A Practical Framework for Promoting Justice-Oriented Innovation in Radiology

Abstract

This article argues that innovation should be guided by the values of the field it hopes to advance. As radiology has come to recognize its role in creating or perpetuating imaging disparities, it has become evident that imaging disparities may arise from innovations that fail to consider impacts on justice from the outset. Acknowledging that a radiologist’s deepest commitments as a physician involve doing no harm, doing good, and ensuring justice, we propose redefining stewardship in radiologic innovation to include a positive obligation to prioritize justice in innovation. Engaging in justice-oriented innovation requires an imaging disparity to be identified, understood, and targeted through a concerted developmental effort. To this end, we consider the structural changes necessary to achieve this objective and provide a template outlining a future for radiologic innovation that aims to mitigate imaging disparities. We provide a simple rubric by which innovative efforts can be deemed “justice-oriented innovations” in environments featuring a surplus of ideas and limited resources to facilitate their prioritization. Innovations that are likely to mitigate imaging disparities should have access to accelerated pipelines for development and commercialization.

Summary Sentence:

Innovation that is likely to mitigate imaging disparities—justice-oriented innovations—should be prioritized, and processes should be devised whereby justice-oriented innovations can be developed through an accelerated innovation pipeline.

Introduction

In recent years, radiology has increasingly recognized its role in creating or perpetuating health disparities, some of which may be related to the pace of innovation in radiology, offering an opportunity to reconsider innovative activities in radiology through a justice-oriented lens.^1–11 Innovation is a “human action… [that] is intentional and guided by both economic and ethico-political values,” meaning that every innovative effort is an expression of the values of the individuals engaging in it and at least partially open to intentional guidance.¹² Depending on what is created through innovative efforts and to whom the resulting innovations become available, innovations can entrench existing disparities or create new ones.^1,9 There is little controversy that dissemination challenges typically result in novel technologies being unequally distributed.^9,10 In light of this reality, the growing field of “responsible innovation” has sought to devise processes whereby innovative efforts can be thoughtfully guided, with the goal of ensuring that innovation is ethically acceptable, sustainable, and societally desirable.¹³ Put another way, “responsible innovation means taking care of the future through collective stewardship of science and innovation in the present.”¹⁴ Efforts at reorienting innovation around equity are gaining broad traction, as made evident by the recent publication of a consensus study report titled “Toward Equitable Innovation in Health and Medicine” from the National Academy of Medicine.¹¹

In an effort at incorporating elements of responsible innovation into radiology, we previously characterized various approaches by which innovation can proceed.¹⁵ Justice-oriented innovation is concerned principally with reducing imaging disparities and “views novel technologies, techniques, or processes as mere means to this end.”¹⁵ Distinguishing between innovation approaches is primarily useful in settings where prioritization occurs, such as venture fund investment, grant funding, technology transfer offices, or capital purchases. In these settings, there is always a surplus of ideas and limited resources, forcing prioritization decisions and allowing a preference for justice-oriented innovation to be implemented.

Radiology is a continuously evolving field driven by technological healthcare innovations that can result in better care for our patients. The shape that these technologies take, while in part unpredictable, can be guided by our shared values.^11,16,17 Such guidance will be imperfect and will require frequent reassessment but engaging in this guidance is an important means of fulfilling some of our deepest obligations as physicians: doing good by delivering the highest quality clinical care to our patients, doing the minimum harm, and seeking a just distribution of the benefits of imaging.^11,16,17 Given the difficulties in disseminating new technologies, continuous evaluation and reassessment of the design and implementation of new technologies is necessary to ensure equitable improvement in health outcomes.⁹ For example, new technologies that allow rapid acquisition of CT and MRI images can allow us to deliver better care, but if the design or the implementation of these technologies does not allow breath-holding instructions to be given in multiple languages, they may impact the quality of care delivered to some patients and inadvertently introduce imaging disparities.

As a radiology community with a central role in healthcare delivery and population health, we have a commitment to mitigate existing imaging disparities and to ensure, to the best of our abilities, that foreseeable novel disparities are not created. For instance, given the knowledge that AI deep learning models can predict self-reported race or assist in opportunistic screening of patients, we have the opportunity to leverage these capabilities to create more precise risk prediction models and equitably improve long term health outcomes.^18,19 However, we also have the collective obligation to ensure that these capabilities are not utilized—intentionally or otherwise—to drive discriminatory healthcare decisions.¹⁸ Meeting our obligation to ensure justice in the practice of radiology likely involves structuring our innovative activities to prioritize new technologies that simultaneously allow us to deliver high quality care and mitigate imaging disparities while ensuring the use of these technologies remains cost effective and, as a consequence, practical.

