5

Reimagining the Innovation Life Cycle: Concrete Steps toward Equity

To achieve the vision described in the prior chapters, the committee advances six recommendations reflecting major areas in which efforts are needed to reorient the system of emerging science, technology, and innovation in health and medicine toward one that is equitable and responsive to the needs of a broader range of the system’s users, and more capable of recognizing and addressing inequities as they arise.

INTRODUCTION TO THE RECOMMENDATIONS

Through the committee’s six recommendations, this chapter provides further practical guidance on how to harness current opportunities to incorporate equity in emerging science, technology, and innovation in health and medicine through Executive Orders, agency plans, and extensive public and private efforts. The engagement of current and envisioned federal capacities and infrastructures, as described in Chapter 1, would be essential components of efforts to develop and act on the recommendation areas described below. Examples of key federal partners include but are not limited to

• the White House Steering Committee on Equity;
• the Interagency Working Group on Equitable Data;
• agency equity teams within agencies involved across the research, development, oversight, and delivery system in health and medicine;
• new and existing agencies and initiatives advancing innovation, such as the National Institutes of Health’s (NIH’s) Advanced Research Projects Agency for Health (ARPA-H), the National Science Foundation’s (NSF’s) Directorate for Technology, Innovation and Partnerships (TIPS), and the Federal Trade Commission’s (FTC’s) newly created Office of Technology (FTC, 2023); and
• federal offices currently focused on equity issues, often through designated offices such as the Department of Health and Human Services’ Office of Civil Rights, the

Department of Veterans Affairs’ (VA’s) National Institute on Minority Health and Health Disparities, the Food and Drug Administration’s (FDA’s) Office of Minority Health and Health Equity, and the Office of Rural Health, among others.

Because many recent federal equity-focused efforts have arisen from Executive Orders, sustained commitments to addressing the principle of equity beyond the term of a given administration will be needed. Addressing the six recommendation areas detailed here will require a shared vision for what can and should be done to enhance the alignment of emerging science, technology, and innovation in health and medicine with equity in ways that bridge and integrate current efforts. It will also require making choices on how to shift the culture and ecosystem for emerging science, technology, and innovation and where to incorporate further governance levers, including policy-based and market-based incentives, to ensure that equity is taken seriously. These efforts will take sustained engagement from many parties and participants, necessitating both individual and collective actions to make progress toward this goal. Needed as well will be context-relevant capacity to measure, assess, monitor, and reevaluate how a particular scientific area, technology, or product intersects with equity as it proceeds through the innovation life cycle—capacity that currently is often fractured or insufficient. Addressing the recommendations holistically will thus require ongoing commitment, along with the investment of public and private resources of time, effort, and funding.

A summary of the report’s six recommendations and their desired outcomes is provided in Table 5-1. These recommendations are necessarily high-level and cannot be fully separated from one another—they reflect interrelated needs, and their descriptions provide examples of some of these linkages. The sections that follow present the full text of each recommendation, along with implementation guidance that offers concrete suggestions for steps that various actors could take to implement the recommendation’s aims.

TABLE 5-1 Summary of Recommendations

GALVANIZING NATIONAL LEADERSHP AND SETTING PRIORITIES

Important federal and private efforts are ongoing to address some of the issues raised in this report, including efforts aimed at diversifying the science, technology, engineering, and mathematics (STEM) innovation workforce; increasing community and patient engagement in research; and targeting inequities associated with particular types of emerging medical technologies, such as artificial intelligence (AI). Given the scope of innovation in health and medicine, the significance and breadth of ethical principles that must guide it, and the importance of context, many efforts must flourish, targeting a range of needs and conducted in ways that best address a given issue and situation. But the dynamic and diverse nature of these activities and the number of groups with important roles to play can lead to potential confusion or misalignment of goals, duplication or contradiction of efforts, and lack of coordination.

Recent language around equity often emphasizes achieving equitable outcomes. While ensuring equitable access to new technologies and achieving equitable health outcomes remain important targets, this report and the framework it describes emphasize a complementary focus: how to establish an equitable process for the conception, development, and governance of emerging science, technology, and innovation, applying the framework imperatives described in Chapter 4 across the full life cycle to analyze where and how forms of inequity arise and shift choices and decisions to better align the process with more equitable innovation.

