Many patients are willing to make their health data available for research purposes. However, they want to remain in control and decide for themselves what their data may or may not be used for. The majority therefore do not want to give automatic consent for the use of their data.
This emerges from research conducted by the Patient Federation Netherlands among the Health Care Panel. The reason for the survey is the European Health Data Space, European legislation that is currently under development. However, consider also the recent National Vision on the Health Information System of the Ministry of Health, Welfare and Sport. In both cases, the use of medical data and the extent to which patients have control over it play an important role.
Secondary use
It is specifically about the secondary use of medical data. This refers to the use of data for a purpose other than that for which it was collected. Think of conducting scientific research into a condition, for example, but also the development of new digital applications or better organisation of care. Secondary use of healthcare data helps gather the insights needed for this.
Ernst Kuipers, Minister for Health, Welfare and Sport (VWS), wrote in a letter to Parliament in April: “The healthcare sector faces major challenges. The secondary use of health data is one of the ways to tackle this challenge. I am convinced that it will strengthen our healthcare system.”
Majority wants to judge on a situation-by-situation basis
In the survey, the Dutch Patients’ Federation sets out how members of the Healthcare Panel view the introduction of either an opt-in system (consent system) or an opt-out system (objection system) for the secondary use of their medical data. The findings show that if an opt-out system were to be introduced in the Netherlands, a quarter (25 per cent) would not object at all to the secondary use of their data. 11 per cent do intend to object.
64% want to consider for each situation whether they object to the use of their data. 59% want to look at the purpose of use and 55% at the user. The purpose of secondary use affects patients' opinions. For example, patients are more likely to make data available related to, say, a blood test than data related to their mental state.
Giving patients choices
Patiëntenfederatie Nederland pleads, both in the Netherlands and in Europe, for a system in which patients are given choices about what can be done with their data. Patients should be able to indicate which organisation is allowed to use their data and which is not. There should also be a distinction between the various purposes of data use and the type of data used for this purpose.
In addition, the federation calls for transparent guarantees regarding data protection and patients' rights regarding secondary use. "We must protect patients' rights, safety and trust in our healthcare system. Not least because patients depend on it in the most vulnerable moments. Professional confidentiality and legal safeguards on control are essential here. Ensure with good safeguards trust and willingness among patients to make their data available for secondary use," states Patiëntenfederatie Nederland.
Bottlenecks in secondary data use
In his April parliamentary letter, Minister Kuipers of VWS already pointed out bottlenecks in asking for permission or testing for no objection for the use of data. For instance, control is not uniformly regulated in many cases, and control procedures create a high administrative burden for data holders. In addition, the response rate to control requests is low in many cases.
There is also a risk of bias in the research population, because certain groups do not give permission for their data to be used. As a result, the dataset used is no longer representative of the overall population. Also, verifying whether consent is given for the use of data by potential data users is time-consuming and sometimes even impossible. In practice, patients and citizens have no insight into what control they have and/or have exercised.
The minister is therefore investigating to what extent a 'control register' can solve these bottlenecks. In such a national control register, citizens can, among other things, gain insight into the use of their healthcare data and indicate whether their data may be used for secondary use.
Author: Wouter Hoeffnagel
Photo: Darko Stojanovic via Pixabay
