HIPAA mandates strict safeguards for protected health information (PHI), applying to healthcare providers, health plans, clearinghouses, and their business associates.
Why it matters
- Violations carry penalties from $100 to $50,000 per violation, up to $1.5M annually.
- Data breaches affecting 500+ individuals require public notification and HHS reporting.
- Business associates face same liability as covered entities for PHI breaches.
- Repeated violations can result in criminal charges and imprisonment.
- Patients trust healthcare organizations to protect their most sensitive data.
Key requirements
- Privacy Rule: Standards for PHI use, disclosure, and individual rights.
- Security Rule: Administrative, physical, and technical safeguards for ePHI.
- Breach Notification: 60-day notification for breaches affecting 500+ individuals.
- Encryption: Required for ePHI in transit and at rest (Safe Harbor provision).
- Access controls: Role-based access and audit logging for all PHI access.
- Business associate agreements: Written contracts mandating HIPAA compliance.
- Risk assessments: Regular analysis of potential threats to ePHI.
Technical safeguards
- Unique user identification and emergency access procedures.
- Automatic logoff and encryption/decryption mechanisms.
- Audit controls tracking access to ePHI systems.
- Integrity controls preventing unauthorized PHI modification.
- Transmission security for ePHI sent over networks.
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