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Annex 2b Independent Resource Contracts

Annex 2b Independent Resource Contracts

This page defines reusable FHIR R4 record contracts for three independent Annex 2b implementation groups:

• structured assessments and attestations (e61, e62A, e65);
• sensory and medical-aid orders (e08, e08A, e15, e16H);
• the e16G non-prescription medicine recommendation.

They intentionally do not share one artificial parent. Assessment evidence, visual prescriptions, device requests, and medication recommendations have different lifecycle and data semantics in FHIR R4. The profiles preserve those differences while using consistent patient, author, indication, evidence, and coverage references.

These contracts are reusable clinical records. They are not normative Annex 2b document envelopes, form renderings, dispensing messages, reimbursement claims, or declarations of conformance to an external form package.

Resource-choice verdicts

Form	Primary profiled resource	Verdict	Supporting graph
e61	FPDEE61AssessmentResponse and FPDEE61RehabilitationRequest	Keep the versioned source answers in QuestionnaireResponse. Link the clinician's conclusion as a separate Condition or Observation; the resulting rehabilitation ServiceRequest points to the response through supportingInfo.	QuestionnaireResponse -> evidence Observation/Condition; rehabilitation ServiceRequest.supportingInfo -> QuestionnaireResponse
e62A	FPDEE62AAssessmentReport	Use DiagnosticReport for the clinician-authored potential assessment. Source answers remain in a versioned QuestionnaireResponse; measured results remain in Observation.	DiagnosticReport -> source QuestionnaireResponse; DiagnosticReport.result -> measured Observation
e65	FPDEE65ChildAttestation	Use Composition for the attestation. The child is always Composition.subject; parent context is a separate section entry pointing to a RelatedPerson or a distinct parent Patient.	Composition.subject -> child; child-evidence section -> findings; parent-context section -> parent
e08	FPDEE08VisualAidPrescription	Use VisionPrescription for conventional corrective glasses or contact lenses because it natively carries the lens specification.	Supporting refraction and coverage use the narrow vision-supporting-information and vision-coverage extensions because R4 VisionPrescription has no native equivalents.
e08A	FPDEE08AMagnifyingVisualAidRequest	Use DeviceRequest for a magnifying aid that is specified and supplied as a patient-focused device. Do not force it into the conventional lens structure.	Native reasonReference, supportingInfo, parameter, and insurance
e15	FPDEE15HearingAidRequest	Use DeviceRequest. FHIR R4 explicitly includes hearing aids in the scope of this resource.	Native indication, audiometry, device parameters, and coverage
e16H	FPDEE16HMedicalAidRequest	Use DeviceRequest for patient-focused medical aids.	Native indication, optional measurements, quantity/customization parameters, and coverage
e16G	FPDEE16GMedicationRecommendation	Use MedicationRequest with intent = proposal. The resource supports over-the-counter medicines, while proposal makes the record non-authoritative and distinct from a prescription order.	Medication identity, indication, usage advice, substitution guidance, patient, author, and optional coverage

The resource choices follow the FHIR R4 boundaries for VisionPrescription, DeviceRequest, and MedicationRequest. FHIR R4 describes conventional lens authorization, patient-focused device requests, and medication requests as related but distinct request types.

Assessment decomposition

Content	Resource location	Derivation rule
Form questions and answers	Versioned Questionnaire and QuestionnaireResponse	Keep the authored source content unchanged. QuestionnaireResponse.questionnaire must use canonical\|version.
Measured clinical evidence	Observation	Record the measurement independently with patient and effective time. Link it from the assessment report or evidence extension.
Diagnosed or asserted clinical state	Condition	Record the clinician's conclusion separately from patient answers. Evidence can refer back to observations.
e61 rehabilitation order	ServiceRequest	Link the completed response from ServiceRequest.supportingInfo; the assessment supports the resulting order but does not calculate eligibility. QuestionnaireResponse.basedOn is not used because it identifies a request fulfilled by the response, which would reverse the clinical derivation.
e62A clinician conclusion	DiagnosticReport.conclusion	Link the source response with assessment-evidence and measured evidence through result.
e65 signed attestation	Composition	Keep child evidence and parent context in named sections. Use attester for the professional attestation.

No profile in this group computes rehabilitation eligibility, weaning potential, decannulation potential, or family-care entitlement. A system may author a derived conclusion only when an external, versioned rule contract governs that derivation and the resulting resource preserves provenance to its input evidence.

