The “EHR system” definition’s scope revisited: new findings from Xt-EHR

As the EHTEL Task Force laid out in this "The EHDS regulation of EHR systems: Blind spots and pain points, and how to address them" working paper, many providers, manufacturers and public sector implementers of the EHDS are concerned about the uncertainty which digital health systems will fall into the EHDS’s scope, an uncertainty caused by the wide scope of the definition of EHR systems in the regulation. Who needs to pay attention to the EHDS’s forthcoming implementing acts defining interoperability requirements? Which commercial systems placed on the market after 2029 will be subject to the new product category “EHR systems” and fall under the EHDS’ regulatory regime? 

Meanwhile, the Xt-EHR project is coming to an end in April, delivering critical input for the Commission’s implementing act foreseen for April 2027.  This implementing act will be developed in the EHDS committee (in the comitology process of Commission and Member States), so while the field is waiting, this may be a good time to convene the EHTEL EHDS Implementers Task Force for an informal and informed discussion. 

Especially the draft deliverable D8.1 on "Classification and Functional Profiles of EHR Systems" may offer useful guidance for all stakeholders on how to adopt, conform and/or comply with EHDS requirements when they will take effect, provided the deliverable (and many others) will be reflected and built upon in the implementing act. 

Please join us for a collaborative and interactive discussion on the impact of D8.1 that will leave hopefully everybody smarter.  Here is a link to the latest D8.1 version that was made available for consultation in January.  The guiding questions will be:  

• What are your takeaways from D8.1? Will it make implementation easier? How? 

• Does D8.1 help hospitals, providers and industry to understand if their systems are in scope and how far it is in scope? 

• Is the distinction between the different roles (provider, transmitter, consumer) actionable and sufficiently straightforward? 

A  stakeholder panel will bring together three speakers from industry and the public sector:

• Stefano Dalmiani (Fondazione Toscana Gabriele Monasterio, IT)
• Klára Jiráková (Ministry of Health of the Czech Republic, CZ)
• Mikael Rinnetmäki (Sensotrend, FI)

Agenda

• Welcoming participants

• An overview of Xt-EHR and a presentation of D8.1, by Luc Nicolas
  

• Stakeholder panel 

• Open discussion with the audience and Q&A

• Closing, take-aways, next steps 

The workshop will be moderated by Michael Strübin.