United States: New York AG Takes Enforcement Action Against Heart Monitoring Apps: Murmurs Of Concern Are Heard In Mhealth App World

Last Updated: April 12 2017
Article by Kristi Kung and Sean M. Cuddihy

In a move sure to cause murmurs in the large and growing mobile health application industry, the Office of New York Attorney General Eric Schneiderman (OAG) has used state trade laws to extract concessions and monetary penalties from mHealth app developers, including the developer of a supposed fetal heart monitoring smartphone app.

Designed by Israel-based Matis Ltd., the app, originally marketed as "My Baby's Beat—Baby Heart Monitor App," is designed to register fetal heartbeat sounds using only the smartphone microphone, and to isolate and amplify those sounds.1 The OAG's investigation revealed that Matis claimed that its app transformed a smartphone into a fetal heart monitor and therefore could be used to play an unborn baby's heart rate,2 even though the app was not an FDA-approved fetal heart monitor.3

The OAG emphasized that Matis made claims that its app functioned as a fetal stethoscope without providing sufficient evidence substantiating that the app actually plays the sound of the fetal heartbeat (as opposed to, for example, the heartbeat of the mother.)4 In the OAG's opinion, the developer had used in-app and promotional imagery, text, and categorization to characterize its app as comparable to a medical device,5 without making clear enough whether the developers had adequate evidence to support claims of medical reliability.6

Matis had taken some precautions against false advertising liability; for instance, "My Baby's Beat—Baby Heart Monitor App" incorporated various disclaimers and a warning to seek professional help with any medical questions or concerns.7 Even so, the OAG determined that the developer had "[m]arket[ed] a Health Measurement App without substantiation of its accuracy and that it measures what it purports to measure," which would "constitute [a] deceptive business practice[] in violation of" New York consumer protection statutes.8 Under the settlement, Matis agreed to remove all references to the app's functionality as a medical device as well as display the following disclaimer: "This app is NOT a medical device, has not been reviewed by the FDA, and is NOT intended as a replacement for medical advice of any kind. For any medical questions or concerns regarding your pregnancy and your baby's health, please consult with your doctor/midwife."9

OAG also objected to the app's privacy policy, which, did not disclose to users that Matis collected and stored the following information: (i) a global unique identifier of the user's device; (ii) an internal numeric score indicating how engaged the user is with the app; (iii) the user's feedback regarding the app (such as ratings and emails); and (iv) recordings that users share via the app.10 Notably, Matis stated that it would not sell or otherwise transfer data it collects from consumers to any other person or entity but may "combine users' information with information from other users to create aggregated data", which may be disclosed to third parties.11 Importantly, Matis represented that the aggregated data did not contain any information that could be used to identify users, did not warn customers of the possibility that those third parties could use other sources of information to "re-identify" users and associate them with private health data.12

Accordingly, the State, with the counsel of Assistant Attorney General Michael Reisman (a member of OAG's Health Bureau), charged Matis a $20,000 civil penalty.13 The developer also promised to maintain enhanced consumer disclosure practices that it had developed and implemented in response to OAG's investigations.14 The app now requires affirmative consent to Matis's privacy policy and discloses that Matis collects (i) an internal numeric score indicating how engaged the user is with the app; (ii) the user's feedback regarding the app (such as ratings and emails); and (iii) recordings that users share via the app; however, Matis no longer collects the global unique device identifier and limits its sharing of aggregated data to only those third parties responsible for Matis' storage, security, and internal analytics.15 As part of the settlement, Matis did not admit to the OAG's findings, though it did fully cooperate with the agency's investigation.

Notably, the FDA has adopted a comprehensive strategy for evaluating whether certain mobile health apps meet the Food, Drug, and Cosmetic Act's (FDCA) definition of a "device" and are therefore, subject to enforcement. Whether the federal agency would agree with OAG in this particular case, that smartphone fetal pulse detector apps "transform[] a mobile platform into a medical device"16 and merit intervention is uncertain; however, the OAG's actions demonstrate that states are willing to impose their own interpretations, separate and apart from the FDA, thereby subjecting those entering the healthcare market to multiple enforcement schemes that may not always align. An active role for states in this realm raises the question whether states will agree with the FDA when it comes to which apps pose less risk and deserve "enforcement discretion" under the federal FDCA.17

OAG's enforcement action also highlights the potential for gaps between state and federal requirements regarding app user privacy protections. The Federal Trade Commission (FTC) has actively pursued entities under its Section 5 authority for "unfair and deceptive" practices in the form of inadequate and/or misleading privacy policies,18 and has warned about what practices it views as unacceptable. While the FTC has released guidance with respect to privacy and security practices and policies, there are no authoritative regulations dictating what standards are required. Overlapping enforcement by federal agencies (FTC and, for HIPAA-covered entities, the HHS-Office for Civil Rights) and state Attorneys General offices dramatically increases the likelihood of a conflict, and subjects mobile health app developers to uncertainty with respect to the sufficiency of their policies and practices.

State enforcement actions, such as New York's, demonstrate that digital health companies are subject to a number of regulatory schemes and developers must be cognizant of both the federal requirements as well as independent state consumer protection laws that could potentially be implicated by their products. Health app developers should review their privacy and security policies as well as their marketing claims to ensure that they are compliant with applicable laws and regulations.


1.See Assurance of Discontinuance 2, 5, In the Matter of Matis Ltd., No. 16-101 (Feb. 13, 2017), https://ag.ny.gov/sites/default/files/matis_aod_executed.pdf.

2.Id. at 3.

3.Id. at 7.

4.Id. at 7.

5.Id. at 4–7.

6.Id. at 7.

7.Id. at 6 n.7.

8Id. at 12.

9.at 13-14.

10.Id. at 10.

11.Id. at 10.

12.Id. at 10–11.

13.Id. at 15.

14.See id. at 13–14.

15.Id. at 11.

16."Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff" (Feb. 9, 2015), https://www.fda.gov/downloads/UCM263366.pdf.

17.See id. at 15.

18.See, e.g., FTC v. Wyndham Worldwide Corp., 799 F. 3d 236 (3d Cir. 2015).

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.

Events from this Firm
15 Nov 2019, Conference, Chicago, United States

Value-Based Contracting: Will It Blow Up Fee-for-Service?

19 Nov 2019, Panel, New York, United States

We have assembled a panel of experts and prepared a simulation of a series of common crises facing retail and fashion companies today, including cybersecurity and privacy issues and retail advertising and marketing issues.

19 Nov 2019, Webinar, Los Angeles, United States

Advertising has changed a great deal in recent years, and brands are facing mounting pressure to look for creative and innovative ways to resonate with their consumers.

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