Programpunkter

AI is everywhere in healthcare software, but when is it actually safe? This session explains what separates regulated medical-grade AI from uncontrolled tools, how manufacturers manage LLM unpredictability, and what questions buyers should ask any vendor claiming clinical AI capabilities.

Authors: Jeanette Jackson, Sheliza Ladhani, Ava Mehdipour, Chyloe Healy, Roland Simon, Maz Rahman, Guy DeSantis, Tim Cooke, Jae-Yung Kwon, Richard Sawatzky

Authors: Kara Schick-Makaroff, Richard Sawatzky, Melissa Moynihan, Katrin Micklitz

Authors: Charlotte Abrahamsen, Ditte Høgsgaard, Cecilie Lindström Egholm, Christian Backer Mogensen, Søren Thorgaard Skou, Jess Søndergaard, Ditte Orbesen, Mette Elkjær

The talk will explain the full journey of creating a Software as a Medical Device from concept to certification. It will outline the key stages including defining intended use, design and usability engineering, regulated software development, clinical evaluation strategies and the CE marking process. The session will also highlight differences between class I and higher class SaMD products which require more rigorous controls and notified body involvement. The presentation will share realistic minimum timelines and cost ranges based on completed European projects to help companies plan their investment and avoid common pitfalls.

Healthcare systems face rising costs and growing pressure to improve results, yet decisions are still often based on activities and assumptions rather than measured value across the full care pathway. This session shows how outcomes, patient experience, and total cost can be measured together at pathway level for defined conditions, making trade-offs visible and supporting informed clinical and management decisions grounded in real results. By treating care as a long-term investment and using reproducible models over time, organizations can improve outcomes, manage resources responsibly, and create value for patients and society.

From the agenda:Relevant standards for secure data sharing in health informaticsThe relationship between current standards from ISO/CEN, FHIR, SNOMED CT, and others  Collaboration among the Nordic standardization organizationsThis session is arranged in cooperation by SIS, the Swedish Institute for Standards, Standard Norge, SFS Finnish Standards, Dansk Standard, and Icelandic Standards.

Authors: Cecilia Larsdotter, Stina Nyblom, Henrik Imberg, Richard Sawatzky, Joakim Öhlén

Authors: Tanya McCance, Val Wilson, Karen Tuqiri, Mary Mulcahy, Deborah Muldrew

In this talk, Ana Catarina Silva shares her journey through academia, diagnostics, and MedTech across Portugal, Italy, and Sweden, and how it ultimately led her to women’s health innovation and Akira Science. Reflecting on two decades at the intersection of science, culture, and leadership, she explores how purpose emerged through addressing one of the most overlooked areas in healthcare: breast cancer reconstruction. Her talk argues that women’s health is not a niche, but a compass for the future of medicine.

This session presents Region Stockholm's ongoing work on the HL7 FHIR standard.

Get a glimpse of tomorrow’s healthtech breakthroughs at the Healthtech Startup Pitch Event, where 6 promising startups presents their solutions.

Healthcare regions and laboratories are facing rising data complexity and increasing demands for interoperability and precision medicine. Traditional Laboratory Information Management Solutions (LIMS) are not built for this environment. This session introduces how the Nordic Data Model provides a modern data architecture that connects laboratory data with clinical context and analytics, enabling a shift from volume-oriented operations to value driven services. Participants will see how this approach supports smarter testing, stronger decision making and scalable regional infrastructures.