Summary¹

Innovation in health and medicine emerges from novel applications of knowledge that bring health and economic benefits to patients, consumers, and society. But alignment of the ecosystem for science, technology, and innovation (STI) with such ethical concepts as equity, justice, fairness, and the common good has not always been a priority. This report is motivated by the goal of achieving an innovation system that advances emerging science and technology while recognizing and mitigating potentially harmful applications, that fairly distributes potential benefits and burdens arising from STI, and that engages and meets the needs of the system’s full range of users. A central emphasis of the report is that users of the innovation system include not only those who have typically been active in STI, such as innovators, research funders, investors, and health care experts, but also those who may not always have seen themselves as involved stakeholders and rights holders with rights in the system’s functioning and outputs, including members of underserved communities and scholars from such disciplines as the social sciences and humanities. To help achieve the goal of such an innovation system, this report seeks to advance an understanding of opportunities and responsibilities across the processes by which innovation in health and medicine arises and is governed.

CONTEXT AND IMPETUS FOR THE STUDY

Technologies with the potential to transform medicine and society continue to advance rapidly through progress in such fields as synthetic biology, neuroscience, biomanufacturing, communications technologies, and others. In recent years, advances in such areas as machine learning and artificial intelligence have generated greater awareness of the potential of technology to benefit society, as well as information privacy concerns and the negative consequences of unrepresentative or biased data. Disparities in rates of infection, hospitaliza-

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¹ This summary does not include reference citations. References for the information herein are provided in the full report.

tion, and death during the COVID-19 pandemic and the need to distribute initially limited vaccines and therapeutics fairly brought further attention to equity in health and medicine.

How better to assess and attend to the societal implications of emerging STI, how to balance public and private interests and advance the common good, under what circumstances government should act to steer the innovation system toward particular outcomes, how to anticipate the effects of such interventions, and what roles market forces and profit-making incentives should play are long-standing considerations for the governance of STI, with governance approaches shifting in response to political, economic, and social dynamics in the United States and globally. In the current system, market and consumer forces play important roles in who benefits from STI, and equity-focused work has sometimes been controversial, framed as unfairly privileging certain groups or perceived as government overreach. However, there have been targeted instances in which equity has shaped governance—for example, in expanding access to kidney dialysis and prohibiting discrimination based on genetic data.

The current moment provides an opportunity to reexamine the system for emerging STI in health and medicine and the processes by which it is developed and governed, including how it generates or reduces inequities, how it provides or fails to provide a fair distribution of benefits and burdens, and how public and private interests can be balanced to facilitate the development and use of transformative technologies while enhancing societal benefit and mitigating anticipated harms. This report focuses on alignment with equity not because it is the only normative principle that should guide STI in health and medicine, but because it has received less systematic attention and action than other values (e.g., autonomy) in traditional biomedical frameworks. Moral, social, and economic arguments can be made for seeking a better understanding of opportunities and potential trade-offs entailed in addressing equity; this report’s recommendations can also be viewed as consistent with a vision for an innovation system that better abides by the nation’s Constitutional principles and that moves toward an ideal of universalization—that an effective and fair system is one that accounts for the full range of the system’s users.

This effort to address and enhance equity does not exist within a vacuum. Multiple public and private activities are focused on enhancing the STI ecosystem, including efforts to diversify the science, technology, engineering, and mathematics (STEM) workforce, establish equity-focused teams in federal agencies, strengthen patient and community engagement, and identify and collect data to inform decision making. Still other public and private actors are interested in how their work can align with equity but may be unclear about or even wary of what steps they can take.

In January 2020, the National Academy of Medicine established the standing Committee on Emerging Science, Technology, and Innovation in Health and Medicine (CESTI) to consider potential societal, ethical, legal, and workforce implications of emerging science, engineering, and technology, and to incubate ideas for a governance framework aligned with ethical principles. To build on and advance this work, the National Academies of Sciences, Engineering, and Medicine and the National Academy of Medicine convened an ad hoc committee of experts to produce this report. The committee was asked to develop a cross-sectoral governance framework for emerging STI in health and medicine with a particular focus on equity.

