What if a HIPAA covered entity (or business associate) uses a CSP to maintain ePHI without first executing a business associate agreement with that CSP? What if a HIPAA covered entity (or business associate) uses a CSP to maintain ePHI without first executing a business associate agreement with that CSP?
Issued by: Office for Civil Rights (OCR)
What if a HIPAA covered
entity (or business associate) uses a CSP to maintain ePHI without
first executing a business associate agreement with that CSP?
Answer:
If a covered entity (or business associate) uses a CSP to maintain
(e.g., to process or store) electronic protected health information
(ePHI) without entering into a BAA with the CSP, the covered entity (or
business associate) is in violation of the HIPAA Rules. 45 C.F.R
§§164.308(b)(1) and §164.502(e). OCR has entered into a resolution agreement and corrective action plan
with a covered entity that OCR determined stored ePHI of over 3,000
individuals on a cloud-based server without entering into a BAA with the
CSP.[1]
Further, a CSP that meets the definition of a business associate –
that is a CSP that creates, receives, maintains, or transmits PHI on
behalf of a covered entity or another business associate – must comply
with all applicable provisions of the HIPAA Rules, regardless of whether
it has executed a BAA with the entity using its services. See 78 Fed.
Reg. 5565, 5598 (January 25, 2013). OCR recognizes that there may,
however, be circumstances where a CSP may not have actual or
constructive knowledge that a covered entity or another business
associate is using its services to create, receive, maintain, or
transmit ePHI. The HIPAA Rules provide an affirmative defense in cases
where a CSP takes action to correct any non-compliance within 30 days
(or such additional period as OCR may determine appropriate based on the
nature and extent of the non-compliance) of the time that it knew or
should have known of the violation (e.g., at the point the CSP knows or
should have known that a covered entity or business associate customer
is maintaining ePHI in its cloud). 45 CFR 160.410. This affirmative
defense does not, however, apply in cases where the CSP was not aware of
the violation due to its own willful neglect.
If a CSP becomes aware that it is maintaining ePHI, it must come into
compliance with the HIPAA Rules, or securely return the ePHI to the
customer or, if agreed to by the customer, securely destroy the ePHI.
Once the CSP securely returns or destroys the ePHI (subject to
arrangement with the customer), it is no longer a business associate.
We recommend CSPs document these actions.
While a CSP maintains ePHI, the HIPAA Rules prohibit the CSP from
using or disclosing the data in a manner that is inconsistent with the
Rules.
| Enforcement Results as of September 30, 2022 Since the compliance date of the Privacy Rule in April 2003, OCR has received over 309,475 HIPAA complaints and has initiated over 1,053 compliance reviews. We have resolved ninety-seven percent of these cases (300,427). OCR has investigated and resolved over 29,779 cases by requiring changes in privacy practices and corrective actions by, or providing technical assistance to, HIPAA covered entities and their business associates. Corrective actions obtained by OCR from these entities have resulted in change that is systemic and that affects all the individuals they serve. OCR has successfully enforced the ...read more |
| Health Plan Corrects Impermissible Disclosure of PHI through Training, Mitigation, and Sanctions Covered Entity: Health Plans Issue: Impermissible Uses and Disclosures An employee of a major health insurer impermissibly disclosed the protected health information of one of its members without following the insurer's authorization and verification procedures. Among other corrective actions to resolve the specific issues in the case, OCR required the health insurer to train its staff on the applicable policies and procedures and to mitigate the harm to the individual. In addition, the employee who made the disclosure was counseled and given a written warning. ...read more |
| Private Practice Revises Policies and Procedures Addressing Activities Preparatory to Research Covered Entity: Private Practice Issue: Impermissible Disclosure-Research A private practice physician who was the principal investigator of a clinical research study disclosed a list of patients and diagnostic codes to a contract research organization to telephone patients for recruitment purposes. The disclosure was not consistent with documents approved by the Institutional Review Board (IRB). The private practice maintained that the disclosure to the contract research organization was permissible as a review preparatory to research. Activities considered “preparatory to research” include: preparing a research protocol; developing a research hypothesis; ...read more |
| 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 |
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