How to Navigate DiGa in Germany? A Real Experience From a Digital Health Company
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Regulatory clearance and the right commercialization model for a digital health product are key components of success in this rapidly growing space. Germany’s Digital Healthcare Act (DVG) and the Digital Health Applications Ordinance (DiGAV) have the potential to play a key role in not only providing a path to reimbursement but also increasing provider awareness and trust in digital health solutions.
What do you need to know to navigate the DiGA framework?
Read the key takeaways from the Masterclass on ‘How to Navigate DiGa in Germany?’:
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.
For either a permanent or probational listing, get your paperwork in order. For a permanent listing, ideally, a study should be completed according to ISO 14155 guidelines with patients that are a representative sample for Germany.
For probational listings, a systematic data analysis with 30 to 50 patients should work. Resist the temptation to report more than required, keep the focus on showing a positive care effect.
There are a lot of product requirements - more than 100. These range from the completion of a penetration test, (a simulated cyber attack against your computer system to check for exploitable vulnerabilities) to meeting data protection guidelines.
Take advantage of the option to have a consulting meeting with the Federal Institute for Drugs and Medical Devices (BfArM). Aside from this being a good opportunity to clarify the requirements for the DiGA, it is also a good opportunity to introduce the company and build a relationship. The BfArM often focuses on evidence, this can be the most important and trickiest component. Make sure your study is correctly set up.
During an assessment (which can take three months) companies will often receive deficiency letters, which are very comprehensive. Here is where having a personal relationship with an assessor can be vital - you may need to look to clarify what the most important points are within a deficiency letter. Be on point and answer the questions consistently.
Don't give more info than required, use marketing language and spend less time worrying about getting expert opinions endorsing the product and more time getting legal advice to make sure everything is in order.
Make sure to report any changes to the BfArM, the organization sets out a list of what needs to be reported to them and this should be consulted in detail.
When it comes to pricing, the federal association of sickness funds (GKV-SV) is your new partner. The reimbursement price for the first 12 months is capped and can be calculated, from the 13th month onwards it is individually negotiated with GKV-SV.
After you become listed the real work starts to get doctors and patients on board.
The presentation for this Masterclass can be viewed here.
(This content was originally published on 16th June, 2022.)
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