The UK government’s White Paper – ‘A pro-innovation approach to AI regulation’ sets out an intention to implement a ‘flexible’ outcome-oriented approach to AI regulation positioning the UK as a leading country for AI innovation. Five principles are intended to underpin the regulatory framework and appropriately manage AI risks:
- Safety, security and robustness;
- Appropriate transparency and explainability;
- Fairness;
- Accountability and governance; and
- Contestability and redress.
The White Paper proposes that these principles will not be enforced using legislation at least not initially. Instead, existing sector regulators will be tasked with proportionately implementing them on a non-statutory basis using their domain-specific expertise and tailored to the specific-context. During an initial period of implementation, there will be ongoing collaboration with regulators to identify barriers to proportionate application of the principles and evaluate whether the framework is having the desired effect.
AI and health
In advance of the White Paper, the Medicines and Healthcare products Regulatory Agency (MHRA) has already proactively begun to update its approaches to enable AI. In 2022, it published a roadmap that set out the requirements for AI and software used in medical devices. It is currently updating its regulatory framework to ensure patients are protected and that the UK’s global reputation for responsible innovation is upheld. It intends to issue guidance on the transparency and interpretability of AI which forms part of a medical device. This will include health and social care sector-specific challenges posed by AI to meet legal product safety requirements.
In addition, the MHRA intends to work with the ICO and National Data Guardian to consider patient data protection and trust in medical devices. The intention is that this will provide manufacturers with clear requirements for responsible future innovation.
Further, the AI and Digital Regulations Service has been established. It is funded by NHS England’s NHS AI Lab (in collaboration with NICE, MHRA, HRA and CQC) to help innovators understand the regulatory requirements and improve confidence in using AI and digital technology by healthcare providers. It provides an up-to-date central database of regulatory and best practice guidance that has been collated across regulators and public bodies.
The UK government has stated it will continue to monitor, support and adapt the scope of any sector-specific regulation/enforcement by regulators to ensure appropriate scope.
Looking to the future
The consultation on the proposals set out in the White Paper, alongside the AI regulation impact assessment, will close on 21 June 2023.
We expect that, as technology evolves, the UK’s regulatory approach will need to be adjusted. Over the next six months, the UK government will review the consultation responses and engage with specific sector regulators to adapt the framework. It is likely that the health sector and other sector-specific regulators will start to provide guidance on how they intend to implement the five-principles framework. This may be followed by legislative proposals for higher-risk areas, for example, medical devices.