A FRAMEWORK FOR GOVERNANCE OF EMERGING SCIENCE, TECHNOLOGY, AND INNOVATION IN HEALTH AND MEDICINE

Aligning innovation with the ideal of equity begins with explaining what the concept of equity entails. Given the wide range of technologies, issues, and situations involved in biomedical innovation, who is underserved or marginalized depends on the context. Such groups may often include, for example, rural communities, people who experience disability, or historically marginalized racial or ethnic populations, but there is no one answer. Critically, advancing equitable innovation also involves parsing “equity,” since effective solutions depend on addressing the root of the challenge. While equity can be defined in different ways, this report describes the following dimensions:

• Topical equity: An innovation portfolio should include topics of relevance to diverse communities, including populations that have traditionally experienced injustices.
• Innovator equity: Innovators should reflect diverse populations, including members of underserved or marginalized communities, so as to tap a broad scope of imagination and creativity.
• Input equity: Development and implementation processes should include teams with diverse representation in order to make products relevant and of interest to a wide community of users, demonstrate respect for affected communities, and enhance accountability.
• Evaluation equity: New technologies should be evaluated in diverse or representative populations to reduce errors in assessing their benefits and harms and broaden their eventual applications.
• Deployment equity: Technologies should be accessible to and benefit a diverse population, including traditionally underserved or marginalized groups.
• Value capture equity: The value created from new technologies should be captured and distributed fairly.
• Contextual equity: New technologies should not perpetuate past injustices and should address or correct past injustices where possible.
• Attention equity: Organizations and innovators should attend to the equity concerns outlined above, including by actively seeking and mitigating inequities in how technologies are deployed.

This report’s framework for aligning emerging science, technology, and innovation with equity is provided in Figure S-1. Equity considerations can arise during all of the phases through which an emerging technology passes, and the choices made by various stakeholders along the way influence the technology’s further trajectory. These choices include such decisions as funding and research approvals; identification and management of intellectual property; continued investment and scale-up; performance evaluation to support public availability; cost, insurance coverage, and other factors affecting product access and availability; and analysis of postmarket impacts and responses. The framework is depicted as a circle rather than a linear progression to recognize that information gained from prior research, development, and use ideally feeds into and informs future innovation efforts, along with the discovery of new knowledge and the incorporation of other sources of information, including community knowledge.

In applying the framework, actors in the innovation system should be guided by five imperatives to connect the actions and decisions they make individually and collectively to the goal of advancing equitable innovation:

• Broadening participation and sharing responsibility to empower a wider range of stakeholders. This imperative involves identifying, convening, and incentivizing diverse stakeholders to center equity in their respective roles and to work in coordination to help achieve the vision for a system that fairly and equitably meets the needs of all users.
• Aligning incentives to encourage equitable decision making. To address limitations and bridge gaps in the current system, this imperative recognizes the role of incentives in influencing the interests and behaviors of stakeholders to center and prioritize equity in innovation.
• Determining how inequities develop along technology innovation life cycles and taking responsibility for mitigating them. Collective curiosity about the dynamic causes and patterns of inequity is needed. This imperative asks how the equity dimensions associated with the development and deployment of new science and technology can be identified proactively and reassessed periodically in light of information gained.
• Crafting timely guidance for pursuing equitable ends. Given the wide-ranging nature of STI in health and medicine and the diverse needs and issues associated with differing technologies and contexts of use, this imperative recognizes the need for specific, context-relevant guidance to aid stakeholders as they make decisions about what to do at key choice points.
• Sharpening ongoing, iterative oversight and evaluation along innovation life cycles. Finally, reflexive governance provides the mechanisms for encouraging or enforcing actions that track and shape the system’s alignment with equity.

RECOMMENDATIONS

As can be inferred from the framework above, the ecosystem of STI in health and medicine offers opportunities for multiple public and private actors—affected and underserved communities, researchers and inventors, funders, investors, regulators, end users, and many others—to consider questions of equity. And many ongoing efforts can help address equity considerations with regard to particular stakeholders, types of technologies, and phases of development.

