Summary: Choosing the wrong blockchain partner for a healthcare app can derail interoperability, security, and compliance timelines. This guide shows decision‑makers exactly how to evaluate vendors against 2025-era healthcare standards (TEFCA, HTI‑1, DSCSA, NIST, FTC HBNR), with concrete checks, red flags, and sample RFP criteria grounded in real implementations and current rules.

How to Evaluate a Blockchain Healthcare App Development Partner

Healthcare’s compliance and interoperability goalposts moved in 2024–2025. TEFCA went live with an expanding roster of Designated QHINs and a published FHIR Roadmap. ONC’s HTI‑1 rule locked in USCDI v3 as the 2026 baseline and advanced SMART v2. FTC finalized a Health Breach Notification Rule that explicitly covers health apps outside HIPAA. DSCSA enforcement timelines continue with exemptions by partner type through 2025–2026. Your partner must build to this reality on day one. (rce.sequoiaproject.org)

Below is a concrete, testable evaluation playbook 7Block Labs uses with startups and enterprises to select blockchain development partners for regulated healthcare.

---

1) Regulatory literacy: insist on specifics, not slogans

• HIPAA Security Rule implementation competence
  • Ask vendors to map their technical plan to NIST SP 800‑66r2’s key activities (risk analysis, access controls, transmission security) and show how they leverage the CPRT mappings to NIST SP 800‑53r5 controls. Require a written crosswalk for your app’s data flows. (csrc.nist.gov)
• HIPAA Privacy Rule obligations that impact ledgers
  • Probe how they’ll meet the right to amend (45 CFR 164.526) while using an immutable ledger. Look for append‑only “correction” records, off‑chain truth sources, and Fabric private data purge patterns (see Section 4). If they can’t explain the amendment workflow and auditability, that’s a red flag. (law.cornell.edu)
• HIPAA de‑identification nuance
  • Confirm the team understands that “hashed” PHI can still be PHI depending on derivation. Demand an Expert Determination or strict Safe Harbor methodology, not “we hashed it on-chain.” (hhs.gov)
• Non‑HIPAA scenarios (consumer health apps, wellness, genomics wallets)
  • Require a documented FTC HBNR posture: breach notification content, timelines (≤60 days), and how they’ll identify third parties that received data. Many blockchain health apps are HBNR‑covered even if not HIPAA‑covered. (ftc.gov)
• Reproductive health PHI
  • Ask how they’ll operationalize the 2024 OCR final rule restricting certain disclosures—and how they’re tracking the 2025 litigation affecting parts of that rule. You want both legal monitoring and technical mitigations (segmentation, access attestations). (hhs.gov)

Practical acceptance criteria:

• Provide a HIPAA/NIST 800‑66r2 control mapping for your MVP’s architecture within 10 working days.
• Provide a written FTC HBNR incident response playbook tailored to your app’s data stores and analytics.

---

2) Interoperability and TEFCA readiness: validate against today’s network, not yesterday’s pilots

• TEFCA status matters (for U.S. deployments)
  • In 2023 the first QHINs were designated; by 2025 the list expanded (e.g., eClinicalWorks, Surescripts; Netsmart designated as the 10th QHIN). Ask which QHINs the partner has integrated with (directly or via participants) and to show transaction metrics from test or production flows. (rce.sequoiaproject.org)
• TEFCA FHIR Roadmap alignment
  • The RCE’s roadmap outlines staged progression from intra‑network FHIR to QHIN‑facilitated and end‑to‑end FHIR API exchange. Your vendor should map your use case to these stages and plan capabilities accordingly. (rce.sequoiaproject.org)
• HTI‑1 implications for your APIs
  • Verify SMART App Launch v2 adoption plans, granular SMART v2 scopes, and publication of standardized FHIR endpoints by the required dates. Ensure a strategy to support USCDI v3 as the baseline by Jan 1, 2026. (himss.org)

Practical checks:

• Request a one‑page TEFCA integration plan indicating which QHIN(s), which exchange purpose(s), and an outline of FHIR versus IHE‑based flows.
• Ask for a demo of SMART v2 granular scopes in a sandbox (e.g., grant only Observation.lab with search filter).

