Identifying Ethical Considerations for Machine Learning Healthcare Applications
Open accessAbstract
Along with potential benefits to healthcare delivery, machine learning healthcare applications (ML-HCAs) raise a number of ethical concerns. Ethical evaluations of ML-HCAs will need to structure the overall problem of evaluating these technologies, especially for a diverse group of stakeholders. This paper outlines a systematic approach to identifying ML-HCA ethical concerns, starting with a conceptual model of the pipeline of the conception, development, implementation of ML-HCAs, and the parallel pipeline of evaluation and oversight tasks at each stage. Over this model, we layer key questions that raise value-based issues, along with ethical considerations identified in large part by a literature review, but also identifying some ethical considerations that have yet to receive attention. This pipeline model framework will be useful for systematic ethical appraisals of ML-HCA from development through implementation, and for interdisciplinary collaboration of diverse stakeholders that will be required to understand and subsequently manage the ethical implications of ML-HCAs.
AI snapshot
Written from the paper’s full text.
TL;DR
This paper argues that ethical appraisal of machine learning healthcare applications should begin with a structured map of the technology’s lifecycle and parallel oversight tasks, rather than ad hoc reactions. It proposes a pipeline framework that links stage-specific questions and value conflicts to both familiar and potentially novel ethical considerations.
Key findings
- The authors propose a pipeline model covering conception, development, calibration, implementation, and evaluation/oversight, with a parallel track for evaluation and oversight; onto this they layer questions that surface value-based issues and ethical considerations.
- They identify five challenges to identifying ethical issues: uncertainty about emerging technology impacts, questionable AI/ML exceptionalism, wide breadth of applications, narrow focus on algorithmic fairness/bias, and diverse stakeholder perspectives.
- Across stages, they highlight ethical concerns such as transparency/auditability and conflicts of interest at conception; training-data bias, data ownership/privacy, and risk of perpetuating inequities at development; accuracy trade-offs and equitable performance at calibration; and adverse events, ongoing accuracy monitoring, unintended uses, workflow/resource effects, and access equity at implementation/evaluation.
- No quantitative results or effect sizes are reported; the paper is conceptual and cites examples from other contexts (e.g., recidivism prediction, Framingham risk data) rather than presenting new empirical data.
Methods
- Design: conceptual/normative framework development, using a pipeline model and overlaying key questions and ethical considerations.
- Data or sample: literature review to identify ethical considerations (review methods said to be in an appendix, not included in the provided text); no human subjects or empirical dataset.
- Main analysis: mapping ML-HCA lifecycle stages to evaluation/oversight tasks and linking stage-specific value questions to ethical considerations; intended for interdisciplinary stakeholder dialogue.
Limitations
- Stated: the authors say the framework and its mapping are incomplete and need further work by diverse stakeholders; it does not assign responsibility; and it focuses on identifying considerations, not evaluating them or resolving trade-offs.
- Stated: subsequent trade-off decisions require detailed content and context-specific knowledge.
- Evident: the paper offers no empirical validation or application of the framework, and the literature review methods are not available in the provided text (appendix referenced but absent), so the review’s rigor cannot be assessed.
Model-written summary. Check it against the paper before relying on it.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
0 of 46 cited sources checked · 0 supported · 0 flagged
- Findingcitation
The paper's literature review identified privacy of personal data in business arrangements as a cited ethical consideration for ML-HCAs.
“the privacy of personal data in business arrangements”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites Comfort N. 2016
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- cites Hern 2017
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- Premisecitation
ML-HCAs will substantially affect healthcare processes, quality, cost, and access.
“Almost certainly, ML-HCAs will have a substantial impact on healthcare processes, quality, cost, and access”
Quote in the paperSubstantial claim0 of 3 sources checked- cites Obermeyer and Emanuel 2016
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- cites Rajkomar, Dean, and Kohane 2019
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- cites Maddox, Rumsfeld, and Payne 2019
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- Premisecitation
ML-HCAs raise specific and possibly unique ethical considerations in healthcare.
“in so doing will raise specific and perhaps unique ethical considerations and concerns in the healthcare context”
Quote in the paperSubstantial claim0 of 3 sources checked- cites Obermeyer and Emanuel 2016
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- cites Rajkomar, Dean, and Kohane 2019
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- cites Maddox, Rumsfeld, and Payne 2019
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- Interpretationreasoning
The identification of ethical concerns for ML-HCAs has been reactive, ad hoc, and fragmented.
“the identification of ethical concerns arising from this emerging, complex, cross-disciplinary technology that potentially affects many aspects of healthcare has thus far been reactive, ad hoc, and fragmented”
Quote in the paperSubstantial claim- Rests on an assumption: No systematic approach has yet emerged regarding how to survey the landscape of ML-HCA conception, development, calibration, implementation, evaluation, and oversight.
- Interpretationreasoning
The associations between the data elements that underwrote the outcome prediction are likely to change over time, due to changes in populations, technology, and processes of care.
“The associations between the data elements that underwrote the outcome prediction are likely to change over time, due to changes in populations, technology, and processes of care.”
Quote in the paperSubstantial claim
- Interpretationcitation
Conversely, an algorithm's over-reliance on research-grade data alone may miss important clinically relevant sources of knowledge, lowering the quality of care delivered.
