Data and Evidence of Real Clinical Practice: A Comparative Legal Study

Abstract

The development of technologies collecting and processing large amounts of data for medical purposes, as well as the development of digital tools and the growth of medical information collected by both private and public medical institutions, determine the scientific interest in the problems discussed in this paper. One of the effective tools for collecting such data is data from real clinical practice and evidence of real clinical practice, which make it possible to collect information about the individuals’ health status, safety and effectiveness of medicines and medical devices, as well as other data. At the same time, the conceptual and categorical apparatus necessary for the formation and implementation of regulatory policy in this area started its development relatively recently. An analysis of Russian and foreign legislation and the practice of their application allows us to conclude that this element of sectoral legal regulation is in the initial stage of its formation and is characterized by the use of inconsistent terminology and different approaches to understanding the source and subject matter of such data.