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Toward Equitable Innovation in Health and Medicine: A Framework (2023)

Chapter: Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19

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Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Appendix B

Technology Governance and Equity in the United States from the Cold War to COVID-19


Michael F. McGovern and Keith A. Wailoo

Prepared for the National Academies of Sciences, Engineering, and Medicine and the National Academy of Medicine

Committee on Creating a Framework for Emerging Science, Technology, and Innovation in Health and Medicine

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×
Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×
Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×
Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

Abstract: A review of the past eight decades of U.S. science, health, and technology policy reveals that federal government efforts to promote equity and fairness in technology development have been piecemeal and unsystematic. This investigation finds that policy makers have embraced equity—defined as attention to justice, proportional fairness, and inclusion—as a value only in particular social contexts and instances: in the early 1970s, for example, to ensure equitable access to new technologies such as kidney dialysis, in the 1980s to incentivize industry to develop “orphan drugs” to benefit disease populations whose small numbers attracted little private sector research and development (R&D), and in the 2000s to restrict insurance-based discrimination aimed at people on the basis of their genetic conditions. These actions in the name of equity and fairness in science and technology governance have been sporadic, often contested, and uneven. Nonetheless, identifiable trends in equity and technology governance have emerged as government policies shifted over the decades. The 1950s marked an era promoting innovation without guardrails, and inequities in the system were widespread; the 1960s and 1970s witnessed important attempts to govern innovation with modest attention to removing system-wide inequities, for example, in the exploitation of vulnerable subjects and to using the lever of government programs to equalize access to technology products; and the decades since the 1980s have seen both rollbacks on these commitments as well as specific targeted piecemeal efforts to advance equity in science, technology, and medicine. One finding of this report is that over the past 80 years, equity concerns have never been a primary commitment in technology policy and assessment. Nor has the U.S. government undertaken a systematic approach to equity in technological development. Another finding is that the goal of incorporating equity into technology innovation has been contentious and difficult to sustain. Small progress in specific areas has been vulnerable to rollbacks. For most of the past eight decades, other values have guided innovation governance: namely, a commitment to laissez-faire innovation, deference to pursuit of profit and speed in innovation, and willingness to allow market and consumer forces to play leading roles in determining who benefits from science and technological innovation. The result of this policy history has been persistent and sustained large-scale inequity, punctuated by specific narrow crises and zones (protection of subjects, health insurance access, genetic discrimination, orphan drugs, kidney dialysis access, and so on) in which equity ideals have surfaced and shaped laws, procedures, and policies.

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

INTRODUCTION

This white paper explores technology governance in the United States from the period following World War II to today. In particular, it examines milestone policies and controversies within the U.S. technology governance ecosystem1 during this period. Such touchstones include the dialysis entitlement within Medicare, the creation and demise of the congressional Office of Technology Assessment (OTA), the National Vaccine Injury Compensation Program (VICP), and important legislation such as the Genetic Information Nondiscrimination Act (GINA) and laws supporting adaptive technology following the passage of the Americans with Disabilities Act (ADA). The review examines the language of legislation, regulation, and enactments, as well as social commentary, in order to document changes over time in the underlying values and principles that have guided technology governance.

The report argues that if there was a high point in the federal government’s commitment to equity in technology access, it occurred in the late 1960s and early 1970s, but that this commitment has been slowly eroded over time. The apex of that commitment to equity was passage of dialysis legislation in 1972, in which explicit principles of fair distribution of a life-saving technological good was the focal point of technology governance. Such a commitment was the outgrowth of an era of intense focus on civil rights, social welfare, and sweeping health legislation. Another milestone development of the era was a bold and sweeping interest in technology assessment that led to the creation of the OTA in 1974. Yet, even in this era of heightened concern for distributive questions, equity in technology access was often an afterthought rather than the impetus for major policy initiatives.

In subsequent years, owing to transformations in American political culture, fiscal conservatism, and shifting pro-market ideologies, there has been a great deal of backsliding in regard to these equity commitments. Later decades have been defined by sporadic and piecemeal efforts, like the passage of the Orphan Drug Act (1983) and GINA (2008), which have targeted specific sectors and interest groups to curb inequities that have developed in the health marketplace. On the whole, however, efforts to promote equity in technology governance—whether by incentivizing industry or restricting discriminatory applications—have been piecemeal. In recent decades, such efforts have largely sought to fix problems of maldistribution in the market. For the most part, in U.S. technology policy, equity has become a minor value. Concerns for efficiency and speed of innovation, alongside risk mitigation, play more central roles in technology governance.

A substantial and sweeping commitment to equity in technology governance has yet to be pursued as a matter of federal policy; however, such a commitment is not entirely without precedent. Here, we consider how equity has often been an implicit value associated with broader ideas about “the public good.” Making equity concerns explicit is an important step toward a technology governance that will work for all.

INNOVATION WITHOUT GUARDRAILS: THE INEQUITIES OF SCIENCE AS AN “ENDLESS FRONTIER”

As federal funding for science, technology, and medicine rose dramatically in the post-World War II years, considerations of equity—how benefits would be distributed, or how

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1 By “technology governance,” we refer to the broad array of strategies through which the federal government has addressed itself to the benefits and harms—actual and projected—of technological developments. These might include obligations tied to federal grants, market incentives and intellectual property protection, safety regulations and standards, compensation programs, and more. Only a capacious definition such as this can capture the multiple ways that equity concerns become manifest.

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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technological progress or failures might address or exacerbate existing social inequities—were not evident in policy discussions. Using vulnerable people as experimental subjects in scientific research was the norm; informed consent did not exist in any formal sense. Nor did researchers spend much effort considering how the fruits of scientific research would be distributed equitably. The United States in the wake of World War II was a fragmented society where racial segregation was perfectly legal in many states. In other words, inequities in science, innovation, and society were a norm, and not often considered to be connected.

Despite these inequities, policy makers were silent on the question of whether technology innovation should advance social equity. It was simply not a question worth asking. Indeed, as historian David Rothman has argued, laissez-faire policies prevailed.

The values driving government investment in science gestured toward the role of scientific innovation in advancing social welfare and economic progress. On November 17, 1944, President Roosevelt wrote to Vannevar Bush, director of the wartime Office of Scientific Research and Development, seeking recommendations on how to put military research to civilian ends, wage further war against disease, aid research activity, and nurture future scientific talent. Bush responded with the report Science: The Endless Frontier, often hailed as laying the foundation for U.S. science and technology policy. The report articulated a vision of science and technology innovation that would result in a lifting of all boats, with government funding of science serving as a catalyst for social progress, jobs, and a generalized commitment to public welfare. Notably, the report remained largely silent about exactly how basic research would be translated into applications and who would have a say in the process.

Science itself was understood as a fundamental general good, with little attention to equity, fairness, or justice in its practices or outputs. The report’s centerpiece was a proposal for a new agency—later partially realized in the National Science Foundation—guided by a set of five principles that elevated scientific autonomy above utility. The agency would provide stable funds for long-range programs doled out by citizens who understood and valued the research process over any potential outcomes. Moreover, it would neither operate its own laboratories nor attempt to impose its own rules upon the operation of universities and research institutes. Nonetheless, this scientific research organization would seek to “maintain the proper relationship between science and other aspects of a democratic system” through “[the] usual controls of audits, reports, budgeting, and the like,” adjusted to “the special requirements of research” (Bush, 1945, p. 33). It would be accountable, but only on its own terms. These principles articulated what subsequent commentators have referred to as a “social contract of science”: the government provides money to scientists and gets out of the way, since the results of research will eventually translate into beneficial technologies (Guston, 1994).2 There was no discussion of justice, fairness, equity, or ethics that should underpin or inform the expansion of research funding, let alone concern for inequities in how the eventual goods flowing from research would be distributed.