“Conversely, an algorithm’s over-reliance on research-grade data alone may miss important clinically relevant sources of knowledge, lowering the quality of care delivered”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Fenton et al. 2007
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- Premisecitation
In healthcare, when used to predict cardiovascular event risk in non-Caucasian populations, Framingham study data has shown bias both over- and under-estimating risk for different specific populations.
“In healthcare, when used to predict cardiovascular event risk in non-Caucasian populations, Framingham study data has shown bias both over- and under-estimating risk for different specific populations”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites Gijsberts et al. 2015
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- Premisecitation
Just as there are debates regarding drug pricing, when the initial development of a drug was supported by federal or non-profit funding prior to acquisition and further development by a pharmaceutical company, similar debates are already emerging with ML-HCAs.
“Just as there are debates regarding drug pricing, when the initial development of a drug was supported by federal or non-profit funding prior to acquisition and further development by a pharmaceutical company, similar debates are already emerging with ML-HCAs”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites Ornstein 2018
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- Premisecitation
An important and acknowledged concern in the development of ML-HCAs relates to the possibility of bias, particularly whether latent biases in training data may be perpetuated or even amplified.
“An important and acknowledged concern (Char, Shah, and Magnus 2018)(Rajkomar, Dean, and Kohane 2019) in the development of ML-HCAs relates to the possibility of bias, particularly whether latent biases in training data may be perpetuated or even amplified.”
Quote in the paperSubstantial claim0 of 2 sources checked- cites Char, Shah, and Magnus 2018
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- cites Rajkomar, Dean, and Kohane 2019
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- Premisereasoning
A key aspect of determining the safety of any healthcare application depends upon the ability to inspect the application.
“A simple but key aspect of determining the safety of any healthcare application depends upon the ability to inspect the application”
Quote in the paperSubstantial claim - Premisecitation
ML programs designed to aid judges in sentencing by predicting an offender's risk for recidivism have shown a disturbing propensity for racial discrimination.
“ML programs designed to aid judges in sentencing by predicting an offender’s risk for recidivism have shown a disturbing propensity for racial discrimination”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites Angwin et al 2016
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- Premisereasoning
ML-HCAs can present a 'black box' problem, with workings that are not inspectable by evaluators, clinicians, and patients.
“ML-HCAs, however, can present a ‘black box’ problem, with workings that are not inspectable by evaluators, clinicians, and patients.”
Quote in the paperSubstantial claim - Premisecitation
Transparency about intentions or specific goals enables stakeholders to exercise evaluative and decisional autonomy.
“When designers and implementers of a ML-HCA clearly declare the intentions, indications for use, and goals for an application, clinicians, patients, regulators, and other stakeholders are better enabled to exercise their own evaluative and decisional autonomy.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Feudtner et al. 2018
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- Premisenone given
The clinical applications all seek to perform standard healthcare tasks, such as diagnosis, generating a prognosis, or assisting with treatment decision-making.
“The clinical applications all seek to perform, in novel and hopefully better ways, standard healthcare tasks, such as diagnosis, generating a prognosis, or assisting with treatment decision-making.”
Quote in the paperSubstantial claim - Interpretationreasoning
These tasks each have already identified ethical considerations that likely apply to ML-HCAs.
“These tasks each have already identified ethical considerations that likely apply to ML-HCAs.”
Quote in the paperNot a substantial claim - Interpretationcitation
Without transparency about intentions or specific goals, stakeholders cannot decide whether to support these intentions or whether the ML-HCA will advance them.
“Without transparency about intentions or specific goals, stakeholders will not be able to decide for themselves whether they want to support these intentions, or whether they believe that the ML-HCA will advance these intentions and the stated goals”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Feudtner et al. 2018
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- Premisenone given
For certain ML approaches such as neural networks, the learning methods of the system can be opaque even to system designers.
“for certain ML approaches (such as neural networks) the learning methods of the system can be opaque even to system designers”
Quote in the paperSubstantial claim - Premisecitation
Even when post hoc explainability can be provided, black box, neural-network based systems are vulnerable to 'catastrophic failures' and implicit biases in the training sets compared to more explainable ML architectures.
“Even when post hoc explainability can be provided, such black box, neural-network based systems are vulnerable to ‘catastrophic failures’ and implicit biases in the training sets compared to more explainable ML architectures”
Quote in the paperSubstantial claim0 of 2 sources checked- cites Finlayson et al. 2019
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- cites Shah et al. 2018
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- Interpretationcitation
Training of ML-HCAs against real world data, rather than high-quality research-grade data, may simply perpetuate sub-optimal clinical practices that are not aligned with the best scientific evidence.
“Training of ML-HCAs against real world data, rather than high-quality research-grade data, may simply perpetuate sub-optimal clinical practices that are not aligned with the best scientific evidence.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Fenton et al. 2007
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- Premisecitation
Mores and values can intentionally or unintentionally become embedded in the design of engineered systems.
“with growing understanding that mores and values can intentionally or unintentionally become embedded in the design of engineered systems”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Manders-Huits 2011
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- Interpretationnone given
For diagnostic ML-HCAs, training data will likely be based on data collected from individual patients obtained during routine clinical care or from individual enrollees in health insurance plans, along with personal demographic information.
