The bold vision and promise of the European Health Data Space

How the convening and curating of health data within a clear governance and access framework can bring better health futures for all

The European Union ( EU) is working on the creation of a European Health Data Space (EHDS) to advance the exchange of health data – both to enhance diagnosis and treatment, and to accelerate research and development – across Europe, while ensuring privacy over that data. A robust and secure EHDS is long overdue.

Consider the vision in Sophie’s story and the impact such a data space would have on her health over the next 30 years.

Sophie just turned seven. She loves math, playing football, riding horses and is fluent in four languages. She arrives at her doctor for a regular checkup. Before the appointment, her doctor reviewed her heart rate, blood pressure, height, weight and sleep efficiency stats for the past months, thanks to wearable technology, a secure electronic health record and a virtual pre-consultation with Sophie’s dad, who works at a local bank. A traveling nurse came by the family’s home the day before the appointment to draw a blood sample. The doctor notes a history of diabetes on her father’s side and orders diagnostic tests. Sophie is healthy, but this will be something to watch in years ahead. Similarly, there’s a history of cancer on her mother’s side.

“No need to worry,” the doctor tells her parents. “Thanks to personalised medicine and genomic data, we can diagnose disease earlier these days than in the past.” He explains that because we share a significant pool of secure data on diseases like these from across the EU, we know more about them than ever, and can often prevent disease before it happens.

Fast forward 30 years. Sophie is the VP of a multinational bank. She has two children and still rides and competes recreationally in stadium jumping. Thanks to regular testing, her doctor noticed small changes in Sophie’s insulin levels just before her 14th birthday. Through innovations in personalised healthcare and monitoring, doctors were able to prevent her from developing diabetes. Sophie’s mom was diagnosed and treated for breast cancer when Sophie turned 18. With early diagnosis, a secure and robust EU data system, and precision therapies based on genomic insights, her mom is cancer-free and now a grandmother. Sophie has yearly tests to detect even the smallest changes at a genomic level.

In Research & Development of medicines for rare diseases, the constraint is often securing enough participants for clinical trials due to the small size of the patient population. Across the scale of Europe’s 450 million people, the pooling of participating patients is an enabler of efficiency in clinical trials for rare diseases. The scale is an enabler.

Likewise with healthcare data, the greater the scale, and the more standardised and interoperable its structure, the more it can power medical research. The scale helps uncover patterns, which throw up clues on how to address disease, and accelerates medical knowledge. Data at scale has also profound potential for health systems in promoting full case visibility, reducing burden, and rework. It also can support patients in joining the dots across the health system, from diagnosis to post treatment care, lowering frictions in their experience of traversing the system, but also in fostering productive attention to our own healthcare.

The challenge is to draw the data out of today’s fragmented, siloed landscape into a cohesive, effective architecture, with robust, multistakeholder governance. Some of the data is in registries of individual conditions, or in the electronic health records of patients across public or private general practice. Academia, teaching hospitals and companies also hold data on clinical trials that they have sponsored. Many of us also generate health data daily on smart phones and fitness trackers. So while the challenge of pooling health data in a meaningful way - such that it yields actionable insights and new innovative approaches - is significant, the vision of the EHDS is already a step forward, and holds great promise for future patient outcomes.

The EHDS plans to support primary care as well as the development of new treatments, medicines, medical devices and services. At Roche, we share and support this mission. We see its potential to improve patient care and access for all, and lower costs to society.

Doctors today are a little like pilots flying without the benefit of an effective radar. Their ability to provide the holistic, joined up benefit to the patient is compromised. For the patient outcome, the more data that exists about their condition, and about other people with the same condition, (i.e. presenting with comparable symptoms or with the same genetic alteration underlying their disease), the better. That data shows patterns and provides insights about treatments and the path forward, and it increases the likelihood that the decisions made on their disease management pathway will be the right ones. Europe has the scale to actually derive these insights and help the value of personalized healthcare become an embedded reality.

Personalised healthcare has the potential to revolutionise patient care in the next few decades. To a great degree, it already has. But to fully leverage what’s increasingly possible a truly data-enabled healthcare system needs a robust, unified, and secure data space. The needed data is already out there and companies like Roche already share a lot of data. But to effectively harness the available data sets, the public and private sector need to seize the opportunity to work together to create and successfully implement the EHDS.

