration between businesses and the MHRA could make the UK an attractive destination for AIaMD products.