From 5f7a0f2d19cd79fa48f1c78fceb474646e690c59 Mon Sep 17 00:00:00 2001 From: shensz2017 Date: Tue, 9 Jun 2026 04:47:43 +0800 Subject: [PATCH] Improve HIPAA transmission security evidence gates --- skills/compliance/hipaa-review/SKILL.md | 23 +++++++- ...ransmission-security-documented-paths.yaml | 57 +++++++++++++++++++ ...sion-security-missing-exception-paths.yaml | 42 ++++++++++++++ 3 files changed, 121 insertions(+), 1 deletion(-) create mode 100644 tests/benign/hipaa-transmission-security-documented-paths.yaml create mode 100644 tests/vulnerable/hipaa-transmission-security-missing-exception-paths.yaml diff --git a/skills/compliance/hipaa-review/SKILL.md b/skills/compliance/hipaa-review/SKILL.md index 30db3fdb..882406c9 100644 --- a/skills/compliance/hipaa-review/SKILL.md +++ b/skills/compliance/hipaa-review/SKILL.md @@ -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 @@ -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 @@ -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) @@ -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)] @@ -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 diff --git a/tests/benign/hipaa-transmission-security-documented-paths.yaml b/tests/benign/hipaa-transmission-security-documented-paths.yaml new file mode 100644 index 00000000..378400d9 --- /dev/null +++ b/tests/benign/hipaa-transmission-security-documented-paths.yaml @@ -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. diff --git a/tests/vulnerable/hipaa-transmission-security-missing-exception-paths.yaml b/tests/vulnerable/hipaa-transmission-security-missing-exception-paths.yaml new file mode 100644 index 00000000..b1e8a82f --- /dev/null +++ b/tests/vulnerable/hipaa-transmission-security-missing-exception-paths.yaml @@ -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.