“For diagnostic ML-HCAs, training data will likely be based on data collected from individual patients obtained during routine clinical care (such as laboratory test values, biopsy findings, or diagnostic images) or from individual enrollees in health insurance plans (such as medical diagnoses from medical encounters or health care utilization patterns), along with personal demographic information.”
Quote in the paperSubstantial claim - Interpretationreasoning
No sound reason as yet exists to believe that the health applications powered by ML are, in and of themselves, exceptional.
“no sound reason as yet exists to believe that the health applications powered by ML are, in and of themselves, exceptional.”
Quote in the paperNot a substantial claim - Interpretationreasoning
Standard ethical considerations about these data also likely apply to ML-HCAs.
“standard ethical considerations about these data also likely apply to ML-HCAs.”
Quote in the paperNot a substantial claim - Interpretationreasoning
Even if a ML-HCA underwent exemplary development and rigorous initial evaluation, subsequent evaluations of accuracy will be necessary over time due to association half-life.
“Even if a ML-HCA underwent exemplary development and rigorous initial evaluation, subsequent evaluations of accuracy will be necessary over time due to what can be thought of as association half-life.”
Quote in the paperSubstantial claim - Premisenone given
The technology itself is also built from essentially standard clinical information, such as patient demographic or clinical information, such as laboratory values or diagnostic images.
“The technology itself is also built from essentially standard clinical information, such as patient demographic or clinical information, such as laboratory values or diagnostic images”
Quote in the paperSubstantial claim - Interpretationreasoning
With continuous learning, 'distributional shift' can occur if target training data does not match ongoing patient data, leading an ML-HCA to begin to draw inaccurate conclusions.
“With continuous learning, ‘distributional shift’ can occur, if target training data does not match ongoing patient data (such as if the ML-HCA is applied to a population with higher pre-test probability of disease than the training population data), leading an ML-HCA to begin to draw inaccurate conclusions.”
Quote in the paperSubstantial claim - Premisecitation
There is a tendency to judge machine-based error more severely than human error.
“In such instances, there is a tendency to judge machine-based error more severely than human error (Cathy O’Neil 2017).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Cathy O’Neil 2017
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- Interpretationreasoning
Some unintended uses of an ML-HCA may be predictable before implementation.
“Some potential unintended uses may be predictable before implementation (such as a ML system for mortality prediction being co-opted to limit hospital mortality statistics or costs).”
Quote in the paperNot a substantial claim - Interpretationreasoning
The estimated accuracy of an ML-HCA depends on the clinical context in which it is assessed.
“the estimated accuracy of a ML-HCA is dependent on the clinical context in which the application is being assessed.”
Quote in the paperSubstantial claim - Premisecitation
The breadth of emerging ML-HCAs, regarding what they aim to do, how they are constructed, and where they are being applied, is remarkably broad.
“The breadth of emerging ML-HCAs, regarding what they aim to do, how they are constructed, and where they are being applied, is remarkably broad.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Ching et al. 2018
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- Premisecitation
In real-world settings, an ML-HCA's true accuracy is typically lower than in idealized validation, even when the underlying ML-HCA is locked and unchanged.
“But in real-world settings – where there is the potential for human operator error, data inputs of lower quality and nearly infinite variance, and additional potentially relevant data captured in a modality not accessible to the ML-HCA – the true accuracy is typically lower, even when the underlying ML-HCA has been locked and unchanged (Abràmoff et al. 2018).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Abràmoff et al. 2018
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- Interpretationnone given
An ML-HCA's interpretation of patient data will not be perfect even if it is superior to human interpretation.
“ML-HCA’s interpretion of patient data, even if superior to human interpretation, will certainly not be perfect.”
Quote in the paperNot a substantial claim - Interpretationreasoning
Changes in measured sensitivity, specificity, and determinability will change potential benefits, potential harms, and the benefit-to-harm ratio.
“As the measured sensitivity, specificity, and determinability change, so too will the potential benefits and potential harms, and the resulting benefit-to-harm ratio.”
Quote in the paperSubstantial claim - Interpretationreasoning
ML-HCA output, even if advisory, may take on an authority never intended.
“The output from a ML-HCA – even one that is billed as being only advisory, to offer guidance – may take on an authority never intended.”
Quote in the paperSubstantial claim - Premisecitation
In non-healthcare contexts, individuals challenging an ML-based recommendation have often been required to provide more robust evidence than the evidence on which the recommendation was based.
“This has been the case in non-healthcare contexts, where individuals who have challenged a ML-based recommendation have frequently been required to provide significantly more robust evidence to refute the ML recommendation than the evidence or data which the ML recommendation was actually based on (Cathy O’Neil 2017).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites Cathy O’Neil 2017
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- Premisecitation
ML-HCAs range from fully autonomous artificial intelligence diagnosis of diabetic retinopathy in primary care settings to non-autonomous mortality predictions to guide insurance and allocation of healthcare resources.
“ML-HCAs range from fully autonomous artificial intelligence diagnosis of diabetic retinopathy in primary care settings to non-autonomous mortality predictions to guide insurance and allocation of healthcare resources”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Ching et al. 2018
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- Premisecitation
Reference gold standards in healthcare are a known challenge.
