Regulation of Health mobile apps in Europe: The Appsaludable Distinctive


The Andalusian Agency for Healthcare Quality is a pioneer in setting a regulation regarding the quality and the security of Healthcare apps

The mobile health or mHealth is changing the way health services are offered, promising a better life quality and a better security system for patients, offering new and more efficient means of work and improving the participation and the implication of citizenship. 

Nonetheless, this system brings up important challenges for healthcare systems and patients since there is no regulation associated to its outstanding development. This issue is a problem to an extent that the only barriers for commercializing apps found nowadays are the ones set by the markets, what implies a conflict of interests. This problem does not exist in any other medical or health sector. 

Furthermore, there are many research studies and scientific items aiming to warn about the risks of an improper use of mobile apps by patients. 

A proper regulation would help avoiding, or at least minimizing, the risks of patients concerning the usage of health apps and it would guide them in choosing the right applications regarding their needs. In addition, the use of health informatics tools would improve enhancement of communication between professionals and patients and would allow app developers to distinguish themselves from their competitors, which would lead to a creation of better products and a better position in the market. 


European Scenario 

Regarding this question, the European commission launched in 2014 a “Green Paper on mHealth”, a public consultation on the use of mobile technology in order to ensure the improvement of Healthcare systems in Europe. This document suggests that the implementation of mobility in Health systems would represent a great impact towards improvement of life quality, empowerment of patients and the efficiency and sustainability of Healthcare. The paper also estimates that a massive use of mHealth by society should lead to a saving of about EUR 99.000 million in the healthcare budget.

However, the fact that there is no common regulatory framework established by the European Union in this sector has caused the emergence of different isolated initiatives in some of the member countries. Some of these initiatives have only been announced, and some others have already been launched, as it is happening currently in Andalucía. This is with no doubt a positive fact, but there is risk we are facing a situation of excessive fragmentation if all these different projects are not connected in a legal European framework.


Initiatives in Andalucía

Andalucía has a long experience performing certification in different areas of healthcare services, such as health centres and health units, the skills of the healthcare professionals, the ongoing healthcare education and the healthcare websites. The fast entrance of mobile apps in the healthcare sector kept us thinking about its opportunities and its risks concerning patients and organizations. Seeing that there were barely any regulation initiatives, we decided to start our own certification project focussed on the evaluation of health apps quality and security. 

Thus, the Quality and Security Strategy on mobile health apps (Estrategia de Calidad y Seguridad en aplicaciones móviles de salud) was created in February 2012, publishing in the first place a Design, use and evaluation of mobile health apps Recommendations Guide (Guía de Recomendaciones para el diseño, uso y evaluación de aplicaciones móviles de salud) (, becoming the first Spanish publication on this subject.  


The Distinctive AppSaludable 

The Distinctive AppSaludable (Distintivo AppSaludable) was created on May 2013; a little bit after we launched our Recommendations Guide (, and it represents the first Spanish project that regulates quality and security of public and private health applications ( 

From ACSA, we carry out an evaluation to decide whether the product is applicable for the Appsaludable distinctive. This evaluation is based in the 31 recommendations that can be found in the Guide, structured in 4 blocks concerning: design, appropriateness, quality and security of its information and service provision, confidentiality and privacy. 

We strongly believe that this kind of initiatives constitute an increase of public confidence in the applications they use relating to their health issues. 

Likewise, and far from becoming a break for the development of new products, it represents a great chance to grow in quality and innovation. In our experience, we have already seen the creation of important synergies between the private sector and the app development companies, who have shown great interest in proving their quality and security when it comes to the development of their products. 

In Andalucía we are aware of these matters and because of it we have already decided to take a next step: we are working on the creation of a corporative catalogue of health applications which can personalize and integrate its services in the Andalusian public healthcare system framework. To do so, certification will be the key element which will give access to any kind of initiative within this framework. 


Javier Ferrero Álvarez-Rementería


Head of Digital Environments, Technology and Systems in the Andalusian Agency for Healthcare Quality (Agencia de Calidad Sanitaria de Andalucía)