Internal security rule law

Internal Security Rule (ISR) is a set of regulations issued by the U.S. Department of Health and Human Services (HHS) under the Health Insurance Portability and Accountability Act (HIPAA) of 1996. The ISR was introduced in 2003 to ensure the confidentiality, integrity, and availability of electronic protected health information (ePHI) held by covered entities, such as healthcare providers, health plans, and healthcare clearinghouses.

The ISR applies to all covered entities that maintain or transmit ePHI, and requires them to implement certain administrative, technical, and physical safeguards to protect the security of ePHI. The rule is designed to prevent unauthorized access, use, disclosure, modification, or destruction of ePHI.

The ISR consists of three main components:

1. Administrative Safeguards: These requirements focus on the policies and procedures that covered entities must implement to ensure the security of ePHI. Examples include:
   • Assigning a security officer or official to oversee security efforts
   • Conducting risk assessments and risk management activities
   • Implementing policies and procedures for access controls, authentication, and authorization
   • Providing training and education to employees on security policies and procedures
2. Physical Safeguards: These requirements focus on the physical measures that covered entities must implement to protect ePHI. Examples include:
   • Implementing access controls for facilities and equipment
   • Securing workstations and devices
   • Implementing procedures for disposal of ePHI
   • Implementing procedures for responding to security incidents
3. Technical Safeguards: These requirements focus on the technical measures that covered entities must implement to protect ePHI. Examples include:
   • Implementing encryption and decryption of ePHI
   • Implementing firewalls and intrusion detection systems
   • Implementing access controls for electronic devices and networks
   • Implementing procedures for auditing and logging security-related events

The ISR also requires covered entities to:

• Conduct regular risk assessments and risk management activities
• Implement incident response and reporting procedures
• Provide breach notification to affected individuals and HHS in the event of a breach of unsecured ePHI
• Conduct regular security audits and evaluations

Violations of the ISR can result in civil monetary penalties, criminal penalties, and other enforcement actions.