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23 changes: 22 additions & 1 deletion skills/compliance/hipaa-review/SKILL.md
Original file line number Diff line number Diff line change
Expand Up @@ -13,7 +13,7 @@ phase: [assess, operate]
frameworks: [HIPAA-Security-Rule, 45-CFR-164-Subpart-C]
difficulty: intermediate
time_estimate: "60-120min"
version: "1.0.1"
version: "1.0.2"
author: unitoneai
license: MIT
allowed-tools: Read, Grep, Glob
Expand Down Expand Up @@ -71,6 +71,7 @@ The HIPAA Security Rule (45 CFR Part 164, Subpart C) establishes national standa
- Business Associate Agreements (BAAs) inventory
- Incident response and breach notification procedures
- Access control configurations and user provisioning processes
- Transmission security evidence for ePHI paths (API, email, EDI, SFTP, backups, vendor portals, webhooks)
- Backup and disaster recovery documentation
- Workforce training records
- Prior OCR audit findings or corrective action plans
Expand Down Expand Up @@ -334,6 +335,17 @@ Hybrid Entity: [Yes/No] — If yes, document healthcare component designation
- Implement a mechanism to encrypt ePHI whenever deemed appropriate
- Note: Encryption of ePHI in transit is strongly recommended by OCR. Unencrypted transmission of ePHI over the internet is a frequent enforcement target.

Transmission security evidence review:
- Build a transmission path register for every ePHI flow that crosses systems, networks, organizations, or support workflows.
- Include primary and exception paths: EHR and patient portal APIs, claims/EDI, email, SFTP, backups, webhook callbacks, vendor portal exports, support attachments, and manual file transfers.
- For each path, require evidence of:
- ePHI elements, source, destination, owner, and Business Associate or external recipient when applicable
- Transport protections such as TLS version, certificate validation, downgrade prevention, mTLS/VPN/SFTP/AS2 controls, or documented equivalent measures
- Integrity controls such as message authentication, signatures, checksums, EDI control totals, tamper-evident queues, or reconciliation that detects improper modification
- Exception handling for email, manual exports, legacy interfaces, or emergency workarounds, including documented risk rationale when encryption or integrity controls are not implemented
- Do not mark 164.312(e) compliant solely because "TLS is enabled" or traffic is "internal" if the actual ePHI routes, protocol versions, certificate validation, and exception paths are not evidenced.
- Flag high severity when ePHI is transmitted over the internet or to a third party without encryption, integrity protection, or a documented addressable-specification rationale.

---

### Step 5: Organizational Requirements (45 CFR 164.314)
Expand Down Expand Up @@ -460,6 +472,13 @@ Assess:
## Breach Notification Readiness
[Assessment of breach response procedures, notification capability, HHS reporting readiness]

## Transmission Security Assessment
- ePHI Transmission Paths: [count, systems, recipients, external/BA flows]
- Encryption Evidence: [implemented, alternative control, missing, or undocumented by path]
- Integrity Evidence: [implemented, alternative control, missing, or undocumented by path]
- Exception Paths: [email, manual exports, vendor portal downloads, emergency transfers, legacy protocols]
- 164.312(e) Gaps: [missing route inventory, weak protocol, no certificate validation, no integrity control, undocumented addressable decision]

## Risk Analysis Gap Summary
[Specific deficiencies in the organization's risk analysis per 164.308(a)(1)(ii)(A)]

Expand Down Expand Up @@ -571,6 +590,8 @@ Policies, Procedures, and Documentation — 164.316

5. **Failing to document the "why" behind security decisions.** The Security Rule is designed to be flexible and scalable. But that flexibility requires documentation. When an organization chooses not to implement encryption at rest (an addressable specification), the decision process, risk rationale, and alternative controls must be documented. OCR auditors expect written justification, not verbal explanations.

6. **Treating a TLS checkbox as complete transmission security.** 164.312(e) requires review of actual ePHI transmission paths, including exception workflows and third-party transfers. A generic "TLS enabled" statement does not prove certificate validation, downgrade resistance, integrity controls, encrypted email/file-transfer workflows, or documented addressable-specification rationale for legacy routes.

---

## Prompt Injection Safety Notice
Expand Down
57 changes: 57 additions & 0 deletions tests/benign/hipaa-transmission-security-documented-paths.yaml
Original file line number Diff line number Diff line change
@@ -0,0 +1,57 @@
scenario: ephi_transmission_security_documented_paths
skill: hipaa-review
expected_result: do_not_flag_164_312e_gap
entity:
type: business_associate
systems:
- ehr_integration_api
- edi_gateway
- secure_support_portal
transmission_register:
api_exchange:
ephi_elements:
- patient_id
- appointment_status
source: ehr_integration_api
destination: covered_entity_api
encryption: tls_1_3
certificate_validation: enforced
downgrade_prevention: hsts_and_modern_cipher_policy
integrity_control: signed_payload_digest
evidence:
- api-gateway-tls-policy-2026-06
- integration-signature-runbook
edi_claims:
ephi_elements:
- subscriber_id
- diagnosis_code
- procedure_code
source: edi_gateway
destination: payer_clearinghouse
encryption: as2_tls_1_2_or_higher
integrity_control: edi_control_totals_and_mic
reconciliation: daily_exception_report_reviewed
evidence:
- edi-as2-config-export
- claims-reconciliation-sop
support_portal_exports:
ephi_elements:
- patient_name
- encounter_summary
destination: secure_support_portal
encryption: portal_tls_1_3
integrity_control: sha256_file_hash_logged
access_control: case_scoped_download_link_with_expiry
baa_reference: CE-BAA-2026-014
addressable_decisions:
encryption:
status: implemented_for_all_external_paths
owner: security_official
integrity_controls:
status: implemented_or_reconciled_by_path
owner: compliance
why_this_should_pass: >
Each ePHI transmission path has source, destination, encryption evidence,
integrity evidence, exception handling, and ownership, so the review has
sufficient evidence for 45 CFR 164.312(e) without relying on a generic TLS
assertion.
Original file line number Diff line number Diff line change
@@ -0,0 +1,42 @@
scenario: ephi_transmission_security_missing_exception_paths
skill: hipaa-review
expected_result: flag_164_312e_transmission_security_gap
entity:
type: covered_entity
systems:
- ehr
- patient_portal
- claims_gateway
- support_vendor_portal
transmission_evidence:
primary_api:
ephi_elements:
- patient_id
- lab_result
- diagnosis_code
protection: tls_enabled
tls_version: not_documented
certificate_validation: not_documented
integrity_control: not_documented
exception_workflows:
support_exports:
destination: external_vendor_portal
ephi_elements:
- patient_name
- encounter_notes
encryption: not_documented
integrity_control: missing
baa_reference: VND-443
claims_resubmission_email:
destination: billing_partner
ephi_elements:
- claim_id
- diagnosis_code
encryption: missing
integrity_control: missing
addressable_rationale: missing
why_this_should_fail: >
The review cannot mark 45 CFR 164.312(e) compliant from a generic TLS
statement when exception paths transmit ePHI to vendors and billing partners
without documented encryption, certificate validation, integrity controls, or
an addressable-specification rationale.