Direct Liability of Business Associates
Direct Liability of Business Associates In 2009, Congress enacted the Health Information Technology for Economic and Clinical Health (HITECH) Act, making business associates of covered entities directly liable for compliance with certain requirements of the HIPAA Rules. Consistent with the HITECH Act, the HHS Office for Civil Rights (OCR) issued a final rule in 2013 to modify the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules. Among other things, the final rule identifies provisions of the HIPAA Rules that apply directly to business associates and for which business associates are directly liable. 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 (a) the covered entity or (b) the individual or the individual’s designee (whichever is specified in the business associate agreement) to satisfy a covered entity's obligations under 45 CFR 164.524(c)(2)(ii) and 3(ii), respectively, with respect to an individual’s request for an electronic copy of PHI.
- 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.
For example, where the business associate’s agreement with a covered entity requires it to provide an individual with an electronic copy of his or her ePHI upon the individual’s request and the business associate fails to do so, OCR has enforcement authority directly over the business associate for that failure. (See No. 6 above.) By contrast, OCR lacks the authority to enforce the “reasonable, cost-based fee” limitation in 45 CFR 164.524(c)(4) against business associates because the HITECH Act does not apply the fee limitation provision to business associates. A covered entity that engages the services of a business associate to fulfill an individual’s request for access to their PHI is responsible for ensuring that, where applicable, no more than the reasonable, cost-based fee permitted under HIPAA is charged. If the fee charged is in excess of the fee limitation, OCR can take enforcement action against only the covered entity.
| Pharmacy Chain Enters into Business Associate Agreement with Law Firm Covered Entity: Pharmacy Chain Issue: Impermissible Uses and Disclosures; Business Associates A complaint alleged that a law firm working on behalf of a pharmacy chain in an administrative proceeding impermissibly disclosed the PHI of a customer of the pharmacy chain. OCR investigated the allegation and found no evidence that the law firm had impermissibly disclosed the customer’s PHI. However, the investigation revealed that the pharmacy chain and the law firm had not entered into a Business Associate Agreement, as required by the Privacy Rule to ensure that PHI is ...read more |
| May a covered entity use or disclose protected health information for litigation? Answer: A covered entity may use or disclose protected health information as permitted or required by the Privacy Rule, see 45 CFR 164.502(a) (PDF); and, subject to certain conditions the Rule typically permits uses and disclosures for litigation, whether for judicial or administrative proceedings, under particular provisions for judicial and administrative proceedings set forth at 45 CFR 164.512(e) (GPO), or as part of the covered entity’s health care operations, 45 CFR 164.506(a) (PDF). Depending on the context, a covered entity’s use or disclosure of protected health information in ...read more |
| State Hospital Sanctions Employees for Disclosing Patient's PHI Covered Entity: Health Care Provider / General Hospital Issue: Impermissible Disclosure A nurse and an orderly at a state hospital discussed the HIV/AIDS status of a patient and the patient's spouse within earshot of other patients without making reasonable efforts to prevent the disclosure. Upon learning of the incident, the hospital placed both employees on leave; the orderly resigned his employment shortly thereafter. Among other actions taken to satisfactorily resolve this matter, the hospital took further disciplinary action with the nurse, which included: documenting the employee record with a memo of ...read more |
| Can a covered entity use existing aspects of the HIPAA Privacy Rule to give individuals the right to decide whether sensitive information about them may be disclosed to or through a health information organization (HIO)? Yes. To the extent a covered entity is using a process either to obtain consent or act on an individual’s right to request restrictions under the Privacy Rule as a method for effectuating individual choice, policies can be developed for obtaining consent or honoring restrictions on a granular level, based on the type of information involved. For example, specific consent and restriction policies could ...read more |
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1/21/25 Understanding Business Associate Agreements
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11/12/22 May a covered entity use or disclose protected health information for litigation?
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