Below are the 11 questions with partial answers to keep this brief but provide a good overview:
1. May a HIPAA covered entity or business associate use a cloud service to store or process ePHI?
Yes, provided the covered entity or business associate enters into a HIPAA-compliant business associate contract or agreement (BAA) with the CSP that will be creating, receiving, maintaining, or transmitting electronic protected health information (ePHI) on its behalf, and otherwise complies with the HIPAA Rules. Among other things, the BAA establishes the permitted and required uses and disclosures of ePHI by the business associate performing activities or services for the covered entity or business associate, based on the relationship between the parties and the activities or services being performed by the business associate. The BAA also contractually requires the business associate to appropriately safeguard the ePHI, including implementing the requirements of the Security Rule
2. If a CSP stores only encrypted ePHI and does not have a decryption key, is it a HIPAA business associate?
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. 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 and therefore cannot view the information. For convenience purposes this guidance uses the termno-viewservices 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.
3. Can a CSP be considered to be a “conduit” like the postal service, and, therefore, not a business associate that must comply with the HIPAA Rules?&
Generally, no. CSPs that provide cloud services to a covered entity or business associate that involve creating, receiving, or maintaining (e.g., to process and/or store) electronic protected health information (ePHI) meet the definition of a business associate, even if the CSP cannot view the ePHI because it is encrypted and the CSP does not have the decryption key.
4. Which CSPs offer HIPAA-compliant cloud services?
OCR does not endorse, certify, or recommend specific technology or products.
5. 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?
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 stored ePHI of over 3,000 individuals on a cloud-based server without entering into a BAA with the CSP
6. If a CSP experiences a security incident involving a HIPAA covered entity’s or business associate’s ePHI, must it report the incident to the covered entity or business associate?
Yes. The Security Rule at 45 CFR § 164.308(a)(6)(ii) requires business associates to identify and respond to suspected or known security incidents; mitigate, to the extent practicable, harmful effects of security incidents that are known to the business associate; and document security incidents and their outcomes. In addition, the Security Rule at 45 CFR § 164.314(a)(2)(i)(C) provides that a business associate agreement must require the business associate to report, to the covered entity or business associate whose electronic protected health information (ePHI) it maintains, any security incidents of which it becomes aware. A security incident under 45 CFR § 164.304 means the attempted or successful unauthorized access, use, disclosure, modification, or destruction of information or interference with system operations in an information system. Thus, a business associate CSP must implement policies and procedures to address and document security incidents, and must report security incidents to its covered entity or business associate customer.
7. Do the HIPAA Rules allow health care providers to use mobile devices to access ePHI in a cloud?
Yes. Health care providers, other covered entities, and business associates may use mobile devices to access electronic protected health information (ePHI) in a cloud as long as appropriate physical, administrative, and technical safeguards are in place to protect the confidentiality, integrity, and availability of the ePHI on the mobile device and in the cloud, and appropriate BAAs are in place with any third party service providers for the device and/or the cloud that will have access to the e-PHI.
8. Do the HIPAA Rules require a CSP to maintain ePHI for some period of time beyond when it has finished providing services to a covered entity or business associate?
No, the HIPAA Rules generally do not require a business associate to maintain electronic protected health information (ePHI) beyond the time it provides services to a covered entity or business associate. The Privacy Rule provides that a business associate agreement (BAA) must require a business associate to return or destroy all PHI at the termination of the BAA where feasible. 45 CFR § 164.504(e)(2)(J).
9. 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?
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 the risks to such ePHI may vary greatly depending on its geographic location. In particular, outsourcing storage or other services for ePHI overseas may increase the risks and vulnerabilities to the information or present special considerations with respect to enforceability of privacy and security protections over the data. Covered entities (and business associates, including the CSP) should take these risks into account when conducting the risk analysis and risk management required by the Security Rule. See 45 CFR §§ 164.308(a)(1)(ii)(A) and (a)(1)(ii)(B). For example, if ePHI is maintained in a country where there are documented increased attempts at hacking or other malware attacks, such risks should be considered, and entities must implement reasonable and appropriate technical safeguards to address such threats.
10. Do the HIPAA Rules require CSPs that are business associates to provide documentation, or allow auditing, of their security practices by their customers who are covered entities or business associates?
No. The HIPAA Rules require covered entity and business associate customers to obtain satisfactory assurances in the form of a business associate agreement (BAA) with the CSP that the CSP will, among other things, appropriately safeguard the protected health information (PHI) that it creates, receives, maintains or transmits for the covered entity or business associate in accordance with the HIPAA Rules. The CSP is also directly liable for failing to safeguard electronic PHI in accordance with the Security Rule and for impermissible uses or disclosures of the PHI. The HIPAA Rules do not expressly require that a CSP provide documentation of its security practices to or otherwise allow a customer to audit its security practices. However, customers may require from a CSP (through the BAA, service level agreement, or other documentation) additional assurances of protections for the PHI, such as documentation of safeguards or audits, based on their own risk analysis and risk management or other compliance activities.
11. If a CSP receives and maintains only information that has been de-identified in accordance with the HIPAA Privacy Rule, is it is a business associate?
No. A CSP is not a business associate if it receives and maintains (e.g., to process and/or store) only information de-identified following the processes required by the Privacy Rule. The Privacy Rule does not restrict the use or disclosure of de-identified information, nor does the Security Rule require that safeguards be applied to de-identified information, as the information is not considered protected health information. See the OCR guidance on de-identification for more information.