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      • Round 1
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Response

LR-7XP ("HL7 FHIR interoperability standard compliance") is a labeling requirement that specifies the IFU shall document the device's compliance with HL7 FHIR interoperability standards. This requirement has three sub-points: (1) the device outputs follow FHIR specifications, returning a DiagnosticReport resource; (2) DiagnosticReport status is marked as 'preliminary' to indicate outputs support, not replace, clinical judgment; and (3) FHIR-compliant data format for healthcare system integration. We provide both the labeling verification (confirming the IFU documents FHIR compliance) and the software verification (proving the device actually produces FHIR-compliant output).

Labeling verification (IFU content review). LR-7XP has been verified as part of the labeling requirements verification described in Q2. The verification record in R-TF-001-006 IFU and Label Validation (section "Labeling requirements verification") confirms that all three sub-points of LR-7XP are documented in the IFU Endpoint Specification. Specifically: Sub-point 1 (DiagnosticReport resource) is documented at line 21, which states "you send images, and you receive a DiagnosticReport as defined in HL7's FHIR specifications". Sub-point 2 (preliminary status) is documented at line 40, which states the DiagnosticReport is "labeled as a DiagnosticReport with a status of preliminary". Sub-point 3 (FHIR-compliant format) is documented at line 36, which states the output "adheres to the FHIR standard". The verification method is content review per EN 62304 § 5.5.2, which permits verification by review, inspection, or analysis for documentation requirements.

Software verification (FHIR DiagnosticReport tests). Beyond documenting FHIR compliance in the IFU, we provide evidence that the device actually produces FHIR-compliant output. Software requirement SRS-F05 ("Generate FHIR DiagnosticReport Base Structure") specifies that the system shall create a FHIR DiagnosticReport resource with resourceType set to DiagnosticReport, status set to preliminary, category set to IMG (Diagnostic Imaging) from the HL7 terminology code system, and code populated with LOINC codes 100063-7 and 10206-1 to designate the report as a "Skin condition analysis". Two test cases directly verify SRS-F05:

Test case C368 (T230), titled "Verify FHIR DiagnosticReport base structure for a detector", verifies that detector models produce a correctly structured FHIR DiagnosticReport. The test sends an API request with a clinical image to a detector endpoint and validates that the response contains a DiagnosticReport resource with the required fields: resourceType equals DiagnosticReport, status equals preliminary, category contains IMG code, code contains LOINC codes, and all required sub-fields (identifier, issuedAt, analysisDuration, imageAnalysis, findings) are present and correctly typed. Test result: Passed. Reviewer: Gerardo Fernández. Review status: Approved.

Test case C453 (T271), titled "Verify FHIR DiagnosticReport base structure for a segmenter", verifies that segmenter models produce a correctly structured FHIR DiagnosticReport. The test sends an API request with a clinical image to a segmenter endpoint and validates the same DiagnosticReport structure requirements as T230. Test result: Passed. Reviewer: Gerardo Fernández. Review status: Approved.

Related DiagnosticReport tests. Five additional test cases verify specific DiagnosticReport fields and are mapped to other SRS codes: T231 (SRS-FMG) verifies the analysisDuration field is present and non-negative; T235 and T236 (SRS-K6N) verify the imageAnalyses array structure for single and multiple images; T239 and T240 (SRS-W5Z) verify identifier assignment and uniqueness across reports. All five tests passed and have been reviewed and approved by Gerardo Fernández.

Regulatory basis. The labeling verification satisfies EN 62304 § 5.5.2 (verification by content review). The software verification satisfies EN 62304 § 5.5 (each software requirement verified by test execution). Both layers together satisfy MDR Annex II 6.1(a)(b) (description of verification activities and evidence) and GSPR 17.2 (verification per state of the art).

Traceability. LR-7XP is traced to its verification evidence in R-TF-001-006 (labeling verification record). SRS-F05 is traced to test cases C368 and C453 in R-TF-012-043 Traceability Matrix. The complete verification chain is: LR-7XP (labeling requirement) → R-TF-001-006 (content verification confirming IFU documents FHIR) → SRS-F05 (software requirement implementing FHIR) → C368/C453 (test cases verifying FHIR output) → attached evidence (actual API payloads).

Attached evidence​

The following evidence files are attached to this response to demonstrate complete verification of LR-7XP:

Evidence 1: T230 API request/response payload (FHIR DiagnosticReport for detector). This file contains the actual API request sent to a detector endpoint during test execution and the complete JSON response received from the device. The response shows a fully formed FHIR DiagnosticReport resource with resourceType set to "DiagnosticReport", status set to "preliminary", category containing the IMG code from the HL7 terminology system, code containing LOINC codes 100063-7 and 10206-1, and all required fields (identifier, issuedAt, analysisDuration, imageAnalysis, findings) correctly populated. Source: s3://legit-health-plus/software-tests/v1.1.0.0/02_software_verification/preproduction/test-plan-13/test_run_230/

Evidence 2: T271 API request/response payload (FHIR DiagnosticReport for segmenter). This file contains the actual API request sent to a segmenter endpoint during test execution and the complete JSON response received from the device. The response demonstrates the same FHIR DiagnosticReport structure as Evidence 1, confirming that both detector and segmenter model types produce FHIR-compliant output. Source: s3://legit-health-plus/software-tests/v1.1.0.0/02_software_verification/preproduction/test-plan-13/test_run_271/

These evidence files prove that the device produces correctly structured FHIR DiagnosticReport resources with "preliminary" status, confirming the truthfulness of the IFU's FHIR compliance claims documented in LR-7XP.

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