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Masterclass: How Germany Channelled Digital Health Apps into its Health System: Navigating the DiGA Framework
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.
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Masterclass: How Germany Channelled Digital Health Apps into its Health System: Navigating the DiGA Framework
Join this HealthXL Event today:
Participate in this Digital Health Sprint in order to:
- Deep dive into a topic over 2 focused sessions.
- Engage with a small group of 10 global thought-leaders throughout.
- This sprint is outcome-focused: HealthXL and participants create exclusive outputs.
- Grow your network with our break out sessions.
You actively participate in this discussion. Spaces are limited to 8 - 12 people, allowing you to focus on quality in-depth conversations.
Don't miss your opportunity to connect with senior leaders to shape the future of digital health. Because only if you are prepared now can you lead the future.
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.
Participants
Participants
Jonas Albert
Senior Consultant and Digital Health Expert, fbeta
Hans Holger Bless
Partner, fbeta
Ekta Foster Lachmandas
Digital Health Innovation & Business Creation with the Roche Startup Creasphere
Fulvio Michelis, PhD
Digital Strategy Director, Merck Group
Serdar Gemici
Co-Founder, Albert Health
Ralph Morales III
Director, Healthcare Innovation, Oura
Ivan Jurisic
Founder/Business Consultant, Patients Influence
Richard Bunney
Digital Health Regulation and Compliance Lead, ETHOS Ltd
Francesca Wuttke
CEO and Founder, nen Health
Anna-Maria Heidinger
Head of Digital Innovation Hub Europe, Daiichi Sankyo Europe GmbH
Jean Ledger
Health researcher
Carman Ho
Vice President, L1 Health
Jorge Juan Fernández García
Director of Innovation, EIT Health
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Jyri Yli-Villamo
Head of Strategic Partnerships at Kaiku Health
Matt Norton
Vice President of Marketing & Commercial Development at S3 Connected Health
Ashutosh Malhotra
Digital Business Development & Innovation Scouting Manager Europe at Daiichi Sankyo Europe GmbH
Mark Wuttke
CEO, Dopavision
Up to 12
Masterclass: How Germany Channelled Digital Health Apps into its Health System: Navigating the DiGA Framework
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.
HealthXL Meetings
HealthXL Digital Health Meetings connect you with senior leaders around the world to discuss, solve and support each other.
Your time is valuable. This is why each Digital Health Meeting is limited to 75 minutes - long enough for engaging discussions but short enough to fit into your busy weekly schedule.
Digital Health Meetings are fully interactive and promote conversation - be ready to talk!
HealthXL Digital Health Meetings are not webinars. There is no audience, no recordings and no hiding behind a screen. Discuss, reflect and share learnings in a private but interactive group.
No long speeches, no wait, no travel. Take a productive deep dive into different digital health topics in just 75 minutes - perfect for when you’re on a break.
Join a community of gamechangers in digital health. With a HealthXL membership, you meet like-minded people with unique perspectives. And as a HealthXL member, you get access to regular Digital Health Meetings.
Stay informed on the HealthXL Communities Hub. Connect with your peers, receive notifications about the latest interactive Meetings, get curated digital health news and access industry reports, insights, shared resources and more.
Join from anywhere
No need for a high end laptop to display fancy 3D personas or interactive conference rooms: All you need is a working camera and an internet-ready device to join.
The world of Digital Health in one Hub
Be ready for the future of Digital Health and join a community of passionate leaders, innovators and gamechangers.
As a HealthXL member, you get access to a wealth of information, resources and connections. From daily curated news by our in-house expert team to industry reports each retailing at €2000 - you have the world of Digital Health right at your fingertips.
Our community is growing fast. Don’t miss out on your opportunity to lead the future.
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Frequently Asked Questions
What is a HealthXL Digital Health Meeting?
HealthXL Digital Health Meetings are private group meetings limited to a maximum of 10 people across different demographic and stakeholder groups. They are not webinars, but participant-led group meetings to allow you to explore every facet of digital health with peers.
How can I become a member of the Digital Health Community?
We invite you to create a free account on our Community Hub to have a look behind the curtains. We'd love to show you the platform in a personal call. Click here to schedule a free session with a member of our team.
When can I access the Meeting recording?
Our Meetings are all about honest, open discussions. This is why we do not record our them. After each Meeting, if you were a participant, you will receive a link to the key takeaways; a short summary of the Meeting.
I am participating in this meeting, but can't attend anymore. Can I cancel it?
It can always happen that you cannot attend meetings due to unforeseen reasons. Due to the small group size, even missing one person can be disruptive. We'd like to ask all participants to inform us with at least 48 hours notice or suggest a suitable replacement for themselves.
Masterclass: How Germany Channelled Digital Health Apps into its Health System: Navigating the DiGA Framework
Masterclass: How Germany Channelled Digital Health Apps into its Health System: Navigating the DiGA Framework
Masterclass: How Germany Channelled Digital Health Apps into its Health System: Navigating the DiGA Framework
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.
Join this group of peers and get a feel of what it's like to belong to a community of digital health gamechangers.
All meetings are limited to 10 people to allow for honest discussions, so apply fast or become a HealthXL member and get priority access to all meetings, latest industry reports and and much more.
Frequently asked questions:
What are HealthXL Virtual Meetings?
HealthXL Virtual Meetings are private group meetings limited to 10 people across different demographic and stakeholder groups. For 75 minutes, you take a deep dive into your chosen topic and explore it from different angles. Virtual Meetings are not webinars: There is no audience, no recording and no hiding behind a screen. You actively participate in a discussion to solve your present challenges and design the future of digital health. And through our Community Hub, you stay up-to-date on the latest news and insights, allowing you to fully immerse yourself in the topic before, during and after.
How can I connect with other digital health leaders?
HealthXL brings together gamechangers of digital health to support honest discussions in small, private groups. In our Community Hub, for which you can register for free, you can follow a wide range of communities across telehealth, digital therapeutics, patient engagement and more. As a full HealthXL member, you also get access to curated news, the latest insights and an expert network to connect with. Join exclusive virtual meetings to exchange strategies, viewpoints and learnings with members from like-minded yet diverse stakeholder groups.
What are the benefits of being a HealthXL community member?
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.
