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.
| If a CSP stores only encrypted ePHI and does not have a decryption key, is it a HIPAA business associate? Answer: Yes, because the CSP receives and maintains (e.g., to process and/or store) electronic protected health information (ePHI) for a covered entity or another business associate. Lacking an encryption key for the encrypted data it receives and maintains does not exempt a CSP from business associate status and associated obligations under the HIPAA Rules. An entity that maintains ePHI on behalf of a covered entity (or another business associate) is a business associate, even if the entity cannot actually ...read more |
| Thursday, November 10, 2022 Five Former Methodist Hospital Employees Charged with HIPAA Violations Memphis, TN – A federal grand jury has indicted five former Methodist Hospital Employees for conspiring with Roderick Harvey, 40, to unlawfully disclose patient information in violation of the Health Insurance Portability and Accountability Act of 1996, commonly known as “HIPAA.” United States Attorney Kevin G. Ritz announced the indictment today. HIPAA was enacted by Congress in 1996 to create national standards to protect sensitive patient information from being disclosed without a patient’s knowledge or consent. HIPAA’s provisions make it a crime to disclose patient information, ...read more |
| Must a covered entity inform individuals in advance of any fees that may be charged when the individuals request a copy of their PHI? This guidance remains in effect only to the extent that it is consistent with the court’s order in Ciox Health, LLC v. Azar, No. 18-cv-0040 (D.D.C. January 23, 2020), which may be found at https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2018cv0040-51. More information about the order is available at https://www.hhs.gov/hipaa/court-order-right-of-access/index.html. Any provision within this guidance that has been vacated by the Ciox Health decision is rescinded. Yes. When an individual requests access to her PHI and the covered entity intends to charge the ...read more |
| Health Sciences Center Revises Process to Prevent Unauthorized Disclosures to Employers Covered Entity: General Hospitals Issue: Impermissible Uses and Disclosures; Authorizations A state health sciences center disclosed protected health information to a complainant's employer without authorization. Among other corrective actions to resolve the specific issues in the case, including mitigation of harm to the complainant, OCR required the Center to revise its procedures regarding patient authorization prior to release of protected health information to an employer. All staff was trained on the revised procedures. ...read more |
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