“This is a known challenge with reference ‘gold standards’ in healthcare (Frieden 2017).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Frieden 2017
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- Interpretationnone given
Interpretation errors by an ML-HCA may cause patient harm.
“Interpretation errors may result in patient harm.”
Quote in the paperSubstantial claim - Premisecitation
Machine learning can achieve higher accuracy than individual experts when interpreting clinical images such as radiologic scans, pathology slides, and skin lesion photographs.
“While ML accuracy can be higher than that of individual experts in interpretation of clinical images such as radiologic scans, pathology slides, and photographs of skin lesions (Ching et al. 2018)”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites Ching et al. 2018
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- Classified as probably not a substantial claim. 28
- May combine two claims. 21
Probably not a substantial claim: may not pass S3 (load-bearing).
FindingcitationThe paper's literature review identified bias from training data as a cited ethical consideration for ML-HCAs.
“our review of the literature (see appendix for review methods) identified a variety of ethical considerations and concerns that have been cited, such as bias arising from the training data set”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites Challen et al. 2019
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Probably not a substantial claim: may not pass S3 (load-bearing).
FindingcitationThe paper's literature review identified accountability for ML-HCA failings as a cited ethical consideration.
“accountability for ML-HCA’s failings”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites Ross and Swelitz 2017
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Probably not a substantial claim: may not pass S3 (load-bearing).
FindingcitationThe paper's literature review identified ownership of data used to train ML-HCAs as a cited ethical consideration.
“ownership of the data used to train ML-HCAs”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites Ornstein and Thomas 2018
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Classified as probably not a substantial claim.
PremisecitationA common attribute of problem structuring methods is creating and clarifying a shared conceptual mental map of the problem.
“A common attribute across these methods is creating and clarifying (ideally with a diverse group of stakeholders) a shared conceptual mental map of the problem”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Rosenhead and Mingers 2008
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Classified as probably not a substantial claim. May combine two claims.
PremisecitationWicked problems typically defy a singular formulation, are nested within systems with interrelated problems, and have social values woven into their fabric such that solutions are better or worse rather than true or false.
“typically defy a singular formulation of the problem, are nested within systems that have interrelated problems, and have social values woven into their fabric such that solutions are not simply true or false but rather better or worse”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Rittel and Webber 1973
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InterpretationcitationEquipped with a shared conceptual map, problem solvers may identify more decisions and their interconnected consequences, which may advance value-focused thinking and improve ethical decision-making.
“Equipped with such a map, problem solvers may identify more decisions and their interconnected consequences, which in turn may advance value-focused thinking (Keeney 1992) and improve ethical decision-making (Stenmark et al. 2011).”
Quote in the paperSubstantial claim0 of 2 sources checked- cites Keeney 1992
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- cites Stenmark et al. 2011
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Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based). May combine two claims.
Interpretationnone givenMost likely, large health systems will have generated and compiled much of this 'big data', which in turn was paid for by insurance premiums and co-pays.
“Most likely, large health systems will have generated and compiled much of this “big data”, which in turn was paid for by insurance premiums and co-pays.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationThe aggregation and curation of large datasets raises issues regarding specifying the standards that high-quality reference standard data must achieve, data privacy, and data ownership.
“The aggregation and curation of these large datasets raises not only issues regarding specifying the standards that high-quality reference standard data must achieve, but also issues regarding data privacy and data ownership”
Quote in the paperSubstantial claim0 of 3 sources checked- cites Aboueid et al. 2019
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- cites Amarasingham R. et al. 2016
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- cites Cohen et al. 2014
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- Rests on an assumption: Machine learning requires large amounts of training data.
Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.
InterpretationreasoningThe pipeline framework is useful for systematic ethical appraisals of ML-HCA from development through implementation, and for interdisciplinary collaboration of diverse stakeholders.
“This pipeline model framework will be useful for systematic ethical appraisals of ML-HCA from development through implementation, and for interdisciplinary collaboration of diverse stakeholders”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based). May combine two claims.
Interpretationnone givenThe pipeline framework is neither too narrow nor too broad, applies across a wide variety of ML-HCAs, and accommodates the perspectives and concerns of different groups of stakeholders.
“This pipeline framework is neither too narrow nor too broad, applies across a wide variety of ML-HCAs, and accommodates the perspectives and concerns of different groups of stakeholders.”
Quote in the paperNot a substantial claimMay combine two claims.
InterpretationreasoningA non-inspectable, autonomous system poses a higher risk of patient harm, raises questions about the responsibility of the system in situations of harm, and could engender significant backlash against autonomous systems.
“A non-inspectable, autonomous system poses a higher risk of patient harm, raises questions about the responsibility of the system in situations of harm (and the need for the system to have malpractice insurance), and could engender significant backlash against autonomous systems.”
Quote in the paperSubstantial claimMay combine two claims.
InterpretationreasoningEvaluating the safety, efficiency, and equity for a continuous learning ML-HCA is more challenging than for a locked ML-HCA, and therefore understanding ethical considerations and addressing concerns is more difficult.
“evaluating the safety, efficiency, and equity for a continuous learning ML-HCA is more challenging, and therefore understanding ethical considerations and addressing concerns is more difficult.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based).
