Establishing and implementing a responsible artificial intelligence framework: a 1-year review
Open accessAbstract
Objective: This work highlights successes and challenges of implementing a novel responsible artificial intelligence (RAI) framework, emphasizing healthcare disciplines needed to operationalize it. Materials and Methods: UNC Health developed an RAI framework to assess artificial intelligence (AI) solutions, featuring a 21-question intake survey aligned with institutional goals to promote fairness, transparency, accountability, and trustworthiness, and evaluated by clinical, analytical, and operational experts. Results: Twelve survey evaluations revealed low fairness scores and resulted in 83% conditional approvals. Discussion: Learnings included the importance of representative training datasets, systematic evaluation of vendor-provided models, and robust post-implementation monitoring. Challenges included the infrequency of analyses stratified by demographics, limited vendor transparency, and reliance on volunteer engagement for survey evaluations. Conclusions: Our framework provides a roadmap to assess AI tools in healthcare but requires overcoming implementation barriers like resource constraints and vendor cooperation. Future iterations should consider tiered evaluations based on risk likelihood and member engagement for scalability.
AI snapshot
Written from the paper’s full text.
TL;DR
UNC Health developed and implemented a responsible AI (RAI) framework built on four pillars—fairness, transparency, accountability, and trustworthiness—operationalized through a 21-question vendor intake survey scored by volunteer multidisciplinary evaluators. After one year and 12 evaluations, the framework produced 83% conditional approvals but exposed low fairness scores, limited vendor transparency, and an unsustainable volunteer-dependent review process.
Key findings
- Twelve survey evaluations were conducted; 10 (83%) received conditional approval and 2 were rejected, one of which was a "rapid rejection" where no official scoring could be done because the vendor could not provide adequate detail (its underlying machine vision model was built with another vendor's software).
- Fairness scores were lowest among the pillars, ranging from 55.8% to 90.0%; most respondents did not stratify validation performance by demographic groups, and none did so for underserved populations. Other pillar ranges were 60.4%–89.6% (transparency), 62.0%–87.2% (accountability), and 61.3%–92.8% (trustworthiness).
- Most evaluations (58%) assessed tools using radiologic imaging as input, intersecting with cardiology, neurology, and oncology; neural networks were the most prevalent modeling technique. Training sample sizes varied between 90 and tens of thousands.
- Lower transparency scores stemmed from reluctance to share proprietary-adjacent model details; lower accountability scores from absent monitoring and retraining processes (often shifting error reporting to users); lower trustworthiness scores from lack of independent published validation. The median number of evaluators was 5.5, reflecting difficulty sustaining volunteer engagement.
Methods
- Design: a single-institution, system-level RAI governance framework at UNC Health, developed by the AI and Automation Advisory (AAA) group beginning in 2023, translating four pillars (fairness, transparency, accountability, trustworthiness) into a 21-question intake survey with each pillar scored to a maximum of 5 points per question.
- Process: AI tool requests trigger three reviews (architecture, security, RAI); RAI survey responses are scored independently by at least five volunteer evaluators from twelve disciplines (never IT-only) on a 5-point Likert scale, with consensus discussion and a vote recommending approval, conditional approval, or rejection, submitted to AAA.
- Analysis: a 1-year retrospective review of 12 completed survey evaluations, with scores reported as the sum of evaluators' points relative to maximum possible points, summarized by pillar in Table 2.
Limitations
- Stated: the volunteer structure provided no protected administrative time, resulting in minimal engagement and long decision lead times; the volume of timely, thorough evaluations was unsustainable. The framework also lacks a formulaic score threshold to dictate approval or rejection, and some intake questions were misaligned with the models employed (some techniques are not easily interpretable).
- Stated: the intake survey could benefit from additional questions on how training and validation data were collected, and on risk severity and likelihood; it was developed before ONC HTI-1 guidance, though most questions align closely with it.
- Evident from the text: findings rest on only 12 evaluations at a single health system, with a median of 5.5 evaluators per tool, and the underlying data cannot be shared publicly due to vendor confidentiality agreements, limiting external verification.
Model-written summary. Check it against the paper before relying on it.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
1 of 5 cited sources checked · 1 supported · 0 flagged
- Findingown data
Twelve survey evaluations were conducted according to the RAI framework.
“To date, 12 survey evaluations were conducted according to the RAI framework.”
- Also stated in: § Abstract · plain
“Twelve survey evaluations revealed low fairness scores and resulted in 83% conditional approvals.”
