Despite the favourable evidence towards the adoption of eHealth solutions, the progress so far has been slow, with several actors showing reluctance or facing hardships when employing new approaches and tools.
Medical professionals have raised doubts about Telemedicine, as they fear it might disrupt the traditional patient-doctor relationship. Furthermore, they often lack incentives to provide care via telemedicine solutions, with no clear supporting policy from social security providers. Most EU countries
lack a precise legal framework to regulate telemedicine practises, with a lack of standards and guidelines for interoperability across the Union. Recently, Germany has taken the lead, establishing
specific compensations for healthcare professionals performing eHealth-related tasks and paving the way for a broad usage and
reimbursement of digital health applications.
Experts, such as mHealth-pioneer
Eric Topol, hope that one day doctors will be able to safely
prescribe medical-grade apps to patients. mHealth offers
great possibilities when it comes to improving mindfulness of disease, adherence to medications, activities, data collection, and communication with and within care teams. However, other medical experts have lamented the scarcity of scientific evidence on the effectiveness of the mHealth apps currently available, expressing scepticism towards the quality of the data collected and produced by smartphones.
There are no binding rules in the EU concerning the delimitation between lifestyle and wellbeing apps and a medical device or an in vitro diagnostic medical device, which are subject to the safety standards of the
Medical Devices Regulation and of the
In-Vitro Medical Devices Regulation. Several studies have shown that often apps that make claims regarding health and well-being can give wrong, if not dangerous, insights. Some initiatives have been taken in this direction, such as the
European Directory of Health Apps, which contains facts about 200 mHealth apps recommended by the European patient groups.
A key issue concerning the broad adoption of mHealth, lies in the fact that some national legislations still provide that a medical act can only be performed with the physical presence of both the patient and his doctor,
preventing the reimbursement of more innovative solutions.
Furthermore, concerns have been raised about the appropriate processing of the data collected, which can happen in third countries outside the European Economic Area (EEA). Many popular health-related apps have been
found to transmit data to some of the dominant data tracking companies. Privacy concerns have been found to be a
major factor when it comes to user’s expectations for mHealth apps, with 45% of consumers being concerned about unwanted use of their data when using mobile devices for health-related activities, such as data being shared with employers or insurers. Many mHealth apps have
been found to only comply partially to the GDPR requirements when it comes to health data.
In the context of mHealth, wearables can help for early disease detection along with all the other perks of mHealth solutions. Most of them are marketed as fitness devices, however, healthcare professionals have been found
using them to support diagnoses,
track trends, and motivate patients. Wearables generate significant amounts of data, which could boost healthcare research and innovation. However, researchers face many challenges when it comes to using them: they are usually collected in a fragmented way (each device usually collects data in its own portal), in different formats that are hard to share with doctors and care coordinators.
On the other hand,
re-identification strategies could allow malicious actors to violate the privacy of subjects whose data is published in research papers containing their anonymised data.
