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Masterclass: A Roadmap to Digital Health Compliance: Navigating Regulations, Security & Privacy

14th June 2023 @ 10:45AM EDT

Are your Digital Health innovations being slowed or even derailed by regulatory, security, privacy or legal compliance considerations? As concerns over patient safety and privacy grow, organizations must navigate complex and ever-evolving legal and regulatory frameworks. However, achieving compliance for SaMD and Digital Health offerings creates tremendous financial, organisational and product design burdens that are stifling digital health innovation and our industry’s ability to fix healthcare. How can we successfully manage these challenges and ensure compliance, while maintaining innovation agility?

Orthogonal.io and Anavo DX have launched a research study to understand the burden and complexity of Digital Health compliance, and its effects on development cost, release frequency and design. By understanding the root causes of waste and inefficiency, these two organizations propose to chart a new and improved development approach for our industry. Join this discussion with David Feygin (CEO & Founder of Anavo DX) and Randy Horton (Chief Solutions Officer at Orthogonal) and be among the first to access emerging study insights. We will discuss: 

  1. Complying with SaMD and Digital Health regulations can stifle innovation in healthcare. Financial, organizational and product design burdens of achieving regulatory, security, privacy and legal compliance. 
  2. Current approaches to achieving digital health compliance. What are the root causes of waste and inefficiency with current approaches? 
  3. Case studies and today’s best practices for achieving compliance. Are these transformational or incremental?”
  4. Future-gazing. How can we adapt less burdensome and more agile approaches tailored toward digital technologies? How to best approach regulators?

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: A Roadmap to Digital Health Compliance: Navigating Regulations, Security & Privacy

Randy Horton
Chief Solutions Officer, Orthogonal
David Feygin
CEO & Founder, ANAVO DX

Masterclass: A Roadmap to Digital Health Compliance: Navigating Regulations, Security & Privacy

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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.

14th June 2023 @ 10:45AM EDT

Are your Digital Health innovations being slowed or even derailed by regulatory, security, privacy or legal compliance considerations? As concerns over patient safety and privacy grow, organizations must navigate complex and ever-evolving legal and regulatory frameworks. However, achieving compliance for SaMD and Digital Health offerings creates tremendous financial, organisational and product design burdens that are stifling digital health innovation and our industry’s ability to fix healthcare. How can we successfully manage these challenges and ensure compliance, while maintaining innovation agility?

Orthogonal.io and Anavo DX have launched a research study to understand the burden and complexity of Digital Health compliance, and its effects on development cost, release frequency and design. By understanding the root causes of waste and inefficiency, these two organizations propose to chart a new and improved development approach for our industry. Join this discussion with David Feygin (CEO & Founder of Anavo DX) and Randy Horton (Chief Solutions Officer at Orthogonal) and be among the first to access emerging study insights. We will discuss: 

  1. Complying with SaMD and Digital Health regulations can stifle innovation in healthcare. Financial, organizational and product design burdens of achieving regulatory, security, privacy and legal compliance. 
  2. Current approaches to achieving digital health compliance. What are the root causes of waste and inefficiency with current approaches? 
  3. Case studies and today’s best practices for achieving compliance. Are these transformational or incremental?”
  4. Future-gazing. How can we adapt less burdensome and more agile approaches tailored toward digital technologies? How to best approach regulators?

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.

Register to AttendApply to Attend

Participants

Participants

Randy Horton

Chief Solutions Officer, Orthogonal

David Feygin

CEO & Founder, ANAVO DX

Richard Bunney

Digital Health Regulation and Compliance Lead, ETHOS Ltd

Gazal Vakili

Director, Digital Health Innovation, Sumitomo Pharma America Holdings, Inc.

Ashutosh Malhotra

Digital Business Development & Innovation Scouting Manager Europe at Daiichi Sankyo Europe GmbH

Oleg Cohen

Strategic Advisor, ANAVO DX

Patrick Leyseele

Founder and CEO, 3.life

Mariam Shokralla

Digital Health Consultant, World Health Organization

Chris Cera

CEO, Arcweb Technologies

Amir Lahav

Digital Health Innovation Advisor

Weronika Michaluk

Principal , HTD Health

Mansa Shroff

Head of Partnerships at WKD.SMRT

Ralph Morales III

Director, Healthcare Innovation, Oura

Nicolas Bertrand

Global Go-to-market Manager - Digital Solutions, Bayer Pharmaceuticals

Number of Participants


Up to 12
Date  
June 14, 2023
Community

Masterclass: A Roadmap to Digital Health Compliance: Navigating Regulations, Security & Privacy

Are your Digital Health innovations being slowed or even derailed by regulatory, security, privacy or legal compliance considerations? As concerns over patient safety and privacy grow, organizations must navigate complex and ever-evolving legal and regulatory frameworks. However, achieving compliance for SaMD and Digital Health offerings creates tremendous financial, organisational and product design burdens that are stifling digital health innovation and our industry’s ability to fix healthcare. How can we successfully manage these challenges and ensure compliance, while maintaining innovation agility?

