# Technology Assessment

Reports News from the GAO

- Air Quality Sensors: Policy Options to Help Address Implementation Challenges What GAO FoundLower-cost air quality sensors (sensors) are portable devices that can measure local air quality in real time. Although these sensors are generally less accurate than more expensive instruments, they can be deployed in large number to supplement information provided by the national air quality monitoring system. Among their many uses are identifying pollution hot spots, monitoring industrial sites and nearby neighborhoods, and conducting scientific research. Sensors can be more accurate for some pollutants, such as fine particulate matter, than others. They are as of yet unavailable for certain air toxics such as benzene and metals.Air Quality SensorsGAO identified several challenges users face in implementing sensor technologies. For example, some users have struggled to:Access expertise and resources. Some users may lack the knowledge or funding to select the right sensors or deploy them in a way that best fits their goals. Potential sources of expertise—such as universities or state and local agencies responsible for air quality management—may lack incentives or resources to partner with those users.Understand sensor capabilities. Some vendors are not transparent about sensor performance. For example, some stakeholders told GAO that some vendors claim capabilities that are questionable. In the absence of reliable information on performance, users may struggle to choose appropriate sensors.Compile and compare sensor data. Sensors produce data in many formats, and there are currently no widely accepted standards for reporting data from these different formats. In addition, some users do not report metadata that describe information such as environmental conditions or correction factors. Both issues can make it difficult for users to compile or compare data.Spur action. Some users collect sensor data to spur action. But users and decision-makers may have different expectations about the level of quality assurance required. For example, some users seek evidence of pollutants that could trigger regulators to investigate a pollution source. However, these users may not realize that their data are not of sufficient quality for that purpose due to unclear guidance on the level of quality assurance needed.GAO identified seven policy options that could help address challenges to developing and using air sensors. The options identify possible actions by policymakers, including legislative bodies, government entities, academia, industry, and other groups. See tables 5–11 in the report for a full list of the policy options, potential implementation approaches, and opportunities and considerations.Policy Options to Address Challenges to Developing and Using Air SensorsPolicy Option			Opportunities			Considerations		Maintain status quo&nbsp;			(report p. 31)						Current efforts may address some challenges without additional resources.				Resources that would be allocated to additional interventions could be used for other opportunities.									Current efforts are not likely to address all challenges described in this report.					Enhance sensor performance transparency (report p. 32)For example, government entities or standards-setting organizations could establish additional standardized performance testing protocols and targets.						Standardized testing could increase transparency and build trust among users.				Performance targets could help ensure sensors work adequately for specific uses.									Reaching consensus on standards can take considerable time.				Standardized testing could increase costs.				Industry could choose not to adopt voluntary performance testing protocols and targets.					Support innovation in sensor technologies (report p. 33)For example, the sensor industry could choose to invest in additional research and development to improve existing sensors or develop new sensor technologies.						Could enable detection of additional pollutants or existing pollutants at lower levels.									Time frames for research and development are unclear.				Could require substantial funding and other resources.					Facilitate access to expertise&nbsp;			(report p. 34)For example, universities could collaborate with others to establish technical assistance mechanisms that connect users with experts.						Could help users identify and collaborate with experts to ensure optimal use of sensors.				Could alleviate the burden on government entities or provide additional resources to carry out this work.									Some government entities and other experts may require additional resources to fully collaborate with communities.				Participating experts may be overwhelmed by inquiries or requests for help.					Improve access to guidance&nbsp;			(report p. 35)For example, nonprofit organizations and other policymakers could collaborate with others to maintain a website with links to or copies of existing guidance.						Could help users locate guidance more easily, helping them improve sensor use.				Could enable users to compare guidance more easily, allowing them to select guidance that best aligns with their needs.									Could be time and resource intensive and may need frequent updates.				Users may not know such a resource exists or trust it without endorsement and advertisement by a trusted entity.				Storing guidance in a repository may require consent from authors and owners.					Improve data management and sharing (report p. 36)For example, standards-setting organizations could collaborate with others to develop data and metadata standards.&nbsp;						Data standards could help facilitate data aggregation, comparison, and sharing.&nbsp;				Metadata standards could help users ascertain whether data are comparable.