By Sascha Marschang, EPHA Policy Manager for Health Systems and Milena Richter, Senior Director European Public Affairs, Sanofi.

While healthcare systems move towards integrated care models each in their own different way, the improved availability of health data and information will change the way that health systems operate, involve the end user and make decisions. One of the key enablers of that change is the availability of new means of communication technologies and mobile health technology (or “mHealth”). It allows sharing of huge quantities of information between different parts and actors of the healthcare system driving evidence-based care practice and research. It can also help develop integrated care models that are more closely oriented to the needs and involvement of patients.

As the European Commission’s 2014 Green Paper on mobile health rightly highlights, mHealth can play a part in the transformation of healthcare. This reflects a growing consensus that mHealth holds the potential of improving patient care notably through better access to specialist care through remote links, of improving patient access through inclusion of the elderly, people with disabilities, migrants etc. thus potentially contributing to addressing Europe’s persistent inequities in access to healthcare, and of driving improved health outcomes by empowering patients to manage their condition from home, increasing adherence to treatment and reducing the onset of complications. In the area of diabetes, for example, telemonitoring programs that include a system of clinician notification and informal caregiver involvement can have an impact on medication adherence and diabetes self-management behaviours.

Positive change in terms of improved care, improved access, improved outcomes will however not happen simply because the new technology is available. In practice, it needs to be effectively and appropriately integrated into healthcare systems, understood, trusted and accepted by its users and where it achieves better health outcomes and potentially reduces healthcare costs, become a routine part of the system of care. Looking at the current healthcare delivery models, this is not yet the case over the whole spectrum of technologies available, whether that is measured in terms of people’s use of apps or for example in terms of use of remote monitoring devices in particular areas of chronic disease. Three areas for consideration are worth highlighting:


Policy actions taken to drive integration of mHealth into healthcare systems need to differentiate between the broad range of mHealth technologies. There is indeed a broad spectrum of mHealth applications and technologies on offer. We are seeing a continuum that spans from mHealth solutions aimed at educating and informing users, technologies to modify behaviour by tracking and coaching all the way to managing and modifying treatment of patients through real-time remote monitoring and interventions. Each of these mHealth solutions addresses different aspects of more integrated way of managing healthcare delivery.

Such differentiation will allow calibrating the nature and level of intervention aimed at a particular technology, for example to ensure its safe and secure use and the protection of personal data. In the area of apps, for example, this differentiation is essential to identify where an app is a supporting tool rather than a health intervention and the European Commission has issued guidance on when an app falls into the scope of the medical device or in vitro diagnostic device legislations.


Secondly, where solutions contribute to improved clinical outcomes by preventing complications and potentially hospital stays via remote monitoring, for example, the question arises how quantification of such benefit is best established in terms of methodology and criteria used. These considerations should involve providers of the technology, healthcare professionals and patients, alongside payers and healthcare authorities. It is essential that this dialogue take place with a broader perspective of the need to move towards outcomes-driven healthcare where approaches are based on targets for improving patient outcomes and clear measurement of the impact on total cost of care.


Finally, considering their interactive nature, the choices and flexibility they offer, and the potential they have to increase patient autonomy mHealth technologies can only be a meaningful part of health and healthcare systems if the end users for a particular technology are involved from the beginning of the solution design. Where mHealth technologies are used in the area of disease management, the involvement of patients, carers and health professionals in the design and modalities of use is essential.

Policy initiatives at European level will be important to address these various areas outlined above in order to encourage the integration of mHealth into healthcare systems. Equally important will be the need to ensure a coherent policy approach in view of the various aspects that are involved.

- Safety of mHealth solutions and protection of personal data is key to build trust in the system. Here, one needs to distinguish mHealth solutions that involve the entry and processing of highly sensitive health data. Clarity over the “intended use” of the solution, how the data is used and by whom as well as the explicit consent of the user in allowing it are key elements in determining what safety features are needed. “Encrypted data transmission” to decrease the risk of leakage and unintended use by third parties should be specifically considered in the case of patient remote monitoring and guidance/coaching by healthcare professionals. However, users may opt to allow additional data collection or secondary use, provided the scope of these uses and associated safeguards are transparently proposed. Methods for data anonymisation/pseudonymisation will need to be developed.

- Research into methodological approaches to improve the “quality” and reliability of big data related to health should be encouraged to determine adequate quality standards, share good practice and enable big data to be used appropriately, for example through the definition of common standard measurement units that enable adequate comparisons (apples-with-apples).

- The European Commission can support the collection and assessment of obstacles to change, best practice and experiences with mHealth and subsequently upscale those approaches that have the most impact in improving outcomes thus building solid knowledge in this area. The focus could be in the first instance on mHealth solutions that have a realistic chance of increasing efficiency in those areas that will drive system cost in the coming years, develop guidelines and quality indicators and driving research on the actual impact of mHealth on behaviors both in the fields of prevention and disease management.

- Member States’ efforts towards strengthening their information infrastructure flows and ensuring these are channeled appropriately to all necessary healthcare actors should also be supported.

- Digital health literacy (as a combination of different literacies applied together) needs to be developed, including among non-traditional users. It may be useful to consider the development of information standards so that the widest possible population is able to understand mHealth, and to explore incentives for developers to create solutions specifically for vulnerable groups and individuals with specific diseases that may otherwise not be captured.

Last modified on September 1 2014.