Technology is changing every industry and healthcare is no exception. In the past, you might have had to join a long waiting list to see your local GP. Today, mobile healthcare (“mHealth”) allows you to download an app, consult a practitioner by video call, access your records, get diagnosed, monitor your symptoms remotely, manage your prescriptions, set reminders for treatment and that’s just on your morning coffee break. mHealth may have your healthcare covered, but who is looking after your personal data stored in cyberspace?

What is mHealth?

mHealth refers to the practice of using mobile devices or other wireless technology in delivering and supporting medical care services. According to a report by Tech Ireland, health and medical technology companies have the highest rate of funding in the Irish technology sphere. By 2020 the mHealth market is estimated to be worth over €60 billion, growing at a rate of 34% annually. mHealth is effectively transforming mobile devices into a virtual healthcare support network that you can place in your pocket.

If mHealth is to have continued success, users must trust the mHealth industry and how it is regulated. There are important data privacy implications where sensitive personal data relating to individual’s health is collected and processed on such a large scale. Data harvested from a typical mHealth app could include health, fitness, lifestyle habits, stress levels and sleep. To date, there has been little collaboration between EU Member States on how to manage, organise or regulate the data protection implications for this sector.

Origins of the Code of Conduct

The European Commission’s ‘eHealth Action Plan 2012-2020’ sought to distinguish between self-administration of healthcare and the traditional provision of clinical care. It’s not surprising that the European Commission is now addressing the lack of regulation in mHealth apps with a working set of guidelines aiming to ensure such apps are properly regulated.

In June 2016, the European Commission proposed and submitted a ‘Code of Conduct on privacy for mHealth apps’ (the “Code”) to the Article 29 Working Party, the collective body of EU data protection authorities. Once approved, the Code will be applied in practice. App developers can, but will not be obliged to, follow the Code.

The Code at a glance

The European Commission aims to bridge gaps in the mHealth industry, specifically the gaps in processing sensitive data and securing the sensitive data collected. This regulation comes in the form of the proposed Code and is focused solely on “data concerning health”. The Code excludes regulation of any app that deals only with users’ lifestyles, such as an app that tracks footsteps solely for measuring the user’s sports activity.

The key compliance areas highlighted by the Code are:

  • User consent: the need to obtain free, specific, informed and explicit consent from the data subject to collect and use their data.
  • Data protection principles: purpose limitation, data minimisation, transparency, privacy by design and privacy by default, data subject rights.
  • User information: Disclosures to users before and after installation of the app, such as the purpose for which their data is collected and processed, identity of the developer, storage details, rights to access/correct/delete data, and the right to data portability.
  • Data retention: only storing personal data for as long as is necessary.
  • Security: ‘privacy impact assessments’ and adopting security measures.
  • Advertising: ensuring any advertising within the mHealth app is authorised by the user.
  • Use of data for secondary purposes: particularly in instances where data could be used for scientific research or other big data analysis.
  • Disclosing data to third parties: an agreement with the third party is essential.
  • Data Transfers: all apps must comply with the rules around international data transfers.
  • Data breaches: practical steps have been included on what to do and who to notify when a data breach occurs.
  • Children’s data: the Code addresses mHealth apps that are specifically aimed at children.

Governing the Code in Practice

In operation, it has been proposed that a three-tiered governance system will be in place under the Code:

1. General Assembly: comprising representatives of all stakeholders, namely app developers, regulatory bodies, industry associations and end-users.

2. Governance Board: comprising 6-10 members selected from the General Assembly to manage everyday interpretation and maintenance of the Code or amendments.

3. Monitoring Body: in charge of monitoring compliance, enforcing the Code in accordance with GDPR, reviewing app developers’ applications, and maintaining a public registry of app developers who have met the Code’s requirements.

The Code in Practice

mHealth can contribute to healthcare research and innovation, given the large volume of data gathered. Big Data analytics can be used to analyse unstructured data in high quantities and from varying sources by linking data and producing statistical information in a cost effective manner. This type of information can be used to identify patterns and environmental factors that will enable improved patient treatment.

While the core aim of the Code is to regulate and secure the data gathered by mHealth apps, there is currently no guarantee that compliance with the Code means compliance with data protection law. Any code for mHealth will need to be consistent with the meaning and spirit of the General Data Protection Regulation (“GDPR”), which will come into law on 25 May 2018. In our follow up article, Privacy in Mobile – mHealth Apps (Part II), we will assess the interplay between the proposed Code and the GDPR.