Sparcle for Healthcare

PHI identifiers masked before any LLM call. The auditor verifies.

HIPAA-covered workloads have a non-negotiable boundary: PHI cannot leave the covered-entity perimeter. Bolt and Aeira ship for that boundary: PII masked at the LLM call, audit chain inside your perimeter, per-person erasure with a signed receipt, and per-tenant crypto-shred that preserves record-retention.

Schedule healthcare review Download 1-page brief

Compliance frameworks

What Sparcle ships against.

Healthcare compliance is the intersection of HIPAA, 21 CFR Part 11 for FDA-regulated workflows, HITECH, and the HHS Section 1557 (2024) provisions on algorithmic decision-support tools. Each row below maps to a concrete implementation.

Healthcare compliance frameworks and what Sparcle ships against each
FrameworkWhat Sparcle ships against it
HIPAA Privacy / Security / Breach NotificationBolt and Aeira are architecturally deployable for HIPAA-covered workloads. The PII-masking layer keeps PHI from reaching the LLM in plaintext; the audit chain captures the unmasked record inside your perimeter for the auditor. BAA available: we keep PHI out of Sparcle systems, or sign a BAA where we may access PHI once our HIPAA training and background checks are complete (target November 2026).
21 CFR Part 11Electronic-record and electronic-signature requirements for FDA-regulated workflows. Bolt's Ed25519-signed audit chain gives your validation team a tamper-evident record it can check offline with the standalone verifier. Bolt does not provide Part 11 electronic signatures, so those stay with your validated systems.
HITECH + HHS Section 1557 (2024)HHS Section 1557 (2024) provisions on nondiscrimination in patient-care decision-support tools, including algorithmic clinical decision-making. The Authority Policy SDK lets clinical informatics encode evidence-ladder ranking that demotes non-current guidance below the cut.
GDPR Art. 17 + retention dutiesPer-person erasure handles a Right-to-be-Forgotten request with a signed receipt, while sealed audit records are retained for SOX, SEC, and HHS duties. Crypto-shred is per organization. Detailed construction at /trust/cryptographic-erasure.

Data residency posture

The covered-entity boundary, enforced.

Structured PHI identifiers are masked before any LLM call; names and narrative are masked once the optional on-prem name model is on. PHI does not transit Sparcle infrastructure.

Bolt's runtime, the agent loop, the prompt assembly, the PII masking, and the audit log all live inside your perimeter in every shipping topology.

BAA-ready architecture

Sparcle's sub-processor disclosure is asymmetric by design. Customer-configured sub-processors (your IdP, your cloud, your KMS, your LLM provider) hold customer data; Sparcle's own sub-processors handle software delivery.

Customer-held KMS

Vault Transit, AWS KMS, Azure Key Vault, or PKCS#11 HSM. Per-tenant crypto-shred, and per-person erasure with a receipt. Sparcle cannot read tenant data without the customer-held CMK.

Audit-trail responses your compliance team can sign off on

Every result carries the why-filtered context regulators ask for during HHS-OCR reviews. What was shown, what was suppressed, why. The artifact a compliance officer points to during audit.

1-page brief

Take this to your compliance officer.

The healthcare-vertical brief covers HIPAA posture, the audit-chain evidence a 21 CFR Part 11 validation can use, BAA-readiness, and the trust artifacts a compliance officer reviews.

Click the brief to open it full-screen.
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Workflows the founding team has built for

Four anchor use cases.

The workflows below are scoped with healthcare design partners. The healthcare Authority Policy pack is the per-customer tuning point.

  • Prior-authorization review Cross-source synthesis across payer policy, clinical guidelines, and chart documentation. The Authority Policy ranks current clinical guidelines above superseded versions; every Aeira search behind the review is sealed into the audit chain for case review.
  • Clinical-evidence Q&A with current-CME demotion The healthcare Authority Policy pack demotes expired CME, retracted papers, and superseded guidelines below the cut. Cited evidence resolves to current source-of-record.
  • MAC and OCR audit response Time-bounded audit-chain export with the standalone verifier binary. The OCR investigator runs the verifier; Sparcle is not in the verification loop.
  • M&A and IPO due-diligence response Privilege-walled retrieval across diligence corpora. Per-matter ACLs keep restricted material out of partner review packets unless explicitly authorized.

Trust dossier for healthcare

The four artifacts your compliance officer will ask for.

/trust/cryptographic-erasure

Per-tenant disposal with retention preserved, and how one person's erasure request is handled. The packet your DPO or external auditor receives.

/trust/where-the-model-runs

How PHI identifiers are masked before any outbound LLM call; how the three deployment modes (on-prem, in-tenant cloud, public vendor) compare for HIPAA-covered workloads.

/trust/verify

The standalone audit-chain verifier. Your compliance team runs it offline; no network calls, no Sparcle dependencies. Evidence your 21 CFR Part 11 validation team can include in its own pack.

/trust/controls

Controls evidence map walking HIPAA Security Rule controls to concrete implementations. Pre-positioned for OCR review.

Want to walk this against your specific covered-entity posture?

A 30-minute healthcare architecture review covers your HIPAA posture, your KMS choice, your clinical-evidence ranking needs, and the workflows your team needs. Founder-led; the engineering team is on the call.

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