How are HIPAA-covered entities audited for compliance?

by | Jul 24, 2023 | HIPAA News and Advice

HIPAA-covered entities are audited for compliance through various methods, including random audits conducted by the Office for Civil Rights (OCR), investigations based on complaints and breaches, and the HIPAA Audit Program, which involves examinations of policies, procedures, and safeguards implemented to protect the privacy and security of individuals’ health information. HIPAA-covered entities, including healthcare providers, health plans, and healthcare clearinghouses, are subject to audits and evaluations to ensure their adherence to the regulations outlined in the HIPAA Privacy, Security, and Breach Notification Rules. The Office for Civil Rights (OCR), a division of the U.S. Department of Health and Human Services (HHS) serves to maintain the integrity of healthcare data management.

HIPAA Audit Related TermsExplanation
HIPAA Audit ProgramConducted by OCR to evaluate covered entities’ compliance with HIPAA regulations.
Types of AuditsPrivacy Rule Audit, Security Rule Audit, and Breach Notification Rule Audit.
Privacy Rule AuditFocuses on policies and procedures related to the privacy of patients’ health information, assessing compliance with PHI uses and disclosures.
Security Rule AuditEvaluates technical and administrative safeguards for protecting electronic PHI (ePHI) in terms of confidentiality, integrity, and availability.
Breach Notification Rule AuditAssesses covered entity’s response to breaches, including breach detection, assessment, and notification processes.
Complaint-Based AuditsTriggered by complaints filed by individuals believing their health information privacy rights were violated.
Breach-Triggered AuditsResult from data breaches involving unsecured PHI affecting 500+ individuals, requiring OCR reporting and subsequent investigation.
Audit Process StagesIncludes audit notification, pre-audit questionnaire, and on-site/remote audit procedures.
Auditor AssessmentAuditors evaluate compliance efforts, document findings, and identify strengths and areas for improvement.
Corrective Action PlansCovered entities respond to audit findings with corrective action plans addressing identified deficiencies.
Penalties and Corrective ActionsSerious non-compliance may lead to corrective actions, policy revisions, enhanced safeguards, and employee training.
Financial PenaltiesViolations may result in financial penalties, with amounts based on the nature and severity of the breach.
Maintaining Patient TrustAudits help preserve patient trust by ensuring health information confidentiality, integrity, and availability.
Upholding HIPAA PrinciplesAuditing reinforces core HIPAA principles, promoting responsible data management and safeguarding health information.
Table: HIPAA Audit-Related Terms Explained

Audits for HIPAA compliance serve as a safeguard against potential breaches, unauthorized disclosures, and other security vulnerabilities that could compromise patients’ private health information. The audit process involves meticulous assessments of a covered entity’s policies, procedures, and technical safeguards, all of which contribute to the goal of securing patient data. One method through which HIPAA-covered entities are audited is the HIPAA Audit Program. This initiative was established by the OCR to systematically review and evaluate the compliance efforts of covered entities. The Audit Program consists of three types of audits: the Privacy Rule Audit, the Security Rule Audit, and the Breach Notification Rule Audit. Each of these audits focuses on specific aspects of HIPAA compliance.

The Privacy Rule Audit delves into the implementation of policies and procedures that safeguard the privacy of patients’ health information. It assesses the covered entity’s compliance with the regulations that govern the permissible uses and disclosures of protected health information (PHI). Entities are evaluated on their management of individual rights, such as providing patients with access to their own health records and granting them the ability to request amendments. The Security Rule Audit examines the measures a covered entity has taken to ensure the confidentiality, integrity, and availability of electronic PHI (ePHI). Technical safeguards, such as encryption and access controls, are scrutinized to ensure they align with the HIPAA Security Rule’s requirements. The audit also evaluates administrative safeguards, including risk assessments and workforce HIPAA training, which are important in mitigating security risks. The Breach Notification Rule Audit involves OCR’s assessment of a covered entity’s response to breaches of PHI. This includes the entity’s ability to detect breaches, conduct timely risk assessments, and notify affected individuals and regulatory bodies as necessary. Properly handling breaches demonstrates an entity’s commitment to both security and transparency.

Covered entities can also be audited in response to complaints or reports of potential non-compliance. Individuals who believe their health information privacy rights have been violated can file complaints with the OCR. If an investigation reveals evidence of non-compliance, the OCR may conduct a focused audit to address the specific concerns raised in the complaint. Data breaches can also trigger audits. When a covered entity experiences a breach of unsecured PHI affecting 500 or more individuals, it is required to report the breach to the OCR. Subsequently, the OCR may initiate an investigation and audit to determine the causes of the breach and whether the entity had appropriate safeguards in place to prevent it.

