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Masterclass: The Regulation of DTx in the US
How to successfully take a DTx product through the regulatory pathways in the US? What is going to happen to SaMD products that were marketed under the enforcement discretion during Covid? In DTx-pharma partnerships, what is pharma responsible for from a regulatory perspective?
HealthXL members often ask these questions in our meetings, seeking advice and best practices in their regulatory strategies in the US. However, knowing the answers can be difficult. Join this US-focused Masterclass led by Jason Brooke, medical device attorney and regulatory/quality advisor. He will walk us through:
- Current status of SaMD regulation: what does the regulation of SaMD look like? What should digital health companies go after as a SaMD maker - de novo, breakthrough device or classic 510k?
- Regulation differences between clinical decision support software and SaMD
- What will the regulation of DTx look like in the next few years? What pilots are under testing, evaluation or discussion (e.g. FDA Pre-Cert Program, proposed regulatory framework for AI/ML-based SaMD, etc)?
- Recommended approach for developing the best regulatory strategy for a DTx product
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Masterclass: The Regulation of DTx in the US
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.
How to successfully take a DTx product through the regulatory pathways in the US? What is going to happen to SaMD products that were marketed under the enforcement discretion during Covid? In DTx-pharma partnerships, what is pharma responsible for from a regulatory perspective?
HealthXL members often ask these questions in our meetings, seeking advice and best practices in their regulatory strategies in the US. However, knowing the answers can be difficult. Join this US-focused Masterclass led by Jason Brooke, medical device attorney and regulatory/quality advisor. He will walk us through:
- Current status of SaMD regulation: what does the regulation of SaMD look like? What should digital health companies go after as a SaMD maker - de novo, breakthrough device or classic 510k?
- Regulation differences between clinical decision support software and SaMD
- What will the regulation of DTx look like in the next few years? What pilots are under testing, evaluation or discussion (e.g. FDA Pre-Cert Program, proposed regulatory framework for AI/ML-based SaMD, etc)?
- Recommended approach for developing the best regulatory strategy for a DTx product
Participants
Participants
Jason Brooke
Attorney & Managing Member, Brooke Consulting, LLC
Arthur Bretonnet, MBA
Global digital innovation immunology at UCB
Brian Binkowski
Director of Quality, Twill
Susanne Gruber
Strategic Advisor, Ignited Vision
Wen Dombrowski
Chief Convergence Officer
Amanda Marinov
Quality Assurance and Regulatory Affairs, Happitech
Chris Cera
CEO, Arcweb Technologies
Zina Manji
Sr Director of Regulatory Affairs at GSK
Jo Masterson
Chief Executive Officer, 2Morrow, Inc.
Adriano Garcez
Director, Evidence Generation & Outcomes Research, ZS Associates
Nemanja (Nick) Kovačev
MedTech Expert, HTEC Group
Emma Carr, PhD
Co-Founder and CSO, Amara Therapeutics
Up to 12
Masterclass: The Regulation of DTx in the US
How to successfully take a DTx product through the regulatory pathways in the US? What is going to happen to SaMD products that were marketed under the enforcement discretion during Covid? In DTx-pharma partnerships, what is pharma responsible for from a regulatory perspective?
HealthXL members often ask these questions in our meetings, seeking advice and best practices in their regulatory strategies in the US. However, knowing the answers can be difficult. Join this US-focused Masterclass led by Jason Brooke, medical device attorney and regulatory/quality advisor. He will walk us through:
- Current status of SaMD regulation: what does the regulation of SaMD look like? What should digital health companies go after as a SaMD maker - de novo, breakthrough device or classic 510k?
- Regulation differences between clinical decision support software and SaMD
- What will the regulation of DTx look like in the next few years? What pilots are under testing, evaluation or discussion (e.g. FDA Pre-Cert Program, proposed regulatory framework for AI/ML-based SaMD, etc)?
- Recommended approach for developing the best regulatory strategy for a DTx product
HealthXL Roundtables
HealthXL community meetings connect senior leaders from around the world.
Our virtual Roundtables are small, participant-led discussions where the HealthXL community discuss digital health challenges and offer solutions.
HealthXL community members lead discussion on a defined topic among a maximum of 12 participants. There is no audience and no recordings, just an interactive space to reflect and share learnings.
At 60-minutes long, roundtables are long enough for meaningful discussion among peers, but short enough to fit into busy schedules.
Set up a free HealthXL platform account for a taste of what the community has to offer. Or talk to us about upgrading to a premium account:
- Join any virtual and in-person events
- Invite peers to meetings
- Network
- Gain full access to all articles and HealthXL reports
- Get personalised recommendations
- Join specialised communities in areas like DTx, AI, Clinical Trials Innovation and more
- Full access to community insights and meeting takeaway reports
HealthXL Masterclasses
HealthXL community events give unparalleled access to digital health leaders from around the world.
Our virtual Masterclasses are 60-minute sessions where a recognised expert in their field provides an in-depth learning experience to a small audience of 8-12 members.
HealthXL Masterclasses give you a chance to join a small group of peers and ask questions of recognised experts in a private, convenient setting.
Set up a free HealthXL platform account for a taste of what the community has to offer. Or talk to us about upgrading to a premium account:
- Join any virtual and in-person events
- Invite peers to meetings
- Network
- Gain full access to all articles and HealthXL reports
- Get personalised recommendations
- Join specialised communities in areas like DTx, AI, Clinical Trials Innovation and more
- Full access to community insights and meeting takeaway reports
HealthXL Webinars
HealthXL community events give unparalleled access to digital health experts from around the world.
Our webinars bring together panels of 3-4 global leaders from the HealthXL community to discuss core trends in digital health.
Gain insights on the latest topics in digital health and ask questions of the expert panel via chat. Webinars run for 60 minutes and recordings are shared with all attendees afterwards.
Set up a free HealthXL platform account for a taste of what the community has to offer. Or talk to us about upgrading to a premium account:
- Join any virtual and in-person events
- Invite peers to meetings
- Network
- Gain full access to all articles and HealthXL reports
- Get personalised recommendations
- Join specialised communities in areas like DTx, AI, Clinical Trials Innovation and more
- Full access to community insights and meeting takeaway reports
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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Masterclass: The Regulation of DTx in the US
Masterclass: The Regulation of DTx in the US
Masterclass: The Regulation of DTx in the US
How to successfully take a DTx product through the regulatory pathways in the US? What is going to happen to SaMD products that were marketed under the enforcement discretion during Covid? In DTx-pharma partnerships, what is pharma responsible for from a regulatory perspective?
HealthXL members often ask these questions in our meetings, seeking advice and best practices in their regulatory strategies in the US. However, knowing the answers can be difficult. Join this US-focused Masterclass led by Jason Brooke, medical device attorney and regulatory/quality advisor. He will walk us through:
- Current status of SaMD regulation: what does the regulation of SaMD look like? What should digital health companies go after as a SaMD maker - de novo, breakthrough device or classic 510k?
- Regulation differences between clinical decision support software and SaMD
- What will the regulation of DTx look like in the next few years? What pilots are under testing, evaluation or discussion (e.g. FDA Pre-Cert Program, proposed regulatory framework for AI/ML-based SaMD, etc)?
- Recommended approach for developing the best regulatory strategy for a DTx product
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.
