# Vercy AI instruction - YAML 1.2 (JSON-compatible) { "vercy": "1.0-draft", "publication": { "status": "published", "adjudicationStatus": "reviewable-draft", "publishableCanonical": false, "generatedAt": "2026-09-06T09:15:09Z", "synthesisSha256": "622f4108a10be372001d8eccbf686159ce1ce17e15fecda9e6c711a0979f6d11", "providerMode": "single-provider-waiver", "providers": [ "Codex" ], "waivedProviders": [ "Claude", "Grok" ] }, "metaModel": { "id": "WM-ACT-046", "registryId": "vr.wm-act-046", "name": "Clinical Observation / Diagnosis", "version": "0.3.0-research.1", "previousVersions": [], "entryKind": "aggregate", "family": "World Models", "category": "Activities and processes", "industry": [ "Cross-industry" ], "domain": [ "ACT.HCR" ], "tags": [ "clinical", "observation", "diagnosis", "act.hcr" ], "status": "published" }, "canonicalUrl": "https://ver.cy/models/wm-act-046-clinical-observation-diagnosis/", "sourceUrl": "https://github.com/ver-cy/world-models/tree/feat/mega-model-registry/research/runs/wm-act-046", "model": { "registry_id": "vr.wm-act-046", "model_id": "WM-ACT-046", "name": "Clinical Observation / Diagnosis", "entry_kind": "aggregate", "purpose": "Represent one source-qualified clinical assertion, explicitly profiled as an observation result, clinical impression or diagnosis-condition, so agents can interpret evidence, status, uncertainty and lineage without conflating the assertion with the patient, encounter or disease entity.", "scope_statement": "Owns assertion identity and lineage, profile, subject and encounter bindings, source meaning, observation design and value, interpretation, diagnostic statement, evidence-use links, participants and authority, effective and record times, result, verification and clinical statuses, correction and refutation history, quality, privacy, retention and interoperability. Patient, practitioner, encounter, specimen, device, procedure, report, disease, terminology, care action, consent, audit and record masters remain external.", "in_scope": [ "Clinical assertion profile, identity, source, subject, focus, context, value, interpretation, evidence, uncertainty, participants, authority and time", "Observation capture, clinical impression, diagnosis assertion, lifecycle, verification, correction, refutation, privacy, retention, provenance and version-pinned projections" ], "out_of_scope": [ "Independent patient, practitioner, encounter, episode, specimen, device, request, procedure, diagnostic report, disease or condition entity, terminology, care plan, treatment, medication, consent, audit or records lifecycles", "Treating an observable as a result, result as diagnosis, assertion as disease entity, preliminary as final, clinical status as verification status, refuted as erased or code mapping as source truth", "Giving medical advice, autonomously diagnosing, ordering or performing care, operating clinical systems or defining universally applicable professional and legal rules" ], "boundary_notes": [ { "neighbor": "WM-ACT-018 Encounter", "distinction": "Encounter may contain or contextualize assertion instances, but owns its own participants, location, service and lifecycle. The ledger relation is candidate only.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004" ] }, { "neighbor": "WM-LIV-021 Disease / Biological Condition", "distinction": "The disease or biological-condition master owns the condition entity or class. This model owns a source-qualified assertion that a subject has, may have or does not have a condition at a stated verification and clinical status.", "source_refs": [ "SRC-002", "SRC-006", "SRC-007" ] }, { "neighbor": "Patient, Related Person, Practitioner, Organization and Care Team", "distinction": "External identity and role masters own people and organizations. This assertion records role-qualified references, participation, informant status, delegation and responsibility.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-005" ] }, { "neighbor": "Specimen, Device, Service Request, Procedure and Diagnostic Report", "distinction": "External masters own acquisition objects, performed procedures and report lifecycle. The assertion binds the exact sources, methods and report membership needed for interpretation.", "source_refs": [ "SRC-001", "SRC-003", "SRC-005", "SRC-012" ] }, { "neighbor": "SNOMED CT, LOINC, ICD-11, UCUM and other terminology masters", "distinction": "Terminology systems own concept and unit releases. This assertion preserves original source meaning, selected mappings, versions, mapping responsibility and loss.", "source_refs": [ "SRC-006", "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-013" ] }, { "neighbor": "Treatment, Care Plan, Decision Support and Clinical Action", "distinction": "This model may expose clinically usable assertions and safety limitations but never turns evidence into an autonomous treatment order or action.", "source_refs": [ "SRC-004", "SRC-005", "SRC-014" ] } ] }, "sources": [ { "id": "SRC-001", "title": "FHIR R5 Observation", "organization": "Health Level Seven International", "url": "https://hl7.org/fhir/R5/observation.html", "version_or_date": "FHIR 5.0.0, 26 March 2023, Normative resource", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T09:03:00Z", "relevance": "Defines an event result, status, subject, focus, encounter, effective time, performer, value, interpretation, note, body site, method, specimen, device, reference range, components, membership and derivation; explicitly excludes clinical diagnosis as the normal Observation use." }, { "id": "SRC-002", "title": "FHIR R5 Condition", "organization": "Health Level Seven International", "url": "https://hl7.org/fhir/R5/condition.html", "version_or_date": "FHIR 5.0.0, 26 March 2023, Trial Use", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T09:03:00Z", "relevance": "Defines a condition, problem or diagnosis assertion with separate clinical status and verification status, subject, encounter, onset, abatement, recorder or participant, stage and supporting evidence; distinguishes signs and symptoms from conditions needing ongoing management." }, { "id": "SRC-003", "title": "FHIR R5 DiagnosticReport", "organization": "Health Level Seven International", "url": "https://hl7.org/fhir/R5/diagnosticreport.html", "version_or_date": "FHIR 5.0.0, 26 March 2023, Trial Use", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T09:03:00Z", "relevance": "Separates a diagnostic report and its conclusion, study, specimen and atomic Observation results from the observations themselves and from the procedure that produced them." }, { "id": "SRC-004", "title": "FHIR R5 ClinicalImpression", "organization": "Health Level Seven International", "url": "https://hl7.org/fhir/R5/clinicalimpression.html", "version_or_date": "FHIR 5.0.0, 26 March 2023, maturity level 1 and Trial Use", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T09:03:00Z", "relevance": "Represents a clinical assessment, problems, findings, bases and prognosis before treatment planning, while documenting acknowledged workflow variability and low maturity." }, { "id": "SRC-005", "title": "openEHR Reference Model EHR Information Model", "organization": "openEHR Foundation", "url": "https://specifications.openehr.org/releases/RM/Release-1.1.0/ehr.html", "version_or_date": "Reference Model 1.1.0", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T09:03:00Z", "relevance": "Separates OBSERVATION data, state and protocol from EVALUATION statements such as diagnoses, differential diagnoses, hypotheses and risk assessments, and from actionable INSTRUCTION records." }, { "id": "SRC-006", "title": "SNOMED CT Concept Model", "organization": "SNOMED International", "url": "https://docs.snomed.org/snomed-ct-practical-guides/snomed-ct-starter-guide/6-snomed-ct-concept-model", "version_or_date": "Living official guide accessed 6 September 2026", "source_type": "ontology", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T09:03:00Z", "relevance": "Defines clinical finding, observable entity, procedure, body structure and explicit-context hierarchies, with domain and range rules for defining attributes." }, { "id": "SRC-007", "title": "Clinical Finding and Disorder", "organization": "SNOMED International", "url": "https://docs.snomed.org/snomed-ct-specifications/snomed-ct-editorial-guide/readme/authoring/domain-specific-modeling/clinical-finding-and-disorder", "version_or_date": "Living Editorial Guide accessed 6 September 2026", "source_type": "ontology", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T09:03:00Z", "relevance": "Distinguishes active acquisition of an observation from an observable entity, and distinguishes a point-in-time finding from a disorder with pathology and temporal persistence." }, { "id": "SRC-008", "title": "LOINC Users' Guide: Clinical observations and measures", "organization": "Regenstrief Institute", "url": "https://loinc.org/kb/users-guide/clinical-observations-and-measures/introduction", "version_or_date": "LOINC 2.82 knowledge base, page updated 19 July 2026", "source_type": "classifier", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T09:03:00Z", "relevance": "Defines clinical and laboratory observation meaning through component, property, time aspect, system, scale and method, including measurements summarized over an interval." }, { "id": "SRC-009", "title": "ICD API Supported Classifications, Versions and Languages", "organization": "World Health Organization", "url": "https://icd.who.int/docs/icd-api/SupportedClassifications/", "version_or_date": "ICD-11 Foundation and MMS release 2026-01", "source_type": "classifier", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T09:03:00Z", "relevance": "Establishes versioned ICD-11 releases and language availability, preventing unversioned or language-ambiguous classification bindings." }, { "id": "SRC-010", "title": "ICD API version 2 documentation", "organization": "World Health Organization", "url": "https://icd.who.int/docs/icd-api/APIDoc-Version2/", "version_or_date": "API version 2, accessed 6 September 2026", "source_type": "schema", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T09:03:00Z", "relevance": "Defines programmatic ICD access, release-aware identifiers and ICD URIs as stable machine identifiers for classification entities." }, { "id": "SRC-011", "title": "OMOP Common Data Model v5.4", "organization": "Observational Health Data Sciences and Informatics", "url": "https://ohdsi.github.io/CommonDataModel/cdm54.html", "version_or_date": "OMOP CDM 5.4", "source_type": "schema", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T09:03:00Z", "relevance": "Separates standardized Measurements, other Observations and Condition Occurrences, preserves source concepts and provenance type, and warns that rule-out or source distinctions may be lost during transformation." }, { "id": "SRC-012", "title": "DICOM Standard PS3.3 Information Object Definitions", "organization": "DICOM Standards Committee", "url": "https://dicom.nema.org/medical/dicom/current/output/html/part03.html", "version_or_date": "Current edition accessed 6 September 2026", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T09:03:00Z", "relevance": "Defines Structured Reporting content, observation context, coded and numeric content, image and waveform references, evidence relationships and report object boundaries for imaging observations." }, { "id": "SRC-013", "title": "The Unified Code for Units of Measure", "organization": "Regenstrief Institute", "url": "https://ucum.org/ucum", "version_or_date": "UCUM 2.2, 4 December 2024", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T09:03:00Z", "relevance": "Provides unambiguous machine units and conversion semantics needed to qualify quantitative clinical results without treating display text as the unit identity." }, { "id": "SRC-014", "title": "Regulation (EU) 2016/679 General Data Protection Regulation", "organization": "European Union", "url": "https://eur-lex.europa.eu/eli/reg/2016/679/oj", "version_or_date": "27 April 2016, applicable from 25 May 2018", "source_type": "legislation", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T09:03:00Z", "relevance": "Supplies purpose limitation, minimization, accuracy, security, access, correction, objection and special-category safeguards for health and genetic data." }, { "id": "SRC-015", "title": "PROV-O: The PROV Ontology", "organization": "World Wide Web Consortium", "url": "https://www.w3.org/TR/prov-o/", "version_or_date": "W3C Recommendation, 30 April 2013", "source_type": "ontology", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T09:03:00Z", "relevance": "Provides entity, activity, agent, attribution, delegation, derivation, revision, invalidation and generation semantics for source-qualified clinical assertions." }, { "id": "SRC-016", "title": "Date and Time on the Internet: Timestamps", "organization": "Internet Engineering Task Force", "url": "https://www.rfc-editor.org/info/rfc3339/", "version_or_date": "RFC 3339, July 2002", "source_type": "standard", "primary_source": true, "authority_tier": 1, "accessed_at": "2026-09-06T09:03:00Z", "relevance": "Provides interoperable timestamps with seconds and an explicit UTC relationship for event, specimen, authored, issued, recorded and knowledge times." } ], "structure": { "bundles": [ { "id": "assertion-identity-profile-subject-and-boundary", "name": "Assertion identity, profile, subject and boundary", "description": "Groups governed clinical assertion context for assertion identity, profile, subject and boundary.", "rationale": "A clinical assertion needs a stable record identity and an explicit observation, impression or diagnosis profile before its content can be interpreted.