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Track: medicine regulatory and payer pathways (health_technology_pathways_20260714) #42
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ci-requiredRequires local checks and GitHub Actions monitoring.Requires local checks and GitHub Actions monitoring.comparative-studyComparative study selection or implementation.Comparative study selection or implementation.conductor-trackIssue mirrors a local Conductor track.Issue mirrors a local Conductor track.github-projectGitHub Issues/Projects synchronization.GitHub Issues/Projects synchronization.health-processHealth policy, law, governance, and process demonstratorsHealth policy, law, governance, and process demonstratorshta-pathwayRegulatory, HTA, payer, listing, and access pathway studyRegulatory, HTA, payer, listing, and access pathway studyhuman-gateRequires Dylan approval, submission, merge, or decision.Requires Dylan approval, submission, merge, or decision.process-profilePlatform-neutral process profile contracts and validationPlatform-neutral process profile contracts and validationv1-roadmapRaC Conformance v1.0 maturity and release programmeRaC Conformance v1.0 maturity and release programme
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ci-requiredRequires local checks and GitHub Actions monitoring.Requires local checks and GitHub Actions monitoring.comparative-studyComparative study selection or implementation.Comparative study selection or implementation.conductor-trackIssue mirrors a local Conductor track.Issue mirrors a local Conductor track.github-projectGitHub Issues/Projects synchronization.GitHub Issues/Projects synchronization.health-processHealth policy, law, governance, and process demonstratorsHealth policy, law, governance, and process demonstratorshta-pathwayRegulatory, HTA, payer, listing, and access pathway studyRegulatory, HTA, payer, listing, and access pathway studyhuman-gateRequires Dylan approval, submission, merge, or decision.Requires Dylan approval, submission, merge, or decision.process-profilePlatform-neutral process profile contracts and validationPlatform-neutral process profile contracts and validationv1-roadmapRaC Conformance v1.0 maturity and release programmeRaC Conformance v1.0 maturity and release programme
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Parent programme: #38
Objective
Compare market-authorisation, HTA, funding, listing, exception, implementation, and post-market pathways without conflating regulator, payer, and service-funding authority.
Authority boundary
Medsafe/Pharmac, TGA/PBAC-PBS/MSAC-MBS, MHRA/NICE, and FDA/payer-specific US pathways are mapped by function and handoff. FDA is not a payer; MBS is not a medicine regulator.
Acceptance
Local spec and plan are authoritative.
Dependencies
Cross-domain safety handoff
Cross-referenced with #41: a narrowly typed public or appropriately de-identified aggregate post-market signal may cross the process boundary only with provenance, authority, jurisdiction, permitted-purpose, and human-review state. It must not carry patient-level incident data or imply causation, regulatory action, funding action, restriction, or access outcome.
Implementation home
Source ledgers, authority matrices, candidate mappings, and synthetic scenarios live under
subrepos/process-mappings/profiles/health-technology/during #50 incubation. Normative PIC contracts remain in rac-conformance.