The German healthcare market is just as attractive as its regulation is complex. We guide you through the regulatory challenges: From DiGA listing, pre-qualification, funding applications, data protection, or AI regulation.
Our DiGA experts support you on your DiGA journey: From the initial strategy for your digital health application to a successful listing in the DiGA Fast Track process, to price negotiation and beyond.
Both, PZN (Central Pharmaceutical Number) and HiMiPo (Medical Device Position Number), are essential for your product to be prescribed by physicians and reimbursed by statutory health insurance.
PECAN is the French equivalent to the German DiGA Fast-Track process. Together with our French partners, we support your PECAN approval process and bring your DiGA to the French market.
Regulation for artificial intelligence (AI) is currently in progress on many levels. We bring your AI product to the German market and assess the potential for existing products.
Prequalification is a mandatory requirement for medical device manufacturers to distribute their products directly to patients and directly bill statutory health insurers in Germany. We prepare your prequalification and guide you through the process.
Understand the specific requirements and challenges of digital care applications: Whether it’s DiPA or digital care in general, we actively shape the future of care with you – from strategy to go-to-market.
Until end of 2024, the German Innovation Fund supports health service research in Germany with 200 million euros. We take care of the preparation of your funding application and guide you through the application process.
After the ePrescription for drugs, Gematik is planning the ePrescription (eVerordnung) for medical aids and remedies. This will be a particular challenge for all healthcare providers who do not have an on-site presence where patients can simply show their electronic health card. If you currently receive prescriptions on paper, we can assist you with the transition.
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Ludwig Thiede2024-06-25 10:09:202024-07-01 12:12:59Whitepaper: Digital Health Applications (DiGA) in Portugal
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