The European Health Data Space will not work without trust from healthcare communities, warn officials and patient associations

DIGITALEUROPE’s Executive Council for Health held a roundtable on 23 November, discussing our new report on building trust for the European Health Data Space (EHDS). The event brought together health, technology, pharmaceutical and medical technology companies, with officials from the European Commission, French government, European Patients’ Forum (EPF) and the European Cancer Patient Coalition (ECPC).

Kicking-off the discussion, Francesco Buonarroti, Chair of the Executive Council for Health and Vice-President at Johnson & Johnson, summed up the key takeaway of the roundtable and report: “Trust is mission-critical, and innovation is part-and-parcel to that mission. Data helps the global healthcare community to unlock insights that ultimately save lives. For instance, international collaboration and data sharing made it possible to understand the COVID-19 pandemic and develop vaccines and treatments in record time.”

Throughout, we heard a common ambition to create a patient-centric health data environment in Europe, coinciding with a sense of urgency to get it right from the start, making sure we solve privacy and security issues more timely.

The members of DIGITALEUROPE’s Executive Council for Health

Key takeaways

During the roundtable, we discussed the EHDS, whose proposal is set to be announced by the Commission at the beginning of 2022. The EHDS will enable the primary use of health data (for healthcare delivery) and secondary use of data (for research, policymaking and regulating).

DIGITALEUROPE’s Director General Cecilia Bonefeld-Dahl emphasised the need to set targets, so that we know exactly what we are trying to achieve. She then went on to point out the measures needed to build trust in this system: “If we don’t have some form of interoperable easy-to-use eID services, how can we verify and authenticate who are those wanting to share or use health data? Member States should have an ‘opt-out’ system in place for secondary use of health data.”

The message is clear: we need to reduce barriers for patients, healthcare workers, researchers, and innovators to improve healthcare together. Several of our guest officials chimed in to share their views:

Pierre Delsaux, Deputy Director General of the European Commission’s DG SANTE, said: “Why should we not be able to reach the target of all Europeans having access to their health records online by 2030? Look at the digital COVID-19 certificate. It is a success, despite all the difficulties – and if you look at the number of citizens using the certificate, and how many have accepted its principle, I believe it makes a difference.”
Isabelle Zablit-Schmitz, eHealth Europe & International Director at the French ministerial delegation for health data, followed up, reminding us that “while health is a national matter – it is important to bear this in mind – we also acknowledge that the pandemic has stressed the value of European coordination and ambition. Indeed, we need to go beyond that, because we need this level of ambition, which ultimately translates to increased European sovereignty. We need smart solutions for the consent process.”
Antonella Cardone, Director of the ECPC called for evidence-based healthcare systems: “We believe that only what is measured gets done. Efficiency must be continuously measured, according to the achievement of pre-defined health outcomes. To this end, policymakers must urgently invest in, and implement, policy frameworks that harness the full potential of data for the benefit of all the people with cancer.”
Dimitrios Athanasiou, Board Member of the EPF, called for more patient awareness: “To develop trust, it is important to empower patients by making it clear that health data is one’s own property, and that one has to do something about it. We should also move beyond the altruism model – this does not work anymore. Now, patients and the civil society want something back for their data. We need to clearly outline the benefits, but also the obligations coming from sharing data.”

Deep dive: Demonstrating benefits, ensuring privacy

The in-depth section of the roundtable began with an exchange on our first 2 pillars for trust: demonstrating the benefits of the EHDS for all health communities and ensuring the protection and security of our data.

We can transform our understanding of diseases: “Patients are increasingly using wireless wearable devices and apps on their mobile phones to check their health status. Examples are monitoring of blood pressure and heart rate, as well as early detection of progression of neurological diseases such as multiple sclerosis. The use of health data has the potential to make health systems more efficient and sustainable, by transforming our understanding of disease, diagnosis, and treatment, and enabling physicians to make more timely, confident decisions.” Padraic Ward (Roche)
We are technology-ready but must collaborate on security: “We need to address cyber risks collaboratively. They often start at a local level and spread to regional then national level. We should build cyber resilience form the ground up, identifying cyber risks, and standardise assurance. Without this, we cannot ensure trust for a large-scale common health data space. Governments and companies, and health providers should collaborate in rolling out upgrades in Europe to ensure high security standards.” Elena Bonfiglioli (Microsoft)
Data collection and curation starts bottom-up: “Interoperable Electronic Health Records are part and parcel of a better health system. We need a mechanism to be put in place where citizens and patients contribute data to improve care and treatment they receive from physicians, to overcome health inequalities such as with rare diseases, remote locations, or adverse circumstances, but also to provide data to support the development of AI-based technologies to make medicine more precise and healthcare system more efficient, and to enable physicians devote more time to patients.” Bernd Ohnesorge (Siemens-Healthineers)
We should look at health from a holistic perspective: “Health care cannot be a one-size-fits-all approach. By offering multiple ways to meet people in their homes – using data and technology that enhance their care – we can operate more efficiently and deliver more personalised care when and where patients need it most.” Padraig Monaghan (UnitedHealth Group)

Deep dive: Leveraging existing successes and rolling-out eHealth services

The latter part of the roundtable was focused on our second 2 pillars for trust: how we can leverage existing successes and roll out patient-centric services across Europe.

Industry-led standards are the key: “To make the EU a globally competitive territory that attracts investments and retains talents especially in innovative MedTech and life sciences, reliable access for public and private research to robust, standardised and interoperable data is crucial. Industry-led, consensus-based standards are often most effective in addressing interoperability challenges. They are key to the future of health interoperability.” Jeanne Kehren (Bayer)
National data spaces show early successes: “ResMed has recently supported a study in France that analysed anonymised data of 480,000 sleep apnoea patients treated with CPAP from the French insurance claims database (SNDS). The study found that patients who continued therapy long term (at least one year) were 39% more likely to survive, compared to patients who discontinued therapy. Other research has shown that adherence may be significantly improved with remote monitoring.” Katrin Pucknat (ResMed)
Fast progress is possible: “We provide examples in our report, for instance where a collaboration of health, cloud tech, and academia allowed clinical research centres around the globe to securely analyse COVID-19 genome sequences for variants of concern under 4 hours, which brings policy decision making to near real-time speed.” Miguel Coelho (Oracle)
We need collaboration between public and private sectors: “Making clear the complexities of the technology to the people is key for adoption; there is a joint ownership there between the public side, which owns the data, and the private side, which can provide the services.” Nicolas Monsarrat (Accenture)

DIGITALEUROPE’s report “A digital health decade: from ambition to action” is the first of a series of papers focusing on the digital transformation of our healthcare systems. The second one will be launched in March, focusing on the potential for digital health innovations in Europe.

In the meantime, join us at Masters of Digital on 3 February 2022 to hear more from our Executive Council for Health.