If a CSP stores only encrypted ePHI and does not have a decryption key, is it a HIPAA business associate? If a CSP stores only encrypted ePHI and does not have a decryption key, is it a HIPAA business associate?
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 view the ePHI.[1]
Thus, a CSP that maintains encrypted ePHI on behalf a covered entity
(or another business associate) is a business associate, even if it does
not hold a decryption key[i] and therefore cannot view the information. For convenience purposes this guidance uses the term no-view services
to describe the situation in which the CSP maintains encrypted ePHI on
behalf of a covered entity (or another business associate) without
having access to the decryption key.
While encryption protects ePHI by significantly reducing the risk of
the information being viewed by unauthorized persons, such protections
alone cannot adequately safeguard the confidentiality, integrity, and
availability of ePHI as required by the Security Rule. Encryption does
not maintain the integrity and availability of the ePHI, such as
ensuring that the information is not corrupted by malware, or ensuring
through contingency planning that the data remains available to
authorized persons even during emergency or disaster situations.
Further, encryption does not address other safeguards that are also
important to maintaining confidentiality, such as administrative
safeguards to analyze risks to the ePHI or physical safeguards for
systems and servers that may house the ePHI.
As a business associate, a CSP providing no-view services is not
exempt from any otherwise applicable requirements of the HIPAA Rules.
However, the requirements of the Rules are flexible and scalable to take
into account the no-view nature of the services provided by the CSP.
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| 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 ...read more |
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