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Eligibility and Scope

An initial consultation and readiness review are used to confirm whether an activity fits an available scenario package and can be assessed under controlled and reproducible conditions.

Activities That May Be Eligible

An activity may be eligible when all of the following are true:

  • The activity is intended for physician learning or continuing medical education.
  • The learner interacts with the activity through text-based questions, searches, or prompts.
  • The activity provides clinical explanations, recommendations, summaries, or evidence retrieval.
  • The intended clinical domain fits an available scenario package.
  • The applicant can identify the intended learner, intended use, and boundaries of the activity.
  • The applicant can provide a stable system version, configuration, and testing environment.
  • The applicant can provide appropriate access, technical support, and permission to capture test outputs.
  • The assessment can be conducted without protected health information or personally identifiable information.

What One Assessment Covers

One assessment covers one defined AI-enabled CME activity. The assessment scope specifies the system version, configuration, intended use, learner population, clinical domain, retrieval sources, guardrails, and learner workflow that will be evaluated.

Multiple modules, materially different intended uses, different clinical domains, or substantial system changes may require separate assessments.

Current Clinical Scope

  • Adult ambulatory primary care
  • Physician learners
  • Text-based learner interactions
  • A stable system version and configuration
  • A standardized battery of 25 clinical scenarios
  • Clinical content validity, evidence integrity, uncertainty, and commercial influence

Activities Outside an Available Package

Additional scenario packages may be added as the service grows. Organizations whose activities fall outside the currently available package may contact the AI Assurance Lab to discuss fit, future packages, or a separately scoped engagement.