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Compliance & Standards

Every framework. Every page. On the record.

Conceptual Health is a regulated healthcare network operating under HIPAA, SOC 2, HITRUST, GDPR, state medical practice acts, FDA pre-cert, and money-transmitter law in 49 states. This page is the index. The threaded interior is the long-form. The regulator portal is the cleared-access door.

23
Active frameworks
147
Public attestations
≤ 1 hr
Breach-notification SLA
24/7
SOC + on-call counsel

Frameworks

Twelve we live under, eleven we honor.

Tap any card for the threaded posture: scope, controls, audit cadence, attestation document, last-tested date, and the named owner inside the company.

45 CFR 160 / 164 Live · BAA
HIPAA Privacy & Security
Covered entity (clinical), business associate (datavault, AI, chain). Privacy Rule, Security Rule, Breach Notification Rule.
Owner: CCO + Privacy Officer
AICPA SSAE 18 Annual
SOC 2 Type II
Trust Services Criteria: Security, Availability, Processing Integrity, Confidentiality, Privacy. Independent CPA-firm audit scheduled with Phase 2.
Renewed Q1 each year
HITRUST CSF v11 r2 · 2-yr
HITRUST CSF
r2 certification spanning 156 controls across 14 categories. Interim review every 12 months, full re-cert every 24.
Owner: CISO
EU 2016/679 Live · DPA
GDPR + UK GDPR
EU operations under GDPR. UK under UK GDPR + Data Protection Act 2018. Standard contractual clauses for transatlantic transfer.
DPO: Independent counsel, EU
Cal. Civ. §1798.100 Live
CCPA / CPRA
California consumer privacy rights honored network-wide regardless of residency. CPRA-grade access, deletion, opt-out workflows.
Owner: Privacy Officer
21 CFR Part 11 Validated
FDA 21 CFR Part 11
Electronic records and electronic signatures for clinical research data. Validated computer systems, signed audit trails, secure timestamps.
Owner: Clinical IT QA
FDA SaMD Pre-cert
FDA Software-as-a-Medical-Device
AI Scribe and Master Equation diagnostic-support modules in pre-cert pathway. Algorithmic transparency, model-card publishing, bias auditing on deployment.
Owner: CMO + Reg Affairs
State MT Acts 49 states
Money-Transmitter Licensing
Conceptual Health Exchange holds money-transmitter licenses or qualifies for exemption in 49 states + DC. Trust company custodies HCR/HCC reserves.
Owner: CFO + State Counsel
31 CFR 1010 Pending
FinCEN MSB Registration
Money Services Business filing in preparation. KYC/AML program, OFAC screening, SAR filing capability, written compliance program — implemented and self-attested. Public FinCEN MSB number will appear here once issued.
Owner: BSA Officer
21 CFR 1300 Pending · EPCS
DEA EPCS
Electronic Prescriptions for Controlled Substances. Two-factor authentication, identity-proofing, tamper-evident audit logs - implemented and self-attested. DEA-approved EPCS audit scheduled before EPCS go-live (Phase 2).
Owner: Pharmacy Compliance
42 CFR Part 2 Live
42 CFR Part 2 (SUD)
Substance use disorder records held to elevated consent standard. Per-disclosure consent, prohibition on re-disclosure without authorization.
Owner: Privacy Officer
ONC Cures Act Compliant
21st Century Cures · Info Blocking
USCDI v3 export, FHIR R4 API, individual-access exception support. No information-blocking practices; full data portability on patient request.
Owner: Interop Lead
W3C WCAG 2.2 AA target
WCAG 2.2 AA + Section 508
Patient-facing surfaces built to WCAG 2.2 AA: skip-link, prefers-reduced-motion, 44x44 touch targets, focus-visible, AAA contrast where feasible. Independent accessibility audit and VPAT 2.4 publication open with Phase 2.
Owner: Design Systems
NIST CSF 2.0 / 800-66 Mapped
NIST Cybersecurity Framework
Controls mapped to NIST CSF 2.0 functions (Govern, Identify, Protect, Detect, Respond, Recover). 800-66 Rev. 2 used as HIPAA Security Rule implementation reference.
Owner: CISO
FedRAMP Moderate In progress
FedRAMP Moderate
Authorization in progress for federal-customer surfaces (VA, IHS pilots). 3PAO engaged. ATO target Q4 next year.
Owner: GovCloud Lead
FIPS 140-3 Validated
FIPS 140-3 Cryptography
All cryptographic modules use FIPS 140-3 validated implementations. AES-256-GCM, TLS 1.3, Ed25519 signing, X25519 key agreement.
Owner: Security Engineering
PCI DSS v4.0 SAQ-D pending
PCI DSS v4.0
Patient and clinic card payments are routed through a PCI-validated processor with no PAN ever touching our systems. Conceptual Health is SAQ-D scoped; QSA engagement opens with the first card-present clinic in Phase 2.
Owner: Treasury Ops
45 CFR 46 Live · IRB
Common Rule + IRB Oversight
Research Marketplace gated by IRB approval. Common Rule and FDA HSR. Approved IRB partners; per-record consent; revocable in one tap.
Owner: Research Ops

Coverage matrix

Which framework applies to which surface.

Conceptual Health is not one product — it is a network. Some frameworks apply network-wide, others scope to specific surfaces. This matrix is the truth table.

Framework ↓  ·  Surface →
Clinical EHR
Patient Portal
DataVault
Pharmacy
Exchange
Chain
AI Scribe
HIPAA
SOC 2 Type II
HITRUST CSF
21 CFR Part 11
DEA EPCS
State MT Acts + FinCEN
42 CFR Part 2 (SUD)
21st Century Cures
WCAG 2.2 AA

Full coverage  ·  Partial / scope-limited  ·  Not applicable

For regulators & auditors

A door, not a hallway. Cleared access in 24 hours.

If you represent OCR, HHS, FDA, FTC, SEC, a state attorney general, a state DOI, a state medical board, or an accredited audit firm, the regulator portal grants credentialed access to gated documents (SOC 2 detail, pen-test reports, breach forensics, AI model cards, training records) within 24 hours of identity verification.

Named, on the record

Who to call. By name. By role.

Compliance is people, not process. Every framework has a named owner inside the company. For HIPAA-covered concerns, our Privacy Officer responds in one business day. For breach-coordination, our SOC is reachable 24/7.

Privacy Officer

privacy@conceptualhealth.com · +1 (555) 010-PRIV

HIPAA inquiries, individual rights requests (access, amendment, accounting), accounting-of-disclosures, Notice of Privacy Practices.

Chief Compliance Officer

cco@conceptualhealth.com · +1 (555) 010-COMP

Framework-level matters, regulatory correspondence, audit coordination, OCR/HHS/AG inquiries, MOU/MOA negotiation.

Chief Information Security Officer

ciso@conceptualhealth.com · +1 (555) 010-CISO

Security architecture, SOC 2 / HITRUST / NIST, vulnerability disclosure (security.txt), penetration testing windows, vendor risk reviews.

24/7 Security Operations Center

soc@conceptualhealth.com · +1 (555) 010-SOC0

Active incidents, suspected breach reports, government emergency-access requests under 45 CFR 164.512.