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.
| Issued by: Office for Civil Rights (OCR) Do the HIPAA Rules allow a covered entity or business associate to use a CSP that stores ePHI on servers outside of the United States? Answer: Yes, provided the covered entity (or business associate) enters into a business associate agreement (BAA) with the CSP and otherwise complies with the applicable requirements of the HIPAA Rules. However, while the HIPAA Rules do not include requirements specific to protection of electronic protected health information (ePHI) processed or stored by a CSP or any other business associate outside of the United States, OCR notes that ...read more |
| Pharmacy Chain Enters into Business Associate Agreement with Law Firm Covered Entity: Pharmacy Chain Issue: Impermissible Uses and Disclosures; Business Associates A complaint alleged that a law firm working on behalf of a pharmacy chain in an administrative proceeding impermissibly disclosed the PHI of a customer of the pharmacy chain. OCR investigated the allegation and found no evidence that the law firm had impermissibly disclosed the customer’s PHI. However, the investigation revealed that the pharmacy chain and the law firm had not entered into a Business Associate Agreement, as required by the Privacy Rule to ensure that PHI is ...read more |
| 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 |
| Entity Rescinds Improper Charges for Medical Record Copies to Reflect Reasonable, Cost-Based Fees Covered Entity: Private Practice Issue: Access A patient alleged that a covered entity failed to provide him access to his medical records. After OCR notified the entity of the allegation, the entity released the complainant’s medical records but also billed him $100.00 for a “records review fee” as well as an administrative fee. The Privacy Rule permits the imposition of a reasonable cost-based fee that includes only the cost of copying and postage and preparing an explanation or summary if agreed to by the individual. To ...read more |
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