Every week, HealthXL communities connect to tackle the challenges in digital health. If you missed any of these meetings, here are some key takeaways from the past couple of weeks.
Masterclass: How to navigate DiGA in Germany? A real experience from a digital health company
What’s a DiGA? By definition, it is in medical device risk class I or IIa (low risk class) and supports the recognition, monitoring, treatment or alleviation of diseases, injuries or disabilities. The main function must be based on digital technologies and used only by the patient; or by the patient and the healthcare provider together. This is an important distinction, as it means providers must be careful with any coaching/guidance components as the human element must only be used for patient safety and ensuring the intended use, not for any therapeutic elements.
You can view the full meeting takeaways here.
Masterclass: DTx Reimbursement in the US - Value-Based Contracting Basics
Value-based contracts (VBCs) can be an opportunity to meet interests of a number of health ecosystem stakeholders. VBCs may be linked to clinical and/or financial outcomes, which include adherence, prevalence of events, total cost of care, capitation, among others. The health ecosystem stakeholders will all have a unique interest in VBCs but some will cross over and that is what we should target in our approach.
You can view the full meeting takeaways here.
Masterclass: Regulation of SaMD in the EU
With the new European Medical Device Regulation (MDR), there is a transition period. Any medical device can remain on the market until 26th May 2024 provided that they have a valid declaration of conformity (DoC) dated before 26th May 2021, it has not significant changes and has a vigilance system MDR compliant. But a lot of devices are transitioning, which is creating a bottleneck because there is insufficient notified body capacity. This could lead to many devices having to be taken off the market. As a result of all this, the EU market is no longer the market of choice for first regulatory approval.
You can view the full meeting takeaways here.
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