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Compliance and Enforcement

Privacy Rule Enforcement Highlights

(As of March 31, 2007)

The HIPAA Privacy Rule is a set of federal standards to protect the privacy of patients' medical records and other health information maintained by covered entities: health plans, which include many governmental health programs, such as the Veterans Health Administration, Medicare and Medicaid; most doctors, hospitals and many other health care providers; and health care clearinghouses. These standards provide patients with access to their medical records and significant control over how their personal health information is used and disclosed. Compliance with the standards was required as of April 14, 2003 for most entities covered by HIPAA. On that date, OCR began accepting complaints involving the privacy of personal health information in the health care system.

Enforcement Results as of the Date of This Summary

  • HHS / OCR has investigated and resolved over 4,447 cases by requiring changes in privacy practices and other corrective actions by the covered entities. Corrective actions obtained by HHS from these entities have resulted in change that is systemic and affects all the individuals they serve. HHS has successfully enforced the Privacy Rule by applying corrective measures in all cases where an investigation indicates noncompliance by the covered entity including:
    • National pharmacy chains;
    • Major medical centers;
    • Health plans;
    • Hospital chains; and
    • Small provider offices.

  • In another 2,155 cases, our investigations found no violation had occurred.

  • In the rest of our completed cases (13,875), HHS determined that the complaint did not present an eligible case for enforcement of the Privacy Rule. These include cases in which:
    • OCR lacks jurisdiction under HIPAA – such as a complaint alleging a violation prior to the compliance date or alleging a violation by an entity not covered by the Privacy Rule;
    • the complaint is untimely, or withdrawn or not pursued by the filer;
    • the activity described does not violate the Rule – such as when the covered entity has disclosed protected health information in circumstances in which the Rule permits such a disclosure.

  • In summary, since the compliance date in April 2003, HHS has received over 26,408 HIPAA Privacy complaints. We have resolved three quarters of complaints received (over 20,477): through investigation and enforcement (over 4,447), through investigation and finding no violation (2,155) and through closure of cases that were not eligible for enforcement (13,875).

The compliance issues investigated most frequently are, in order of frequency:

  1. Impermissible uses and disclosures of protected health information;
  2. Lack of safeguards of protected health information;
  3. Lack of patient access to their protected health information;
  4. Uses or disclosures of more than the Minimum Necessary protected health information; and
  5. Lack of or invalid authorizations for uses and disclosures of protected health information.

The most common types of covered entities that have been required to take corrective action to achieve voluntary compliance are, in order of frequency:

  1. Private Practices;
  2. General Hospitals;
  3. Outpatient Facilities;
  4. Health Plans (group health plans and health insurance issuers); and,
  5. Pharmacies.

DOJ 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 Rule. As of the date of this summary, OCR made over 384 such referrals to DOJ.

Outreach and Education
HHS also obtains privacy compliance through outreach and education efforts. OCR has reached hundreds of thousands of covered entities and consumers through educational conferences, a toll-free call line, and an interactive website. HHS has had over 3.5 million visits to its Privacy Web pages and over 4 million visits to the frequently asked questions on the Privacy Web pages. HHS has distributed announcements and educational information to over 17,000 subscribers to the Privacy listserve.

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