audit controls (HIPAA)

Covered entities must implement audit controls as a part of their technical safeguards. The Security Rule defines this requirement as "implement[ations] of hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use electronic protected health information [PHI]." (Note: There is no separate implementation specification.)

"Entities have flexibility to implement the standard in a manner appropriate to their needs as deemed necessary by their own risk analyses" [required as part of the security management process]. (Final Rule, p.132) But, since the standard is required rather than addressable, it would appear that such flexibility does not extend to having no audit trail mechanisms at all.

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