Authors' objectives: The aim of this study is to offer recommendations to the Belgian health authorities on how to further develop the existing Belgian framework for the assessment of medical apps to support a clearer and more transparent procedure for the evaluation of DMTs in Belgium and respond to the multiple challenges it poses. The research needed to be undertaken bearing two important principles in mind • First, recommendations would need to facilitate the implementation of reimbursement decisions for DMTs. • Second, they should rely on scientific grounds but avoid lengthy and burdensome processes. To achieve this goal, a clear scope needed to be defined. Preliminary searches for information and discussions with stakeholders completed during the scoping phase of this project, indicated that the current scope of the Belgian framework (limited to mobile health apps) could be too restrictive and thus, a broader scope was defined for this research. This can be described as follows: DMTs, categorised as MDs, such as apps, web browser-based (and other software-based) solutions, used with or without sensors or other non- invasive wearables. These should be used as support to prevent (secondary prevention) diagnose, predict, prognose, (tele)monitor, treat, or alleviate medical conditions, by means of their specific digital functions. The perspective would be that of the compulsory health insurance Belgium. Thus, given that primary prevention falls outside the responsibility of the NIHDI, DMTs for primary prevention have not been studied. DMTs used autonomously by healthcare professionals (e.g. prescribing software) or by patients (e.g. apps not requiring a prescription or any involvement of healthcare providers) are also considered out of scope. Finally, teleconsultations are excluded from this report, since communication systems are not considered as MDs when their only purpose is to transfer electronic information. The centre of attention of this research is on procedures for the scientific evaluation of those technologies in the context of reimbursement decisions. As compliance with safety and performance, general data protection regulation (GDPR) and requirements for safe and interoperable data exchanges are prerequisite for being considered for reimbursement, this report describes the current state of affairs also for these aspects in a selection of studied countries.

Authors' results and conclusions: A discussion of the key learnings from this research that should be considered in a future Belgian framework is provided. These learnings have been used to inform and inspire recommendations to the Belgian health authorities. - Scope and focus of the established DMT evaluation frameworks - Evaluation and reimbursement of a DMT in isolation versus within a care process - Generic listing versus nominal listing and evaluations for DMTs - Processes and resources for evaluation - Evidence Requirements - Temporary reimbursement - Timing of payment - Stepwise approach - Limitations

Authors' recommendations: Recommendations can be found in two separate documents publicly available on our website that present a summary of our research followed by the recommendations. These syntheses are aimed at Belgian decision makers and are thus, only available in French and Dutch.

Project Status: Completed

Year Published: 2023

URL for published report: https://doi.org/10.57598/R362C

URL for additional information: https://kce.fgov.be/en/publications/evaluation-of-digital-medical-technologies

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Belgium

DOI: 10.57598/R362C

Organisation Name: Belgian Health Care Knowledge Centre

Contact Address: Administrative Centre Botanique, Doorbuilding (10th floor), Boulevard du Jardin Botanique 55, B-1000 Brussels, Belgium tel: +32 2 287 33 88 fax: +32 2 287 33 85

Contact Name: info@kce.fgov.be

Contact Email: info@kce.fgov.be

Copyright: Belgian Health Care Knowledge Centre (KCE)