New law on health data requires new research

Denmark is known for having a unique collection of health data and records which holds great potential for research into diseases and new medicine. And Danish health sciences is world leading in areas based on this data. But the forthcoming data protection regulation from the EU imposes new demands on how Danish health data is stored and used.

Among other things, there will be stricter requirements on research designs and data minimisation which means that it will not be allowed to collect more information than necessary. It will therefore become more resource demanding to get access to health data.

The Lundbeck Foundation awards DKK four million to a new research project which will map out the future rules and ensure that Danish researchers will be able to use health data to make the health-related breakthroughs.

- We are talking about a complicated new regulatory framework which is important to shed light on and interpret carefully so as to avoid uncertainty about what is allowed when it comes to the use of health data. Researchers of health sciences are involved in the project, and this is a clear advantage. They are the ones who know the processes and, ultimately, must gather and use health data correctly, says Anne-Marie Engel, who is Research Director at the Lundbeck Foundation.

Wants to make the research process easier
- We know that researchers use huge resources on acquainting themselves with the rules and getting research projects approved, but also that the debate on health data causes uncertainty for both patients and researchers. This is why it is crucial to clarify the new rules. This will facilitate the research process and improve infrastructure for the researchers who use health information for research purposes, and it will also strengthen patients' confidence in Danish health research, says Kent Kristensen.

He is an Associate Professor of health law at the University of Southern Denmark and is in charge of the project which includes leading researchers in health law, personal data protection law and health sciences from Aarhus University, University of Copenhagen and University of Southern Denmark.

The research group will be in dialogue with an appointed advisory board which will ensure that researchers of health sciences continuously can call attention to the specific challenges concerning personal data which they encounter in the planning and execution of their research.

Great societal value
- It is of great significance to scientists, doctors and legal professionals to gain insight into how the new EU regulation is translated into practice. An important part of the project is to highlight the importance of the rules for Danish research, and that researchers are required to meet greater demands in the future. This applies to requirements for data minimisation as the regulation demands that researchers already in the shaping of the research design incorporate rules for the collection and processing of health information, says Kent Kristensen.

The legal analyses of the project can also be included as a source, when the authorities and courts have to assess specific issues regarding the use of data in health research.

A number of symposia have been planned in cooperation with the Organization of Danish Medical Societies, so there will be ongoing opportunity to keep up with the research results. In addition, anyone interested can keep themselves updated on the new rules and legal practices on a website and in newsletters and blogs during the project. Also, the results will be summarised in blueprint to ensure a quick overview of the rules applicable in specific situations.

FACTS:
The project "JURFAST – Legal framework for researchers' use of health data" is funded with DKK four million from the Lundbeck Foundation. The project runs from September 2017 and three years onwards and is conducted in a collaboration between legal and health science researchers from Aarhus University, University of Copenhagen and University of Southern Denmark.

The main forces behind the project are Kent Kristensen, Associate Professor at the Department of Law, University of Southern Denmark; Hanne Marie Motzfeldt, Associate Professor at the Department of Law, Aarhus University, and Jens Søndergaard, Professor at the Research Unit of General Practice, University of Southern Denmark.  

Further information:
Contact Kent Kristensen, Principal Investigator and Associate Professor of health law at the Department of Law, University of Southern Denmark on phone 5071 4850 or by email kkr@sam.sdu.dk

Anne-Marie Engel, Research Director at the Lundbeck Foundation on phone 3912 8000 or by email ame@lundbeckfonden.com