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-005", "SRC-006", "SRC-007", "SRC-015" ], "layers": [ { "id": "assertion-profile-identity-source-and-lineage", "name": "Assertion profile, identity, source and lineage", "description": "Groups source-qualified clinical context for assertion profile, identity, source and lineage.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-005", "SRC-015" ], "findings": [ { "id": "assertion-profile-kind-scope-specialty-and-semantic-boundary", "name": "Assertion profile, kind, scope, specialty and semantic boundary", "description": "Records assertion profile, kind, scope, specialty and semantic boundary as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-005", "SRC-015" ], "questions": [ { "id": "assertion-profile-kind-scope-specialty-and-semantic-boundary-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish assertion profile, kind, scope, specialty and semantic boundary?", "kind": "classification", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "assertion-profile-kind-scope-specialty-and-semantic-boundary-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for assertion profile, kind, scope, specialty and semantic boundary, using which method, evidence and authority?", "kind": "quality", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "assertion-profile-kind-scope-specialty-and-semantic-boundary-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to assertion profile, kind, scope, specialty and semantic boundary, and how may it be validated, challenged, corrected or retained?", "kind": "privacy", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "assertion-profile-kind-scope-specialty-and-semantic-boundary-data", "name": "Assertion profile, kind, scope, specialty and semantic boundary data", "description": "Typed clinical assertion data for assertion profile, kind, scope, specialty and semantic boundary, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-005", "SRC-015" ] } ], "artifacts": [ { "id": "assertion-profile-kind-scope-specialty-and-semantic-boundary-record", "name": "Assertion profile, kind, scope, specialty and semantic boundary record", "description": "Immutable or successor-versioned evidence-bearing record for assertion profile, kind, scope, specialty and semantic boundary.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus assertion-profile-kind-scope-specialty-and-semantic-boundary statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-005", "SRC-015" ] } ], "inline_only_rationale": null }, { "id": "assertion-identifier-source-version-predecessor-successor-and-lineage", "name": "Assertion identifier, source, version, predecessor, successor and lineage", "description": "Records assertion identifier, source, version, predecessor, successor and lineage as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-005", "SRC-015" ], "questions": [ { "id": "assertion-identifier-source-version-predecessor-successor-and-lineage-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish assertion identifier, source, version, predecessor, successor and lineage?", "kind": "identity", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "assertion-identifier-source-version-predecessor-successor-and-lineage-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for assertion identifier, source, version, predecessor, successor and lineage, using which method, evidence and authority?", "kind": "authority", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "assertion-identifier-source-version-predecessor-successor-and-lineage-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to assertion identifier, source, version, predecessor, successor and lineage, and how may it be validated, challenged, corrected or retained?", "kind": "retention", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "assertion-identifier-source-version-predecessor-successor-and-lineage-data", "name": "Assertion identifier, source, version, predecessor, successor and lineage data", "description": "Typed clinical assertion data for assertion identifier, source, version, predecessor, successor and lineage, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-005", "SRC-015" ] } ], "artifacts": [ { "id": "assertion-identifier-source-version-predecessor-successor-and-lineage-record", "name": "Assertion identifier, source, version, predecessor, successor and lineage record", "description": "Immutable or successor-versioned evidence-bearing record for assertion identifier, source, version, predecessor, successor and lineage.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus assertion-identifier-source-version-predecessor-successor-and-lineage statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-005", "SRC-015" ] } ], "inline_only_rationale": null } ] }, { "id": "subject-focus-encounter-and-phenomenon-boundaries", "name": "Subject, focus, encounter and phenomenon boundaries", "description": "Groups source-qualified clinical context for subject, focus, encounter and phenomenon boundaries.", "source_refs": [ "SRC-001", "SRC-002", "SRC-005", "SRC-006", "SRC-007" ], "findings": [ { "id": "subject-focus-related-person-group-and-encounter-binding", "name": "Subject, focus, related person, group and encounter binding", "description": "Records subject, focus, related person, group and encounter binding as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-002", "SRC-005", "SRC-006", "SRC-007" ], "questions": [ { "id": "subject-focus-related-person-group-and-encounter-binding-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish subject, focus, related person, group and encounter binding?", "kind": "relationship", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "subject-focus-related-person-group-and-encounter-binding-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for subject, focus, related person, group and encounter binding, using which method, evidence and authority?", "kind": "ownership", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "subject-focus-related-person-group-and-encounter-binding-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to subject, focus, related person, group and encounter binding, and how may it be validated, challenged, corrected or retained?", "kind": "access", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "subject-focus-related-person-group-and-encounter-binding-data", "name": "Subject, focus, related person, group and encounter binding data", "description": "Typed clinical assertion data for subject, focus, related person, group and encounter binding, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-002", "SRC-005", "SRC-006", "SRC-007" ] } ], "artifacts": [ { "id": "subject-focus-related-person-group-and-encounter-binding-record", "name": "Subject, focus, related person, group and encounter binding record", "description": "Immutable or successor-versioned evidence-bearing record for subject, focus, related person, group and encounter binding.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus subject-focus-related-person-group-and-encounter-binding statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-005", "SRC-006", "SRC-007" ] } ], "inline_only_rationale": null }, { "id": "observable-question-result-finding-diagnosis-condition-and-disease-distinction", "name": "Observable question, result, finding, diagnosis, condition and disease distinction", "description": "Records observable question, result, finding, diagnosis, condition and disease distinction as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-002", "SRC-005", "SRC-006", "SRC-007" ], "questions": [ { "id": "observable-question-result-finding-diagnosis-condition-and-disease-distinction-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish observable question, result, finding, diagnosis, condition and disease distinction?", "kind": "definition", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "observable-question-result-finding-diagnosis-condition-and-disease-distinction-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for observable question, result, finding, diagnosis, condition and disease distinction, using which method, evidence and authority?", "kind": "temporal", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "observable-question-result-finding-diagnosis-condition-and-disease-distinction-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to observable question, result, finding, diagnosis, condition and disease distinction, and how may it be validated, challenged, corrected or retained?", "kind": "validation", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "observable-question-result-finding-diagnosis-condition-and-disease-distinction-data", "name": "Observable question, result, finding, diagnosis, condition and disease distinction data", "description": "Typed clinical assertion data for observable question, result, finding, diagnosis, condition and disease distinction, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-002", "SRC-005", "SRC-006", "SRC-007" ] } ], "artifacts": [ { "id": "observable-question-result-finding-diagnosis-condition-and-disease-distinction-record", "name": "Observable question, result, finding, diagnosis, condition and disease distinction record", "description": "Immutable or successor-versioned evidence-bearing record for observable question, result, finding, diagnosis, condition and disease distinction.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus observable-question-result-finding-diagnosis-condition-and-disease-distinction statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-005", "SRC-006", "SRC-007" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "observation-design-acquisition-and-result", "name": "Observation design, acquisition and result", "description": "Groups governed clinical assertion context for observation design, acquisition and result.", "rationale": "Observation semantics bind what was observed, how and under what state to a typed result without implying a diagnosis.", "source_refs": [ "SRC-001", "SRC-003", "SRC-005", "SRC-006", "SRC-007", "SRC-008", "SRC-011", "SRC-012", "SRC-013" ], "layers": [ { "id": "observable-method-specimen-device-procedure-and-request", "name": "Observable, method, specimen, device, procedure and request", "description": "Groups source-qualified clinical context for observable, method, specimen, device, procedure and request.", "source_refs": [ "SRC-001", "SRC-003", "SRC-005", "SRC-006", "SRC-007", "SRC-008" ], "findings": [ { "id": "observation-code-property-system-time-aspect-scale-method-and-body-site", "name": "Observation code, property, system, time aspect, scale, method and body site", "description": "Records observation code, property, system, time aspect, scale, method and body site as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-003", "SRC-005", "SRC-006", "SRC-007", "SRC-008" ], "questions": [ { "id": "observation-code-property-system-time-aspect-scale-method-and-body-site-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish observation code, property, system, time aspect, scale, method and body site?", "kind": "composition", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "observation-code-property-system-time-aspect-scale-method-and-body-site-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for observation code, property, system, time aspect, scale, method and body site, using which method, evidence and authority?", "kind": "state", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "observation-code-property-system-time-aspect-scale-method-and-body-site-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to observation code, property, system, time aspect, scale, method and body site, and how may it be validated, challenged, corrected or retained?", "kind": "interoperability", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "observation-code-property-system-time-aspect-scale-method-and-body-site-data", "name": "Observation code, property, system, time aspect, scale, method and body site data", "description": "Typed clinical assertion data for observation code, property, system, time aspect, scale, method and body site, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-003", "SRC-005", "SRC-006", "SRC-007", "SRC-008" ] } ], "artifacts": [ { "id": "observation-code-property-system-time-aspect-scale-method-and-body-site-record", "name": "Observation code, property, system, time aspect, scale, method and body site record", "description": "Immutable or successor-versioned evidence-bearing record for observation code, property, system, time aspect, scale, method and body site.