generated: '2026-07-20'
method: searched
source: https://beacon.bio/open-source-software + https://github.com/beacon-biosignals + https://beacon.bio/news
notes: >-
  Beacon Biosignals has no public web API, so the usual API-layer conformance axes (OAuth 2.0, OIDC,
  RFC 9457, JSON:API, OData, pagination, idempotency) are all NOT APPLICABLE rather than failed — there
  is no HTTP interface to conform. What Beacon does conform to is a set of real DATA-FORMAT and
  REGULATORY standards, evidenced by shipped open-source code and by a named FDA clearance. Those are
  asserted below with evidence. Absence of an assertion is not a negative finding.
standards:
- id: edf
  name: European Data Format (EDF / EDF+)
  conforms: true
  evidence: EDF.jl (https://github.com/beacon-biosignals/EDF.jl, v0.8.1, MIT) is a first-party
    reader/writer for EDF and EDF+ files, registered in the Julia General registry.
- id: bdf
  name: BioSemi Data Format (BDF)
  conforms: true
  evidence: EDF.jl documents and implements BDF read/write alongside EDF/EDF+.
- id: apache-arrow
  name: Apache Arrow
  conforms: true
  evidence: The Onda format is defined atop Apache Arrow; Onda states the format is intentionally
    language-agnostic and that any producer/consumer supporting Apache Arrow can read/write
    Onda-compliant Arrow tables. Legolas.jl provides schema construction/validation over Arrow tables.
- id: onda
  name: Onda signal-data format (Beacon-authored open specification)
  conforms: true
  self_published: true
  evidence: Specification maintained in https://github.com/beacon-biosignals/Onda.jl (schemas versioned
    via Legolas). The former standalone spec repo https://github.com/beacon-biosignals/OndaFormat is
    archived and superseded.
- id: semver
  name: Semantic Versioning
  conforms: true
  evidence: All 24 first-party Julia packages are released under SemVer through the Julia General
    registry and GitHub Releases (see changelog/beacon-changelog.yml).
- id: fda-510k
  name: FDA 510(k) clearance (Software as a Medical Device)
  conforms: true
  evidence: Dreem 3S cleared under 510(k) K223539 (August 2023); marketed as Waveband since June 2025
    (name change only, no change to clearance status).
  reference: https://beacon.bio/news/fda-authorizes-beacon-s-dreem-3s-as-first-sleep-wearable-with-predetermined-change-control-plan-paving-the-way-for-continuous-algorithm-enhancements-in-sleep-monitoring
- id: fda-pccp
  name: FDA Predetermined Change Control Plan (PCCP) for AI/ML-enabled devices
  conforms: true
  evidence: In December 2024 the FDA authorized a PCCP for the Dreem 3S sleep-staging algorithm — the
    first sleep wearable to receive one — allowing algorithm updates without a new 510(k) submission.
not_applicable:
- id: oauth2
  reason: no public API and no published authorization server
- id: oidc
  reason: no public API; /.well-known/openid-configuration returns 404 on beacon.bio
- id: rfc9457
  reason: no public API, so no HTTP problem-details envelope
- id: json-api
  reason: no public API
- id: odata
  reason: no public API
- id: fhir
  reason: no published FHIR interface found on any Beacon surface
- id: scim
  reason: no published SCIM interface
- id: fapi
  reason: not a financial-grade API provider
- id: psd2
  reason: not a payments provider
- id: pagination
  reason: no public API
- id: idempotency
  reason: no public API
unverified:
- id: hipaa
  note: Beacon handles protected health information as a US home-sleep-testing provider, so HIPAA
    obligations almost certainly apply, but NO public HIPAA attestation, BAA page or compliance
    statement was found on beacon.bio. Not asserted.
- id: soc2
  note: no public SOC 2 report, trust center or attestation found.
- id: iso-27001
  note: no public ISO 27001 certification found.