In an era where health innovations have the potential to revolutionize health and care, the challenge remains in having an impact at a systemic level. The Digital Health Policy Summit 2024 will delve into the intricate and evolving regulatory and policy landscapes that are critical to achieving this goal. From the latest developments in digital medical device regulation to the European Health Data Space, the AI Act, and beyond, this summit will bring together global leaders, subject matter experts and key stakeholders to explore the promises and challenges of driving the digital health ecosystem forward. 

Directed by: Alberta Spreafico, SVP Health Innovation at EVERSANA; Adjunct Professor of Policy & Economics at the University of Pavia 

2:00pm - 2:30pm | Charting a Path Forward with Health Innovation   

• Prof. Alberta Spreafico, SVP Health Innovation, EVERSANA; Adjunct Professor Policy & Economics, University of Pavia; Director Digital Health Policy Summit 
• Prof. Detlev Ganten, Founding President World Health Summit 
• Roberto Ascione, President, Health Innovation, EVERSANA; Chairman Frontiers Health 
   

2:30pm  – 3:15pm | Digital Medical Devices: Innovation Assessment, Reimbursement, and Adoption – From Local Pioneers to Regional Collaboration and Global Impact: Focus on Europe  

• 2:30pm - 2:45pm | 4 Years of DiGA: Successes, Lessons Learned, and Future Perspectives 
  Keynote Speaker: Dr. Barbara Höfgen, Head of Unit on DiGA and DiPA, Federal Institute for Drugs and Medical Devices (BfArM), Germany 
• 2:45pm - 3:15pm | Digital Medical Devices: Assessment and Reimbursement in Europe
  Moderator: Prof. Alberta Spreafico, SVP Health Innovation, EVERSANA; Director Digital Health Policy Summit 
  Speakers: 
• Dr. Barbara Höfgen, Head of Unit on DiGA and DiPA, Federal Institute for Drugs and Medical Devices (BfArM)
• Louisa Stüwe, Project Director - Digital Health Delegation, Ministère de la Santé

3:15pm – 3:45pm | Digital Medical Devices: The Voice of the Industry  
Moderator: Emilie Lopes-Fernandes, Head of European Policy, Digital Therapeutics Alliance (DTA) 
Speakers: 

• Anne Sophie Geier, Managing Director, Spitzenverband Digitale Gesundheitsversorgung
   
• Stéphane Tholander, Head of Digital Health commission, France Biotech
• Steven Vandeput, Advisor Digital MedTech and Services & Technologies Home Assistance, beMedTech

3:45pm – 4:30pm | Digital Medical Devices: A global Outlook  

• 3:45pm – 4:00pm | A global outlook on digital medicines regulatory pathways and opportunities 
  Speaker:  Megan Coder, Vice President of Product & Policy, Digital Medicine Society (DiMe
• 4:00pm - 4:10: Evolving scenario, insights and opportunities in APAC  
  Speaker:  Roberta Sarno, Head of APAC Policy, Digital Therapeutics Alliance  
• 4:10pm – 4:30pm  | New regulatory and reimbursement frontiers in the USA 
• Marty Culjat, SVP, Global Head of Digital Medicine & Regulatory Innovation, EVERSANA
• Andy Molnar, CEO,  Digital Therapeutics Alliance 

 4:30pm – 5:00pm | The European Health Data Space and the AI Act: Evolving Scenario, Challenges and Opportunities for Health Innovation  

• 4:30pm - 4:45pm | Post-Marketing Surveillance of Digital Medicines & AI-Enabled Innovations: Generating Real World Evidence in the era of the European Health Data Space and AI Act  

           Speaker: Ariel Stern, Alexander von Humboldt Professor for Digital Health, Economics & Policy, Hasso Plattner  Institute

• 4:45pm – 5:00pm  | The European Health Data Space and the AI Act: Insights & Implications for Health Innovation 

           Speaker: Emilie Passemard, Head of regulatory and european affairs unit - Ministerial delegation for digital health,  Ministry of Health 

5:00pm– 5:30pm | Enabling Systemic Innovation for Health for all: from Policy to Practice    

           Speakers:  

• Moredreck Chibi, Regional Public Health Innovation Lead, World Health Organization (WHO) 
• Diana McGhie, Leader for Healthcare Policy, World Economic Forum
• Prof. Alberta Spreafico, SVP Health Innovation, EVERSANA; Director Digital Health Policy Summit