When people think about cancer research, they usually picture doctors caring for patients, scientists working in laboratories, advanced technologies and the search for new treatments. Legal research is rarely the first thing that comes to mind. Yet scientific breakthroughs can only benefit patients if they are supported by legal frameworks that promote trust, protect patients’ rights and enable their responsible use in healthcare.
The DECIDER project demonstrates this well. By combining genomic, pathological and clinical data with advanced artificial intelligence (AI) methods, DECIDER has generated new knowledge about drug resistance in ovarian cancer and developed tools that may support more personalised treatment decisions. Alongside these scientific advances, the project’s legal work package explored a different but equally important question: what legal conditions are needed to ensure that these innovations can safely and effectively reach patients? Our work focused on three closely connected legal questions.
- How can AI be used responsibly in clinical decision-making?
- How can patients’ rights be protected while enabling innovation?
- And how can regulatory frameworks ensure timely and equitable access to new treatments?
Within DECIDER, AI is designed to support clinical judgement by integrating highly heterogeneous data – from pathology images and genomic information to clinical variables and longitudinal follow-up – into clinically meaningful analyses that support, rather than complicate, medical decision-making. Equally important is ensuring that these systems remain clinically interpretable. Clinicians must be able to understand which findings or biological features contribute to the system’s assessment and critically evaluate its recommendations.
These are not only technical challenges but also legal ones. Under the EU AI Act, many AI systems used in healthcare are likely to be classified as high-risk systems. The law therefore requires that such systems are transparent, reliable and subject to meaningful human oversight.
The development of personalised medicine also raises important questions about patients’ rights. European human rights law recognises that patients should be able to benefit from advances in medicine. Translating research findings into clinical practice is therefore not only a scientific ambition but also a legal and ethical responsibility.
DECIDER contributes to this objective by substantially improving the understanding of drug resistance in ovarian cancer. For some patients, the project has also helped identify promising treatment options among existing medicines. Improved patient stratification may furthermore support future clinical trials and facilitate the wider adoption of personalised cancer care.
The legal team of the DECIDER project from University of Helsinki led by Päivi Korpisaari.
Our legal research furthermore addressed, how patients can gain timely access to innovative treatments while maintaining high standards of safety and quality. Existing pharmaceutical legislation seeks to balance these objectives, but access to mechanisms such as off-label use, compassionate use and early access programmes still differs considerably across Europe. Consequently, patients’ opportunities to benefit from innovation may depend not only on scientific evidence but also on national regulation, reimbursement systems and healthcare policies.
As personalised medicine continues to evolve, these legal questions will become even more significant. The ongoing implementation of the AI Act, the European Health Data Space and the reform of European pharmaceutical legislation will shape how innovative technologies are translated into everyday clinical practice.
DECIDER demonstrates that legal research is not an afterthought to scientific innovation. For us, DECIDER has been an opportunity to explore how legal research can contribute to one of the most rapidly evolving areas of modern healthcare. We hope that the legal perspectives developed in DECIDER will contribute not only to future research but also to the broader discussion on how Europe can create regulatory frameworks that support the responsible development of personalised medicine. Ultimately, our shared objective is simple: to help ensure that scientific innovation can be translated into safe, equitable and effective patient care.