Harnessing this array of efforts to achieve a shared vision for enhancing the biomedical innovation ecosystem will help align current activities and inform the development of new ones targeted toward needs, challenges, and opportunities that remain, as well as those that will continue to emerge as science and technology advance. While multiple avenues of guidance and the efforts of agencies, offices, and other key stakeholders are making crucial progress, coordination and coherence are required to build and sustain maximum impact. Establishing such a system-wide vision can provide clarity on how multiple actors and their efforts fit together in an equity-aligned innovation process as groups make progress in tackling different goals and accelerating implementation. Federal leadership is needed to provide this system-wide view, help institutionalize the framework described in this report, and drive systemic change. This federal leadership must in turn be combined with extensive consultation beyond the federal government through a multistakeholder, public–private coalition of stakeholders in the ecosystem of emerging science, technology, and innovation. National leadership can also enhance engagement around equity in innovation in international settings, bringing together policy makers, researchers and developers, members of affected communities, private-sector actors, and government stakeholders through such venues as the World Health Organization, World Trade Organization, World Intellectual Property Organization, and Organisation for Economic Co-operation and Development, among others.

technology, and innovation into an initial set of goals to be accomplished over the next decade.

• Partner with the broader community of stakeholders in biomedical innovation to engage proactively with underserved communities to identify specific actions that address identified goals and provide insight on equity benchmarks, measures, and metrics (see Recommendation 5), including how to incorporate them at each phase of the innovation life cycle and how they can be used to achieve greater equity.
• Federal, state, and local policy makers should upgrade existing or create new policy and oversight mechanisms to drive the alignment of emerging biomedical science, technology, and innovation with the priorities and goals identified by OSTP, relevant departments and agencies, and the EBI Task Force.

The ecosystem of emerging biomedical science, technology, and innovation involves a wide range of federal and nonfederal stakeholders whose engagement is needed in these efforts. Relevant federal departments and agencies include, but are not limited to, the White House National Science and Technology Council (NSTC) and the U.S. Department of Health and Human Services (HHS) and its agencies (e.g., the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, the FDA, the Health Resources and Services Administration, the Indian Health Service, NIH, and the Substance Abuse and Mental Health Services Administration). The OSTP can also draw on its relationships with the Office of Management and Budget and advisory bodies such as the President’s Council of Advisors on Science and Technology. Additional agencies funding research or programs relevant or contributing to science and technology in health and medicine, such as NSF; the Department of Energy; the National Institute of Standards and Technology; and other agencies involved in decision making and oversight relevant to biomedical innovation, including the FTC and the U.S. Patent and Trademark Office, are also important to this ecosystem. In addition, the VA provides health care to a substantial population and conducts key biomedical research, thus offering a key opportunity to pilot changes in practices, incentives, or other governance levers that could drive more equitable outcomes.

Similarly, many nonfederal partners and stakeholders should be involved in activities to establish an equitable biomedical innovation ecosystem. These groups include biomedical innovators from academia and industry; scholars and experts from such disciplines as economics, science education, social sciences, and humanities; numerous professional societies in relevant disciplines; public and private organizations that conduct research and development; venture capitalists; health insurers and other payers; state and territorial health departments; and health care professionals and delivery organizations. This array of cross-sectoral stakeholders should also include patient and consumer advocacy groups; advocacy groups concerned about data privacy and use; and community organizations, including those representing historically marginalized and underserved communities.

ENHANCING THE CULTURE OF ETHICAL INNOVATION

Foundational to the practice of responsible science, technology, and innovation in health and medicine is alignment with ethical principles, the understanding of which has evolved over time. Achieving the vision described in this report of a system able to consider and address the needs of all users more equitably will require that those who undertake innovation conceive of their responsibilities as broader than such issues as patient safety, data privacy, and informed consent, although this is by no means to diminish the vital importance of these issues as manifestations of the core ethical principles of autonomy and individual good. Indeed, innovation must be guided by the full set of ethical principles identified in Chapter 1, which include justice, fairness, and collective good (recognizing that equivalent

ethical concepts are identified in the literature using different terms). This report focuses on equity as one key expression of alignment with these principles and with the foundational principles of the U.S Constitution to promote the general welfare and affirm the equal rights of all persons. The report thus provides a framework for enhancing development and governance in health and medicine guided by five core imperatives:

• broadening participation and sharing responsibility to empower a wider range of stakeholders;
• aligning incentives to encourage equitable decision making;
• determining how inequities develop along technology innovation life cycles and taking responsibility for mitigating them;
• crafting timely guidance for pursuing equitable ends; and
• sharpening ongoing, iterative oversight and evaluation along innovation life cycles.

