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Masterclass: How to Navigate DiGA in Germany? A Real Experience from a Digital Health Company

8th June @ 10:30AM EDT

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. 

What do you need to know to navigate the DiGA framework? Join us in this interactive masterclass led by Dr. Victor Stephani (responsible for Market Access and Chief of Staff at HelloBetter), who will walk us through: 

  • General overview: what DiGA is and what it’s not, why it is an opportunity for digital health companies in the European market.
  • How to apply, requirements and keys to succeed: what are the requirements for evidence, data security, UX, interoperability, etc. What are the do’s and don’ts regarding the correspondence with the authorities? How do you report significant changes in the product? 
  • How do the pricing negotiations work? What is the best pricing strategy for digital health companies?
  • Experiences with other European reimbursement paths such as France.

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Masterclass: How to Navigate DiGA in Germany? A Real Experience from a Digital Health Company

Dr. Victor Stephani
Chief of Staff, HelloBetter
Paul Wicks
Independent Consultant, Wicks Digital Health
Apply to Attend

Masterclass: How to Navigate DiGA in Germany? A Real Experience from a Digital Health Company

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8th June @ 10:30AM EDT

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. 

What do you need to know to navigate the DiGA framework? Join us in this interactive masterclass led by Dr. Victor Stephani (responsible for Market Access and Chief of Staff at HelloBetter), who will walk us through: 

  • General overview: what DiGA is and what it’s not, why it is an opportunity for digital health companies in the European market.
  • How to apply, requirements and keys to succeed: what are the requirements for evidence, data security, UX, interoperability, etc. What are the do’s and don’ts regarding the correspondence with the authorities? How do you report significant changes in the product? 
  • How do the pricing negotiations work? What is the best pricing strategy for digital health companies?
  • Experiences with other European reimbursement paths such as France.
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Participants

Participants

Dr. Victor Stephani

Chief of Staff, HelloBetter

Paul Wicks

Independent Consultant, Wicks Digital Health

Polina Veltmann

Impact Entrepreneur, Evoleen

Daphne Petrich

Senior Business Development Manager at HelloBetter

Ricardo C. Berrios

Executive Founder, Adhera Health Inc

Kendal Dinsmore

Senior Director, Global RA/QA at Mahana Therapeutics

Ravi Janapureddy

Co-founder & CEO at RCube Health

Aahuti Rai

Strategic Advisor, Healthcare Innovation at Four Points Consulting Ltd

Jean-Noel Courvoisier

Sr. Manager Global regulatory Affairs, Mahana Therapeutics

Cyndi Williams

Founder & CEO, Quin

Marc Brumagne

Senior Director Global Commercial Operations HIV, Gilead Sciences

Jyri Yli-Villamo

Head of Strategic Partnerships at Kaiku Health

Bernhard Kappe

Founder & CEO, Orthogonal

Anna-Maria Heidinger

Head of Digital Innovation Hub Europe, Daiichi Sankyo Europe GmbH

Maria Lemonidou

Corporate Digital Marketing Manager, Neuraxpharm

Joseph Rubinsztain

CEO & Co-Founder, ChronWell

Number of Participants


Up to 12
Date  
June 8, 2022
Community

Masterclass: How to Navigate DiGA in Germany? A Real Experience from a Digital Health Company

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. 

What do you need to know to navigate the DiGA framework? Join us in this interactive masterclass led by Dr. Victor Stephani (responsible for Market Access and Chief of Staff at HelloBetter), who will walk us through: 

  • General overview: what DiGA is and what it’s not, why it is an opportunity for digital health companies in the European market.
  • How to apply, requirements and keys to succeed: what are the requirements for evidence, data security, UX, interoperability, etc. What are the do’s and don’ts regarding the correspondence with the authorities? How do you report significant changes in the product? 
  • How do the pricing negotiations work? What is the best pricing strategy for digital health companies?
  • Experiences with other European reimbursement paths such as France.
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Masterclass: How to Navigate DiGA in Germany? A Real Experience from a Digital Health Company

8th June @ 10:30AM EDT
Digital Therapeutics (DTx)

Masterclass: How to Navigate DiGA in Germany? A Real Experience from a Digital Health Company

8th June @ 10:30AM EDT
Digital Therapeutics (DTx)
Dr. Victor Stephani
Chief of Staff, HelloBetter
LinkedIn Profile
Paul Wicks
Independent Consultant, Wicks Digital Health
LinkedIn Profile
Polina Veltmann
Impact Entrepreneur, Evoleen
LinkedIn Profile
Daphne Petrich
Senior Business Development Manager at HelloBetter
LinkedIn Profile
Ricardo C. Berrios
Executive Founder, Adhera Health Inc
LinkedIn Profile
Kendal Dinsmore
Senior Director, Global RA/QA at Mahana Therapeutics
LinkedIn Profile
Ravi Janapureddy
Co-founder & CEO at RCube Health
LinkedIn Profile
Aahuti Rai
Strategic Advisor, Healthcare Innovation at Four Points Consulting Ltd
LinkedIn Profile
Jean-Noel Courvoisier
Sr. Manager Global regulatory Affairs, Mahana Therapeutics
LinkedIn Profile
Cyndi Williams
Founder & CEO, Quin
LinkedIn Profile
Marc Brumagne
Senior Director Global Commercial Operations HIV, Gilead Sciences
LinkedIn Profile
Jyri Yli-Villamo
Head of Strategic Partnerships at Kaiku Health
LinkedIn Profile
Bernhard Kappe
Founder & CEO, Orthogonal
LinkedIn Profile
Anna-Maria Heidinger
Head of Digital Innovation Hub Europe, Daiichi Sankyo Europe GmbH
LinkedIn Profile
Maria Lemonidou
Corporate Digital Marketing Manager, Neuraxpharm
LinkedIn Profile
Joseph Rubinsztain
CEO & Co-Founder, ChronWell
LinkedIn Profile

Masterclass: How to Navigate DiGA in Germany? A Real Experience from a Digital Health Company

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. 

What do you need to know to navigate the DiGA framework? Join us in this interactive masterclass led by Dr. Victor Stephani (responsible for Market Access and Chief of Staff at HelloBetter), who will walk us through: 

  • General overview: what DiGA is and what it’s not, why it is an opportunity for digital health companies in the European market.
  • How to apply, requirements and keys to succeed: what are the requirements for evidence, data security, UX, interoperability, etc. What are the do’s and don’ts regarding the correspondence with the authorities? How do you report significant changes in the product? 
  • How do the pricing negotiations work? What is the best pricing strategy for digital health companies?
  • Experiences with other European reimbursement paths such as France.
When:
8th June @ 10:30AM EDT
Apply to attend
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As member of HealthXL, you join a community of digital health thought leaders, innovators and game changers around the world. With your membership, you get access to hundreds of insights, reports and resources. You can browse a database with over 90k healthcare organizations and view their active strategic partnerships, commercial relationships, latest funding rounds and research. Through our in-house curated digital health newsfeed, you stay informed on the most impactful news and you can regularly meet with members to share learnings, discuss the latest developments and connect with peers of different demographical stakeholder groups. Contact us today to find out about pricing options.

Through focus groups, we bring together 6-10 thought leaders and industry stakeholders in a series of virtual meetings to collaborate around a defined topic. Each meeting gives the group the opportunity to examine, analyze and collaborate with one another around a digital health topic as well as produce a shareable result.