Blockchain Development Services for Healthcare: A Procurement Guide for Hospitals and Insurers

Summary: A step‑by‑step buying guide for selecting and deploying blockchain solutions that actually move the needle on provider data accuracy, prior authorization, and drug supply chain compliance—mapped to 2025–2027 U.S. regulatory timelines, FHIR/TEFCA realities, and security controls hospitals and payers must enforce.

Why blockchain now: three market signals decision‑makers can’t ignore

TEFCA is live and scaling. Eight QHINs were designated by January 16, 2025 (including eClinicalWorks, CommonWell, eHealth Exchange, Epic Nexus, Health Gorilla, Kno2, KONZA, MedAllies), and more than 9 million documents had already been exchanged via TEFCA by late 2024, with volumes accelerating. This makes trustworthy cross‑network exchange and provenance more valuable than ever. (sequoiaproject.org)
CMS’s Interoperability & Prior Authorization Final Rule (CMS‑0057‑F) compresses admin cycles. Impacted payers must meet operational PA decision timeframes starting January 1, 2026, and stand up FHIR‑based Patient/Provider/Payer‑to‑Payer/Prior‑Authorization APIs by January 1, 2027 (with public reporting of metrics). HHS also granted enforcement discretion so FHIR‑only PA APIs aren’t penalized for not using X12 278 during implementation. (cms.gov)
DSCSA package‑level traceability is entering full enforcement by role‑based phase. FDA’s post‑stabilization exemptions extend through 2025 for manufacturers/repackagers and distributors, through November 27, 2025 for large dispensers, and to November 27, 2026 for small dispensers—so interoperable, auditable drug tracing is a 2025–2026 must‑have, not a pilot. (fda.gov)

Together, these shifts reward solutions that can prove data lineage, automate trust across organizations, and produce audit‑ready trails—sweet spots for permissioned blockchain.

Buy for outcomes, not hype: three high‑ROI healthcare use cases

1) Provider data accuracy and credentialing

Regulations: Under the No Surprises Act, commercial plans must verify provider directory entries at least every 90 days, update within 2 business days of change, and respond to member inquiries within 1 business day—requirements that expose stale data and fragmented updates. (dfs.ny.gov)
Reality check: Even after NSA took effect, longitudinal analyses show inaccuracies persisting for 540+ days for a large share of listings—so governance and shared updates matter as much as tech. (ajmc.com)
What works: A shared, permissioned ledger that:
- Stores signed attestations of provider data changes, plus hashes of credential documents, with FHIR‑mapped payloads off‑chain in your PDM/MDM.
- Issues W3C Verifiable Credentials (VC 2.0) for practitioner identity and privileges; verifiers check proofs without re‑collecting documents. (w3.org)
- Feeds your TEFCA/QHIN directory services and payer portals from a single source of truth.
Proof point: The Synaptic Health Alliance reports multi‑payer ROI; one member cites 500% annual ROI on provider directory collaboration—achieved by validating millions of public records via a shared ledger. (synaptichealthalliance.com)

What to require in an RFP:

VC/DID support aligned to W3C DID Core 1.0 for issuer/holder/verifier flows (e.g., DID methods with rotation and revocation). (w3.org)
2‑day SLA for propagating verified changes to consuming directories; per‑change provenance and cryptographic evidence export.

2) Prior authorization you can audit end‑to‑end

Regulations: CMS‑0057‑F requires FHIR APIs and transparency: PA decisions within 72 hours (expedited) and 7 days (standard), public metrics from March 31, 2026, and a yes/no attestation measure for electronic PA in 2027. HIPAA Administrative Simplification enforcement discretion permits FHIR‑only PA API implementations. (cms.gov)
Standards to anchor:
- HL7 Da Vinci PAS (v2.1.0 current; v2.2.0 in ballot) for PA transactions, plus CRD (v2.1.0) and DTR (v2.1.0) to capture payer rules and documentation computably. (hl7.org)
- ONC HTI‑1 baseline: USCDI v3 by Jan 1, 2026; SMART App Launch v2 adoption by Dec 31, 2025, affecting API security and app registration. (healthit.gov)
- ONC HTI‑4 (effective Oct 1, 2025) adds certified criteria around e‑prescribing, RTPB, and ePA that will shape EHR/payer interfaces your solution must integrate with. (healthit.gov)
Why blockchain:
- Immutable, time‑stamped state transitions for CRD → DTR → PAS events enable fine‑grained PA metrics (cycle time, rework, denial reasons) and defensible audits—without storing PHI on‑chain.
- Cross‑org rules updates: payer policy changes are versioned as signed artifacts (hashes on‑chain, CQL/Questionnaire off‑chain) so providers can prove which rule set triggered a decision on a given date.

