United States: A Closer Look At The OCR's Guidance On Ransomware

Last Updated: August 31 2016
Article by Scott Koller

In the wake of several high-profile ransomware infections targeting hospitals and healthcare organizations, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) has issued guidance on the growing threat of ransomware.

Ransomware is a type of malware that denies access to systems and data. It uses strong cryptography to encrypt files to prevent access without a decryption key. To receive the decryption key and restore access, the entity must pay a ransom, typically in the form of a cryptocurrency such as Bitcoin. While this type of malware has been around for years, it has recently made headlines in the healthcare industry, most notably after Hollywood Presbyterian Medical Center was forced to use pen and paper when its computer systems were held hostage by ransomware back in February. Like an infectious disease, ransomware has spread throughout the healthcare industry, causing havoc and potentially jeopardizing patient care.

Given the publicity and the potential for harm, it should come as no surprise that the OCR has issued guidance in this area. As the regulatory agency that enforces HIPAA, when the OCR speaks, healthcare organizations should take heed.

OCR's Guidance

The OCR's ransomware guidance is laid out in a series of FAQs, several of which ask whether HIPAA compliance can help covered entities prevent, detect or recover from ransomware. Surprisingly, the OCR's answer is yes. However, the key takeaway is that the OCR considers ransomware to be a subcategory of malware. As such, the steps a covered entity or business associate needs to take to protect against ransomware are similar to other types of malware, which include: (1) conducting a four-factor risk assessment under HIPAA; (2) implementing procedures to guard against malware; (3) training users on identifying and detecting malware; and (4) limiting access to ePHI to authorized users. Further, the steps for responding to a ransomware infection are nearly identical to the steps for responding to any other type of malware. This does not mean that entities can simply ignore the ransomware threat as just another piece of malware. Instead, the OCR fully expects healthcare organizations to account for the ransomware threat in their policies, procedures, risk analyses and security incident response plans.

Notification of Ransomware

Perhaps the most illuminating information contained in the OCR's ransomware guidance was its position on notification. HIPAA requires covered entities and their business associates to provide notification following a breach of unsecured PHI, as defined under HIPAA.

Most ransomware does not exfiltrate data. Instead, the ransomware denies access to the data by encrypting it in place, with the information contained within the encrypted file never leaving the organization. Due to the lack of unauthorized access or acquisition of the PHI by an unauthorized person, most ransomware will not qualify as a reportable breach as defined by HIPAA. The OCR's guidance does not change the outcome, although it may be surprising how OCR reached that conclusion.

The OCR guidance makes it clear that the presence of ransomware (or any malware) is a security incident and possibly "a breach, depending on the facts and circumstances of the attack." Also, the guidance confirmed that, "whether or not the presence of ransomware would be a breach under the HIPAA rules is a fact-specific determination." This is consistent with the approach conducted by covered entities prior to the OCR's guidance. Had the OCR stopped its analysis at that point, there would be no issue. However, the OCR took the additional step of stating, "When [ePHI] is encrypted as a result of a ransomware attack, a breach has occurred because the ePHI encrypted by the ransomware was acquired[,] and thus is a `disclosure’ not permitted under the HIPAA Privacy Rule."

Consider the implications of this statement. Under the OCR's guidance, the mere act of encrypting the data qualifies as an acquisition or disclosure, regardless of whether the perpetrator can view the PHI, read its contents or retain the information in any way. Remember, ransomware is programmed to perform certain steps in an automated fashion, without outside input or interaction. Can there be an "acquisition" of information by a piece of computer code even if that information is not reviewed or accessible by any unauthorized person? Can there be a "disclosure" of information to a computer, independent of an actual person? Under the OCR guidance, the answer is a mind-boggling yes.

Ignoring for a moment the mental gymnastics required to reconcile the OCR's interpretation of these terms, "acquisition" and "disclosure" are used extensively in state breach notification laws and state regulators routinely look to the OCR for guidance on interpreting and enforcing these statutory frameworks. Consider the use of "acquisition" under California law where a breach is defined as the "unauthorized acquisition of computerized data that compromises the security, confidentiality, or integrity of personal information[.]" Cal Civ. Code 1798.82. Unlike HIPAA, California's breach notification statute does not contain a risk of harm or risk assessment analysis. Therefore, if "acquisition" is interpreted the same as it is under HIPAA, then nearly all ransomware infections would arguably require notification, a result that is clearly not intended.

Unconcerned with how others interpret "acquisition" outside the context of HIPAA, the OCR has articulated a process for determining whether a breach involving ransomware requires notification. In short, the OCR wants covered entities to presume ransomware infections are a breach unless the covered entity or business associate can demonstrate that there is a low probability that the PHI has been compromised. While the OCR could have reached this conclusion without the logical inconsistencies describe above, the result is the same. It is the HIPAA risk assessment that will ultimately determine whether notification to affected individuals is required.

HIPAA Risk Assessment

With the HIPAA risk assessment playing a significant role in whether notification is required, the OCR has provided some helpful commentary on the four factors and how they should be applied in a ransomware situation. In apparent recognition of the unique characteristics of ransomware, the OCR's guidance focuses on identifying the exact type and variant of the ransomware. Doing so will help to assess the ransomware's capabilities, including an analysis of what it is programmed to do versus what it is told to do from external commands, and whether it exfiltrates data. The factor that is critical is whether forensically a covered entity is able to demonstrate that the PHI was not actually viewed or acquired and hence overcoming the presumption of a breach.

However, the OCR guidance goes one step further. While access to PHI is an important factor in the risk analysis, the OCR has said that unavailability of data alone may warrant notification. Since the primary goal of ransomware is to deny access (or availability) of data, this should be an important factor in the risk analysis. Moreover, covered entities faced with a ransomware infection must consider not only the possible disclosure of PHI, but also whether the unavailability of that PHI could potentially jeopardize healthcare services or patient safety. If so, notification to affected individuals may be required.


The newly released guidance on ransomware by the OCR has provided valuable insight into the OCR's expectations for preparing for and responding to ransomware infections. In light of this information, covered entities and business associates should consider the following actions:

  1. Update internal policies and procedures, including incident response plans.
  2. Test existing backup procedures to assess their ability to recover from a ransomware infection.
  3. Ensure risk assessments consider the potential threats to PHI stemming from malware, including ransomware.
  4. Provide training to users on identifying and preventing ransomware infections.
  5. If faced with an incident involving ransomware, presume the incident is a breach unless the evidence demonstrates a low probability of compromise based on the HIPAA breach risk assessment factors and specifically be able to demonstrate that the PHI was not actually viewed or acquired.
  6. When conducting a HIPAA breach risk assessment, consider the ransomware's capabilities and whether the incident presents a high risk of unavailability of the data or a high risk to the integrity of the data.
  7. Ensure that logging is available for a forensics review to support the risk assessment factors.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.