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UK Pro-Innovation AI for clinical AI workflows

UK Pro-Innovation AI in clinical AI workflows: what compliance requires, who asks for evidence, and the records to keep.

Legal forceNon-statutory policy; regulators apply it under existing powers
Applies from6 Feb 2024
SectorMedicine
Checked21 Oct 2026

01 / The rule

What UK Pro-Innovation AI requires

UK sector regulators (such as the ICO, FCA, CMA, Ofcom and MHRA), which apply the principles to organisations they already supervise.

  1. 01Regulators apply the principle of safety, security and robustness to AI in their sectors.
  2. 02Regulators apply appropriate transparency and explainability expectations.
  3. 03Regulators apply fairness, accountability and governance expectations using existing law.
  4. 04Regulators ensure routes for contestability and redress against harmful AI outcomes.
  5. 05Organisations comply with existing law that applies to AI, such as UK GDPR, the Equality Act 2010 and consumer law.

02 / In this sector

In a clinical AI workflow

The principles are written for AI, but obligations on businesses come only from existing law and regulator guidance in each sector. Frontier developers participate in voluntary pre-deployment testing with the AI Security Institute.

Usually asked by

Clinical committees and health system AI governance.

Named alongside

HHS §1557 · HIPAA · FDA PCCP.

Sector pagePlanisphere for medicine

03 / Records

Records to keep

  1. 01Mapping of AI uses to the relevant sector regulator's guidance
  2. 02Data protection impact assessments covering AI processing
  3. 03Fairness and equality testing results for AI-assisted decisions
  4. 04Records of explanations and challenge routes offered to affected people

Optional evidence · where Planisphere fits

Keep a record anyone can check

When your team meets a duty, Planisphere can seal the event it reports as a receipt.

01 · Your teamRecord the event

A disclosure shown, a review signed, a model change approved: the event your system reports.

02 · PlanisphereSeal it

The event becomes a sealed receipt, dated and attributed to whoever is signed in.

03 · AnyoneCheck it

Paste the receipt into Verify. No account or key.

A record supports your compliance evidence process. It is not a legal finding or a certification. Systems that call Planisphere's gate API can also hold or refuse an action before it runs.

SOURCES

Go back to the source

PRIMARY
A pro-innovation approach to AI regulation: government response

UK Department for Science, Innovation and Technology (GOV.UK)

PRIMARY
AI Opportunities Action Plan

UK Department for Science, Innovation and Technology (GOV.UK)

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