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

Many Business Associates think that by simply signing a Business Associate Agreement (BAA), they are automatically compliant with HIPAA regulations. But a BAA is just the beginning. The Office of Civil Rights (OCR) recently issued a new fact sheet that provides a clear outline of all provisions by which a business associate can be held liable for compliance under certain requirements of the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (“HIPAA Rules”).

HIPAA compliance is not ‘business-as-usual’. It requires a review of all processes, security of data, and HIPAA-specific documentation to be ready for a possible audit or investigation. HIPAAcraticRx can get started on the path to compliance by performing an annual Security Risk Analysis. This will uncover any vulnerabilities in your processes or systems that need to be mitigated, and help you lay out a plan for mitigation.

OCR has authority to take enforcement action against business associates for the 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 here, along with OCR’s guidance on business associates.

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