generated: '2026-08-26'
method: searched
source: >-
  https://www.pillarbiosci.com/technology/pivat/ and
  https://www.pillarbiosci.com/technology/ (fetched 2026-08-26), plus the PiVAT
  RUO release notes RN-0025 Rev 2 (2023-07-25).
name: Pillar Biosciences conformance
description: >-
  Standards and regulatory posture Pillar Biosciences states on its own public
  pages. Pillar publishes NO machine-readable API contract, so every entry below
  is a documentation claim rather than something derived from a spec, and each
  one records the exact page it came from. No entry is asserted without a quote.
entries:
  - id: hipaa
    name: HIPAA
    conforms: true
    basis: vendor-claim
    evidence:
      url: https://www.pillarbiosci.com/technology/pivat/
      http_status: 200
      quote: 'HIPAA Compliance — Cloud-based PiVAT is fully compliant with HIPAA requirements'
    note: >-
      A stated compliance claim on the PiVAT product page. Pillar publishes no
      trust center, no certification report and no attestation document, so this
      is the company's own assertion, not a verified audit.
  - id: ivd
    name: In Vitro Diagnostic (IVD) product line
    conforms: true
    basis: vendor-claim
    evidence:
      url: https://www.pillarbiosci.com/technology/pivat/
      http_status: 200
      quote: 'the IVD version of PiVAT is available with Pillar''s IVD products'
    note: >-
      Pillar maintains a separate IVD product line (site navigation carries an
      "IVD Products" section) alongside research-use-only kits. A CE-IVD PiVAT
      user manual (UM-0038) is published on the company's own domain.
  - id: ruo
    name: Research Use Only (RUO) labelling
    conforms: true
    basis: vendor-document
    evidence:
      url: https://pillar-panel-user-guides.s3.amazonaws.com/RN-0025+-+PiVAT+RUO+SW+Release+Notes+2023.1.0.pdf
      http_status: 200
      quote: 'Legal Notice — For Research Use Only'
    note: The RUO PiVAT software is explicitly labelled research use only in its release notes.
  - id: oncokb
    name: OncoKB knowledge base integration
    conforms: true
    basis: vendor-claim
    evidence:
      url: https://www.pillarbiosci.com/technology/pivat/
      http_status: 200
      quote: >-
        OncoKB integration: Cloud-PiVAT users also have the option to generate
        tertiary analysis reports for Pillar panels using OncoKB, an
        FDA-recognized oncology knowledge base.
    note: >-
      An integration with an external knowledge base, consumed by Pillar — not a
      contract Pillar exposes to third parties.
domain_standards:
  note: >-
    0.12.0 domain_standard_conformance is REWARD-ONLY and reads the CONTRACT, not
    a marketing page. Pillar publishes no contract, so nothing can be awarded
    here. The probes below were run against the healthcare/genomics standards
    shortlist and are recorded as honest misses, not as penalties.
  probed:
    - standard: HL7 FHIR
      found: false
      detail: No FHIR base URL, CapabilityStatement or FHIR resource shape on any Pillar host.
    - standard: HL7 v2 messaging
      found: false
      detail: >-
        No ORU^R01 / OML^O21 message documentation published. PiVAT's stated
        integration surface is file formats (FASTQ, BAM, VCF, PDF), not messaging.
    - standard: GA4GH (htsget / Beacon / Data Repository Service)
      found: false
      detail: No GA4GH-conformant endpoint published on any Pillar host.
    - standard: Phenopackets / VRS
      found: false
      detail: Not referenced in any public Pillar document reviewed.
  awarded: none
interchange_formats:
  note: >-
    Pillar's actual, published machine-readable interface is bioinformatics FILE
    formats, not an API. Recorded here because it is the real integration surface
    a lab would build against.
  formats:
    - FASTQ (paired-end preferred)
    - BAM
    - VCF
    - PDF (report output)
  evidence:
    url: https://www.pillarbiosci.com/technology/pivat/
    http_status: 200
    quote: 'formats: FASTQ files (paired-end preferred), BAM, VCF, PDF'
summary:
  entries_total: 4
  conforms_true: 4
  domain_standard_awarded: false
  derived_from_contract: false