Envisioning A Practical Framework for Promoting Justice-Oriented Innovation

While much work will be required, a future that supports justice-oriented innovation in radiology is feasible and aligns with broad trends attempting to reorient innovation within medicine towards more equitable outcomes.¹¹ A pipeline for promoting justice-oriented innovation begins with the fundamentals of health disparities research, which typically follows a 3-step process: detecting disparities, exploring their underlying mechanisms, and intervening to reduce them.^20,21 This involves practicing radiologists collaborating with health services researchers and healthcare innovators through all the steps of the process, from conceptualization through implementation of new technologies in clinical practice.^22,23 Without a coordinated research agenda from the broader radiology community, the necessary background information necessary to generate justice-oriented innovations will remain insufficient. Diverse collaborations will also be able to assess the clinical impact of new technologies and articulate the case for equitable access across different practice settings. To facilitate these efforts, the foundational work accomplished in breast imaging, as an example, can be leveraged as a guide, demonstrating many of the necessary elements to achieve justice-oriented innovations in specific radiology practice settings.²⁴

Accelerating Justice-Oriented Innovation Pipelines

The next step in promoting justice-oriented innovation requires the existence of accelerated innovation pipelines for innovations likely to reduce imaging disparities and use of such accelerated pipelines by innovators. Academic medical centers, professional societies, funding bodies, and philanthropic organizations can spearhead the creation of such pipelines and can devise the advertising campaigns necessary to ensure that innovators with the relevant backgrounds are informed of accelerated pathways for justice-oriented innovation. This will require understanding the population that comprises the next generation of healthcare leaders and characterization of the barriers to their participation in innovation.²⁵ To this end, targeted educational programs aimed at providing baseline innovation education can broaden access to the fundamental principles of healthcare innovation, laying the foundation of future successes of innovation incubators or accelerator programs.²³ A broad variety of innovation incubators already exist at numerous academic medical centers and the past few decades have introduced a broad variety of accelerators for promoting rapid innovation.^26–28 These existing structures provide a useful foundation and would likely be broadly supportive of collaborative efforts at promoting justice-oriented innovations.

Identifying Probable Justice-Oriented Innovations

To gain access to accelerated innovation pipelines, innovators will need to demonstrate that they are engaged in justice-oriented innovation, and radiology leaders across healthcare institutions and professional organizations will need to be able to stratify innovative efforts based on their conformity with the expectations of justice-oriented innovation. At this stage, it would be premature to call an early innovation justice-oriented, as it will not yet have demonstrated impact on an imaging disparity, but it is possible to determine innovative efforts that are probable justice-oriented innovations.

A proposed simple rubric (Figure 1) can assist innovators and decision makers in systematically assessing whether new technologies can be considered probable justice-oriented innovations. For an innovative effort to be considered a probable justice-oriented innovation, it must be able to respond in the affirmative to the four questions proposed in the rubric, and there must be evidence to support these responses. An imaging disparity must be identified, underlying drivers of the disparity must be known, the proposed innovation should address a driver, and addressing the driver should be expected to lead to a clinically meaningful reduction in the imaging disparity. For example, there are disparities in outcomes related to osteoporosis, with low income and poverty as risk factors for osteoporotic fractures, which may be related to disparities in access to screening.²⁹ A group, identifying this disparity and the potential driver of disparities in access to screening, noted that patients at risk for lung cancer routinely undergo chest CTs, which may allow opportunistic osteoporosis screening utilizing AI.²⁹ This was shown to be technically feasible and identified a high prevalence of osteoporosis across races, income classes, and sexes, suggesting AI-based opportunistic screening may provide an avenue for addressing disparities in outcomes related to osteoporosis, such as fragility fractures.²⁹ Considerations such as those in the proposed rubric are beginning to feature in important funding sources. For example, the recently established Advanced Research Projects Agency for Health (ARPA-H) includes the following question in its application process: “To ensure equitable access for all people, how will cost, accessibility, and user experience be addressed?”^11,30 Having a systematic approach to screening ideas for their potential impacts on justice provides an opportunity to guide the development process of new technologies and transparency in the prioritization decisions that occur at the time of initial funding. In this way, new technologies in radiology could conceivably be deemed “equitable by design,” similar to the notion of “secure by design” in software development.³¹ From the perspective of an innovator, such a rubric can be paired with a traditional grant application or the seed funding process to provide a brief systematic articulation of potential impacts on an imaging disparity. From the perspective of funding bodies, assuming some sort of preference for justice-oriented innovations, it can serve as a means for evaluating all innovative proposals, stratifying and prioritizing them by their likely impacts on documented imaging disparities.

