ArticleBMC medical informatics and decision making2025
Streamlining medical software development with CARE lifecycle and CARE agent: an AI-driven technology readiness level assessment tool.
Article in BMC medical informatics and decision making, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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Who cites it
3 citing papers in PubMed.
- Guidance for laboratory implementation, governance and continuous assurance of artificial intelligence in histopathology.Virchows Archiv : an international journal of pathology · 2026Review
- Review
- A Systematic Literature Review on Integrated Deep Learning and Multiagent Vision-Language Frameworks for Pathology Image Analysis and Report Generation.Computational and structural biotechnology journal · 2026Review
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDeveloping medical software requires navigating complex regulatory, ethical, and operational challenges. A comprehensive framework that supports both technical maturity and clinical safety is essential for effective artificial intelligence and machine learning system deployment. This paper introduces the Clinical Artificial Intelligence Readiness Evaluator Lifecycle and the Clinical Artificial Intelligence Readiness Evaluator Agent-a framework and AI-driven tool designed to streamline technology readiness level assessments in medical software development.
methodsWe developed the framework using an iterative process grounded in collaborative stakeholder analysis. Key institutional stakeholders-including clinical informatics experts, data engineers, ethicists, and operational leaders-were engaged to identify and prioritize the regulatory, ethical, and technical requirements unique to clinical AI/ML development. This approach, combined with a thorough review of existing methodologies, informed the creation of a lifecycle model that guides technology maturation from initial concept to full deployment. The AI-driven tool was implemented using a retrieval-augmented generation strategy and evaluated through a synthetic use case (the Diabetes Outcome Predictor). Evaluation metrics included the proportion of correctly addressed assessment questions and the overall time required for automated review, with human adjudication validating the tool's performance.
resultsThe findings indicate that the proposed framework effectively captures the complexities of clinical AI development. In the synthetic use case, the AI-driven tool identified that 32.8% of the assessment questions remained unanswered, while human adjudication confirmed discrepancies in 19.4% of these instances. These outcomes suggest that, when fully refined, the automated assessment process can reduce the need for extensive multi-stakeholder involvement, accelerate project timelines, and enhance resource efficiency.
conclusionsThe Clinical Artificial Intelligence Readiness Evaluator Lifecycle and Agent offer a robust and methodologically sound approach for evaluating the maturity of medical AI systems. By integrating stakeholder-driven insights with an AI-based assessment process, this framework lays the groundwork for more streamlined, secure, and effective clinical AI development. Future work will focus on optimizing retrieval strategies and expanding validation across diverse clinical applications.
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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.