The principles of Science: The Endless Frontier are fundamentally products of their time and place. The report is suffused with Bush’s confidence in a compact between government and the market. In this light, the report related to equity in two ways: (1) it sought to expand science education; and (2) it envisioned basic research as promoting application by others, which then was intended to support full employment and advance the public welfare. Science was understood merely as the catalyst for social changes that would occur elsewhere,

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2 “Crudely, it holds that the federal government provides funds for basic research in academia and agrees not to interfere with scientific decision making, in exchange for unspecified technological benefits that could ultimately flow from such research.” (Guston, 1994, p. 215)

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

in steps labeled “applications.” The public good imagined in Science: The Endless Frontier was an aggregate good.

The report, and its commitments to expanding access to university education and building “scientific capital,” emerged in an era in which specific class, racial, and gender assumptions prevailed about who did science (Bush, 1945).3 Although studies showed that “talented individuals [could be found] in every part of the population,” higher education remained a realm of the wealthy. Bush appealed to ideals of equal opportunity, proposing merit scholarship programs as a counterbalance to economic inequality. If racial equality of opportunity was absent as a goal in this report, so too was equality of opportunity for women in the sciences. Although the report mentions women explicitly, the judgment of history does not bear favorably on what came to pass. In these post war years, passage of the GI Bill, which expanded access to college and science education, would benefit almost exclusively white, straight, male veterans. Jim Crow segregation and funding practices continued to prevent Black K–12 students from accessing science education (Katznelson, 2005; Malcolm, 2022).

Central to the report’s vision for public welfare was the potential for “scientific capital” to further the goal of full employment. Bush’s assumption was that this “capital” of basic research could then generate dollars and national welfare. All that was needed was for the government to clarify tax deductions for research expenditures in industry and strengthen intellectual property protections. The market would do the rest (Bush, 1945, p. 7).

Of course, there were many limitations in the vision of science and social progress laid out in Science: The Endless Frontier. It downplayed both the destructive potential of innovation and the threat that technological developments might generate social harms like mass unemployment. Bush’s report was released in July of 1945, just a month before the atomic bombings of Hiroshima and Nagasaki. Indeed, the report’s biggest shortcoming was its apparent lack of concern for the consequences of scientific innovation, assuming that science would lead inexorably toward undifferentiated social good. Critics of Bush’s view of innovation were quick to emerge in the postwar years. In a 1947 letter to the Atlantic Monthly, published as “A Scientist Rebels,” Norbert Wiener wrote that in the wake of the bomb, “to provide scientific information is not a necessarily innocent act, and may entail the gravest consequences” (Wiener, 1947, p. 46). He refused to participate in further military research, raising new questions that would continue throughout the years of the Korean War and into the era of the Vietnam War about unethical and socially beneficial uses of science. Further, Weiner cast aspersions on Bush’s neat equation between scientific progress and full employment, writing to the head of the American Auto Workers Union in 1949 to warn that automation could lead to “large scale industrial unemployment” (Michael et al., 2017). These criticisms suggested that technological innovation needed to be regulated carefully, and watched closely, lest its effects generate new social inequities.

One shocking example of the price paid for the government’s laissez-faire approach to science was the Cutter incident in 1955, in which supplies of polio vaccine mistakenly containing an active disease-causing virus were distributed and caused multiple cases of polio. As historian Allan Brandt has noted, “By abdicating a more active role” in the testing and distribution of the vaccine, “the government invited the possibility of crisis.” Pharmaceutical companies like Cutter Laboratories were trusted to manufacture safe products under intense pressure, with neither regulation nor incentives to secure that obligation. This avoidable

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3 “Two great principles have guided us in this country as we have turned our full efforts to war. First, the sound democratic principle that there should be no favored classes or special privilege in a time of peril, that all should be ready to sacrifice equally; second, the tenet that every man should serve in the capacity in which his talents and experience can best be applied for the prosecution of the war effort. In general we have held these principles well in balance.” (Bush, 1945, p. 24)

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

incident compounded with troubling ethical oversights in the testing of the vaccine on human subjects (Brandt, 1978, p. 268).

Innovation policy produced inequities in the post-World War II era not merely by ignoring the downsides of technology, but also because policy makers were inattentive to the fact that scientific innovation generated harms by itself relying upon social inequities in the generation of new knowledge. Innovators at the time also relied upon inequities and the absence of ethical guardrails in conducting research (see Box B-1). Research was routinely conducted among vulnerable populations without their consent, including prisoners, institutionalized patients with mental illness, nursing home residents, soldiers, and patients at academic health centers. Some of the leading researchers of the era, such as Jonas Salk, relied on institutionalized children with mental illness in testing polio vaccines. Scientific research thus embodied a profound paradox: the promise of public goods for all was often built upon exploitation of vulnerable people, whose bodies were crucial to the testing of drugs and new technologies.

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

In the decades that followed, these routine exploitative practices, such as the use of institutionalized persons as research subjects, practices that were elemental parts of scientific innovation, would be subject to scathing social criticism, policy critique, and expanding oversight. But the fundamental tensions of the “Endless Frontier” era remained, pitting the laissez-faire governance approach to innovation, along with the assumption that the advance of science would naturally foster social welfare, against an emerging contrary perspective: the argument that technology innovation, whether in drug development, military applications, private enterprise, or academic research, needed some degree of oversight in order to fulfill those ideals. Moreover, this emerging criticism contended that the system of scientific innovation itself was founded on deep inequities.

These tensions over governing scientific and technological innovation would animate U.S. science and technology policy in the decades to come.

PURSUING EQUITY IN SCIENCE, MEDICINE, AND TECHNOLOGY GOVERNANCE IN THE 1960S: IDEALS AND LIMITATIONS

A fundamental driver of policy making in the 1960s was the contention that science, technological innovation, and their applications required greater oversight in order to serve the common welfare. In a decade defined by civil rights activism and legislation, consumer consciousness, advancements for women in the academy, deinstitutionalization of the mentally ill and hopes of their integration into society, public insurance reform expanding health insurance access for the elderly and poor, burgeoning antiwar protest, and the “war on poverty,” the definition of the public good was changing rapidly. Scientific and technological innovations became subject to unprecedented scrutiny. The decade would see sweeping reforms in scientific innovation and technology governance, many of which sought to reduce or remove vexing inequities.

Several high-profile failures of governance had already become glaring as early as the late 1950s. At the time, congressional hearings focused on the pharmaceutical industry’s failures to disclose drug side effects, but it would take the thalidomide scandal in 1960 to drive major reform. Congress, previously hesitant to expand oversight, enlarged the authority of the Food and Drug Administration (FDA) to require proof that a drug was both safe and effective. New governance systems for innovation emerged slowly over the next two decades, with new practices of informed consent, new institutions to govern ethical conduct, and laws mandating disclosure of side effect risks to consumers and imposing other requirements on researchers and manufacturers in the name of protecting the public health. This episode was indicative of the mood of the decade, in which the government was increasingly held accountable for the harms of technological development.

Early in the 1960s, a confluence of factors shaped a new commitment to “technology assessment” that would dramatically attenuate Vannevar Bush’s idea of the endless frontier of scientific innovation. Two developments stand out. First, the political economy of Cold War spending led to a vast expansion of research and higher education. That decade produced new prosperity and rapid growth in domestic consumption, such that it was christened as “the decade of the consumer.” Second, the 1960s was also a decade of social turmoil. Antiwar and civil rights movements aimed to hold the government accountable for inequity and unjustified violence. President Johnson’s “Great Society” programs aimed to address gaps in the New Deal’s provisions for economic citizenship in ways that were sensitive to problems of equity and structural disadvantage. These trends birthed a new regulatory climate by promoting the rights of consumers, minorities, and conscientious

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

objectors, which spurred a broader conversation about civilian participation in technological decision making.

