Clarifying validation terminologies in healthcare
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