Interpretationnone givenTransparency needs to be balanced against protection of the intellectual property of ML-HCA design.
“Transparency, however, needs to be balanced against protection of the intellectual property of ML-HCA design.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Interpretationnone givenThe developer's choice of a ML-HCA's level of autonomy has clear implications for assumption of responsibility and liability.
“Since the developer’s choice of a ML-HCA’s level of autonomy has clear implications for assumption of responsibility and liability, this autonomy level needs to be apparent.”
Quote in the paperSubstantial claimMay combine two claims.
InterpretationreasoningAny perpetuated biases incorporated into a ML-HCA may subsequently impact clinical decisions and support self-fulfilling prophesies.
“Furthermore, any perpetuated biases incorporated into a ML-HCA may subsequently impact clinical decisions and support self-fulfilling prophesies.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).
InterpretationreasoningThe subsequent effort to curate the data and then develop the ML-HCA adds value to the raw data, but certainly not all of the value.
“The subsequent effort to curate the data and then develop the ML-HCA adds value to the raw data, but certainly not all of the value.”
Quote in the paperNot a substantial claimMay combine two claims.
InterpretationreasoningIn many cases a goal of ML-HCA is lowering cost, yet for certain conditions obtaining high quality long-term outcome data needed for validation and subsequent updating may require more not less financial resources.
“In addition, in many cases a goal of ML-HCA is lowering cost, yet for certain conditions (such as most chronic diseases, where costs are driven by long-term adverse outcomes), obtaining high quality long-term outcome data needed for validation and subsequent updating may require more not less financial resources.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Interpretationnone givenStakeholders do not need to understand in detail the inner working of an ML-HCA in order to achieve auditability.
“Stakeholders do not need to understand in detail the inner working of an ML-HCA in order to achieve “auditability.””
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
PremisecitationPotential conflicts of interest include individual financial interests and operational interests of the organization that may not be aligned with the duty of clinicians and health care delivery organizations to advance the best interest of each patient under their care.
“These potential conflicts of interest include individual financial interests (such as payment for services or personal ownership of stocks) as well as any operational interests of the organization that may not be aligned with the duty of clinicians and health care delivery organizations to advance the best interest of each patient under their care”
Quote in the paperSubstantial claim0 of 3 sources checked- cites Kohli et al. 2017
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- cites Fischer et al. 2016
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- cites Jaremko et al. 2019
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Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).
Interpretationnone givenMany data sets, particularly those involving image or biopsy interpretations, may also reflect the significant intellectual contributions of interpreting clinicians.
“Many data sets, particularly those involving image or biopsy interpretations, may also reflect the significant intellectual contributions of interpreting clinicians.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.
Interpretationnone givenOther ML-HCAs may be based on data from non-clinical sources such as personal devices, social media, financial, or legal sources, which may contain potentially controversial data elements or have been collected via novel means that we cannot foresee.
“Other ML-HCAs may be based on data from non-clinical sources (such as personal devices, social media, financial, or legal sources), which may contain potentially controversial data elements or have been collected via novel means that we cannot foresee.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationExamples already exist of predictive scores failing both because of poorly composed training data and because, when expanded to broader populations, racially discriminatory outcomes occurred.
“Examples already exist of predictive scores failing both because of poorly composed training data and because, when expanded to broader populations, racially discriminatory outcomes occurred”
Quote in the paperSubstantial claim0 of 2 sources checked- cites Char, Shah, and Magnus 2018
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- cites Obermeyer et al. 2019
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Probably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningTransparency on the part of ML-HCA developers allows clinicians, patients, and society as a whole to independently assess potential conflicts of interest and other harms that may have negative consequences outside of the AI developer's direct control.
“Transparency on the part of ML-HCA developers allows clinicians, patients, and society as a whole to independently assess potential conflicts of interest and other harms that may have negative consequences outside of the AI developer’s direct control.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationThere has been ongoing patient activism for inclusion in recognition for specimen contribution to scientific advances.
“There has also been ongoing patient activism for inclusion in recognition for specimen contribution to scientific advances”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites Bledsoe and Grizzle 2013
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InterpretationcitationHighly focused approaches such as this assume an a priori comprehensive understanding of where and why such biases are occurring; if this assumption is wrong, these approaches risk introducing a complex set of unintended biases in attempts to correct the initial bias.
“Highly focused approaches such as this assume an a priori comprehensive understanding of where and why such biases are occurring; if this assumption is wrong, these approaches risk introducing a complex set of unintended biases in attempts to correct the initial bias”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Goodman et al 2018
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Probably not a substantial claim: may not pass S4 (based).
Interpretationnone givenML-HCA is likely to raise complex and only partially considered ethical considerations with implementation.
“Along with many potential benefits to healthcare delivery, ML-HCA is likely to raise complex and as yet only partially considered ethical considerations with implementation.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationMany medical decisions and diagnoses lack a perfectly correct or incorrect label, and their downstream outcomes cannot always be predicted.
“many medical decisions and diagnoses cannot be perfectly labeled as correct or incorrect and down-stream outcomes cannot always be anticipated (Fenton et al. 2007).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Fenton et al. 2007
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Classified as probably not a substantial claim.