&nbsp;									Standards require consensus, which takes time and resources to build.				Organizations may not adopt voluntary data standards, especially if they were created without their input.				May be time and resource intensive.					Clarify level of quality assurance needed to spur action&nbsp;			(report p.37)For example, government entities could collaborate with others to develop guidance on the level of quality assurance required for various applications. &nbsp;						Clarity on the level of quality assurance required could help users collect data that are appropriate for their specific purposes.&nbsp;									Given the number of current and potential sensor applications, it may be difficult to clarify the level of quality assurance for each one.					Source: GAO. &nbsp;| &nbsp;GAO-24-106393Why GAO Did This StudyU.S. ambient air quality is monitored by federal, state, and local agencies through the national ambient air quality monitoring system. However, that system is unable to provide some of the information that users may need to better manage health risks from air pollution. Lower-cost air quality sensors have the potential to help meet some of the monitoring information needs that require pollution measurements in additional locations or more real-time data.This report describes (1) sensor technologies for monitoring air quality, (2) their benefits and uses, (3) how well they perform and factors that affect their performance, (4) challenges to their use, and (5) options policymakers could consider to help address these challenges.GAO reviewed key reports and scientific literature; interviewed federal and state agency officials and other stakeholders from academia, industry, and nongovernmental organizations; attended a workshop on issues related to lower-cost air quality sensors; and convened a 2-day meeting of 12 experts. These experts included those who conduct research on sensor technologies and their uses, develop or manufacture sensor technologies, or use or consider using sensor technologies and data. GAO is identifying policy options in this report.For more information, contact Karen L. Howard at (202) 512-6888 or howardk@gao.gov or J. Alfredo Gómez at (202) 512-3841, GomezJ@gao.gov.
- Precision Agriculture: Benefits and Challenges for Technology Adoption and Use What GAO FoundPrecision agriculture technologies can improve resource management through the precise application of inputs, such as water, fertilizer, and feed, leading to more efficient agricultural production. Precision agriculture can be implemented through a suite of technologies that can be used in isolation or in conjunction with other technologies. Examples of emerging precision agriculture technologies are in the table below.Examples of emerging precision agriculture technologiesTechnology			Description		Remote sensing platforms			Drones and ground robots can provide new ways to provide measurements on crop conditions.		In-ground sensors			Provide farmers near-real-time information on soil and plant properties such as temperature, moisture, and nutrients.		Targeted spray systems			Use machine learning to precisely spray in a specific spot.		Automated mechanical weeders			Use machine learning to start and stop weeding blades to avoid damaging the growing crops.		Source: GAO summary of literature, interviews, and agency documentation. &nbsp;| &nbsp;GAO-24-105962While precision agriculture technologies, such as variable rate fertilizer applications and yield monitoring, have been available since the 1990s, only 27 percent of U.S. farms or ranches used precision agriculture practices to manage crops or livestock, based on 2023 U.S. Department of Agriculture (USDA) reporting.Use of precision agriculture practices by U.S. farms, June 2022–June 2023Federal agencies support precision agriculture adoption, research and development, education, and training. USDA supports precision agriculture technology adoption with financial assistance and loan programs, such as through payments for implementing practices that provide a conservation benefit. USDA and the National Science Foundation (NSF) have provided almost $200 million for precision agriculture research and development funding in fiscal years 2017—2021. This funding includes partnerships between the two agencies to support artificial intelligence (AI) research institutes.Benefits to using precision agriculture technologies include:&nbsp;Increased profits. Farmers can increase yields and thus profits with the same amount of inputs or achieve an equivalent yield with fewer inputs.	Reduced application of crop inputs. Technologies can reduce the application of crop inputs such as fertilizer, herbicide, fuel, and water. They can also address water scarcity by promoting the efficient use of water in agriculture.	Environmental benefits. Technologies can prevent excessive use of chemicals and nutrients in a field, potentially reducing runoff into soil and waterways.Challenges limiting the broader adoption and use of precision agriculture include:High up-front acquisition costs. Acquisition costs for the latest technologies can be prohibitive for farmers with limited resources or access to capital.	Farm data sharing and ownership issues. Concerns regarding farm data sharing and ownership can pose obstacles to the widespread use of AI in agriculture.	