Several types of inequity came into view, along with new governance systems for managing innovation, first among which was consumer protection. Described by President Kennedy in 1962 as “the only important group in the economy who are not effectively organized, whose views are often not heard,” consumers moved to the center of the policy stage (Browne Ittig, 1983). Endowing consumers with rights—to safety, choice, information, and a voice at the table—empowered new legislation and administrative oversight of technological development. Most visible were the efforts of Ralph Nader, whose 1965 book Unsafe at Any Speed led to the passage of the Highway Safety Act the following year and served as inspiration for a group of law and graduate students, known as “Nader’s Raiders,” who brought his research-led model to other regulatory agencies.

In a similar vein, science and technology oversight expanded to address inequities that had built up over previous decades: protecting research subjects and patients and expanding equitable access to new technologies. In many of the reforms undertaken, racial inequities remained subsidiary concerns, lagging in importance behind general questions of safety—wholesale protections of consumers, research subjects, patients, and other disadvantaged categories of persons from the harms that scientific innovators had visited upon them (Cohen, 2003).4

First, there was the problem of how vulnerable subjects and consumers were exploited or harmed by scientific innovation in academic and non-academic research. In the early 1960s, for example, FDA authority over drug approval expanded dramatically in the wake of public shock over revelations that thalidomide, a drug prescribed for morning sickness, was tied to deaths and birth defects in thousands of infants. Protecting consumers and research subjects required a different kind of governance altogether. “From a policeman of safety,” explained William Curran, “the FDA was transformed into an arbiter of value, quality, and success in scientific achievement” (Curran, 1969, p. 552). New practices emerged, including informed consent, the creation of Institutional Review Boards (IRBs), and consumer protection laws that aimed to hold innovators accountable and empower vulnerable research subjects and consumers. The FDA oversaw an expansive set of new requirements on industry, including proof of therapeutic efficacy for drugs, comprehensive requirements for clinical testing, controls on drug advertising, labeling to disclose contraindications and harmful side effects, and the elimination of a loophole that led to automatic approval of an application after a passage of time.

Second, there were also inequities in access to beneficial medicines and health technologies. Pressures to create a national health insurance program led to the establishment of Medicare and Medicaid in 1965. Ever since President Truman’s call for a Fair Deal for Americans via a national health insurance program, the proposal had faced stiff opposition. As Theodore Marmor argues, by the mid-1960s Medicare was conceived to be a first step toward that broader goal (Marmor, 2000). As a program targeted at the elderly, the problem that Medicare and Medicaid sought to address was truly one of social inequity because of the yawning gaps between an employer-based private health insurance system and those left behind by age or poverty, thus lacking access to insurance and to health care.

Medicare and Medicaid legislation also created new institutions to oversee, regulate, and guide coverage, albeit ones that continued the existing trend of using funding as leverage to

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4 Consumption was itself an arena for civil rights activism. Historian Lizabeth Cohen has shown how “Don’t Buy Where You Can’t Work” efforts that began during the Great Depression fed into a mass movement geared toward direct action in the consumer marketplace. In turn, Cohen argues, “[the] legal and commercial right to participate drew more attention than the economic right to a fair share,” stealing the spotlight from questions of redistribution and equity (Cohen, 2003, p. 190).

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

shape the socially, geographically, and demographically equitable application of innovation to health care. The use of government leverage to accomplish equity goals—along lines of race but also regional access—would become the topic of ongoing political debate (Cohen et al., 2015; Katz Olsen, 2010; Oberlander, 2003). The evenness of Medicare’s implementation across U.S. states contrasted with the unevenness of Medicaid coverage, prompting critics in the 1970s to observe that “although it is well known that Medicaid eligibility varies among states, very little effort has been made to implement the program more equitably” (Okada and Wan, 1978, p. 343).

Attention to certain vulnerable groups—research subjects, consumers, the elderly, the poor—exposed one face of social inequity during the 1960s; at the same time, deep-seated racial and ethnic inequalities in science, technological, and medical innovation also came into focus. The Black Freedom movement brought stark racial inequities to center stage with demands for the freedom to vote, freedom from employment discrimination, and equal access to educational and housing opportunities. Passage of the Civil Rights Act, Voting Rights Act, and Housing Rights Act helped to chip away at entrenched racism and the legacies of legalized segregation. When coupled with litigation or other legislation aimed at undoing segregation and racism, these acts turned a language of rights that had previously worked against regulation (for example, state’s rights) into a formidable tool (civil rights) for addressing institutional harms.

The convergence of Medicare reform and civil rights showed how the federal government could use funding leverage to advance health equity, making large advances in rapid and dramatic fashion. On the eve of passage of Medicare and Medicaid, racial inequities in health care were deeply entrenched. Most blatantly, many medical institutions remained segregated, but the mid-1960s saw a sea change in the federal government’s use of funding to advance racial equity. The 1963 federal court ruling in Simkins v. Cone opened the door for the federal government to use funding for hospitals as leverage to compel hospitals to reform, integrate, and remedy persistent inequities in access to care. For decades since the 1945 passage of the Hill-Burton Act, also known as the Hospital Survey and Construction Act, federal dollars had flowed to states, many of which used the funds to build and sustain segregated facilities. The passage of Medicare in 1965 created a convergence of forces. A new stream of funding to hospitals, along with commitments to equity, provided extraordinary leverage to a new agency charged with implementing Medicare to compel hospitals to desegregate. As Historian David Barton Smith notes, “The most controversial section of the civil rights bill, Title VI, prohibited the provision of federal funds to organizations or programs that discriminated on the basis of race.” In early 1966, the Surgeon General’s Office created the Office of Equal Health Opportunity (OEHO), a unit delegated with the specific responsibility of certifying hospitals to become Medicare providers. The process was politically contentious, but, as Smith explains, by the time Medicare was implemented “hospitals became the most racially and economically integrated private institutions in the nation” (Smith, 2015). See Box B-2 for quoted material regarding these new systems.

The turmoil of the era informed new approaches to governance in the name of justice, fairness, and equity in science. The idea that scientific, medical, and technological innovation needed robust oversight also expanded, inspiring new laws, new administrative agencies and powers, new exercises of funding leverage, new rights recognized for subjects and patients, and new professional norms. Across areas of technological, science, and medical innovation, investigators were confronted with shocking allegations of persistent mistreatment of research subjects, misaligned incentives in research, and the need for ethical reform.

Anti-technology skepticism flourished in many of the movements of the era, from the rise of environmentalism in the wake of the publication of Silent Spring in 1962 to protests over

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

chemical weapons used in Vietnam to concerns over the threat of nuclear technology. One scholar of the decade, Matthew Wisnioski, notes that by 1968 these strands became woven together within the burgeoning counterculture: “Never before had technological power appeared simultaneously so autonomous and so inextricable from political power, and not since the machine-breaking uprisings of the early nineteenth century had so many citizens perceived technology as a force to be resisted” (Wisnioski, 2012, p. 5).5

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5 “By 1968, strands of critical thought provided commonality between countercultural, environmental, civil rights, and antiwar movements in what historian Theodore Roszak characterized as ‘a cultural constellation that radically diverges from values and assumptions that have been in the mainstream at least since the Scientific Revolution of the seventeenth century.’” (Wisnioski, 2012, p. 5)

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

A new idea of “technology assessment” emerged in this context. Many academics were chastened by the political mood, balking at their colleagues’ eagerness to join picket lines. Others, Wisnioski shows, sought to carve out a middle ground and reclaim the narrative of scientific progress, albeit one attenuated by social forces. Harvard University led an IBM-sponsored Program on Technology and Society, which supported numerous reports, books, and articles on how to “understand and control technology to good social purpose” (Wisnioski, 2012, pp. 52-54). Democratic congressman Emilio Daddario, a member of its bipartisan, multisector steering committee, was instrumental in bringing its findings to the federal government. The idea of “technology assessment” crystallized around a perceived need to “discipline technological progress,” to carve out a “middle ground” of regulation that would allay the anti-technology sentiment threatening a key front of the Cold War. Technology: Processes of Assessment and Choice, the 1969 report by the National Academy of Sciences to Congress, spoke of systemic risks, while only gesturing toward “potentially injurious effects upon sectors of society” as a major issue for technology governance (NRC, 1969, p. 13).