Incorporating these imperatives into the ecosystem of emerging science, technology, and innovation will require a culture that reflects the values, expectations, and norms guiding how those involved in the innovation ecosystem understand their roles and responsibilities—in the conception of new research ideas, the design and conduct of research, the development and scale-up of resulting products and technologies, performance assessment, and patient and consumer use. This culture and the operationalization of the five governance imperatives within the many organizations that make up the ecosystem of health and medicine critically influence how innovation is carried out, how impacts are assessed, and whether and what actions are taken in response to information learned during these processes. Recommendation 2 therefore focuses on the culture of innovation, affirms that members of the system should be mindful of how their choices affect equity, and aims to help foster a shared understanding of equity and why and how it is relevant in innovation. Progress toward Recommendations 5 and 6 below will also provide key information about the equity considerations, concerns, opportunities, and types of actions that are most relevant to a given area of advancement in science and technology, thereby assisting organizations across the life cycle in implementing the aims of this recommendation.

• Demonstrate a commitment to these ethical principles and framework imperatives in their operations and processes. This commitment should include the ability to assess the extent to which the organization’s overall portfolio reflects alignment with forms of equity, whether any misalignments might be anticipated for a particular technology, and with what implications for decision-making processes (see Recommendation 6).

MAKING TARGETED USE OF GOVERNANCE INCENTIVES

As stressed throughout this report, a governance framework for emerging science, technology, and innovation should establish policies and practices that foster an innovation system with the capacity to address the needs and concerns of all of the system’s users, including those who have historically been marginalized or underserved. Yet the U.S. innovation system results in gaps and negative consequences, including disparities in opportunities to be included in the system and substantial inequities in health outcomes. Multiple levers are available to redress these inequities by changing incentives and disincentives and influencing the decisions of innovation stakeholders. These levers include federal and state laws and regulations; professional standards and best practices; the use of targeted funding; requirements for research design, funding, approval, publication, and evaluation; market incentives; and many others. These various levers can be applied to produce both “pushes” leading to further innovation, such as new and transformational science developments, and “pulls,” such as offers of patent exclusivity or advance purchase commitments.

Achieving a more equitable system of emerging technology and innovation will require both individual and collective actions to create positive feedback loops that shift the system toward a sustained focus on equitable benefit. While policy and regulatory changes or new funding will be needed in some cases to achieve a more equitable health ecosystem, many essential elements are already in place and require only the necessary political and professional will.

EXPANDING WHO PARTICIPATES IN INNOVATION

The concept of being an innovation “stakeholder” or “rights holder” carries assumptions about deriving benefits and having power to influence decisions and trade-offs. The report’s framework and recommendations are aimed at broadening who sees themself as being (and who is empowered to be) a stakeholder or rights holder in this system, and at identifying avenues for historically underserved and marginalized communities to play expanded roles in the technologies that have consequences for their health and well-being.

While various efforts have sought to prioritize the perspectives and needs of patients, research subjects, underserved communities, and other groups in innovation, equitable

innovation requires expanding and rethinking which groups participate in innovation and how. All interested parties should have opportunities to inform the process and governance of innovation in health and medicine, including through sustained, bidirectional engagement that expands the participation of historically underserved populations throughout the process, including at early stages.

A more equitable health innovation ecosystem will require redesign to be more accountable and responsive to the interests and needs of patients and underserved communities. To this end, it can draw on patient and community advocacy organizations as research and innovation drivers that can help build trust and broaden and diversify research to characterize diseases and design solutions more accurately so they are most applicable to community needs. Indeed, some funders are already recognizing patients and underserved communities as central stakeholders in the ecosystem. Models include those operationalized by the Patient-Centered Outcomes Research Institute (PCORI) and some NIH programs, in which community partnerships are required as a condition for funding in certain research areas. For example, the NIH ComPASS (Community Partnerships to Advance Science for Society) program focuses on innovations designed to address social determinants of health and requires that the community partner serve as the lead applicant, with an appropriate academic research partner as a subrecipient. Other opportunities for action include incorporating varied perspectives and backgrounds on the panels that review proposals (see also the implementation guidance box for Recommendation 4 below). Such models providing targeted funding help recognize community members as coproducers of knowledge and true partners in the innovation pipeline. Ongoing efforts can also support diversifying the workforce in science, technology, and innovation and investing in diverse innovators, including those from underrepresented communities.