And the promised, transformative benefits to health systems are enormous. The EHDS would give European countries many opportunities to advance health care. A large, secure data set makes precision, evidence-based, personalised care a reality. This will also allow the EU to remain at the forefront of innovation, attracting the brightest minds and staying competitive as the world rapidly evolves towards more data-driven ecosystems and digital economies. It is a chance to act collectively to protect and improve health and wellbeing, while ultimately lowering costs to society.

The pandemic revealed how disconnected the EU member states are from one another when it comes to healthcare. The limitations of the current system became clear. Only about half of the countries in Europe have a national electronic health record, and in many cases the fundamentals of modern, robust data infrastructure are still missing.

During the first months of the COVID-19 crisis, for instance, the use of fax machines to report and count national cases was common. That created a lag in reporting, because total case numbers were updated in batches, rather than instantly. In Italy, an EU country hit hard by the first wave of the pandemic, data sharing among hospitals and provinces could have helped hospitals and governments identify and track the rapid spread of the disease earlier.

In the early months of the COVID-19 pandemic, there was a strong belief that some existing medicines could help to reduce the symptoms of the disease. What was needed, however, was data about the effectiveness of those drugs and how patients responded to them. In Europe, 18 pharmaceutical companies had such data, which they wanted to contribute to help the response to the global crisis.

“It took three months for all of the agreements and processes to be in place to allow the data to flow,” says Padraic Ward, Head of Pharma International at Roche. “You might say that three months doesn't sound like a lot for 18 companies to come together with governments and health systems to share data. But at the beginning of the pandemic, when we didn't have vaccines and we didn't really know what the disease was, many people became very ill and many died in three months. The delay was a good illustration of why we need to have the public and the private sector working together on data sharing.”

Our global response to the pandemic was completely stifled by questions of sharing of data – the availability of it, whether it's good quality, and even testing and diagnosis. Governments cannot ignore this gap anymore.

The pandemic experience is validation of the European Commission’s plans to set up the EHDS, to be put in place by 2025. The EHDS will comprise a set of standards and regulations that will enable researchers, physicians and innovators such as pharmaceutical companies to access and share data more quickly and effectively. Patients, too, will be given confidence that they can share their health data safely.

The EHDS proposal by the EU Commission would promote health data exchange across Europe for better healthcare, better policy making, and better research and innovation. There would be clear governance, rules, and quality standards while ensuring strict protection of the privacy of citizens.

The EHDS can be a powerful enabler of benefits for patients, public authorities and researchers, public or private. Our vision is the adoption of a final regulation that is fit-for-purpose (taking into account the variety of health data sources and digital / data- sharing infrastructures and practices across the European Union), future-fit (adaptable to the incredibly fast pace of digital technologies and emerging health data types) and workable (avoiding red tape, safeguarding clinical data and aligning with existing and future legislations).

What role should industry play in this data ecosystem and its governance? At Roche, we’re keenly aware of our responsibility as an industry partner to contribute in a meaningful way to this once-in-a-generation opportunity. Only through a multistakeholder governance model can we tackle the fragmentation of data head-on and hope to achieve the ultimate goal of helping people live longer, healthier lives. From practitioners to patients, good data governance holds the key to unlocking better healthcare outcomes. At Roche we support:

  • An ecosystem approach; data shared for broad patient benefit across the care continuum

  • Access to and insight from health data to enable personalised healthcare and improved outcomes across the EU

  • Strict rules ensure data is secure, individual rights to privacy are protected

  • Equal and consistent rules across private and public sectors, and academia

  • Broad, inclusive rules and governance, across public and private sectors, to improve interoperability, define quality data standards and ensure transparency

  • Sustainable growth, more patient benefits and less cost to society

The opportunities to power innovation and improve patient health through data are profound. The EHDS represents a once-in-a-generation opportunity to transform healthcare and – with health systems around the world under increasing pressure from rising demand, ageing populations and the aftershocks of COVID-19 – it’s an opportunity we cannot afford to miss.

If the EHDS is successful, Europe will see better patient outcomes, more diseases prevented and a much stronger life sciences industry and research sector. Robust health data ecosystems hold the potential to deliver more sustainable healthcare.

We must all embrace the challenge and act now to ensure clear and inclusive governance is in place and that EU Member States have the infrastructure and confidence needed to adopt and implement EHDS consistently across borders. “If we can get the terms of governance and access right” says Ward, “it’s going to be great for patients, it is going to be great for healthcare systems. We are talking about a total game-changer”.


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