generated: '2026-07-21'
method: searched
source: https://tandemhealth.ai/product/data-security
summary: >-
  Tandem Health is a regulated clinical-AI provider. Its published compliance
  posture centers on EU medical-device regulation (CE marked, EU MDR Class IIa),
  a quality/information-security/AI/environmental management-system stack of ISO
  certifications, and healthcare data-protection standards. No cross-cutting API
  interoperability standards (OAuth2/OIDC/FHIR/SCIM/RFC 9457) are asserted here
  because the provider publishes no public API surface.
standards:
- id: eu-mdr-class-iia
  conforms: true
  evidence: CE marked as a Class IIa medical device under EU Medical Device Regulation (AI Scribe, Coding Assistant, Clinical Decision Support)
- id: iso-13485
  conforms: true
  evidence: ISO 13485 quality management system for medical device companies
- id: iso-27001
  conforms: true
  evidence: ISO 27001 information security management, published on data-security page and trust centre
- id: iso-42001
  conforms: true
  evidence: ISO 42001 responsible AI management system
- id: iso-14001
  conforms: true
  evidence: ISO 14001 environmental management system
- id: gdpr
  conforms: true
  evidence: Patient data handled under EU GDPR
- id: nen-7510
  conforms: true
  evidence: NEN 7510 Dutch healthcare information security standard
- id: nhs-dspt
  conforms: true
  evidence: Stated NHS compliant, meeting NHS data and security requirements
- id: uk-cyber-essentials-plus
  conforms: true
  evidence: UK Cyber Essentials Plus, independently verified
- id: lvv-class-a
  conforms: true
  evidence: LVV Class A (Netherlands) medical device registration
- id: oauth2
  conforms: false
- id: oidc
  conforms: false
- id: fhir
  conforms: false
- id: rfc9457-problem-details
  conforms: false