Legal barriers stand in the way of health data potential, says Danish analysis

The full potential of health data will not be realised until certain legal barriers standing in the way are overcome, states the Danish Life Science Cluster in a new analysis. [Shutterstock]

The full potential of health data will not be realised until certain legal barriers standing in the way are overcome, according to a new independent analysis welcomed by the Danish government. 

Just a few months after a new “vision for strategic cooperation” regarding the use of health data was presented in Denmark last October, an analysis by the Danish Life Science Cluster has been published this week, highlighting the legal barriers for realising the full potential of health data.

The challenges concern legal interpretations, the waiting time, and diverse organisational conditions of data managers.

The concerns come from both companies and scientists, who face a long process when they wish to make use of the health data for the development of innovative, data-driven solutions.

The analysis was funded through a political agreement aiming to restart Danish exports in 2020. The recommendations are built on interviews with 34 scientists, companies, and key people, followed by a legal analysis of chosen cases based on real-life projects, experiences and solutions.

The Danish study can offer food for thought at the EU level ahead of the long-awaited legislative proposal for setting up a health data space, expected to be adopted in 2022.

With the proposal, the EU executive will try to simplify the exchange of and access to health data for different uses, including healthcare provisions, digital health services, and research.

EU grapples with building a 'house' for health data

Having drilled the first bolts of its ambitious EU health agenda, the European Commission is now called to the challenging task of creating a trustworthy, patient-centred European health data space.

So, how to handle the barrier?

One key point in the analysis is that the legislation is particularly complex. To combat those challenges, it would be beneficial to strengthen the legal guidance, the analysis concludes.

Additionally, getting the application for using health data approved is a lengthy and complex administrative process. Therefore, another recommendation is to make some organisational changes for those approving the applications in order to streamline and shorten the process.

Lastly, as seen in many areas, technology develops fast and can overtake existing laws. This also happens to be the case with the Danish regulatory framework for the use of health data.

It includes exploratory research and pattern recognition in large data sets, such as genomic data, and continuous access to updated data in the development and quality control of algorithms for patient care.

Based on this, the analysis’ final recommendation is to review the legislation in these areas.

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Government is on board

The recommendations have already been welcomed by the Danish government, which wants to look at solutions with the “National Partnership for Health Data” to create more clarity for the use of health data in science.

“It’s crucial that we ensure the greatest possible clarity on the current rules for the use of health data, so we can exploit the new opportunities and at the same time ensure a high level of protection for Danish health data,” said Danish Health Minister Magnus Heunicke.

“Therefore, we need to strengthen guidance on the use of health data and address the legal challenges,” Heunicke said in a press release following the publication of the analysis.

His comments were reinforced by the Danish Minister of Industry, Business and Financial Affairs, Simon Kollerup, who said it is “crucial that we give companies the best toolbox to create tomorrow’s solutions while continuing to ensure a high level of protection for Danish health data”.

[Edited by Gerardo Fortuna/Zoran Radosavljevic]

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