Although the Big Data revolution is only in its early days, the potential for value creation is huge in the healthcare sector. Not only can clinical data help us to understand diseases and develop therapies; it can also drive the transition towards modern health systems, focused on health outcomes for patients.
Real world evidence, i.e. patient healthcare data, collected routinely outside of controlled environments (such as clinical trials), has the potential to make healthcare systems more efficient and quality-driven; with such data, we would be able to assess what treatments are most effective for particular conditions, create new clinical hypotheses, or even compare healthcare services. Most of this data is pooled in patient registries and databases, which are the only way to achieve a sufficient sample size for research.
The power of Big Data to improve care is enormous, as long as that data can be analysed and shared, and the cost to collect the data is low. The General Data Protection Regulation, as it currently stands, may create significant uncertainty with regards to the potential use of real world patient data and patient registries.
The European Parliament’s report does not allow for broad consent, nor do the Council and Parliament provide for a harmonised exemption that would cover these information systems. The Regulation should recognise the value of broad consent as a means of making data available for re-use, so that the massive amount of data already collected in patient registries will not be lost for innovation…
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