security management process (HIPAA)

Covered entities must implement a security management process as a part of their administrative safeguards. The HIPAA Security Rule defines that process as the "implement[ation] of policies and procedures to prevent, detect, contain and correct security violations."

The process is further defined as including four implementation specifications, all of them required:

  • risk analysis
  • risk management
  • a sanction policy, and
  • an information system activity review.

DHHS has noted that this standard and its four components "form the foundation upon which an entity's necessary security activities are built." Accordingly, it must be given particularly careful attention. However, as with all other elements of security safeguards, entities are given latitude in determining the details of implementation: "Numerous factors, including ... but not limited to, their size, degree of risk and environment" will determine what is reasonable and appropriate. (Final Rule, p.78)

That said, DHHS has also been clear that every covered entity is required to keep its security measures "current," and so these efforts "must be periodically reassessed and updated as needed." (Final Rule, p.79) This is not a "one off" effort.

The first of the four implementation specifications, risk analysis, includes "an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity and availability of electronic protected health information (PHI) held by the covered entity." A thorough and accurate risk analysis must consider "all relevant losses" that would be expected if security measures were not in place, including losses caused by unauthorized uses and disclosures as well as losses of data integrity or accuracy.

Risk management requires implementation of security measures sufficient to reduce those risks and vulnerabilities "to a reasonable and appropriate level."

Sanctions policies must be in place to apply appropriate penalties and punishments against workforce members who fail to comply with the organization's security policies and procedures. (The type and severity of sanctions imposed, and the categories of "violation," are left entirely to the determination of the covered entity.)

The last of the four, information systems activity review (formerly termed "internal audit"), includes implementation of "procedures to regularly review records of information systems activity, such as audit logs, access reports, and security incident tracking reports." (Again, the frequency and intensity of these reviews is left to the discretion of the covered entity.)

See also:

 
 

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