United States: HHS Releases Guidance On Privacy And Security Audits And Ransomware

If your organization operates in the healthcare industry, particularly if it qualifies as a covered entity or business associate under the Health Insurance Portability and Accountability Act (HIPAA), you may have noticed the recent flurry of activity from the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR). First, HHS has recently launched phase two of its three-part audit of compliance with HIPAA privacy, security and breach notification rules. Second, HHS has provided guidance on ransomware which states that the presence of ransomware is a "security incident," which triggers breach disclosure obligations. Organizations subject to HIPAA should review its security incident procedures in light of the upcoming audits and the ransomware guidance and even entities outside the healthcare industry may also benefit from reviewing these guidance documents since other agencies and governmental authorities may follow HHS's lead in these interpretations.

HHS OCR Phase Two Audits Focus on Privacy, Security and Breach Notification Rules 

Last month, the HHS Office of Civil Rights officially launched phase two of its HIPAA audit program, sending out notification letters to 167 selected covered entities. In an effort to provide the selected covered entities with greater understanding of the audit process, HHS recently posted guidance on its website in the form of a FAQ. According to the FAQ, the purpose of these audits is to provide HHS "an opportunity to examine mechanisms for compliance, identify best practices, discover risks and vulnerabilities that may not have come to light through OCR's ongoing complaint investigations and compliance reviews, and enable us to get out in front of problems before they result in breaches."

The desk audit program has already begun. Those covered entities selected to participate in desk audits received letters from HHS on July 11th via email. HHS advises covered entities to check their spam and junk mail filter to ensure that communications from HHS are not inadvertently deleted. Although every covered entity is eligible for selection to participate in the desk audits, OCR is endeavoring to select entities that represent a wide range of health care providers, health plans, health care clearinghouses and (for the desk audits commencing in the fall) business associates. The current set of desk audits will examine compliance with specific requirements of HIPAA Privacy, Security and/or Breach Notification Rules. Those selected for audit will receive document request letters from HHS, outlining the specific subject of the audit.

How the desk audit program works. Per HHS's FAQ, the audit process for phase two will employ common audit techniques. HHS will send request to those entities selected for audit to provide certain specified documents and other data. Those audited entities will then be required to submit the requested documents and data through a new secure audit portal on HHS's website within 10 business days of the date of HHS's request. HHS auditors will review the submitted documentation and then share their draft findings with the audited entity. The audited entity will then have 10 business days to respond in writing to the HHS auditor's draft findings. The auditor will have 30 business days to complete the final audit report following the audited entity's response. The final audit report will describe how HHS conducted the audit, discuss any findings, and include the audited entity's responses to the draft findings. HHS will share a copy of the final report with the audited entity.

Onsite audits. Following the conclusion of all desk audits at the end of this calendar year, HHS will commence a third set of audits which will be onsite and examine a broader scope of requirements from the HIPAA rules than the desk audits. HHS has stated that entities selected for desk audits may be subject to these subsequent onsite audits. Entities selected for onsite audits will be notified via email of their selection and each onsite audit will be conducted over 3 to 5 days onsite, depending on the size of the entity. As with the desk audits, audited entities will have 10 business days to review and provide written comments to the draft findings of the HHS auditor, the auditor will complete a final audit report within 30 business days of the audited entity's response, and HHS will share a copy of the final report with the audited entity.

What happens after the audit. If an audit report indicates a serious compliance issue for an audited entity, HHS may initiate a compliance review. Although HHS will not post a listing of audited entities or the findings of an individual audit which clearly identifies the audited entity, HHS may be required to release audit notification letters and other information about these audits pursuant to a Freedom of Information Act request. HHS will aggregate data from all final reports and will use that information to determine what types of technical assistance should be developed and what types of corrective action would be most helpful. HHS will also develop tools and issue guidance to assist the industry in compliance with HIPAA requirements.

How to Prepare for an Audit

All covered entities and business associates should be prepared for an audit by HHS. Covered entities and business associates should review their privacy, security and breach notification policies and practices. In particular, they should confirm their compliance with the following HIPAA requirements:

  • Notice of Privacy Practices. Organizations must provide printed copies of the organization's current privacy  notice to patients and make this notice available on the organization's website. These notices must include their effective date as well as: (a) how the organization may use and disclose protected health information (PHI); (b) the patient's rights with respect to PHI and how the patient may exercise these rights, including how the patient may complain to the organization; (c) the organization's legal duties with respect to PHI, including a statement that the covered entity is required by law to maintain the privacy of PHI; and (d) a contact for further information about the organization's privacy policies.
  • Written HIPAA policies and procedures. An organization's HIPAA policies and procedures should conform with the administrative, technical and physical safeguards promulgated by HHS and should identify any risks or vulnerabilities in the organization's collection, storage or use of PHI. The organization should implement safeguards for all paper, electronic and verbal PHI, including PHI on mobile devices and storage media.
  • Risk assessment. Organizations should both conduct risk assessments and promptly implement appropriate security measures to address any identified risks. These assessments should include, at a minimum, an evaluation of the likelihood and impact of potential risks to PHI, documentation of the organization's security measures and, where required, the rationale for adopting such measures. Organizations must also conduct periodic follow-up security risk assessments to identify, address and document any deficiencies so as to maintain continuous, reasonable and appropriate security protections. And in light of HHS's new guidance on ransomware (discussed below), organizations should include the threat posed by ransomware attacks in their security assessments.
  • Breach Procedures. Organizations must implement notification policies and procedures that conform to HIPAA requirements for breaches of unprotected PHI (including HHS guidelines for breaches affecting 500 or more individuals). Organizations should conduct training for new employees and ongoing training for all staff on how to appropriately respond to a security breach.