Figure 1:

Identifying Probable Justice-Oriented Innovations

Accelerated Commercialization of Justice-Oriented Innovations

Once a structure has been devised for identifying probable justice-oriented innovations, a corresponding structure must be devised for bringing them to use. This entails broadly stratifying them into two potential categories: (1) those likely to be commercially successful in markets due to the intrinsic market value of the innovation and (2) those unlikely to be commercially successful but still likely to lead to meaningful reductions in imaging disparities.

As a low-cost means of answering this question, partnerships at academic institutions with affiliated business schools can be fostered. It would be useful to formalize a relationship whereby the business school assists radiology departments with stratifying probable justice-oriented innovations into those that are likely to be commercially viable and those that are not. Such a collaboration could offer a useful filter for determining which probable justice-oriented innovations may be able to succeed on their own commercial outlook and those that would need ancillary assistance to become a reality. One such formal program at our institution is the MESH Incubator Innovation Teams biodesign program.^22,23,32 There are numerous such incubators present at academic medical centers throughout the nation, many of which are ideally situated to bridge the various stakeholders necessary for identifying commercially viable justice-oriented innovations.^26,27

Where a probable justice-oriented innovation would broaden access to an already reimbursed element of radiology practice, a synergy may exist between what is financially feasible for a radiology practice and promoting justice.¹¹ The economic burden of racial and ethnic health inequities is estimated to be over 400 billion US dollars, suggesting that achieving justice has the potential to result in some degree of economic returns if capitalized on successfully.^11,33 In such circumstances, the incentives related to return-on-investment would not differ substantially from an innovation without potential impacts on imaging disparities, and since a pipeline for acceleration would exist for justice-oriented innovations, such returns should be expected to occur with less friction than with a parallel innovation that lacks access to an accelerated pathway. In these scenarios, the role of the field of radiology is not to provide a specific financial incentive to proceed with a justice-oriented innovation but to instead offer an accelerated path to bringing such innovations to reality. In pursuing such innovations, radiology practices are ideally situated to take advantage of the lean startup model, an iterative approach to entrepreneurship emphasizing a build, measure, and learn feedback loop.³⁴ This approach shares origins with the implementation science that is common at academic medical centers but emphasizes efficiency in achieving a minimum viable product, which can be thought of as an innovative product with the minimum number of features that will persuade an end-user to purchase the product.^26,34

Decoupling the incentives for innovation from the logic of the market has been challenging because a justice-oriented lens typically gets incorporated after implementation rather than at the conceptualization or design phases of an innovation. For example, patients with physical accessibility needs encounter obstacles to routine diagnostic imaging, such as mammography, which has the unintended and undesirable result of producing imaging disparities in terms of access.^3,35,36 Innovations addressing these accessibility needs likely would not require substantial technological innovation but rather a better understanding of the needs of the population served and a range of modestly innovative solutions that address this gap in care. In cases such as these, the healthcare marketplace may not offer sufficient returns to catalyze important solutions to drivers of pervasive imaging disparities.

To encourage justice-oriented innovation addressing these types of disparities, radiology could follow a similar model to the Millennium Prize Problems, a venture from the Clay Institute that created $1 million dollar prizes for projects solving difficult problems in the field of mathematics.³⁷ Radiology has begun the process of funding health equity related research and this could be expanded through the establishment of Key Imaging Disparities Problems, which could be linked with substantial grant funding for work meant to address these key problems or with prizes that would be awarded to groups that demonstrate innovations successfully mitigating these key problems. Relatively small grant awards or prize amounts from prominent organizations within radiology (such as academic departments or professional societies) or from philanthropic organizations could spur significant research efforts, particularly since the ever present population of radiology trainees is consistently seeking funding mechanisms that will assist with small but meaningful projects, is well positioned to engage in the sort of on-the-ground research that will identify imaging disparities, and is not yet accustomed to the large grants that may be necessary to incentivize established researchers or innovators.

Incentives at the level of compensation can also be considered. New payment models that incorporate the documentation of health-related social needs, identification of health disparities, and development of programs to address them could be incorporated into radiology practices along with incorporation of an innovation RVU system, which has been discussed as a means of tracking and rewarding innovative efforts by radiologists.³⁸ Contributing to mitigation of key imaging disparities could activate a multiplier for innovation RVUs, leading to disproportionate emphasis on these problems in innovative efforts.

