Target Trial Emulation brings the logic of randomized trials into real-world data
Target Trial Emulation does not replace randomized controlled trials, but it applies their logic and rigor to real-world data analysis.
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 is EHDS?
The European Health Data Space (EHDS) is an EU initiative aiming to:
- Empower individuals to control and access their personal health data (e.g. prescriptions, medical records) across EU countries.
- Enable the use of health data for research, innovation, policy-making, and public health in a secure, privacy-respecting way (called secondary use).
Key Points:
- Patients can access and share their electronic health records across borders.
- Researchers and policymakers can use anonymized data to improve healthcare systems.
- EHDS introduces common standards, infrastructure, and governance across the EU.
- It aims to balance data protection (GDPR) with health innovation.
Contact us!
Medaffcon, founded in 2009, is a Nordic research and consulting company specializing in Real-World Evidence, Medical Affairs, and Market Access. With offices in Stockholm, Sweden, and Espoo, Finland, we provide expert services across the Nordic region. Our services combine strong medical and health economic expertise with modern data science.
The company employs some 30 experts. Since 2017, Medaffcon has been a subsidiary of Tamro Oyj and is part of the PHOENIX group, which is a leading provider of healthcare services in Europe.
