Red heart made out of binary digits.Photo by Alexander Sinn on Unsplash

Using data for better health

Ioana Gligor, from the European Commission, discusses the new European Health Data Space proposal with the Sciana Network

The new European Health Data Space will support the use of data for "better health care, better research, and better policymaking," according to Ioana Gligor.

Gligor, responsible for digital health and European Reference Networks at the European Commission, spoke in a recent online program for the Sciana Network titled, "European Data Governance: Delivering a modern social contract in health."

This program's purpose was to introduce the Network to some of the latest European data governance developments and explore ways Europe is advancing legislation on data for health care, research, policymaking, digital health services and artificial intelligence (AI).

Creating a European Data Space that includes the health sector is one of the European Commission's 2019-2025 priorities. Three pillars support the work towards the European Health Data Space: a robust data governance system and rules for data exchange, aspects related to data quality and interoperability, and strong infrastructure and capacity building. Gligor told the Sciana Network people would also have more substantial control of their health data due to this new system.

The Commission and member states have already developed several infrastructures which support the sharing of health data. This infrastructure includes MyHealth @ EU, which enables patient data exchange when people travel abroad, providing health care professionals access to this data in their language. Gligor said the Commission is also supporting digital infrastructures that allow for data in research and policymaking.

By the end of 2021, Gligor said the Commission hopes to have 15 member states where patients can share their data with health care providers when travelling abroad (currently, seven member states share this kind of health data). However, she warned that the COVID-19 pandemic and the discussion on digital green certificates had shown a need to go further. She said, "We need to go to how the citizens actually can control the access to their data and how they can use it whenever it's needed."

Altruistic data donations

Last year, Sciana Member Tobias Gantner responded to the COVID-19 outbreak by launching Faster than Corona, a data donation platform to track previously unknown medical correlations. Users fill out a questionnaire and provide basic data, such as sex, age, previous health conditions, and email. They are then regularly prompted to donate their data to help Gantner and his team identify trends to help stop the pandemic from spreading. Gantner asked Gligor for her thoughts on people giving away their data for free and who should have access to this information.

Gligor began her answer by explaining the Data Governance Act, which provides rules for data altruism. The European Health Data Space legal proposal will take this further and specify it for the health sector.
Work is ongoing in preparing the legislative proposal. For instance, a series of workshops and consultations have been organized to look at the framework for the primary and secondary use of health data in member states. Lessons have also been learned from data permit authorities set up in Finland, France, Germany and their access level.

There is broad access to data provided by these bodies, and Gligor said this is something the Commission would look into in the legislation and digital infrastructure. The aim would be to support access to data in several countries and allow cross-country studies. The Commission would start by looking toward the public health authorities, the EMA, and ECDC. Nevertheless, this still has to be designed and defined with the member states and relevant authorities.

Gligor said the argument supporting the development of data altruism is a "very important one" and is something the Commission wants to clarify and build on in the Data Governance Act for the health sector. She said, "Data altruism indeed will be an important element for the European Health Data Space legal proposal."

Reflecting on Faster than Corona's beginnings, Ganter said people working in the data protection field said they couldn't do their work. However, as the second and third waves came, "the voices became more and more silent." To date, Faster than Corona has had about 20,000 active data donators from 81 countries. He'd like to explore the legal framework further and the discussion surrounding implementing data trustees.

Four key challenges

Sciana Member Annabel Seebohm, secretary-general of the Standing Committee of European Doctors, believes the European Health Data Space has "huge potential" to improve disease prevention, patient-oriented health care, and better treatment options. But the system requires trust that the data will be secured and handled correctly.

Seebohm identified four key challenges facing the European Health Data Space. The first challenge concerns identifying its purpose. While the Space's creation claims to be in the public interest, Seebohm said this was a "very volatile term" that is up for interpretation.
 
She said, "To give you an example, it is in the public interest to respond to unmet medical needs, as we wish to end suffering. Now, the term 'unmet medical need' is often or currently used to justify pharma innovation in profitable areas that are not necessarily neglected or unmet, while AMR or dementia remains largely unaddressed. So here you see an example for innovation in the public interest, which in fact, is not in the public interest but the industry's interest."

Seebohm called for collaborative leadership among patients, professionals, providers, academia, business, and governments to agree on the premise in which they work. This links to the second key challenge, which involves clarifying legitimate users and contributors to such a space.

The third key challenge, according to Seebohm, is knowing what data will be included. Data has to be of high quality, interoperable, and relevant. Care has to been taken to ensure that the data does not discriminate and that anonymization remains an essential tool.

Seebohm said, "[The fourth] key challenge is the governance of such a space. We need to have an independent authority with overarching control of the generated data sets, where I think independent experts from each member states should be represented. But, of course, such authority also must be subject to supervision again." A code of conduct should govern the space, added Seebohm, applicable to any public or private entity.

In response, Gligor said a fundamental aspect of the European Health Data Space was to allow patients access to their data and move it between health care providers. There is no plan for a digital cloud or for data to be stored in Brussels. Instead, a framework will be created to enable access at a national level.

Gligor said it is important to learn from countries that have found a compromise between simplifying the administrative burden while maintaining the data's secure storage and protection. "If we lose the achievements of the GDPR in terms of protection, protection of the data, [and] protection of the data subject, we are losing everything," she said. The priority is to build a trusted framework for access to health.

Following Gligor, Gantner, and Seebohm's remarks, Sciana Members broke out into smaller working groups to reflect on what they had heard and the broader topic of data governance in their countries.

By:Sciana
array ( 'tx_ttnews' => array ( 'tt_news' => '2299', ), )