EHDS makes Finland an even more attractive place for RWE research  

Finland will become an even more attractive place for conducting RWE (real-world evidence) research when it becomes a seamless part of the European Health Data Space (EHDS). Thus, health data can be used more efficiently across the European Union (EU), and datasets can be combined on an EU-wide basis. 

“EU legislation may seem difficult and even frightening to our customers. I would tell them not to worry; this will be handled. Medaffcon’s clients don’t need to fret, as Medaffcon will take care of this on their behalf,” assures Riikka Mattila, PhD, Medaffcon’s Scientific Advisor.  

Finland’s Act on the Secondary Use of Health and Social Data forms the basis for the EHDS 

Finland’s starting points for implementing the European Health Data Space (EHDS) legislation are excellent. Finland’s Act on the Secondary Use of Health and Social Data forms the basis of EHDS legislation.  

The Finnish Social and Health Data Permit Authority Findata has been practicing EHDS-like legislation for the secondary use of social and health data in Finland since 2019. Medaffcon has been operating in Finland in accordance with EHDS-like legislation since 2020, promoting a regulatory-compliant and innovative research environment.  

According to Medaffcon Scientific Advisor, PhD, Riikka Mattila, the impact of EHDS will be maneagable in the Finnish market but considerably larger elsewhere in Europe.  

“While it is not yet precisely known how the law will ultimately be harmonised in Finland, the necessary adjustments will be smoothly integrated by Medaffon’s RWE team.”  

EHDS facilitates cross-border real-world evidence (RWE) research  

“We have a significant head start. One could say that the further a country is from Finland, the bigger the changes caused by EHDS,” Riikka Mattila states.  

The most important effect of EHDS changes is that these changes help combine data from different countries. Currently Finnish data cannot leave Finland, nor can Danish data leave Denmark.  

Once EHDS is in force, the movement of data across Europe will be possible.  

“That is a huge step forward in RWE research” Scientific Advisor, PhD Riikka Mattila says. 

What happens in the FinHITS project at Findata in the context of Pharma? 

• Improvement of Findata’s customer service 
• Development of a national dataset catalog 
• Development of Kapseli to be more efficient and versatile.
  Kapseli is a secure operating environment for handling individual-level data. 
• Development of technical solutions for cross-border data exchange 
• Improvement of health data quality