# Adaptive Biotechnologies — standards + compliance conformance
generated: '2026-09-07'
method: searched
source: https://www.adaptivebiotech.com/licenses-and-accreditation/
note: >-
  Adaptive Biotechnologies publishes no machine-readable API contract, so nothing here is derived
  from a specification. Every entry below is read from a page the company publishes. The
  laboratory and quality-system credentials are real and named on the Licenses & Accreditation
  page; the healthcare interoperability standards are recorded as NOT declared because Adaptive's
  own public pages — including the clonoSEQ EMR integration page — name integration partners
  (Epic, Epic Aura, Flatiron OncoEMR, Carequality) but never name HL7 v2, FHIR, C-CDA or any
  other interchange standard. That is an honest absence of a public declaration, not evidence
  that the underlying interfaces do not use those standards.
standards:
- id: iso-27001
  conforms: true
  evidence: >-
    "ISO – 27001 Certification" listed and linked on
    https://www.adaptivebiotech.com/licenses-and-accreditation/
- id: iso-13485
  conforms: true
  evidence: >-
    "ISO – 13485 Certification" listed and linked on
    https://www.adaptivebiotech.com/licenses-and-accreditation/
- id: mdsap
  conforms: true
  evidence: >-
    "MDSAP Certification" (Medical Device Single Audit Program) listed on
    https://www.adaptivebiotech.com/licenses-and-accreditation/
- id: eu-ivdr
  conforms: true
  evidence: >-
    "IVDR Certificate" (EU In Vitro Diagnostic Regulation 2017/746) listed on
    https://www.adaptivebiotech.com/licenses-and-accreditation/
- id: clia
  conforms: true
  evidence: >-
    "CLIA License" listed on https://www.adaptivebiotech.com/licenses-and-accreditation/;
    the Seattle laboratory is described as CLIA-certified on
    https://www.adaptivebiotech.com/contact-us/
- id: cap-accreditation
  conforms: true
  evidence: >-
    "CAP Accreditation" (College of American Pathologists) listed on
    https://www.adaptivebiotech.com/licenses-and-accreditation/
- id: hipaa
  conforms: true
  evidence: >-
    A HIPAA Notice of Privacy Practices is published at
    https://www.adaptivebiotech.com/hipaa-notice/ and a protected-health-information request
    process at https://www.adaptivebiotech.com/request-for-protected-health-information/
- id: state-clinical-laboratory-licensure
  conforms: true
  evidence: >-
    California, Maryland, New York, Pennsylvania and Rhode Island clinical laboratory
    licenses/permits listed on https://www.adaptivebiotech.com/licenses-and-accreditation/
- id: hl7-v2
  conforms: false
  evidence: >-
    Not declared. https://www.clonoseq.com/emr-integration/ (HTTP 200) describes lab order and
    result exchange with Epic and OncoEMR and "40+ direct data connections" but names no HL7
    message profile; no interface specification is published on any Adaptive host.
- id: fhir
  conforms: false
  evidence: >-
    Not declared. No FHIR CapabilityStatement, endpoint or mention on any Adaptive-controlled
    host; /openapi.json, /swagger.json and the whole /.well-known set return 404 on
    www.adaptivebiotech.com, www.clonoseq.com and clients.adaptivebiotech.com.
- id: c-cda
  conforms: false
  evidence: >-
    Not declared. Result distribution is described as flowing through Carequality and health
    information exchanges on https://www.clonoseq.com/emr-integration/, which implies a document
    standard, but Adaptive names none.
- id: oauth2
  conforms: false
  evidence: >-
    Not applicable. No public API and no OAuth surface; /.well-known/oauth-authorization-server
    and /.well-known/openid-configuration return 404 on every Adaptive host probed 2026-09-07.
- id: rfc9457-problem-details
  conforms: false
  evidence: No published API contract to carry problem+json responses.