---

3) Data standards: FHIR Bulk Data, directories, and imaging

• FHIR Bulk Data (Flat FHIR) for population analytics
  • Ensure the team has implemented Bulk Data export ($export) for research/quality or payer use cases with proper async handling and ndjson outputs. Look for experience with US Core and Bulk Data IG conformance. (hl7.org)
• Validated healthcare directory integration
  • For provider credentialing and network integrity use cases, ask about HL7 Validated Healthcare Directory (VHDir) IG profiles (Practitioner, OrganizationAffiliation, Endpoint) and how updates flow to on‑chain credentials or attestations. (build.fhir.org)
• DICOM and imaging governance
  • If imaging is in scope, demand a documented approach to de‑identifying DICOM tags (including OCR of burnt‑in PHI) before any cryptographic commitments are recorded on‑chain. Cloud Healthcare API capabilities can be orchestrated with rigorous human review gates. (cloud.google.com)

Practical checks:

• Request evidence of Bulk Data exports over ≥10M resources and a retry/back‑pressure design.
• Ask for a VHDir data ingestion plan showing how license validations propagate to verifiable credentials.

---

4) Ledger architecture for PHI: off‑chain first, privacy by design

• Keep PHI off‑chain
  • Expect a default posture where only proofs, pointers, or selective metadata are on‑chain. Store PHI in FHIR stores or encrypted object stores with strict key management and access controls; write audit hashes or consent receipts to the ledger.
• Use permissioned stacks with mature privacy controls
  • Hyperledger Fabric remains a reliable choice for healthcare: v2.5 LTS is current and adds private data purge API to address data minimization and “selective erasure” of sensitive records (hashes remain as evidence). Vendors should be fluent in channel design, private data collections, and purge policies. (lf-decentralized-trust.github.io)
• Identity and credentials
  • Ask how they’ll implement W3C DIDs and Verifiable Credentials for provider/staff credentialing or consent artifacts. VC 2.0 became a W3C Recommendation in May 2025—your partner should target this baseline. (w3.org)

Practical checks:

• Demand a “shared nothing” breach model: if an FHIR store or analytics enclave is compromised, on‑chain data should not be enough to reidentify.
• Review a Fabric private‑data purge demo with retention policies and evidence hashes.

---

5) Key management, crypto, and ops maturity (prove it with certifications)

• HSMs and FIPS validation
  • For keys signing VCs or consent receipts, require HSM‑backed key storage using FIPS 140‑validated modules. AWS KMS HSM has an active FIPS 140‑3 Level 3 certificate—ask for your partner’s validation approach and boundary. (csrc.nist.gov)
• HITRUST CSF awareness (not a substitute for HIPAA, but strong hygiene)
  • Many payers/providers now expect vendors to align with HITRUST v11.x. Ask what version their security program tracks (v11.5/v11.6 updates were published in 2025) and which assessment type (e1/i1/r2) they target. (hitrustalliance.net)
• Digital identity assurance
  • If your app includes identity proofing or wallets, confirm alignment with NIST SP 800‑63‑4 (published 2025) for IAL/AAL/FAL and support for passkeys and wallets called for in the revision. (pages.nist.gov)

Practical checks:

• Require evidence of FIPS‑validated cryptographic modules for signing and KMS‑managed key rotation policies.
• Request a written control mapping to HITRUST v11.x (scope, planned assessment level, and timeline).

