(JMIR Publications, 18.10.2022) Degen, Markus; Babrak, Lmar; Smakaj, Erand; Agac, Teyfik; Asprion, Petra; Grimberg, Frank; Van der Werf, Daan; Van Ginkel, Erwin Willem; Tosoni, Deniz David; Clay, Ieuan; Brodbeck, Dominique; Natali, Eriberto; Schkommodau, Erik; Miho, Enkelejda
Digital technologies are transforming the health care system. A large part of information is generated as real-world
data (RWD). Data from electronic health records and digital biomarkers have the potential to reveal associations between the benefits and adverse events of medicines, establish new patient-stratification principles, expose unknown disease correlations, and inform on preventive measures. The impact for health care payers and providers, the biopharmaceutical industry, and governments is massive in terms of health outcomes, quality of care, and cost. However, a framework to assess the preliminary quality of RWD is missing, thus hindering the conduct of population-based observational studies to support regulatory decision-making and real-world evidence.