Quote in the paperNot a substantial claim - Also stated in: § Abstract · plain
- Findingown data
Despite several response iterations to the intake survey, the vendors were unable to provide adequate details that could be evaluated because another vendor's software was used to build the underlying machine vision model.
“Despite several response iterations to the intake survey, the vendors were unable to provide adequate details that could be evaluated as another vendor's software was used to build the underlying machine vision model.”
Quote in the paperNot a substantial claim - Findingown data
The median number of evaluators was 5.5.
“A survey evaluation was not considered complete until at least five evaluators had submitted scores; however, the median number of evaluators was 5.5.”
Quote in the paperSubstantial claim - Findingreasoning
There was occasional misalignment of the input importance question with the model employed, as some techniques are not easily interpretable.
“Secondary to detail omission, there was occasional misalignment of the input importance question (3.2.1.)with the model employed, as some techniques are not easily interpretable.”
Quote in the paperNot a substantial claim - Findingown data
Lower transparency scores in the survey evaluation were often caused by a reluctance to share proprietary-adjacent model details in the intake survey responses.
“Lower transparency scores in the survey evaluation were often caused by a reluctance to share proprietary-adjacent model details in the intake survey responses.”
Quote in the paperNot a substantial claim
- Findingnone given
Most vendors provided limited specifics about model performance monitoring, minimum performance assurances, or retraining criteria and frequency, placing the responsibility on the health system to monitor.
“Most vendors provided limited specifics about model performance monitoring, minimum performance assurances, or retraining criteria and frequency, placing the responsibility on the health system to monitor.”
Quote in the paperSubstantial claim - Findingnone given
Vendors often neglected bias investigations or mitigation methods for potential biases in training data.
“Similarly, vendors often neglected bias investigations or mitigation methods for potential biases in training data.”
Quote in the paperSubstantial claim - Findingown data
There was noteworthy variation in training sample size ranging between 90 and tens of thousands.
“There was also noteworthy variation in training sample size ranging between 90 and tens of thousands.”
Quote in the paperNot a substantial claim - Findingreasoning
The most prevalent modeling technique employed in the evaluated tools was a neural network.
“As image classification and segmentation are common for radiologic use cases, the most prevalent modeling technique employed was a neural network.”
Quote in the paperNot a substantial claim - Findingnone given
The framework was intentionally and primarily enforced by a diverse community of clinicians, analysts, and staff, who are closest to patient care and most aware of the risks that unvetted AI can pose.
“Uniquely, this framework was intentionally and primarily enforced by a diverse community of clinicians, analysts, and staff, who are closest to patient care and most aware of the risks that unvetted AI can pose.”
Quote in the paperSubstantial claim - Findingown data
Most survey evaluations (58%) assessed tools that utilized radiologic imaging as input, intersecting with cardiology, neurology, and oncology applications.
“Most survey evaluations (58%) assessed tools that utilized radiologic imaging as input, intersecting with cardiology, neurology, and oncology applications.”
Quote in the paperNot a substantial claim - Findingown data
Lower trustworthiness scores aligned with a lack of independent, published validation of model performance.
“Lastly, lower trustworthiness scores aligned with a lack of independent, published validation of model performance.”
Quote in the paperNot a substantial claim - Findingown data
Some vendors admitted that demographic data was not collected.
“Other vendors justified their non-response by admitting such data was not collected, implying fairness was not a development priority.”
Quote in the paperNot a substantial claim - Interpretationreasoning
For those vendors who admitted demographic data was not collected, fairness was not a development priority.
“Other vendors justified their non-response by admitting such data was not collected, implying fairness was not a development priority.”
Quote in the paperNot a substantial claim - Interpretationnone given
Introducing the RAI review to existing security and architecture reviews added complexity to the final implementation decision.
“From an organizational perspective, introducing the RAI review to existing security and architecture reviews added complexity to the final implementation decision.”
Quote in the paperNot a substantial claim - Interpretationreasoning
After 1 year, it was evident that the volume of thorough assessments was unsustainable without a larger body of evaluators and system-level support and incentives.
“After 1 year, it was evident that the volume of thorough assessments was unsustainable without a larger body of evaluators and system-level support and incentives.”
Quote in the paperSubstantial claim - Premisecitation
National frameworks such as the Blueprint for Trustworthy AI offer high-level guidance on fairness, transparency, and safety but stop short of prescribing actionable processes for health systems.
“National frameworks, such as the Blueprint for Trustworthy AI, offer high-level guidance on fairness, transparency, and safety but stop short of prescribing actionable processes for health systems.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [1] Coalition for Health AI, 2023
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Interpretationown data
The low evaluator median and the total number of evaluations completed over 1 year were emblematic of difficulties maintaining volunteer community engagement.