Attention to racial inequities were rarely part of these new debates over technology assessment, an omission that mirrored conversations in the medical realm. As many scholars have documented, the field of bioethics emerged and expanded amid the tensions of the 1960s. “Medical schools and university hospitals are increasingly dominated by investigators,” wrote Henry Beecher in his shocking 1966 New England Journal of Medicine exposé on widespread medical experimentation without informed consent. Beecher’s review of the literature revealed routine and dangerous procedures conducted without patient consent, from liver biopsies to cardiac catheterization and injection of live cancer cells. In other cases, standard procedures were withheld for the sake of a scientific study. In Beecher’s assessment, the interests of science and the interests of patients were diverging. His careful documentation helped inspire efforts to reform scientific innovation, to establish guardrails around innovation, and to make science not only more ethical and just but also less inequitable in the risks borne by unwitting research subjects and patients.

Beecher’s essay highlighted a growing divide between the interests of researcher and subject and doctor and patient, exacerbated by the growth of the research enterprise. Decades of funding geared toward innovation and global competitiveness in science, medicine, and technology had produced a culture that routinely harmed patients and subjects, even as it produced many new products and lifesaving interventions. The incentives of the system had warped researchers’ values, Beecher suggested. Anyone seeking promotion to a medical professorship had to “[prove] himself as an investigator,” and the availability of research funds placed extreme pressure on ambitious young physicians. This professional dynamic, along with “the great power for good and harm in new remedies,” Beecher warned, “can lead to unfortunate separation between the interests of science and the interests of the patient” (Beecher, 1966, pp. 1354-1360).

Importantly, Beecher’s exposé had one glaring blindspot: it never mentioned the racial and ethnic minority inequities at the center of the ongoing exploitation of research subjects. One example was the use of women in Puerto Rico for testing high estrogen birth control pills in the 1950s. Within a few years of Beecher’s exposé, the topic of racial exploitation would become unavoidable. It burst into the open in the early 1970s with public disclosure of the ongoing Tuskegee study of untreated syphilis in African American men in Macon County, Alabama, a U.S. Public Health Service study that stretched from the 1930s until 1970. It would not be until the late 1970s that the Belmont Report on human subjects research noted that these specific groups constituted a “special instance of injustice” and vulnerability to research exploitation, because “racial minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as research subjects, owing to their

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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ready availability in settings where research is conducted” (OHRP, 1979). Statements like this confirmed that racial exploitation had been a key facet of research abuses, all made easier by socioeconomic conditions, geographic isolation, the illiteracy of the research subjects, compromised capacities, administrative convenience, and manipulation of existing power dynamics (OHRP, 1979).

By the end of the 1960s, new social values and a heightened awareness of potential abuses of power were reshaping the ecosystem of science. Government was called upon to reduce exploitation and to police the harms inherent to scientific innovation, though the means of doing so varied. Legal obligations of equal protection made funding a lever to enforce equal access to medical services. Yet the larger question of how to “discipline technological progress” and ensure equitable distribution of its harms and benefits remained on the table as the 1970s began.

DISCIPLINING TECHNOLOGICAL INNOVATION IN THE 1970S: PROMISES AND PITFALLS

The 1970s were a high-water mark of commitments to equity. Many of these advances came in the guise of new professional norms, while others came through government programs enacted to ensure equity. However, without universal programs or equivalent expansions of government authority, the latter advances rested on unstable ground. The regulatory constraints on innovation in the 1960s had dramatically expanded the role of government beyond merely funding innovation, and there was little credibility left in the assumption that social and medical benefits would be equitably distributed without explicit guidance. Where this system of science governance would go in the 1970s was subject to heated debate, with arguments for continued government oversight facing stiff new opposition. Indeed, as the gains of the prior decade became manifest, the groundwork was laid for opposition and limits upon that vision of governance. This shift was reflected across several policy spheres, from expansion of Medicare to cover access of dialysis, to passage of the 1973 Health Maintenance Organization (HMO) Act, to a new congressional Office of Technology Assessment (OTA).

The case of access to kidney dialysis highlighted the continuing power of direct federal government funding of new entitlements to enhance social equity in access to life-saving science and technology. In 1972, Congress expanded Medicare to include two new provisions. One ensured that people with disabilities were covered under the program, not only the elderly. The second expanded the program to ensure that patients with end-stage renal disease would have access to dialysis. The dialysis entitlement was a specific example of how concern for market-created inequities continued to drive health legislation.

Passage of the Kidney Dialysis Entitlement in Medicare represented a high point in the federal government’s attempt to remedy market inequity with regard to a single life-saving technology. The market for patients with kidney failure was ridden with stark inequities, with patients with insurance more likely to be able to afford dialysis, and other patients with kidney failure who lacked financial means being denied access to the critical life-saving technology. As the influential Congressman Wilbur Mills explained, equity within this class of patient was the policy maker’s concern: “to assure that any individual who suffers from chronic renal disease will have available to him the necessary life-saving care and treatment for such disease and will not be denied such treatment because of his inability to pay for it” (Rettig, 1991, pp. 189-190). As analyst Richard Rettig has explained, these considerations over dialysis disparities—the glaring fact that life and death hinged on access to a single technology—were central to the passage of the legislation (Rettig, 1991).

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Amid the discussions about how to implement a national health insurance, health policy scholar Rashi Fein indicated that definitions and measures of equity needed to be sharpened: Some forms of equity should focus on creating a common baseline of services that equalize access for people in the same economic circumstances, while other definitions of equity would work to reduce disparities across people in different economic circumstances, and that better measures of equity were needed (Fein, 2005).6 Fein pointed to the inherent limitations of cost-benefit analysis for dealing with distributive questions and suggested that overall, the difficulty of quantifying equity often led to its neglect. The technology-specific dialysis legislation also raised the specter that government actions were introducing new inequities while attempting to remedy others (Berman, 2022).7 Why, after all, was this specific patient group and this single technology singled out for Medicare coverage?

If dialysis legislation continued to build on the 1960s model of government addressing equity through financing, to a large extent the HMO act and the creation of the OTA represented a break in this form of technology governance. These emerged not from pressures to ensure equity or fairness in the development of technologies, but from policy actors who valued efficiency as they expanded the role of economic analysis in government affairs. In this era, policy makers who were tasked with administering these programs adopted principles of budgeting and systems analysis developed for the military, what historical sociologist Elizabeth Popp Berman calls an “economic style of reasoning” that elevated efficiency over equity as a keystone value. In practice, this economic logic and attention to budgets would limit the ideals of the 1960s Great Society programs. Budgetary concerns undermined efforts to expand programs like Medicare universally, even if they also allowed for adding specific new entitlements to the program in the name of equity.

Senator Ted Kennedy’s failed effort to pass national health insurance and the passage of the HMO Act of 1973 highlights how the tide was shifting away from global equity-based arguments for expanding access and toward specific market incentives that advanced more limited equity ideals—specifically, rural and urban health. In 1971, Kennedy introduced a Health Security bill that proposed replacing Medicare and Medicaid with federally-run, universal insurance. Its opening salvo declared that adequate health care should be recognized as a right, not a privilege, a view endorsed by civil rights leaders and feminists in addition to public health experts (Berman, 2022). Few in the Nixon administration opposed the idea. However, growing interest in cost control through market incentives held greater appeal, which led them to embrace legislation establishing health maintenance organizations (HMOs) as an alternative to universal insurance.