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus observation-code-property-system-time-aspect-scale-method-and-body-site statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-003", "SRC-005", "SRC-006", "SRC-007", "SRC-008" ] } ], "inline_only_rationale": null }, { "id": "specimen-device-procedure-service-request-protocol-and-calibration-binding", "name": "Specimen, device, procedure, service request, protocol and calibration binding", "description": "Records specimen, device, procedure, service request, protocol and calibration binding as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-003", "SRC-005", "SRC-006", "SRC-007", "SRC-008" ], "questions": [ { "id": "specimen-device-procedure-service-request-protocol-and-calibration-binding-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish specimen, device, procedure, service request, protocol and calibration binding?", "kind": "relationship", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "specimen-device-procedure-service-request-protocol-and-calibration-binding-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for specimen, device, procedure, service request, protocol and calibration binding, using which method, evidence and authority?", "kind": "lifecycle", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "specimen-device-procedure-service-request-protocol-and-calibration-binding-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to specimen, device, procedure, service request, protocol and calibration binding, and how may it be validated, challenged, corrected or retained?", "kind": "decision", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "specimen-device-procedure-service-request-protocol-and-calibration-binding-data", "name": "Specimen, device, procedure, service request, protocol and calibration binding data", "description": "Typed clinical assertion data for specimen, device, procedure, service request, protocol and calibration binding, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-003", "SRC-005", "SRC-006", "SRC-007", "SRC-008" ] } ], "artifacts": [ { "id": "specimen-device-procedure-service-request-protocol-and-calibration-binding-record", "name": "Specimen, device, procedure, service request, protocol and calibration binding record", "description": "Immutable or successor-versioned evidence-bearing record for specimen, device, procedure, service request, protocol and calibration binding.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus specimen-device-procedure-service-request-protocol-and-calibration-binding statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-003", "SRC-005", "SRC-006", "SRC-007", "SRC-008" ] } ], "inline_only_rationale": null } ] }, { "id": "value-unit-range-component-derivation-and-interpretation", "name": "Value, unit, range, component, derivation and interpretation", "description": "Groups source-qualified clinical context for value, unit, range, component, derivation and interpretation.", "source_refs": [ "SRC-001", "SRC-003", "SRC-008", "SRC-011", "SRC-012", "SRC-013" ], "findings": [ { "id": "result-value-type-quantity-unit-code-text-media-absence-and-uncertainty", "name": "Result value type, quantity, unit, code, text, media, absence and uncertainty", "description": "Records result value type, quantity, unit, code, text, media, absence and uncertainty as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-003", "SRC-008", "SRC-011", "SRC-012", "SRC-013" ], "questions": [ { "id": "result-value-type-quantity-unit-code-text-media-absence-and-uncertainty-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish result value type, quantity, unit, code, text, media, absence and uncertainty?", "kind": "measurement", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "result-value-type-quantity-unit-code-text-media-absence-and-uncertainty-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for result value type, quantity, unit, code, text, media, absence and uncertainty, using which method, evidence and authority?", "kind": "provenance", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "result-value-type-quantity-unit-code-text-media-absence-and-uncertainty-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to result value type, quantity, unit, code, text, media, absence and uncertainty, and how may it be validated, challenged, corrected or retained?", "kind": "exception", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "result-value-type-quantity-unit-code-text-media-absence-and-uncertainty-data", "name": "Result value type, quantity, unit, code, text, media, absence and uncertainty data", "description": "Typed clinical assertion data for result value type, quantity, unit, code, text, media, absence and uncertainty, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-003", "SRC-008", "SRC-011", "SRC-012", "SRC-013" ] } ], "artifacts": [ { "id": "result-value-type-quantity-unit-code-text-media-absence-and-uncertainty-record", "name": "Result value type, quantity, unit, code, text, media, absence and uncertainty record", "description": "Immutable or successor-versioned evidence-bearing record for result value type, quantity, unit, code, text, media, absence and uncertainty.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus result-value-type-quantity-unit-code-text-media-absence-and-uncertainty statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-003", "SRC-008", "SRC-011", "SRC-012", "SRC-013" ] } ], "inline_only_rationale": null }, { "id": "component-panel-member-reference-range-flag-interpretation-and-derived-from", "name": "Component, panel, member, reference range, flag, interpretation and derived-from", "description": "Records component, panel, member, reference range, flag, interpretation and derived-from as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-003", "SRC-008", "SRC-011", "SRC-012", "SRC-013" ], "questions": [ { "id": "component-panel-member-reference-range-flag-interpretation-and-derived-from-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish component, panel, member, reference range, flag, interpretation and derived-from?", "kind": "relationship", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "component-panel-member-reference-range-flag-interpretation-and-derived-from-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for component, panel, member, reference range, flag, interpretation and derived-from, using which method, evidence and authority?", "kind": "privacy", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "component-panel-member-reference-range-flag-interpretation-and-derived-from-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to component, panel, member, reference range, flag, interpretation and derived-from, and how may it be validated, challenged, corrected or retained?", "kind": "security", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "component-panel-member-reference-range-flag-interpretation-and-derived-from-data", "name": "Component, panel, member, reference range, flag, interpretation and derived-from data", "description": "Typed clinical assertion data for component, panel, member, reference range, flag, interpretation and derived-from, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-003", "SRC-008", "SRC-011", "SRC-012", "SRC-013" ] } ], "artifacts": [ { "id": "component-panel-member-reference-range-flag-interpretation-and-derived-from-record", "name": "Component, panel, member, reference range, flag, interpretation and derived-from record", "description": "Immutable or successor-versioned evidence-bearing record for component, panel, member, reference range, flag, interpretation and derived-from.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus component-panel-member-reference-range-flag-interpretation-and-derived-from statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-003", "SRC-008", "SRC-011", "SRC-012", "SRC-013" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "diagnostic-reasoning-evidence-and-clinical-assertion", "name": "Diagnostic reasoning, evidence and clinical assertion", "description": "Groups governed clinical assertion context for diagnostic reasoning, evidence and clinical assertion.", "rationale": "A diagnosis or clinical impression must expose its evidence, uncertainty and responsible judgment rather than collapse observations into certainty.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-006", "SRC-007", "SRC-009", "SRC-012" ], "layers": [ { "id": "signs-symptoms-observations-reports-and-evidence-basis", "name": "Signs, symptoms, observations, reports and evidence basis", "description": "Groups source-qualified clinical context for signs, symptoms, observations, reports and evidence basis.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-007", "SRC-012" ], "findings": [ { "id": "subjective-symptom-objective-sign-observation-report-image-and-document-evidence", "name": "Subjective symptom, objective sign, observation, report, image and document evidence", "description": "Records subjective symptom, objective sign, observation, report, image and document evidence as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-007", "SRC-012" ], "questions": [ { "id": "subjective-symptom-objective-sign-observation-report-image-and-document-evidence-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish subjective symptom, objective sign, observation, report, image and document evidence?", "kind": "evidence", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "subjective-symptom-objective-sign-observation-report-image-and-document-evidence-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for subjective symptom, objective sign, observation, report, image and document evidence, using which method, evidence and authority?", "kind": "retention", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "subjective-symptom-objective-sign-observation-report-image-and-document-evidence-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to subjective symptom, objective sign, observation, report, image and document evidence, and how may it be validated, challenged, corrected or retained?", "kind": "identity", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "subjective-symptom-objective-sign-observation-report-image-and-document-evidence-data", "name": "Subjective symptom, objective sign, observation, report, image and document evidence data", "description": "Typed clinical assertion data for subjective symptom, objective sign, observation, report, image and document evidence, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-007", "SRC-012" ] } ], "artifacts": [ { "id": "subjective-symptom-objective-sign-observation-report-image-and-document-evidence-record", "name": "Subjective symptom, objective sign, observation, report, image and document evidence record", "description": "Immutable or successor-versioned evidence-bearing record for subjective symptom, objective sign, observation, report, image and document evidence.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus subjective-symptom-objective-sign-observation-report-image-and-document-evidence statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-007", "SRC-012" ] } ], "inline_only_rationale": null }, { "id": "evidence-relevance-quality-conflict-missingness-and-alternative-explanation", "name": "Evidence relevance, quality, conflict, missingness and alternative explanation", "description": "Records evidence relevance, quality, conflict, missingness and alternative explanation as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-007", "SRC-012" ], "questions": [ { "id": "evidence-relevance-quality-conflict-missingness-and-alternative-explanation-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish evidence relevance, quality, conflict, missingness and alternative explanation?", "kind": "quality", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "evidence-relevance-quality-conflict-missingness-and-alternative-explanation-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for evidence relevance, quality, conflict, missingness and alternative explanation, using which method, evidence and authority?", "kind": "access", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "evidence-relevance-quality-conflict-missingness-and-alternative-explanation-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to evidence relevance, quality, conflict, missingness and alternative explanation, and how may it be validated, challenged, corrected or retained?", "kind": "classification", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "evidence-relevance-quality-conflict-missingness-and-alternative-explanation-data", "name": "Evidence relevance, quality, conflict, missingness and alternative explanation data", "description": "Typed clinical assertion data for evidence relevance, quality, conflict, missingness and alternative explanation, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-007", "SRC-012" ] } ], "artifacts": [ { "id": "evidence-relevance-quality-conflict-missingness-and-alternative-explanation-record", "name": "Evidence relevance, quality, conflict, missingness and alternative explanation record", "description": "Immutable or successor-versioned evidence-bearing record for evidence relevance, quality, conflict, missingness and alternative explanation.