Orthogonal.io and Anavo DX have launched a research study to understand the burden and complexity of Digital Health compliance, and its effects on development cost, release frequency and design. By understanding the root causes of waste and inefficiency, these two organizations propose to chart a new and improved development approach for our industry. Join this discussion with David Feygin (CEO & Founder of Anavo DX) and Randy Horton (Chief Solutions Officer at Orthogonal) and be among the first to access emerging study insights. We will discuss: 

  1. Complying with SaMD and Digital Health regulations can stifle innovation in healthcare. Financial, organizational and product design burdens of achieving regulatory, security, privacy and legal compliance. 
  2. Current approaches to achieving digital health compliance. What are the root causes of waste and inefficiency with current approaches? 
  3. Case studies and today’s best practices for achieving compliance. Are these transformational or incremental?”
  4. Future-gazing. How can we adapt less burdensome and more agile approaches tailored toward digital technologies? How to best approach regulators?

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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Your Digital Health Corner

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Digital Health’s ‘Easy-Money Era’ is Over. So, What Comes Next?
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May 24, 2023
Tess’ Top Takes from this Month’s Meetings in Digital Health
Tess’ Top Takes from this Month’s Meetings in Digital Health
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May 19, 2023
Beyond Patient Engagement: Why Collaboration is Essential in Health Tech
Beyond Patient Engagement: Why Collaboration is Essential in Health Tech
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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.

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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.

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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.

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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.

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Masterclass: A Roadmap to Digital Health Compliance: Navigating Regulations, Security & Privacy

14th June 2023 @ 10:45AM EDT
Digital Therapeutics (DTx)

Masterclass: A Roadmap to Digital Health Compliance: Navigating Regulations, Security & Privacy

14th June 2023 @ 10:45AM EDT
Digital Therapeutics (DTx)
Randy Horton
Chief Solutions Officer, Orthogonal
LinkedIn Profile
David Feygin
CEO & Founder, ANAVO DX
LinkedIn Profile
Richard Bunney
Digital Health Regulation and Compliance Lead, ETHOS Ltd
LinkedIn Profile
Gazal Vakili
Director, Digital Health Innovation, Sumitomo Pharma America Holdings, Inc.
LinkedIn Profile
Ashutosh Malhotra
Digital Business Development & Innovation Scouting Manager Europe at Daiichi Sankyo Europe GmbH
LinkedIn Profile
Oleg Cohen
Strategic Advisor, ANAVO DX
LinkedIn Profile
Patrick Leyseele
Founder and CEO, 3.life
LinkedIn Profile
Mariam Shokralla
Digital Health Consultant, World Health Organization
LinkedIn Profile
Chris Cera
CEO, Arcweb Technologies
LinkedIn Profile
Amir Lahav
Digital Health Innovation Advisor
LinkedIn Profile
Weronika Michaluk
Principal , HTD Health
LinkedIn Profile
Mansa Shroff
Head of Partnerships at WKD.SMRT
LinkedIn Profile
Ralph Morales III
Director, Healthcare Innovation, Oura
LinkedIn Profile
Nicolas Bertrand
Global Go-to-market Manager - Digital Solutions, Bayer Pharmaceuticals
LinkedIn Profile

Masterclass: A Roadmap to Digital Health Compliance: Navigating Regulations, Security & Privacy

Are your Digital Health innovations being slowed or even derailed by regulatory, security, privacy or legal compliance considerations? As concerns over patient safety and privacy grow, organizations must navigate complex and ever-evolving legal and regulatory frameworks. However, achieving compliance for SaMD and Digital Health offerings creates tremendous financial, organisational and product design burdens that are stifling digital health innovation and our industry’s ability to fix healthcare. How can we successfully manage these challenges and ensure compliance, while maintaining innovation agility?

Orthogonal.io and Anavo DX have launched a research study to understand the burden and complexity of Digital Health compliance, and its effects on development cost, release frequency and design. By understanding the root causes of waste and inefficiency, these two organizations propose to chart a new and improved development approach for our industry. Join this discussion with David Feygin (CEO & Founder of Anavo DX) and Randy Horton (Chief Solutions Officer at Orthogonal) and be among the first to access emerging study insights. We will discuss: 

  1. Complying with SaMD and Digital Health regulations can stifle innovation in healthcare. Financial, organizational and product design burdens of achieving regulatory, security, privacy and legal compliance. 
  2. Current approaches to achieving digital health compliance. What are the root causes of waste and inefficiency with current approaches? 
  3. Case studies and today’s best practices for achieving compliance. Are these transformational or incremental?”
  4. Future-gazing. How can we adapt less burdensome and more agile approaches tailored toward digital technologies? How to best approach regulators?

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.

When:
14th June 2023 @ 10:45AM EDT
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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.