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 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.”
“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.
The European Health Data Space (EHDS) is an EU initiative aiming to:
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.
The conference explores how real-world data (RWD) and artificial intelligence (AI) can transform drug development, regulatory and HTA decision-making, and ultimately drive value-based, patient-focused healthcare.
Medaffcon develops the Patient Dynamics tool based on customer feedback and user experience.
Patient Dynamics tool compiles up-to-date and regional data on medicine use in Finland and Sweden.
Sr. Scientific Advisor
PhD
Riikka joined Medaffcon in February 2021. She has a wide-ranging experience from different therapy areas from atherosclerosis and birth asphyxia to neurodegeneration. She has more than 15 years of experience in research, three of which in Max Planck Institute in Germany. Her PhD thesis from 2011 focused on cholesterol metabolism.
Riikka’s strenghts include broad know-how and interest in diverse therapy areas, as well as enthusiasm and experience in both written and verbal scientific communication. At Medaffcon she enjoys varied projects and effectiveness of research.
Real world evidence fascinates Riikka because there is so much data, and more accumulating all the time, and most of this data is unused. There is potential for findings to support clinicians and the pharmaceutical industry, as well as alleviate the lives of patients. She is also happy that decisions in health care are increasingly evidence based.