ArticleJournal of medical Internet research2024
Suitability of the Current Health Technology Assessment of Innovative Artificial Intelligence-Based Medical Devices: Scoping Literature Review.
Article in Journal of medical Internet research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it.
- AI for IMPACTS Framework for Evaluating the Long-Term Real-World Impacts of AI-Powered Clinician Tools: Systematic Review and Narrative Synthesis.Journal of medical Internet research · 2025Pooled it
- Beyond CE Marking: The Need for Life-Cycle Health Technology Assessment of Medical Devices for Patient Safety and Health-System Value.Healthcare (Basel, Switzerland) · 2026Review
- Ethical Considerations in Health Technology Assessment for Precision Medicine: A Delphi Study in a Greek Setting.Journal of personalized medicine · 2026Article
- Artificial intelligence in population-based cancer screening: evidence from a national survey of Italian professionals.BMC public health · 2026Article
- Exploring the challenges of developing hospital-based health technology assessment in Iran: a qualitative study.Health research policy and systems · 2026Article
- Management Model for the Evaluation of needs and Acquisition of Biomedical Equipment in Healthcare Institutions: Based on WHO Recommendations, and National Regulations.Journal of medical systems · 2026Article
- Artificial Intelligence in Lung Cancer: A Narrative Review of Recent Advances in Diagnosis, Biomarker Discovery, and Drug Development.Pharmaceutics · 2026Review
- Dual-database Bibliometric Analysis Combined with Gephi-based Network Visualization of Artificial Intelligence Applications in the Identification and Diagnosis of Thyroid Space-occupying Lesions.Current medical imaging · 2026Article
- [Proposal for Responsible Use of Generative Artificial Intelligence in Medical Practice].Revista de neurologia · 2025Review
- An ecosystem approach to governing commercial actors in healthcare AI.Policy studies (Policy Studies Institute) · 2025Article
- Ethical, Legal, and Social Assessment of AI-Based Technologies for Prevention and Diagnosis of Rare Diseases in Health Technology Assessment Processes.Healthcare (Basel, Switzerland) · 2025Article
- Determinants of Visual Impairment Among Chinese Middle-Aged and Older Adults: Risk Prediction Model Using Machine Learning Algorithms.JMIR aging · 2024Article
- Artificial Intelligence Applicability in the Pharmaceutical Industry: Present Perspectives and Future Formations.Inquiry : a journal of medical care organization, provision and financingArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundArtificial intelligence (AI)-based medical devices have garnered attention due to their ability to revolutionize medicine. Their health technology assessment framework is lacking.
objectiveThis study aims to analyze the suitability of each health technology assessment (HTA) domain for the assessment of AI-based medical devices.
methodsWe conducted a scoping literature review following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methodology. We searched databases (PubMed, Embase, and Cochrane Library), gray literature, and HTA agency websites.
resultsA total of 10.1% (78/775) of the references were included. Data quality and integration are vital aspects to consider when describing and assessing the technical characteristics of AI-based medical devices during an HTA process. When it comes to implementing specialized HTA for AI-based medical devices, several practical challenges and potential barriers could be highlighted and should be taken into account (AI technological evolution timeline, data requirements, complexity and transparency, clinical validation and safety requirements, regulatory and ethical considerations, and economic evaluation).
conclusionsThe adaptation of the HTA process through a methodological framework for AI-based medical devices enhances the comparability of results across different evaluations and jurisdictions. By defining the necessary expertise, the framework supports the development of a skilled workforce capable of conducting robust and reliable HTAs of AI-based medical devices. A comprehensive adapted HTA framework for AI-based medical devices can provide valuable insights into the effectiveness, cost-effectiveness, and societal impact of AI-based medical devices, guiding their responsible implementation and maximizing their benefits for patients and health care systems.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.