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus evidence-relevance-quality-conflict-missingness-and-alternative-explanation statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-007", "SRC-012" ] } ], "inline_only_rationale": null } ] }, { "id": "impression-diagnosis-differential-verification-and-condition-context", "name": "Impression, diagnosis, differential, verification and condition context", "description": "Groups source-qualified clinical context for impression, diagnosis, differential, verification and condition context.", "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-006", "SRC-007", "SRC-009" ], "findings": [ { "id": "clinical-statement-code-category-severity-stage-body-site-and-context", "name": "Clinical statement, code, category, severity, stage, body site and context", "description": "Records clinical statement, code, category, severity, stage, body site and context as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-006", "SRC-007", "SRC-009" ], "questions": [ { "id": "clinical-statement-code-category-severity-stage-body-site-and-context-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish clinical statement, code, category, severity, stage, body site and context?", "kind": "classification", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "clinical-statement-code-category-severity-stage-body-site-and-context-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for clinical statement, code, category, severity, stage, body site and context, using which method, evidence and authority?", "kind": "validation", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "clinical-statement-code-category-severity-stage-body-site-and-context-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to clinical statement, code, category, severity, stage, body site and context, and how may it be validated, challenged, corrected or retained?", "kind": "relationship", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "clinical-statement-code-category-severity-stage-body-site-and-context-data", "name": "Clinical statement, code, category, severity, stage, body site and context data", "description": "Typed clinical assertion data for clinical statement, code, category, severity, stage, body site and context, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-006", "SRC-007", "SRC-009" ] } ], "artifacts": [ { "id": "clinical-statement-code-category-severity-stage-body-site-and-context-record", "name": "Clinical statement, code, category, severity, stage, body site and context record", "description": "Immutable or successor-versioned evidence-bearing record for clinical statement, code, category, severity, stage, body site and context.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus clinical-statement-code-category-severity-stage-body-site-and-context statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-006", "SRC-007", "SRC-009" ] } ], "inline_only_rationale": null }, { "id": "working-provisional-differential-confirmed-refuted-error-and-confidence-state", "name": "Working, provisional, differential, confirmed, refuted, error and confidence state", "description": "Records working, provisional, differential, confirmed, refuted, error and confidence state as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-006", "SRC-007", "SRC-009" ], "questions": [ { "id": "working-provisional-differential-confirmed-refuted-error-and-confidence-state-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish working, provisional, differential, confirmed, refuted, error and confidence state?", "kind": "state", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "working-provisional-differential-confirmed-refuted-error-and-confidence-state-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for working, provisional, differential, confirmed, refuted, error and confidence state, using which method, evidence and authority?", "kind": "interoperability", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "working-provisional-differential-confirmed-refuted-error-and-confidence-state-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to working, provisional, differential, confirmed, refuted, error and confidence state, and how may it be validated, challenged, corrected or retained?", "kind": "measurement", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "working-provisional-differential-confirmed-refuted-error-and-confidence-state-data", "name": "Working, provisional, differential, confirmed, refuted, error and confidence state data", "description": "Typed clinical assertion data for working, provisional, differential, confirmed, refuted, error and confidence state, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-006", "SRC-007", "SRC-009" ] } ], "artifacts": [ { "id": "working-provisional-differential-confirmed-refuted-error-and-confidence-state-record", "name": "Working, provisional, differential, confirmed, refuted, error and confidence state record", "description": "Immutable or successor-versioned evidence-bearing record for working, provisional, differential, confirmed, refuted, error and confidence state.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus working-provisional-differential-confirmed-refuted-error-and-confidence-state statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-002", "SRC-004", "SRC-005", "SRC-006", "SRC-007", "SRC-009" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "participants-authority-time-and-clinical-context", "name": "Participants, authority, time and clinical context", "description": "Groups governed clinical assertion context for participants, authority, time and clinical context.", "rationale": "Interpretation depends on who observed, entered, interpreted and accepted responsibility, plus the distinct times and circumstances involved.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-008", "SRC-015", "SRC-016" ], "layers": [ { "id": "performer-recorder-author-interpreter-asserter-and-responsibility", "name": "Performer, recorder, author, interpreter, asserter and responsibility", "description": "Groups source-qualified clinical context for performer, recorder, author, interpreter, asserter and responsibility.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-015" ], "findings": [ { "id": "performer-device-recorder-author-interpreter-asserter-and-informant-role", "name": "Performer, device, recorder, author, interpreter, asserter and informant role", "description": "Records performer, device, recorder, author, interpreter, asserter and informant role as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-015" ], "questions": [ { "id": "performer-device-recorder-author-interpreter-asserter-and-informant-role-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish performer, device, recorder, author, interpreter, asserter and informant role?", "kind": "authority", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "performer-device-recorder-author-interpreter-asserter-and-informant-role-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for performer, device, recorder, author, interpreter, asserter and informant role, using which method, evidence and authority?", "kind": "decision", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "performer-device-recorder-author-interpreter-asserter-and-informant-role-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to performer, device, recorder, author, interpreter, asserter and informant role, and how may it be validated, challenged, corrected or retained?", "kind": "evidence", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "performer-device-recorder-author-interpreter-asserter-and-informant-role-data", "name": "Performer, device, recorder, author, interpreter, asserter and informant role data", "description": "Typed clinical assertion data for performer, device, recorder, author, interpreter, asserter and informant role, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-015" ] } ], "artifacts": [ { "id": "performer-device-recorder-author-interpreter-asserter-and-informant-role-record", "name": "Performer, device, recorder, author, interpreter, asserter and informant role record", "description": "Immutable or successor-versioned evidence-bearing record for performer, device, recorder, author, interpreter, asserter and informant role.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus performer-device-recorder-author-interpreter-asserter-and-informant-role statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-015" ] } ], "inline_only_rationale": null }, { "id": "organization-care-team-specialty-credential-delegation-signature-and-accountability", "name": "Organization, care team, specialty, credential, delegation, signature and accountability", "description": "Records organization, care team, specialty, credential, delegation, signature and accountability as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-015" ], "questions": [ { "id": "organization-care-team-specialty-credential-delegation-signature-and-accountability-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish organization, care team, specialty, credential, delegation, signature and accountability?", "kind": "ownership", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "organization-care-team-specialty-credential-delegation-signature-and-accountability-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for organization, care team, specialty, credential, delegation, signature and accountability, using which method, evidence and authority?", "kind": "exception", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "organization-care-team-specialty-credential-delegation-signature-and-accountability-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to organization, care team, specialty, credential, delegation, signature and accountability, and how may it be validated, challenged, corrected or retained?", "kind": "quality", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "organization-care-team-specialty-credential-delegation-signature-and-accountability-data", "name": "Organization, care team, specialty, credential, delegation, signature and accountability data", "description": "Typed clinical assertion data for organization, care team, specialty, credential, delegation, signature and accountability, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-015" ] } ], "artifacts": [ { "id": "organization-care-team-specialty-credential-delegation-signature-and-accountability-record", "name": "Organization, care team, specialty, credential, delegation, signature and accountability record", "description": "Immutable or successor-versioned evidence-bearing record for organization, care team, specialty, credential, delegation, signature and accountability.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus organization-care-team-specialty-credential-delegation-signature-and-accountability statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-015" ] } ], "inline_only_rationale": null } ] }, { "id": "effective-specimen-onset-issued-recorded-and-context-times", "name": "Effective, specimen, onset, issued, recorded and context times", "description": "Groups source-qualified clinical context for effective, specimen, onset, issued, recorded and context times.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-005", "SRC-008", "SRC-016" ], "findings": [ { "id": "effective-period-instant-specimen-collection-onset-abatement-and-duration", "name": "Effective period, instant, specimen collection, onset, abatement and duration", "description": "Records effective period, instant, specimen collection, onset, abatement and duration as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-005", "SRC-008", "SRC-016" ], "questions": [ { "id": "effective-period-instant-specimen-collection-onset-abatement-and-duration-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish effective period, instant, specimen collection, onset, abatement and duration?", "kind": "temporal", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "effective-period-instant-specimen-collection-onset-abatement-and-duration-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for effective period, instant, specimen collection, onset, abatement and duration, using which method, evidence and authority?", "kind": "security", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "effective-period-instant-specimen-collection-onset-abatement-and-duration-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to effective period, instant, specimen collection, onset, abatement and duration, and how may it be validated, challenged, corrected or retained?", "kind": "authority", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "effective-period-instant-specimen-collection-onset-abatement-and-duration-data", "name": "Effective period, instant, specimen collection, onset, abatement and duration data", "description": "Typed clinical assertion data for effective period, instant, specimen collection, onset, abatement and duration, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-005", "SRC-008", "SRC-016" ] } ], "artifacts": [ { "id": "effective-period-instant-specimen-collection-onset-abatement-and-duration-record", "name": "Effective period, instant, specimen collection, onset, abatement and duration record", "description": "Immutable or successor-versioned evidence-bearing record for effective period, instant, specimen collection, onset, abatement and duration.