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Victor Stephani

Lead Policy & Regulatory Affairs Manager

HelloBetter

Cologne, Germany

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Digital health leader linking regulation, evidence and market access. Policy & Regulatory Affairs lead at HelloBetter; PhD in Health Economics.

My organisation

HelloBetter

HelloBetter

Small and medium-sized enterprise

Cologne, Germany

HelloBetter (trademark of GET.ON Institut für Online Gesundheitstrainings GmbH) is a digital therapeutics manufacturer in the field of e-mental health. HelloBetter offers online courses for mental health problems, like depression, sleep problems or panic. Currently, there are 11 HelloBetter medical devices on the market. The courses have been developed and evaluated over many years of research by an interdisciplinary team of psychologists and researchers. So far, HelloBetter has conducted over 30 randomized controlled trials on the effectiveness of its online mental health courses.
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About me

I’m Dr. Victor Stephani, a digital health leader with 8+ years driving evidence-based digital therapeutics from idea to market across Europe and the U.S. At HelloBetter, I led policy and regulatory affairs and previously served as Chief of Staff—securing FDA Breakthrough Device Designation, shaping value-based pricing with GKV-SV, and guiding AI-enabled medical devices through pre-market pathways. I advise health ministries in Germany, France, and Austria, co-chair the DTA’s Europe Policy Task Group, and have testified before the German Parliament. With a PhD in Health Economics and ISO 13485/14155 expertise, I translate regulation and evidence into scalable products that improve patient outcomes and unlock market access.

Speaker sessions (1)

Wednesday, 15 October 2025

11:00 - 12:15

A3: Reimbursement of digital health applications across Europe

Location:Room 8: Sophie

Moderator: Philipp Lindinger