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14 Feb 2022 | 03:45 PM GMT
Past Meeting

Masterclass: The regulation of SaMD in the US

Anchored by:

Bernhard Kappe
Founder & CEO
ORTHOGONAL
Clay Anselmo
VP Quality Assurance and Regulatory Affairs
SHRINER AND ASSOCIATES

Participants:

Bernhard Kappe Founder & CEOOrthogonal
Bernhard Kappe
Founder & CEOOrthogonal
Clay Anselmo VP Quality Assurance and Regulatory AffairsShriner and Associates
Clay Anselmo
VP Quality Assurance and Regulatory AffairsShriner and Associates
Adam Samson President, National Center Clinical TrialsAdvocate HealthHealth System & Providers
Health System & Providers
Adam Samson
President, National Center Clinical TrialsAdvocate Health
BB
Brian Binkowski Director of QualityTwill
BB
Brian Binkowski
Director of QualityTwill
Cathy Zaremba Director, Product MarketingBrightInsightOther
Other
Cathy Zaremba
Director, Product MarketingBrightInsight
Dorothy Hoffman Exec Dir, Head of Global ImmunologNovartisOther
Other
Dorothy Hoffman
Exec Dir, Head of Global ImmunologNovartis
Gandolf Finke CEOSynagenOther
Other
Gandolf Finke
CEOSynagen
Ivan Jurisic Head of ProductPatients Influence
Ivan Jurisic
Head of ProductPatients Influence
Jo Masterson CEO2Morrow, Inc.Health Tech & Solutions
Health Tech & Solutions
Jo Masterson
CEO2Morrow, Inc.
Krys Zaluski Director, External GrowthBiogenLife Sciences, Pharma & Biotech
Life Sciences, Pharma & Biotech
Krys Zaluski
Director, External GrowthBiogen
Randy Horton VP of Solutions and PartnershipsOrthogonalOther
Other
Randy Horton
VP of Solutions and PartnershipsOrthogonal
Smit Patel Partnership & Commercial GTM ExecutiveCVS HealthPayer & Insurer
Payer & Insurer
Smit Patel
Partnership & Commercial GTM ExecutiveCVS Health

About this Meeting

Regulation is an absolute essential for companies who want to get their SaMD accepted into clinical and payer groups. What are the must know and do’s and don’ts when attempting to take your SaMD through regulatory pathways in the US? Join us in this US-focused Masterclass led by Clay Anselmo and Bernhard Kappe. They will walk us through: 

  •  Current status of SaMD regulation: what does the regulation of SaMD look like? Why is it so challenging to regulate and how is the FDA responding today? 
  •  Understanding the existing regulatory pathways: what should digital health companies go after as a SaMD maker - de novo, breakthrough device or classic 510k?  
  •  Regulatory Innovation at the FDA and its impact on SaMD:  What will the regulation of SaMD look like in the next few years?  What pilots are under testing, evaluation or discussion (e.g. FDA Pre-Cert Program, framework for GMLP, software change management etc)? 
  •  Recommended approach to use today for developing, launching and evolving SaMD under current regulatory frameworks and guidance.

About Us

HLTH Inc. is a dynamic community delivering unique value to the healthcare industry through a mix of unparalleled global events, inspirational content, and impact-driven initiatives.

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USA Event Dates

2026 | HLTH: Nov 15 – 18 | Las Vegas | Register | Sponsor
2027 | ViVE: Mar 14 – 17 | Nashville | Be First to Know | Sponsor
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Europe Event Dates

2027 | HLTH Europe: Jun 21 – 24 | Amsterdam | Sponsor
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