Whether it be an encounter with a physician or nurse, a prescription for medication from a pharmacy, or admittance of a student loan—every contact that we have with health care personnel or the social security system generates data related to our health and well-being. Currently, the Finnish Ministry of Social Affairs and Health is preparing a law renewal to enhance the utilization of this ever-growing amount of information.
To get a better view of what is going on, we went to meet Sirpa Soini, Senior Legal Adviser at Helsinki Biobank, Academic Medical Centre of Helsinki (AMCH).
It was estimated already in 2012 that up to 30% of the total health budget may be spent—one way or another—on handling, collecting, looking for, or storing information. As our social and health care systems are undergoing a digital revolution, information that has previously been captured only in paper form can now be accessed electronically. We are now in a situation in which there is a constantly growing potential—but also need—to efficiently and more extensively utilize this vast amount of data to benefit the whole of society.
Secondary use of health care and social welfare data refers to use of information that has been collected in the course of providing health care or social welfare services for other purposes than direct patient care. Currently, the data collected during Finnish health care or social welfare processes can only have secondary use which is strictly limited to scientific and public authority purposes.
According to Soini, the renewal of the law is a necessity: it will help to secure that the invaluable data and information collected in our registers and databases will not be lost in unnecessarily heavy bureaucracy.
“The slow permission processes related to the utilization of health care data have been identified as one of the main barriers for the successful implementation of Finland’s Health Sector Growth Strategy”.
The law renewal, says Soini, will allow greater flexibility in the utilization of data, for example to support decision-making, knowledge-based management, or teaching. Besides scientific research, the law will be extended to also cover product development and innovation activities, allowing better utilization of data for commercial applications. The new law will adopt a broader concept of scientific research to ensure uniform interpretation of the law following the new EU Data Protection Regulation. However, pure marketing research is still out of the question, and the basis of development and innovation activities must be robust.
Unraveling bureaucracy, improving security
According to Soini, the law renewal aims to unravel unnecessary and overlapping bureaucracy and bring all regulations related to the secondary utilization of health and social data under the same law. Currently, the rules regarding the utilization of health care data are spread between several different laws and the definition of scientific research has been relatively ambiguous.
“The scientific community has long been complaining that the current laws and regulations are too confusing and outdated”, Soini states, “so it’s about time that we actually do something about this.”
Indeed, as Soini sees it, one of the most important revisions in the law is the “one-stop shop” principle planned for the research permits; instead of having to apply separate permissions from all different data owners, the National Institute for Health and Welfare (THL) will be responsible for all permission processes, including ethical evaluation, related to the secondary use of health and welfare data. This, in turn, is supposed to make permission processes related to data utilization faster and simpler, and allow more efficient utilization of the valuable data to benefit research and innovation purposes.
Besides more efficiently using data, the reform will also make the access to health and welfare data more secure. The data from different sources will from now on be combined and accessed via a single portal. “In practice, the new law will make data processing and data linkage easier and more secure”, Soini summarizes and continues with a laugh, ”Perhaps we’ll finally get rid of printed copies of patient health record data.”
When talking about potential risks of the secondary use of healthcare data, Soini emphasizes the need for expertise to deal with the complicated real-world data. “The worst-case scenario would be that someone who doesn’t fully understand the data will make correctly-looking but wrong conclusions from the data, and these conclusions are then used as a basis for decision-making or updating treatment practices, for example”. New kind of expert services at the interface between registers and end-users could help to avoid this risk.
The law currently under reconstruction is likely to come into force next year. However, changes will not happen overnight. There is still no information on how quickly different registry keepers will be able to adapt their current practices or resources to meet the new regulations. Furthermore, the effects of the EU’s new Data Protection Directive are so far unclear—and also the prices for data access are yet to be discussed.
Even so, Soini sees that the development is currently moving in the right direction. More versatile utilization of data gives both public and private operators a plethora of new possibilities. Soini believes that this will encourage both new innovations as well as investments in Finland. “Our system has been relatively flexible before”, she summarizes, “but unraveling unnecessary bureaucracy will definitely put Finland at the forefront of real-world data based research”.
Sirpa Soini is the Senior Legal Adviser at Helsinki Biobank, Academic Medical Centre of Helsinki (AMCH). She is a specialist in biomedical law and regulation, and her core interests include public health, genomics, personalized medicine, and digital health.
MedEngine and TurkuCRC will organize a joint symposium at the 2nd Nordic Congress on Real World Data in Helsinki on September 27th, 2017.