Compliance & Registrations

DEA 21 CFR Part 1311 compliant electronic prescribing for Schedule II–V controlled substances. TOTP two-factor authentication on every signing event, identity proofing at enrollment, DEA auditable signing log. Schellman EPCS Third-Party Audit engaged.

Real-time interstate PDMP query via NABP PMPInterConnect hub. Mandatory query before any Schedule II–IV Rx signing. Flags doctor-shopping risk: 5+ Rxs/30 days, 3+ prescribers, or 3+ pharmacies. State direct APIs wired: NV, CA, TX, FL, NY.

Substance Use Disorder records enforced under 42 CFR Part 2 — stricter than HIPAA. Consent must be patient-specific, recipient-specific, and purpose-specific. Platform blocks all SUD data at the data layer for ICD-10 F10–F19 and MAT medications (buprenorphine, methadone, naloxone, naltrexone). Treatment provider exception built in.

Direct electronic prescription routing to pharmacies using the NCPDP SCRIPT 2017071 standard. Transmits NewRx, CancelRx, RxChangeRequest, RefillRequest, and RxFill transactions with NPI-matched pharmacy routing on every Rx.

CMS-0057-F effective January 1, 2026. Implements Da Vinci PAS IG v2.0.1 — FHIR R4 Claim resource with use="preauthorization". CDS Hooks integration for real-time coverage-requirement-prefetch. 6 major payers wired: CMS Medicare Advantage, UHC, Aetna, Cigna, Humana, Anthem.

HRSA OPAIS live database query verifying 340B covered entity eligibility. FQHCs, rural health centers, Ryan White clinics, and DSH hospitals qualify for 20–60% drug discounts. Required for any FQHC-serving EHR.

Live CMS QPP public API integration. Real-time MIPS provider quality scores by NPI — providers see their QPP performance data directly in the EHR portal.

Every drug lot receives a unique DRG NFT at manufacture. Supply chain custody recorded on-chain: manufactured → distributed → at_pharmacy → dispensed → recalled. Live FDA openFDA recall check on every patient scan. Counterfeiting eliminated at the lot level.

Each participant receives a soulbound TRL NFT — cryptographic proof of consent, randomization assignment (blinded until unblinding), and adverse event log. Eliminates paper ICF audit trails. FDA-auditable electronic consent per 21 CFR Part 11.

Live NLM RxNav API — every medication resolved to an RxCUI code and checked for drug-drug interactions. LOINC and SNOMED CT terminology validation via NLM VSAC. Required for all US Core FHIR R4 conformance and ONC (g)(10) certification.

Live CMS CLIA database query on every lab result import — verifies the originating laboratory's certification before any DiagnosticReport is accepted into the EHR. Required under 42 CFR Part 493 and ONC US Core Lab profiles.

Live integration with VA Lighthouse FHIR API — the federal portal for veteran health data under the MISSION Act. 9M+ enrolled veterans. Platform can pull FHIR R4 records for any veteran who has authorized access. Directly positions MyRxWallet for VA/Oracle Health contract displacement.

HRSA Uniform Data System Plus — mandatory annual FHIR bulk reporting for FQHCs (Federally Qualified Health Centers). Platform generates UDS+ bulk ndjson exports directly from the EHR. Critical capability for FQHC customer acquisition (NVPCA, CPCA, TACHC targets).

Live NPPES API integration for organizational NPI lookup and enrollment. Any healthcare organization onboarded through the platform can have their NPI validated and Type 2 organizational NPI enrollment initiated programmatically.

Hyperledger Fabric 2.5.6 LTS deployed on production VPS. 4 permissioned channels (identity, consent, health, rewards) with 5 Go CaaS chaincodes. HIPAA-compatible — no PHI on-chain, only SHA-256 hashes and event IDs. Zero gas fees. No public chain exposure.

On-chain governance with MRT-weighted proposal voting. Pure governance utility — no profit distribution, no financial returns, no Howey investment contract. 10% quorum (10M MRT), 48-hour voting window. Proposal types: parameter changes, treasury grants, integration approvals, research grants, emergency actions.

Complete on-chain patient identity and healthcare record system. Each token is a soulbound (non-transferable) cryptographic proof of a healthcare event — cannot be forged, altered, or transferred. All anchored on Hyperledger Fabric.

Patient-controlled data marketplace with atomic 85/15 split — enforced at transaction level. 12 curated categories including diabetes ($12), oncology ($25), rare disease ($50), genomics ($35), opioid recovery ($18, Part 2 protected), clinical trial RWE ($30). Patients set price floors. All transactions cryptographically logged.