The HMO legislation provides a case in point of the new focus on incentives in health and technology governance. The law exemplified a flawed idea: that incentives for new health organizations could address ongoing problems of rural and urban “ghetto” access. As Clark Havighurst wrote in 1970, Nixon saw the HMO concept as “altering incentives in health care delivery to induce efficiencies and reduce overutilization,” proposing $22 million in

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6 “We can distinguish between horizontal and vertical equity. By horizontal equity we mean that the health care system shall provide essentially the same set of health services (or a distribution of services that equalize outcomes) for persons in approximately the same economic circumstances…Vertical equity, ‘fairness,’ in the provision of services for persons in different economic circumstances, is more difficult to define.” (Fein, 2005, p. 9)

7 The significance of the dialysis entitlement becomes clearer in the context of the 1970s debate over national health insurance. In response to Kennedy’s Health Security bill, the Nixon administration solicited a proposal from the RAND Corporation for a Health Insurance Experiment to evaluate whether the fully insured would “overuse” care compared with those on cost-sharing programs. The study took 15 years and cost $80 million, but paid dividends. Economist John Nyman argued in 2007 that this early work on moral hazard “provided the intellectual justification for transforming the health care delivery system of the 1960s and 1970s into the one we have today.” (Berman, 2022, p. 122).

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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subsidies for HMOs that would serve rural and urban areas where medical resources were in particularly short supply (Havighurst, 1970, p. 725). Among other justifications, the HMO model was rooted in a genuine belief that such incentives could fix inequities in access to care—specifically, the geographic maldistribution of health care institutions. It thus represented a shift in approach to Great Society “welfare” programs that aimed to advance equity (Berman, 2022, p. 117).8 The program was founded on a technocratic ideal: providing for “an ongoing quality assurance program for its health services which [stressed] health outcomes.” As health policy scholars Steven Schroeder and Molla Donaldson noted, “This provision followed in the wake of congressional testimony criticizing proprietary HMOs serving the urban poor in California…and represented an attempt to protect consumers by mandating quality assurance procedures” (Schroeder and Donaldson, 1976, pp. 49-56). HMOs were an effort to innovate in equity and health governance, one that pitted the idea that incentives, quality assessment, and new structures could reduce inequities against the government-run programs of the Great Society era (see Box B-3).

The rise of the OTA in these years, and its fraught history and ultimate demise in the 1990s, epitomizes the promise of this new type of technology governance in the 1970s and its limitations. Writing in 1971, physician Lewis Thomas observed that technology assessment had become a new idea. It was now “a routine exercise for the scientific enterprises on which the country is obliged to spend vast sums for its needs…committees are continually evaluating the effectiveness and cost of doing various things in space, defense, energy, transportation and the like, to give advice about prudent investments for the future” (Thomas, 1971, pp. 1366-1368). Though such evaluations were on the rise, the groups that conducted them were, by design, limited in their authority.

A multitude of environmental and scientific concerns, from oil spills to the implications of supersonic aircraft and sonic booms to pesticide use and air pollution, suggested the need for an advisory body to assess technology (Assessing U.S. Technology, 1970.) The OTA, promoted by Congressman Emilio Daddario, sought to create an “early-warning system—a means of identifying the probable consequences, either good or bad, of technological developments before they reach widespread use.” What the mechanisms of that system would be, “who should operate it, and how the findings should be implemented,” remained an open question in 1970. The goal for such an office was formidable—to advise Congress on the consequences of emerging technologies, and “in the case of detrimental technologies, it would seek and foster alternative approaches” (Clauser, 1970, pp. 315-317). Nonetheless, responsibility to act would be left to the executive and legislative branches.

For policy makers, the need for expertise was a driving force behind the OTA; issues of equity and the disparate social effects of technology did not figure at all in the vision for the office. As one Senate aide explained, the primary concerns hinged on the need for experts to envision consequences. In the lead-up to the law establishing the OTA, “two recent battles helped sell Congress” on the need for such an office, the aide explained: the ABM [anti-ballistic missile system] and the SST [supersonic transport]. Without authoritative expertise of its own, Congress’s ability to act was limited (Cohn, 1972). Understanding inequities and variations in technology’s effects was not front and center in this vision of technology assessment.

The OTA’s early reports reflected the controversies that gave rise to it, and even its proponents pointed to limitations in the model early on. For its first few years, the Office was

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8 For example, Social Security, which in principle benefited both the needy and well-off, came under increased scrutiny. Debating the economist Milton Friedman on whether Social Security should be means-tested rather than universal, Department of Health, Education and Welfare secretary Wilbur Cohen argued in 1972 that “[a] program for the poor will most likely be a poor program.”

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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largely devoted to the assessment of transit projects, natural gas, and the procurement of raw materials, reflecting the overwhelming influence of the energy crisis of the time. When it did consider other topics, like the development of medical technology, the limitations of the framework seemed to almost outweigh the opportunities. Authors of a 1976 report cited prohibitive costs, in addition to a lack of standard methods, “weaknesses in the tools and techniques of social science,” and a difficulty coordinating among experts as obstacles for effectively implementing technology assessment for medical innovation (OTA, 1976, p. 47).9 Objective measurement of social consequences, perhaps unsurprisingly, was an elusive goal.

Meanwhile, the energy crisis of the 1970s raised particular concerns about energy needs, social equity, and government policy regarding the energy sector. Following the Organization of the Petroleum Exporting Countries (OPEC) oil embargo of the early 1970s and the ensuing national energy crisis, observers like Ellis Cose, in a book titled Energy and Equity, noted that

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9 In fact, one of the report’s recommendations was not to implement any technology assessment processes at the National Institutes of Health.

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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minorities and the poor were particularly vulnerable to energy crises. Such observations did have modest impact in reshaping technology policy. For example, in 1978 a National Energy Conservation Policy Act, Public Law 95-619, created an Office of Minority Economic Impact within the Department of Energy. Its role was to “advise the Secretary on the effect of energy policies, regulations, and other actions of the Department and its components on minorities and minority business enterprises” (Equity in energy, 1979, p. 7; Poyer, 1990, p. 10). Minority was defined as “Negro, Puerto Rican, American Indian, Eskimo, Oriental, or Aleut or… Spanish speaking individual of Spanish descent.” As one policy scholar, David Poyer, later noted, the law “affirmed the fact that American society is pluralistic and that the enactment of policy can without care adversely affect certain population groups relative to others.” But the office remained merely advisory to the Secretary, with no directives to pursue equity in energy policy. Looking back in lament on the 1970s, Poyer observed “the development of a comprehensive national energy policy, let alone one in which equity issues were addressed, has been difficult and in the view of many unsuccessful (Poyer, 1990, p. 7).

These limitations of technology assessment, including its inattention to inequities or inability to mitigate unequal impact, did not go unnoticed by insightful critics. Writing in The Black Scholar in 1974, for example, policy scholar Lenneal Henderson called for “more black involvement in the emerging discipline of ‘technology assessment,’ the attempt to analyze and make informed decisions about the implications of technological developments.” From his perspective, “technology assessment models and techniques rarely include the economic and political conditions, dynamics and aspirations of black urban communities,” not to mention that the impacts of transit, water, and sewage systems “on the political economy of particular and aggregate black metropolitan neighborhoods are neither known nor included in the planning and evaluation of these technologies.” The answer was not merely to collect more data, but to reevaluate how “such evidence is conceptualized and related to black goals and values [and this] needs more attention from those involved in technology assessment and decisions.” Henderson called for assessment to consider “the needs, goals and conditions of black metropolitan dwellers and the capabilities and limitations of these technological systems in providing for black people,” as well as “a multidimensional plan for black participation in technological decision-making and technological assessment,” and “black participation…in the inchoate Office of Technology Assessment” (Henderson, 1974, pp. 9-18).

