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Ensuring AI explainability in healthcare: problems and possible policy solutions
Abstract
AI promises to address health services’ quality and cost challenges, however, errors and bias in medical devices decisions pose threats to human health and life. This has also led to the lack of trust in AI medical devices among clinicians and patients. The goal of this article is to assess whether AI explainability principle established in numerous ethical AI frameworks can help address these and other challenges posed by AI medical devices. We first define the AI explainability principle, delineate it from the AI transparency principle, and examine which stakeholders in healthcare sector would need AI to be explainable and for what purpose. Second, we analyze whether explainable AI in healthcare is capable of achieving its intended goals. Finally, we examine robust regulatory approval framework as an alternative – and a more suitable – way in addressing challenges caused by black-box AI.
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“Patients, with their highly limited technical and clinical knowledge, are less likely to draw relevant insights from such technical explanation modalities such as activation maps and feature attribution plots [119].”
From Explainable and Interpretable AI for Voice and Speech Analysis in Clinical Care: Systematic Review (2026) · cites this paper as [119]
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Mersha, M. A., Lâm, K. N., Wood, J., AlShami, A. K., & Kalita, J. K. (2024) · Neurocomputing · doi:10.1016/j.neucom.2024.128111 · Cited by 346
“Transparency and accountability [22], fairness and bias mitigation [165], ethical frameworks and guidelines [167], privacy and confidentiality [168] are some of the key ethical aspects of XAI in healthcare.”
BackgroundA historical perspective of biomedical explainable AI research
Malinverno, L., Barros, V., Ghisoni, F., Visonà, G., Kern, R., Nickel, P. J., Ventura, B. E., Šimić, I., Stryeck, S., Manni, F., et al. (2023) · Patterns · doi:10.1016/j.patter.2023.100830 · Cited by 46
“42 Briefly, XAI algorithms can be divided into two main categories: transparent models that convey some intrinsic degree of interpretability and post hoc explainability techniques.”
BackgroundBlackman, J., & Veerapen, R. J. (2025) · BMC Medical Informatics and Decision Making · doi:10.1186/s12911-025-02891-2 · Cited by 38
“…o v e rr i d e i n c o rr e c t d e c i s i o n s a n d t h u s a v o i d h a r m , a s w e ll a s h e l p i m p r o v e A I t e c hn o l o g y ” [ 30 ] “ A p r o t o t y p i c a l e x a m p l e o f t h i s i s a [ h e a l t h c a r e m a c h i n e l e a r n i n g ] m o d e l w h i c h e rr o n e…”
InfluentialToumaj, S., Heidari, A., & Navimipour, N. J. (2025) · Artificial Intelligence in Medicine · doi:10.1016/j.artmed.2025.103243 · Cited by 36
Settouti, N., & Saidi, M. (2023) · Evolutionary Intelligence · doi:10.1007/s12065-023-00833-3 · Cited by 15
“In recent years, there has been growing interest in using explainable machine learning models, which provide inter-pretable predictions, in the healthcare field [4, 12, 20, 22, 39, 45, 53].”
Metadata
- Authors
- Aranovich, T. D. C., & Matulionyte, R.
- Affiliations
- Universidade Federal do Rio Grande do Sul (BR)
- Law School, Macquarie University, Sydney, Australia
- Corresponding author
- Aranovich, Tatiana de Campos
- Venue
- Information & Communications Technology Law
- Publisher
- Informa UK Limited
- Published
- 2022-11-14
- Volume
- 32
- Issue
- 2
- Pages
- 259-275
- ISSN
- 1360-0834 (ISSN-L)
- 1469-8404
- OpenAlex
- W4308998881
- Cited by
- 18
- References
- 0
- Citations by year
- 2026: 4 · 2025: 10 · 2024: 2 · 2023: 2
- FWCI
- 1.15
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Information & Communications Technology Law (publishedVersion)
- Topics
- Physical Sciences › Computer Science › Artificial Intelligence › Explainable Artificial Intelligence (XAI)
- Physical Sciences › Computer Science › Artificial Intelligence › Ethics and Social Impacts of AI
- Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
- Keywords
- explainable AI, artificial intelligence in healthcare, AI medical devices, AI transparency, algorithmic bias, AI errors, trust in AI, AI ethics framework, regulatory approval, black-box AI, AI policy
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- CoChat. (2026). Citation check: Ensuring AI explainability in healthcare: problems and possible policy solutions. https://app.cochat.ai/papers/10.1080/13600834.2022.2146395
- The paper
- Aranovich, T. D. C., & Matulionyte, R. (2023). Ensuring AI explainability in healthcare: problems and possible policy solutions. Information & Communications Technology Law. https://doi.org/10.1080/13600834.2022.2146395