28-29 January 2025, Helsinki
The 5th Nordic RWE and AI Conference brought together around 300 participants from the pharmaceutical industry, technical data solution providers, consultancy firms, universities, healthcare providers, and the health authorities. The conference was held at the University of Helsinki under the management of the university’s Mia Bengtström.
Most of the participants came from the Nordics, though with some attendees from other countries within Europe, highlighting the growing interest in Nordic RWE. In addition to the presentations, there were opportunities for networking during breaks and the reception at Helsinki City Hall.
The focus on the first day was on the regulatory frameworks around RWE data and the challenges and opportunities ahead as the European Health Data Space (EHDS) enters into force in Europe[1]. The EDHS seeks to foster a single market for electronic health record systems, providing a trustworthy way to use health data for research and empowering individuals to take control of their health data. The status of the VALO project[2], a Nordic collaboration that aims to establish common principles for Nordic countries implementing EHDS, was discussed. The project aims to highlight the benefits of Nordic collaboration in the secondary use of health data. Another piece of legislation that will be key for how health data is used is the AI Act, which becomes effective in August 2025[3].
The unique qualities of health data registers were highlighted several times as a competitive edge when it comes to real world evidence in the Nordics. Other countries are catching when it comes to collecting data in registers, but to keep the competitive edge Nordic countries have gained, they will need to look at enhancing the ways the data is used.
Challenges with data access, particularly for industry partners, was identified as a bottleneck, as were the legal restrictions to using data, such as the EU’s General Data Protection Regulation (GDPR) and other country-specific data protection laws[4],[5]. Federated data and methods for anonymizing data, as well as secure processing environments were solutions proposed to overcome some of the hurdles.
Another challenge is that while regulators are using RWE data for decision making, there is a need to take steps to ensure the use of RWE meets regulatory standards concerning the quality of data[6].
The second day of the conference focused on the possibilities and limitations of using RWE in the Nordics. Interoperability was discussed as a way to make the data more usable, especially when linking data from different data sources, and also enabling alignment between the Nordic countries.
The use of real-time data to support doctors and nurses with decision-making remains underutilized. A possible reason for this is legislative restrictions. Also discussed during the conference was the possibility of using health data sources for prospective data collection in randomized clinical trials.
In addition, several interesting use cases were presented where Nordic RWE has been used to assist patients either in terms of market access, accessing a clinical study, or by evaluation of treatment guidelines.
The final speaker at the conference spoke about the reliability of using tools such as ChatGPT to draw conclusions on data, suggesting that humans still are superior to AI when it comes to interpretation of data.
A key takeaway from the conference is that for Nordic health data to continue to be an attractive source of information, legislation, technology, innovation and regulatory frameworks need to be aligned to enable patient integrity while continuing to develop new functionalities.
[1] European Health Data Space, European Commission. https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en
[2] VALO. https://www.sitra.fi/en/projects/value-from-nordic-health-data-valo/
[3] AI Act, European Commission. https://digital-strategy.ec.europa.eu/en/policies/regulatory-framework-ai
[4] Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation), EUR-Lex. https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng
[5] Data Protection Laws and Regulations Norway 2024-2025. https://iclg.com/practice-areas/data-protection-laws-and-regulations/norway
[6] Data Quality Framework for EU medicines regulation: application to Real-World Data, EMA. https://www.ema.europa.eu/en/documents/other/draft-data-quality-framework-eu-medicines-regulation-application-real-world-data_en.pdf
