Cited by 90Artificial Intelligence in Healthcare and EducationEthics and Social Impacts of AISafety Systems Engineering in Autonomy

A practical framework for appropriate implementation and review of artificial intelligence (FAIR-AI) in healthcare

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Wells, Brian J., Nguyen, Hieu M., McWilliams, Andrew, Pallini, Matt, Bovi, Amy, Kuzma, Andrew, Kramer, Justin, Chou, Shih-Hsiung +25 more·2025·npj Digital Medicine

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Abstract

Health systems face the challenge of balancing innovation and safety to responsibly implement artificial intelligence (AI) solutions. The rapid proliferation, growing complexity, ethical considerations, and rising demand for these tools require timely and efficient processes for rigorous evaluation and ongoing monitoring. Current AI evaluation frameworks often lack the practical guidance for health systems to address these challenges. To fill this gap, we developed a prescriptive evaluation framework informed by a literature review, in-depth interviews with key stakeholders, including patients, and a multidisciplinary design workshop. The resulting framework provides health systems an outline of the resources, structures, criteria, and template documents to enable pre-implementation evaluation and post-implementation monitoring of AI solutions. Health systems will need to treat this or any alternative framework as a living document to maintain relevance and effectiveness as the AI landscape and regulations continue to evolve.

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  • Evidence from activated systems undergoing longitudinal monitoring provides the strongest basis for judging whether a system remains safe, equitable, clinically useful, and governable once embedded in everyday care.

    “Guidance documents can define what should matter; deployment-proximal evaluations can show whether activation appears plausible in a target setting; however, evidence from activated systems undergoing longitudinal monitoring provides the strongest basis for judging whether a system remains safe, equitable, clinically useful, and governable once embedded in everyday care.”

    From Beyond Model Development in Healthcare AI: Post-Development Robustness, Post-Deployment Monitoring, and Lifecycle Governance—A Scoping Review of Reviews (2026) · cites this paper as [50]

    In Results (Framework for the appropriate implementation and review of AI; page unavailable), the paper calls for continuous monitoring of deployed systems to check benefits, emerging risks, bias, and alignment with the approved use case. The narrative review also calls for assessing clinical utility and equity. It does not establish that evidence from longitudinally monitored systems is the strongest basis for judgment relative to guidance or deployment-proximal evaluations. (LLM, conf=0.83)

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  • These assumptions may not hold equally across low- and middle-income countries, smaller hospitals, rural systems, or institutions with limited digital maturity, where the infrastructure required for continuous monitoring, subgroup surveillance, drift detection, formal change control, and incident response may be more difficult to sustain.

    “These assumptions may not hold equally across low- and middle-income countries, smaller hospitals, rural systems, or institutions with limited digital maturity, where the infrastructure required for continuous monitoring, subgroup surveillance, drift detection, formal change control, and incident response may be more difficult to sustain [49,50,51,52].”

    From Beyond Model Development in Healthcare AI: Post-Development Robustness, Post-Deployment Monitoring, and Lifecycle Governance—A Scoping Review of Reviews (2026) · cites this paper as [50]

    Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

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  • The feasibility of lifecycle governance is likely to vary substantially across health systems because many recommendations assume access to data infrastructure, informatics expertise, technical staffing, procurement capacity, legal support, regulatory maturity, and multidisciplinary oversight structures.

    “The feasibility of lifecycle governance is likely to vary substantially across health systems because many recommendations assume access to data infrastructure, informatics expertise, technical staffing, procurement capacity, legal support, regulatory maturity, and multidisciplinary oversight structures [49,50,51,52].”

    From Beyond Model Development in Healthcare AI: Post-Development Robustness, Post-Deployment Monitoring, and Lifecycle Governance—A Scoping Review of Reviews (2026) · cites this paper as [50]

    Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

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  • Recent implementation-oriented perspectives emphasise that safe deployment depends on structured governance, staged review, and durable post-deployment accountability rather than one-time technical approval alone.

    “Recent implementation-oriented perspectives make a similar point by emphasising that safe deployment depends on structured governance, staged review, and durable post-deployment accountability rather than one-time technical approval alone [15,50,51].”
  • Comparable emphases on lifecycle management, local governance, and organisational readiness are visible in recent clinical AI implementation and oversight frameworks and in WHO guidance on AI for health.

    “Comparable emphases on lifecycle management, local governance, and organisational readiness are visible in recent clinical AI implementation and oversight frameworks, as well as in WHO guidance on AI for health [50,51,52].”

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Research works printed but not linked: 25

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Authors
Wells, B. J., Nguyen, H. M., McWilliams, A., Pallini, M., Bovi, A., Kuzma, A., Kramer, J., Chou, S.-H., Hetherington, T., Corn, P., Taylor, Y. J., Cuison, A., Gagen, M., Isreal, M., FAIR-AI Consortium, Akbilgic, O., Barr, K., Bowers, A., Caffrey, R., Carroll, M. S., CiRullo, M., Downs, S. M., Hardy, N., Heuay, J., Katzovitz, K., Kirkendall, E., Lindgren, E., Lonergan, L., McKinley, E., Pajewski, N. M., Sak-Castellano, L., Setliff, E., & Wright, G.
Affiliations
  • Wake Forest University Health Sciences (US)
  • Advocate Health Care (US)
Corresponding author
Nguyen, Hieu M.
Venue
npj Digital Medicine
Published
2025-08-11
Volume
8
Issue
1
Pages
514-514
ISSN
2398-6352 (ISSN-L)
OpenAlex
W4413107286
Cited by
90
References
13
Citations by year
2026: 80 · 2025: 10
FWCI
21.66
Type
journal article
Language
en
Open access
Locations
  • npj Digital Medicine (publishedVersion, cc-by)
  • Research Square (acceptedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
Duke Endowment (AWD00002292)
Topics
  • Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
  • Social Sciences › Safety Research › Ethics and Social Impacts of AI
  • Physical Sciences › Engineering › Safety, Risk, Reliability and Quality › Safety Systems Engineering in Autonomy
Keywords
artificial intelligence in healthcare, algorithmic fairness, AI evaluation framework, pre-implementation evaluation, post-implementation monitoring, health system implementation, AI ethics, AI safety, stakeholder engagement, living document

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