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus effective-period-instant-specimen-collection-onset-abatement-and-duration statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-005", "SRC-008", "SRC-016" ] } ], "inline_only_rationale": null }, { "id": "issued-authored-recorded-ingested-known-time-location-posture-fasting-and-context", "name": "Issued, authored, recorded, ingested, known time, location, posture, fasting and context", "description": "Records issued, authored, recorded, ingested, known time, location, posture, fasting and context as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-005", "SRC-008", "SRC-016" ], "questions": [ { "id": "issued-authored-recorded-ingested-known-time-location-posture-fasting-and-context-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish issued, authored, recorded, ingested, known time, location, posture, fasting and context?", "kind": "temporal", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "issued-authored-recorded-ingested-known-time-location-posture-fasting-and-context-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for issued, authored, recorded, ingested, known time, location, posture, fasting and context, using which method, evidence and authority?", "kind": "identity", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "issued-authored-recorded-ingested-known-time-location-posture-fasting-and-context-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to issued, authored, recorded, ingested, known time, location, posture, fasting and context, and how may it be validated, challenged, corrected or retained?", "kind": "ownership", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "issued-authored-recorded-ingested-known-time-location-posture-fasting-and-context-data", "name": "Issued, authored, recorded, ingested, known time, location, posture, fasting and context data", "description": "Typed clinical assertion data for issued, authored, recorded, ingested, known time, location, posture, fasting and context, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-005", "SRC-008", "SRC-016" ] } ], "artifacts": [ { "id": "issued-authored-recorded-ingested-known-time-location-posture-fasting-and-context-record", "name": "Issued, authored, recorded, ingested, known time, location, posture, fasting and context record", "description": "Immutable or successor-versioned evidence-bearing record for issued, authored, recorded, ingested, known time, location, posture, fasting and context.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus issued-authored-recorded-ingested-known-time-location-posture-fasting-and-context statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-005", "SRC-008", "SRC-016" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "lifecycle-correction-refutation-safety-and-use", "name": "Lifecycle, correction, refutation, safety and use", "description": "Groups governed clinical assertion context for lifecycle, correction, refutation, safety and use.", "rationale": "Clinical history is append-only: status, verification, correction and refutation change use without erasing the earlier source-qualified assertion.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-011", "SRC-014", "SRC-015" ], "layers": [ { "id": "result-condition-verification-and-publication-lifecycles", "name": "Result, condition, verification and publication lifecycles", "description": "Groups source-qualified clinical context for result, condition, verification and publication lifecycles.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005" ], "findings": [ { "id": "registered-preliminary-final-amended-corrected-cancelled-unknown-and-entered-in-error", "name": "Registered, preliminary, final, amended, corrected, cancelled, unknown and entered-in-error", "description": "Records registered, preliminary, final, amended, corrected, cancelled, unknown and entered-in-error as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005" ], "questions": [ { "id": "registered-preliminary-final-amended-corrected-cancelled-unknown-and-entered-in-error-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish registered, preliminary, final, amended, corrected, cancelled, unknown and entered-in-error?", "kind": "lifecycle", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "registered-preliminary-final-amended-corrected-cancelled-unknown-and-entered-in-error-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for registered, preliminary, final, amended, corrected, cancelled, unknown and entered-in-error, using which method, evidence and authority?", "kind": "classification", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "registered-preliminary-final-amended-corrected-cancelled-unknown-and-entered-in-error-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to registered, preliminary, final, amended, corrected, cancelled, unknown and entered-in-error, and how may it be validated, challenged, corrected or retained?", "kind": "temporal", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "registered-preliminary-final-amended-corrected-cancelled-unknown-and-entered-in-error-data", "name": "Registered, preliminary, final, amended, corrected, cancelled, unknown and entered-in-error data", "description": "Typed clinical assertion data for registered, preliminary, final, amended, corrected, cancelled, unknown and entered-in-error, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005" ] } ], "artifacts": [ { "id": "registered-preliminary-final-amended-corrected-cancelled-unknown-and-entered-in-error-record", "name": "Registered, preliminary, final, amended, corrected, cancelled, unknown and entered-in-error record", "description": "Immutable or successor-versioned evidence-bearing record for registered, preliminary, final, amended, corrected, cancelled, unknown and entered-in-error.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus registered-preliminary-final-amended-corrected-cancelled-unknown-and-entered-in-error statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005" ] } ], "inline_only_rationale": null }, { "id": "active-recurrence-relapse-inactive-remission-resolved-and-verification-status", "name": "Active, recurrence, relapse, inactive, remission, resolved and verification status", "description": "Records active, recurrence, relapse, inactive, remission, resolved and verification status as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005" ], "questions": [ { "id": "active-recurrence-relapse-inactive-remission-resolved-and-verification-status-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish active, recurrence, relapse, inactive, remission, resolved and verification status?", "kind": "state", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "active-recurrence-relapse-inactive-remission-resolved-and-verification-status-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for active, recurrence, relapse, inactive, remission, resolved and verification status, using which method, evidence and authority?", "kind": "relationship", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "active-recurrence-relapse-inactive-remission-resolved-and-verification-status-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to active, recurrence, relapse, inactive, remission, resolved and verification status, and how may it be validated, challenged, corrected or retained?", "kind": "state", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "active-recurrence-relapse-inactive-remission-resolved-and-verification-status-data", "name": "Active, recurrence, relapse, inactive, remission, resolved and verification status data", "description": "Typed clinical assertion data for active, recurrence, relapse, inactive, remission, resolved and verification status, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005" ] } ], "artifacts": [ { "id": "active-recurrence-relapse-inactive-remission-resolved-and-verification-status-record", "name": "Active, recurrence, relapse, inactive, remission, resolved and verification status record", "description": "Immutable or successor-versioned evidence-bearing record for active, recurrence, relapse, inactive, remission, resolved and verification status.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus active-recurrence-relapse-inactive-remission-resolved-and-verification-status statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005" ] } ], "inline_only_rationale": null } ] }, { "id": "amendment-supersession-refutation-decision-support-and-contestability", "name": "Amendment, supersession, refutation, decision support and contestability", "description": "Groups source-qualified clinical context for amendment, supersession, refutation, decision support and contestability.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-011", "SRC-014", "SRC-015" ], "findings": [ { "id": "amendment-correction-replacement-duplicate-refutation-retraction-and-history", "name": "Amendment, correction, replacement, duplicate, refutation, retraction and history", "description": "Records amendment, correction, replacement, duplicate, refutation, retraction and history as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-011", "SRC-014", "SRC-015" ], "questions": [ { "id": "amendment-correction-replacement-duplicate-refutation-retraction-and-history-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish amendment, correction, replacement, duplicate, refutation, retraction and history?", "kind": "provenance", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "amendment-correction-replacement-duplicate-refutation-retraction-and-history-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for amendment, correction, replacement, duplicate, refutation, retraction and history, using which method, evidence and authority?", "kind": "measurement", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "amendment-correction-replacement-duplicate-refutation-retraction-and-history-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to amendment, correction, replacement, duplicate, refutation, retraction and history, and how may it be validated, challenged, corrected or retained?", "kind": "lifecycle", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "amendment-correction-replacement-duplicate-refutation-retraction-and-history-data", "name": "Amendment, correction, replacement, duplicate, refutation, retraction and history data", "description": "Typed clinical assertion data for amendment, correction, replacement, duplicate, refutation, retraction and history, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-011", "SRC-014", "SRC-015" ] } ], "artifacts": [ { "id": "amendment-correction-replacement-duplicate-refutation-retraction-and-history-record", "name": "Amendment, correction, replacement, duplicate, refutation, retraction and history record", "description": "Immutable or successor-versioned evidence-bearing record for amendment, correction, replacement, duplicate, refutation, retraction and history.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus amendment-correction-replacement-duplicate-refutation-retraction-and-history statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-011", "SRC-014", "SRC-015" ] } ], "inline_only_rationale": null }, { "id": "clinical-use-alert-decision-support-risk-limit-review-and-contestability", "name": "Clinical use, alert, decision support, risk, limit, review and contestability", "description": "Records clinical use, alert, decision support, risk, limit, review and contestability as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-011", "SRC-014", "SRC-015" ], "questions": [ { "id": "clinical-use-alert-decision-support-risk-limit-review-and-contestability-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish clinical use, alert, decision support, risk, limit, review and contestability?", "kind": "decision", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "clinical-use-alert-decision-support-risk-limit-review-and-contestability-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for clinical use, alert, decision support, risk, limit, review and contestability, using which method, evidence and authority?", "kind": "evidence", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "clinical-use-alert-decision-support-risk-limit-review-and-contestability-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to clinical use, alert, decision support, risk, limit, review and contestability, and how may it be validated, challenged, corrected or retained?", "kind": "provenance", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "clinical-use-alert-decision-support-risk-limit-review-and-contestability-data", "name": "Clinical use, alert, decision support, risk, limit, review and contestability data", "description": "Typed clinical assertion data for clinical use, alert, decision support, risk, limit, review and contestability, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-011", "SRC-014", "SRC-015" ] } ], "artifacts": [ { "id": "clinical-use-alert-decision-support-risk-limit-review-and-contestability-record", "name": "Clinical use, alert, decision support, risk, limit, review and contestability record", "description": "Immutable or successor-versioned evidence-bearing record for clinical use, alert, decision support, risk, limit, review and contestability.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus clinical-use-alert-decision-support-risk-limit-review-and-contestability statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-004", "SRC-011", "SRC-014", "SRC-015" ] } ], "inline_only_rationale": null } ] } ] }, { "id": "quality-provenance-privacy-retention-interoperability-and-agents", "name": "Quality, provenance, privacy, retention, interoperability and agents", "description": "Groups governed clinical assertion context for quality, provenance, privacy, retention, interoperability and agents.", "rationale": "Source fidelity, protected access and loss-aware projections make the assertion reusable without obscuring uncertainty or transformation.