DAORX is designed to operate consistent with HIPAA Privacy, Security, and Breach Notification Rules, and HITECH Act requirements. Patient health information is intended to be held on a permissioned clinical data layer separate from the public chain, with smart-contract consent enforcement designed to satisfy the Privacy Rule’s authorization requirements at the moment of access. Business associate agreements are designed to govern relationships with covered entity participants.
DAORX is designed to align with HL7 FHIR R4 and R5 resource specifications and U.S. Core Data for Interoperability v7. Patient identity binding through soulbound credentials is intended to address the structural gap in current USCDI: the absence of a portable, cryptographic, patient-controlled identity layer beneath the demographic-matching infrastructure that exists today.
DAORX architecture is designed to support compliance with CMS interoperability rules, including the developing CMS-0053-F covered entity attachment requirements with effective date in 2028. The architecture is intended to position covered entity participants for compliance rather than to impose compliance burden on them.
DAORX is designed to support Drug Supply Chain Security Act traceability requirements for prescription pharmaceuticals through MedicationStatement and MedicationDispense FHIR resources anchored to provenance records on the chain. Scope is intended to align with the federal DSCSA exemption framework — generic and biosimilar pharmaceuticals are exempt; the architecture targets patented prescription pharmaceuticals where provenance regulation applies.
DAORX is designed to operate consistent with the Guiding and Establishing National Innovation for U.S. Stablecoins Act (Public Law 119-27, enacted July 18, 2025). The native unit of account on DAORX is not a payment stablecoin within the meaning of the GENIUS Act — it does not maintain a fixed monetary peg, does not promise redemption at fixed value, and is not represented as maintaining stable value relative to fiat currency. DAORX is not a permitted payment stablecoin issuer and does not issue payment stablecoins.
The native unit of account on DAORX is designed to operate as a network token within the meaning of the developing Digital Asset Market Clarity Act framework — intrinsically linked to a distributed ledger system, deriving value from the use of the system, treated as a non-security solely for purposes of federal securities law to the extent the developing framework is enacted. The validator-admission roadmap is designed to advance the system toward mature blockchain status as defined in the developing framework.
Royalty distributions to rights holders for licensed use of their data are designed to operate as property income on licensed use of owned property, not as inducements within the meaning of the Anti-Kickback Statute. Where reward flows touch participants who are also Medicare or Medicaid beneficiaries, AKS safe harbor structuring is intended to be applied per applicable safe harbor frameworks, with documented analysis.
DAORX is designed to implement a Bank Secrecy Act-grade anti-money-laundering and counter-terrorism-financing program: KYC at credential issuance, OFAC screening at all transfers above applicable thresholds, transaction monitoring for suspicious patterns, and capability for suspicious activity reporting where required.
MyRxWallet is positioned as critical healthcare infrastructure under the U.S. critical-infrastructure-sector framework administered by the Cybersecurity and Infrastructure Security Agency. The healthcare and public health sector designation enhances the legitimacy of sovereign infrastructure operation under Executive Order 14178 and provides important context for the policy purpose of consent-enforced data rights administration.
Clarity on regulatory posture requires clarity on what DAORX is not.
DAORX is healthcare data rights administration, delivered as sovereign blockchain infrastructure. The category has not existed before in regulated healthcare. DAORX is designed to establish it.