Whenever equity concerns did appear in the OTA, they appeared in a limited and circumscribed way. For example, in 1977 the OTA initiated a long-range program on R&D policies and priorities with an expansive scope. One of the many items for further consideration, true to its technocratic origins, was “the development of objective criteria for assessing health and performance of the science and technology enterprise.” Another was “the equity of access to the career opportunities provided by scientific and technological systems,” reflecting attention to professional norms that was on the rise even as other equity commitments diminished (Brooks, 1977). In 1980, the OTA conducted its own extensive study of cost-benefit analysis, concluding that while the common practice had “the potential to be very helpful to decision makers,” cost-effectiveness had “too many methodological…weaknesses to justify relying solely or primarily on the results of formal studies in making decisions.” One of the weaknesses in this type of assessment was “the inability of analysis to adequately incorporate equity and political considerations” (Banta and Behney, 1981, pp. 445-479).

From the outset, supporters of the OTA sought to distance technology assessment from regulation, and positioned it as an information provider above all else. Its ultimate aim was to regulate the balance of power between branches of government through information: “to lessen [Congress’s] dependence on executive branch agencies and special-interest groups for

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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scientific and technical information and analysis” (Stine, 1998, pp. 815-816). It was shaped by a particular set of values and commitments that prevented it from being an effective ally in the environmental justice movement, one of the initial visions for the office. Despite this emphasis on neutrality, during the 1980s the office would wade into controversy surrounding defense spending, ultimately leading to its demise.

The 1970s began with faith, carried over from the 1960s, that institutions—Medicare, HMOs, and the OTA—might fulfill a broader mission of science for the common good. Over the course of the decade, these ideals confronted significant limitations: ideological opposition, fiscal limitations, and growing skepticism about the use of government powers to advance social equity. For a host of reasons, the OTA never really grew into the office it was originally envisioned to become. Nor was it capable of responding to the call from scholars like Lenneal Henderson to incorporate Black concerns and perspectives into technology assessment. The vision of technology governance would become even more circumscribed in the pro-business and deregulatory climate of the 1980s. The rise of conservative approaches to governance would limit earlier ambitions, undermining the idea that government should continue to use its leverage to advance racial and economic equity.10

PIECEMEAL EQUITY IN TECHNOLOGY GOVERNANCE: THE REAGAN ERA AND BEYOND

In the 1980s, three pieces of legislation highlight a conservative political turn in the federal government’s approach to addressing inequities that arose in science, technology, and medicine. In the increasingly pro-business, deregulatory climate defined by market-oriented drug and technology development, the piecemeal approach to equity prevailed (see Box B-4 for policy examples). Whenever problems of inequity in science and technology innovation appeared in this era, the solutions would be largely (but not exclusively) pro-business. These included incentives to help the private sector redress market inequities and injustices, incentives for universities to share in innovation, and reforms to limiting industry liability for innovations that produced harms.

The ideal of governing science and technology innovation to promote equity—that is, greater fairness in the distribution of benefits from innovation—did not disappear entirely, but the governance philosophy behind it adapted to more conservative times, with increasing attention paid to the idea of incentivizing for equity. This was not a return to the gilded age of the “endless frontier,” nor was it a full-scale rejection of activist governance. Rather, this era in some ways extended a formula for governance that had begun in the Nixon years, echoing ideas that created the HMO Act of 1973. The 1980s policy makers embraced attempts to balance innovation and equity in specific sectors where the injustices had become most politically problematic: for example, the Orphan Drug Act of 1983.

In an atmosphere of deep hostility to the idea of government oversight, the programs that had become associated with equity—Medicare, Social Security, Medicaid, Head Start, and so on—were subject to harsh criticism. Opponents of Medicare, for example, framed their opposition to the program as a matter of “generational equity,” a sly rhetorical effort to highlight that in an insurance system, the elderly benefited at the cost of the young. As health policy scholar Theodore Marmor noted, for critics “the prospective retirement of the baby boomers beginning in 2010 figured prominently in the picture of an American government

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10 In education policy, opposition to school bussing to achieve equality of access came under attack; opposition to affirmative action grew. In social welfare policy, skepticism and outright hostility expanded toward programs from Head Start to Aid to Families with Dependent Children.

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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facing a tidal wave of expenses from programs directed at the growing number of elderly citizens…[an] apocalyptic conception of the future” (Marmor, 2000, p. 140). In this cynical portrait, government action in the name of equity was cast not only as costly but also as inequitable.

Even prior to the Reagan revolution, throughout the Carter administration a pro-business, regulation-wary climate was growing in government. The Patent and Trademark Act Amendments of 1980 (also known as the Bayh-Dole Act) created new incentives for commercialization by allowing universities to benefit financially from patenting innovations, facilitating technology transfer and industry spin-offs. Social equity was an afterthought. Three years after the Bayh-Dole Act came passage of the Orphan Drug Act, which explicitly acknowledged that incentives in drug development were heavily skewed toward large markets and profit potentials, and against “orphan diseases”—that is, rare disorders where industry had no incentives to conduct drug research and development because there were so few patients and such meager profits. In this era, enhanced business incentives became the guiding strategy for addressing social inequities stemming from technology development.

The establishment of special vaccine courts to compensate people injured by vaccines exemplified the new ecosystems for dealing with science and technological harms in this era. Like the Orphan Drug Act and Bayh-Dole, it offered an industry-friendly incentive: reducing industry liability when vaccine technologies proved harmful. Signed into law as part of the 1986 National Childhood Vaccine Injury Act, the National Vaccine Injury Compensation Program was intended to promote fairness. As health law scholar Wendy Mariner observed, “Most members of Congress hoped it would also contribute to stabilizing vaccine supplies and prices and to improving immunization rates.” The basis for this hope was “the assumption that potential liability was a disincentive to manufacturers to enter or stay in the vaccine business,” one that government was in a position to remove by creating an alternative to the traditional tort system (Mariner, 1991, p. 422). As political scientist Anna Kirkland explains in her book, Vaccine Court, the new program was the product of an elaborate compromise:

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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“In the end, the parents got a route to compensation and an open if not unimpeded path to a tort suit, the manufacturers got stability and protection from litigation, and pediatricians were reassured that the nation would have an uninterrupted supply of childhood vaccines” (Kirkland, 2016, p. 72).

The result of these laws—incentivizing drug production, reducing liability, and speeding technology transfer from universities to the private sector—was a new ecosystem that prioritized technology development above other conceptions of the public good. Dialing back on equity commitments had consequences. After 25 years of Bayh-Dole, for example, financial benefits to universities skewed heavily toward a small number of powerful universities. According to a government study, out of 141 universities with licensing income, 22 accounted for 80 percent of the patent licensing income. This skew would lead some universities to take “a broader view of the appropriate metrics of technology transfer activity to emphasize more regional economic development.” The Association of American Medical Colleges and several universities, led by Stanford, generated “nine points” to guide technology transfer, including one equity guideline. Point 9 suggested that licensing “consider provisions that address unmet needs, such as those of neglected patient populations or geographical areas, giving particular attention to improved therapeutics, diagnostics, and agricultural technologies for the developing world” (House of Representatives, Committee on Science and Technology, Subcommittee on Technology and Innovation, 2007).

