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14 Mar 2023 | 10:00 AM GMT

Masterclass: How Germany Channeled Digital Health Apps into its Health System: Navigating the DiGA Framework

Anchored by:

Hans Bless
Partner
FBETA
Jonas Albert
Partner
FBETA

Participants:

Hans Bless Partnerfbeta
Hans Bless
Partnerfbeta
Jonas Albert Partnerfbeta
Jonas Albert
Partnerfbeta
Frank Kenny Clinical Specialist PhysiotherapistRehab Rooms Physio Clinic
Frank Kenny
Clinical Specialist PhysiotherapistRehab Rooms Physio Clinic
Ashutosh Malhotra Director Digital Health Strategy & PartnersDaiichi Sankyo
Ashutosh Malhotra
Director Digital Health Strategy & PartnersDaiichi Sankyo
Carman Ho Vice PresidentL1 Health
Carman Ho
Vice PresidentL1 Health
Francesca Wuttke Founder & CEOnen Health
Francesca Wuttke
Founder & CEOnen Health
Ivan Jurisic Head of ProductPatients Influence
Ivan Jurisic
Head of ProductPatients Influence
Jean Ledger Research and evaluation consultantAdora Digital Health
Jean Ledger
Research and evaluation consultantAdora Digital Health
Jorge Juan Fernández García Chief Innovation OfficerHospital Clínic Barcelona
Jorge Juan Fernández García
Chief Innovation OfficerHospital Clínic Barcelona
Jyri Yli-Villamo Head of Pharma Global Strategic PartnershipsKaiku Health
Jyri Yli-Villamo
Head of Pharma Global Strategic PartnershipsKaiku Health
Mark Wuttke CEODopavision
Mark Wuttke
CEODopavision
Matt Norton VP of Marketing & Commercial DevelopmentS3 Connected Health
Matt Norton
VP of Marketing & Commercial DevelopmentS3 Connected Health
Richard Bunney DirectorDeviceology
Richard Bunney
DirectorDeviceology
Serdar Gemici CEO & Co-founderAlbert Health
Serdar Gemici
CEO & Co-founderAlbert Health

About this Meeting

Each Masterclass is led by an expert anchor in their field as they dive into their specialty topic in front of a small intimate audience of 8-12 participants. Masterclasses also have an interactive element, allowing you a safe space to share your thoughts and experiences as well as pose questions to the expert anchors.

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 for increasing provider awareness and trust in digital health solutions. Despite its pitfalls, the DiGA framework is still the role model in Europe; how can companies make the most of it? What do you need to know to navigate the DiGA framework? Join us in this interactive masterclass led by Jonas Albert (Digital Health Expert at fbeta) and Hans-Holger Bleß (Partner at fbeta), who will walk us through:
  • Evidence and product requirements: what are the evidence requirements for permanent vs. probational listing? What are the requirements around data security, UX, interoperability, and other product-related aspects?
  • Communication with the BfArM: Preparing, conducting and evaluating consulting meetings, BfArM “habits”, and answering to requests for clarification during application.
  • Manufacturer’s price vs. negotiated price. How do the pricing negotiations work? What is the best pricing strategy for digital health companies?
  • I got listed under DiGA, what now? What comes next for digital health companies that get through DiGA? How do they actually get physicians to prescribe and patients to use the solutions? 


We would like to remind you that our meetings are small and intimate sessions with a limited number of seats available, therefore we rely on your attendance and participation to ensure a high quality and valuable meeting for all. If you are confirmed for this meeting we ask if you can please ensure your attendance on the day.