Sparcle for Healthcare

PHI masked before any LLM call. The auditor verifies.

HIPAA-covered, 21 CFR Part 11-eligible 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, cryptographic erasure designed to satisfy Right-to-be-Forgotten obligations while preserving record-retention duties.

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 frame below maps to a concrete implementation.

HIPAA Privacy / Security / Breach Notification

Bolt 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. A BAA can be put in place under NDA during pilot evaluation.

21 CFR Part 11

Electronic-record and electronic-signature requirements for FDA-regulated workflows. Bolt's Ed25519-signed audit chain is designed to satisfy the integrity, retention, and verifiability requirements; the standalone verifier is the artifact your validation team runs.

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 duties

Cryptographic erasure is designed to satisfy Right-to-be-Forgotten obligations while preserving SOX, SEC, and HHS record-retention duties via the same primitive. Detailed construction at /trust/cryptographic-erasure.

Data residency posture

The covered-entity boundary, enforced.

PHI is masked before any LLM call and 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. Provable cryptographic erasure for HIPAA Right-to-be-Forgotten. 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, 21 CFR Part 11 validation artifacts, BAA-readiness, and the trust artifacts a compliance officer reviews.

Download PDF Open in new tab ↗

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; the audit chain records every retrieval 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 — The construction designed to satisfy HIPAA Right-to-be-Forgotten obligations while preserving HIPAA record-retention. The packet your DPO or external auditor receives.
  • /trust/where-the-model-runs — How PHI is 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. The artifact a 21 CFR Part 11 validation pack relies on.
  • /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.

Schedule healthcare review All industries