By Jaanus Pikani, Chairman, ScanBalt &
Oliver Stenzel, Director of Network Research and Innovation, Novartis
Any views expressed herein are not necessarily the views of CIPL nor Hunton Andrews Kurth LLP
Oliver Stenzel, Director of Network Research and Innovation, Novartis
Any views expressed herein are not necessarily the views of CIPL nor Hunton Andrews Kurth LLP
European data space for health data has been developing for several years. However, so far there has been no clear commitment from the European nation states to shape this process in a structured and coordinated way. The national paradigm of subsidiarity in health care is too strong. As a result, the existing European data space is fragmented and exists mainly limited in extent in some member states with more advanced digital ecosystem or around high level innovative centres of science and research. Several examples of evidence on effective data sharing were provided at an international conference of meta- cluster organisation ScanBalt: 30 promising projects for digital solutions in dealing with the COVID-19 crisis were gathered from 15 different European regions. The examples ranged from cross-border data exchange for patient care, decentralised digital patient monitoring or the creation of new databases for research into COVID-19 therapies.
The majority of these initiatives were supported by private-public cooperation. This is certainly the most important lesson from the COVID-19 crisis: A health crisis of pandemic proportions can only be overcome through collaborative efforts between public (academic) and private (industrial) research. The fact that these new forms of cooperation must be digitally designed is now a matter of course that should not even be worth a marginal note - and yet there is still a lack of meaningful digital linkage across national borders in Europe.
Against the backdrop of the COVID-19 pandemic, European scientific and research regions have taken stock of the digitisation of European health systems and formulated a joint declaration, the ScanBalt Declaration "Towards a European Common Dataspace in Health in the Time of COVID-19", describing the current situation, bottlenecks and possible solutions to create a European health data space. The declaration brings together countries known for their innovative digital health systems as well as regions where the pressure of Coronavirus infections has greatly accelerated existing digital care approaches. Input for the declaration comes from countries such as Estonia, Sweden, Denmark, Norway, Finland, Italy, Spain, the Netherlands, Belgium, Portugal, the UK, Austria, Germany and Poland.
As the "voice of European civil society", the participating cluster organisations support the promising digitisation initiatives of the current EU Council Presidency of the countries Germany, Portugal and Slovenia. (see: https://scanbalt.org/eu-health-data-space/)
All initiatives have in common the high importance of data protection - which is indispensable as a basic prerequisite for all activities, whether in care or in research. Data protection is understood here above all as a right of citizens to their data and to self-determined handling of their data. All European citizens must have access to a complete electronic record of their health data and retain control over it in accordance with the EU General Data Protection Regulation. At the same time, European citizens must be free to decide for themselves on sharing their data with for medical treatment, preventive services, research and product development, or for any other purpose they deem appropriate. It is important that they can be confident that potential partners are authorised and permanently vetted. European regulators thus have a key role in building trust in healthcare institutions. Importantly, the whole thing also only works if the EU agrees on uniform, internationally recognised and tested standards/codes across Europe to ensure interoperability.
To secure this, Europe needs strengthened pan-European institutions. Current promising initiatives from the European Commission include strengthening the European Centre for Disease Prevention and Control (ECDC) to improve its coordination capacity and mandate to respond to the crisis. And at the same time, European policy on the legal situation and legal interpretation in data protection law should be coordinated between the member states on the basis of the EU General Data Protection Regulation in appropriate detail.
But it is not only institutions and health systems that need to be digitised - citizens also need to learn how to handle their health data on their own responsibility. Only informed citizens can make competent decisions about the use and exchange of their sensitive health data. Therefore, we urgently need a Europe-wide support programme to strengthen citizens' digital health literacy.
The majority of these initiatives were supported by private-public cooperation. This is certainly the most important lesson from the COVID-19 crisis: A health crisis of pandemic proportions can only be overcome through collaborative efforts between public (academic) and private (industrial) research. The fact that these new forms of cooperation must be digitally designed is now a matter of course that should not even be worth a marginal note - and yet there is still a lack of meaningful digital linkage across national borders in Europe.
Against the backdrop of the COVID-19 pandemic, European scientific and research regions have taken stock of the digitisation of European health systems and formulated a joint declaration, the ScanBalt Declaration "Towards a European Common Dataspace in Health in the Time of COVID-19", describing the current situation, bottlenecks and possible solutions to create a European health data space. The declaration brings together countries known for their innovative digital health systems as well as regions where the pressure of Coronavirus infections has greatly accelerated existing digital care approaches. Input for the declaration comes from countries such as Estonia, Sweden, Denmark, Norway, Finland, Italy, Spain, the Netherlands, Belgium, Portugal, the UK, Austria, Germany and Poland.
As the "voice of European civil society", the participating cluster organisations support the promising digitisation initiatives of the current EU Council Presidency of the countries Germany, Portugal and Slovenia. (see: https://scanbalt.org/eu-health-data-space/)
All initiatives have in common the high importance of data protection - which is indispensable as a basic prerequisite for all activities, whether in care or in research. Data protection is understood here above all as a right of citizens to their data and to self-determined handling of their data. All European citizens must have access to a complete electronic record of their health data and retain control over it in accordance with the EU General Data Protection Regulation. At the same time, European citizens must be free to decide for themselves on sharing their data with for medical treatment, preventive services, research and product development, or for any other purpose they deem appropriate. It is important that they can be confident that potential partners are authorised and permanently vetted. European regulators thus have a key role in building trust in healthcare institutions. Importantly, the whole thing also only works if the EU agrees on uniform, internationally recognised and tested standards/codes across Europe to ensure interoperability.
To secure this, Europe needs strengthened pan-European institutions. Current promising initiatives from the European Commission include strengthening the European Centre for Disease Prevention and Control (ECDC) to improve its coordination capacity and mandate to respond to the crisis. And at the same time, European policy on the legal situation and legal interpretation in data protection law should be coordinated between the member states on the basis of the EU General Data Protection Regulation in appropriate detail.
But it is not only institutions and health systems that need to be digitised - citizens also need to learn how to handle their health data on their own responsibility. Only informed citizens can make competent decisions about the use and exchange of their sensitive health data. Therefore, we urgently need a Europe-wide support programme to strengthen citizens' digital health literacy.
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