These policies promoted speed and innovation in the technology development, limiting government oversight that had expanded through efforts to mitigate harm and advance social equity. In many respects, this era witnessed a fundamental rethinking of the existing ecosystem. The fast-tracking of AIDS drug approval and other FDA innovations aimed at speeding experimental medicines to the market attracted praise, as well as concern about drugs that needed to be removed from the market after detrimental effects appeared postapproval. As George Annas observed in 1989, “The politics of AIDS has produced strange political alliances. The anti-regulatory Reagan and Bush administrations and the gay community probably have only one interest in common: deregulating the drug approval process” (Annas, 1989, p. 778). The result was new drugs, as well as new surrogate marker measurements for speeding drug approval, and the blurring of lines between experimental drugs and therapy. The market in pain drugs was another case in point of market booms that began in the 1980s, with slowly emerging calamities in later decades, leading to calls for stiffer post-market accountability and liability law figuring more and more prominently in pursuing accountability in this new ecosystem (Wailoo, 2015).11

Perhaps not surprisingly, the Reagan revolution also saw intensifying criticism of the goals of “technology assessment” and the demise of the Office of Technology Assessment (OTA) when Republicans gained legislative power in 1992. As with the ABM controversy under the Nixon administration, the OTA waded into controversy when it came out in opposition to President Reagan’s Strategic Defense Initiative. The administration fired back that the office had exposed defense secrets, and while it weathered these charges, it would not survive for long. As part of Congressman Newt Gingrich’s sweeping “contract with America,” the OTA budget was eliminated as excessive spending. For some, it was a wonder that the

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11 For example, Eli Lilly’s Oraflex was approved in 1981; annual sales totaled $1.9 billion; by 1982, the drug was linked to multiple deaths; by mid-1982, the drug was off the market. In 1985, the company pled guilty to misdemeanor charges, admitting to mislabeling the drug and failing to inform the FDA about adverse reactions in the approval process. In some cases, the court system was left to assess the damage and provide relief. One Alabama man whose mother had died after taking Oraflex won a jury award for $6 million in federal court. Other painkiller drugs, such as Syntex’s Toradol, attracted similar controversy (Wailoo, 2015, p. 192).

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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office lasted at all; others lamented that the office had sacrificed authority and influence for the sake of stability (Bimber and Guston, 1997).

The policies of the 1980s and 1990s created a new set of ground rules, a profound shift in the ecosystem of technology governance. Promoting—not disciplining—innovation made financial incentives, rather than careful assessment and regulation, the instrument of choice, as equity considerations moved to the background. The passage of the Orphan Drug Act revealed the ways in which even conservative lawmakers embraced federal laws (using the mechanism of incentives) to restore fairness in a drug development system where markets created large inequities.

THE GROWING CRISIS OF ACCESS, ACCOUNTABILITY, AND CALLS FOR EQUITY-BASED POLICIES

In the last two decades, as economic trends have increased social inequalities, the topic of equity and technological innovation has figured ever more prominently in academic policy discussions regarding technological, scientific, and medical innovation. One aspect of the equity discussion addresses equitable access to the fruits of science, technology, and medical innovation—that is, building systems for ensuring equity in access to the products of scientific and technological innovation. Another related aspect of the equity discussion addresses preventing inequities in technology development, or ensuring that scientific research processes, human subjects research, researchers’ engagement with communities, and technological development do not exacerbate existing inequities. The urgency of these concerns has been widely recognized in policy discussions, even if there are few concrete steps proposed for addressing these equity challenges.

One example of a U.S. law that subjected one area of science and technology innovation to extraordinary market constraints in the name of social equity and preventing discrimination stands out: GINA, passed in 2008. Policy makers in the 1990s had grown increasingly aggressive about regulating insurance companies, banning them from denying coverage to people with preexisting conditions. Developments in genetics resulting from the sequencing of the human genome and identification of genes linked to diseases added a new concern for lawmakers. These advances promised new medicines, but they also prompted fears that insurance companies might unfairly discriminate against patients on the basis of genetic information.

The result was sweeping legislation banning the use of this innovative technology and an entire class of biological data from use by the health insurance industry. These restrictions showed that even conservative government was not above placing outright restrictions on the use of technologies when those uses were understood to foster new forms of discrimination and social inequities. In a shift away from the incentive-based ecosystem of technology governance, GINA saw the government taking a proactive role, restricting the use of genetic information in anticipation of social inequities that might arise if genetic data became part of the insurance business model. These definitions of inequity, however, focused on specific, even speculative vulnerable groups—people with genetic disorders—rather than federally recognized minorities who have historically been singled out by governments and businesses alike.12

Over the past two decades, other problems with the innovation-oriented, deregulatory, pro-business ecosystem have emerged, leading to calls for accountability and improved regulation, including postmarket surveillance (see Box B-5 for a range of examples). The opioid

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12 There have also been proposals to overturn GINA (Zhang, 2017).

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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crisis provides one example of how and why calls for better governance have grown louder in recent decades. The drug OxyContin was approved in the late 1990s and charted a path through market approval toward wider prescription and use. By the mid-2000s, a social crisis of addiction and overdoses (seen in the early years as prevalent in white rural areas such as Appalachia) began to emerge. The side-effects of other drugs, like Vioxx, were also attracting lawmaker concern. By 2006, critics of both the FDA and the industry, such as Senator Charles Grassley, saw the removal of Vioxx from the market as a reason to consider stronger reforms: “Vioxx was like a dead canary in the coal mine,” he explained, “a warning that worse may come…there’s no question left that we need to strengthen postmarket surveillance in order to improve drug safety and save lives” (Wailoo, 2015, p. 192).

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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The wave of lawsuits against drug companies brought by pregnant women, children, and others harmed by illegal marketing over the past 20 years highlights the heavy toll that deregulation has had on the public health. These cases raise sweeping questions about governance and regulatory failure, only hinting at the underlying inequities in the users affected by the malfeasance. Examples are numerous. In 2009, Eli Lilly agreed to pay $1.4 billion to settle in response to off-label allegations involving the drug Zyprexa (DOJ, 2009). That same year, Pfizer paid $2.3 billion for a health fraud settlement. In 2013, Johnson & Johnson paid $2.2 billion for illegal off-label marketing of Risperdal to children, among others, and in 2022, Purdue Pharma reached an $8.3 billion settlement with the Justice Department, pleading guilty to three felonies relating to the marketing and distribution of OxyContin (OPA, 2009a,b, 2013; Thomas, 2013). The opioid settlements have been wide ranging, involving not only the drug manufacturer but other industries—including consulting firms and pharmacies—in the drug market ecosystem who were strongly incentivized to build painkiller markets without concern for public welfare (Forsythe and Bogdanich, 2021).

In this context, a number of National Academies studies have sought to push equity to the foreground in technology governance—even if implementation remains a challenge. For example, a 2021 Study, “Racial Equity Addendum to Critical Issues in Transportation,” acknowledged that “transportation has…contributed to racial inequalities” in freeway development, rail transit infrastructure, and other ways. Though light on policy solutions, the report insisted that innovation in the transportation industry provided an opportunity to “build more equity into the system” and to ensure that the “equity chasm does not widen” (NASEM, 2021). In a similar vein, a 2022 NASEM study, titled “Realizing the Promise of Equity in the Organ Transplantation System” is one of a few studies of science, technology, and medicine that has pushed concerns about equity to the foreground. Its authors noted the fact that despite years of rhetorical attention to equity, implementation of those ideals has lagged: “Although equity in access and allocation has been a proclaimed principle of the organ transplantation system for decades, and appears in federal regulations directing allocation policy, equity has, until recently, been absent as a stated goal or vision in the strategic plans of many organizations working in organ transplantation.” The study concluded that new governance and oversight of the transplantation system was needed in order to achieve these goals, specifying that oversight should begin before patients are placed on waitlists, at the level of referrals and evaluations (NRC, 2022, p. 87). New technological developments, in fields from genetics to cryptocurrency to new modalities of transportation, as well as longstanding questions of access and consumerism, have kept the question of equity and science governance in the forefront of policy discussion.

Against the backdrop of history, the years 2020–2022 mark a sea change, with equity emerging as a new governance ideal. Historically speaking, the Biden administration’s decision in 2021 to prioritize racial equity in an “ambitious whole-of-government equity agenda” is unprecedented, although some of its ideals and features certainly resonate with equity commitments of the past, particularly those of the 1960s and 1970s. The administration called for “a comprehensive approach to advancing equity for all, including people of color and others who have been historically underserved, marginalized, and adversely affected by persistent poverty and inequality.” Though it made no mention of science, medical, and technology innovation, the report drew together a number of familiar as well as new steps relevant for equity-based technology innovation: Identifying Methods to Assess Equity; Conducting an Equity Assessment in Federal Agencies; Allocating Federal Resources to Advance Fairness and Opportunity; Promoting Equitable Delivery of Government Benefits and Equitable Opportunities; Engagement with Members of Underserved Communities; and Establishing an Equitable Data Working Group (White House, 2021).

