In 2009, the Health Information Technology for Economic and Clinical Health (HITECH) Act, imposed direct liability on business associates for certain violations of the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (the “HIPAA Rules”). The resulting 2013 HHS Office for Civil Rights (OCR) final rule modified the HIPAA Rules accordingly. In May of this year, OCR posted guidance on the HHS website reiterating the parameters of business associate liability, as follows:
As set forth in the HITECH Act and OCR’s 2013 final rule, OCR has authority to take enforcement action against business associates only for those requirements and prohibitions of the HIPAA Rules as set forth below.
Business associates are directly liable for HIPAA violations as follows:
- 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.
- 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.
- Failure to comply with the requirements of the Security Rule.
- Failure to provide breach notification to a covered entity or another business associate.
- Impermissible uses and disclosures of PHI.
- 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.
- Failure to make reasonable efforts to limit PHI to the minimum necessary to accomplish the intended purpose of the use, disclosure, or request.
- Failure, in certain circumstances, to provide an accounting of disclosures.
- 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.
- Failure to take reasonable steps to address a material breach or violation of the subcontractor’s business associate agreement.
While OCR describes its enforcement power as limited to the ten infractions enumerated above, the scope of liability for business associates is broad. For instance, business associates are liable for failure to comply with the Security Rule and for all “impermissible uses and disclosures of PHI.”
This guidance puts business associates on notice and may indicate a move toward increased enforcement. Business associates should audit compliance with the HIPAA Rules and business associate agreements, as consequences can be severe. In one past OCR action, the theft of a mobile device containing PHI led to a $650,000 penalty for an information technology provider that served as a business associate to skilled nursing facilities.
For assistance with HIPAA compliance, please contact Bill Keefer at email@example.com, (716) 847-5488, or Michael Borrello at firstname.lastname@example.org, (716) 504-5702.