May 29, 2019.On May 24, the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) published a Fact Sheet entitled: Direct Liability of Business Associates, “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.” The ten provisions that directly apply to business associates for which they are directly liable are:

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 (ePHI) 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.”
In issuing the Fact Sheet, OCR Director Roger Severino stated: “’We want to make it as easy as possible for regulated entities to understand and comply with their obligations under the law’”.

For additional information, see OCR’s Guidance entitled: Business Associates, which was updated on May 24, 2019, to include reference to the Fact Sheetdescribed herein.

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