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-005", "SRC-006", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-013", "SRC-014", "SRC-015", "SRC-016" ], "layers": [ { "id": "source-quality-provenance-access-consent-and-confidentiality", "name": "Source quality, provenance, access, consent and confidentiality", "description": "Groups source-qualified clinical context for source quality, provenance, access, consent and confidentiality.", "source_refs": [ "SRC-001", "SRC-002", "SRC-005", "SRC-011", "SRC-014", "SRC-015" ], "findings": [ { "id": "source-record-terminology-release-mapping-transformation-derivation-and-quality", "name": "Source record, terminology release, mapping, transformation, derivation and quality", "description": "Records source record, terminology release, mapping, transformation, derivation and quality as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-002", "SRC-005", "SRC-011", "SRC-014", "SRC-015" ], "questions": [ { "id": "source-record-terminology-release-mapping-transformation-derivation-and-quality-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish source record, terminology release, mapping, transformation, derivation and quality?", "kind": "provenance", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "source-record-terminology-release-mapping-transformation-derivation-and-quality-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for source record, terminology release, mapping, transformation, derivation and quality, using which method, evidence and authority?", "kind": "quality", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "source-record-terminology-release-mapping-transformation-derivation-and-quality-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to source record, terminology release, mapping, transformation, derivation and quality, and how may it be validated, challenged, corrected or retained?", "kind": "privacy", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "source-record-terminology-release-mapping-transformation-derivation-and-quality-data", "name": "Source record, terminology release, mapping, transformation, derivation and quality data", "description": "Typed clinical assertion data for source record, terminology release, mapping, transformation, derivation and quality, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "1", "required": true, "source_refs": [ "SRC-001", "SRC-002", "SRC-005", "SRC-011", "SRC-014", "SRC-015" ] } ], "artifacts": [ { "id": "source-record-terminology-release-mapping-transformation-derivation-and-quality-record", "name": "Source record, terminology release, mapping, transformation, derivation and quality record", "description": "Immutable or successor-versioned evidence-bearing record for source record, terminology release, mapping, transformation, derivation and quality.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus source-record-terminology-release-mapping-transformation-derivation-and-quality statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-005", "SRC-011", "SRC-014", "SRC-015" ] } ], "inline_only_rationale": null }, { "id": "sensitivity-consent-purpose-access-redaction-break-glass-and-disclosure", "name": "Sensitivity, consent, purpose, access, redaction, break-glass and disclosure", "description": "Records sensitivity, consent, purpose, access, redaction, break-glass and disclosure as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-002", "SRC-005", "SRC-011", "SRC-014", "SRC-015" ], "questions": [ { "id": "sensitivity-consent-purpose-access-redaction-break-glass-and-disclosure-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish sensitivity, consent, purpose, access, redaction, break-glass and disclosure?", "kind": "privacy", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "sensitivity-consent-purpose-access-redaction-break-glass-and-disclosure-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for sensitivity, consent, purpose, access, redaction, break-glass and disclosure, using which method, evidence and authority?", "kind": "authority", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "sensitivity-consent-purpose-access-redaction-break-glass-and-disclosure-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to sensitivity, consent, purpose, access, redaction, break-glass and disclosure, and how may it be validated, challenged, corrected or retained?", "kind": "retention", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "sensitivity-consent-purpose-access-redaction-break-glass-and-disclosure-data", "name": "Sensitivity, consent, purpose, access, redaction, break-glass and disclosure data", "description": "Typed clinical assertion data for sensitivity, consent, purpose, access, redaction, break-glass and disclosure, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-005", "SRC-011", "SRC-014", "SRC-015" ] } ], "artifacts": [ { "id": "sensitivity-consent-purpose-access-redaction-break-glass-and-disclosure-record", "name": "Sensitivity, consent, purpose, access, redaction, break-glass and disclosure record", "description": "Immutable or successor-versioned evidence-bearing record for sensitivity, consent, purpose, access, redaction, break-glass and disclosure.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus sensitivity-consent-purpose-access-redaction-break-glass-and-disclosure statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-005", "SRC-011", "SRC-014", "SRC-015" ] } ], "inline_only_rationale": null } ] }, { "id": "retention-projection-validation-and-safe-agent-operation", "name": "Retention, projection, validation and safe agent operation", "description": "Groups source-qualified clinical context for retention, projection, validation and safe agent operation.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-005", "SRC-006", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-013", "SRC-014", "SRC-015", "SRC-016" ], "findings": [ { "id": "retention-hold-disposition-tombstone-correction-duty-and-audit-reference", "name": "Retention, hold, disposition, tombstone, correction duty and audit reference", "description": "Records retention, hold, disposition, tombstone, correction duty and audit reference as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-005", "SRC-006", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-013", "SRC-014", "SRC-015", "SRC-016" ], "questions": [ { "id": "retention-hold-disposition-tombstone-correction-duty-and-audit-reference-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish retention, hold, disposition, tombstone, correction duty and audit reference?", "kind": "retention", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "retention-hold-disposition-tombstone-correction-duty-and-audit-reference-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for retention, hold, disposition, tombstone, correction duty and audit reference, using which method, evidence and authority?", "kind": "ownership", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "retention-hold-disposition-tombstone-correction-duty-and-audit-reference-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to retention, hold, disposition, tombstone, correction duty and audit reference, and how may it be validated, challenged, corrected or retained?", "kind": "access", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "retention-hold-disposition-tombstone-correction-duty-and-audit-reference-data", "name": "Retention, hold, disposition, tombstone, correction duty and audit reference data", "description": "Typed clinical assertion data for retention, hold, disposition, tombstone, correction duty and audit reference, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-005", "SRC-006", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-013", "SRC-014", "SRC-015", "SRC-016" ] } ], "artifacts": [ { "id": "retention-hold-disposition-tombstone-correction-duty-and-audit-reference-record", "name": "Retention, hold, disposition, tombstone, correction duty and audit reference record", "description": "Immutable or successor-versioned evidence-bearing record for retention, hold, disposition, tombstone, correction duty and audit reference.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus retention-hold-disposition-tombstone-correction-duty-and-audit-reference statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-005", "SRC-006", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-013", "SRC-014", "SRC-015", "SRC-016" ] } ], "inline_only_rationale": null }, { "id": "fhir-openehr-snomed-loinc-icd-omop-dicom-ucum-projection-and-loss", "name": "FHIR, openEHR, SNOMED, LOINC, ICD, OMOP, DICOM, UCUM projection and loss", "description": "Records fhir, openehr, snomed, loinc, icd, omop, dicom, ucum projection and loss as a source-qualified clinical assertion while preserving external clinical masters and the separation between observable, result, interpretation and diagnosis.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-005", "SRC-006", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-013", "SRC-014", "SRC-015", "SRC-016" ], "questions": [ { "id": "fhir-openehr-snomed-loinc-icd-omop-dicom-ucum-projection-and-loss-q01", "text": "Which stable identities, profile, clinical meanings, values and explicit unknowns establish fhir, openehr, snomed, loinc, icd, omop, dicom, ucum projection and loss?", "kind": "interoperability", "answer_data": [ "identifiers and profile", "coded and original meanings", "values, qualifiers and unknowns" ] }, { "id": "fhir-openehr-snomed-loinc-icd-omop-dicom-ucum-projection-and-loss-q02", "text": "Who or what supplied, performed, recorded, interpreted or accepted responsibility for fhir, openehr, snomed, loinc, icd, omop, dicom, ucum projection and loss, using which method, evidence and authority?", "kind": "temporal", "answer_data": [ "participants and roles", "method and evidence", "authority, confidence and limitations" ] }, { "id": "fhir-openehr-snomed-loinc-icd-omop-dicom-ucum-projection-and-loss-q03", "text": "Which event, effective, specimen, onset, issued, recorded and knowledge times apply to fhir, openehr, snomed, loinc, icd, omop, dicom, ucum projection and loss, and how may it be validated, challenged, corrected or retained?", "kind": "validation", "answer_data": [ "distinct clinical and record times", "validation and challenge", "successor correction and retention" ] } ], "data_elements": [ { "id": "fhir-openehr-snomed-loinc-icd-omop-dicom-ucum-projection-and-loss-data", "name": "FHIR, openEHR, SNOMED, LOINC, ICD, OMOP, DICOM, UCUM projection and loss data", "description": "Typed clinical assertion data for fhir, openehr, snomed, loinc, icd, omop, dicom, ucum projection and loss, including profile, source meaning, context, time, authority, status and provenance.", "value_kind": "collection", "cardinality": "0..n", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-005", "SRC-006", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-013", "SRC-014", "SRC-015", "SRC-016" ] } ], "artifacts": [ { "id": "fhir-openehr-snomed-loinc-icd-omop-dicom-ucum-projection-and-loss-record", "name": "FHIR, openEHR, SNOMED, LOINC, ICD, OMOP, DICOM, UCUM projection and loss record", "description": "Immutable or successor-versioned evidence-bearing record for fhir, openehr, snomed, loinc, icd, omop, dicom, ucum projection and loss.", "media_or_form": [ "logical clinical assertion", "observation, assessment, status, provenance or projection record" ], "serial": true, "identity_strategy": "Clinical assertion ID plus fhir-openehr-snomed-loinc-icd-omop-dicom-ucum-projection-and-loss statement or event ID; patient name, code, value, encounter and date never identify the assertion alone.", "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-005", "SRC-006", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-013", "SRC-014", "SRC-015", "SRC-016" ] } ], "inline_only_rationale": null } ] } ] } ] }, "functions": [ { "id": "register-clinical-assertion", "name": "Register clinical assertion", "description": "Governed operation to register clinical assertion without hidden mutation of external clinical masters.", "inputs": [ "profile discriminator", "source record", "subject binding", "authority" ], "outputs": [ "assertion root and lineage" ], "preconditions": [ "stable identity, profile, subject and boundary pass" ], "effects": [ "a bounded assertion exists without creating patient, encounter or disease masters" ], "source_refs": [ "SRC-001", "SRC-002", "SRC-005", "SRC-015" ] }, { "id": "capture-observation-result", "name": "Capture observation result", "description": "Governed operation to capture observation result without hidden mutation of external clinical masters.", "inputs": [ "observable definition", "source value", "method and context" ], "outputs": [ "source-qualified observation result" ], "preconditions": [ "value type, unit, time, method, subject and status pass" ], "effects": [ "the observed result is represented without implying diagnosis" ], "source_refs": [ "SRC-001", "SRC-005", "SRC-008", "SRC-013" ] }, { "id": "assemble-observation-components", "name": "Assemble observation components", "description": "Governed operation to assemble observation components without hidden mutation of external clinical masters.", "inputs": [ "atomic observations", "panel or grouping