HIPAA UPDATES

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

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.

* This information was originally published in an email dated 5.24.19 and was sent  from the OCR-Privacy-List listserv, operated by the Office for Civil Rights (OCR) in the US Department of Health and Human Services.