10 Requirements and Prohibitions the OCR can Enforce of Business Associates under HIPAA Rules
The HHS Office for Civil Rights (OCR) just recently issued a fact sheet that explains all requirements a business associate can be held directly liable for under HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (HIPAA Rules).
In 2013, OCR issued a final rule that, among other things, identified HIPAA Rules requirements that apply directly to business associates and for which business associates are directly liable.
OCR has the authority to take enforcement action against business associates only for those requirements and prohibitions of the HIPAA Rules that appear on the following list.
- 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 people for filing a HIPAA complaint, participating in an investigation or other enforcement processes, 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 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.
- 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.
According to OCR Director Roger Severino, these facts should "make it as easy as possible for regulated entities to understand, and comply with, their obligations under the law."
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