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.
Pharmacy Chain Institutes New Safeguards for PHI in Pseudoephedrine Log Books Covered Entity: Pharmacies Issue: Safeguards A grocery store based pharmacy chain maintained pseudoephedrine log books containing protected health information in a manner so that individual protected health information was visible to the public at the pharmacy counter. Initially, the pharmacy chain refused to acknowledge that the log books contained protected health information. OCR issued a written analysis and a demand for compliance. Among other corrective actions to resolve the specific issues in the case, OCR required that the pharmacy chain implement national policies and procedures to safeguard the ...read more |
SCOPE OF CRIMINAL ENFORCEMENT UNDER 42 U.S.C. § 1320d-6 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, and the knowingly element of the offense set forth in that provision requires only proof of knowledge of the facts that constitute the offense. MEMORANDUM OPINION FOR THE GENERAL COUNSEL DEPARTMENT OF HEALTH AND HUMAN SERVICES AND THE SENIOR COUNSEL TO THE DEPUTY ATTORNEY GENERAL You have asked jointly for our opinion concerning the scope of 42 U.S.C. § 1320d-6 (2000), the criminal enforcement provision of the ...read more |
A Covered Entity is: A health plan. An individual or group plan that provides, or pays the cost of, medical care. Health plans include private entities (e.g., health insurers and managed care organizations) and government organizations (e.g., Medicaid, Medicare, and the Veterans Health Administration) A health care provider. A provider of health care services and any other person or organization that furnishes, bills, or is paid for health care in the normal course of business. Health care providers (e.g., physicians, hospitals, and clinics) are covered entities if they transmit health information in electronic form in connection with a transaction ...read more |
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