UK regulators have launched a website to help developers and adopters of AI and digital technologies in health and social care understand their regulatory obligations.
The service aims to provide a checklist for both Health Tech companies and care providers, to ensure they are doing the right things, in the right order, to meet their obligations under law and in accordance with best practice guidelines. It has been established to create a central resource collating the relevant legislation, guidelines and best practice guidance, covering the steps from developing products and bringing them to market to ongoing evaluation and monitoring of health and care services.
The new Artificial Intelligence and Digital Regulations Service was created by a partnership of the UK’s key health and care regulators, the NHS Health Research Authority (HRA), National Institute for Health and Care Excellence (NICE), Care Quality Commission (CQC) and Medicines and Healthcare products Regulatory Agency (MHRA). They say that the site will be kept updated as the law changes.
This is a welcome service for both developers and users of Health Tech products, helping them to understand the current regulatory landscape and keep abreast of the raft of changes due to come in as part of sweeping reforms in this area.
A public beta version of the website was launched on 7 March 2023, which means it is available to view, but changes are still being made based on feedback from users. This provides Health Tech companies and buyers the opportunity to provide feedback on the service directly.
The Artificial Intelligence and Digital Regulations Service says it is particularly aimed at those either developing or planning to use a technology in health or social care that is:
• Software as Medical Device (SaMD)
• Digital technology
• AI, or data-driven technology
The site says users can "learn what regulations to follow and how to evaluate effectiveness, whether you're a 'developer' of AI and digital technology or an 'adopter' who will buy or use them in health and social care".
There is a separate area for adopters, aimed at social care providers, NHS organisations (providers and commissioners, including primary care, community care and mental health) and independent healthcare providers. Those organisations will need to set up an account to access the relevant resources. The equivalent part of the service for developers can be used as a tool by tech companies, data science organisations, health tech businesses, researchers and NHS staff (including spin-out companies) creating their own technologies.
While the Chancellor’s commitment to increase funding for the MHRA and investment in AI grabbed the headlines this week, as the regulatory reforms that funding is meant to deliver come in, Health Tech companies may find the new Artificial Intelligence and Digital Regulations Service a useful tool for staying abreast of their changing obligations.
If you want to discuss any issues with developing, regulating or buying Health Tech products, please contact one of our Health Tech team.
This article was written by Rory Trust and Callum Duckmanton.
Learn what regulations to follow and how to evaluate effectiveness, whether you're a 'developer' of AI and digital technology or an 'adopter' who will buy or use them in health and social care