A HIPAA compliance violation is any act or omission by a HIPAA Covered Entity or HIPAA Business Associate that fails to meet a requirement, standard, implementation specification, or prohibition in the HIPAA Privacy Rule, HIPAA Security Rule, HIPAA Breach Notification Rule, or related enforcement requirements, including impermissible uses or disclosures of protected health information and failures to implement required administrative, physical, or technical safeguards.
Violations under the HIPAA Privacy Rule include using or disclosing protected health information without a permitted purpose or a valid authorization, failing to apply the HIPAA Minimum Necessary Rule where it applies, and failing to provide required individual rights such as access to records within required timeframes, an accounting of disclosures when applicable, or a compliant Notice of Privacy Practices. Privacy Rule violations also include disclosing protected health information to a vendor or service provider that meets the definition of a Business Associate without a compliant business associate agreement.
Violations under the HIPAA Security Rule include failing to conduct an accurate and thorough risk analysis for electronic protected health information, failing to implement reasonable and appropriate risk management measures, and failing to apply access controls, audit controls, integrity protections, and transmission security consistent with the organization’s environment. Security failures can also include weak authentication practices, uncontrolled shared accounts, inadequate device and media controls, and insufficient workforce security procedures when those gaps create impermissible access to electronic protected health information.
Violations under the HIPAA Breach Notification Rule include failing to provide required notifications to affected individuals, the Department of Health and Human Services, and, when applicable, the media after a breach of unsecured protected health information, or providing notifications outside required time limits. Documentation failures can also constitute noncompliance, including missing policies and procedures, incomplete training records, absent sanction policy enforcement, and failure to maintain required written documentation for the required retention period.
A HIPAA violation occurs when a covered entity or business associate uses or discloses protected health information or fails to implement required safeguards in a manner that does not meet the standards, implementation specifications, or prohibitions in the HIPAA Privacy Rule, HIPAA Security Rule, and HIPAA Breach Notification Rule.
The Regulatory Text About HIPAA Violations
The HIPAA Privacy Rule sets the baseline compliance test for impermissible uses and disclosures. The general standard at 45 CFR 164.502(a) states “A covered entity may not use or disclose protected health information, except as permitted or required by this subpart or by subpart C of part 160 of this subchapter.” The HIPAA Breach Notification Rule uses the breach definition at 45 CFR 164.402, which states “Breach means the acquisition, access, use, or disclosure of protected health information in a manner not permitted under subpart E of this part which compromises the security or privacy of the protected health information.” The combination of these provisions links impermissible uses and disclosures to breach assessment and, when unsecured protected health information is involved, to the notification duties in the HIPAA Breach Notification Rule.
HIPAA Staff Training
HIPAA staff training reduces avoidable violations by ensuring workforce members understand how to apply organizational policies and procedures to daily tasks involving protected health information and electronic protected health information. The HIPAA Privacy Rule training standard at 45 CFR 164.530(b)(1) states “A covered entity must train all members of its workforce on the policies and procedures with respect to protected health information required by this subpart and subpart D of this part, as necessary and appropriate for the members of the workforce to carry out their functions within the covered entity.” The HIPAA Security Rule training standard at 45 CFR 164.308(a)(5)(i) states “Implement a security awareness and training program for all members of its workforce (including management).” Training administration should include role-based assignment, onboarding delivery before system access is granted, refresher scheduling, and retention of completion records suitable for compliance reviews. The HIPAA Journal Training can be used for this purpose because it is online, comprehensive, and suitable for onboarding and annual refresher training.