generated: '2026-08-27' method: searched source: 'https://sibelhealth.com/remote-patient-monitoring/, https://sibelhealth.com/security/, and the FDA 510(k) database via https://api.fda.gov/device/510k.json?search=applicant:"Sibel Health"' summary: 'Sibel Health is a regulated medical-device manufacturer, so its strongest conformance evidence is regulatory rather than protocol-level. Five FDA 510(k) clearances were confirmed directly against the FDA''s own openFDA device database. What is NOT present is any conformance evidence read from a machine-readable contract: no OpenAPI, no FHIR CapabilityStatement, no SCIM schema URN, no OData $metadata, no HL7v2 message profile. The health regime shortlist in scoring.yml (fhir, smart-on-fhir, us-core, uscdi, hl7-v2, dicom, cds-hooks, c-cda) was checked and none of it is declared anywhere Sibel publishes. Domain-standard conformance is therefore recorded as not-established — a measured absence, not a penalty.' regulatory: - id: fda-510k authority: U.S. Food and Drug Administration conforms: true evidence: source: openFDA 510(k) device database url: 'https://api.fda.gov/device/510k.json?search=applicant:%22Sibel+Health%22' status: 200 clearance_count: 5 clearances: - k_number: K223711 device_name: ANNE One product_code: DRG decision_date: '2023-08-10' - k_number: K240251 device_name: ANNE Chest product_code: DRG decision_date: '2024-06-03' - k_number: K240305 device_name: ANNE Limb product_code: DQA decision_date: '2024-05-28' - k_number: K242842 device_name: ANNE View, Central Hub product_code: MSX decision_date: '2025-01-08' - k_number: K253021 device_name: ANNE Maternal product_code: HGM decision_date: '2026-02-26' - id: eu-mdr-ce-mark authority: European Union Medical Device Regulation (EU) 2017/745 conforms: true classification: Class IIb evidence: url: https://www.prnewswire.com/news-releases/sibel-health-receives-eu-mdr-class-iib-ce-mark-for-anne-one-the-first-wireless-wearable-patient-monitoring-platform-certified-to-key-interoperability-standards-302796155.html status: 200 date: '2026-06-10' quote: 'ANNE One system has received CE Mark certification under the European Union Medical Device Regulation (EU MDR 2017/745) as a Class IIb medical device.' note: Notified body not named in the release. compliance: - id: hipaa conforms: true claim_type: self-declared evidence: url: https://sibelhealth.com/remote-patient-monitoring/ status: 200 quote: ANNE Care is HIPAA and GDPR compliant. note: A published compliance claim on the company's own product page. No SOC 2, ISO 27001 or third-party attestation report is published, and no trust center exists. - id: gdpr conforms: true claim_type: self-declared evidence: url: https://sibelhealth.com/remote-patient-monitoring/ status: 200 quote: ANNE Care is HIPAA and GDPR compliant. - id: soc-2 conforms: false evidence: note: Not claimed anywhere on sibelhealth.com. The /security/ page carries a vulnerability disclosure policy only and names no certification. - id: iso-27001 conforms: false evidence: note: Not claimed on any public Sibel Health page probed on 2026-08-27. - id: iso-13485 conforms: null evidence: note: 'Not published on sibelhealth.com. An ISO 13485 quality system is a practical prerequisite for the company''s FDA 510(k) clearances, but Sibel does not state it publicly, so this is recorded as unknown rather than asserted.' domain_standards: - id: ieee-11073-sdc label: IEEE 11073 Service-Oriented Device Connectivity (SDC) conforms: true claim_type: certified evidence: url: https://www.prnewswire.com/news-releases/sibel-health-receives-eu-mdr-class-iib-ce-mark-for-anne-one-the-first-wireless-wearable-patient-monitoring-platform-certified-to-key-interoperability-standards-302796155.html status: 200 date: '2026-06-10' quote: 'ANNE One is the first wireless wearable monitoring platform certified to the IEEE 11073 Service-Oriented Device Connectivity (SDC) family of standards.' supporting_quote: 'The solution is designed to communicate natively with other SDC-compatible devices and hospital IT systems, without proprietary gateways or vendor lock-in.' note: 'This is the domain standard for Sibel Health''s market, and the conformance is certified rather than merely asserted — the strongest signature in this file. Two important qualifications. First, the certification attaches to the ANNE One DEVICE platform, not to the api.sibelhealth.com cloud REST API this profile records. Second, it is read from the company''s own announcement, not from a machine-readable contract: SDC is carried over DPWS/SOAP web services, but Sibel publishes no WSDL, no device description, and no conformance statement. ?wsdl and ?singleWsdl were probed on api.sibelhealth.com and returned HTTP 403 like every other path. A buyer who already speaks SDC can integrate the devices without a bespoke connector; a buyer integrating the CLOUD still needs the undocumented, gated REST API.' - id: fhir conforms: false evidence: note: No FHIR endpoint, CapabilityStatement, US Core or SMART-on-FHIR surface is published or referenced. /.well-known/smart-configuration was not offered on any host. - id: hl7-v2 conforms: false evidence: note: No HL7 v2 message profile or interface specification is published. cross_cutting: - id: oauth2 conforms: null evidence: note: '/.well-known/oauth-authorization-server returned 404 on sibelhealth.com and 403 on api.sibelhealth.com. The API gateway advertises an Authorization header but does not disclose the token scheme anonymously.' - id: rfc9457 conforms: false evidence: note: 'Anonymous error bodies from api.sibelhealth.com are AWS API Gateway defaults — {"message":"..."} with content-type application/json, not application/problem+json.' - id: idempotency conforms: null evidence: note: No idempotency documentation exists and no idempotency header was observable anonymously. - id: pagination conforms: null evidence: note: Undocumented; no contract to derive from.