palleos healthcare provides services from consulting on scientific advice meetings, trial design and trial execution, covering the complete DiGA process for medical devices.
Many new medical products with applications (apps) are currently being developed. Through the promotion of digital health apps (DiGA), an “app on prescription” – i.e. reimbursement by the health insurance funds – is made possible in accordance with the “Digital Health Care Act” – (DVG).
The BfArM usually requires clinical studies to prove the positive health care effect, whereby the studies must fullfil very high quality standard in accordance with medical device regulations.
The BfArM procedure to enter the „DiGA“ library is designed as a “fast track” process over 3 months. In the review process, data protection, user-friendliness and the positive care effect of the DiGA are evaluated on the basis of clinical data and/or clinical studies. Extensive and valid clinical data must be submitted so that a positive supply effect can be proven. In case no sufficient data points can be provided, the manufacturer may also be provisionally listed in the DiGA directory thus being eligible for reimbursement. Such can be achieved by conducting a randomised study within a trial period of up to a maximum of two years, which has to be accepted by the BfArM for eligibility. As soon as a DiGA is listed in the directory, it is eligible for reimbursement, so that the DiGA can already be billed via the health insurance funds.
palleos healthcare provides services from design consulting and assisting in BfArM advice meetings to the execution and evaluation of the study.