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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, Divya ORCID: 0000-0001-5135-3592 (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. ISSN 1744-1331

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Identification Number: 10.1017/S1744133123000208

Abstract

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.

Item Type: Article
Additional Information: © 2023 The Author
Divisions: Health Policy
Social Policy
Subjects: R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine
T Technology
Date Deposited: 24 Aug 2023 10:39
Last Modified: 27 Feb 2024 17:24
URI: http://eprints.lse.ac.uk/id/eprint/120062

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