Abstract
The development of digital health has forced practitioners to embrace changes in their clinical practice and is now leading researches to re-evaluate clinical trial methods when applied to digital innovations for healthcare. Analyses of clinical data are incompatible with the life cycle of applied digital technologies due to the time required to obtain validated results through the widely used statistical mathematics for biomedical research. New paradox is arising in regard to the perspectives of digital health: the correct application of EBM in digital health produces reliable scientific results; however, by the time these studies are completed, the technology is no longer appliable since it has become obsolete. A new approach to evidence-based clinical trials in the field of digital health can be developed, but a coherent healthcare system that provides standard evaluation criteria and methods is needed. Precision medicine is based on the convergence into one integrated system of digital health with mobile technologies, electronic health records, data science, genomic, phenotypic and metabolic analyses, other information sources, and progressive reduction of their costs. Such integration leads to more detailed definition of diagnosis and advances in a personalized approach to patient care. In other words, as a first step we will be able to go beyond the “phenotype-driven therapy,” and then we will apply precision or personalized medicine in routine clinical care. It is important and urgent to achieve the first goal, since expensive drugs such as biologics and biosimilars have a negative impact on the sustainability of the healthcare system.
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