Lack of standards. An absence of uniform standards can hamper interoperability between different precision agriculture technologies.GAO examined three policy goals and associated options that could help address adoption challenges or enhance the benefits of precision agriculture technologies. These policy options identify possible actions by policymakers, which include Congress, federal agencies, state and local governments, academic and research institutions, and industry. In addition, for each policy goal, policymakers may choose no additional policy interventions, maintaining the status quo by continuing existing activities.Policy Goals and Options That Could Address Challenges or Help Enhance Benefits of Adoption and Use of Precision Agriculture TechnologiesPolicy goals and options			Implementation approaches			Opportunities and considerations		Encourage greater adoption and use&nbsp;(report p. 43)		Provide additional incentives or other financial support						Consider modifying eligibility criteria for existing governmental financial assistance programs.				Consider expanding levels of financial assistance through new or existing programs.									Consider what types of programs to provide to farmers, such as loan guarantees or grants.				Overall program cost, the extent to which equipment acquisition and operating costs are covered, and the potential trade-off with other agricultural programs could be factors.				Programs could be devised to realize goals, such as environmental protection and food insecurity.					Better understand and quantify benefits and costs						Support development of analytical tools and models to quantify benefits and costs.									Analytical tools could be configured for farm geography, soil type, and other factors.				Farmer confidence could increase if estimates of benefits are data-driven and based on real-world experiences.					Promotion and outreach to farmers						Consider expanding Extension services to enable development of more expertise and technical support to farmers.				Increase on-field demonstrations.									The extent to which federal agencies could provide more training, such as through USDA service centers.				Technology companies and dealerships could assume more of a role in educating or helping farmers.					Encourage further innovation&nbsp;(report p. 48)		Conduct research and development to improve on-farm data gathering and analysis						Support research for in-ground sensors for measuring soil conditions.				Examine ways that remote imagery, such as from drones, can be more effectively used to gather data.									In-ground sensors can provide more detailed information on soil conditions, which can enable farmers to further optimize the application of inputs to increase yields and minimize costs.				New remote imagery sensors from drones or ground robots promise to provide greater resolution, more frequent data, and quicker data delivery than traditional satellite sources.&nbsp;					Promote the development and use of standards						Promote data standards that could improve equipment interoperability.				Financial assistance programs could specify that precision agriculture equipment comply with certain standards.									Standards can improve interoperability and compatibility among different devices and platforms.				A lack of standards could result in challenges assessing the quality of the data derived from farm measurements.				Consider the level of federal involvement in standards development and use.					Manage greater amounts of data&nbsp;(report p. 52)		Enhance data analysis						Support the development of software to help farmers better manage their farms.				Examine how AI and machine learning could help facilitate analysis and interpretation of data.									Data analytics and high-performance computing approaches promise to generate valuable information for farmers but are dependent on the availability of large amounts of data.				Farmers may have tools, such as yield monitors, to help identify outcomes of decisions, but few analytical tools and software are available to enhance analysis and translate farm data into actionable decisions.					Encourage data sharing						Develop a governance framework to manage and store agricultural data and its access.				Establish easy-to-understand data license agreements and codes of conduct to enable better flow of data.									Farmers often do not trust the ways farm data are being collected and managed; thus, terms and conditions regarding data use should be simple, transparent, and accountable.				Farmer concerns about data sharing include a potential loss of competitive advantage, data security, and additional regulatory scrutiny may increase as AI is increasingly used for data analysis.					Source: GAO. &nbsp;| &nbsp;GAO-24-105962Why GAO Did This StudyPrecision agriculture involves collecting, analyzing, and taking actions based on data. It can help the agricultural sector meet increasing demand for food products, while also helping farmers improve efficiencies such as through reduced input costs.The Advancing IoT for Precision Agriculture Act of 2021, contained in what is commonly referred to as the CHIPS and Science Act of 2022, included provisions for GAO to conduct a technology assessment and review federal programs.This report examines (1) emerging precision agriculture technologies and precision agriculture technology adoption; (2) federal programs providing support for precision agriculture; (3) benefits and challenges of adopting and using precision agriculture technologies; and (4) policy options that could address challenges or help enhance benefits of adopting and using precision agriculture technologies.To conduct this technology assessment and review, GAO reviewed scientific literature and other key reports; interviewed officials and representatives from government, industry, academia, and associations; conducted two site visits to observe technology operations and obtain stakeholder perspectives; and convened a 3-day virtual expert meeting in collaboration with the National Academies of Sciences, Engineering, and Medicine. GAO is identifying policy options in this report.For more information, contact Brian Bothwell at (202) 512-6888 or BothwellB@gao.gov, or Steve D. Morris at (202) 512-3841, morriss@gao.gov.
