European Union: Privacy In mHealth Apps (Part II)

Last Updated: 4 September 2017
Article by Mark Adair, Jevan Neilan and Brigid Moore

Most Read Contributor in Ireland, October 2017

In our recent article, Privacy in Mobile mHealth Apps (Part I), we discussed the core aim of the 'Code of Conduct on privacy for mHealth apps' (Code): to regulate and secure the personal data gathered by mHealth apps. However, compliance with the Code doesn't necessarily equate to compliance with data protection law. Any code for mHealth will need to be consistent with the meaning and spirit of the GDPR, which comes into effect in 2018. Now, we assess the interplay between the proposed Code and the GDPR.

The Code and GDPR

The Article 29 Working Party (WP29) – the collective group of EU data protection authorities – provided recommendations to amend the text of the Code in April 2017. In a letter issued to the project editor of the draft Code, WP29 underlined that the Code should not only be compliant with current law, the Data Protection Directive (Directive), but also with GDPR. WP29 also highlighted that consent to personal data processing for data controllers must comply with all requirements of the GDPR, the Directive, and with guidance in relation to obtaining consent to the processing of children's data.

"Data concerning health" is treated as a special category of data under the Directive but is not defined further. The GDPR has improved upon this and introduces a definition of health data encompassing mHealth data. Like the Directive, health data is categorised as 'sensitive personal data'. In practice, this means that processing this data is prohibited unless based on one or more additional conditions:

  • the individual's explicit consent;
  • necessity for archiving purposes in the public interest;
  • scientific, historical research or statistical purposes; and/or
  • where Member States have introduced further conditions or limitations, known as "further conditions".

Health data under GDPR

Under GDPR, the purpose limitation principle is linked to the processing purposes which have been disclosed to the individual at the time of data collection. This means that the data can only be processed in the manner described to the individual or within their reasonable expectation. Without appropriate disclosures, and potentially obtaining additional consents, using big data and analytics techniques for further different purposes (e.g. profiling or marketing activities) would not be permitted. Also, the processing of health data and manipulation of large amounts of data runs the risk of creating inaccurate conclusions relating to health or misusing individuals' data. Providers of mHealth services must ensure that they define clear, compatible and legitimate purposes to guard against misuse of the individual's data.

On the issue of security, WP29 stated that the Code should include more details and relevant examples on how app developers can integrate 'privacy by design' and 'privacy by default' into their development processes, as well as being attentive to legal restrictions relating to retention periods. Until now, the adoption of data protection by design was voluntary but considered best practice. The GDPR now makes it essential for a data controller "having regard to the state of the art and the cost of implementation...[to] implement appropriate technical and organisational measures". These measures include robust internal policy and practices, such as pseudonymising and encrypting personal data, improved security features, and increased transparency.

Organisations that collect or process EU citizens' health data, whether or not these organisations are established in the EU, will need to be GDPR compliant. It is hoped that the publication of the Code will provide clear guidance for mHealth developers on achieving such compliance. Importantly, failure to comply could result in fines up to €20m or 4% of the businessannual turnover, whichever is greater.

What is next?

The number and variety of mHealth apps has multiplied in recent years. A harmonised EU code aims to provide guidance to mHealth app developers on the level of data protection and security that mHealth app users should expect.

As previously mentioned, Member States will be able to adopt "further conditions" for processing health data. This means that differences may arise between EU Member States. Organisations processing health data and mHealth developers should consider whether they are subject to further conditions set out by separate Member States and, if they are operating in several EU jurisdictions, whether they understand the differences of each Member State.

Organisations now face extra costs associated with GDPR compliance, such as accountability and notification obligations, and, in some cases, the appointment of a Data Protection Officer. The GDPR will also place increased legal obligations on data processors meaning that data processors failing to comply with their obligations will also be exposed to the high sanctions provided for under the GDPR.

WP29 has called for careful consideration on what "added value" the Code will provide and, in particular, what specific examples, practical solutions or recommendations can be drawn from discussions with stakeholders. In the meantime, given the shortage of guidance in this area, mHealth developers and organisations processing health data should consider following the Code and the recommendations from WP29 in order to conform to best practice.

It's not yet known when the Code will be approved by WP29. Once approved, app developers can sign up to the Code on a voluntary basis, thereby committing to following its rules. While it is not fully clear what extra advantages or benefits can be enjoyed by those who voluntarily sign up to the Code, the Code should make strides to provide direction to mHealth app developers and those dealing with health data to be legally compliant.

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

Click to Login as an existing user or Register so you can print this article.

Events from this Firm
28 Nov 2017, Conference, Dublin, Ireland

Deirdre Nagle, Senior Planning Lawyer, Mason Hayes & Curran, will speak at the Irish Solar Energy Association’s Solar Ireland 2017 Conference taking place in Croke Park on 28 and 29 November. The conference will play host to key stakeholders in the Irish and international solar industry.

6 Dec 2017, Other, Dublin, Ireland

Our annual Contemporary Art at Christmas exhibition will take place on Wednesday 6 December 2017 from 6.00pm - 8.00pm in our offices on Barrow Street.

In association with
Up-coming Events Search
Font Size:
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
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (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

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’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.


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.


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 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.


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.


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.


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.


From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

*** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


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

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

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

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.