“This low evaluator median and the total number of evaluations completed over 1 year were emblematic of difficulties maintaining volunteer community engagement.”
Quote in the paperNot a substantial claim - Interpretationown data
Fairness appears to be an under-considered model attribute.
“Given many vendors failed to provide performance metrics stratified by patient demographics and did not consider or address training data bias, fairness appears to be an under-considered model attribute, which should prompt implementation apprehension.”
Quote in the paperSubstantial claim - Interpretationreasoning
The volume of timely and thorough evaluations was unsustainable.
“Coupled with increasing system interest in AI tools, the volume of timely and thorough evaluations was unsustainable.”
Quote in the paperSubstantial claim - Premisecitation
Trivedi et al introduced a specialty-specific rubric developed by a Radiology AI Council to assess clinical utility, integration, and post-deployment performance of radiology AI tools.
“Trivedi et al introduced a specialty-specific rubric developed by a Radiology AI Council to assess clinical utility, integration, and post-deployment performance of radiology AI tools.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [3] Trivedi, 2025, AI in action: a road map from the radiology AI council for effective model evaluation and deployment, J Am Coll Radiol source
- Classified as probably not a substantial claim. 19
- May combine two claims. 15
- The quote only partly states this claim. 1
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationSaenz et al developed a system-wide governance model at Mass General Brigham, operationalizing responsible AI principles through a structured intake process, shadow deployments, and a real-world case study in generative AI documentation.
“Similarly, Saenz et al developed a system-wide governance model at Mass General Brigham, operationalizing responsible AI (RAI) principles through a structured intake process, shadow deployments, and a real-world case study in generative AI documentation.”
Quote in the paperNot a substantial claim1 of 1 sources checked- cites [4] Saenz, 2024, Establishing responsible use of AI guidelines: a comprehensive case study for healthcare institutions, NPJ Digit Med source
Classified as probably not a substantial claim.
Findingnone givenVendors claimed negligible differences in magnetic resonance imaging or computed tomography scans across race.
“Vendors claimed negligible differences in magnetic resonance imaging or computed tomography scans across race, but a stratified analysis is necessary to unambiguously demonstrate not only fairness but also transparency, trustworthiness, and applicability across all populations.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingnone givenMost of the intake survey questions align closely with ONC's source attributes guided by fair, appropriate, valid, effective, and safe principles.
“While our framework was developed before ONC's guidance, most of our intake survey questions align closely with their source attributes guided by fair, appropriate, valid, effective, and safe principles.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataThe remaining pillars showed similar score ranges: 60.4% to 89.6% for transparency, 62.0% to 87.2% for accountability, and 61.3% to 92.8% for trustworthiness.
“The remaining pillars showed a similar range in scores: 60.4% to 89.6% for transparency, 62.0% to 87.2% for accountability, and 61.3% to 92.8% for trustworthiness.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataMost respondents did not stratify validation performance by demographic groups, and none did so for underserved populations.
“Most respondents did not stratify validation performance by demographic groups, and none did so for underserved populations.”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataLower accountability scores were commonly due to a lack of monitoring processes, often placing responsibility on users to monitor and report errors to the vendor, and a lack of retraining processes without a regular cadence for model updates.
“Lower accountability scores were commonly due to a lack of monitoring processes in place, often placing the responsibility on users to monitor and report errors to the vendor, as well as a lack of retraining processes in place without a regular cadence for model updates.”
Quote in the paperNot a substantial claimThe quote only partly states this claim.
Findingown dataThrough the UNC Health investigation, four concepts emerged as key pillars of responsible AI models: fairness, transparency, accountability, and trustworthiness.
“Through this investigation, four concepts emerged as key pillars of RAI models.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingown dataOne of the two rejections was a rapid rejection, which differed from a traditional rejection as no official scoring could be done.
“One of the 2 rejections was a”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingnone givenOne exemplary intake survey response (evaluation L) provided important interpretation.
“However, one exemplary intake survey response (evaluation L) provided such important interpretation.”
Quote in the paperNot a substantial claimMay combine two claims.
FindingreasoningThe volunteer structure did not provide protected administrative time, resulting in minimal engagement and long lead times for a decision.
“Though the formation of a multidisciplinary committee to perform RAI evaluations was met with enthusiasm, the volunteer structure did not provide protected administrative time, resulting in minimal engagement and long lead times for a decision.”
