Top Blockchain Healthcare Use Cases Beyond Medical Records

Summary: Decision-makers don’t need another “blockchain for EHRs” explainer. Here are the highest‑ROI healthcare use cases emerging right now—driven by new U.S. rules and industry timelines—with concrete architectures, example deployments, dates, KPIs, and gotchas you can act on in 2026–2027.

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Why this matters now

Over the next 24 months, several U.S. policies force multi‑party interoperability in ways that a tamper‑evident, shared log is uniquely good at:

• Drug Supply Chain Security Act (DSCSA): the FDA granted a phased enforcement path that pushes interoperable, electronic traceability into day‑to‑day operations through late 2025–2026, including exemptions that expire on May 27, 2025 (manufacturers/repackagers), Aug 27, 2025 (wholesalers), and Nov 27, 2025 (large dispensers), with small dispensers exempt to Nov 27, 2026. (fda.gov)
• CMS Interoperability & Prior Authorization Final Rule (CMS‑0057‑F): tighter turnaround clocks (72 hours expedited; 7 days standard starting Jan 1, 2026) and FHIR‑based APIs (compliance primarily Jan 1, 2027), with enforcement discretion allowing all‑FHIR Prior Auth without X12 278. (cms.gov)
• Medical device cybersecurity: section 524B now requires SBOMs and robust cyber plans in premarket submissions; FDA finalized guidance updates in 2025. (fda.gov)
• National exchange: TEFCA Common Agreement v2.0 brings FHIR API exchange into the “network of networks,” enabling verifiable identity and audit overlays. (healthcareitnews.com)

Below are the top blockchain use cases we’re implementing with clients in 2025–2027—beyond medical records—with step‑by‑step patterns, KPIs, and pitfalls.

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1) DSCSA compliance at scale: product verification, interoperable traceability, and chargeback automation

Why it’s hot

• DSCSA now expects interoperable, electronic package‑level tracing; exemptions run out in 2025–2026, and regulators are already using verification tools in the field. (fda.gov)
• FDA and GS1 point to EPCIS for standardized data exchange, and solution providers have matured conformance programs. (supplychain.gs1us.org)

What’s working in the wild

• MediLedger’s Product Verification and Contracts & Chargebacks solutions (permissioned blockchain) are widely used for sub‑second product verification, with coverage claims across the majority of U.S. medicines, and for eliminating chargeback disputes by enforcing shared business rules. (mediledger.com)
• NABP acquired MediLedger’s Product Verification System (PVS) and incorporated it into Pulse by NABP, which regulators in 20+ states—and even DEA field offices—use for near‑real‑time verification (e.g., suspect Ozempic in Arkansas, Jan 2025). (nabp.pharmacy)
• EPCIS maturity: vendors have secured full GS1 US EPCIS trustmarks to ensure file‑level conformance for DSCSA messages. (tracelink.com)

Reference architecture

• Data layer: GS1 EPCIS 1.2/1.3 for serialized events (off‑chain in your traceability platform). (supplychain.gs1us.org)
• Ledger layer: permissioned network (e.g., Hyperledger Besu/Fabric or similar) stores only cryptographic fingerprints of EPCIS event batches, dispute states, and product verification requests/responses.
• Directory/VRS: integrate with industry Verification Router Service and Pulse to route verification pings and regulator queries without exposing PII. (nabp.pharmacy)

KPIs to track

• Product verification SLA: 95%+ responses in <1s at receiving and returns. (mediledger.com)
• Dispute cycle time: chargeback resolution days → hours via shared rules and evidence trail. (mediledger.com)
• DSCSA readiness: % inbound EPCIS matched at receipt; % serialized returns accepted; regulator response time.

Implementation tips

• Don’t store EPCIS payloads on‑chain. Hash them and keep the source in your DSCSA platform; use the ledger for notarization and dispute workflows.
• Align identifiers (GLN/GTIN/SSCC) and aggregation rules early; reconcile master data across trading partners. (supplychain.gs1us.org)
• Plan for the phased “sunrise” of EPCIS 1.3 after exemptions—starting with dispensers in Q3 2026. (gs1us.org)

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2) Prior authorization and claims event transparency

Why it’s hot

CMS has locked in response timeframes (72 hours expedited; 7 days standard) and requires FHIR‑based APIs by Jan 1, 2027; HHS won’t enforce X12‑only requirements if you go all‑FHIR. That means payers, providers, and vendors must coordinate across organizational boundaries with auditable timing. (cms.gov)

Pattern that works

• Event sourcing: record each PA step (submit, pended info, clinical attachments received, decision) as FHIR resources in your API and append event hashes to a consortium ledger.
• Smart policies: encode timing windows and exception handling in smart contracts to trigger alerts/penalties if SLAs are breached (useful for audits and state reviews).
• Data exchange: keep all clinical content in your FHIR store; write only minimal, non‑PHI metadata to the chain (request ID, timestamps, decision code, hash).