Who, specifically, represents a “marginalized or underserved community” and how to better center the interests of patients, users, and members of affected communities in the innovation ecosystem will depend on careful assessment of whether and how a technology could potentially produce misalignments with the forms of equity described in this report (see Recommendation 2). The individuals and communities that should be engaged in a particular area of emerging technology development will vary with the research topic, intended uses, and other critical contextual factors.

DEVELOPING EQUITY SCIENCE

A governance framework for more equitable development and governance of emerging science, technology, and innovation in health and medicine requires credible methods, metrics, and benchmarks for assessing equity throughout the system in a purpose-driven, contextually sophisticated manner, enabling both anticipatory analysis of inequities that may arise and retrospective analysis of efforts to mitigate inequities. Having such measures can help in identifying and understanding sources of inequity, assessing the extent to which trade-offs occur (or not) between considering equity and advancing innovation and commercialization, encouraging members of the system to implement practices that enhance alignment with equity or deimplement negative practices, and supporting accountability and iterative system improvement.

Methods for measuring equity encompass steps, processes, and analytical tools by which dimensions of equity can be assessed; qualitative and quantitative equity metrics are the specific indicators or measures that can be gathered; and benchmarks represent the goals or targets against which progress toward greater equity can be envisioned. A robust field of equity science needs all three of these elements. Systematic and iterative progress will require establishing target benchmarks, developing suitable conceptual and methodologic strategies, and collecting and analyzing identifiable metrics, and then using the resulting information to make decisions, assess the results of those decisions, and revise them as needed within the context of a learning system.

No single measure will capture the multiple equity dimensions and issues associated with the innovation life cycle in health and medicine. The equity methods, metrics, and benchmarks that are developed will need to have clear purpose and meaningful content and to be modifiable, meaning that knowable actions by identified actors can be taken to shift the value of a metric in the desired direction. The equity methods, metrics, and bench-

marks also will need to support inquiry and analysis at three levels—individual people, social groups, and the entire population. Examples of types of metrics that could be considered for further development include those providing greater transparency in intellectual property decisions and outcomes and measures of equity that can inform clinical decision making.

Public and private efforts are ongoing to improve the measurement of equity and develop equity-relevant metrics. Examples include the federal equitable data vision from the interagency Equitable Data Working Group (“Equitable data are those that allow for rigorous assessment of the extent to which government programs and policies yield consistently fair, just, and impartial treatment of all individuals” [White House, 2022]), NSF’s Analytics for Equity Initiative,¹ state activities such as the COVID-19 health equity metrics reported by the California Department of Public Health,² academic programs such as the Equity Metrics program at the University of California-Berkeley,³ philanthropic efforts such as the Robert Wood Johnson Foundation’s report on Chartering a Course for an Equity-Centered System (RWJF, 2021), and others. In addition to key agencies such as NIH and NSF, other partners that will need to be engaged in the development and deployment of new equity science metrics for innovation in health and medicine include PCORI, the FDA, the Agency for Healthcare Research and Quality (AHRQ), the Centers for Medicare & Medicaid Services (CMS), and the VA (for the development of metrics relevant to health system performance and health equity); and the USPTO and Department of Commerce through the National Institute of Standards and Technology (NIST) (for the development of metrics addressing such areas as patenting and licensing). Equity-relevant metrics are also being developed in specific areas of emerging science and technology, such as algorithmic fairness and data representativeness.⁴

This report calls for developing a robust and comprehensive field of equity science, building on current efforts in equity metrics; maturing this field of knowledge; and applying it to the biomedical innovation system. Building the field of equity science is not a short-term goal; it will require sustained commitment to produce value over a multiyear timeline. Equity science for biomedical innovation will require a multistakeholder and multidimensional approach guided by the governance imperatives described in this report and able to account for the many dimensions and factors involved.

Ideally, the field of equity science developed under this recommendation will support enhanced efforts to assess and monitor developing technologies against equity considerations and revisit governance actions and innovation choices in light of the results of these efforts. As described in this report, U.S. federal agencies, private-sector actors, payers, and others may not systematically conduct such equity assessments now. Although holistic technology assessment remains a need, equity science can build a foundation for future efforts and discussions aimed at enhancing system capacity.

