Digital health applications (DiGA) have so far been limited to low-risk class I and IIa medical devices. This means that products for the self-management of certain diseases are currently excluded from reimbursement. As part of the current digitization strategy, the German Federal Ministry of Health recently announced that reimbursement via DiGA listing will be extended to medical devices in risk class IIb in the future.
A look into the DiGA world: Medical devices in risk class IIb will be able to get reimbursement as DiGA in the future
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