InterpretationreasoningThe pipeline framework is an approach for systematically identifying ethical considerations and facilitating interdisciplinary dialogue and collaboration to manage ethical implications of ML-HCAs.
“The pipeline framework, starting with a map of the conception, development, implementation, and the parallel evaluation and oversight tasks of ML-HCAs, and then layering over this map key questions, value-based issues, and ethical considerations, is an approach for systematically identifying these ethical considerations and for facilitating inter-disciplinary dialogue and collaboration to better”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S2 (checkable). May combine two claims.
InterpretationreasoningFor the ethical appraisal of any given ML-HCA, detailed content and context-specific knowledge will always be needed to provide more thorough and precise ethical evaluation, and this will require cross-disciplinary collaborations.
“For the ethical appraisal of any given ML-HCA, detailed content and context-specific knowledge will always be needed to provide more thorough and precise ethical evaluation, and this will require cross-disciplinary collaborations.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based).
Premisenone givenML-HCAs are likely to have a broad range of stakeholders, from patients and health care practitioners, to computer scientists, engineers, and entrepreneurial developers, to healthcare organizations and payers, to oversight bodies charged with regulating medical practice.
“ML-HCAs are likely to have a broad range of stakeholders, from patients and health care practitioners, to computer scientists, engineers, and entrepreneurial developers, to healthcare organizations and payers, to oversight bodies charged with regulating medical practice.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based).
InterpretationreasoningML-HCA developers and users inherit ethical operating characteristics from previous decisions about how the ML-HCA was constructed.
“ML-HCA developers and users poised at a particular point in the pipeline inheret the ethical operating characteristics that arise from previous decisions about how the ML-HCA has been constructed.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
InterpretationreasoningThe broadness of the framework helps combat narrow focus on one ethical consideration and neglect of others.
“The broadness of the framework will help combat any tendency to focus narrowly on one ethical consideration while potentially neglecting other relevant considerations and thus sidestepping grappling with tradeoffs.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim. May combine two claims.
InterpretationreasoningThe pipeline framework can be used to anticipate future development and implementation and to aid ethical evaluation and decisions.
“Heading in the other direction, the framework can also be used to look ahead, anticipating future development and implementation (or implementations in other settings). Identification of potential future consequences can aid ethical evaluation and decisions regarding design, development, implementation, and evaluation.”
Quote in the paperSubstantial claimMay combine two claims.
InterpretationreasoningWhen machine-based and human-based errors are equivalent in nature, probability, and harm magnitude, judging the machine error more severely is not legitimate and reflects pro-human or anti-machine bias.
“If, comparing the machine-based and the human-based scenarios, the nature and probability of the error and the magnitude of the ensuing harm are equivalent, this tendency does not appear to legitimate, instead reflecting a pro-human or anti-machine bias.”
Quote in the paperNot a substantial claimMay combine two claims.
InterpretationreasoningThe common basic elements of the pipeline allow comparison of ML-HCA pipelines to those of other medical technologies and show that ML-HCAs raise both novel and common issues.
“the common basic elements of the pipeline – an application is conceived of, developed, calibrated, implemented, and evaluated, with various forms of oversight – allows for ready comparison of the ML-HCA pipeline to the pipelines of other medical technologies, and to see that while ML-HCAs do raise some novel issues, they also raise many issues common to existing diagnostic or therapeutic”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
InterpretationreasoningThe pipeline framework provides a guide for individuals and groups to identify and evaluate present, past, and future ethical issues.
“the pipeline framework provides a guide to help these individuals and groups with the task of identifying and evaluating present, past, and future ethical issues.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningThis comparison can check unwarranted ML-HCA exceptionalism in ethics thinking.
“This can put a check on unwarranted ML-HCA exceptionalism in our thinking about the ethics of this emerging technology.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
InterpretationreasoningThe pipeline framework offers diverse stakeholder groups a bigger picture that can help forge a shared mental model of relevant questions and ethical considerations.
“The pipeline framework also offers groups of diverse stakeholders a “bigger picture” of ML-HCAs that can, with dialogue, help to forge a shared mental model of the range of revelant questions and ethical considerations that should guide design and evaluation decisions.”
Quote in the paperSubstantial claimMay combine two claims.
InterpretationreasoningA highly restrictive focus and limited framework may be applicable for ultimately addressing a specific ethical consideration and set of concerns, but will not suffice to manage the uncertainty regarding other potential ethical considerations.
“More generally, a highly restrictive focus and limited framework may be applicable for ultimately addressing a specific ethical consideration and set of concerns, but will not suffice to manage the uncertainty regarding other potential ethical considerations.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
InterpretationreasoningAccuracy in an ML-HCA inherently involves trade-offs among test characteristics, and these trade-offs are guided by designer value judgments with ethical implications.
“The notion of accuracy in an ML-HCA, inherently involves trade-offs between test characteristics, guided by designer value judgments with consequent ethical implications.”
Quote in the paperSubstantial claimMay combine two claims.
InterpretationreasoningML-HCAs will create new information flows and require resource allocation.
“ML-HCAs will create new information flows and consequently need resource allocation, including the important resource of clinical attention.”
Quote in the paperSubstantial claim- Rests on an assumption: Clinical attention is an important resource that must be allocated.