- Artificial Intelligence in Natural Hazard Modeling: Severe Storms, Hurricanes, Floods, and Wildfires What GAO FoundGAO found that machine learning, a type of artificial intelligence (AI) that uses algorithms to identify patterns in information, is being applied to forecasting models for natural hazards such as severe storms, hurricanes, floods, and wildfires, which can lead to natural disasters. A few machine learning models are used operationally—in routine forecasting—such as one that may improve the warning time for severe storms. Some uses of machine learning are considered close to operational, while others require years of development and testing.GAO identified potential benefits of applying machine learning to this field, including:Reducing the time required to make forecasts by replacing components of models that are slow and that increase the cost of modeling.	Increasing model accuracy by more fully exploiting available data, using other data that traditional models cannot, and creating synthetic data to fill gaps.	Reducing the uncertainty of model output by improving ensemble modeling—the processes of generating combined predictions from numerous models—and making better use of historical data.Forecasting natural disasters using machine learningGAO also identified challenges to the use of machine learning. For example:Data limitations hamper the training of machine learning models and can reduce accuracy in some regions, such as rural areas where weather observations are sparse.	A lack of trust and understanding of the algorithms as well as concerns about bias can make forecasters and other users hesitant to use machine learning models.	Limited coordination and collaboration create challenges for fully developing some machine learning models. For example, some forecasters told us they lack opportunities to interact with researchers and convey their needs.	Workforce and resource gaps also create challenges. For example, the upfront costs to develop and run machine learning models are high, and some companies working on these models do not fully understand the data and phenomena they are modeling, according to academic researchers.GAO identified five policy options that could help address these challenges. These options are intended to inform policymakers, including Congress, federal and state agencies, academic and research institutions, and industry of potential policy implementations. The status quo option illustrates a scenario in which government policymakers take no additional actions beyond current ongoing efforts.Policy Options to Help Address Challenges to the Use of Machine Learning in Natural Hazard ModelingPolicy Option			Opportunities			Considerations		Facilitate improved data collection, sharing, and use (report p. 37).			Government policymakers could expand use of existing observational data and infrastructure to close gaps, expand access to certain data, and (in conjunction with other policymakers) establish guidelines for making data AI-ready.						Efforts to address gaps in data sets can improve machine learning model performance.				&nbsp;Expanded access to existing data would improve the ability of researchers and groups to develop and test machine learning technologies.				Adopting standards for AI-ready data could reduce resources needed to curate data and facilitate more efficient modeling.									Expanding observational infrastructure can be expensive and could divert limited resources from other efforts.				Agencies need to weigh the benefits of greater data sharing against any increase in risks related to data security and privacy.				Strict data standards may slow research and innovation if they burden or constrain machine learning researchers.					Expand education and training (report p. 38).			Government policymakers could update education requirements to include machine learning-related coursework and expand learning and support centers, while academic policymakers could adjust physical science curricula to include more machine learning coursework.						Updating education requirements would better prepare students to use machine learning in government.				More robust education can better prepare both researchers and end users in fields like meteorology and climatology to develop and use machine learning.									Education and training reforms may need to be repeatedly adjusted, as technological change in this space can be rapid and unpredictable.				Establishing and expanding professional development and training opportunities throughout government may require substantial investment.					Address hiring and retention barriers and certain resource shortfalls (report p. 39).			Government policymakers could address pay scale limitations for positions that include machine learning expertise and work with private sector policymakers to expand the use of public-private partnerships (PPP).						Providing workforce incentives to government employees for machine learning development could allow agencies to bolster workforce capacities.				Expanding PPPs might help agencies overcome computational resource shortfalls and help industry draw on government expertise.									Increasing salary limits for some employees would require agency budget increases or cuts to other budget items.				Expanding the use of PPPs could magnify resource disparities between government and private industry.				PPPs that entail hosting government data on collaborator systems may pose security risks that would need to be considered and addressed.					Take steps to mitigate bias and foster trust in data and machine learning models (report p. 40).			