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.
| Direct Liability of Business Associates In 2009, Congress enacted the Health Information Technology for Economic and Clinical Health (HITECH) Act,1 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.2 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.3 As set forth in the HITECH ...read more |
| HMO Revises Process to Obtain Valid Authorizations Covered Entity: Health Plans / HMOs Issue: Impermissible Uses and Disclosures; Authorizations A complaint alleged that an HMO impermissibly disclosed a member’s PHI, when it sent her entire medical record to a disability insurance company without her authorization. An OCR investigation indicated that the form the HMO relied on to make the disclosure was not a valid authorization under the Privacy Rule. Among other corrective actions to resolve the specific issues in the case, the HMO created a new HIPAA-compliant authorization form and implemented a new policy that directs staff to obtain patient signatures ...read more |
| Pharmacy Chain Revises Process for Disclosures to Law Enforcement Covered Entity: Pharmacies Issue: Impermissible Uses and Disclosures A chain pharmacy disclosed protected health information to municipal law enforcement officials in a manner that did not conform to the provisions of the Privacy Rule. Among other corrective actions to resolve the specific issues in the case, OCR required this chain to revise its national policy regarding law enforcement's access to patient protected health information to comply with the Privacy Rule requirements, including that disclosures of protected health information to law enforcement only be made in response to written requests from ...read more |
| Tuesday, November 1, 2022 Modernizing Medicine Inc. (ModMed), an electronic health record (EHR) technology vendor located in Boca Raton, Florida, has agreed to pay $45 million to resolve allegations that it violated the False Claims Act (FCA) by accepting and providing unlawful remuneration in exchange for referrals and by causing its users to report inaccurate information in connection with claims for federal incentive payments. The Anti-Kickback Statute prohibits anyone from offering or paying, directly or indirectly, any remuneration — which includes money or any other thing of value — to induce referrals of items or services covered by Medicare, ...read more |
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11/12/22 Covered entities and those persons rendered accountable by general principles of corporate criminal liability may be prosecuted directly under 42 U.S.C. § 1320d-6
11/12/22 The Delaware Division of Developmental Disabilities Services Data Breach
11/12/22 OCR Settles Three Cases with Dental Practices for Patient Right of Access under HIPAA
11/12/22 HHS Issues Guidance on HIPAA and Audio-Only Telehealth
11/12/22 Five Former Methodist Hospital Employees Charged with HIPAA Violations
11/12/22 May a covered entity use or disclose protected health information for litigation?
11/12/22 When does the Privacy Rule allow covered entities to disclose protected health information to law enforcement officials?
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