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Healthcare & life sciences

In healthcare and life sciences, AI touches patient safety, clinical decisions and sensitive health data, so governance must be rigorous and demonstrable. Gamut gives clinical safety, information governance, research and quality teams one place to assess these systems, evidence their safety and prove oversight to regulators, ethics committees and partners.

AI systems typically in scope

Section titled “AI systems typically in scope”
  • Clinical decision support and triage tools.
  • Diagnostic and imaging models.
  • Patient-facing assistants and symptom checkers.
  • Research and pharmacovigilance copilots.
  • Operational AI for scheduling, coding and administration.

Governance drivers

Section titled “Governance drivers”
  • Patient safety and clinical risk. Evidence that a system is safe, monitored and overseen by clinicians.
  • EU AI Act. Many clinical and diagnostic uses are high-risk with specific obligations.
  • Health-data protection. Strict handling of special-category data.
  • Impact assessment. Documented assessment of effect on patients and affected groups.

Use cases

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Assess a clinical decision support tool for safety and oversight

Section titled “Assess a clinical decision support tool for safety and oversight”

How Gamut solves it: register and model-card the tool, run intake flagging special-category data and human oversight, route to GTSAF, the EU AI Act and an ISO/IEC 42005 impact assessment, and evidence clinical validation and monitoring with control tests.

Run an AI impact assessment for an affected patient group

Section titled “Run an AI impact assessment for an affected patient group”

How Gamut solves it: ISO/IEC 42005 routing structures the impact assessment; intake’s affected-persons and human-impact signals feed the risk tier and the depth of controls required.

Govern a research copilot over sensitive data

Section titled “Govern a research copilot over sensitive data”

How Gamut solves it: register the copilot, document its data flows, and for any agentic or tool-using behaviour govern it through Agentic CISO and Gateway so it never reaches data or tools outside policy.

Quick start

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  1. Register the system in AI System Records with a model card.
  2. Run intake, flag special-category data, human oversight and affected persons, and confirm the tier.
  3. Route to GTSAF, EU AI Act and ISO/IEC 42005.
  4. Evidence clinical validation, safety and monitoring in the Evidence Tracker and Testing Centre.
  5. Track gaps on the Remediation Roadmap.
  6. Produce assurance reports for clinical safety, ethics committees and regulators from reporting.

Frameworks that apply

Section titled “Frameworks that apply”

GTSAF, EU AI Act, ISO/IEC 42005, ISO/IEC 42001 and NIST AI RMF.

Next

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