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  • The complaint is untimely, or withdrawn by the filer; and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.



Private Practice Ceases Conditioning of Compliance with the Privacy Rule Covered Entity: Private Practice Issue: Conditioning Compliance with the Privacy Rule A physician practice requested that patients sign an agreement entitled “Consent and Mutual Agreement to Maintain Privacy.” The agreement prohibited the patient from directly or indirectly publishing or airing commentary about the physician, his expertise, and/or treatment in exchange for the physician’s compliance with the Privacy Rule. A patient’s rights under the Privacy Rule are not contingent on the patient’s agreement with a covered entity. A covered entity’s obligation to comply with all requirements of the Privacy Rule ...read more



Private Practice Revises Process to Provide Access to Records Regardless of Payment Source Covered Entity: Private Practices Issue: Access At the direction of an insurance company that had requested an independent medical exam of an individual, a private medical practice denied the individual a copy of the medical records. OCR determined that the private practice denied the individual access to records to which she was entitled by the Privacy Rule. Among other corrective actions to resolve the specific issues in the case, OCR required that the private practice revise its policies and procedures regarding access requests to reflect the ...read more



Must a covered entity inform individuals in advance of any fees that may be charged when the individuals request a copy of their PHI? 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. Yes. When an individual requests access to her PHI and the covered entity intends to charge the ...read more



If a CSP stores only encrypted ePHI and does not have a decryption key, is it a HIPAA business associate? Answer: Yes, because the CSP receives and maintains (e.g., to process and/or store) electronic protected health information (ePHI) for a covered entity or another business associate.  Lacking an encryption key for the encrypted data it receives and maintains does not exempt a CSP from business associate status and associated obligations under the HIPAA Rules.  An entity that maintains ePHI on behalf of a covered entity (or another business associate) is a business associate, even if the entity cannot actually ...read more

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