JMIR Publications

ABSTRACT

Background:

Ownership of patient information in the context of Big Data is a relatively new problem, apparently not yet fully recognized by the medical academic community. The problem is interdisciplinary, incorporating legal, ethical, medical and aspects of information and communication technologies and a more sophisticated analysis of the issue is needed. However, no previous scoping review has mapped existing studies on the subject.

Objective:

The aim of this study is to determine how the medical academic community perceives the issue of ownership of patient information in the context of Big Data, its possible solutions and implemented practical applications.

Methods:

A scoping review, based on the five-stage framework outlined by Arksey and O’Malley and further developed by Levac, Colquhoun and O’Brien was conducted. The organization and the reporting of the results of the scoping review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and its extensions for Scoping Reviews (PRISMA-ScR). A systematic and comprehensive search of four scientific information databases, PubMed, ScienceDirect, Scopus and Springer was performed for studies published between January 2000 and October 2019. Two authors independently assessed eligibility and extracted data.

Results:

The review included 32 eligible articles authored by academicians and corresponding to three focus areas: problem (ownership); area (healthcare); context (Big Data). Five major aspects were studied: scientific area of publications, aspects and academicians’ perception of ownership in the context of Big Data, proposed solutions and practical applications for data ownership issues in the context of Big Data. The aspects in which publications consider ownership of medical data are not clearly distinguished, but can be summarized as: ethical, legal, political and managerial. Ownership of patient data is perceived primarily as a challenge being fundamental to conducting medical research including data sales and sharing, and in a smaller degree as a means of control, problem, threat and opportunity also in view of primarily medical research. Although numerous solutions are falling into three categories: technology, law and policy are proposed, only three real applications are discussed.

Conclusions:

The issue of ownership of patient information in the context of Big Data is poorly researched, is not addressed consistently and in its integrity, and there is no consensus on the ethical requirement for justice and the necessary legal regulations. What is missing is, in fact, adequate policy decisions expressed through the relevant legal framework. And in order to develop appropriate policies and regulations, ethical principles must be known, understood and upheld.