MedTech Europe: The value of digital health in the European Union.

MedTech Europe: The value of digital health in the European Union.

Are you part of the European Medical devices industry? Are you currently developing new technologies to improve the European health systems?

Check out this interesting summary regarding MedTech’s latest position paper on digital health apps.

On 16thNovember 2021 MedTech Europe, released the position paper: “Recognising the value of digital health apps: An assessment of five European healthcare systems.”The text provides a useful overview of the leading digital tools utilized in the Health and Medical fields and their degree of importance in the following EU countries: Belgium, England, Germany, France, and The Netherlands.


The premise

The European health system is currently facing several new challenges. Modern issues such as changes in demographics, the increase of chronic diseases, and the current shortage of healthcare professionals are undermining the European healthcare systems, hampering their ability to provide services.

It is a worrying situation, which requires a strong response from the European governments.

The role of DHTs

In the last years, Digital health technologies (DHTs) have played a prominent role in providing modern and concrete solutions aimed to reduce modern healthcare’s struggles.

The term DHTincludes a wide range of products, among which:

· Devices (smartphones and tablets);

· Products (software, apps);

· Advanced Technologies (Robotics).

The main advantage of such technologies is their ability to create, process, and transmit data. Proper use of DHT resources can positively impact on the European healthcare systems. Thus, it will provide better treatment for patients and citizens with faster and more accurate data.

Nonetheless,because of several issues (mainly rooted in unlocking funding), the DHTlevel of deployment in Europe remains low and incoherent.

The European countries’ initiatives

In the last years,  as specified by MedTech research, several European countries have given their support to Digital health technologies, providing funding pathways for one particular DHT category: health apps.

The correct utilization of such technology can improve many aspects of the healthcare systems such as:

· Patients’ treatment and recovery;

· Information spreading;

· Promotion of healthier lifestyle alternatives;

· Surgery recovery management.

As mentioned, MedTech focused its research on five European countries, analysing their regional initiatives and unique funding paths of digital health apps.


The five countries

To promote and regulate digital health apps, the analysed countries have used funding initiatives with particular focus on:

· Safety to ensure quality and reliability. In this regard:  “most European markets already require that health apps considered for reimbursement be CE-marked under the applicable EU medical device (MDR) or in vitro diagnostic device (IVD) directives and regulations” (MedTech Europe, 2021).

· Legal aspects (to ensure compliance with national and EU law);

· Apps benefits and outcomes (to ensure the apps positively affect the citizens).


A.    Belgium:

Belgium recently introduced a “Provisions for national funding or reimbursement of digital health applications” system. In February, the National Institute for Health and Disability Insurance (NIHDI) created a special task force dedicated to develop DHTs’ reimbursement procedures.

Moreover, an important task is being performed by the Belgian digital platform for validated healthcare apps: mHealthBelgium. The platform management is organized by two industry federations: Agoria and beMedTech.

Regarding health apps validation, the Belgian system relies on three criteria, defined by three separate authorities.

1. The Federal Agency for Medicine and Health Products (FAMHP):  assess the safety and quality of health products (first criteria or M1);

2. The eHealth Platform: it builds the necessary informational infrastructures for the healthcare system, ensuring safe connections between devices (second criteria or M2);

3. The National Institute for Health and Disability Insurance (NIHDI): is responsible for reimbursement of healthcare products. It ensures that the devices function correctly, assessing the added value they can provide to the Belgian healthcare system (third criteria or M3).

To be eligible for reimbursement, a healthcare product must meet all three criteria (M1, M2, M3).


B.    England:

In the case of England, health apps are administered through registration in the National Health Service (NHS) Apps Library. This tool ensures acceptance for the relevant apps, collecting the ones assessed and deemed as secure.

Since October 2020, the app assessment has been performed through the Digital Technology Assessment Criteria(Clinical safety, Data protection, Technical assurance, Interoperability and Usability, and accessibility). Moreover, the National Institute for Health and Care Excellence (NICE) provides information and assessment on standards for health app providers and commissioners on evidence levels for DHTs.


C.    France:

In France, the Haute Autorité de Santé (HAS) oversees the reimbursement of medical devices.

Recently, its scope has been enlarged to include Connected medical devices (CMDs) in the list of products and services that qualify for reimbursement (LPPR). Unfortunately, enlisting health apps in the LPPR is difficult and requires a high level of evidence.

Nonetheless, some health apps can be reimbursed via “ETAPES” (experimental programme for telemonitoring in France), a temporary programme launched in nine French regions in 2014 and later expanded nationally.


D.    Germany:

In 2019, Germany took a significant step towards digitalization with the Digital Healthcare Act (DVG). The latter provided reimbursement for health apps as well as for other DHTs. In any case, manufacturers need to apply to the Federal Institute for Drugs and Medical Dives (BfArM) to become eligible for reimbursement.

Under the regulation, the health apps are reimbursed by the statutory health insurance funds.


E.    The Netherlands

In this last case, the Dutch government closely monitors the development and adoption of apps, leaving the major economic decisions to the market itself. There is no national reimbursement framework for health apps available. Consequently, the most common path for reimbursement is the assessment from individual insurance companies.

The latter performs the process based on the needs of their stakeholders (patients, care providers, and many more).


Conclusions

Of the five analysed countries, it appears that Belgium, France, and Germany have a system of national reimbursement for health apps. England has one nationally reimbursed app, whereas The Netherlands does not, leaving the task to individual insurance companies.

This situation underlines the presence of uneven funding and reimbursement mechanisms for DHTs in Europe. Despite the analysed countries’ efforts, MedTech Europe underlines that the lack of coherence will undermine the possible benefits of employing digital health apps.

Consequently, further development will be required to advance in the DHT field.


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Davide Flore

Obelis Regulatory Affairs Department

16/12/2021


References:

- MedTech Europe. (2021). Recognising the value of digital health apps: An assessment of five European healthcare systems. Retrieved on 15/12/2021 from https://www.medtecheurope.org/wp-content/uploads/2021/11/2111_v4.8_mte_dht_reimbursement16.11.2021.pdf