This morning session is intended for digital health project leaders and entrepreneurs, solution manufacturers and software developers, as well as startups, researchers, and healthcare professionals who wish to develop or integrate a digital innovation.

What level of knowledge is expected? There are no prerequisites. The presentations are designed to be accessible to everyone: regulatory and technical concepts (ISO 27001, HDS, NIS2, CE marking, MDR, AI Act) will be explained and illustrated with real-world examples. Whether you’re new to the e-health ecosystem or already familiar with the subject, you’ll leave with concrete guidance and useful contacts.

Program 

• 9:15 a.m. – 9:30
  a.m. Introduction to e-health: Understanding the ecosystem to innovate
  more effectively—Key players, uses, and challenges of digital health; national and regional governance; digital health policy; and the role of GRADeS in working with manufacturers
• 9:30 a.m. – 10:00
  a.m. Presentation – Cybersecurity in Healthcare:
  From Compliance to Trust—ISO 27001, HDS, NIS2
  . Guidelines and best practices for securing your projects, featuring the ISO 27001 Club and cybersecurity professionals
• 10:00 a.m. – 10:45
  a.m. Roundtable – Digital
  Medical Devices: The Path to Compliance: CE Marking, MDR, AI Act
  . Regulatory expertise and testimonials from manufacturers, followed by a Q&A session
• 10:45 a.m. – 11
  :00 a.m. Break
• 11:00 a.m. – 11:40
  a.m. Presentation: Market
  Access Innovation, yes. But how about the market?
  Market access strategy, reimbursement, and business models to transition from a project to a sustainable business
• 11:40 a.m. – 12:30
  p.m. Focus on AI in Healthcare
  : What Are the Promises and Responsibilities?
  Applications, data sovereignty, societal and environmental impacts: the choices behind the technology
• 12:30 p.m. – 2:00 p.m.
  Networking: Cocktail reception and informal discussions, scheduling meetings.