Health data is more important than ever for the development of personal medicine. We urge politicians to safeguard researchers' access to Danish health data.

2016.12.15

By Ole Steen Nielsen, Acting Dean of the Faculty of Health (Aarhus University), Ulla Wewer, Dean of the Faculty of Health and Medical Sciences (University of Copenhagen), Ole Skøtt, Dean of the Faculty of Health Sciences (University of Southern Denmark) and Lars Hvilsted Rasmussen, Dean of the Faculty of Medicine (Aalborg University).

In 2017, Danish politicians will have to take a position on the Danish interpretation of the European Parliament’s data protection reform, which will take effect in 2018. The data protection reform safeguards all of us on a general level against identity theft of our data, so that we can safely use social media and shop online securely.

There are good grounds for our current concern about the misuse of personal data. The general digitisation has led to many benefits, but it has also paved the way for a plethora of shady undertakings that earn their money from our personal data. Our consumption patterns are worth money, as is knowledge of cultural, sexual or religious preferences.

But the data protection reform also covers health data. And this is where we, as the deans of the Danish health science faculties, see a risk that the Danish politicians may – with the best intentions and in order to protect us – come to adopt such narrow frameworks and regulations for the use of health data, that they can come to affect the population and patients in the future. This will happen if it is not possible for healthcare professionals to utilise health sufficiently in the development of new treatments and diagnostic methods. Our greatest concern with the data protection reform is that it forces health data use to comply with strict consent rules. This will negatively impact on research at a time when Danish health data can become */more important than ever.

Fewer than every other cancer patient profits from the medicine they receive. Many patients suffer severe side effects as a consequence of chemotherapy, but very little or no effect from the treatment, while others react positively to the treatment with few side effects. Additionally, the treatments are expensive and represent a challenge to the number of healthcare services that we as a society can afford, if everyone with the same disease receives the same treatment. With personal medicine, you benefit from the major breakthroughs in the field of molecular biological and biochemical methods, and from the comparison of health data that makes it possible to provide the right treatment for the individual patient with much greater precision.

As individuals we are all special and each of us has our own special version of a disease – but we also have some common traits. Personal medicine is thus a tailored solution that can help the individual receive better treatment and quality of life.

The development of personal medicine and other health-related research is dependent on access to Danish health data and the Danish registers. It is therefore important that special Danish rules take into account the researchers who are working to improve future treatments and ensure that their access to this data is safeguarded.

Danish register-based researchers have made significant discoveries by combining register information and studying correlations between selected diseases and specific types of medicine. For example, we know that heart patients should be cautious about taking certain types of arthritis medicine. Some of the most important health-related breakthroughs are also based on health data. The correlation between cot death and babies sleeping on their stomachs is one example. Health data has similarly revealed that neither the MFR vaccine nor anti-depressives are the cause of autism in children.

The above are examples of the benefits that our shared data collection can lead to if we automatically share data knowing that it will not be misused. Fortunately, there have not been any cases in Denmark in which health data has been misused in connection with research.

With the new EU data protection reform, we fear that each time a Danish citizen uses healthcare services, he or she will have to sign a form stating that the data in can be used for research anonymised form. For many people, this will be difficult to deal with and relate to immediately after giving birth, visiting the A&E department or having another form of contact with the healthcare sector, where their focus is somewhere else entirely.

Another problem will arise if you as a citizen must actively consent to the use of anonymised health data for research purposes. There is a risk that only a few specific population groups will give consent. There are probably very few people who find the anonymised use of their data controversial. But a requirement for active permission will lead to many people disappearing from this group, as they will not always get the forms signed. Organ donation is an example of this.

Worst of all, it will skew the Danish health data and the registers will become useless for large scientific studies. This would be a disaster for register-based research. It would also prevent the patients of the future from benefiting from the insights which we could have gained.

The special rules that need to be adapted to Denmark should therefore take scientific research into account, in order to be able to deliver the best healthcare treatment and prevention for the country’s population. Now is the time for Danish politicians to decide whether our researchers and practitioners throughout the healthcare sector should have a good framework for utilising health data to ensure the best possible treatment for each individual.

The opinion is published in the newspaper Politiken 6 December 2016.