A shared vision is needed for identifying what can and should be done in the innovation ecosystem in ways that bridge, integrate, and expand on current efforts. This report’s governance framework is one key element in achieving this systems-level approach. The report also offers six recommendations for supporting an equitable ecosystem for STI in health and medicine. An important thread running through these recommendations is the need to convene those individuals, organizations, and groups doing thoughtful work in these six areas as a next step in building the coalitions necessary to accomplish these goals—whether in the development of equity science, the establishment of substantive community partnerships, the crafting of context-specific guidance, or other key areas.

The six recommendations are presented below and summarized in Table S-1. The full text of each recommendation is provided in Chapter 5, which also includes implementation guidance consisting of suggestions for and actions that can be taken by multiple parties. Although this guidance is targeted largely to U.S. actors, the report’s proposed framework may be adaptable to and help inform other national and international conversations on centering equity in the development and governance of science and technology.

TABLE S-1 Summary of Recommendations

National Leadership

Addressing the six recommendations will require sustained engagement from many participants, involving individual and collective action. Culture change to drive greater equity is a leadership issue and thus requires coordinated action. Building on and expanding beyond ongoing White House equity efforts in this area (see Chapter 1), national leadership from the White House Office of Science and Technology Policy (OSTP) is necessary to set priorities and goals, monitor progress, and harness current opportunities across multiple agencies and departments, as well as extensive public and private interests and efforts, to produce improved cross-sectoral governance and a consistent focus on equity in the innovation ecosystem.

This recommendation calls for OSTP to lead the effort to translate and operationalize this report’s governance framework, including through a multistakeholder, cross-sectoral task force. Building on the areas identified in this report, the EBI Task Force should articulate near-, intermediate-, and long-term priorities and work with agency equity teams and the White House Steering Committee on Equity to translate those priorities into an initial set of goals over the next decade. The EBI Task Force should also partner with the broader community of biomedical innovation stakeholders, including underserved communities, to provide insight on benchmarks, measures, and metrics that can be incorporated at each point of the life cycle to achieve greater equity in the innovation process.

Culture of Innovation

Actors across the innovation ecosystem have roles to play in its governance. Needed to support these efforts is a culture of innovation that builds awareness of equity and its intersection with STI. Disciplinary norms for fields of emerging science and technology can further integrate information on the forms and dynamics of inequity and on the governance imperatives identified in this report, providing guidance on roles and responsibilities.

This recommendation is particularly relevant to organizations that establish norms, conduct and oversee research and development, and generate intellectual property, including funders, universities, companies, and licensing and patent offices. To implement this recommendation, organizations can take multiple actions to demonstrate a commitment to the report’s governance framework in their operations and processes. Selected examples include requiring and incorporating case studies in training on responsible conduct of research to

raise awareness of the consequences of misalignment of innovation and equity; assisting researchers and developers in assessing and mitigating equity implications associated with proposed designs; enhancing engagement with researchers, social science experts, and others to address equity considerations in new intellectual property; and adopting equity science tools and data systems to link choices to financial or logistical implications for populations of intended users or to assess whether a portfolio represents an equitable distribution of investigators, institutions, and anticipated risks/benefits.

Aligning Innovation with Equitable Benefit

Achieving a more equitable system of emerging STI in health and medicine will also require reassessment and deployment of governance levers that affect incentives, as well as disincentives in the system to facilitate attention to societal benefit. These levers can take many forms, and this recommendation is particularly relevant to those stakeholders able to direct such levers, which include the imposition of requirements (whether via federal and state laws and regulations; professional standards and best practices; or policies affecting research design, funding, approval, publication, and evaluation) and the use of positive motivations for equity (such as targeted funding and enhancements to market incentives such as patent rights).

This recommendation highlights choice points in which assessment of alignment with equity should occur, including

• funding and research approvals;
• patenting, licensing, investment, and scale-up;
• assessment and approval for widespread use;
• cost and coverage decisions; and
• postmarket analyses.

