European Union: Privacy In mHealth Apps (Part II)

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 Mondaq.com.

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

Authors
Similar Articles
Relevancy Powered by MondaqAI
Mason Hayes & Curran
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Mason Hayes & Curran
Related Articles
 
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