Data Science

Leveraging the European Health Data Space White Paper

The impact of the European Health Data Space on healthcare users

HIMSS and PCHA submitted a joint response to the European Commission’s Public Consultation on the European Health Data Space (EHDS) which welcomes the concept of the EHDS and its potential to become a core tool to allow all partners in healthcare to collaborate and build more sustainable and resilient healthcare systems for all.

We believe digital health connects and empowers people and populations to manage health and wellness, augmented by accessible and supportive provider teams working within flexible, integrated, interoperable and digitally enabled care environments that strategically leverage digital tools, technologies and services to transform care delivery.

This paper supplements the response questionnaire HIMSS and PCHA submitted jointly to the European Commission public consultations, focusing on the potential of a EHDS as well as on the special demands of AI in high-risk healthcare solutions. We seek to provide supportive input to the European institutions as they continue to drive the adoption of digital health tools in Europe.

An EHDS would require that data is available, accessible and portable, and that the data space has a robust governance framework to build trust in the quality of the data and the appropriateness of their use.

Data Availability

A workable EHDS demands that data is both available and accessible. The two concepts are closely linked and address the generation of data as well as the capacity to use it. One concept discussed in previous consultations to address the generation of data to be made accessible through the EHDS is a mechanism to support data altruism. This demands both a system for allowing data controllers to provide access to data for secondary research, as well as educational tools to build trust and confidence of data subjects (patients) in such a system.

Data Accessibility

Currently, most patient data are stored across various healthcare providers (hospitals, health professionals, imaging clinics or labs) in disparate systems that are not interoperable. This is the case not only at national or regional level, but also locally, meaning that in many cases data cannot be shared easily even between departments of the same hospital or with associated physicians’ offices. This results in difficulties for practitioners to exchange information and medical decisions not benefitting from longitudinal view of the patient.

Data Portability

HIMSS and PCHA emphasise the importance of the European data strategy’s empowerment of individuals with respect to the use of their data. We also ask the EU to support initiatives to ensure that the right to portability of data, as provided for in Article 20 GDPR, is truly exercisable by patients. Only when patients can make their data fully accessible to healthcare providers of their choice can they actively be involved in directing their own healthcare. However, this demands that data are interoperable and that patients can truly benefit from access to healthcare within and across EU borders. In addition to making data portable, another critical issue is ensuring that an individual’s contribution of data generated by personal devices or submitted directly by a patient can be more easily integrated with data in healthcare systems, such as electronic health records.