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:
- BAA — counsel-drafted Business Associate Agreement; countersign before any PHI org is provisioned.
- PHI data map — which tables/objects can hold PHI (PDF bytes in R2, field values, audit metadata, email bodies, webhooks).
- Minimum necessary / retention — documented retention + deletion for PHI orgs; webhook payloads must not leak PHI to unconstrained endpoints.
- Access controls — workforce access to prod D1/R2 for PHI orgs; admin break-glass logging.
- Breach process — BA notification timelines wired to on-call (HIPAA breach rule).
- Subprocessors — Cloudflare (and any email/convert workers) listed and covered under BA / CUA as counsel requires.
- 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)
- Legal: BAA template + playbook (SEA-57 adjacent).
- Eng: PHI org flag / plan entitlement that gates AI features and documents subprocessors.
- Ops: onboarding checklist — BAA signed, webhook URL review, retention settings.
- Flip this page’s Decision table to accept with date + owner.
- 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.