RESUMEN
Starting from an epistemological position of individualized medicine this article deals with the ethical analysis of this complex topic. The need for evidence-based decisions--as opposed to interest-driven decisions--is emphasised. Based on the argument of social justifiability it can be first stated as an intermediate result that genome-based research, which aims to promote individualisation of medicine, does not exclude research that uses other diagnostic markers, and the appropriate ethical standards can be applied. Second, the development of individualised preventive medicine in the field of multifactorial diseases should increasingly study the potential cost savings of genetic risk diagnosis compared to the costs for the actual treatment options. For proper, medically reasonable, ethically justifiable and socially desired implementation of all areas of individualised medicine, clear separation between research and care as well as the simultaneous implementation of ethical, legal, methodological and technical standards is desirable; however these must be continuously developed in order to respond to possible boundary changes that may arise. Finally, the challenge remains to make the efficacy, operationalisation, performance, and affordability of individualised medicine plausible in the context of social justifiability.