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HIPAA scoping

When Seal becomes a business associate, what we do not claim, and the gate before health customers

HIPAA scoping

CompAI / SEA-51. Product decision for health-document signing — not a HIPAA certification and not a substitute for counsel.

Decision (current)

Seal declines healthcare / PHI workloads until a signed BAA and PHI control program are in place.

Question Answer today
Is Seal HIPAA-compliant / HITRUST certified? No. Do not claim this.
Can a covered entity use Seal for intake, consent, or health records that include PHI? Not yet — that relationship makes Seal a business associate under HIPAA.
Default product posture General e-sign (contracts, commercial agreements, HR, etc.). Healthcare is an explicit expand decision.
Gate before first health customer (1) Counsel-approved BAA template + countersign process, (2) PHI control checklist below green, (3) founder/ops accept the BA risk.

If a prospect’s documents contain PHI (or they are a covered entity / BA sending PHI through Seal), stop the sale and route to the expand path — do not “just use the normal API.”

When Seal becomes a business associate

Under HIPAA, a vendor that creates, receives, maintains, or transmits PHI for a covered entity is typically a business associate. Signing workflows for:

  • patient intake / consent forms with identifiers or clinical content
  • medical records, Rx, discharge paperwork
  • any PDF where PHI is in the file bytes, fields, or metadata

…put Seal in BA territory. Email of a patient + DOB on a form is enough to trigger the analysis — do not invent a loophole.

Non-health commercial MSAs, vendor agreements, and similar without PHI are outside this ticket’s expand gate.

What Seal already has (necessary, not sufficient)

These help any regulated customer; they do not equal HIPAA readiness:

Control Where
Sealed audit trail SEA-44 hash chain + /audit/verify
Consent / privacy / opt-out SEA-45 / SEA-52 / SEA-58
Final PDF integrity SEA-49 Level 1 PAdES-B
Certificate of Completion SEA-50
Backup / retention primitives SEA-55 (D1 Time Travel, R2 locks)
Encryption in transit HTTPS to Workers / R2
Access via org-scoped API keys + roles Vortex Auth / MCP scopes

PHI control gaps (must close before accepting health)

Track as eng/ops before flipping the decision to accept:

  1. BAA — counsel-drafted Business Associate Agreement; countersign before any PHI org is provisioned.
  2. PHI data map — which tables/objects can hold PHI (PDF bytes in R2, field values, audit metadata, email bodies, webhooks).
  3. Minimum necessary / retention — documented retention + deletion for PHI orgs; webhook payloads must not leak PHI to unconstrained endpoints.
  4. Access controls — workforce access to prod D1/R2 for PHI orgs; admin break-glass logging.
  5. Breach process — BA notification timelines wired to on-call (HIPAA breach rule).
  6. Subprocessors — Cloudflare (and any email/convert workers) listed and covered under BA / CUA as counsel requires.
  7. Optional hardening — customer-managed keys, stricter region pinning, disable AI/anydoc features that send document bytes to models for PHI orgs.

Until that list is owned and green, marketing and sales copy stay: “Seal is not offered for HIPAA-regulated PHI workloads.”

Expand path (accept healthcare later)

  1. Legal: BAA template + playbook (SEA-57 adjacent).
  2. Eng: PHI org flag / plan entitlement that gates AI features and documents subprocessors.
  3. Ops: onboarding checklist — BAA signed, webhook URL review, retention settings.
  4. Flip this page’s Decision table to accept with date + owner.
  5. Only then allow health customers onto api.seal.nyc (or a dedicated HIPAA env if counsel requires isolation).

For RFPs and CompAI

Answer with this page. Correct phrase:

Seal today supports general electronic signatures with a sealed audit trail. We do not currently offer a HIPAA Business Associate relationship or claim HIPAA compliance. Healthcare / PHI use is declined until a BAA and PHI control program are in place.

See also: Trust & evidence, eIDAS levels, Production checklist.

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