rule", "derivation" ], "outputs": [ "component or member graph" ], "preconditions": [ "component interpretability, membership and derivation pass" ], "effects": [ "atomic results remain independently identifiable where required" ], "source_refs": [ "SRC-001", "SRC-003", "SRC-011", "SRC-012" ] }, { "id": "record-clinical-impression", "name": "Record clinical impression", "description": "Governed operation to record clinical impression without hidden mutation of external clinical masters.", "inputs": [ "observations and evidence", "assessment context", "responsible clinician" ], "outputs": [ "bounded impression and differential" ], "preconditions": [ "basis, alternatives, uncertainty and authority pass" ], "effects": [ "an assessment exists without becoming a confirmed diagnosis or treatment order" ], "source_refs": [ "SRC-004", "SRC-005", "SRC-007" ] }, { "id": "assert-diagnosis-or-condition", "name": "Assert diagnosis or condition", "description": "Governed operation to assert diagnosis or condition without hidden mutation of external clinical masters.", "inputs": [ "clinical evidence", "condition meaning", "asserter", "profile" ], "outputs": [ "diagnosis assertion" ], "preconditions": [ "subject, code, evidence, verification and clinical status pass" ], "effects": [ "a source-qualified diagnostic statement exists distinct from the disease master" ], "source_refs": [ "SRC-002", "SRC-004", "SRC-006", "SRC-007", "SRC-009" ] }, { "id": "verify-refute-or-change-status", "name": "Verify, refute or change status", "description": "Governed operation to verify, refute or change status without hidden mutation of external clinical masters.", "inputs": [ "assertion", "new evidence", "authority", "expected revision" ], "outputs": [ "immutable status event and successor assertion" ], "preconditions": [ "allowed transition, evidence, reason and authority pass" ], "effects": [ "clinical and verification status change without erasing prior history" ], "source_refs": [ "SRC-001", "SRC-002", "SRC-015" ] }, { "id": "amend-correct-or-replace-assertion", "name": "Amend, correct or replace assertion", "description": "Governed operation to amend, correct or replace assertion without hidden mutation of external clinical masters.", "inputs": [ "prior assertion", "correction", "reason", "responsible party" ], "outputs": [ "successor assertion and revision link" ], "preconditions": [ "identity, non-overwrite, provenance and safety-impact pass" ], "effects": [ "consumers can distinguish current use from historical source content" ], "source_refs": [ "SRC-001", "SRC-002", "SRC-014", "SRC-015" ] }, { "id": "bind-supporting-evidence-and-report", "name": "Bind supporting evidence and report", "description": "Governed operation to bind supporting evidence and report without hidden mutation of external clinical masters.", "inputs": [ "assertion", "observations", "reports, images or documents" ], "outputs": [ "typed evidence-use graph" ], "preconditions": [ "source identity, relevance, version and access pass" ], "effects": [ "support and contradiction remain attributable without copying evidence masters" ], "source_refs": [ "SRC-002", "SRC-003", "SRC-004", "SRC-012", "SRC-015" ] }, { "id": "project-or-ingest-clinical-representation", "name": "Project or ingest clinical representation", "description": "Governed operation to project or ingest clinical representation without hidden mutation of external clinical masters.", "inputs": [ "assertion", "target profile", "terminology releases", "mapping rules" ], "outputs": [ "projection plus loss declaration" ], "preconditions": [ "version, vocabulary, unit, status and round-trip checks pass" ], "effects": [ "FHIR, openEHR, SNOMED, LOINC, ICD, OMOP, DICOM or UCUM views remain traceable" ], "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-005", "SRC-006", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-013" ] }, { "id": "retire-retain-disclose-and-audit", "name": "Retire, retain, disclose and audit", "description": "Governed operation to retire, retain, disclose and audit without hidden mutation of external clinical masters.", "inputs": [ "assertion", "retention and access policies", "hold state" ], "outputs": [ "tombstone, disclosure or disposition event" ], "preconditions": [ "patient safety, legal hold, correction duty, purpose and minimum necessary checks pass" ], "effects": [ "the record remains reconstructable and protected while external policy owns execution" ], "source_refs": [ "SRC-014", "SRC-015", "SRC-016" ] } ], "composition": [ { "target": "WM-ACT-018 Encounter", "relation": "REFERENCE", "purpose": "Record the candidate inverse containment and clinical context without owning Encounter lifecycle.", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-004" ] }, { "target": "WM-LIV-021 Disease / Biological Condition", "relation": "REFERENCE", "purpose": "Bind the external condition or disease entity while keeping the diagnosis assertion independently identified and qualified.", "required": false, "source_refs": [ "SRC-002", "SRC-006", "SRC-007" ] }, { "target": "Patient, Related Person, Practitioner, Organization, Care Team, Specimen, Device, Request, Procedure and Diagnostic Report models", "relation": "REFERENCE", "purpose": "Resolve authoritative clinical participants and acquisition context without lifecycle cascade.", "required": true, "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005" ] }, { "target": "Evidence, Provenance, Consent, Access, Audit and Record models", "relation": "REFERENCE", "purpose": "Bind evidence, authority, protected use and reconstructable history while their masters retain execution semantics.", "required": false, "source_refs": [ "SRC-014", "SRC-015" ] }, { "target": "FHIR R5, openEHR RM 1.1.0, SNOMED CT, LOINC 2.82, ICD-11 2026-01, OMOP CDM 5.4, DICOM and UCUM", "relation": "ALIGN", "purpose": "Project version-pinned clinical and analytic representations with explicit profile, maturity, terminology, unit and loss declarations.", "required": false, "source_refs": [ "SRC-001", "SRC-002", "SRC-003", "SRC-004", "SRC-005", "SRC-006", "SRC-007", "SRC-008", "SRC-009", "SRC-010", "SRC-011", "SRC-012", "SRC-013" ] } ], "serviceLayers": { "dimension": { "owner_package_requirements": [ "Dimension owner and clinical assertion governance mandate", "Patient, practitioner, encounter, condition, terminology, specimen, device, procedure, report, consent, audit and record registries", "Approved clinical profiles, terminology releases, units, mappings and validation rules", "Privacy, safety, disclosure, correction, retention and agent policies" ], "namespace_guidance": "Mint assertion, observation, component, evidence-use, interpretation, diagnosis, status, revision, disclosure and event IDs; preserve every source-system identifier and terminology release.", "registry_links": [ "https://ver.cy/models/", "https://ver.cy/model-agent-protocol.md" ] }, "canon_and_patch": { "canonicalization_rules": [ "Canonicalize by authoritative source-system clinical assertion identifier, profile, source organization and lineage head, never by patient, code, result, encounter or date alone.", "Keep observable, observation result, interpretation, impression, diagnosis assertion, condition entity, diagnostic report and clinical action distinct." ], "patch_rules": [ "Extensions declare specialty, jurisdiction, terminology, unit, status, privacy, retention and interoperability effects.", "Released results, interpretations and diagnoses are immutable; corrections, amendments, refutations and replacements create linked successors.", "Never silently change subject, focus, source value, code mapping, unit, method, evidence, time, performer, asserter, status, confidence, access or provenance." ], "compatibility_rules": [ "Ignore additive fields only when identity, profile, subject, clinical meaning, value, status, authority, time and provenance survive.", "Every exchange projection pins resource or archetype version, terminology and unit releases, mapping rules and declared information loss." ] }, "artifact_rules": { "identity_priority": [ "Authoritative master-system clinical assertion identifier qualified by source organization and assertion profile.", "Governed globally resolvable clinical assertion IRI.", "Dimension UUID when neither preceding identifier exists." ], "timestamp_rule": "Use RFC 3339 timestamps with seconds and explicit offset or Z; distinguish effective, specimen collection, onset, abatement, performed, authored, issued, recorded, ingested, observation and knowledge times whenever they differ.", "serial_naming_rule": "Use {clinical-assertion-id}--{statement-or-event-id}--{artifact-kind}--{revision-id}.", "integrity_rule": "Store digest, media type, profile, subject and source binding, terminology and unit versions, actor, event and knowledge times, status, access marking and provenance." }, "policies": [ "The clinical assertion is not a Patient, Practitioner, Encounter, Episode, Specimen, Device, Service Request, Procedure, Diagnostic Report, Disease, Biological Condition, Terminology, Care Plan, Treatment, Medication, Consent, Audit or Record master.", "Observable, observation result, interpretation, impression, diagnosis, disease entity, report and action remain separate.", "Preliminary, final, amended, refuted, entered-in-error, unknown, absent and not-performed states are never conflated.", "Agents cannot diagnose, refute, sign, disclose, suppress, delete or trigger clinical action outside explicit role, evidence and policy authority." ], "crud": { "read": [ "Resolve access purpose, assertion profile, subject and encounter bindings, source content, normalized meaning, value, evidence, interpretation, status, lineage, provenance, holds and projection loss." ], "create": [ "Bind stable assertion identity, profile, source, subject, accountable authority, effective time and source meaning before clinical use." ], "update": [ "Append successor results, interpretations, statuses, corrections, refutations and provenance with reason, authority, expected revision, event time and knowledge time." ], "delete": [ "Apply patient-safety, clinical-record, privacy, legal-hold and adopting-Dimension retention policy; retire or tombstone this assertion without cascading to Patient, Encounter, Condition, Evidence or other referenced masters, and let the external records policy execute physical disposition." ] }, "roles": [ { "name": "Clinical assertion steward", "responsibilities": [ "Own model profile, boundary, namespace, lifecycle and quality rules." ] }, { "name": "Observer or performer", "responsibilities": [ "Own source-qualified acquisition and method statements within competence." ] }, { "name": "Recorder or data enterer", "responsibilities": [ "Preserve source fidelity and distinguish entry from clinical responsibility." ] }, { "name": "Interpreter or responsible asserter", "responsibilities": [ "Own interpretation or diagnosis, evidence basis, uncertainty and signature." ] }, { "name": "Terminology and interoperability steward", "responsibilities": [ "Own versioned code, unit and projection mappings with loss declarations." ] }, { "name": "Privacy and consent steward", "responsibilities": [ "Own purpose-bound access, disclosure, redaction and break-glass policy." ] }, { "name": "Clinical safety reviewer", "responsibilities": [ "Own correction impact, contested results and downstream-use review." ] }, { "name": "Records and assurance steward", "responsibilities": [ "Own retention, holds, provenance, auditability and disposition evidence." ] } ], "access": { "default_rule": "Deny health, genetic, biometric, family, reproductive, mental-health, substance-use, infectious-disease and other sensitive assertion content unless purpose-bound policy permits the minimum necessary view.", "scopes": [ "bundle", "layer", "finding", "artifact" ], "exceptions": [ "Declared subject, guardian, care team, emergency, public-health, research, regulator, court or legally authorized access must cite authority, scope, purpose and time limit where applicable and must be logged." ], "audit_requirements": [ "Log actor, agent, role, purpose, assertion, operation, authority, policy, RFC 3339 time, affected fields, source revision and outcome without duplicating unnecessary clinical content." ] }, "agents_bootstrap": { "filename": "AGENTS.md", "required_fields": [ "Name", "Type", "Specification URL", "Storage type URL", "Interface URL", "Processes URL" ], "read_order": [ "Read Dimension clinical safety, terminology, privacy, consent, access, disclosure, correction, records and agent policies.", "Read this model and linked patient, practitioner, encounter, specimen, device, procedure, report, condition, evidence, consent, audit and terminology models before mutation." ] } }, "coverage": { "claim": "WM-ACT-046 covers one source-qualified clinical assertion profiled as observation result, clinical impression or diagnosis-condition from capture and interpretation through verification, correction, protected use, retention and projection. It separates the assertion from patient, practitioner, encounter, specimen, device, procedure, diagnostic report, disease, terminology, care action, consent, audit and record masters. Specialty profiles, jurisdiction rules, the candidate Encounter containment edge, release-pinned implementation testing and independent external review remain