Health Insurance Portability and Accountability Act (HIPAA)
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HIPAA establishes national standards for the protection of individuals' medical records and other personal health information, applying to health plans, health care providers, and health care clearinghouses.
Key Facts
- Enacted in 1996, Privacy Rule effective 2003
- Enforced by Office for Civil Rights (OCR)
- Includes Privacy, Security, and Breach Notification Rules
HIPAA Rules
Privacy Rule
Standards for the protection of individuals' medical records and other personal health information.
Requirements
- Appropriate safeguards implementation
- Patient rights protection
- Use and disclosure limits
- Notice of privacy practices
- Business associate agreements
Examples
- Patient authorization forms
- Privacy policy documentation
- Access request procedures
- Minimum necessary standards
Security Rule
National security standards to protect electronic protected health information (ePHI).
Requirements
- Administrative safeguards
- Physical safeguards
- Technical safeguards
- Risk analysis
- Security management process
Examples
- Access control systems
- Encryption implementation
- Audit controls
- Facility security plans
Breach Notification Rule
Requirements for notification following a breach of unsecured protected health information.
Requirements
- Breach risk assessment
- Notification procedures
- Documentation requirements
- Timing requirements
- Content of notifications
Examples
- Breach notification letters
- Risk assessment documentation
- Media notifications
- HHS reporting procedures
Compliance Requirements
Risk Assessment and Management
Organizations must conduct regular risk assessments and implement appropriate security measures.
Implementation Steps
- Identify potential risks
- Evaluate current safeguards
- Assess likelihood of threats
- Determine potential impact
- Implement security measures
Required Documentation
- Risk assessment reports
- Security policies
- Mitigation plans
- Review schedules
- Implementation records
Workforce Training
Regular training for all workforce members on privacy and security policies.
Implementation Steps
- Develop training materials
- Schedule regular sessions
- Track attendance
- Assess understanding
- Document completion
Required Documentation
- Training materials
- Attendance records
- Assessment results
- Certification records
- Policy acknowledgments
Business Associate Management
Establish and maintain agreements with business associates handling PHI.
Implementation Steps
- Identify business associates
- Review relationships
- Execute agreements
- Monitor compliance
- Update agreements
Required Documentation
- Business associate agreements
- Compliance reports
- Monitoring records
- Review documentation
- Update logs
Enforcement & Penalties
Civil Monetary Penalties
OCR can impose civil money penalties based on tiered violation categories.
Penalty Categories
Example Cases
Criminal Penalties
The Department of Justice can pursue criminal penalties for HIPAA violations.