Terminology governance

The table records the terminology disposition as assessed on 2026-07-28. External content is not copied into this IG unless its distribution and versioning contract is explicit.

Assessments and attestations

Domain	Source and version	Licensing or ownership	Binding disposition
ICF functional evidence	BfArM German ICF reference edition 2005, based on the WHO ICF	WHO classification; the BfArM reference is available under its published download terms. This IG does not mirror the classification.	No binding in this release. Use externally governed ICF codings where available; profile bindings remain open until a versioned FHIR terminology package with acceptable distribution terms is selected.
e62A AKI assessment concepts	KBV outpatient intensive care guidance, assessed 2026-07-28	KBV/G-BA form and guidance content. No reusable machine-readable terminology package was identified.	Explicit gap. Evidence codes remain open; implementations must retain the source system and version.
Attestation and form identity	Annex 2b amendment dated 2025-05-23	KBV and GKV-Spitzenverband source document. The IG-owned artifact codes classify local assessment roles and do not reproduce form content.	Required fixed artifact codes from Annex2bAssessmentArtifactTypeCS, version 2025-05-23. Clinical evidence remains externally coded.

Visual, hearing, and medical aids

Domain	Source and version	Licensing or ownership	Binding disposition
Refraction and visual-function observations	BfArM LOINC service, terminology status assessed 2026-07-28	Regenstrief Institute LOINC terms apply. No LOINC content is redistributed by this IG.	Open in this release. Use a versioned LOINC code when an appropriate observation concept exists; retain text when no agreed code exists.
Audiometry observations	Same BfArM/LOINC source and assessment date	Same LOINC ownership and distribution disposition.	Open in this release. Do not assert an arbitrary required audiometry code before a German implementation set is governed.
Device kind and medical-aid directory	GKV-Spitzenverband Hilfsmittelverzeichnis, live directory assessed 2026-07-28	GKV-Spitzenverband owns and maintains the directory. This IG has no authorization to publish a complete mirror.	Explicit gap. DeviceRequest.code[x] remains open; a consumer may carry the official directory code and source version under its own access contract.
Form role	Annex 2b amendment dated 2025-05-23	IG-owned classification derived from the source form identity, without copying proprietary catalogs.	Required by the corresponding profile identity, not used as the requested device code.

Non-prescription medicine recommendation

Domain	Source and version	Licensing or ownership	Binding disposition
Medication identity	BfArM ATC/DDD official German edition 2026 for substance/class context; IFA/PZN product identity remains IFA-governed	BfArM publishes the official German ATC edition under download terms. IFA owns PZN and related product data. No ATC or PZN catalog is mirrored here.	Open medication binding. Use the product or substance coding appropriate to the implementation and preserve its system and version. Free text is allowed when no governed identifier is available.
Recommendation category	Annex 2b amendment dated 2025-05-23	IG-owned local classification of the e16G record role, intentionally separate from the assessment classifier and from medication identity.	Required fixed Annex2bMedicationRecommendationCategoryCS#e16g-otc-recommendation, version 2025-05-23.

Workflow boundaries

• VisionPrescription, DeviceRequest, and MedicationRequest record the clinical request or proposal. They do not prove that an item was supplied.
• Dispensing, provision, fitting, or device-use events require their own workflow resources and external contract.
• Coverage references preserve the payer context but do not represent a claim, authorization response, or reimbursement decision.
• e16G excludes MedicationRequest.dispenseRequest and fixes intent = proposal. It must not be sent as an electronic prescription unless a separate conversion creates a resource conforming to the official prescription contract.
• These profiles do not define a Bundle or Composition envelope for Annex 2b transport, except for the e65 clinical attestation record itself.

Validation evidence

Positive examples are published for every form:

• annex2b-e61-assessment-response
• annex2b-e62a-assessment-report
• annex2b-e65-child-attestation
• annex2b-e08-visual-aid-prescription
• annex2b-e08a-magnifying-aid-request
• annex2b-e15-hearing-aid-request
• annex2b-e16h-medical-aid-request
• annex2b-e16g-medication-recommendation

The repository validation gate also checks negative evidence and resource-choice fixtures: missing e61 order linkage, missing e62A source-response linkage, conflated e65 child/parent identity, e08A assigned to VisionPrescription instead of DeviceRequest, and e16G prescription intent.