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Saint Petersburg · working policy concept

Evidence before autonomy.

A proposed health AI sandbox where a system earns permission for one bounded clinical action — never for “medicine in general”. Humans validate the system, handle uncertainty and can stop every version.

Open evidence packInternational peer review
STATUS / 19 AUG 2026Concept. Not operational.

Not an official programme of the Government of Saint Petersburg. Not a medical service, trial invitation or regulatory approval.

No. But removing case-level confirmation should require stronger system-level controls: a narrow intended purpose, independent local validation, an abstention envelope, a closed human escalation path, version control and continuous outcome monitoring.

Human control ≠ human click

The proposal moves attention from a ceremonial signature to demonstrable governance before, during and after each decision. Whether Russian law can permit A3 remains a federal legal question.

Autonomy is a permission layer

A0

Digitisation

Scheduling, search and data transfer.

A1

Decision support

A clinician makes the decision.

A2

Delegated protocol

A clinician performs meaningful case-level confirmation.

A3

Bounded autonomy

A proposed special regime for one validated action, with mandatory abstention.

A4

Legal act

Prescription or sick leave only through a separate federal legal gateway.

  1. Breast screeningImage quality, independent second reading and worklist prioritisation; interval cancers and false positives are co-primary evidence.
  2. Low-dose lung CTNodule detection, measurement and follow-up priority — with downstream CTs and invasive procedures measured alongside findings.
  3. Digital pathologySlide quality and second-read quality control for a defined organ and scanner; final reporting remains with the pathologist.
  4. Treatment toxicityePRO, laboratory thresholds and human escalation; skin computer vision remains in shadow mode.
  5. Radiotherapy and colonoscopyDraft contours and real-time lesion cueing with meaningful human review, not autonomous treatment.
  6. Cross-specialty referencesRetinal screening, selected ECG tasks, closed-loop diabetes and acute-symptom safety routing remain separate candidates.

Read the Russian evidence review

The concept learns from the EU AI Act sandbox framework, the UK MHRA AI Airlock, Singapore’s AI-SaMD sandbox, FDA-authorised autonomous screening systems and WHO guidance. It does not claim equivalence or foreign endorsement.

  • machine-readable intended purpose and exclusion envelope;
  • locked external validation and meaningful subgroup analysis;
  • prospective clinical utility, workflow and health-economic endpoints;
  • public stop events, negative results and model-change history;
  • four evidence labels: measured, assumption, modelled, target.

Review primary sources