United States: Sixth Circuit Affirms Dismissal Of False Claims Act Case Based On HITECH Data Breach

In United States ex rel. Sheldon v. Kettering Health Network, 816 F.3d 399 (6th Cir. 2016), the Sixth Circuit affirmed the lower court's dismissal of a False Claims Act ("FCA") suit based on a data breach involving electronic health records. The relator alleged that defendant Kettering Health Network ("Kettering") violated the FCA by falsely certifying its compliance with the Health Information Technology for Economic and Clinical Health Act (the "HITECH Act" or the "Act"), under which it received incentive payments from the federal government. The Sixth Circuit held that the conduct the relator complained of in this case did not constitute a violation of the Act, particularly as the Defendant had policies and procedures in place to protect the information. As a result, the relator had not alleged facts that established a false statement or false attestation of compliance. The panel also held that dismissal of the complaint was independently warranted because the relator had failed to plead any false claims for payment by the government with the particularity required by Rule 9(b).

Background

The HITECH Act was designed to encourage health care providers to adopt the use of electronic health records ("EHR").1 Under the Act the federal government makes incentive payments to health care providers that meet certain standards for the use of EHR technology. To receive such payments, a provider must certify that it meets roughly two dozen "meaningful use" objectives, one of which relates to the protection of electronically maintained health information.2 Providers must comply with certain Health Insurance Portability and Accountability Act ("HIPAA") standards, including implementing encryption mechanisms, sanctioning those who fail to comply, and implementing policies to review system activity.3 Kettering allegedly certified that it had implemented the required protections, and therefore received such government payments.

The relator sued Kettering under the FCA, alleging that the hospital's handling of her protected health information showed that Kettering was not in compliance with the HITECH Act. Arguing Kettering's compliance certification was false, she sought recovery of the "meaningful use" payments, which were substantial. Specifically, the relator alleged that her then-husband, a Kettering employee, had accessed her medical records as well as those of other individuals, in the course of an affair with another Kettering employee. The relator learned of the breach when she was notified of it by a letter from Kettering. After learning of the breach, she asked the hospital to provide her with certain EHR system monitoring reports that she alleged should be routinely run, but the hospital refused to do so. From this, she inferred that the hospital did not run the reports at all and alleged that its assumed failure to do so was another breach of HITECH that made Kettering's compliance attestations false. While this federal suit was pending but still under seal, the relator filed suit in Ohio state court alleging state law torts arising from the same data breach.4

The district court granted Kettering's motion to dismiss, finding the relator had not plausibly alleged a violation of the HITECH Act, had failed to plead with sufficient particularity any specific false claims submitted by Kettering, and that the Ohio state court's final judgment dismissing Sheldon's state tort case served as res judicata to bar her FCA claims as well.

The Sixth Circuit's Decision

The Sixth Circuit affirmed, unanimously holding the relator failed adequately to plead a "false statement" or a "claim for payment" as required by FCA.5

With regard to the alleged false statements, the court reasoned that the HITECH Act and its implementing regulations require Kettering take certain steps to secure its system, including conducting a risk analysis and implementing appropriate security policies and procedures for its EHR system. The Sixth Circuit found, however, that the alleged individual breaches did not amount to a violation of the HITECH Act, nor did Relator's allegations regarding the individual breaches show a lack of the policies and procedures required by the Act. In reaching that conclusion, the court noted that the Act contemplates that breaches may occur, even when policies and procedures are in place, and does not impose strict liability for such occurrences. Furthermore, Kettering's response to the alleged breaches demonstrates that it had measures in place to detect and investigate unauthorized access. As for Kettering's decision not to provide the specific monitoring report requested by the relator, the court concluded that HITECH itself did not require the use of specific software, let alone use of that specific report, and thus, even if the court credited Relator's assumption that failing to provide the report to her meant the report had not been run at all, relator had failed to allege a violation of the Act.

The Sixth Circuit also affirmed the district court's determination that relator's complaint failed to allege any false claims with the specificity required by Rule 9(b). In the Sixth Circuit, there is "[a] clear and unequivocal requirement that a relator allege specific false claims" in order to survive a motion to dismiss an FCA complaint. Sheldon, 816 F.3d at 411. A relator must plead with specificity "characteristic" examples that are "illustrative of the class" of claims covered by the alleged scheme. Id. at 412. Here, the relator failed to point to any specific claim for payment and instead relied on the assumption that false claims "must have been submitted at some point." Because this approach is one the Sixth Circuit had previously held fails to satisfy Rule 9(b), the panel held the complaint had been properly dismissed.

Implications of the Decision

The Sixth Circuit's decision offers some comfort to entities that must comply with the HITECH Act. A data breach and the resulting harms are distinct from a violation of the laws and regulations governing the protection of that data. Specific disclosures of information cannot be assumed to be sufficient to show non-compliance with a broader obligation to implement data security policies and procedures. Furthermore, the response to a data breach actually provides an entity with an opportunity to demonstrate its adherence to its policies and procedures.

Footnotes

1. The Health Information Technology for Economic and Clinical Health Act, Pub. L. No. 111-5, Title XIII, 123 Stat. 226 (2009).

2. 42 C.F.R. § 495.2.

3. 45 C.F.R. § 164.308(a)(1).

4. See decision in Sheldon v. Kettering Adventist HealthCare, 2014 CV 03304, 2014 Ohio Misc. LEXIS 18 (Montgomery Cty. Ct. Com. Pl. 2014).

5. The panel also affirmed the district court's analysis of the res judicata effect of the state court's judgment.

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
 
In association with
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
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.

Disclaimer

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.

Registration

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.

Cookies

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.

Links

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.

Mail-A-Friend

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.

Security

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.