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

The one area in which federal and state governments have sought to translate equity concerns into practice is the distribution of COVID-19 technologies. Amid the COVID-19 pandemic, the development of tests and vaccines raised anew and in sweeping fashion the need for coordinated governance in the name of equity. In its 2020 Framework for Equitable Allocation of COVID-19 Vaccine, one National Academies report explicitly asked, “What criteria should be used in setting priorities for equitable allocation of vaccine?” In addressing which groups should be in the first tier when vaccines became available, the report made explicit that the government must play an active role in these distributional questions, lest the market reproduce existing disparities. Matters of equity that came forcefully into view included prioritizing distribution among the elderly, people with underlying health conditions, and those at higher occupational risk and prioritizing “populations at higher risk (e.g., racial and ethnic groups, incarcerated individuals, residents of nursing homes, and individuals who are homeless.)” In establishing equity-based plans for COVID-19 mitigation, it was also clear that communicating about equity was essential. As the report asked, “How can we communicate to the American public about vaccine allocation to minimize perceptions of lack of equity?” (NASEM, 2020; Tai et al., 2020).13

In many respects, the pandemic crisis and its disparities in infection rates, hospitalizations, and mortality along lines of racial and socioeconomic difference pushed equity discussions into the foreground. Moreover, the rapid development of vaccines presented an opportunity to translate longstanding discussions and promises to prioritize equity into policy guidance and action.

CONCLUSION

The history of technology governance in the United States since the 1950s is characterized by a fundamental tension between a laissez-faire approach to innovation and a conviction that active government is necessary to ensure that the fruits of innovation are equitably distributed. Though the basic tenet that innovation contributes to social welfare has rarely been called into question, the tension between these two approaches manifests in shifting ecosystems of technology governance: from a “gilded age” era of robust science funding without oversight to an era in which government programs embraced the idea that funding and financing provided crucial leverage to advance equity, toward a more pro-business era in which government scaled back on the promise of equity, and finally a pivot to using softer incentives to balance equity and innovation.

U.S. policies have aimed at governing technology innovation with attention to specific equity concerns. At times, the focus has been on redressing inequities of harms to subjects and enhancing governance of research; at times, attention turned to redressing inequities caused the market and by government’s laissez-faire approach to inequalities in who benefits from science. At other times, policies have used new federal institutions, power, and funding (for example in Medicare) to leverage equity in access to science and technological services. At yet other historical junctures, policies have focused on incentivizing the private sector to prioritize more equitable development of products.

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13 A range of social inequities lay the groundwork for COVID-19 disparities. The report (NASEM, 2020) cited numerous instances, including, for example, that “minority groups also comprise a greater percentage of essential workers—only 20 percent of African Americans are able to work from home, for example—and many rely on public transportation to travel to work, which increases their likelihood of exposure to SARS-CoV-2” (NASEM, 2020 p. 31; Tai et al., 2020).

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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The gaps in this approach to technology, science, and medicine governance are glaring. Technology policy in the name of equity has been largely reactive—responding to crises, growing inequities in the private sector. While the OTA focused initially on the problem of anticipating the social impact of technology, little attention was given to analyzing disparate social impact. In science funding, technology design, and early-stage development, there has been little attention to equity considerations in granting. In cases where technologies produce egregious harms, lawsuits and legal action have functioned as a retroactive check, imposing a price on innovation that goes wrong. Little attention has been paid over the years to the goal of postmarket assessment or to building system-wide efforts to incorporate equity considerations into the funding, development, assessment, and deployment of technological and scientific innovation.

Several conclusions may be drawn from this history.

First, the unfinished work of the 1960s and 1970s provides clear lessons for today. There is ample precedent for equity-based governance of technology, most notably in the 1960s and early 1970s. However, a substantial and sweeping commitment to equity in technology governance has yet to be pursued as a matter of U.S. federal policy. Since the 1960s and 1970s, even as policy makers accept that science, medical, and technological innovation, and their applications, require greater oversight to serve the common welfare, robust governance for fair distribution of the benefits of science and technology has lagged as a policy commitment.

Second, using federal powers for equity has often yielded significant results. Several important federal programs, such as Medicare, have exercised power to ensure equity. The convergence of Medicare reform and civil rights, for example, showed how the federal government could use funding leverage to advance health equity, making large advances in rapid and dramatic fashion. Medicare and Medicaid legislation (as well as kidney dialysis legislation) created new institutions of government to oversee, regulate, and guide coverage; such institutions also continued the important trend of using funding as leverage to shape the socially, geographically, and demographically equitable application of innovation to health care.

Third, policy makers should consider the precedent for restricting technology. Even with the increasing reliance on incentives to promote equity in technology governance since the 1980s, the example of GINA stands out—an instance in which government restricted an entire industry from accessing information in service of preventing inequities. Fear of curtailing innovation extends back to Science: The Endless Frontier, but a proper balancing of interests can allow scientific research to advance while restricting its potentially harmful applications.

Fourth, it is abundantly clear that lack of governance produces inequities. The price paid for abdicated governance of technologies is severe and lasting, with the burden often borne by the most vulnerable members of the population. Prior to the 1960s, for example, policy makers were inattentive to the prospect that scientific innovation generated harms—most notably by unregulated use of human subjects, institutionalized persons, and other vulnerable groups. This practice produced deep social inequities in the process of generating new knowledge. Laissez-faire governance in later eras similarly fostered inequities via neglect.

Fifth, incentives can work for remedying inequities, but they can also fail. The Orphan Drug Act remains a powerful model of incentives for equity in drug development. The HMO legislation provides a case in point of how incentives in health and technology governance (originally aimed in part at increasing access in underserved areas) have, in subsequent years, strayed far from these stated ideals. Though they gradually became the default over the course of the twentieth century, this history reminds us that incentives are simply one tool among many policy options.

Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Finally, the history recounted here evidences the need for a new model of technology assessment. Going forward, a commitment to comprehensively assess the disparate social effects of technology is an important goal, but any new model of technology assessment in the twenty-first century must not repeat historical errors and blind spots. For example, attention to racial inequities were rarely part of debates over technology assessment in the 1970s. These limitations in technology assessment (its inability to consider inequities or to act to mitigate unequal impact) did not go unnoticed by insightful critics. Policy scholar Lenneal Henderson’s critique—that the dominant “models and techniques rarely include the economic and political conditions, dynamics and aspirations of black urban communities”—as well as his call for more Black involvement in the field, rings as true today as it did in 1974. Going forward, technology assessment can be updated for the twenty-first century through commitment to studying inequities and expansion of its keystone values and tenets to include broadening participation and sharing responsibility.

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Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Page 188
Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Page 189
Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Page 190
Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Page 191
Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Page 192
Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Page 193
Suggested Citation:"Appendix B: Technology Governance and Equity in the United States from the Cold War to COVID-19." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Page 194
Next: Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation »
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Advances in biomedical science, data science, engineering, and technology are leading to high-pace innovation with potential to transform health and medicine. These innovations simultaneously raise important ethical and social issues, including how to fairly distribute their benefits and risks. The National Academies of Sciences, Engineering, and Medicine, in collaboration with the National Academy of Medicine, established the Committee on Creating a Framework for Emerging Science, Technology, and Innovation in Health and Medicine to provide leadership and engage broad communities in developing a framework for aligning the development and use of transformative technologies with ethical and equitable principles. The committees resulting report describes a governance framework for decisions throughout the innovation life cycle to advance equitable innovation and support an ecosystem that is more responsive to the needs of a broader range of individuals and is better able to recognize and address inequities as they arise.

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