04/11/2015

Obelis SA Obelis European Authorized Representative Center

Results of the mHealth in Europe Consultation

On the 12th January 2015, the European Commission published the results of the consultation on the Green Paper on mobile health. Public Authorities, healthcare providers, patients’ organisations and web entrepreneurs, inside and outside the EU, gave feedback on eleven issues related to the uptake of mobile Health (mHealth) in the EU.


The Commission will, in the course of 2015, discuss with stakeholders the options for policy actions (legislation, self- or co-regulation, policy guidelines, etc.). A series of actions to support mHealth deployment are already foreseen under Horizon 2020 and will be taken into account in future work programmes. mHealth will be one of the key topics on the agenda of eHealth Week in Riga in May 2015.


Background


Mobile Health (mHealth) refers to the use of mobile communication devices for health and well-being services and information purposes as well as mobile health applications. This is an extremely emerging field: about 100,000 mHealth apps are currently available across multiple platforms on the global market.


mHealth is a promising field in addition to the traditional delivery of healthcare as it includes applications that carry out the following:
•Perform measurements (e.g. of glucose levels)
•Complement medical devices (e.g. helping in the delivery of insulin by transmitting control signals to the pump from a mobile platform)
•Remind patients they should take their medication
•Provide recommendations (e.g. meditating techniques) to improve users’ overall health & wellbeing


Outcome of the consultation


On April 10th 2014 the European Commission published a Green Paper on mobile health which launched a public consultation, in which it invited stakeholders to provide their views on 11 identified barriers to the uptake of mHealth in the EU.


According to the responses, privacy and security, patient safety, a clear legal framework and better evidence on cost-effectiveness are all required to help mHealth flourish in Europe. However, on the other hand, recent statistics confirm that national and EU funding initiatives are flourishing and that Europe is set to become the largest market by 2018.


According to the statistics published by BCC Research Report on the 25th of March 2014, the global mHealth market is projected to grow to nearly $21.5 billion by 2018.


The feedback expressed by the stakeholders can be summarized as follows:
•46% believe that strong privacy and security tools are essential to build users’ trust calling for a strengthened enforcement of data protection;
•Nearly half of the respondents ask for more patient safety and transparency of information, by means of certification schemes or quality labelling of lifestyle and wellbeing apps;
•Greater emphasis should be put on actions to promote open standards and the use of the common open architecture and interfaces;
•Health professionals, caregivers and users should be actively involved in co-designing mHealth solutions.


More evidence is needed on the cost-effectiveness of mHealth. According to a study from Telenor Group, trials in the Nordic countries have shown that mHealth could generate a 50-60% reduction in hospital nights and re-hospitalization for patients with Chronic Obstructive Pulmonary Disease.


With more than 25 years of experience in CE marking and product compliance to EU Regulations, Obelis is providing a wide range of services to ensure mHealth products are compliant with EU Requirements and that the products are safely placed on the market.


Please feel free to contact us!