How OCR Enforces the HIPAA Privacy & Security Rules (2024)

OCR is responsible for enforcing the HIPAA Privacy and Security Rules (45 C.F.R. Parts 160 and 164, Subparts A, C, and E). One of the ways that OCR carries out this responsibility is to investigate complaints filed with it. OCR may also conduct compliance reviews to determine if covered entities are in compliance, and OCR performs education and outreach to foster compliance with requirements of the Privacy and Security Rules.

OCR may only take action on certain complaints. See What OCR Considers During Intake and Review of a Complaint for a description of the types of cases in which OCR cannot take an enforcement action.

If OCR accepts a complaint for investigation, OCR will notify the person who filed the complaint and the covered entity named in it. Then the complainant and the covered entity are asked to present information about the incident or problem described in the complaint. OCR may request specific information from each to get an understanding of the facts. Covered entities are required by law to cooperate with complaint investigations.

If a complaint describes an action that could be a violation of the criminal provision of HIPAA (42 U.S.C. 1320d-6), OCR may refer the complaint to the Department of Justice for investigation.

OCR reviews the information, or evidence, that it gathers in each case. In some cases, it may determine that the covered entity did not violate the requirements of the Privacy or Security Rule. If the evidence indicates that the covered entity was not in compliance, OCR will attempt to resolve the case with the covered entity by obtaining:

  • Voluntary compliance;
  • Corrective action; and/or
  • Resolution agreement.

Most Privacy and Security Rule investigations are concluded to the satisfaction of OCR through these types of resolutions. OCR notifies the person who filed the complaint and the covered entity in writing of the resolution result.

If the covered entity does not take action to resolve the matter in a way that is satisfactory, OCR may decide to impose civil money penalties (CMPs) on the covered entity. If CMPs are imposed, the covered entity may request a hearing in which an HHS administrative law judge decides if the penalties are supported by the evidence in the case. Complainants do not receive a portion of CMPs collected from covered entities; the penalties are deposited in the U.S. Treasury.

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How OCR Enforces the HIPAA Privacy & Security Rules (2024)

FAQs

How OCR Enforces the HIPAA Privacy & Security Rules? ›

OCR plays several roles in enforcing HIPAA's Privacy and Security Rules. It investigates complaints, conducts compliance reviews, and educates relevant entities about compliance requirements. If needed, it can levy penalties against non-compliant entities and even refer them to the Department of Justice.

How OCR enforces the HIPAA privacy and security rules? ›

OCR enforces the Privacy and Security Rules in several ways: Investigating complaints filed with it. Conducting compliance reviews to determine if covered entities are in compliance.

How is responsible for enforcing the HIPAA privacy and security rules? ›

The Department of Health and Human Services (HHS), Office for Civil Rights (OCR) is responsible for administering and enforcing these standards, in concert with its enforcement of the Privacy Rule, and may conduct complaint investigations and compliance reviews.

Are the HHS and OCR responsible for administering and enforcing the security rule? ›

OCR is responsible for enforcing the HIPAA Privacy and Security Rules (45 C.F.R. Parts 160 and 164, Subparts A, C, and E). One of the ways that OCR carries out this responsibility is to investigate complaints filed with it.

Who enforces HIPAA privacy security and breach notification rules? ›

HHS' Office for Civil Rights is responsible for enforcing the Privacy and Security Rules. Enforcement of the Privacy Rule began April 14, 2003 for most HIPAA covered entities.

What is the OCR HIPAA? ›

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) enforces federal civil rights laws, conscience and religious freedom laws, the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach Notification Rules, and the Patient Safety Act and Rule, which ...

What is the enforcement rule in HIPAA? ›

The HIPAA Enforcement Rule contains provisions relating to compliance and investigations, the imposition of civil money penalties for violations of the HIPAA Administrative Simplification Rules, and procedures for hearings. The HIPAA Enforcement Rule is codified at 45 CFR Part 160, Subparts C, D, and E.

Who is responsible for obeying the HIPAA privacy Rule? ›

HIPAA and the Privacy Act

According to HHS, covered entities that are Federal agencies or Federal contractors that maintain records that are covered by the Privacy Act not only must obey the Privacy Rule's requirements, but also must comply with the Privacy Act.

Who must comply with the HIPAA privacy Rule and security Rule? ›

Who Must Comply with HIPAA Rules? Covered entities and business associates must follow HIPAA rules. If you don't meet the definition of a covered entity or business associate, you don't have to comply with the HIPAA rules.

What are the three main rules of HIPAA? ›

The Health Insurance Portability and Accountability Act (HIPAA) lays out three rules for protecting patient health information, namely:
  • The Privacy Rule.
  • The Security Rule.
  • The Breach Notification Rule.

What are the laws of OCR? ›

Office for Civil Rights (OCR)

OCR ensures that recipients of financial assistance from OJP, OVW, and COPS comply with Federal laws prohibiting discrimination in employment and delivery of services or benefits based on race, color, national origin, sex, religion, age, and disability.

How does an OCR complaint work? ›

If the OCR decides to investigate, they will send you and the school a letter stating that the OCR is opening an investigation. If the OCR decides to investigate your complaint, the OCR may review documents and interview you, any witnesses, and personnel of the school you are bringing the complaint against.

What is the penalty for violating HIPAA OCR? ›

Criminal Penalties

According to the U.S. Department of Health and Human Services Office for Civil Rights (OCR): A person who knowingly obtains or discloses individually identifiable health information in violation of the Privacy Rule may face a criminal penalty of up to $50,000 and up to one-year imprisonment.

What is a breach under the HIPAA privacy and security rules? ›

HIPAA's Breach Notification Rule requires covered entities to notify patients when their unsecured protected heath information (PHI) is impermissibly used or disclosed—or “breached,”—in a way that compromises the privacy and security of the PHI.

Who is responsible for reporting HIPAA breach? ›

Following a breach of Unsecured PHI, Covered Entities must provide notification of the breach to affected individuals, the Secretary of Health and Human Services, and – in some circ*mstances – to the media. Business Associates must notify Covered Entities if a breach occurs at or by the Business Associate.

How do I report a breach to OCR? ›

Should you need assistance with this site or have any questions, please email ocrprivacy@hhs.gov or call us toll-free: (800) 368-1019, TDD toll-free: (800) 537-7697. To file a breach report, please enter information in the wizard pages below. A field with an asterisk (*) before it is a required field.

When OCR publishes the final rule on the proposed changes to the HIPAA privacy Rule? ›

The Final Rule expands and strengthens patient privacy protections by prohibiting Covered Entities and their business associates (together with Covered Entities, Regulated Entities) from using or disclosing patients' PHI related to the provision of “lawful reproductive health care,” including abortion care, for the ...

Does the OCR require that hospitals train their staff on HIPAA rules annually? ›

The HIPAA Privacy Rule states that training must be provided to “each new member of the workforce within a reasonable period of time after the person joins the covered entity's workforce” and to “each member of the covered entity's workforce whose functions are affected by a material change in the policies or ...

What is the overall process of submitting a health information privacy complaint to the OCR? ›

Your complaint must:
  • Be filed in writing by mail, fax, e-mail, or via the Office for Civil Rights (OCR) Complaint Portal.
  • Identify the relevant covered entity or business associate and explain the actions or inactions that, in your opinion, breached the Privacy, Security, or Breach Notification Rules.
Nov 20, 2023

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