The first versions of the Code of Conduct for mHealth apps were prepared against the background of the European Commission's 2014 mHealth Green Paper consultation, which revealed that people often do not trust mHealth apps because of privacy concerns.
Following this consultation, the European Commission encouraged industry stakeholders to create a code of conduct on mobile health apps, covering privacy principles, in order to increase trust.
The objective was that the Code of Conduct would obtain the formal approval of European data protection authorities. Before, this was the so-called Article 29 Working Party. But as of May 2018, under the current General Data Protection Regulation (GDPR), this role of assessing codes has been transferred to the European Data Protection Board, the successor of the Working Party. Codes approved by the European Data Protection Board can be granted general validity across the European Union through an implementing act.
History and current status
The work on an mHealth Code of Conduct started in April 2015, when a drafting team of industry members started developing the text of the code. The European Commission acted as a facilitator, provided legal and policy expertise, oversaw the development of this work and provided resources.
This drafting team included the App Association (ACT), App developers Alliance, Apple, COCIR, Digital Europe, ECHA, DHACA, EFPIA, Google, Intel, Microsoft, Qualcomm and Samsung. They worked through regular meetings, and presented the work at various events in order to obtain further feedback. The vision was that the Code should be easily understandable, also for SMEs and individual developers who may not have access to legal expertise.
An early version of the work was submitted by the drafting team to the Article 29 Working Party on 7 June 2016 for a first round of feedback. Following various suggestions for improvement from the Working Party, the Code was reworked, and formally submitted on 7 December 2017, requesting approval under the Data Protection Directive.
On 11 April 2018, the Working Party published its assessment, finding that - in view of the entry into force of the GDPR on 25 May 2018 - the criteria of the GDPR should be applied, and that the existing Code did not yet adequately address these requirements. As a result, the Code was not approved.
The Commission is engaged with a range of industry stakeholders in order to encourage the further development of the current draft Code, so that it may be submitted to the European Data Protection Board in the future to seek a formal approval.
Main provisions for app developers
The current draft of the Code consists of practical guidance for app developers on data protection principles while developing mHealth apps. The Code addresses notably the following topics:
User consent: The user consent for the processing of personal data must be free, specific and informed. Explicit consent needs to be obtained for the processing of health data. Any withdrawal of consent has to result in the deletion of the user's personal data.
Purpose limitation and data minimisation: The data may be processed only for specific and legitimate purposes. Only data that are strictly necessary for the functionality of the app may be processed.
Privacy by design and by default: The privacy implications of the app have to be considered at each step of the development and wherever the user is given a choice. The app developer has to pre-select the least privacy invasive choice by default.
Data subject rights and information requirements: The user has the right to access their personal data, to request corrections and to object to further processing. The app developer needs to provide the user with certain information on the processing.
Data retention: Personal data may not be stored longer than necessary.
Security measures: Technical and organisational measures need to be implemented to ensure the confidentiality, integrity and availability of the personal data processed and to protect against accidental or unlawful destruction, loss, alteration, disclosure, access or other unlawful forms of processing.
Advertising in mHealth apps: There is a distinction between advertising based on the processing of personal data (requiring opt-in consent) and advertising not relying on personal data (opt-out consent).
Use of personal data for secondary purposes: Any processing for secondary purposes needs to be compatible with the original purpose. Further processing for scientific and historical research or statistical purposes is considered as compatible with the original purpose. Secondary processing for non-compatible purposes requires a new consent.
Disclosing data to third parties for processing operations: The user needs to be informed prior to disclosure and the app developer needs to enter into a binding legal agreement with the third party.
Data transfers: For data transfers to a location outside the EU/EEA, there needs to be legal guarantees permitting such transfer, e.g. an adequacy decision of the European Commission, European Commission Model Contracts or Binding Corporate Rules.
Personal data breach: The Code provides a checklist to follow in case of a personal data breach, in particular the obligation to notify a data protection authority.
Data gathered from children: Depending on the age limit defined in national legislation, the most restrictive data processing approach needs to be taken and a process to obtain parental consent needs to be put in place.
The drafting process: