Enforcement Highlights - April 2021
For information on the history of and details about each of the HIPAA Rules, please visit https://www.hhs.gov/hipaa/for-professionals/index.html and click on "Privacy," "Security," or "Breach Notification" from the left-hand tool-bar.
Enforcement Results as of April 30, 2021
Since the compliance date of the Privacy Rule in April 2003, OCR has received over 262,586 HIPAA complaints and has initiated over 1,082 compliance reviews. We have resolved ninety-nine percent of these cases (258,683).
OCR has investigated and resolved over 28,838 cases by requiring changes in privacy practices and corrective actions by, or providing technical assistance to, HIPAA covered entities and their business associates. Corrective actions obtained by OCR from these entities have resulted in change that is systemic and that affects all the individuals they serve. OCR has successfully enforced the HIPAA Rules by applying corrective measures in all cases where an investigation indicates noncompliance by the covered entity or their business associate. To date, OCR has settled or imposed a civil money penalty in 99 cases resulting in a total dollar amount of $135,298,482.00. OCR has investigated complaints against many different types of entities including: national pharmacy chains, major medical centers, group health plans, hospital chains, and small provider offices.
In another 13,012 cases, our investigations found no violation had occurred.
Additionally, in 47,546 cases, OCR has intervened early and provided technical assistance to HIPAA covered entities, their business associates, and individuals exercising their rights under the Privacy Rule, without the need for an investigation.
In the rest of our completed cases (169,287), OCR determined that the complaint did not present an eligible case for enforcement. These include cases in which:
- OCR lacks jurisdiction under HIPAA. For example, in cases alleging a violation by an entity not covered by HIPAA;
- The complaint is untimely, or withdrawn by the filer; and
- The activity described does not violate the HIPAA Rules. For example, in cases where the covered entity has disclosed protected health information in circumstances in which the Privacy Rule permits such a disclosure.
From the compliance date to the present, the compliance issues most often alleged in complaints are, compiled cumulatively, in order of frequency:
- Impermissible uses and disclosures of protected health information;
- Lack of safeguards of protected health information;
- Lack of patient access to their protected health information;
- Lack of administrative safeguards of electronic protected health information; and
- Use or disclosure of more than the minimum necessary protected health information.
The most common types of covered entities that have been alleged to have committed violations are, in order of frequency:
- General Hospitals;
- Private Practices and Physicians;
- Outpatient Facilities;
- Pharmacies; and
- Community Health Centers.
OCR refers to the Department of Justice (DOJ) for criminal investigation appropriate cases involving the knowing disclosure or obtaining of protected health information in violation of the Rules. As of the date of this summary, OCR made 1,081 such referrals to DOJ.
Watch for monthly updates reporting the number of cases received, investigated or resolved.