Immediate value

• Audit‑ready clock: cryptographic proof of when you received additional documentation or returned a decision.
• Faster appeals: shared state avoids “he said/she said,” reducing payer‑provider friction and rework.
• Regulatory comfort: the ledger record plus FHIR API logs demonstrate compliance with CMS timelines and transparency requirements. (cms.gov)

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3) Provider credentialing, privileges, and cross‑network identity with verifiable credentials

Why it’s hot

Provider onboarding delays revenue and care access. With TEFCA moving toward FHIR APIs across networks and the W3C Verifiable Credentials (VC) family maturing toward v2.0, you can issue cryptographically verifiable, selectively disclosable credentials for licensure, board certification, DEA registration, and hospital privileges. (healthcareitnews.com)

How to build it

• Issuers: state boards, hospitals, specialty boards, DEA become VC issuers.
• Wallets: clinicians hold credentials in enterprise or personal wallets; selective disclosure via BBS+ signatures reduces oversharing. (w3c.github.io)
• Revocation: maintain status lists (bitstring revocation) on a permissioned ledger for high availability and auditability. (w3c.github.io)
• Interop: map VC claims to CAQH data elements so payers can accelerate primary source verification, not replace it on day one. (caqh.org)

What to measure

• Cycle time: initial credentialing time cut by 30–50% in pilots by reusing digitally signed artifacts (license, education, NPDB checks).
• Re‑credentialing: push‑button updates when an issuer rotates or suspends a credential; zero manual outreach.

Guardrails

• Keep PII off‑chain; the ledger only holds credential status lists and key registries.
• Define governance: trust framework, liability, and fallback processes (lost wallet, emergency overrides).

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4) Medical device identity, SBOM attestation, and patch accountability

Why it’s hot

As of March 29, 2023, “cyber devices” must include SBOMs and cyber plans in premarket submissions, and FDA’s 2025 guidance strengthens expectations. Hospitals want continuous assurance for networked device fleets, not PDFs. (fda.gov)

Pattern to implement

• Device DID: assign each device a decentralized identifier bound to the UDI and manufacturer PKI.
• SBOM anchoring: post a hash of each SBOM version and patch bundle to the ledger on release; include machine‑readable references (SPDX/CycloneDX).
• Zero‑trust verify: hospital asset managers verify the device’s current firmware/SBOM hash against the ledger before connecting to clinical networks.
• Coordinated disclosure: timestamp vulnerability intake, manufacturer advisories, and deployment of mitigations for auditability.

KPIs

• Percent of deployed devices with verifiably current SBOMs.
• Mean time to remediate (MTTR) from disclosure to patch applied, with evidence trail for regulators and auditors.

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5) Clinical trial integrity, DCT orchestration, and privacy‑preserving AI

What’s driving this

FDA finalized guidance on trials with decentralized elements in 2024; sponsors must prove data integrity across in‑home visits, wearables, and local labs. Anchoring key trial events to an immutable log reduces disputes and inspection pain. (fda.gov)

Practical patterns

• eConsent and protocol amendments: anchor consent hashes, versioned amendments, and time‑boxed consent scopes on a ledger; store documents in your eTMF.
• ePRO/eCOA and sensor data: integrity‑stamp batches (e.g., hourly or per device session) to the ledger to demonstrate no back‑fill or “data drift.”
• IP and cold‑chain: hash shipping events and temperature excursions to support deviation management.
• Privacy‑preserving AI: use “swarm learning” to coordinate cross‑site model training via a permissioned blockchain that handles secure onboarding, leader election, and parameter merging—keeping raw data local. (nature.com)

Real‑world signals

• Triall and Mayo Clinic collaborated to embed blockchain proofs for data integrity in a multi‑site pulmonary arterial hypertension study (eClinical functions incl. eConsent and eTMF). (newswire.com)

Bonus: RWE without data movement

• Pair a ledger audit layer with “clean room” approaches for cross‑dataset queries (e.g., Datavant Connect with AWS Clean Rooms) to maximize provenance while minimizing data exchange. (datavant.com)

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6) AI model and dataset provenance in clinical systems

Why it’s hot

ONC’s HTI‑1 final rule establishes transparency for algorithms embedded in certified health IT; NIST’s AI RMF gives a blueprint for risk management. A ledger can anchor data cards, training lineage, tuning checkpoints, and deployment approvals. (healthit.gov)

Operating model

• Dataset cards: record hashes of training/validation datasets, cohort filters, and known exclusions.
• Model cards: anchor version, hyperparameters, and performance at release time; link to post‑market drift monitoring events.
• Access logs: write privacy‑preserving proofs of model use in high‑risk clinical contexts.

Outcome

• Faster safety investigations and regulator conversations because provenance is discoverable, consistent, and tamper‑evident.

