#EAPM: Commission steps up health-care data strategy

The European Commission has in recent weeks published a Communication that focuses on digital issues and challenges in Europe and its own response to them,

Entitled ‘Mid-Term Review on the implementation of the Digital Single Market Strategy, A Connected Digital Single Market for All’, the Commission states that it will “adopt a Communication in 2017 addressing the need and scope for further measures in the area of digital health and care, in line with legislation on the protection of personal data, patient rights and electronic identification”.

A key section, in the view of the Brussels-based European Alliance for Personalised Medicine (EAPM) and its multi-stakeholders, names one priority as follows: “Supporting data infrastructure, to advance research, disease prevention and personalised health and care in key areas including rare, infectious and complex diseases.”

EAPM is, of course, delighted that the EU executive has highlighted personalised medicine in this way, as the areas it mentions are among the core goals that the Alliance has been working to achieve since its formation in the spring of 2012.

The Communication also refers to recent regulations on medical devices which “will become progressively applicable over the next five years”.

The regulations, the Commission says, “foresee the establishment of a new comprehensive EU-wide database on medical devices, whose big data deployment will serve the development of innovative digital diagnostic and therapeutic solutions and the early detection of safety issues”.

This database will be known as ‘Eudamed'.

Another key element of the Communication refers to “facilitating feedback and interaction between patients and healthcare providers, to support prevention and citizen empowerment as well as quality and patient-centred care, focusing on chronic diseases and on a better understanding of the outcomes of healthcare systems”.

Again, EAPM believes that the European Commission should be congratulated on such stated goals.

Indeed, the December 2015 landmark Luxembourg Council Conclusions on access for patients to personalised medicine broadly raised many of these points and was the culmination of intense work and a high-level conference on the subject (in which EAPM played a major role).

The publication of the Commission Communication coincides well with the fact that it is currently eHealth week under the Maltese Presidency. Its overarching theme is Data for Health: the key to personalised sustainable care.

Malta has stated: “Data lies at the heart of service delivery and the development of effective health policy. During eHealth Week, speakers and delegates will explore the changing ways in which personal health data is created, stored, shared and used.”

Also this week, EAPM and colleagues were engaging with the European Parliament on the vital issue of the use of Big Data in medicine, which backed up an Alliance letter signed by cross-party MEPs and sent to European Commissioners Andrus Ansip (Digital Single Market) and Vytenis Andriukaitis (Health and Food Safety).

This calls for a Data Task Force to develop further the Commission’s digital strategy in health, as well as a one-million-genomes initiative for Europe.

It dovetails into a number of initiatives under the title of 'Big Data for Better Outcomes' being run by the Innovative Medicines Initiative (IMI).

At the heart of genetics-based personalised medicine – aimed at giving the right treatment to the right patient at the right time – lies the collection, storage, use and sharing of data. There is now so much of it that it is termed Big Data and, while it is vital in pushing back the boundaries of medical research, there have been - and still are - many barriers to its optimum and ethical use.

Current research infrastructure remains too compartmentalized, which adds cost and slows down the speed of new discoveries. This can partly, but not wholly, be blamed on proprietary technology but there is also a clear need for greater interoperability, within and between member states. The Commission can be hugely influential in this regard.

To make the most of all this massive amount of valuable information flowing into super computers and biobanks there needs to be a shared vocabulary and data-set standards, with agreed universal protocols for sending, receiving, and querying the information.

Meanwhile, data storage formats need to be interoperable although, granted, this may prove difficult in a competitive environment such as commercially based pharmaceutical research.

All of this information needs to be interpreted properly too, not least by clinicians working on the front line (continuous education of healthcare professionals is, of course, another huge issue that EAPM is working on).

In essence, there is clearly a need to build a health data ecosystem, as shown by mounting evidence that better use of data leads to greater efficiency (and thus lower costs) within member state health systems.

Most stakeholders will benefit from this and it is likely to bring about more investment, greater competition within industry, less duplication of research across Europe, better decision making and, crucially, a better ability to treat the needs of individual patients.

Barriers of course remain and Europe clearly needs more funding for health infrastructure, such as IMI pilot projects and European Reference Centres, while there also needs to be more trust, co-ordination and collaboration in the rapidly expanding area of Big Data.

The Commission’s work is to be congratulated, as previously stated, and it is now time for other stakeholders, such as patients, industry and researchers, to step up to the plate in a strong coalition to move these vital matters along swiftly.