Key Takeaways

  • Audit guidance is important for all covered entities and business associates. HHS has stressed that its guidance for phase two audits "should be helpful to audited entities as well as other covered entities and business associates seeking assistance with improving their compliance with these important requirements of the HIPAA Rules."
  • Your organization may still be selected for an audit. Phase two audits, including both desk audits and onsite audits, will continue throughout this year. Even if your organization is not selected to participate in a phase two audit, phase three audits are just around the corner.
  • Organizations should be prepared for an audit. All covered entities and business associates should carefully review their policies and procedures for compliance with HIPAA rules. Particular attention should be paid to compliance with the Security Rule.

Guidance on Ransomware

In addition to the FAQ on the phase two desk audits, HHS Office of Civil Rights released important new guidance on how to protect against and respond to ransomware attacks. Citing cyber-attacks on electronic health information systems as "one of the biggest current threats to health information privacy," the new guidance issued by HHS in July 2016 reinforces activities required by HIPAA to help organizations prevent, detect, contain and respond to ransomware.

And while only organizations subject to the HIPAA Security Rule are obligated to comply with this guidance, other entities which may be targeted by ransomware can also benefit from reviewing these requirements since it is likely that other agencies and governmental authorities will follow HHS's lead.

What is ransomware? Ransomware is a type of malicious software that prevents or limits users from accessing their own system, either by locking the system's screen or by encrypting the user's files. Users are then forced to pay a ransom (hence the term "ransomware") in order to regain access to their system. Though ransomware is a serious threat to any organization, for healthcare entities who deal with medical emergencies on a daily basis, even a few hours of system downtime can be potentially life-threatening. These healthcare entities are then often forced to pay the ransom, thereby encouraging future attacks on similar organizations. And there has indeed been a sharp increase in the number of ransomware attacks on hospitals and other covered entities over the past few years. The HHS Guidance cites to a recent US Government interagency report which indicates that there have been 4,000 daily ransomware attacks since early 2016, compared to 1,000 daily ransomware attacks reported in 2015. With the threat of ransomware growing, OCR has issued new guidance to better protect patients.

Ransomware attacks are security incidents. The key takeaway from OCR's guidance is that ransomware attacks will generally be considered a security incident under the HIPAA Security Rule. A breach is presumed to have occurred unless the covered entity or business associate can demonstrate a low probability that protected health information has been compromised. Thus, organizations subject to the HIPAA Security Rule that suffer from a ransomware attack must comply with the Security Rule breach notification requirements, including the requirement to notify the affected individuals, the Secretary of HHS and in certain cases the media if it affects more than 500 individuals.

Breach notification requirements may be avoided in certain cases. As noted above, HHS's guidance does allow for organizations to demonstrate that there is a low probability of protected health information having been compromised, thereby avoiding the breach notification obligations. To do this, these organizations must conduct a risk assessment by considering four factors: (a) the nature and extent of the protected health information involved; (b) the unauthorized person who used the PHI or to whom the disclosure was made; (c) whether PHI was actually acquired or viewed; and (d) the extent to which the risk to PHI has been mitigated. Furthermore, HHS's guidance encourages organizations "to consider additional factors, as needed, to appropriately evaluate the risk that the PHI has been compromised." This risk assessment must be thorough, completed in good faith and reach conclusions that are reasonable given the circumstances. Additionally, organizations must maintain sufficient documentation supporting their conclusions.

Organizations must prepare for attacks. In addition, HHS's guidance also requires organizations to proactively implement policies and procedures that will help it respond to and recover from a ransomware attack. These policies and procedures include: (a) implementing a security management process, which includes conducting a risk analysis to identify threats and vulnerabilities to ePHI and implementing security measures to mitigate or remediate those identified risks; (b) implementing procedures to guard against and detect malicious software; (c) training users on malicious software protection so they can assist in detecting malicious software and know how to report such detections; and (d) implementing access controls to limit access to ePHI to only those persons or software programs requiring access.

OCR further reminds organizations that "the Security Rule includes requirements for all covered entities and business associates to conduct an accurate and thorough risk analysis of the potential risks and vulnerabilities to the confidentiality, integrity and availability of all of the ePHI the entities create, receive, maintain or transmit and to implement security measures sufficient to reduce those identified risks and vulnerabilities to a reasonable and appropriate level." It is therefore incumbent on organizations to address the threat posed by ransomware in their risk assessments. It is not enough to simply respond to ransomware and report them as security incidents; organizations must be prepared to prevent, detect and contain them as security threats.

Key Takeaways

  • Ransomware attacks pose a serious threat, and they are increasing. Ransomware attacks are often successful and they are increasingly targeting hospitals and other entities in the healthcare industry. For many covered entities and business associates, the question is "when" and not "if" they will be attacked with ransomware.
  • Ransomware attacks are considered a security incident under the HIPAA Security Rule. When a covered entity or business associate suffers a ransomware attack, a breach is presumed to have occurred unless that organization can demonstrate a low probability that protected health information has been compromised. This will trigger a requirement for the victim entities to notify individuals whose information is involved in the breach "without unreasonable delay" and in no case later than 60 days following the discovery of the breach. Breach notification rules may also require notice to the HHS Secretary and the media.
  • Organizations must prepare for attacks. HHS's new guidance requires all covered entities and business associates to implement policies and procedures addressing ransomware attacks. All such organizations should carefully review their policies and procedures to ensure compliance with this new guidance.
  • Organizations in all sectors can benefit from reviewing the HHS requirements. Once a major agency like HHS defines an obligation to detect, prevent, combat and report ransomware attacks, other regulatory agencies may also follow suit in issuing similar guidance.

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
Morgan Lewis
Ropes & Gray LLP
Akin Gump Strauss Hauer & Feld LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Morgan Lewis
Ropes & Gray LLP
Akin Gump Strauss Hauer & Feld 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