Practical requirement:

Map each PA request/response to a chain event with a deterministic ID and include the denial reason codes required by CMS in the off‑chain FHIR bundle referenced from the ledger entry. (cms.gov)

3) DSCSA package‑level traceability and exceptions handling

2025–2026 reality: FDA’s exemptions stagger enforcement beyond the 2024 stabilization period—Aug 27, 2025 for distributors; Nov 27, 2025 for large dispensers; Nov 27, 2026 for small dispensers—so traceability, verification, and exception management must interoperate across trading partners. (fda.gov)
Proven pattern: The MediLedger FDA pilot (25 pharma leaders) demonstrated confidential, interoperable change‑of‑ownership using blockchain—blueprints many manufacturers and wholesalers drew on for DSCSA‑ready design. (mediledger.com)
What to buy:
- A permissioned network supporting EPCIS/GS1 events, product verification flows, and dispute resolution anchored in smart contracts—plus integration to your serialization repository and VRS.
- Evidence package exports (hash chains, signatures) acceptable to auditors when exceptions–like serial mismatches or unverifiable returns–are resolved.

A reference architecture that passes real‑world scrutiny

Permissioned DLT core: Hyperledger Fabric or Besu‑based networks are common choices for healthcare consortia (private data collections/channels; Byzantine‑fault‑tolerant finality; on‑prem/HIPAA‑eligible cloud deployment).
On‑chain vs. off‑chain:
- On‑chain: content‑addressed references, cryptographic commitments (SHA‑256 hashes) to FHIR bundles, signed attestations, event/state indices, consent receipts.
- Off‑chain: all PHI and large artifacts (e.g., FHIR Resources, PDFs) in your EHR, payer platform, or an encrypted data lake; retrieve via auditable APIs.
Identity and credentials:
- W3C DID/VCs for practitioners, facilities, and organizations; issue, present, and revoke credentials without centralizing raw documents. (w3.org)
- Map patient matching to Project US@ address standard to improve deterministic linkage in FHIR resources exchanged via APIs and TEFCA. (govinfo.gov)
Interop edges:
- FHIR R4 US Core 6.1/7.0, SMART v2, Bulk Data, Da Vinci IGs; TEFCA endpoints/QHIN connectivity for clinical payloads and directory services. (himss.org)

Security, privacy, and compliance checklists your vendor must pass

HIPAA Security Rule essentials:
- Audit controls: prove you can “record and examine” activity for any system that uses ePHI—map chain events and API logs directly to §164.312(b). (law.cornell.edu)
- Encryption “safe harbor”: encrypt ePHI per HHS guidance/NIST SPs so lost media doesn’t trigger breach notification; ensure keys and ciphertext aren’t co‑located. (hhs.gov)
- Ransomware posture: assume breach if ePHI was accessible in clear at attack time; require immutable audit trails to support risk assessment. (hhs.gov)
Crypto modules and post‑quantum readiness:
- Demand FIPS 140‑3 validated crypto modules (or documented path) and capture certificate numbers; FIPS 140‑2 is acceptable for existing systems but sunsets to “historical list” for new validations after Sept 22, 2026. (csrc.nist.gov)
- Plan PQC migration now: NIST standardized ML‑KEM, ML‑DSA, SLH‑DSA (FIPS 203‑205) in 2024; HQC was selected in March 2025 as a backup KEM. Ask vendors for a hybrid‑crypto plan and timelines aligned to NIST IR 8547 transition guidance. (csrc.nist.gov)
Patient rights vs. immutability:
- Support HIPAA’s right to amend (45 CFR 164.526) by appending correction records and linking them to original entries; blockchain should evidence provenance, not freeze inaccurate data. (law.cornell.edu)
Data‑sharing policy alignment:
- ONC HTI‑1 DSI/AI transparency affects certified tools you’ll integrate with; ensure any AI‑assisted rules used in DTR/Davinci flows expose source attributes and risk controls. (healthit.gov)

Procurement criteria: what to put in your RFP

Ask vendors to respond, with evidence, to the following:

Regulatory alignment and timelines

Demonstrate support for CMS‑0057‑F APIs and metrics, with a delivery plan that hits Jan 1, 2027 for API availability and Jan 1/March 31, 2026 for operational metrics. Include mapping to Da Vinci PAS/CRD/DTR. (cms.gov)
TEFCA connectivity: outline how the solution exchanges or anchors provenance for documents retrieved via designated QHINs. (rce.sequoiaproject.org)
DSCSA: show how chain events integrate with EPCIS repositories and VRS flows for verification exceptions at distributor/dispensing points per the 2025–2026 enforcement schedule. (fda.gov)

Architecture and data handling

A clear on‑chain/off‑chain split with data minimization; no PHI on‑chain; PHI encrypted at rest and in transit per HHS/NIST guidance; key custody model documented (HSM, BYOK, rotation). (hhs.gov)
Standards conformance evidence (test reports) for: FHIR R4 US Core, SMART v2, Bulk Data, Da Vinci IGs enumerated above. (himss.org)

Identity, credentials, and access

W3C DID/VC 2.0 flows for provider credentialing and directory updates; revocation lists or status lists; audit proofs. (w3.org)

Security attestations

FIPS 140‑3 module validation IDs; SOC 2 Type II/HITRUST for hosting; PQC roadmap aligned to NIST. (csrc.nist.gov)

Operational excellence

Documented SRE practices; RTO/RPO targets; disaster‑recovery tests; node and API observability; evidence that audit logs are tamper‑evident and mapped to §164.312(b). (law.cornell.edu)

Exit strategy

Data portability: export of all on‑chain commitments, off‑chain artifacts, and Merkle proofs in standard formats; read‑only node escrow.

