United States: Small-Breach Focus Shows Growing Scope Of HIPAA Probes

This article by partner Joanna Bergmann and associates Christine Moundas and Jamie Liebert was originally published in Law360 on September 27, 2016.

Flexing yet more enforcement muscle under the Health Insurance Portability and Accountability Act, on Aug. 18, 2016, the U.S. Department of Health and Human Services Office for Civil Rights announced that it will more widely investigate breaches of protected health information (PHI) affecting fewer than 500 individuals, termed “small breaches.” 1

Despite statutory authority to investigate all PHI breaches, to date OCR has focused primarily on large-scale breaches and entered into only a handful of settlement agreements with entities affected by small breaches.2 By this, its most recent enforcement initiative, each of OCR’s regional offices has been instructed to “increase its efforts to identify and obtain corrective action to address entity and systemic noncompliance related to … [small] breaches.” 3

As a result, health care providers and other covered entities and their business associates should expect an uptick in the volume of enforcement actions triggered by, and OCR settlements reached in connection with, small-scale PHI breaches. In preparation, entities should ensure that their responses to small breaches are just as thoughtful and methodical as their responses to large breaches.


Since the passage of the Health Information Technology for Economic and Clinical Health Act of 2009 and the subsequent implementation of the HIPAA breach notification rule, OCR’s regional offices have investigated all reported breaches involving the PHI of 500 or more individuals, and have exercised discretion over whether to investigate reports of smaller breaches. 4 In practice, entities are identified for investigation based on mandatory breach reports made to OCR as well as submissions made pursuant to state-level notification requirements. In response, OCR has imposed fines, penalties and, with increasing frequency, corrective action plans (CAPs) on the entities responsible for and affected by such breaches. 5

More recently, OCR has expanded its enforcement arsenal to include proactive measures. OCR has imposed higher fines, steeper penalties and more onerous CAPs on entities that fail to put the necessary preventative framework into place by, for example, conducting adequate risk analyses, implementing reasonable electronic safeguards to protect PHI, and entering into required business associate agreements (BAAs).6

OCR’s record-breaking settlement with Advocate Health Care Network earlier this year, under which Advocate must pay $5.55 million and enter into a two-year CAP subject to independent third-party oversight, illustrates the mounting financial impact OCR HIPAA investigations can have on affected entities.7 The Advocate settlement also marks the 10th OCR enforcement action in the first eight months of 2016 — compared to OCR’s previous one-year high of seven settlements.8

Since January 2013, OCR has entered into only a small handful of settlements with entities affected by small breaches; i.e., breaches of PHI affecting fewer than 500 individuals. These include settlements with Catholic Health Care Services, Triple-S, St. Elizabeth’s Medical Center, QCA Health Plan Inc., and Hospice of North Idaho. OCR’s new initiative, which will increase the number of investigations into these types of small-scale PHI breaches, fits within the agency’s overarching trend of more expansive and aggressive HIPAA enforcement.

New Initiative Guidelines

Going forward, OCR regional offices will increase investigatory and enforcement efforts with respect to small breaches, on the theory that investigating “[t]he root causes of [such] breaches may indicate entity-wide and industry-wide noncompliance with HIPAA’s regulations, and … provide OCR with an opportunity to evaluate an entity’s compliance programs, obtain correction of any deficiencies and better understand compliance issues in HIPAA-regulated entities more broadly.”9

Although regional offices will retain discretion to prioritize which small breaches to investigate, OCR has directed that the following factors be considered in determining whether to launch an investigation:

  • The size of the breach;
  • The amount, nature and sensitivity of the PHI involved;
  • Theft or improper disposal of unencrypted PHI;
  • Breaches involving unwanted intrusions (i.e., hacking) into information technology systems; and
  • Instances where numerous breach reports from a particular covered entity or business associate raise similar issues, or, in contrast, instances where a lack of breach reports for small breaches are reported by a specific covered entity or business associate relative to the amount of small breaches reported by “like-situated covered entities and business associates.”10

These factors, in particular the last, illuminate the ever-expanding scope of OCR HIPAA investigations. By directing regional offices to investigate HIPAA-covered entities and business associates for both an excess and a dearth of breach reports, OCR appears focused on all entities not achieving the Goldilocks of breach reporting.

Implications for Health Care Entities

Given the current enforcement environment, all HIPAA-regulated entities should redouble efforts to ensure that they are diligently adhering to best practices with respect to the full scope of their HIPAA obligations. OCR’s increased investigatory and enforcement activities with respect to small breaches demonstrate that each and every security incident and breach must be addressed with one eye on the specific incident and the other on the entity’s HIPAA compliance program more generally.