Quote in the paperSubstantial claimMay combine two claims.
FindingreasoningFairness scores dipped the lowest amongst the pillars, ranging from 55.8% to 90.0%, mainly due to insufficient consideration for fairness throughout model building.
“Fairness scores dipped the lowest amongst the pillars, ranging from 55.8% to 90.0%, mainly due to insufficient consideration for fairness throughout model building.”
- Also stated in: § Abstract · plain
“Twelve survey evaluations revealed low fairness scores and resulted in 83% conditional approvals.”
Quote in the paperSubstantial claim- Also stated in: § Abstract · plain
May combine two claims.
Findingown dataMany vendors failed to provide performance metrics stratified by patient demographics and did not consider or address training data bias.
“Given many vendors failed to provide performance metrics stratified by patient demographics and did not consider or address training data bias, fairness appears to be an under-considered model attribute, which should prompt implementation apprehension.”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataTen of the survey evaluations (83%) were conditionally approved, and the remaining two were rejected.
“Ten of the survey evaluations (83%) were conditionally approved, and the remaining two were rejected.”
- Also stated in: § Abstract · plain
“Twelve survey evaluations revealed low fairness scores and resulted in 83% conditional approvals.”
Quote in the paperNot a substantial claim- Also stated in: § Abstract · plain
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductnone givenEach AI tool must have a minimum of five evaluators but cannot consist of only IT professionals.
“Each tool must have a minimum of five evaluators but cannot consist of only IT professionals.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based).
InterpretationreasoningContinuous monitoring ensures that models perform accurately and consistently across all patient demographics, maintaining the integrity and reliability of AI applications within the health system.
“Continuous monitoring ensures that models perform accurately and consistently across all patient demographics, maintaining the integrity and reliability of AI applications within the health system.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable). May combine two claims.
InterpretationreasoningCollaboration between vendors and healthcare delivery organizations is essential, and monitoring responsibility should ideally be shared.
“As such, this exercise has reinforced our perspective that collaboration between vendors and healthcare delivery organizations is essential and that monitoring responsibility should ideally be shared.”
Quote in the paperNot a substantial claimMay combine two claims.
Interpretationown dataThe intake survey responses illuminated a need for all vendors to expand upon fairness investigations and to improve transparency efforts for certain algorithm types.
“Additionally, the intake survey responses illuminated a need for all vendors to not only expand upon fairness investigations but to improve transparency efforts for certain algorithm types.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationAs proposed by the Food and Drug Administration, AI tool vendors or manufacturers should be responsible for post-market surveillance through real-world performance monitoring.
“As proposed by the Food and Drug Administration, AI tool vendors or manufacturers should be responsible for post-market surveillance through real-world performance monitoring.29”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [29] Food and Drug Administration (FDA), Department of Health and Human Services (HHS), 2019
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
May combine two claims.
PremisecitationThe World Health Organization presented 6 governance principles and elements that governance frameworks should include, yet fails to offer a specific, enforceable governance framework to systematically and comprehensively assess AI tools in medicine.
“Internationally, the World Health Organization presented 6 governance principles, and elements that governance frameworks should include, yet similarly fails to offer specific, enforceable governance framework to systematically and comprehensively assess AI tools in medicine.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [2] World Health Organization, 2021
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Interpretationnone givenManaging a centralized AI review required balancing enterprise-wide resources with individual hospital needs, primarily accomplished by AAA.
“Managing a centralized AI review required balancing enterprise-wide resources with individual hospital needs, primarily accomplished by AAA, the RAI oversight body.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductnone givenThe survey evaluation is completed independently by each member, with each intake survey response assessed for sufficiency on a 5-point Likert scale.
“The survey evaluation is completed independently by each member whereby each intake survey response is assessed for sufficiency according to a 5-point Likert scale (1 ¼”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningGiven the variety of data ownership policies, system resource constraints, and application specifics, nuanced monitoring responsibility could fall to the vendor or health system.
“However, given the variety of data ownership policies, system resource constraints, and application specifics, nuanced monitoring responsibility could fall to the vendor or health system.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenEvaluators convene to discuss responses with inter-evaluator disagreement or low average score to establish consensus on deficits, followed by a vote to recommend approval, conditional approval, or rejection based on RAI merits.
“Evaluators then convene to discuss responses with inter-evaluator disagreement or low average score to establish consensus on deficits, followed by a vote to recommend approval, conditional approval, or rejection of the tool based on its RAI merits, where conditional approval offers a pathway to approval if specific requirements are met.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown dataThe RAI intake survey responses are evaluated by a group of volunteer technical advisors from twelve disciplines, including medical specialties and health system departments.
