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Recommendations Published for Future Regulation of AI in Healthcare

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a new report setting out recommendations for a future regulatory framework for artificial intelligence (AI) in healthcare. The recommendations were developed by the National Commission into the Regulation of AI in Healthcare, an independent advisory body established by the MHRA to consider how regulation and assurance processes should evolve to support the safe, effective and responsible use of AI technologies in healthcare.

The report recommends a more proportionate and lifecycle-based approach to regulation, recognising that AI technologies can evolve over time and may perform differently across healthcare settings. It outlines recommendations in three key areas:

  • proportionate lifecycle regulation
  • system-wide responsibility and safe management
  • trust, transparency and predictability

The recommendations are intended to support patient safety, public confidence and responsible innovation, while helping ensure healthcare organisations, professionals, developers and regulators are equipped to manage the opportunities and challenges associated with AI-enabled technologies.

A cross-government response is expected to follow, setting out how the recommendations will be considered and taken forward.

Further information: The full report is available on the GOV.UK website. 

Source: National Commission into the Regulation of AI in Healthcare: Recommendations for a future regulatory framework – GOV.UK

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