Data driven healthcare: Europe to change gear
For years, the European Commission has worked patiently together with interoperability experts from various countries towards technically and semantically standardising eHealth applications. These efforts were partly successful: the two standards for electronic prescriptions and for electronic patient summaries are somewhat accepted Europe-wide as templates for cross-border data exchange scenarios. The work on the European level has also contributed to the growing acceptance of international healthcare IT standards in the various EU Member. But despite these successes, on a national level, the tangible results of the European efforts – the electronic prescription and patient summary data sets – still only play a minor role in most European countries. And even with the cross-border scenarios, implementation on the level of the Member States is painfully slow.
The biggest success so far of “eHealth made in Brussels” is not individual standards, but the creation of the eHealth Network in 2011, an informal Europe-wide stakeholder group that has proven sufficiently attractive to survive for seven years now. It brings together representatives of the national Ministries of Health every six months to discuss issues related to healthcare digitisation. These network meetings have become an important window for many European health policy makers to learn about what is happening in other countries. This should not be underestimated in a discipline that is still highly local and heavily regulated on a national level.
A paradigm shift in European eHealth policy
The eHealth Network goes back to the EU Directive 2011/24 on Patients’ Rights in Cross-Border Healthcare. This, again, illustrates how closely linked the EU eHealth efforts have been to cross-border scenarios so far. But this is about to change. In April, the European Commission has issued a new eHealth Communication that can justifiably be called a paradigm shift. This “Communication on enabling the digital transformation of health and care in the Digital Single Market” still hasn’t received the attention it deserves. Its main driving force was Roberto Viola, Director General for Communications Networks, Content and Technology (DG CONNECT): “We are really trying to set a new environment. The new goal for Europe is a data-driven healthcare system. This is a completely different vision from what we were talking about in the past.”
Most of all, the vision is much broader than in the past. Interoperability remains important, but it is only one aspect, one out of three main pillars, and it is looked at not so much from a technology perspective but from a data perspective: “If we want to have a data-driven healthcare system, we need to have the medical records of the patients accessible to varying degrees,” explained Viola in an interview with Insights. “This is why we are very serious about going to the next step in interoperability which is the European Health Record Recommendation.”
The European Health Record Recommendation: eID, MPEG-G, and blockchain
This recommendation, that is currently being prepared, will probably be published by the European Commission late this year or early 2019. Talking to Insights at the EU Digital Assembly 2018 in Sofia, Bulgaria, Viola gave some ideas about the direction in which the Commission is thinking – all very preliminary and not yet decided on. An important component of the recommendation will very likely be to connect electronic health records (EHRs) in one way or the other to the national electronic identities (eID). With the European eIDAS Regulation finally coming into effect on 29 September 2018, national eIDs of EU Member States will become readable all over Europe. This makes the eID or some ID that is derived from it an excellent candidate to harmonise EHR access across Europe.
The European Health Record Recommendation will also talk about content-related standards for documents, images, complex datasets, and multimedia recordings. Viola admitted that there will be discussions around these standards, but he also said that the Commission is not planning to reinvent anything that already exists. Interestingly, the Commission is not only talking about the “usual suspects” among standards, but also about new standards that will be needed for data-driven healthcare, most notably a standard for “mobile” genome data. A good candidate, according to Viola, is the MPEG-G standard, a genomic information representation that is currently being developed by the Moving Picture Experts Group (MPEG). MPEG-G aims to bring the terabyte datasets of whole-genome sequencing down to a few gigabytes. This would allow to them to be stored on a smartphone.
A risk worth taking
The third component of the European Health Record Recommendation could well become blockchain, said Viola, but again nothing of this is decided yet. Discussions within the eHealth Network mentioned earlier are ongoing. Blockchain doesn’t come out of the blue though. Estonia is making good progress with its “blockchained” EHR access files. The European Commission’s attraction to blockchain in the context of EHRs also stems from a successful project called My Health My Data that is being funded within the Horizon 2020 funding initiative.
Beyond healthcare, too, blockchain is on the rise in Europe. On 25 April, 25 EU Member States, including the heavy-weights, have signed an agreement to work together on a public blockchain. “This topic is clearly on our radar,” said Viola. “It will probably not be part of the first release of the recommendations. But the recommendations will be a process anyway.” For the Commission, the European Health Record Recommendations are the “project of projects”. Viola is very aware that it is a risky and complex project: “We will have to slice the complexity. But if we are successful, we will be the most advanced continent in healthcare. There is nothing like this in the US.”
Beyond the records: Supercomputing and genome power for precision medicine
The European Health Record Recommendation is chiefly about opening a way for the patients to make their healthcare data available. The second pillar of the European Commission’s vision of data-driven healthcare is providing the technology that is necessary to extract value out of these data. “The ultimate dream is that every family doctor will be able to access artificial intelligences and super-computing as a service at his desktop, very much like he accesses cloud services like email or electronic prescriptions today,” said Viola. In a scenario like that, treatments could be customised to the individual patient, taking into account, among others, the MPEG-G-compressed genome data on the patient’s smartphone, using cloud-based AI tools that have access to huge patient-databases and the necessary super-computing capacities to make all relevant calculations on-site.
Now this is some way to go, obviously. But the first steps have been taken. In April, 13 EU Member States – Czech Republic, Cyprus, Estonia, Finland, Italy, Lithuania, Luxembourg, Malta, Portugal, Slovenia, Spain, Sweden and the UK – have signed an agreement in which they declare to collaborate on the secure and authorised access to national and regional banks of genetic data and other data relevant for health. Bulgaria, Croatia and Greece have announced to join the agreement.
“The ultimate dream is that every family doctor will be able to access artificial intelligences and super-computing as a service at his desktop.”
And there is another recent agreement that could become highly relevant for the data-driven future of healthcare in Europe. On 25 June, in the context of the Digital Assembly 2018 in Sofia, the European Council has agreed to establish a new European joint undertaking, the European High-Performance-Computing Joint Undertaking (EuroHPC), the headquarters of which will be located in Luxembourg. In essence, the EuroHPC is about pooling super-computing resources in Europe. About €1bn of public money will be invested by 2020, half of which will be provided by the EU, the other half by the Member States.
For its financial commitment, the EU, according to Viola, will have the right to allocate 50% of the total HPC-capacities to a science cloud that will be made available to the European research community. Part of this science cloud will be a medical cloud that would make the kind of AI-assisted genome data computations and 3D-imaging- and biomarker-based organ and therapy simulations possible that are widely expected to become a cornerstone of future medical research and (possibly) routine medical care. All this, and here comes the third and final pillar of the European vision for data-driven healthcare, should not be some state-controlled enterprise, but rather an ecosystem that is open for private entrepreneurs who provide the tools that create value out the vast technological and data resources.