___________________

¹ https://beta.nsf.gov/od/oia/eac/analytics-equity-initiative (accessed June 30, 2023).

² https://covid19.ca.gov/equity/ (accessed June 30, 2023).

³ https://belonging.berkeley.edu/equity-metrics (accessed June 30, 2023).

⁴ For example, see https://www.ibm.com/docs/en/cloud-paks/cp-data/3.5.0?topic=openscale-fairness-metrics-overview (accessed June 30, 2023).

CREATING CONTEXT-SPECIFIC PLAYBOOKS

Equity playbooks can serve as important guides for stakeholders on the strategies, key questions, and specific suggestions that can translate the governance framework in this report into practice, providing tools to advance equity in the innovation life cycle. To be sufficiently specific given the breadth of science, technology, and innovation in health and medicine, these playbooks would need to be technology- or stakeholder-specific and be subject to recurring review. They would also need to be developed with input from a broad and inclusive group of stakeholders. The committee recognizes that not all stakeholders in all areas of emerging science, technology, and innovation will find it equally useful to develop and disseminate equity playbooks, but concludes that all stakeholder groups should consider the value of such playbooks as practical tools for setting norms and standards, and advancing discussion and action to address equity.

Efforts to develop equity playbooks for emerging science, technology, and innovation in health and medicine can draw conceptually on model playbooks that have been developed for particular challenges and communities. Examples of such models include the Equity Playbook from Chicago United for Equity (CUE Fellows, 2019); the COVID-19 Health Equity Playbook for Communities from the California Department of Public Health (CDPH, 2020); the Playbook for New Rural Healthcare Partnership Models of Investment (Thomas-Squance et al., 2022); the Funders Guide to diversity, equity, and inclusion from the Ford Foundation (Ford Foundation 2023a,b,c); and the Algorithmic Bias Playbook, developed through the University of Chicago Booth School of Business by researchers in artificial intelligence to provide guidance on algorithm development and oversight targeted toward health care leaders, technical teams, and regulators (Obermeyer et al., 2021). Federal agencies and philanthropic foundations can provide key support to such efforts.

AN ACTION AGENDA FOR STAKEHOLDERS IN THE INNOVATION SYSTEM

Reimagined governance for emerging science, technology, and innovation in health and medicine will need to involve an array of approaches, including enhanced engagement; targeted use of incentives to prioritize equity, justice, and fairness at phases along the technology development life cycle; regulation and oversight from key federal, state, and local agencies; the deployment of soft governance through awareness raising; and the promulgation of professional norms and creation and dissemination of practical guidance through context-relevant playbooks, along with enhanced coordination, interactive review,

and revision in light of information learned. To operationalize equity in biomedical innovation and implement the six recommendations presented above will thus require commitments from multiple stakeholders across multiple sectors. To encourage stakeholders to act, Table 5-2 provides a high-level summary of actions and desired outcomes for major stakeholder groups.

TABLE 5-2 An Action Agenda for Stakeholders

Reorienting innovation to advance equity is a vital and challenging imperative for 21st century science, medicine, and technology. The coordinated, cross-sectoral governance framework and six recommendations in this report represent important steps to be taken by actors and stakeholders across the ecosystem. These steps aim at achieving the vision for a system of emerging science, technology, and innovation in health and medicine that is equitable, responsive to the needs of a broader range of individuals, and more capable of recognizing and addressing inequities as they arise.

REFERENCES

RWJF (Robert Wood Johnson Foundation). 2021. Charting a course for an equity-centered data system: Recommendations from the National Commission to Transform Public Health Data Systems. https://www.rwjf.org/en/insights/our-research/2021/10/charting-a-course-for-an-equity-centered-data-system.html (accessed June 30, 2023).

Thomas-Squance R., A. Hernandez, C. Flynn, and D. Jutte. 2022. A playbook for new rural healthcare partnership models of investment. Build Healthy Places Network. San Francisco. https://buildhealthyplaces.org/downloads/Build-Healthy-Places-Network-Rural-Playbook.pdf (accessed June 30, 2023).

White House. 2022, April 22. Fact Sheet: Biden-Harris administration releases recommendations for advancing use of equitable data. Washington, DC: The White House. https://www.whitehouse.gov/briefing-room/statements-releases/2022/04/22/fact-sheet-biden-harris-administration-releases-recommendations-for-advancing-use-of-equitable-data/ (accessed June 30, 2023).

This page intentionally left blank.