aid: nines-conformance
name: Nines / Sirona Medical Standards Conformance
description: >-
  Cross-cutting and industry standards conformance for Nines, whose AI radiology
  technology (NinesAI Emergent Triage, NinesMeasure) and team were acquired by
  Sirona Medical in February 2022 and folded into the RadOS platform. Claims are
  taken from Sirona Medical's public security/compliance and interoperability
  pages; there is no public developer API, so API-protocol standards are not
  applicable.
generated: '2026-07-20'
method: searched
source:
- https://sironamedical.com/solutions/security-regulatory-compliance
- https://sironamedical.com/platform/capability/interoperability
- https://sironamedical.com/llms.txt
conformance:
- id: soc2-type-ii
  name: SOC 2 Type II
  conforms: true
  evidence: >-
    "Six consecutive years of SOC 2 Type II certification with zero exceptions",
    independently audited annually across security, availability, processing
    integrity, confidentiality, and privacy.
  source: https://sironamedical.com/solutions/security-regulatory-compliance
- id: hipaa
  name: HIPAA
  conforms: true
  evidence: >-
    "HIPAA-compliant by design" with end-to-end encryption, audit logging,
    access controls, and patient authentication.
  source: https://sironamedical.com/solutions/security-regulatory-compliance
- id: fda-class-i
  name: FDA Class I (medical device platform)
  conforms: true
  evidence: >-
    "The only FDA Class I reporter platform in radiology"; developed under a
    regulated, design-controlled SDLC. Nines contributed two FDA-cleared devices
    (NinesAI Emergent Triage, NinesMeasure lung-nodule algorithm).
  source: https://sironamedical.com/solutions/security-regulatory-compliance
- id: dicom
  name: DICOM
  conforms: true
  evidence: >-
    "Fully managed DICOM, HL7, and FHIR integration" with existing PACS, RIS,
    EMR, and worklist systems.
  source: https://sironamedical.com/platform/capability/interoperability
- id: hl7
  name: HL7
  conforms: true
  evidence: Managed HL7 integration listed among core interoperability capabilities.
  source: https://sironamedical.com/platform/capability/interoperability
- id: fhir
  name: HL7 FHIR
  conforms: true
  evidence: Managed FHIR integration listed among core interoperability capabilities.
  source: https://sironamedical.com/platform/capability/interoperability
- id: iso-13485
  name: ISO 13485 (medical devices QMS)
  conforms: false
  evidence: >-
    Stated as "pursuing" ISO 13485; not yet obtained. Targeted for international
    expansion in 2027.
  source: https://sironamedical.com/solutions/security-regulatory-compliance
- id: eu-mdr
  name: EU MDR
  conforms: false
  evidence: >-
    Stated as "pursuing EU MDR certification"; not yet obtained. Targeted for
    2027 international expansion.
  source: https://sironamedical.com/solutions/security-regulatory-compliance
- id: gdpr
  name: EU GDPR
  conforms: false
  evidence: >-
    GDPR / UK Data Protection Act compliance posture referenced only as part of
    planned international expansion; no current certification claim.
  source: https://sironamedical.com/solutions/security-regulatory-compliance