The Final Security Rule was published on February 20, 2003, with a compliance deadline of April 21, 2005. As the first rule of its kind in healthcare, it mandates that all HIPAA-covered entities adhere to federal guidelines for safeguarding electronic protected health information (ePHI).
In general terms, this rule requires that covered entities must do certain things:
- Ensure the confidentiality, integrity, and availability of all electronic protected health information (PHI) that the covered entity creates, receives, maintains, or transmits.
- Protect against any reasonably anticipated threats or hazards to the security or integrity of such information.
- Protect against any reasonably anticipated uses or disclosures of such information that are not permitted or required under the rule.
- Ensure workforce compliance through appropriate training and oversight
The rule outlines a comprehensive framework, divided into three primary safeguard categories:
- Administrative safeguards (e.g., policies, workforce training)
- Physical safeguards (e.g., facility and device security)
- Technical safeguards (e.g., access control, encryption, audit controls)
Together, these are organized into 18 security standards and 42 specific security areas that the covered organization must address.
While this rule reflects widely accepted best practices from other industries, it is uniquely tailored to meet the specific needs of the healthcare sector. Many of its requirements may already be partially in place, for example, employee security training and the use of authentication protocols to access computer systems. The rule also mandates the development and enforcement of formal policies and procedures that guide daily operations and protect sensitive data.
However, other components, such as encrypting electronic transmissions of protected health information (PHI) that leave the organization’s internal network, may be entirely new and require additional planning and implementation to ensure compliance.
Importantly, the Security Rule is flexible and technology-neutral. It does not prescribe specific software or methods, nor does it dictate exactly how policies should be developed. Instead, it allows each organization to assess its unique environment and adopt reasonable and appropriate security measures that fulfill the rule’s core objectives.