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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| What is a covered entity’s obligation under the Breach Notification Rule if it transmits an individual’s PHI to a third party designated by the individual in an access request, and the entity discovers the information was breached in transit? 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. ...read more |
| Outpatient Surgical Facility Corrects Privacy Procedure in Research Recruitment Covered Entity: Outpatient Facility Issue: Impermissible Uses and Disclosures An outpatient surgical facility disclosed a patient's protected health information (PHI) to a research entity for recruitment purposes without the patient's authorization or an Institutional Review Board (IRB) or privacy-board-approved waiver of authorization. The outpatient facility reportedly believed that such disclosures were permitted by the Privacy Rule. OCR provided technical assistance to the covered entity regarding the requirement that covered entities seeking to disclose PHI for research recruitment purposes must obtain either a valid patient authorization or an Institutional Review Board ...read more |
| Can a covered entity refuse to disclose ePHI to an app chosen by an individual because of concerns about how the app will use or disclose the ePHI it receives? No. The HIPAA Privacy Rule generally prohibits a covered entity from refusing to disclose ePHI to a third-party app designated by the individual if the ePHI is readily producible in the form and format used by the app. See 45 CFR 164.524(a)(1), (c)(2)(ii), (c)(3)(ii). The HIPAA Rules do not impose any restrictions on how an individual or the individual’s designee, such as an app, may use the health information ...read more |
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