---

6) Advanced privacy tech: where it’s useful—and where it isn’t

• Zero‑knowledge proofs (ZKPs) and confidential computation
  • For selective disclosure (e.g., “is practitioner licensed?” without revealing identity) or verifiable aggregate statistics, ZKPs can augment compliance. Ask for concrete performance numbers (proof sizes, verification latency) and where proofs live (off‑chain vs on‑chain). Recent research shows sub‑100 ms verification and small proof sizes for certain healthcare scenarios; feasibility depends on circuit complexity. (jtie.stekom.ac.id)
• Federated learning with verifiability
  • Blockchain‑enabled FL can govern participation and provide audit trails for model updates; ZKP‑assisted aggregation is emerging to harden against Byzantine participants. Treat this as roadmap unless your use case mandates multi‑institution ML now. (arxiv.org)

Practical checks:

• Pin the partner to a minimal, production‑viable ZK use case (e.g., license status or consent age threshold) before entertaining complex ML proofs.

---

7) Supply chain and DSCSA: if you touch pharmaceuticals, require EPCIS‑first designs

• Standards before chains
  • FDA and GS1 guidance emphasizes EPCIS for DSCSA interoperability; many networks (blockchain or not) exchange EPCIS 1.2+ events. Require EPCIS interchange maturity and conformance testing evidence before any blockchain pilot. (supplychain.gs1us.org)
• Timelines and exemptions
  • Don’t let partners gloss over timing: the FDA established a stabilization period to Nov 27, 2024 and issued exemptions beyond that by trading partner type (e.g., dispensers ≥26 FTEs to Nov 27, 2025; certain small dispensers to Nov 27, 2026). Your rollout plan must reflect this. (fda.gov)

Practical checks:

• Ask for successful EPCIS exchanges at scale (millions of events) and GS1 US trustmarks or equivalent proofs. Blockchain can anchor provenance or resolve disputes, but the daily plumbing is EPCIS. (prnewswire.com)

---

8) Cloud and data ops: de‑identification, observability, and rollback plans

• De‑identification pipelines with review gates
  • If using GCP’s Cloud Healthcare API for FHIR/DICOM de‑identification, insist on configuration‑as‑code, deterministic date shifting (managed keys), and mandatory human QA on random samples per batch. Note Google’s own caveat that de‑identification doesn’t guarantee legal compliance—your partner should add domain‑specific rules and review. (cloud.google.com)
• Observability and regulator‑ready logs
  • Require immutably stored audit logs (WORM/S3 Object Lock or equivalent), plus cryptographic commitments on‑chain for critical events (e.g., consent updates). Have them demonstrate incident reconstruction from logs.

Practical checks:

• Run a tabletop test: simulate a mis‑scoped de‑identification run and require a rollback and re‑issue of verifiable consent artifacts in ≤24 hours.

---

9) Concrete RFP questions that separate experts from tourists

Ask vendors to respond with artifacts—not just answers:

• Architecture
  • Draw the full data flow (patient app ↔ FHIR store ↔ ledger ↔ QHIN). Identify exactly which fields, if any, are written on‑chain and why. Show how the design supports USCDI v3 APIs and TEFCA FHIR stages 2–3 by 2026. (himss.org)
• Compliance matrices
  • Provide a NIST SP 800‑66r2 control mapping and an FTC HBNR notification workflow chart for your product. (csrc.nist.gov)
• Identity and credentials
  • Show DID/VC 2.0 schemas for provider credentialing and patient consent; identify the signature suite and revocation model. (w3.org)
• Ledger privacy and retention
  • Demonstrate Hyperledger Fabric private‑data collections with PurgePrivateData() and retention policy docs tied to your record schedules. (hyperledger-fabric.readthedocs.io)
• Interoperability demos
  • Present a working SMART v2 app with granular scopes against a US Core 8.x FHIR server, plus a Bulk Data $export job delivering de‑identified ndjson. (build.fhir.org)
• DSCSA/pharma (if applicable)
  • Provide EPCIS conformance evidence and a transition plan aligned to FDA exemptions dates for your trading partner roles. (fda.gov)
• Security
  • Provide FIPS 140 validation evidence for crypto modules used to sign VCs and store keys (e.g., AWS KMS HSM cert). Provide a path to HITRUST v11.x alignment. (csrc.nist.gov)

