generated: '2026-07-18'
method: searched
source: https://brightinsight.com/standards-regulations-and-certifications
summary: >-
  BrightInsight operates a regulated digital health platform for biopharma and
  medtech and publishes a Standards, Regulations & Certifications page stating
  the platform regularly undergoes independent verification of security, privacy,
  and compliance controls. The named certifications/standards below are quoted
  from that page. No public OpenAPI is published, so cross-cutting API standards
  (oauth2, rfc9457, pagination, idempotency) could not be derived or asserted.
standards:
  - id: iso-iec-27001
    name: ISO/IEC 27001
    conforms: true
    evidence: Listed on standards-regulations-and-certifications page (information security management)
  - id: iso-13485
    name: ISO 13485
    conforms: true
    evidence: Listed on standards-regulations-and-certifications page (medical device quality management)
  - id: hitrust-csf
    name: HITRUST CSF
    conforms: true
    evidence: Listed on standards-regulations-and-certifications page
  - id: hipaa
    name: HIPAA
    conforms: true
    evidence: Listed on standards-regulations-and-certifications page
  - id: gdpr
    name: GDPR
    conforms: true
    evidence: Listed on standards-regulations-and-certifications page
  - id: iec-62304
    name: IEC 62304
    conforms: true
    evidence: Listed on standards-regulations-and-certifications page (medical device software lifecycle)
  - id: iec-82304-1
    name: IEC 82304-1
    conforms: true
    evidence: Listed on standards-regulations-and-certifications page (health software product safety)
  - id: eu-mdr
    name: EU Medical Device Regulation (MDR)
    conforms: true
    evidence: Listed on standards-regulations-and-certifications page
  - id: ce-mark
    name: CE Mark
    conforms: true
    evidence: Listed on standards-regulations-and-certifications page
  - id: mdsap
    name: Medical Device Single Audit Program (MDSAP)
    conforms: true
    evidence: Listed on standards-regulations-and-certifications page
  - id: hds
    name: HDS (Hebergeur de Donnees de Sante)
    conforms: true
    evidence: Listed on standards-regulations-and-certifications page (French health data hosting)
  - id: eu-us-privacy-shield
    name: Privacy Shield
    conforms: true
    evidence: Listed on standards-regulations-and-certifications page