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Agenda

Digital health technologies supporting the self-management of chronic diseases: how to demonstrate evidence facilitating high acceptance and large-scale uptake in the reimbursement markets?

The large-scale uptake of Digital health technologies (DHT) including digital health applications will make significant contribution to a sustainable design of European health systems in the future. Diabetes is a paradigm for closing the loop between the digital collection of health data and the daily adjustment of therapy decisions.

In addition to improving the patient journey, the demonstrated evidence of therapeutic effectiveness plays the main role in assessing the eligibility of digital health technologies for reimbursement and resolving scepticism among stakeholders in the primary healthcare market.

Clinical trials require a significant investment by manufacturers and should therefore generate a maximum return on this investment. When designing the clinical trial scientific, regulatory and operational excellence should be paired with a pragmatic sense for solutions that work.

In this webinar we will discuss

  • approaches to trialling digital health technologies including Remote Decentralised Clinical Trials, digital biomarkers & phenotyping
  • Evidence frameworks including the new European Medical Device Regulation (MDR 2017/745), the Digital Health Applications (DiGA - Germany) fast track, NICE evidence standards, PECAN-ISO 82304-2, mHealth Belgium and the Pre-certification approach tested by the FDA
  • DHTs including DiGA in the primary healthcare market today and in perspective
  • Challenges  those SMEs face that are interested in bringing innovative diabetes DHT to the market

To learn more about the event and to register, click here.

Registration: https://forms.office.com/r/SJ6YMAniSK