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07 Jul 2022 | 09:00 AM GMT

Masterclass: Reimbursement of Digital Health in Europe - the DiGA framework

Anchored by:

Laura Nelde
Senior Consultant
FLYING HEALTH

Participants:

Laura Nelde Senior ConsultantFlying Health
Laura Nelde
Senior ConsultantFlying Health
Jo Peddhinti AdvisoryHLTH Community
Jo Peddhinti
AdvisoryHLTH Community
Claire Donnelly Head of Medical PartnershipsHappitech
Claire Donnelly
Head of Medical PartnershipsHappitech
Ekta Foster-Lachmandas Digital Health Business CreationRoche Diagnostics
Ekta Foster-Lachmandas
Digital Health Business CreationRoche Diagnostics
IP
Ines Pinto Associate ConsultantZS Associates
IP
Ines Pinto
Associate ConsultantZS Associates
Katie Cannon Director - Strategic PartnershipsAvegen Health
Katie Cannon
Director - Strategic PartnershipsAvegen Health
Logan Smith Head of ProductHulaTech
Logan Smith
Head of ProductHulaTech
Paul Ryan Lead Data AnalystHealthXL
Paul Ryan
Lead Data AnalystHealthXL
Piotr Sokolowski Chief Medtech StrategistS3 Connected Health
Piotr Sokolowski
Chief Medtech StrategistS3 Connected Health
Ravi Janapureddy Co-founder & CEOResony
Ravi Janapureddy
Co-founder & CEOResony
Richard Secker-Johnson Associate PrincipalZS Associates
Richard Secker-Johnson
Associate PrincipalZS Associates

About this Meeting

Regulatory clearance and the best commercialization model for a digital health product are among the key components for success in a rapidly growing sector. Germany’s Digital Healthcare Act (DVG) and the Digital Health Applications Ordinance (DiGAV) have the potential to play a key role, not only in providing a path to reimbursement, but also for increasing provider awareness and trust in digital health solutions.  

So far, however, the early fanfare has yet to translate into any major uptake of digital therapeutics (DTx). More than 60 applications were either withdrawn or rejected by German’s Federal Institute for Drugs and Medical Devices (BfArM) and only 31 products approved (as of May 20th). From those already in the listing, the physician uptake remains slim.  

So how can companies successfully navigate the DiGA framework and increase the adoption? Join us in this interactive masterclass led by Flying Health, who will walk us through:  

  • General overview and current landscape: what DiGA is and what it’s not, why it is an opportunity for digital health companies in the EU market, digital health tools approved so far, average price and current prescription and adoption rates. 
  • How to apply, requirements and keys to succeed: what are the requirements for evidence, data security, UX, interoperability, etc.? How do the pricing negotiations work? 
  • Once you have your DiGA approved, what else do you need to ensure a high number of prescriptions and patient adoption? 
  • What is the interest of other European countries in the DiGA model? Brief outlook on France.