m-Health Applications; Legal Framework And Advertising

INTRODUCTION

Along with the rapid development of technology in the mobile sector, has come a growing number of health apps, which can keep track of and analyse everything from the number of steps taken each day to the development of serious cancer. If an app is considered to be a diagnostic and/or therapeutic tool, the app is no longer "just an app". It is to be regarded as a "medical device", which gives rise to the imposing of certain legal obligations in respect of the app.

This creates a number of legal challenges for developers navigating the market of m-Health apps, all the more so due to the differing national implementation of the Medical Device Directive and the requirements of data protection.

The term m-health apps includes applications as lifestyle and wellbeing apps (e.g. fitness) that may be connected to medical devices or sensors (bracelets, watches) as well as personal guidance systems, health information and medication reminders. In addition, there are a number of technological solutions which measure vital signs such as heart rate, blood glucose level, blood pressure, brain activities and so on.

Technological evolution, including above all the wide spread use of smartphones, has boosted the use of mobile apps offering healthcare; the FDA counts more than 100,000 apps on the market. m-Health apps are attractive to consumers, patients and medical professionals as they offer advantages such as an increase in quality of healthcare and more accurate diagnoses and treatment. They also continue the trend of empowerment of patients, making us more independent and better informed.

Some recent examples of m-Health apps include the following:

NIKE +: a fitness coaching app that records your running sessions and counts your steps to allow you to monitor your running activities. Pocket First Aid & CPR: an app that is intended to help you in case of an emergency, such as a heart attack, and provides first aid and rescue information. ASTHMA SENSE: an app that assists you with a chronic disease, like asthma, and includes advice and recommendations. This app comprises a "user-friendly library" on the topic, does not provide personalised health advice, which would take the app into different legal territory. TACTIO: a health tracking app that can record several health parameters and facilitates the communication regarding your health condition between yourself and your doctor. iDialysis: an app that connects to your dialysis device and records vital parameters that you can share with your doctor. Chemotherapy advisor medical apps: these are apps that are intended for healthcare professionals, rather than simply the patient, by, for example providing information that will support oncologists' decisions in terms of therapy and dosage. The app can provide dosage decision support in function of individual patient parameters, which the app can interpret and link to pre-recorded scenarios. LEGAL FRAMEWORK

All apps are subject to the following legislation: data protection; consumer protection; product liability; the eCommerce Directive (2000/31/EC); the Unfair Commercial Practices Directive (UCPD); and the Misleading and Comparative Advertising Directive (2006/114/EC).

If, however, the app is also a device, then the Medical Devices Directive (93/42/EC) (MDD) will apply together with, possibly, the In-Vitro Medical Devices Directive (98/79/EC) (IVMDD) and the Active Implantable Medical Devices Directive (90/385/EC) (AIMDD). Furthermore, the European Commission has issued guidelines on the qualification and classification of standalone software used in healthcare within the regulatory framework of medical devices (MEDDEV guidance 2.1/6).

However, it was suggested that the legislation is no longer fit for all purposes - the majority of respondents to a public consultation on the Green Paper on m-Health, found that the safety and performance requirements were not adequately covered by the current EU legal framework, and whilst some certification schemes (such as the one used by the NHS) were in place and certain quality standards could be made to apply to m-apps, specific legislation for lifestyle and wellbeing apps were suggested.

On 26 September 2012, the European Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on i) medical devices, and ii) in vitro diagnostic (IVD) medical devices. These regulations, once adopted, will replace the existing three medical devices directives mentioned above. The European Commission has created a new m-Health data quality working group which will aim to draft guidelines on m-Health data quality, producing common quality criteria and assessment criteria for health and wellbeing apps.

The forthcoming cybersecurity Directive (Network and Information Security Directive (the NIS Directive)) may also have an impact as it:

applies specifically to the health sector; implementation of technical and organisational measures; obligation to notify security incidents; national authorities may alert incidents to the public; and national authorities will have audit rights. IS AN APP A MEDICAL DEVICE?

In order to determine which of the above regimes governs the regulation and sale of an m-app, it is important to establish whether it falls within the definition of a medical device (as set out identically in both Article 2a of Directives 90/385 and 93/42):

"any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis...

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