The creation of a new multi-agency advisory service for developers and adopters of Artificial Intelligence (AI) and other digital technologies in healthcare started in 2021, funded by NHS AI Lab. Four organizations collaborate in this service: the National Institute of Health and Care Excellence (NICE), the Care Quality Commission (CQC), the Medicines and Healthcare Products Regulatory Agency (MHRA), and the Health Research Authority (HRA).
In March 2023, the public beta website “AI and Digital Regulations Service” became available. For now, it is focused on the developer pathway; the adopter pathway will be added later in 2023. The following technologies are considered:
- Software as Medical Device (SaMD);
- Digital technology;
- AI, or data-driven technology.
The service maps out the regulatory and Health Technology Assessment pathway for AI and digital technologies and helps users understand and navigate the pathway more effectively. Guidance is provided at each stage of the pathway and divided into two types: required (‘must do’) and best practice (‘should do’). Regular updates will be made to account for new developments in this area.
See more details here and here.
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