The implementation guidance for this recommendation provides examples of actions that can support or enhance alignment with equity, including use of equity-focused proposal requirements and scoring elements; partnerships with historically underserved and marginalized communities in research codesign, credit, and benefit; use of funding, tax incentives, public–private partnerships, and other models to spur targeted investment in new technologies or alternative designs for existing technologies to address an identified need or inequity; emphasis on maintaining patent quality and transparency and on intellectual property and licensing arrangements that align with equity; use of postmarket surveillance to identify and understand any inequitable distribution of medical benefits and risks; and other actions.

Empowering Participation in Innovation

To achieve the system vision described above, it will be necessary to expand who participates in innovation in health and medicine and who sees themself as a stakeholder or rights holder with a substantive role in technology development and governance. A consistent theme in this report’s framework is the need for more comprehensive stakeholder engagement and for enhanced cross-sectoral participation. Opportunities to inform the innovation process begin with conceptualization and will need to include sustained, bidirectional engagement that advances the ability of currently underrepresented and underserved groups to take part.

No single actor is responsible for convening across the suite of issues relevant to different phases of emerging science, technology, and innovation in health and medicine, although critical roles can be played by the EBI Task Force proposed in Recommendation 1; federal agencies carrying out their respective activities in research, technology development, and innovation; and philanthropic organizations. Multiple, focused opportunities are likely needed to delve deeply enough into lessons, models, tools, and best practices on specific topics (such as research codesign or community data ownership). As described in the recommendation, such convening should help center the interests of affected communities in the innovation ecosystem and address such areas of decision making as

• how substantive input during research priority setting, funding, conception, design, and conduct can be empowered;
• policies and practices that recognize and value a community’s contributions to and participation in research, including around data access, management, and ownership and intellectual property identification and management; and
• technology performance evaluation, coverage and use determinations, and monitoring of a technology’s impacts and implications.

Equity Science

Methods, metrics, and benchmarks are needed to guide decision making at all stages of STI planning, development, assessment, and oversight. An improved understanding of the causes of and explanations for inequity can inform the specific remedies that will be most effective in redressing or mitigating that inequity. An effective STI system should also be a learning system capable of both anticipatory and retrospective analyses, monitoring, and iterative improvement. To support such a system, a robust field of equity science is needed, building on and extending current efforts directed at identifying and deploying equity metrics.

As described in this recommendation, equity science methods, metrics, and benchmarks should enable the improved assessment of

• how inequities arise, in which contexts, and for which communities across all phases of emerging science, technology, and innovation in health and medicine;
• how innovation systems and processes can change in response to the evidence obtained, including better understanding and evaluating the impacts of different stakeholder actions and choices; and
• near-term and longer-term changes in response to governance choices.

As equity science is developed, actors throughout the innovation process can support system-wide change by adopting the resulting methods, metrics, benchmarks, and data systems to assess the equity-relevant implications of their technology innovation decisions.

Playbooks for Context-Relevant Guidance

Playbooks can serve as important guides for interested stakeholders on practical strategies, key questions, and specific suggestions that can translate the governance framework in this report into practice in different areas of STI and for different stakeholder communities and choice points in the innovation life cycle. Existing playbooks, such as those directed toward artificial intelligence (AI) ethics, community impacts, or environmental heath, can serve as models for the types of information that playbooks for equitable innovation might usefully contain. Materials developed by CESTI and in this report—including the articulation of equity dimensions, the governance framework and its five imperatives, illustrative case examples and boxes, and implementation guidance—can all serve as starting points to inform further discussion and development.

This recommendation focuses on operationalizing the report’s key messages for different fields and purposes. To this end, federal, philanthropic, and private funding organizations in the innovation system for health and medicine should support the development and dissemination of equity playbooks by their stakeholders, including model playbooks created in partnership with affected communities to provide historically marginalized and underserved communities with guidance, strategies, and tools that can enhance their participation in the

innovation system. Professional associations should also play important roles in developing and disseminating equity playbooks as a professional norm for their communities.

LOOKING TO THE FUTURE: AN ACTION AGENDA

Table S-2 provides a high-level summary of opportunities for actors throughout the ecosystem of emerging science, technology, and innovation in health and medicine to help translate the above recommendations into practice.

TABLE S-2 An Action Agenda for Stakeholders

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