DSI extension, TUESDAY 27 DECEMBER 2022
The Europe of health data, the project of which was presented last May, is under construction. What role do manufacturers play in this partition? DSIH handed over the microphone to Sara Luisa Mintrone, Marketing General Manager of the Dedalus group and President of the Digital Health Committee of the Cocir association. It also reveals the importance of developing this ecosystem to accelerate clinical research.
You are building a European health data space. What is the contribution of medical IT manufacturers to the development of such an organization?
The European Health Data Space, EHDS(1), is a tremendous opportunity and a key step in building a united Europe. But inconsistencies and conflicts with other current regulations, including the GDPR and the certification of medical devices or clinical software, are slowing down its implementation. You need to have a holistic approach to analyzing and overcoming these blockages.
The involvement of industrialists through Cocir(2), the European coordination committee for the radiological, electromedical and healthcare IT industries, has made it possible to participate in the construction of documents relating to the EHDS. Dedalus has invested heavily in the committee’s work, particularly on data privacy.
Cocir, which brings together the major medical technology companies such as Dedalus, Siemens, GE Healthcare, Philips, etc., has facilitated the dissemination of the opinions of the industrialists.
Dedalus is also involved in other representative organizations present in the member countries, such as Numeum, the professional union of the digital ecosystem in France which maintains a close dialogue with the European institutions.
What is missing to make a European health data space project a success?
The major difficulty to overcome at the European Union level is that of producing a holistic document, taking care not to repeat elements already covered in other rules and regulations. The risk is that of multiplying texts with the same content expressed in different ways, which makes it difficult to apply.
France announced in May that it was adopting the Snomed CT terminology for describing anatomical sites, in preparation for the construction of the EHDS. How does this decision inspire you?
Sharing of clinical information in EU countries is necessary, but not sufficient. You must be able to understand this information. The world of clinical terminologies has so far been a tower of Babel, with different codings that made it impossible to exchange information. The adoption of a standard such as Snomed CT, used internationally and capable of representing more than 350,000 clinical concepts in a unique and detailed way, represents a turning point in being able to exchange understandable clinical information and use it for clinical research.
In the coming months, Italy will use the European Resilience Fund, part of which is dedicated to digital transformation. We hope this will encourage our country’s institutions to align themselves with the Snomed CT standard.
We want to give our hospital customers across Europe the ability to make the best use of health data, for clinical research purposes and in compliance with the GDPR. The global effort to develop the Covid vaccine has shown that data allows a vaccine to be developed very quickly, where it previously took a decade.
The European Health Data Space is an element to accelerate the responsible use of data, useful for clinical research, with the aim of innovation.
I would add that this standard of clinical terminology is also fundamental for activating the patient summary. The grid of information it must contain has already been defined, but there is no single coding to make it easier to understand at European level.
Has the pandemic slowed down the European health data space project or was it, on the contrary, an acceleration lever?
The Covid-19 pandemic has underlined the importance of exchanging citizens’ vaccination data to facilitate travel, and therefore economic recovery. The pandemic, but also the war in Ukraine and the energy crisis have allowed Europe to work in synergy like never before. The dynamics of a Europe of health data are real today.
Sure, maturity levels and expressions of interest vary from state to state, but member countries are getting used to working together.
(1) European Health Data Area.
(2) European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry. Cocir, created in 1959, brings together companies in the healthcare sector around the different aspects of medical technologies. Its main objective is to represent the voice of industry among the institutional actors of the European Union.