In particular, during an investigation triggered by a small breach, OCR may request information specifically pertaining to the breach, including the:

  • Steps taken to investigate the breach, including any forensic reports;
  • Methods used to determine the number of individuals affected by a breach;
  • Manner in which breach notification was provided to individuals;
  • Actions taken to mitigate, to the extent practicable, any harmful effects of the breach;
  • Actions taken to ensure that the breach does not recur;
  • Sanctions imposed on the person(s) responsible for the breach; and
  • Enhancements made to the HIPAA training program as a result of the breach.

Here, OCR will be interested in confirming that the incident was handled in compliance with the HIPAA breach notification rule. Accordingly, the covered entity or business associate, as appropriate, must ensure that its documentation regarding the investigation and response is carefully and comprehensively compiled and maintained. OCR may also probe why certain incidents were reported and others not. HIPAA-covered entities and business associates should, therefore, ensure that every security incident is timely and sufficiently documented, including, for those incidents not reported, the supporting rationale.

During an investigation triggered by a small breach, OCR may also ask questions designed to shed light on the root causes of the breach, such as any:

  • Existing HIPAA privacy and security rule policies or procedures implicated by the breach, as well as any revisions implemented as a result of the breach;
  • Administrative, technical and physical safeguards that may have failed or been absent during the breach, such as encryption or access controls;
  • BAA oversight procedures (including with business associates and their subcontractors);
  • HIPAA risk analyses performed prior to the breach; and
  • Risk management and remediation plans in place prior to the breach.

Notably, to investigate whether systemic vulnerabilities contributed to the breach, OCR may request documentation going back six years. In this manner, OCR has been converting discrete breach investigations into more comprehensive HIPAA compliance reviews. The very broad scope of these requests shows that a small breach can now lead to a far-reaching and potentially consequential investigation.

In sum, even after a small breach, HIPAA covered entities and business associates must not only satisfy their obligations under the HIPAA breach notification rule, but also undertake to assess the root causes of the breach and remediate any deficiencies detected in their HIPAA compliance program in a holistic and timely manner.

Republished with permission from Law360.


1 Email Notification from Office of Civ. Rights to OS OCR Privacy List, OCR Announces Initiative to More Widely Investigate Breaches Affecting Fewer than 500 Individuals, OCR Security List (Aug. 18, 2016), available at https://list.nih.gov/cgi-bin/wa.exe?A2=OCR-PRIVACY-LIST;65d278ee.1608 (hereinafter "Email Notification from OCR").
2  See Health & Human Servs. Office of Inspector Gen., OEI No. 09-10-0051, OCR Should Strengthen Its Followup Of Breaches Of Patient Health Information Reported By Covered Entities (September 2015), at 8, available at https://oig.hhs.gov/oei/reports/oei-09-10-00511.pdf (hereinafter "OIG Report").
3  Email Notification from OCR, supra note 1.
4  See e.g., OIG Report, supra note 2; U.S. Dept. of Health & Human Servs. Office of Civ. Rights, Breach Notification Rule, HHS.gov,  See e.g., OIG Report, supra note 2; U.S. Dept. of Health & Human Servs. Office of Civ. Rights, Breach Notification Rule, HHS.gov, http://www.hhs.gov/hipaa/for-professionals/breach-notification/index.html.
5  See U.S. Dept. of Health & Human Servs. Office of Civ. Rights, Enforcement Results by Year, HHS.gov,  See U.S. Dept. of Health & Human Servs. Office of Civ. Rights, Enforcement Results by Year, HHS.gov, http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/data/enforcement-results-by-year/index.html#2014 (Graph, Resolutions by Year and Type: Apr. 14, 2003 through Dec. 31, 2012) (showing a steady increase in the number of corrective actions obtained since 2003).
6  See, e.g., U.S. Dept. of Health & Human Servs. Office of Civ. Rights, Resolution Agreements, HHS.gov,  See, e.g., U.S. Dept. of Health & Human Servs. Office of Civ. Rights, Resolution Agreements, HHS.gov, http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/index.html (resolutions from 2015 to 2016 noting the importance of conducting risk analyses, implementing reasonable safeguards and entering into BAAs).
7  See App'x A. to Res. Agreement, Corrective Action Plan between the U.S. Dept. of Health & Human Servs. & Advocate Health Care Network, at §III (July 8, 2016), available at http://www.hhs.gov/sites/default/files/Advocate_racap.pdf.
8  See http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/index.html.
9  Email Notification from OCR, supra note 1.
10  Email Notification from OCR, supra note 1. 

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.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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.


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.


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