HHS Publishes Guidance on HIPAA and Cloud Computing

by Mintz Levin - Health Law & Policy Matters
Contact

On October 7, 2016, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) published guidance to assist cloud service providers (CSPs) and their customers with HIPAA compliance. As discussed below, the guidance clarifies important questions about operating in the cloud, including the role of encryption when determining whether a cloud service provider is a business associate.

In its introduction, OCR articulates a basic principle of HIPAA applicability in the realm of cloud computing:

When a covered entity engages the services of a CSP to create, receive, maintain, or transmit ePHI (such as to process and/or store ePHI), on its behalf, the CSP is a business associate under HIPAA. Further, when a business associate subcontracts with a CSP to create, receive, maintain, or transmit ePHI on its behalf, the CSP subcontractor itself is a business associate.

The guidance then addresses the effect of encryption on the application of HIPAA to cloud providers. In the past, some CSPs have questioned whether they are a business associate if they handle only encrypted ePHI for which they do not have the decryption key. OCR has finally put this question to rest:

Lacking an encryption key does not exempt a CSP from business associate status and obligations under the HIPAA Rules.

As a result, the covered entity (or business associate) and the CSP must enter into a HIPAA-compliant business associate agreement (BAA), and the CSP is both contractually liable for meeting the terms of the BAA and directly liable for compliance with the applicable requirements of the HIPAA Rules.

The guidance then answers questions that OCR believes will help HIPAA-regulated CSPs and their customers in understanding their responsibilities under HIPAA. The following themes emerge from OCR’s answers:

Security Rule Compliance Requires a Thorough Understanding of the CSP’s Services

When asked whether covered entities and business associates can use CSPs to store and process ePHI, OCR responded affirmatively. In addition to the BAA, HIPAA’s Security Rule requires covered entities (and business associates) to conduct their own risk analysis and establish risk management policies. In order to do this, covered entities (and business associates) must understand what the CSP is doing with the ePHI and the CSP’s responsibilities to the ePHI. But gaining this understanding is easier said than done. Unlike traditional vendors, CSPs offer services that are, by their nature, complex and physically removed from the customer. In addition to a well-crafted BAA, the guidance points to the underlying service level agreements (SLAs) between parties as a potential vehicle for fleshing out each party’s responsibilities.

Security Rule Applicable to “No-view Services”

OCR circles back to the question of whether HIPAA applies to CSPs maintaining encrypted ePHI for which they do not hold the decryption key. OCR defines these as “no-view services.” According to OCR, while encryption reduces the risk of unauthorized viewing, it cannot alone safeguard the confidentiality, integrity and availability of ePHI as required by the Security Rule. For example, encryption alone cannot protect corruption by malware or ensure that the data remains available during emergencies and disasters. Full compliance with the Security Rule by CSPs providing no-view services is no longer open to debate.

The Actions of One Party May Satisfy Both Parties’ HIPAA Requirements

In cases where a CSP is providing only no-view services to a covered entity (or business associate) customer, certain Security Rule requirements that apply to the ePHI maintained by the CSP may be satisfied for both parties through the actions of one of the parties. To illustrate this point, the guidance provides an example. If a CSP’s customer implements its own reasonable and appropriate authentication controls and agrees that the CSP need not implement additional procedures to authenticate a person seeking access to the ePHI, then the Security Rule access control responsibilities would be met for both parties by the action of the customer. According to OCR, the CSP is still responsible under the Security Rule for other reasonable and appropriate controls to limit access to information systems that maintain customer ePHI. This would include, for example, internal controls to assure only authorized access to the administrative tools that manage the information systems hosting the ePHI.

Other Highlights

The guidance also addresses other matters related to CSPs, including the following:

  • CSPs cannot argue that they are a “conduit” and therefore not a business associate. CSPs providing cloud services that involve creating, receiving or maintaining ePHI meet the definition of a business associate, even if the CSP is providing no-view services.
  • CSPs must document security incidents just like any other business associate and must satisfy any breach notification requirements that applies to unencrypted data.
  • Health care providers, other covered entities, and business associates may use mobile devices to access ePHI in the 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.
  • As is normally the case under HIPAA, CSPs are not required to maintain ePHI for a period of time beyond when it has finished providing services to a covered entity or business associate.
  • Covered entities and business associates can use CSPs that store ePHI on servers outside the U.S., but should consider the increased risks of hacking or malware that may be present in other countries.  Of course, cross-border transfers of ePHI may raise other regulatory issues.
  • HIPAA does not require CSPs to provide documentation or allow auditing of their security practices by their customers.
  • CSPs that receive and maintain only information that has been de-identified in accordance with the HIPAA Privacy Rule will not be considered a business associate.

OCR’s guidance is a first step in clarifying HIPAA’s reach into the cloud. However, the guidance is just that–a first step. It does not address more complex issues, including, for example, the use of application programming interfaces (APIs) or the distinction between different types of cloud services. Fortunately, OCR has created a question portal that can be used by stakeholders seeking answers to these more discrete questions.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Mintz Levin - Health Law & Policy Matters | Attorney Advertising

Written by:

Mintz Levin - Health Law & Policy Matters
Contact
more
less

Mintz Levin - Health Law & Policy Matters on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.