New HHS Fact Sheet on Direct Liability of Business Associates under HIPAA

24th May 2019

The HHS Office for Civil Rights (OCR) has issued a new fact sheet that provides a clear compilation of all provisions through which a business associate can be held directly liable for compliance with certain requirements of the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (“HIPAA Rules”), in accordance with the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009.  In 2013, under the authority granted by the HITECH Act, OCR issued a final rule that, among other things, identified provisions of the HIPAA Rules that apply directly to business associates and for which business associates are directly liable. 

OCR has authority to take enforcement action against business associates only for those requirements and prohibitions of the HIPAA Rules that appear on the following list. 

  1. Failure to provide the Secretary with records and compliance reports; cooperate with complaint investigations and compliance reviews; and permit access by the Secretary to information, including protected health information (PHI), pertinent to determining compliance.
  2. Taking any retaliatory action against any individual or other person for filing a HIPAA complaint, participating in an investigation or other enforcement process, or opposing an act or practice that is unlawful under the HIPAA Rules.
  3. Failure to comply with the requirements of the Security Rule.
  4. Failure to provide breach notification to a covered entity or another business associate.
  5. Impermissible uses and disclosures of PHI.
  6. Failure to disclose a copy of electronic PHI to either the covered entity, the individual, or the individual’s designee (whichever is specified in the business associate agreement) to satisfy a covered entity’s obligations regarding the form and format, and the time and manner of access under 45 C.F.R. §§ 164.524(c)(2)(ii) and 3(ii), respectively.
  7. Failure to make reasonable efforts to limit PHI to the minimum necessary to accomplish the intended purpose of the use, disclosure, or request.
  8. Failure, in certain circumstances, to provide an accounting of disclosures.
  9. Failure to enter into business associate agreements with subcontractors that create or receive PHI on their behalf, and failure to comply with the implementation specifications for such agreements.
  10. Failure to take reasonable steps to address a material breach or violation of the subcontractor’s business associate agreement.

“As part of the Department’s effort to fully protect patients’ health information and their rights under HIPAA, OCR has issued this important new fact sheet clearly explaining a business associate’s liability,” said OCR Director Roger Severino.  “We want to make it as easy as possible for regulated entities to understand, and comply with, their obligations under the law.”

The new fact sheet may be found at https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/business-associates/index.html along with OCR’s guidance on business associates.

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Our mission is to assist healthcare organizations and business associates in the development, design, and implementation of practices to secure IT systems and comply with HIPAA/HITECH privacy, security, breach and enforcement rules by protecting patient health information.

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