---

10) Red flags we keep seeing (and how to counter them)

• “We put PHI on-chain, but it’s encrypted.”
  • Encryption does not neutralize all risks (keys, future cryptanalysis, re‑identification). Default to off‑chain PHI with on‑chain proofs; require demonstrable key custody controls and FIPS‑validated modules. (csrc.nist.gov)
• “We’ll be TEFCA‑compatible later.”
  • TEFCA is already live and adding QHINs; verify an integration path today with actual endpoints and a staged FHIR roadmap plan. (rce.sequoiaproject.org)
• “HIPAA doesn’t apply; we’re a wellness app.”
  • HBNR likely does. Ask for their HBNR decision memo and breach workflow. (ftc.gov)
• “We use zero‑knowledge everywhere.”
  • ZK is powerful but not a blanket. Demand a targeted use case with measured proof sizes and latencies; otherwise, you’ll pay for complexity you don’t need. (jtie.stekom.ac.id)

---

11) Example: provider credentialing with verifiable credentials + VHDir + TEFCA

A practical pattern we deploy:

• Source of truth: ingest and validate license/board data into a VHDir‑conformant FHIR store (Practitioner, OrganizationAffiliation, Endpoint). (build.fhir.org)
• Credential issuance: issue a W3C VC 2.0 “PractitionerCredential” signed by a FIPS‑validated HSM key; publish only a credential status list hash on‑chain (no PHI). (w3.org)
• Verification: relying parties verify VCs off‑chain and call TEFCA‑connected APIs for clinical context; the ledger provides tamper‑evident status and audit trails. Align scopes with SMART v2 for least privilege. (rce.sequoiaproject.org)
• Lifecycle: when a license changes, update VHDir, revoke prior VC via status list, and append an on‑chain revocation event (hash only). Store the full audit record in secure WORM storage with mapped HIPAA controls. (csrc.nist.gov)

Outcome: Faster onboarding, cryptographically verifiable credentials, and an auditable trail that respects HIPAA and TEFCA ecosystems.

---

12) Team interview prompts (use them verbatim)

• “Show us your last ONC/USCDI upgrade. What broke and how did you fix it?” Expect discussion of SMART v2 scope granularity and US Core alignment. (himss.org)
• “How do you satisfy 45 CFR 164.526 amendments on an immutable log?” Look for off‑chain amends, on‑chain correction entries, and Fabric purge mechanics. (law.cornell.edu)
• “Which QHINs have you transacted with, and can we see logs/metrics?” They should name designated QHINs and show data. (rce.sequoiaproject.org)
• “What’s your de‑identification QA process, including date‑shift keys management?” Expect precise controls and human review gates, not just API calls. (cloud.google.com)
• “Show HBNR breach comms templates tailored to our app.” They should have them. (ftc.gov)

---

13) What “great” looks like in 2025

• Architecture: PHI off‑chain; on‑chain proofs and consent receipts; FHIR‑native data layer; Fabric PDCs with purge and retention; HSM‑backed signing; DID/VC 2.0 identity. (hyperledger-fabric.readthedocs.io)
• Interop: live TEFCA connectivity plan; SMART v2; Bulk Data exports for analytics; VHDir provider data governance. (rce.sequoiaproject.org)
• Compliance: NIST 800‑66r2 mapping; HBNR workflows; reproductive‑health PHI guardrails with legal monitoring; HITRUST v11.x roadmap. (csrc.nist.gov)

---

Final takeaway

Selecting a blockchain healthcare partner in 2025 is less about “which chain” and more about proven interoperability, privacy engineering, and audit‑ready controls mapped to current rules. Use the evaluation items above, require artifacts, and time‑box proofs of concept around FHIR, TEFCA stages, and verifiable credentials. If a candidate can’t meet these concrete asks quickly, move on.