KPIs and SLAs that predict real value

Provider directory accuracy (NSA):
- 2‑business‑day update SLA; <0.5% duplicate entries; <2% bounce on outreach; immutable evidence of verification attempts.
- Cost‑to‑serve reduction: target a 20–30% decrease in manual directory touchpoints against your baseline; CAQH data shows the scale of admin waste and the savings opportunity when automating verification and PA. (caqh.org)
Prior authorization:
- Cycle times: median decision <48 hours standard; <12 hours expedited in pilots; percent with “denial reason provided” = 100% (CMS requirement); resubmission rate <10% after CRD/DTR adoption. (cms.gov)
- Transparency: near‑real‑time dashboards for required CMS PA metrics (public reporting), with drill‑through to cryptographic evidence for each transaction. (cms.gov)
DSCSA:
- Verification response latency at distributor/dispenser edges within target operational thresholds; exception resolution times with signed dispute trails; coverage of interoperable data connections per FDA expectations. (fda.gov)
Security:
- 99.95% API uptime; zero critical CVEs open >30 days; FIPS‑validated modules in production; PQC hybrid testing completed by a defined date tied to your risk posture. (csrc.nist.gov)

Implementation playbook (aligned to 2025–2027 milestones)

0–60 days: compliance gap analysis and target use case selection
- Map NSA directory workflows and PA endpoints; assess DSCSA readiness by partner type.
- Confirm TEFCA/QHIN participation paths and HTI‑1/HTI‑4 dependencies. (rce.sequoiaproject.org)
60–150 days: pilot build
- Spin up a permissioned network in a HIPAA‑eligible cloud; implement DID/VC issuance for one provider cohort; integrate CRD/DTR/PAS with one payer; anchor events on‑chain; no PHI on‑chain.
- Instrument PA metrics per CMS templates; harden audit controls mapped to §164.312(b). (cms.gov)
5–9 months: scale to production
- Add additional payers and provider groups; extend to directory updates and credentialing; set public PA metrics reporting process; validate FIPS module evidence; finalize PQC migration plan. (cms.gov)
2026–2027: compliance and optimization
- Hit CMS 2026 metrics and operational rules; meet 2027 API deadlines; continuously optimize denial reasons, resubmissions, and throughput.
- For pharma/dispensing arms, retire DSCSA exemptions and demonstrate full package‑level interoperability across trading partners by your role‑based deadline. (cms.gov)

Pitfalls to avoid

Putting PHI on‑chain. You’ll complicate breach response and the right‑to‑amend. Keep PHI off‑chain; hash and reference only. (law.cornell.edu)
Ignoring X12/FHIR interplay. Even with FHIR‑only discretion, edge systems will speak a mix; select vendors who bridge standards, not just demo FHIR. (cms.gov)
Overlooking address standardization. Poor patient matching will sink your ledger’s utility; implement Project US@ normalization at your FHIR boundaries. (healthit.gov)
Skipping crypto validation and PQC planning. Ask for FIPS 140‑3 certificates now and a concrete PQC roadmap; retrofit will be costly. (csrc.nist.gov)

What “great” looks like in 2025

A ledger‑anchored provider directory that meets NSA verification timelines, produces cryptographic evidence for every change, and reduces provider outreach fatigue—mirroring multi‑payer ROI seen in production consortiums. (dfs.ny.gov)
An auditable ePA pipeline where CRD flags necessity, DTR collects only what’s needed, PAS submits/receives decisions, and every step is provably linked to a rules version and timestamp—ready for CMS transparency reporting. (hl7.org)
A DSCSA spine that reconciles serializations and exceptions across partners, with on‑chain proofs and off‑chain payloads, aligned with FDA’s phased enforcement cadence. (fda.gov)

How 7Block Labs delivers

Advisory first: we translate CMS/ONC/FDA rules into technical acceptance criteria and RFP language, then quantify savings using CAQH baselines for admin burden. (caqh.org)
Build with guardrails: permissioned DLT, FHIR/SMART/Da Vinci integration, DID/VCs for credentials, TEFCA alignment, and zero PHI on‑chain.
Prove and scale: measurable improvements in directory accuracy, PA cycle time, and DSCSA exception resolution—backed by tamper‑evident logs mapped to §164.312(b). (law.cornell.edu)

If you’d like a tailored procurement checklist or a 6‑week feasibility sprint scoped to your network, we’re ready to help.