Skill 詳細
healthcare-compliance
Engineering guardrails for PHI, compliance, and healthcare interoperability.
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SKILL.md
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--- name: healthcare-compliance description: Engineering-focused guardrails for HIPAA-style privacy, HL7 or FHIR integrations, and safe handling of PHI in e-health systems. allowed-tools: Read, Write, Edit, Glob, Grep --- # Healthcare Compliance > This skill provides engineering guardrails for healthcare and e-health projects. > It is not legal advice; use it to shape technical decisions and checklists. ## How to Use This Skill Use this skill whenever: - The system stores or processes Protected Health Information (PHI). - You touch patient data, clinical notes, lab results, prescriptions, imaging, or billing linked to a person. - You design integrations with hospital systems (HL7, FHIR, LIS or RIS, PACS). Combine it with: - backend-specialist for API and access control decisions. - database-architect for schema, retention, and indexing choices. - security-auditor for security scans and secret management. --- ## 1. Regulatory Scope (High-Level) Focus on common technical expectations across regulations: - HIPAA (US) – Privacy Rule, Security Rule, audit and breach notification. - GDPR or local privacy laws – data minimisation, consent, right to access or delete. - HL7 v2.x – messaging standard used by many legacy hospital systems. - FHIR (R4 or R5) – modern resource-based REST API standard for clinical data. Principle: design for least privilege, auditability, and interoperability. --- ## 2. PHI Data Classification Before coding, identify which fields and tables contain PHI: - Direct identifiers: name, national ID, phone, email, full address. - Quasi-identifiers: date of birth, postal code, gender, rare diagnosis combinations. - Clinical content: encounters, diagnoses, prescriptions, lab results, vitals, imaging reports. - Billing data tied to a person: invoices, insurance details, claim status. Rules: - Do not store PHI in free-text logs, analytics events, or error traces. - Avoid PHI in URLs or document identifiers such as query strings or path parameters. - Encrypt backups and exports containing PHI. --- ## 3. Access Control and Roles Design role-based access control aligned with clinical workflows: - Receptionist: schedule, basic demographics, no access to detailed clinical notes. - Nurse: triage data, vitals, limited orders, partial record view. - Physician: full clinical record, orders, notes, e-prescriptions. - Lab or Imaging: orders, results entry, no financial data. - Billing: invoices, payments, insurance, minimal clinical details. Engineering guidelines: - Enforce RBAC server-side, not just in the UI. - Apply row-level access for sensitive records, for example filter by facility or organisation. - Prefer allowlists, describing who may access, over blocklists. - Log every access to high-risk objects such as patient, encounter, and medical record. --- ## 4. Audit Trails and Logging For PHI-bearing objects, the system should answer who did what, when, and to which record. Minimum requirements: - Version history for key records, using before or after snapshots or field-level changes. - Immutable audit log of security-sensitive actions such as login, impersonation, mass exports. - Record of consent changes, privacy preference updates, and sharing revocations. - Time-synchronised server clocks (NTP) to make logs reliable. Logging rules: - Do not log full payloads of clinical notes, prescriptions, or lab results. - Prefer identifiers plus minimal context such as record id, action, module, user, timestamp. --- ## 5. Data Protection and Deployment Checklist for secure-by-default deployments: - Transport: enforce HTTPS or TLS everywhere, including internal APIs. - At rest: use database encryption at rest and encrypted volumes or backups. - Secrets: store credentials in a secret manager or environment variables, never in Git. - Backups: regular encrypted backups with tested restore procedures. - Retention: configure retention policies per data category such as clinical, billing, logs. - Isolation: sepGitHub で全文を読む (外部ページ)