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On 30 April, the MHRA published its strategy for artificial intelligence (AI). This sets out the MHRA’s approach to AI as a regulator of AI products, and also the use of AI more broadly across the agency. This strategy is based on 5 principles encompassing safety, security and robustness; appropriate transparency and explainability; fairness, accountability and governance; and contestability and redress.

The agency is considering the opportunities and risks of Artificial Intelligence (AI) from three different perspectives:

  • as a regulator of AI products
  • as a public service organisation delivering time-critical decisions
  • as an organisation that makes evidence-based decisions that impact on public and patient safety, where that evidence is often supplied by third parties

The AI Strategy can be found here.

Next steps:

The MHRA are currently in the process of implementing a regulatory reform programme related to AI-driven medical devices (AIaMD). This considers the risks of these products while permitting scope for further development of transformative healthcare.