May combine two claims.
PremisecitationMany ML-HCA computer scientists have already turned away from ethical analysis as unworkable or not adequately responsive to ongoing ML-HCA development, have instead focused exclusively on the ethical consideration of fairness and emerging concerns regarding bias, and have begun to pursue an ideal of 'algorithmic fairness'.
“Many ML-HCA computer scientists have already turned away from ethical analysis as unworkable or not adequately responsive to ongoing ML-HCA development, have instead focused exclusively on the ethical consideration of fairness and emerging concerns regarding bias, and have begun to pursue an ideal of “algorithmic fairness,” or the ability to computationally demonstrate a lack of between-group bias”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Rajkomar et al. 2018
Not checked in the free run.
The paper relies on this without support.
No systematic approach has yet emerged regarding how to survey the landscape of ML-HCA conception, development, calibration, implementation, evaluation, and oversight.
“Notably, no systematic approach has yet emerged regarding how to survey the landscape of ML-HCA conception, development, calibration, implementation, evaluation, and oversight.”
The paper relies on this without support.
Machine learning requires large amounts of training data.
“Machine learning requires large amounts of training data.”
The paper relies on this without support.
Equitable distribution of benefits and harms among patients is ethically required.
“The key ethical consideration would be whether these inaccuracies (and any consequent harms) are outweighed by potential benefits and distributed among patients in an equitable manner.”
The paper relies on this without support.
Clinical attention is an important resource that must be allocated.
“including the important resource of clinical attention.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Distinctive ethical issues arise at different points in an AI model's life cycle, and following the 'pipeline' framework, the ethical assessment process varies with the specific stage and nature of the AI model and associated workflow.
“Distinctive ethical issues arise at different points in an AI model's life cycle, and following the 'pipeline' framework 13 , the ethical assessment process varies with the specific stage and nature of the AI model and associated workflow.”
From Standing on FURM Ground: A Framework for Evaluating Fair, Useful, and Reliable AI Models in Health Care Systems (2024) · cites this paper as [13]
The 2018 Abramoff et al trial was developed under a strict ethical framework.
“developed under a strict ethical framework.16,17”
From Autonomous Artificial Intelligence in Diabetic Retinopathy Testing—Lessons Learned on Successful Health System Adoption (2026) · cites this paper as [17]
The Abstract cites Abràmoff et al. (2018) as an example of an autonomous AI diagnostic system, and the References identify its pivotal trial. The pipeline-framework section proposes ethical considerations for machine-learning healthcare applications generally; it does not say the 2018 trial was developed under a strict ethical framework. Searches for the trial and for an ethical framework yielded no passage establishing that claim. (LLM, conf=0.76)
Experimental — accuracy not yet measuredLumineticsCore is directly connected to the camera and interfaces directly with all available electronic medical record for ordering, billing, and resulting directly.
“The system, which is directly connected to the camera, interfaces directly with all available electronic medical record (EMR) for ordering, billing, and resulting directly.13”
From Autonomous Artificial Intelligence in Diabetic Retinopathy Testing—Lessons Learned on Successful Health System Adoption (2026) · cites this paper as [13]
The Implementation, Evaluation, and Oversight section discusses electronic medical record platforms and a hypothetical diabetic-retinopathy diagnostic system, but does not describe LumineticsCore’s connections or interfaces. Searches for camera and EMR integration, ordering, billing, and resulting found no passage addressing those capabilities; page numbers were unavailable in our copy. (LLM, conf=0.74)
Experimental — accuracy not yet measuredThe degree to which the obligation to maintain confidentiality extends to AI in healthcare remains a matter of debate.
“To what degree this obligation to maintain confidentiality extends to AI in healthcare-which often require access to large amounts of sensitive health data to be effective-remains a matter of debate [36].”
From Operationalising ethics in artificial intelligence for healthcare: a framework for AI developers (2023) · cites this paper as [36]
Some potential solutions have been developed, such as exploring local datasets or local checklists for training AI, and conducting validation checks to mitigate label choice bias, but this challenge seems to persist.
“Some potential solutions have been developed, such as exploring local datasets or local checklists for training AI (Rajkomar et al., 2018(Rajkomar et al., , 2019;;Vollmer et al., 2020), and conducting validation checks to mitigate label choice bias (Char et al., 2020;Obermeyer et al., 2019), but this challenge seems to persist.”
From SHIFTing artificial intelligence to be responsible in healthcare: a systematic review (2022) · cites this paper as Char et al., 2020
These ethical and other concerns with AI in healthcare have been shown by a number of research studies.
“These ethical and other concerns with AI in healthcare have been shown by a number of research studies27–29.”
From Considerations for addressing bias in artificial intelligence for health equity (2023) · cites this paper as [28]
Bioethical analysis of the AI lifecycle by Char et al. highlighted the pipeline, ranging from conception over development to deployment ("access") of AI systems, and the parallel pipeline of evaluation and oversight activities at each stage.
“Bioethical analysis of the AI lifecycle by Char et al.28 highlighted the pipeline, ranging from conception over development to deployment (“access”) of AI systems, and the parallel pipeline of evaluation and oversight activities at each stage.”
