The use of mobile health apps on smartphones or tablets is no longer simply about how many steps you took in the last five days. In fact, digital health applications (or “DiGAs” – Digitale Gesundheitsanwendung, as coined in Germany) are revolutionising healthcare by delivering personalised medical solutions directly to patients, just a download away.
Due to the increasing digitalisation of healthcare, which boomed during the COVID-19 pandemic, these solutions have developed greatly, and partly without supervision. There is thus a need for clear regulatory alignment throughout the European Union (EU).
In this Insight, we aim to briefly outline the challenges and opportunities surrounding DiGAs, explore initiatives adopted in different EU Member States, and discuss what is happening – if anything – at a national level in Portugal, while uncovering paths to implement these innovative tools in regular patient care.
The concept of Digital Health Applications
Not all mobile or browser apps can be considered DiGAs. According to the German Federal Institute for Drugs and Medical Devices (BfArM), DiGAs are CE-marked medical devices based on digital technologies, designed to achieve their medical purpose through their digital functions. They are more than just data collection devices; they aid in recognising, monitoring, treating, and alleviating diseases, injuries or disabilities. Manufacturers of DiGAs must therefore strike a difficult balance, by meeting stringent medical device requirements without compromising the practicality of these devices.
DiGAs can be prescribed by healthcare professionals (HCPs) and are supposed to be used by patients alone or under the supervision of HCPs. Apps used exclusively by HCPs do not qualify as DiGAs.
There is thus a thin, yet perceptible, line between a DiGA and other health apps. For instance, an app that works as a communication platform between patients with mental health challenges and psychotherapists, providing different channels such as video, phone or chat conversations, is not a DiGA. This because it merely digitalises communications without adding therapeutic value.
On the contrary, the “Smoke Free” app, for example, – which helps users quit smoking by tracking their cravings or by identifying triggers that make them smoke – is considered a DiGA. Another example of a DiGA is the “NeuroNation MED” app, which helps people with cognitive impairments improve their brain performance with personalised training sessions.
Challenges and opportunities
Apps such as these present promising opportunities within the healthcare sector, especially with the evolution of artificial intelligence and its further integration into this type of technologies to enhance patient care. The provision of real-time personalised health insights, without bureaucratic or territorial barriers, increases patient access to healthcare services and reduces costs by facilitating remote monitoring and early intervention. However, there are still many challenges to address.
It must be ensured that DiGAs are clinically safe, effective, reliable and safeguard data privacy and security. Healthcare professionals still offer resistance in prescribing these apps, as in many cases they lack the skills to use them, or fear patients will not accept them. The low level of digital literacy among senior citizens is also a hard-to-overcome barrier. Furthermore, authorities are often reluctant to invest in or assume new costs to integrate these technologies, and the majority of healthcare reimbursement systems still solely focus on “classical” medicines and medical devices.
A different but relevant challenge DiGAs face relates to the fragmented legal landscape across Europe in what concerns the qualification, as well as the prescription and reimbursement, of these tools, making it hard for innovator companies to navigate the applicable legal and technical requirements. Despite being classified as medical devices, and therefore falling under the Medical Device Regulation (MDR), DiGAs’ unique features require a tailored legal framework that is not yet in place in the majority of EU Member States.
Unbalanced level playing field across Europe
There are three frontrunner countries setting the stage for DiGAs in the EU by establishing specific approval, evaluation, and reimbursement regimes exclusively for these cutting-edge devices.
Germany approved the Digital Healthcare Act in 2019 and created a fast-track three-month approval process to facilitate the prescription and reimbursement of DiGAs and their integration into the healthcare system. Adoption has grown significantly, demonstrating the effectiveness of this approach. In simple terms, if a health app successfully fulfils certain requirements concerning product quality and proof of positive healthcare effect on the user, it will be listed on the BfArM directory. If all requirements are not yet fulfilled, it is still possible to apply for a provisional listing on the directory while an additional assessment is conducted. There are currently 68 approved DiGAs on the BfArM directory.
Following Germany’s lead, Belgium and France have also developed standardised processes to launch and reimburse DiGAs. Belgium established a “validation pyramid” with several assessment levels that developers must progress through to have their CE-marked medical apps validated and reimbursed. France introduced a similar pathway in 2024, based on the German regime, which includes early access to reimbursement for digital medical devices for a period of up to 12 months, after which developers must provide proof of clinical benefit for the app to be permanently included in the reimbursement regime.
Where does Portugal stand?
Portugal is considered a “certifier”, seeing as it has developed a certification process, currently still applicable on a case-by-case basis, but not a standardised process to access reimbursement for digital solutions. This approach ensures that certain apps which fulfil quality standards (related to performance, safety, public utility, and information security and quality) are included on the “MySNS Selection” platform, but lacks a clear pathway for these apps to be prescribed and reimbursed.
The Portuguese national health service (called the SNS) has developed Telemonit SNS 24, a free mobile app where users can access their personal clinical monitoring plan, proposed by the healthcare professional who accompanies them in the SNS, and can monitor their vital signs using equipment connected to the app. Its use requires a medical prescription. Furthermore, for example, the device FreeStyle Libre glucose meter is 85% subsidised with a medical prescription. Nevertheless, more needs to be done.
Portugal needs a dedicated framework, similar to those being developed in Germany, Belgium, and France, to fully leverage the opportunities and address the challenges of DiGAs. Establishing a structured route for approval, evaluation, and reimbursement will enable Portugal to unlock the potential of DiGAs, while ensuring that these apps are reliable, thereby enhancing disease prevention and patient care.
The Future: Towards a centralised EU model
Looking ahead, several EU Member States are now following the example of leading countries and dedicating their attention to digital health solutions and how they can be approved and reimbursed.
Additionally, the EU is taking significant steps towards creating a centralised framework for the assessment of digital health technologies, including DiGAs. From 2024 to 2028, the EU-funded EDiHTA project will involve researchers in developing a flexible and innovative assessment framework. This model will integrate input from various stakeholders, including patients, hospitals, regulators, and technology developers, with a view to harmonising assessment procedures across Europe.
By fostering such an initiative, the EU acknowledges the critical role of digital health technologies in improving patient care and sets a new standard for their evaluation and integration.
Conclusion
In essence, the future of healthcare lies in embracing digital health innovations like DiGAs, supported by robust and comprehensive legal frameworks based on a European collaborative effort. By doing so, and by levelling the playing field, it will be easier to seize the opportunities presented by DiGAs.
