This Leading Article proposes a conceptual but operationally applicable framework that positions Medical Affairs as a Strategic Enterprise Integrator, responsible for coordinating lifecycle evidence architecture, scientific exchange, insight translation, and governance across development and real-world settings.
This article presents IEGP development as a collaborative and strategic process, which enables pharmaceutical companies to demonstrate the holistic value of a new therapy to a broader range of healthcare decision makers.
Ronaldo Fujii, Masoud Nouri, M. Khan et al.· Pharmaceutical Medicine· 1 citation
The proposed Lifecycle-Integrated Healthcare AI Governance Framework (LIHAG), a four-layer deployment-oriented governance model integrating technical robustness, ethical safeguards, regulatory compliance, regulatory compliance, and human oversight as interdependent dimensions of responsible AI deployment is proposed.
Shehu Mohammed, Neha Malhotra, Sourabh Kumar· AI and Ethics· 0 citations
A critical review examines the intersection of predictive analytics and artificial intelligence and governance at the intersection of these fields, drawing on peer-reviewed literature identified through structured searching of bibliographic metadata registries and biomedical indexes to 1 June 2026.
O. Adewuyi, Moshood Khairah Olayinka· Journal of Advances in Medic...· 0 citations
This work proposes nine operational measures - covering transparency-oriented risk and change control, traceability, subgroup and independent validation, usability-based explainability, calibrated clinical evaluation, structured labeling, version-controlled updates, and regulated end-of-life data handling - to support...
E. Bianchini, L. Billeci, Noemi Conditi et al.· Expert Review of Medical Dev...· 0 citations
A targeted evidence synthesis and framework mapping exercise drawing on review-level evidence, scientific databases and regulatory sources found that a codesigned worksheet approach can support proportionate evidence capture and iterative risk management while remaining adaptable across use cases and maturity levels.
Tahmina Zebin, Jin-Yang Wu, F. Colecchia et al.· BMJ Innovations· 0 citations
A Control–Preventability Principle is proposed that allocates accountability according to control, foreseeability, preventability, and meaningful oversight capacity across developers, deploying institutions, and clinicians, with accountability following control over preventable risk rather than merely the physical loca...
Tony T. Williams, Amna Jatoi, Sazain Malik et al.· Journal of Global Social Tra...· 0 citations
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