generated: '2026-08-04'
method: searched
source: https://www.genalyte.com/legal/notice-of-privacy-practices
note: >-
  Genalyte publishes no machine-readable API specification, so nothing here is derived from a
  contract. Every entry below is grounded in a document Genalyte itself publishes on
  genalyte.com, or is explicitly recorded as not published. Standards the company has not
  claimed are recorded conforms: false with no evidence rather than left out, so a later
  re-run can tell "checked and absent" from "not checked".
standards:
- id: hipaa
  name: Health Insurance Portability and Accountability Act
  conforms: true
  evidence: >-
    Genalyte publishes a HIPAA Notice of Privacy Practices stating "Genalyte, Inc. is required
    by law to maintain the privacy of your individually identifiable health information" under
    HIPAA and HITECH, identifying the company as a covered entity handling PHI from laboratory
    services.
  source: https://www.genalyte.com/legal/notice-of-privacy-practices
  effective_date: '2020-11-25'
- id: hitech
  name: Health Information Technology for Economic and Clinical Health Act
  conforms: true
  evidence: Named alongside HIPAA in the published Notice of Privacy Practices.
  source: https://www.genalyte.com/legal/notice-of-privacy-practices
- id: ccpa
  name: California Consumer Privacy Act
  conforms: true
  evidence: >-
    The privacy policy names the California Consumer Privacy Act as applicable law governing
    business purposes for collected personal data.
  source: https://www.genalyte.com/legal/privacy-policy
  effective_date: '2020-11-25'
- id: fda-510k
  name: FDA premarket clearance (in-vitro diagnostic device)
  conforms: true
  evidence: >-
    Genalyte announced FDA clearance on 2024-07-22 of a Thyroid Stimulating Hormone immunoassay
    run on the silicon-chip-based Maverick device, described as "the first quantitative
    immunoassay to be cleared on a silicon chip based device". The company also previously held
    an FDA Emergency Use Authorization for a rapid COVID-19 antibody test. The specific
    regulatory pathway designation is not stated on the published page.
  source: https://www.genalyte.com/post/fda-clears-silicon-chip-based-blood-test
- id: gdpr
  name: General Data Protection Regulation
  conforms: false
  evidence: null
  note: Not mentioned in the published privacy policy, terms of use, or notice of privacy practices.
- id: clia
  name: Clinical Laboratory Improvement Amendments certification
  conforms: false
  evidence: null
  note: >-
    Not published. The Notice of Privacy Practices references "laboratory services we provide"
    but no CLIA certificate number or certification statement appears on the public site.
- id: cap
  name: College of American Pathologists accreditation
  conforms: false
  evidence: null
  note: Not published on the public site.
- id: soc2
  name: SOC 2
  conforms: false
  evidence: null
  note: No trust center, audit report, or certification claim published.
- id: iso-27001
  name: ISO/IEC 27001
  conforms: false
  evidence: null
  note: No certification claim published.
- id: hl7-v2
  name: HL7 v2 messaging
  conforms: false
  evidence: null
  note: >-
    Genalyte markets EMR result delivery through its CloudLab layer, but publishes no interface
    specification, conformance statement, or integration guide naming HL7 v2, ORM/ORU, or any
    other messaging standard.
- id: hl7-fhir
  name: HL7 FHIR
  conforms: false
  evidence: null
  note: No FHIR endpoint, capability statement, or claim is published.
- id: oauth2
  name: OAuth 2.0
  conforms: false
  evidence: null
  note: No public authorization server; /.well-known/oauth-authorization-server returns 404.
- id: openid-connect
  name: OpenID Connect
  conforms: false
  evidence: null
  note: /.well-known/openid-configuration returns 404 on every reachable host.
- id: rfc9116-security-txt
  name: RFC 9116 security.txt
  conforms: false
  evidence: null
  note: /.well-known/security.txt returns 404.
- id: rfc9457-problem-details
  name: RFC 9457 Problem Details for HTTP APIs
  conforms: false
  evidence: null
  note: Not assessable — no public API contract exists to evaluate.
x-evidence:
  fetched: '2026-08-04'
  sources_fetched:
  - {url: 'https://www.genalyte.com/legal/notice-of-privacy-practices', http_status: 200}
  - {url: 'https://www.genalyte.com/legal/privacy-policy', http_status: 200}
  - {url: 'https://www.genalyte.com/legal/terms-of-use', http_status: 200}
  - {url: 'https://www.genalyte.com/post/fda-clears-silicon-chip-based-blood-test', http_status: 200}