OCR Enforcement Results

Enforcement Results as of September 30, 2022

Since the compliance date of the Privacy Rule in April 2003, OCR has received over 309,475 HIPAA complaints and has initiated over 1,053 compliance reviews.  We have resolved ninety-seven percent of these cases (300,427).

OCR has investigated and resolved over 29,779 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 settled or imposed a civil money penalty in 126 cases resulting in a total dollar amount of $133,519,272.00.  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 14,117 cases, our investigations found no violation had occurred.

Additionally, in 52,133 cases, OCR 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 (204,398), 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  • The complaint is untimely, or withdrawn by the filer; and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;
  • Pharmacies;
  • Outpatient Facilities; and
  • Community Health Centers.

Referrals

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 1,552 such referrals to DOJ.



Pharmacy Chain Revises Process for Disclosures to Law Enforcement Covered Entity: Pharmacies Issue: Impermissible Uses and Disclosures A chain pharmacy disclosed protected health information to municipal law enforcement officials in a manner that did not conform to the provisions of the Privacy Rule. Among other corrective actions to resolve the specific issues in the case, OCR required this chain to revise its national policy regarding law enforcement's access to patient protected health information to comply with the Privacy Rule requirements, including that disclosures of protected health information to law enforcement only be made in response to written requests from ...read more



Health Plan Corrects Impermissible Disclosure of PHI through Training, Mitigation, and Sanctions Covered Entity: Health Plans Issue: Impermissible Uses and Disclosures An employee of a major health insurer impermissibly disclosed the protected health information of one of its members without following the insurer's authorization and verification procedures. Among other corrective actions to resolve the specific issues in the case, OCR required the health insurer to train its staff on the applicable policies and procedures and to mitigate the harm to the individual. In addition, the employee who made the disclosure was counseled and given a written warning. ...read more



When does the Privacy Rule allow covered entities to disclose protected health information to law enforcement officials? Answer: The Privacy Rule is balanced to protect an individual’s privacy while allowing important law enforcement functions to continue. The Rule permits covered entities to disclose protected health information (PHI) to law enforcement officials, without the individual’s written authorization, under specific circumstances summarized below. For a complete understanding of the conditions and requirements for these disclosures, please review the exact regulatory text at the citations provided. Disclosures for law enforcement purposes are permitted as follows: To comply with a court order or ...read more



What is a covered entity’s obligation under the Breach Notification Rule if it transmits an individual’s PHI to a third party designated by the individual in an access request, and the entity discovers the information was breached in transit? This guidance remains in effect only to the extent that it is consistent with the court’s order in Ciox Health, LLC v. Azar, No. 18-cv-0040 (D.D.C. January 23, 2020), which may be found at https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2018cv0040-51. More information about the order is available at https://www.hhs.gov/hipaa/court-order-right-of-access/index.html. Any provision within this guidance that has been vacated by the Ciox Health decision is rescinded. ...read more

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