EHDS Readiness Workshop for Healthtech / Medtech

• Programme overview

  M1 Drogheda Chamber Skillnet is delighted to partner with The Connected Health & Wellbeing Cluster on the upcoming EHDS Readiness Workshop, deliver by Santegic.

  According to the EU Commission, the upcoming EHDS Legislation “aims to establish a common framework for the use and exchange of electronic health data across the EU. It enhances individuals’ access to and control over their personal electronic health data, while also enabling certain data to be reused for public interest, policy support, and scientific research purposes”.

  However, EHDS has still not featured prominently on industry agendas despite regulatory obligations that will apply to member organisations in the near future. Cost efficiency, audit readiness and a practical path to compliance are all key priorities for the wider Health & Life Sciences sectors.

   

  A recent meeting of industry outlined some immediate Priorities:

  • Understanding EHDS obligations to their relevant organisations
  • Identify gaps between current data practices and EHDS requirements
  • Prioritise compliance actions across primary and secondary use obligations
  • Build internal confidence and readiness for upcoming regulatory timelines
  • Align EHDS planning with broader MDR/QMS activities where applicable
  • Content tailored to different product types (SaMD, EHR/PHR, Wellness, medtech, life sciences)
  • Peer leaning with fellow digital health companies facing similar challenges
  • Tangible outputs: a draft readiness assessment and a compliance roadmap
• Learning outcomes

  This intensive one-day EHDS Readiness Workshops has been designed around four principles to maximise practical value for participants:

  • Output-oriented: every session builds toward the end-of-day deliverable: a draft readiness assessment and compliance roadmap
  • Regulation-grounded but practically framed: participants leave with actionable insight, not just legal knowledge
  • Peer learning: structured discussion enables digital health companies facing similar challenges to share experience and solutions
  • Tiered by product type: obligations differ for EHR/PHR vendors, SaMD, wellness apps, remote monitoring, medtech, life sciences, and data platforms; sessions acknowledge this divergence
• Who is the course for

  This workshop is designed for professionals working across the healthtech, medtech, digital health, wellness, and life sciences sectors who need to prepare for the upcoming European Health Data Space (EHDS) regulations.

• What is involved

  What is involved:

  • 8:30-9:00 Registration & Networking
  • 9:00-9:30 Opening: Why EHDS Matters Now; Obligations & Benefits
  • 9:30-10:45 Module 1: EHDS Architecture & Obligations
  • 10:45-11:00 Break
  • 11:00-12:15 Module 2: Primary Use – Patient Rights &
    Product Obligations
  • 12:15-13:00 Module 3: Secondary Use – Research, Innovation & Access
  • 13:00-14:00 Lunch
  • 14:00-15:15 Module 4: Data Readiness Assessment (Guided Self-Assessment)
  • 15:15-15:30 Break
  • 15:30-16:30 Module 5: Compliance Roadmap Building
  • 16:35-17:00 Outputs & Peer Review
  • 17:00-17:30 Close &Next Steps