United States: Mobile Health Apps Continue To Make Headlines

Recently published studies are illustrating the types of issues that mobile health application, or "app," developers will continue to face as the industry matures alongside an evolving regulatory and enforcement landscape.

Study Questions Privacy Policy of Some Mobile Health Apps

Last week, researchers at the Illinois Institute of Technology Chicago-Kent College of Law published a study about the privacy protections of mobile health apps. The study, which analyzed diabetes applications available for download from Google Play (that is, for use on mobile platforms running the Android operating systems), found that over 80% of the diabetes apps had no privacy policies. Further, over 86% of the apps without a privacy policy shared sensitive data with third parties. In addition, nearly 80% of the apps that did have a privacy policy nevertheless shared user information with third parties. Such user information, the researchers note, routinely includes sensitive health information such as insulin and blood glucose levels.  The researchers point out that app developers often sell the information to data aggregation companies, who in turn sell it to credit card issuers, life insurance companies and other third parties.

Study Finds that Some Mobile Health Apps Do Not Function As Advertised

Some app developers are also facing increased scrutiny on a more fundamental issue: the functionality of their apps. Researchers at Johns Hopkins recently found that one of the most popular mobile apps used to measure blood pressure was wrong 8 out of 10 times. The app, called "Instant Blood Pressure," is no longer available for purchase, but users who previously downloaded it are still able to use it. The app measures blood pressure by having the user place their finger over the camera while placing the phone's microphone on their chest. Other apps, including the one below, measure blood pressure through other means:

While some apps like Instant Blood Pressure contained disclaimers that the app was only meant for "Entertainment Purposes," others, including the one pictured above, contain no such disclaimer. Mobile app developers should examine their claims and disclaimers closely, as the failure to properly label and describe the functionality and limitations of an app could lead to potential enforcement measures.

Federal Efforts to Spur Adoption Uncover Limited Reach and Uncertainty Over HIPAA

The growth of mobile health apps is occurring alongside federal government initiatives to spur their adoption. Last year, the federal government announced that it would require electronic health record (EHR) systems to include an application programming interface, or API, in order to be certified under the Meaningful Use program. An API would enable other applications, like mobile medical apps, to interact with the EHR system. According to CMS, the increased use of APIs will:

Enable the development of new functionalities to build bridges across systems and provide increased data access. This will help patients have unprecedented access to their own health records, empowering individuals to make key health decisions.

Patient empowerment is, to be sure, a laudable goal. It is also undisputed that there are potential benefits to mobile health apps. It is less clear, however, how existing law regulates the health and medical app marketplace. Take for example the diabetes apps that sell user data, as identified in the study described above. The primary federal law protecting health information— the Health Insurance Portability and Accountability Act (HIPAA)—applies only to health care providers, health insurers, health care clearinghouses, and the business associates of such entities. So a developer offering a diabetes app on behalf of an insurer would have to abide by HIPAA, but a developer independently offering such apps to the general public would be outside of HIPAA's reach and would not be subject to mandatory patient privacy laws at the federal level. Further complicating matters is the difficulty that the industry has encountered when trying to determine whether HIPAA applies to their particular app product. Fortunately, the U.S. Department of Health and Human Services recently released guidance that analyzes various scenarios involving medical apps and whether HIPAA applies.

Federal Enforcement Paradigm

The issue of non-functioning apps is largely a matter for the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) to oversee under their respective existing authorities. In 2013, FDA released a 44 page guidance document discussing its approach to regulating mobile medical apps as medical devices under the Food, Drug, and Cosmetic Act (FDCA). In its guidance, FDA outlined the categories of apps that it considers to be subject to regulatory oversight as a medical device. One of these categories corresponds to "mobile apps that transform the mobile platform into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices." However, FDA also made clear in its guidance that it will exercise enforcement discretion in cases where a medical app poses a low risk to the public.  Jennifer Rodriguez, an agency spokesperson, recently told Wired magazine that:

The FDA is focusing on a small subset of mobile apps that are medical devices and present the greatest risk to patients if they do not work as intended. For that subset, the FDA might take action were it to determine that an app does not meet relevant regulatory requirements. But our typical approach would be to allow a firm to come into compliance voluntarily before taking enforcement action.

The fact that there are hundreds of mobile apps currently being offered on the various app stores without having gone through FDA medical device review indicates that the agency does not currently have the resources to police all market entrants, including those apps that potentially meet the criteria for being regulated as a medical device.  The agency has also been criticized for offering only recommendations for implementing medical device cybersecurity controls rather than mandatory regulations for the industry to follow. This same criticism can apply to the regulation of app-based devices, which suffer from the same potential hacking and malware risks associated with more traditional (but connected) medical devices.

Developers Face Uncertain, Yet Potentially Large Liability

Even though FDA oversight and enforcement resources are presently stretched thin, developers still face potential liability for unsubstantiated, false, or misleading advertising claims under the FTC Act and, as we noted above, for the scope and content of their privacy policies and data sharing activities.  For example, in 2012, Google agreed to pay $22.5 million to settle FTC allegations that that its privacy policies were misleading. In a separate case last year, Google agreed to pay $8.5 million dollars to settle a class action lawsuit accusing it of improperly selling user data. In light of the increased scrutiny of all aspects of mobile health/medical apps—whether from government agencies or consumer-protection advocates—developers of such products should conduct a thorough legal assessment before making their apps available for download.

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
Klein Moynihan Turco LLP
Klein Moynihan Turco LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Klein Moynihan Turco LLP
Klein Moynihan Turco 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