“The RAI intake survey responses are evaluated by a group of volunteer technical advisors from twelve disciplines including medical specialties (eg, cardiology, radiology, internal medicine, pathology, and laboratory medicine, emergency medicine) and health system departments (eg, nursing, community health, population health, data sciences, IT, ambulatory services, analytics solutions management) (”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Interpretationnone givenHaving procedures to manage one or more rejections was necessary to reconcile all review outcomes.
“Having procedures to manage one or more rejections was necessary to reconcile all review outcomes.”
Quote in the paperNot a substantial claimMay combine two claims.
InterpretationreasoningThe community approach allowed leveraging diverse expertise but also led to variability in the thoroughness of model survey evaluations.
“The community approach allowed us to leverage diverse expertise but also led to variability in the thoroughness of model survey evaluations.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S4 (based).
Interpretationnone givenThe RAI framework formed at UNC Health ensures only models with adequate fairness, transparency, accountability, and trustworthiness will be implemented.
“The RAI framework formed at UNC Health ensures only models with adequate fairness, transparency, accountability, and trustworthiness will be implemented.”
Quote in the paperNot a substantial claim- Rests on an assumption: Health systems face challenges in scaling responsible AI oversight across diverse clinical domains.
Probably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningA stratified analysis is necessary to unambiguously demonstrate fairness, transparency, trustworthiness, and applicability across all populations.
“Vendors claimed negligible differences in magnetic resonance imaging or computed tomography scans across race, but a stratified analysis is necessary to unambiguously demonstrate not only fairness but also transparency, trustworthiness, and applicability across all populations.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningGiven the limited AI model details in those areas, health systems may need to further consider whether internal post-implementation monitoring infrastructure is necessary.
“Given the limited AI model details in those areas, health systems may need to further consider whether internal post-implementation monitoring infrastructure is necessary.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenA survey evaluation was not considered complete until at least five evaluators had submitted scores.
“A survey evaluation was not considered complete until at least five evaluators had submitted scores; however, the median number of evaluators was 5.5.”
Quote in the paperNot a substantial claim
The paper relies on this without support.
Health systems face challenges in scaling responsible AI oversight across diverse clinical domains.
“Despite these efforts, health systems still face challenges in scaling RAI oversight across diverse clinical domains.”
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Reported median evaluator count conflicts with Table 2
MinorTable 2 lists evaluator counts of 6, 5, 5, 6, 7, 7, 6, 8, 5, 5, 6, and 5. Their median is 6, not 5.5; excluding the rapid rejection, which had no official scoring, also gives a median of 6.
“however, the median number of evaluators was 5.5.”
“| Evaluators (n) | | 6 | | | | 5 | | 5 | | 6 | 7 | 7 | | 6 | 8 | 5 | 5 | 6 | 5 |”
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- Authors
- Tsoi, A. H., Gartner, G., Cotten, S. W., Kim, J., Nazarian, J., Thomas, J., McSwain, S. D., Ahmadi-Moosavi, R., & Rimal, R.
- Affiliations
- University of North Carolina Health Care (US)
- University of North Carolina at Chapel Hill (US)
- Corresponding author
- Rimal, Ram
- Venue
- Journal of the American Medical Informatics Association
- Publisher
- Oxford University Press (OUP)
- Published
- 2025-09-13
- Volume
- 32
- Issue
- 11
- Pages
- 1778-1784
- ISSN
- 1067-5027 (ISSN-L)
- 1527-974X
- PMC
- PMC12626206
- OpenAlex
- W4414347756
- Cited by
- 4
- References
- 8
- Citations by year
- 2026: 4
- FWCI
- 0.97
- Type
- journal article
- Language
- en
- Open access
- green
- pmc.ncbi.nlm.nih.gov
- Locations
- Journal of the American Medical Informatics Association (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (submittedVersion)
- UNC Libraries
- Topics
- Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
- Social Sciences › Safety Research › Ethics and Social Impacts of AI
- Physical Sciences › Computer Science › Artificial Intelligence › Explainable Artificial Intelligence (XAI)
- Keywords
- responsible AI, AI governance framework, AI evaluation, fairness, transparency, accountability, trustworthiness, training data representativeness, post-implementation monitoring, demographic stratification, volunteer evaluation
- MeSH terms
- Artificial Intelligence, Humans, Surveys and Questionnaires, Delivery of Health Care, Integrated
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