From Considerations for addressing bias in artificial intelligence for health equity (2023) · cites this paper as [28]
These TPLC phases map in a straightforward manner to the 'pipeline phases' as defined in Char et al. and as operationalized in Abramoff et al.
“These TPLC phases map in a straightforward manner to the ‘pipeline phases’ as defined in Char et al.28 and as operationalized in Abramoff et al.32, see also ref. 46.”
From Considerations for addressing bias in artificial intelligence for health equity (2023) · cites this paper as [28]
The framework developed by Char et al. recognizes specific AI system pipeline phases: conception, development, calibration, implementation, evaluation, deployment, and oversight, and the ethical considerations, including "equity" along each of these phases.
“The framework developed by Char et al., on the other hand, recognizes specific AI system pipeline phases: conception, development, calibration, implementation, evaluation, deployment, and oversight, and the ethical considerations, including “equity” along each of these phases.”
From Considerations for addressing bias in artificial intelligence for health equity (2023) · cites this paper as [28]
Abramoff et al. proposed ethical frameworks for AI to help proactively address the issue of undesirable algorithmic bias as well as other concerns with AI.
“Abramoff et al. proposed ethical frameworks for AI27–31 to help proactively address the issue of undesirable algorithmic bias as well as other concerns with AI.”
From Considerations for addressing bias in artificial intelligence for health equity (2023) · cites this paper as [28]
Such bias reduces the bioethical principle of "Justice".
“Thus, such bias reduces the bioethical principle of “Justice,” as Char et al.28 and Abramoff et al.32 described.”
From Considerations for addressing bias in artificial intelligence for health equity (2023) · cites this paper as [28]
The use of sensitive data in life-course studies poses significant privacy concerns and ethical challenges.
“The use of sensitive data in life-course studies poses significant privacy concerns and ethical challenges [61, 62].”
From Integrating machine learning and artificial intelligence in life-course epidemiology: pathways to innovative public health solutions (2024) · cites this paper as [61]
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Self-citationTowards a pragmatist dealing with algorithmic bias in medical machine learning
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Khan, S. D., Hoodbhoy, Z., Raja, M. H. R., Kim, J. Y., Hogg, H. D. J., Manji, A. A. A., Gulamali, F., Hasan, A., Shaikh, A., Tajuddin, S., et al. (2024) · PLOS Digital Health · doi:10.1371/journal.pdig.0000514 · Cited by 36 · see citing works
Abramoff, M. D., Dai, T., & Zou, J. (2024) · NEJM AI · doi:10.1056/aipc2400083 · Cited by 32 · see citing works
Incorporating Artificial Intelligence into Healthcare Workflows: Models and Insights
Dai, T., & Abràmoff, M. D. (2023) · Tutorials in Operations Research: Advancing the Frontiers of OR/MS: From Methodologies to Applications · doi:10.1287/educ.2023.0257 · Cited by 29 · see citing works
Self-citationEthics dumping in artificial intelligence
Bélisle-Pipon, J.-C., & Victor, G. (2024) · Frontiers in Artificial Intelligence · doi:10.3389/frai.2024.1426761 · Cited by 26 · see citing works
“What fuels AI’s transformative promise and “hype” is precisely its potential to significantly reshape practices, beliefs, and decision-making processes (Matheny et al., 2019; Char et al., 2020).”
Teng, C. W., Patel, S. D., Barkmeier, A. J., Liu, T. Y. A., Myung, D., Henderer, J., Liu, J., Hansen, E., & Al-Aswad, L. A. (2026) · Ophthalmology Science · doi:10.1016/j.xops.2025.100935 · Cited by 23 · see citing works
“16,17 Of note, the statistics are calculated against a prognostic level 1 reference standard, meaning that rather than compare the performance against clinicians, it was compared against diagnostic modalities that include OCT imaging for central-involved diabetic macular edema.”
Abramoff, M. D., Mortensen, Z., & Tava, C. (2021) · Frontiers in Medicine · doi:10.3389/fmed.2021.765936 · Cited by 6 · see citing works
- Authors
- Char, D. S., Abràmoff, M. D., & Feudtner, C.
- Affiliations
- Stanford Medicine (US)
- University of Iowa (US)
- Children's Hospital of Philadelphia (US)
- Corresponding author
- Char, Danton S.
- Venue
- The American Journal of Bioethics
- Publisher
- Informa UK Limited
- Published
- 2020-10-26
- Volume
- 20
- Issue
- 11
- Pages
- 7-17
- ISSN
- 1526-5161 (ISSN-L)
- 1536-0075
- PMC
- PMC7737650
- OpenAlex
- W3093861859
- Cited by
- 415
- References
- 50
- Citations by year
- 2026: 58 · 2025: 87 · 2024: 77 · 2023: 92 · 2022: 50 · 2021: 34 · 2020: 17
- FWCI
- 14.21
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- The American Journal of Bioethics (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (K01HG008498)
- Topics
- Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
- Social Sciences › Safety Research › Ethics and Social Impacts of AI
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Keywords
- machine learning in healthcare, ethical considerations, ethical evaluation, conceptual model, implementation, oversight, stakeholder collaboration, interdisciplinary collaboration, algorithmic ethics
- MeSH terms
- Machine Learning, Delivery of Health Care, Humans, Morals
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