Overcoming Potential Pitfalls

Much of the criticism directed at responsible innovation centers on the difficulty of predicting a nascent innovation’s eventual implications and of responding to undesirable effects once they are entrenched.¹³ While this is certainly a limitation in attempting to steer innovative efforts in a justice-oriented direction, it is not one that should forestall efforts at steering innovation altogether. Prediction is inherently imperfect but demands for perfection often hinder efforts at achieving acceptable outcomes. Our effort in attempting to shift innovative activities in radiology is not an attempt to replace the complex pattern of innovation as it currently occurs. Rather, we hope to direct a meaningful proportion of these innovative activities towards mitigation of imaging disparities. This can be thought of as a field-wide quality improvement effort with the goal of decreasing imaging disparities as the guiding principle.

Some may contend that the proposed framework counterintuitively concentrates the burdens of forecasting potentially unknown future disparities and incorporating them into product design onto innovators alone. However, such a focus on processes early in development of a product mirrors classical tort theory’s approach to “foreseeability.” In brief, manufacturers should “foresee” the potential harms flowing from both the malfunction and misuse of their products at the time of development.³⁹ If they fail to do so, to incorporate safety features, or to warn potential end-users of risks, they are exposed to liability and can find their traditional defenses limited.⁴⁰ This concept is canonical within product liability caselaw and has been consistently applied to medical device suits by US courts.⁴¹

Alternatively, one can adopt a broader construction of the “innovator” by recognizing the multiple contributors to any given product. Weights can be established at key points in the developmental cycle to distribute the onus of achieving justice-oriented innovation from innovators alone at the time of product design onto the range of stakeholders throughout the use of a product. Justice-oriented innovation, understood in these terms, can be conceptualized as a continuous process, akin to the total process lifecycle commonplace in the medical device manufacturing space.⁴² Ideally, radiologists would form partnerships to work in concert across medical disciplines and industry sectors to ensure that justice forms a fixture of product deployment in clinical practice. For example, an insurer may mandate equitable applicability as a condition of reimbursement for new technologies, which would incentivize radiology practices to prioritize justice-oriented translational projects in industry partnerships.

In summary, we are aware that much of the envisioned pipeline for promoting justice-oriented innovations in radiology that we have outlined will need to be built. To that end, we have highlighted central pillars to this effort (Table 1) throughout this article. At present, disparities research within radiology is growing rapidly, and innovative efforts at mitigating these disparities are only just beginning. This is precisely why we believe that now is the time for radiology to take important steps towards catalyzing the creation of accelerated justice-oriented innovation pathways capable of achieving meaningful reductions in imaging disparities throughout our many diverse radiology practices.

Table 1:

Pillars of a Framework for Promoting Justice-Oriented Innovation

Pillar	Importance
Detection of imaging disparities and exploration of their drivers.	Imaging disparities must be identified, and their drivers must be documented, before efforts can be directed at mitigation.
Targeted educational programs for providing baseline innovation education.	Ensuring broad access to the basic principles of innovation establishes a diverse pool of potential innovators with varied interests and abilities who can take advantage of accelerated innovation pipelines.
Establishment of accelerated innovation pipelines for probable justice-oriented innovations.	Innovations that are likely to mitigate imaging disparities should have preferential access to funding mechanisms and to commercialization relative to innovations that are either unlikely to mitigate or likely to exacerbate imaging disparities.
Publicization of accelerated innovation pipelines for justice-oriented innovations.	Accelerated innovation pipelines must be apparent to innovators to be utilized.
Prizes or additional incentives for solving key imaging disparity problems that are not easily addressed through existing healthcare markets.	Some imaging disparities may not be addressed through existing healthcare markets, making the establishment of additional incentives necessary for catalyzing innovative solutions to these problems.

Take Home Points:

1. Innovative activities in radiology can and should be guided by our shared values as physicians, one of which is ensuring justice.

2. Innovations that are likely to mitigate imaging disparities should have access to accelerated pipelines for development and commercialization.

3. Promoting justice-oriented innovation requires investing in the fundamentals of disparities research to ensure that imaging disparities and their drivers are identified.

4. In settings where there is a surplus of ideas and limited resources, impacts on imaging disparities—or lack thereof—should be incorporated as a key distinction in prioritization.

5. New payment models and funding mechanisms may be necessary to promote innovations addressing certain imaging disparities that are unlikely to be mitigated through existing healthcare markets.