Image | Adaptada de Celso Flores
With the initial regulation of mHealth apps in the U.S. and Australia and with more than 95,000 mHealth apps on the market, it was only a question of time before the European Union would start its own regulatory process for these popular and useful IT tools.
With regard to the first point, we should remember that not long ago the American Food and Drug Administration (FDA) an the Australian Therapeutic Goods Administration (TGA) took the first steps towards regulation by defining two types of mHealth apps (informative ones and participative ones), which we analyzed in a post on this website. This measure wants to create awareness among developers and investors to consider the risks from the moment they start configuring their apps and send a message that they are being watched, even though -for the time being- to a very limited extent.
EU will regulate as well
In order to avoid losing too much time for regulation, the European Commission has launched a public consultation in April 2014 which tries to design an adequate itinerary to “improve the health and well-being of Europeans through the implementation of mobile devices”. Tonio Borg, European Health Commissioner, pointed out that “mHealth has a great potential to empower citizens to manage their own health and remain healthy longer, to trigger greater quality of care and comfort for patients, and to assist health professionals in their work.”.
The commissioner added that the creation of mHealth solutions can contribute to better and more efficient health systems, the costs of which usually represent a significant percentage of the national budgets. The European Commission quotes in its press release that mHealth could lead to 99 million Euros in savings by 2017, but only if this industry is being regulated and promoted as it should be.
The public consultation want participants to provide their opinion on central questions like: What kind of safety and damage compensation requirements should be demanded of mHealth apps? What is the best way to promote mHealth entrepreneurship in Europe? What mechanisms are apt to guarantee the security of health data in the mHealth context? The European Commission recommends reading the href=”http://ec.europa.eu/digital-agenda/en/news/commission-staff-working-document-existing-eu-legal-framework-applicable-lifestyle-and”>recommendations guide, which it developed especially for this occasion before responding to the questions.
Image | European Comission
All European citizens are invited to participate in this consultation. Anybody interested can submit their answers and opinions before July 3rd of this year electronically or in print , with the obligation to clarify whether their participation is personal or representing an institution. Once the European Commission receives all submissions, they will be processed and published on their website and they will serve as an important input to elaborate the regulation of mHealth for the European Union.
Is there going to be even more regulation?
With the increasing importance and functionality of these kinds of apps there is obvious going to be even more regulation in the future, just like it happened in other areas of innovation in the health sector, which were legalized gradually. And in the case of mHealth and its ecosystem this is even more justified, given the fact that the well-being and health of people are at stake. We must not forget that app development itself is still in its early stages. It is easy to foresee how its direct involvement and participation in health matters will become greater and so will the associated risks.
There may be different views on how convenient or not regulation of the mHealth field is going to be. And you might expect that developers will want as little regulation as possible so it does not affect the development and creation of new ideas, while health personnel (habitually being traditional) would ask for strict vigilance. But at the end of the day, regulation in this field is focussed on protecting people’s health and necessary to avoid confusion between applications that went through a scientific process of verification and other apps that were developed without previous studies.
This is why many call for a hybrid approach that focusses on educating users to be able to evaluate the origin and the quality of the information generated by these apps, just like it was expressed by Dr. María Luz Ruiz-Falcó, when she was interviewed by Mobile World Capital Barcelona. She is co-creator of the app “Convulsiones”, which is available for Android. In this sense, the mHealth team at MWCapital also works on selecting apps that were approved by competent medical institutions and publishes them in this catalogue.
Given this scenario, the challenge of the future will be to avoid over-regulation which would inhibit the research, investments and development of these technological tools. For the Internet of Things apps will play a crucial role and its development should be promoted. However, just like in many other areas of human civilization, it will be difficult to find the right balance and economic interests will greatly influence this debate, as for 2017 the mHealth market is expected to move 17,600 million Euros, with all its implications.
The mHealth competence centre forms part of Mobile World Capital Barcelona’s Programme of International Competence Centers (PCCI). mHealth works with a three-fold objective: to identify mobile technology opportunities in the provision of health services, to transform current healthcare models and processes, and promote the interoperability of health services in the field of mobile technologies and connectivity, building foundations that make it possible to integrate mobile health solutions.
Mobile World Capital presents a global vision that effectively integrates mobile technologies into the fabric of the industries transforming our lives. Committed to expanding the mobile experience throughout Barcelona, Catalonia and Spain with strong support of the public and private sector.
Mobile World Capital is leading mobile transformation through commitments in Competence Centres, local Industry Development, and Entrepreneurship and Innovation programmes.
MWCapital offers an open platform and exhibition showroom where citizens can understand and experience how mobile is enhancing our lives: The Mobile World Centre, located in the heart of Barcelona on Plaza Catalunya.