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7) Genomics: what to avoid, and what to do instead

Tokenized “genomic data marketplaces” have struggled. LunaDNA shuttered in early 2024; Nebula Genomics users reported service disruptions and a transition to a different operator in 2025. The lesson: don’t try to store or trade sensitive omics data on or via a tokenized ledger. Use the chain only for audit and consent. (insideprecisionmedicine.com)

Safer blueprint

• Keep sequence data in Trusted Research Environments or cloud clean rooms; keep all consent and data‑use events anchored on a ledger for provable provenance (who accessed what, when, and under which IRB). Pair with privacy‑preserving linkage/tokenization for cohort building. (datavant.com)

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Cross‑cutting best practices (that teams skip at their peril)

• Data off‑chain, proofs on‑chain: hash large payloads (EPCIS, FHIR Bundles, eTMF docs); keep PHI out of the ledger.
• Verifiable credentials for people and things: use DIDs/VCs for clinicians, organizations, devices, and software builds; keep revocation/status lists on the ledger. (w3c.github.io)
• Standards first:
  • Supply chain: GS1 EPCIS 1.2/1.3; VRS. (supplychain.gs1us.org)
  • Clinical data: HL7 FHIR R4; TEFCA CA v2.0 expectations for API exchange. (healthcareitnews.com)
  • Security: FDA 524B SBOM expectations; machine‑readable SPDX/CycloneDX. (fda.gov)
• Governance before code: draft a multiparty operating agreement (membership, key management, data responsibilities, exit rules).
• Permissioned, with optional public anchoring: keep business logic on a permissioned network; periodically anchor state roots to a public chain for extra tamper‑resistance if policy allows.
• Measurable value: define 3–5 KPIs per use case (e.g., verification SLA, PA SLA compliance, credentialing cycle time, SBOM coverage, eTMF inspection findings) before sprint 1.

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90‑day pilot plans you can start this quarter

• DSCSA verification and dispute reduction

  • Scope: 2 manufacturers, 1 wholesaler, 2 dispensers; integrate Pulse PVS/VRS.
  • Deliverables: verification SLA dashboard; chargeback rules on‑chain; regulator query playbook.
  • Success: >95% sub‑second verification; 40% faster dispute resolution. (nabp.pharmacy)

• Prior authorization audit ledger

  • Scope: 1 regional payer + 2 large provider groups; FHIR PA API; event hashing to chain; timing policies in smart contracts.
  • Success: 100% of expedited decisions within 72 hours with cryptographic audit trail; appeal cycle time –15%. (cms.gov)

• Provider VC credentialing

  • Scope: 1 hospital system + 1 payer + state board sandbox; issue VCs for licensure and privileges; verifier in payer intake; revocation list on chain.
  • Success: initial credentialing cycle time –30%; zero NCQA audit findings attributed to credential provenance gaps. (w3c.github.io)

• Device SBOM attestation

  • Scope: 2 device families across 3 hospitals; SBOM hashing and attestation; asset verification at network join.
  • Success: 90%+ devices with current SBOM; MTTR –25% on security advisories. (fda.gov)

• DCT integrity and swarm learning

  • Scope: 3 trial sites; anchor eConsent and ePRO batches; swarm learning pilot on pathology images with hospital‑local data.
  • Success: zero critical findings on data integrity in mock inspection; model AUC parity vs centralized baseline. (fda.gov)

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Common traps and how to avoid them

• Putting PHI on a blockchain. Don’t. Hashes only, with strong linkage to off‑chain stores.
• Building a network without an operator. Assign a neutral convener and operating budget (think “network as a product”).
• Ignoring standards release timing. Plan for EPCIS 1.3 “sunrise” and staged TEFCA FHIR expansion; your design should tolerate mixed maturity. (gs1us.org)
• Overfitting to one jurisdiction. U.S. rules (CMS, FDA, ONC) differ from EU AI Act timelines—design policy knobs, not hard‑coded rules. (health.ec.europa.eu)

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What this looks like in your stack

• Integration plane:
  • FHIR server(s) for clinical workflows; EPCIS gateway for supply chain; device management with SBOM registry.
• Trust plane (blockchain):
  • Smart contracts for event attestation, process SLAs, VC status lists, and dispute workflows.
• Security and identity:
  • PKI, DIDs/VCs, HSM‑based key custody, automated rotation.
• Observability:
  • Cross‑party dashboards (verification SLA, PA timelines, credential status, SBOM coverage) and exportable regulator reports.

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Bottom line

If you’re exploring blockchain in healthcare, skip the EHR monoliths and target the seams: multi‑party workflows you cannot secure or audit with a single system of record. In 2025–2027, the strongest business cases are DSCSA, prior authorization, credentialing, device cybersecurity, and trial integrity—each amplified by fresh regulations and industry roadmaps. The technology is ready; the governance and KPIs will make or break your ROI.

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How 7Block Labs can help

• 2‑week opportunity framing mapped to CMS/FDA/ONC timelines and your current stack.
• 6‑week architecture sprint with standards alignment (FHIR/EPCIS/VC), data protection model, and operating playbook.
• 90‑day pilot with measurable KPIs and a path to production.

Let’s de‑risk your first use case and hit the 2026–2027 deadlines with confidence.