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

Last Updated: August 25 2016
Article by Scott Koller

In the wake of several high-profile ransomware infections targeting hospitals and health care organizations, the 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.

Conclusion

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.

Authors
Similar Articles
Relevancy Powered by MondaqAI
Ropes & Gray LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Ropes & Gray LLP
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

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 or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq 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 of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions