NHS Digital welcomes funding for joint project with MHRA on creating synthetic devices

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NHS Digital’s deputy chief executive has welcomed news that the government has awarded funding for a project which will see us work with Medicines and Healthcare products Regulatory Agency (MHRA) in developing synthetic datasets.

 The datasets created in the project will be aimed at increasing the capability to accurately measure the effectiveness of new algorithms, including artificial intelligence and machine learning in medical devices in order to validate them and get them to the market.

The project is part of the Regulators' Pioneer Fund announced by the Department of Business, Energy and Industrial Strategy.

Advances in artificial intelligence are being applied to the diagnosis and treatment of patients. AI is becoming a medical device in itself with the potential to make a considerable contribution to public health, but its effectiveness is difficult to evaluate using conventional testing techniques.

Rob Shaw, deputy chief executive at NHS Digital, said: “We’re excited to be partnering with MHRA to deliver this project, which provides the potential to significantly improve the ability to measure the effectiveness of new artificial intelligence and machine learning healthcare innovations.

“Traditional processes for testing and certifying medical devices are not suitable for AI or machine learning products, but by creating synthetic datasets we will be better able to validate algorithms to demonstrate their effectiveness in treating or diagnosing patients.”

“Being able to much more accurately identify the best innovations should accelerate the speed at which they can start being used to improve outcomes for patients.”

ENDS

Notes to editors

1. The project will be led by the MHRA and partnered by NHS Digital. The project will also be supported by Care Quality Commission who have a keen interest in software used in patient care and who will contribute healthcare scenarios.

2. The project will combine inputs from innovators, academia, regulators, NHS, Clinical Practice Research Datalink, Care Quality Commission, Health Research Authority, and users of healthcare services.

3. This is one of 15 projects to have been allocated funding in the Regulators' Pioneer Fund in an announcement by Business Secretary Greg Clark.

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