deferred.", "confidence": "medium", "checklist": [ { "dimension": "identity", "status": "covered", "notes": "Identity is explicit; specialty profiles, jurisdiction rules, independently reviewed mappings and the candidate Encounter relation remain held where applicable." }, { "dimension": "classification and definition", "status": "covered", "notes": "Classification and definition is explicit; specialty profiles, jurisdiction rules, independently reviewed mappings and the candidate Encounter relation remain held where applicable." }, { "dimension": "direct properties", "status": "covered", "notes": "Direct properties is explicit; specialty profiles, jurisdiction rules, independently reviewed mappings and the candidate Encounter relation remain held where applicable." }, { "dimension": "recognition and observation", "status": "covered", "notes": "Recognition and observation is explicit; specialty profiles, jurisdiction rules, independently reviewed mappings and the candidate Encounter relation remain held where applicable." }, { "dimension": "capabilities and possible actions", "status": "gap", "notes": "Capabilities and possible actions is explicit; specialty profiles, jurisdiction rules, independently reviewed mappings and the candidate Encounter relation remain held where applicable." }, { "dimension": "composition", "status": "covered", "notes": "Composition is explicit; specialty profiles, jurisdiction rules, independently reviewed mappings and the candidate Encounter relation remain held where applicable." }, { "dimension": "lifecycle", "status": "covered", "notes": "Lifecycle is explicit; specialty profiles, jurisdiction rules, independently reviewed mappings and the candidate Encounter relation remain held where applicable." }, { "dimension": "relationships", "status": "covered", "notes": "Relationships is explicit; specialty profiles, jurisdiction rules, independently reviewed mappings and the candidate Encounter relation remain held where applicable." }, { "dimension": "temporal", "status": "covered", "notes": "Temporal is explicit; specialty profiles, jurisdiction rules, independently reviewed mappings and the candidate Encounter relation remain held where applicable." }, { "dimension": "spatial", "status": "gap", "notes": "Spatial is explicit; specialty profiles, jurisdiction rules, independently reviewed mappings and the candidate Encounter relation remain held where applicable." }, { "dimension": "provenance", "status": "covered", "notes": "Provenance is explicit; specialty profiles, jurisdiction rules, independently reviewed mappings and the candidate Encounter relation remain held where applicable." }, { "dimension": "ownership and stewardship", "status": "covered", "notes": "Ownership and stewardship is explicit; specialty profiles, jurisdiction rules, independently reviewed mappings and the candidate Encounter relation remain held where applicable." }, { "dimension": "validation and quality", "status": "covered", "notes": "Validation and quality is explicit; specialty profiles, jurisdiction rules, independently reviewed mappings and the candidate Encounter relation remain held where applicable." }, { "dimension": "access and privacy", "status": "covered", "notes": "Access and privacy is explicit; specialty profiles, jurisdiction rules, independently reviewed mappings and the candidate Encounter relation remain held where applicable." }, { "dimension": "retention and deletion", "status": "covered", "notes": "Retention and deletion is explicit; specialty profiles, jurisdiction rules, independently reviewed mappings and the candidate Encounter relation remain held where applicable." }, { "dimension": "interoperability", "status": "covered", "notes": "Interoperability is explicit; specialty profiles, jurisdiction rules, independently reviewed mappings and the candidate Encounter relation remain held where applicable." } ], "known_omissions": [ "Claude and Grok each timed out on one bounded attempt; no independent external result was admitted.", "WM-ACT-018 Encounter CONTAINS WM-ACT-046 is candidate metadata and not an approved composition edge.", "Specialty-specific diagnostics, pathology, genomics, imaging, laboratory, vital-sign, mental-health and patient-reported outcome profiles remain deferred.", "FHIR R5 resources are Trial Use at varied maturity, ClinicalImpression is maturity level 1, and full SNOMED, LOINC, ICD, OMOP and DICOM conformance requires release-pinned implementation testing." ], "conflicts": [ "An observable definition, observation result, clinical finding, interpretation, impression, diagnosis assertion, condition or disease entity are not interchangeable.", "Observation result status, diagnosis verification status and condition clinical status describe different axes.", "Source fidelity, terminology normalization, analytical usability, privacy, correction rights and patient-safety retention can conflict and require attributable policy decisions." ], "regional_assumptions": [ "Diagnostic authority, signing, disclosure, correction, retention, consent and patient-access rules depend on jurisdiction, care setting and professional scope.", "ICD is primarily a classification and reporting system; clinical terminology, source record and diagnosis semantics must not be inferred solely from an ICD code.", "Exchange profiles, value sets, units and terminology licensing differ by trading partner and jurisdiction." ], "adversarial_checks": [ "Reject an assertion without stable identity, explicit profile, source, subject binding, responsible authority, effective time and lineage head.", "Reject a result represented as a diagnosis, a diagnosis represented as the disease master, a preliminary result represented as final or a refuted assertion represented as deleted.", "Reject a numeric result without unit or explicit unitless status, method and time qualifiers where clinically material, and reject reference ranges detached from population and method.", "Reject corrections that overwrite prior values, interpretations, diagnosis evidence, status, source mapping or authorship.", "Reject autonomous diagnosis, suppression, clinical action, disclosure or disposition outside explicit authority and safety controls." ] }, "researchAdjudication": { "providerMode": "single-provider-waiver", "activeProviders": [ "codex" ], "waivedProviders": [ "claude", "grok" ], "providerPolicy": { "contract_version": "1.0.0", "mode": "single-provider-waiver", "effective_at": "2026-09-06T00:00:00Z", "scope": "Canonical single-stream subject-model research after the six-workstream consolidation", "active_providers": [ "codex" ], "waived_providers": [ { "provider": "claude", "authorized_by": "repository owner", "authorized_at": "2026-09-06T00:00:00Z", "reason": "Claude produced no result on prior 1800-second and 900-second attempts and again timed out on bounded 600-second Sonnet and 300-second Haiku passes. The owner prioritized completion over provider availability." }, { "provider": "grok", "authorized_by": "repository owner", "authorized_at": "2026-09-06T00:00:00Z", "reason": "The repository owner authorized completion without Grok when Grok is unavailable, slow or schema-invalid. Grok may still be attempted as a bounded supplemental reviewer, but its failure never blocks a valid Claude plus no-tools result." } ], "review_rule": "Codex may complete source-grounded fallback research after bounded Claude and Grok attempts fail. It requires a separate no-tools adversarial audit and remains reviewable-draft with a visible absence-of-external-review hold.", "supplemental_provider_attempts": [ { "provider": "claude", "required": false, "maximum_attempts": 1, "failure_policy": "record-and-continue", "admission_rule": "Use only a locally schema-valid result whose sources and boundaries survive adjudication." }, { "provider": "grok", "required": false, "maximum_attempts": 1, "failure_policy": "record-and-continue", "admission_rule": "Use only a locally schema-valid result whose sources and boundaries survive adjudication." } ] }, "boundaryDecision": { "entry_kind": "aggregate", "status": "accepted", "rationale": "The subject-model entry kind aggregate is sound because one assertion coordinates profile, source, subject binding, result or diagnosis content, evidence, authority, time, status, correction and projection without absorbing external masters. The frozen registry record_plane is world-model and its catalogue entry_kind is standalone-mm; neither is the model-research schema entry_kind axis." }, "decisions": [ { "concept": "Observable, result, impression, diagnosis assertion and disease entity separation", "disposition": "accepted", "rationale": "FHIR, openEHR and SNOMED sources support distinct observable, observation-result, evaluation or impression, diagnosis assertion and persistent disease semantics. The required assertion profile and external WM-LIV-021 reference preserve those boundaries." }, { "concept": "Observation status, verification status and clinical status axes", "disposition": "accepted", "rationale": "Result publication state, confidence or verification of a diagnosis, and the subject condition's active or resolved state are independent axes and cannot be substituted for one another." }, { "concept": "Subject, encounter, performer, recorder, interpreter and asserter roles", "disposition": "accepted", "rationale": "The model uses role-qualified external references and separates data entry, observation performance, interpretation and responsibility. It does not own participant or Encounter lifecycles." }, { "concept": "WM-ACT-018 Encounter containment", "disposition": "deferred", "rationale": "The registry ledger records Encounter CONTAINS WM-ACT-046 as candidate metadata. The specification may reference Encounter context but may not publish the candidate relation as approved or infer cascade behavior." }, { "concept": "Immutable correction, refutation and replacement", "disposition": "accepted", "rationale": "Released clinical results and diagnoses are not overwritten. Amendment, correction, entered-in-error, refutation and replacement create attributable successor events and preserve prior content for safety and auditability." }, { "concept": "Source fidelity and terminology normalization", "disposition": "accepted-with-profile-hold", "rationale": "Original values, codes and units remain attributable beside release-pinned mappings. Specialty and adopting-Dimension profiles must decide mapping validation, allowable loss and clinical safety gates." }, { "concept": "Standards maturity and projection scope", "disposition": "accepted", "rationale": "FHIR R5 Observation is normative, while Condition and DiagnosticReport are Trial Use and ClinicalImpression is Trial Use at maturity level 1. openEHR, SNOMED, LOINC, ICD, OMOP, DICOM and UCUM are alignments whose versions, licenses, value sets and losses must be pinned; no universal conformance is claimed." }, { "concept": "Single-provider waiver", "disposition": "accepted-with-mandatory-hold", "rationale": "One Claude Sonnet and one Grok 4.6 attempt for WM-ACT-046 each timed out after 120 seconds. Owner-approved policy permits source-grounded Codex fallback after this separate no-tools audit. Confidence remains medium and assurance remains reviewable-draft with a visible absence-of-external-review hold." } ], "publicationHolds": [ "Absence-of-external-review hold: one Claude Sonnet and one Grok 4.6 attempt for WM-ACT-046 each timed out after 120 seconds. No external result was admitted; the model remains a reviewable draft after the separate no-tools audit.", "Registry edge approval hold: WM-ACT-018 Encounter CONTAINS WM-ACT-046 remains candidate metadata. This blocks complete relationship claims, not standalone reviewable-draft publication.", "Clinical-specialty hold: pathology, genomics, imaging, laboratory, vital-sign, mental-health, patient-reported and other profiles need domain-specific value, method, reference-range, evidence, authority and safety rules.", "Jurisdiction and institution hold: diagnostic authority, signature, consent, disclosure, correction, retention and patient-access rules must bind applicable professional and legal policy before operational use.", "Interoperability hold: FHIR resource maturity varies and all FHIR, openEHR, SNOMED, LOINC, ICD, OMOP, DICOM and UCUM projections require version-pinned mappings, licensed content where applicable, loss declarations and clinical validation.", "Independent external review was explicitly waived by the repository owner; this codex-only result remains a reviewable draft." ], "deferredResearch": [ "Approve or reject the WM-ACT-018 containment edge and define cardinality, encounter context, cross-encounter assertion and non-cascade semantics.", "Create specialty assertion profiles for laboratory, pathology, imaging, genomics, vital signs, mental health and patient-reported outcomes.", "Create jurisdiction and institution profiles for diagnostic authority, signature, consent, disclosure, correction, retention and access.", "Test release-pinned FHIR, openEHR, SNOMED CT, LOINC, ICD-11, OMOP CDM, DICOM and UCUM mappings with mapping-loss and round-trip evidence.", "Obtain supplemental Claude or Grok review and resolve any material challenge before canonical promotion." ] }, "statistics": { "sources": 16, "bundles": 6, "layers": 12, "findings": 24, "questions": 72, "artifacts": 24, "functions": 10 } }