BRUSSELS, 27 April (APM) - Serious deficiencies in the EU's health data framework are jeopardising the exploitation of digital health opportunities, the European Commission admitted at the same time as it launched its new e-health strategy on Wednesday.
"There is no secure, commonly accepted infrastructure at EU level to enable federated access to health data that can support personalised medicine across the EU," according to a background document released alongside the Commission's recommendations for "enabling the digital transformation of health and care".
Making better use of health data
The new strategy is a central component in a series of measures proposed to make better use of data in the EU and to develop the EU's digital single market.
European health commissioner Vytenis Andriukaitis told media in Brussels that he saw digital technologies as key contributors to improving healthcare and medical research.
He said they could drive a health policy reform package that would bring changes in training, organisational structures, financing and incentives.
But a working document detailing the planned measures noted a long list of conditions that still had to be met to make progress possible.
It highlighted "a high level of uncertainty around the quality of capturing and processing of health data."
It cited the "lack of interoperability between data sources, and limitations in data storage and computing capacity."
And it said the different legal regimes at national level for accessing and processing health and health-related data across the EU "remain the major obstacles".
Big data needs big computers
The computer power required - petabytes or even exabytes of data storage, and performance to match - is just not available in the EU for analysing and storing genomes at scale rapidly, says the paper.
Much more is needed to cope when genome data is combined with other applications such as transcriptomics and metabolomics, with other technologies such as imaging and patient monitoring, and with clinical, personal and environmental data.
Knowledge gained from data at a population level is needed to be able to sort through the ‘noise’ of variation in a person’s genome to identify the ‘signal’ of a pattern unique to an individual, the paper points out.
Current EU efforts are not on a scale that can handle the cross-sectional cohort studies of 30,000 to 50,000 cases required to separate the signal from noise and to detect genomic regions associated with a given trait in which disease-related genes or susceptibility factors are located, the paper states.
This is the case with "even some of the largest national programmes to aggregate -omics data, such as the UK government-funded 100,000 genomes project, or France’s Médecine Génomique 2025, which will establish capabilities for sequencing over 200,000 genomes a year."
If it is to become possible to diagnose earlier and to select therapeutic strategies more accurately, more collaboration is needed "to build a whole new framework focused more on big data", able to understand the molecular interactions and to support diagnostic image processing and running of predictive models.
Getting data regulation right
In addition, the background document says, "there is no established digital infrastructure to support cross-border access to relevant health data for research", and "the lack of a European digital infrastructure leads to a high level of fragmentation" of data bases and patient registries.
And "despite technological advances in big data mining and analytics, there are a number of issues that prevent the wider use of real world data".
These include meeting the methodological and legal challenges in generating, collecting, storing and exploiting data, particularly in the further processing of data, because "there is no widely accepted regulatory guidance."
Fears are growing that national implementation of the General Data Protection Regulation - which comes into force in May - will undermine the objective of the free flow of personal data in the EU.
Possible national laws to put into effect the new regulation must be carefully framed. Otherwise, "major barriers could be created for achieving the required critical mass of data to succeed in providing personalised medicine solutions for European health systems and citizens".