Clarifying validation terminologies in healthcare

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Authors: Amanda Dy, Sandra Buetow, Andrew J. Bredemeyer, Monika Lamba Saini, Fabienne McClanahan Lucas, Shannon M. Bennett, Kim Blenman, Keith A. Wharton, Sunil Singhal, M. E. de Baca, Kevin Schap, Matthew G Hanna
+8 more Staci J. Kearney, Norman Zerbe, R. Salgado, Jithesh V. Veetil, Jansen N. Seheult, David S. McClintock, April Khademi, Jochen K. Lennerz
Cited by: 1
References: 35

Abstract

Validation is a cornerstone of reliability and trust in diagnostics, yet discipline-specific assumptions and unspoken contextual differences often lead to miscommunication, misalignment, and avoidable delays. As AI/ML becomes more integrated into healthcare, there is a growing necessity to re-examine how the term validation is used and understood. We highlight inconsistencies in the use of the term validation through an analysis of 94 themes across five domains, including Communication Science (n = 12), AI/ML (n = 26), Clinical and Laboratory Practice (n = 19), Regulatory Science (n = 22), and Business (n = 15). We emphasize how persistent reliance on domain-specific implied definitions impedes interdisciplinary alignment. Rather than advocating for a single definition, we derived five consensus proposals that collectively advocate for more specific and context-aware additions to the term validation to support clarity, reliability, and compliance across disciplines. Our goal is to support clearer communication and provide useful strategies that inform the development, regulation, and use of digital health technologies.

Fields of Study & Subjects

Artificial Intelligence in Healthcare and Education Clinical Reasoning and Diagnostic Skills Electronic Health Records Systems

Publication details

Journal / source
npj Digital Medicine
Publisher
Springer Science and Business Media LLC
Volume
9
Issue
1
Publication date
5 March 2026
Language
EN