As reported by UK Authority, the government’s accepted most key proposals to regulate AI in healthcare devices while keeping innovation flowing
The UK Government has accepted most of the recommendations of the Regulatory Horizons Council (RHC) on the regulation of AI in medical devices.
The Department for Health and Social Care (DHSC) has published a response document to the RHC report on the relevant issues, indicating that it is generally in favour of the proposals to ensure regulations are suitable to protect patients while supporting innovation.
It fully supports the majority of the 15 proposals, including strengthening the regulatory capacity around AI medical devices, aiming for a ‘legislatively light framework’ asking manufactures to provide evidence that they have evaluated and mitigated risks, and the creation of standards for post-market monitoring of performance.
DHSC has also accepted some recommendations in principle. These include that the Medicines and Healthcare Regulatory Agency (MHRA) is given long term funding to create and service a regulatory framework, and that a health institution and device manufacturer should agree as part of the contract to monitoring and responding to performance and safety issues.
In an accompanying letter Baroness Merron, minister at DHSC, says she has asked officials to liaise with the RHC on commissioning a review of generative AI in healthcare.
“Since the publication of this report, generative AI has emerged and revolutionised the way we work and impacted all sectors of the economy,” she says. “The use of generative AI in healthcare poses significant opportunities, but this requires innovation to be balanced with patient safety.”
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