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Promoting the systematic use of real-world data and real-world evidence for digital health technologies across Europe: a consensus framework

Srivastava, D. ORCID: 0000-0001-5135-3592, Henschke, C., Virtanen, L. , Lotman, E-M., Friebel, R., Ardito, V. & Petracca, F. (2023). Promoting the systematic use of real-world data and real-world evidence for digital health technologies across Europe: a consensus framework. Health Economics, Policy and Law, 18(4), pp. 395-410. doi: 10.1017/s1744133123000208


Despite the acceleration in the use of digital health technologies across different aspects of the healthcare system, the full potential of real-world data (RWD) and real-world evidence (RWE) arising from the technologies is not being utilised in decision-making. We examine current national efforts and future opportunities to systematically use RWD and RWE in decision-making in five countries (Estonia, Finland, Germany, Italy and the United Kingdom), and then develop a framework for promotion of the systematic use of RWD and RWE. A review assesses current national efforts, complemented with a three-round consensus-building exercise among an international group of experts (n1 = 44,n2 = 24,n3 = 24) to derive key principles. We find that Estonia and Finland have invested and developed digital health-related policies for several years; Germany and Italy are the more recent arrivals, while the United Kingdom falls somewhere in the middle. Opportunities to promote the systematic use of RWD and RWE were identified for each country. Eight building blocks principles were agreed through consensus, relating to policy scope, institutional role and data collection. Promoting post-market surveillance and digital health technology vigilance ought to rely on clarity in scope and data collection with consensus reached on eight principles to leverage RWD and RWE.

Publication Type: Article
Additional Information: This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (, which permits unrestricted re-use, distribution and reproduction, provided the original article is properly cited. Copyright © The Author(s), 2023. Published by Cambridge University Press
Publisher Keywords: Delphi method, digital health technology vigilance, digitization, post-market surveillance
Subjects: H Social Sciences > HB Economic Theory
R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine
T Technology > T Technology (General)
Departments: School of Health & Psychological Sciences
School of Health & Psychological Sciences > Healthcare Services Research & Management
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