The audit process involves several stages, including the issuance of an audit notification letter to the selected covered entity, data gathering through the completion of a pre-audit questionnaire, and on-site or remote audit procedures. During the audit, auditors assess the entity’s compliance efforts and document findings in an audit report. This report outlines areas of strength and areas that need improvement. Covered entities are then given an opportunity to respond to the audit findings and provide corrective action plans for addressing identified deficiencies. In cases where serious compliance issues are identified, the OCR may impose corrective actions or penalties. Corrective action plans may require the entity to revise policies, enhance safeguards, and implement additional training for employees. Financial penalties can be imposed for HIPAA violations, and these penalties can vary based on the nature and severity of the non-compliance.


HIPAA-covered entities undergo audits for compliance to ensure the safeguarding of patients’ sensitive health information. The OCR conducts audits through the HIPAA Audit Program, responding to complaints, and investigating breaches. These audits assess the entities’ adherence to the HIPAA Privacy, Security, and Breach Notification Rules, covering a range of policies, procedures, and technical safeguards. The audit process serves as a mechanism for maintaining the confidentiality, integrity, and availability of health information, promoting trust between patients and healthcare providers, and maintaining the principles of the HIPAA regulations.

HIPAA Covered Entity Topics

What is the definition of a HIPAA-covered entity?
How does an organization determine if it is a HIPAA-covered entity?
Are all healthcare providers considered HIPAA-covered entities?
What obligations does an entity covered by HIPAA have concerning patient data?
Do insurance companies fall under the category of entities covered by HIPAA?
What is a covered entity under HIPAA?
Who would not be considered a covered entity under HIPAA?
Is an employer a covered entity under HIPAA?
Who should HIPAA complaints be directed to within the covered entity?
What are the penalties for a HIPAA-covered entity that breaches patient confidentiality?
Are health technology companies automatically considered HIPAA-covered entities?
What distinguishes a HIPAA entity from non-covered entities?
Can a HIPAA-covered entity share medical records with another such entity without patient consent?
How often should HIPAA-covered entities review their compliance procedures?
What types of training must employees of an entity covered by HIPAA undergo?
How do entities covered by HIPAA handle data breaches?
What is the role of a privacy officer in a HIPAA-covered entity?
Are dental practices considered HIPAA-covered entities?
Can a patient sue a HIPAA-covered entity for a data breach?
How are HIPAA-covered entities audited for compliance?
What are the reporting obligations of a HIPAA entity in case of data exposure?
How do third-party vendors interact with HIPAA-covered entities?
Can a business associate be considered a HIPAA-covered entity?
How should a HIPAA entity respond to unauthorized access to protected health information?
What security measures must entities covered by HIPAA implement?
Are there exemptions for certain types of entities covered by HIPAA?
How long must a HIPAA-covered entity retain medical records?
What patient rights are recognized by entities covered by HIPAA concerning their personal data?
Are telemedicine platforms typically classified as HIPAA-covered entities?
What distinguishes business associates from HIPAA-covered entities?
How can patients file complaints against a HIPAA entity?
What is the significance of the Notice of Privacy Practices for a HIPAA-covered entity?
How do international medical tourism practices intersect with HIPAA-covered entities?
Are there specific encryption standards that a HIPAA-covered entity must adhere to?
How do federal and state laws regarding patient privacy relate to HIPAA-covered entities?
How do HIPAA-covered entities handle minor patient information?
Are pharmacies and drug stores universally categorized as HIPAA-covered entities?
How can a HIPAA-covered entity ensure compliance when integrating new technologies?
What are the key differences between a HIPAA-covered entity and a HIPAA business associate?
Are research institutions always considered HIPAA-covered entities?
What are the boundaries of marketing activities for an entity covered by HIPAA?
Can cloud service providers be classified as HIPAA-covered entities?
How should a HIPAA entity prepare for an official audit or review?
What documentation is essential for a HIPAA-covered entity’s compliance processes?
How often do regulations impacting HIPAA-covered entities get updated?
Do educational institutions fall under the scope of entities covered by HIPAA?
How do mobile health apps and digital health tools intersect with HIPAA-covered entities?
What is the role of electronic health record systems in a HIPAA-covered entity?
How does the Health Information Exchange (HIE) network impact HIPAA-covered entities?
Are mental health professionals bound by the same rules as other HIPAA-covered entities?
How do mergers and acquisitions impact the status of a HIPAA-covered entity?
Can patients access all their health data held by a HIPAA-covered entity?
Are billing and invoicing data handled differently by entities covered by HIPAA than medical data?
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