MEP Sean Kelly, who serves as the European Parliament´s industry committee rapporteur for the general data protection regulation, was speaking in Brussels at the 2013 ´Transnational Summit on Trustworthy Use of Data for Health´.
The two-day conference on 3 and 4 June attracted European healthcare leaders from the worlds of academia, public health, industry and government.
Hosted by the International Medical Informatics Association (IMIA) - the world body for health and biomedical informatics - the summit builds off of discussions initiated at the 2012 summit.
In a keynote speech to delegates Kelly focused on the commission´s data protection proposals, the largest reform of data privacy law in two decades.
He called on the research community to be "more active" in collaborating to foster a "greater understanding" on the implications of the regulation on data protection for their industry.
The IMIA believes Europe is uniquely placed to lead the world in generating ´real world´ healthcare evidence and supports EU-wide adoption of eHealth.
But, in his speech on data protection, Kelly stressed the importance of preserving data protection rights and people’s privacy "in an age of massive data."
Speaking on Tuesday, he said the commission’s proposal offers exemptions for scientific, statistical and historical research which need to be maintained, adding, "We need to make sure the new regulation does not hinder the work of scientific research."
"A good balance between protecting privacy and allowing health research to continue unhindered is in the common interest," he insists.
In an address at Brussels´ Le Plaza Hotel the former professor turned MEP said it was important to raise awareness on the "risks" to research if exemptions foreseen in the commission’s regulation are eliminated.
The Fine Gael deputy added, "Changes to the commission’s proposal could threaten the use of ‘broad consent’ which allows researchers to use data when needed for further research without having to repeatedly ask for permission. This delays research and increases costs."
Kelly, who was elected in 2009 for the South constituency and is also a member of the Parliament's committee on regional development, told the summit, "We need to make sure the progress of research is unimpeded by unnecessary and costly administrative burdens."
"It is also important to embed discussions on data protection in a broader regulatory context and raise awareness of the necessity of a common international approach on challenges researchers face globally."
This year´s summit was part of IMIA’s broader Transnational Initiative on Trustworthy Use of Data for Health which focuses on stimulating robust discussions about health data reuse at the global level.
The initiative’s ultimate goal is to publish a framework that will encourage large-scale sharing of data, methods and expertise in the meaningful reuse of care records for research and healthcare service development.
The conference heard that it is of "crucial importance" for the aging population of Europe to have healthcare evidence that is relevant to people with the complex problems that characterise the later years of life.
Most clinical trials, for example, exclude people with multiple conditions or on multiple medications, yet this is a common situation in the elderly. So when a new drug is released, many of the circumstances in which the drug will eventually be used have not been studied.
This lack of evidence, it was said, disproportionately affects the elderly and those with complex needs.
Delegates agreed that what is needed to plug this "gap in evidence" is a new kind of healthcare research, for the “real world”.
IMIA, which acts as a bridging organisation, bringing together the constituent organisations and their members, is extending the reach of the discussion regarding health data use to a more global audience.
The aim is to engage key stakeholders to explore a transnational framework to build consensus on the use of data for health for public health, patient, and commercial benefit.
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