Policymakers could establish efforts to better understand and mitigate various forms of bias, support inclusion of diverse stakeholders for machine learning models, and develop guidelines or best practices for reporting methodological choices.						Sustained efforts to address bias in data sets can reduce the likelihood of models negatively affecting certain communities.				Acquiring diverse stakeholder perspectives throughout machine learning models’ life cycles can help reduce certain types of bias in data and models.				Fostering machine learning model transparency could improve end-user and decision-maker trust.									Embedding efforts to address bias throughout the model life cycle may increase model costs and slow model development.					Maintain status quo efforts (report p. 41).			Government policymakers could maintain existing policy efforts and organizational structures, along with existing strategic plans and agency commitments.						Some agency efforts are underway to address the challenges described.									The extent to which agencies will meet their commitments under status quo efforts is unclear. Status quo efforts may not address challenges specific to the use of AI in natural hazard modeling.					Source: GAO. | GAO-24-106213Why GAO Did This StudyNatural disasters cause on average hundreds of deaths and billions of dollars in damage in the U.S. each year. Forecasting natural disasters relies on computer modeling and is important for preparedness and response, which can in turn save lives and protect property. AI is a powerful tool that can automate processes, rapidly analyze massive data sets, enable modelers to gain new insights, and boost efficiency.This report on the use of machine learning in natural hazard modeling discusses (1) the emerging and current use of machine learning for modeling severe storms, hurricanes, floods, and wildfires, and the potential benefits of this use; (2) challenges surrounding the use of machine learning; and (3) policy options to address challenges or enhance benefits of the use of machine learning.GAO reviewed the use of machine learning to model severe storms, hurricanes, floods, and wildfires across development and operational stages; interviewed a range of stakeholder groups, including government, industry, academia, and professional organizations; convened a meeting of experts in conjunction with the National Academies; and reviewed key reports and scientific literature. GAO is identifying policy options in this report.For more information, contact Brian Bothwell at (202) 512-6888 or bothwellb@gao.gov.
- Antiviral Drugs: Economic Incentives and Strategies for Pandemic Preparedness [Reissued with revisions on Sept. 29, 2023] What GAO FoundAntiviral drugs help the body fight off harmful viruses and can ease symptoms and shorten the length of an infection. Some of these drugs can be broadly acting—that is, they can treat infections from multiple viruses. This makes them especially valuable in a future pandemic where the viral threat is unknown in advance. Some scientists predict that viruses are most likely to be the source of the next pandemic because they are able to spread rapidly and because there are fewer treatment options for viruses.The National Institutes of Health (NIH) has identified several viral families that have potential to cause future pandemics. However, as of May 2023, no known drugs for a number of these viral families had been approved or were in clinical trials funded by the Department of Health and Human Services (HHS), according to HHS. GAO identified a number of technologies to speed antiviral drug development, such as using artificial intelligence to identify drug candidates.State of Drug Development for Viral Families with High Potential to Cause Future PandemicsNote: Monoclonal antibodies are lab-produced proteins that can be used to treat or prevent viral infections. Graphic refers to clinical trials funded by either the Biomedical Advanced Research Development Authority or the National Institute of Allergy and Infectious Disease within the Department of Health and Human Services (HHS).Experts GAO spoke with noted that a number of factors complicating the market’s efficient functioning make it unlikely that market forces alone will induce the development of antiviral drugs at levels that would maximally benefit society and aid future pandemic preparedness. However, policymakers could use several mechanisms to incentivize investment in antiviral drugs. “Push” mechanisms, such as research grants, can incentivize early research, while “pull” mechanisms, such as purchase commitments, can incentivize the production of completed antivirals.In 2022, the White House issued the National Biodefense Strategy and Implementation Plan, which called for the development of two novel antiviral drugs. Experts GAO spoke with also identified a number of approaches to guide the use of economic incentives. These approaches include developing (1) a number of antiviral drugs to the point of phase 1 clinical trials, which could be less costly than developing fully approved drugs; (2) a wide range of antiviral drugs that act against different parts of the viral lifecycle; and (3) broadly acting antiviral drugs for a wide range of pathogens.GAO identified three policy options that may help to spur antiviral drug development. These policy options are provided to inform policymakers—including Congress, federal agencies, state and local governments, academia, industry, and international organizations—about potential approaches and actions to address gaps highlighted in this technology assessment. Policymakers would need to consider how to align these potential actions with existing federal programs and initiatives. See below for a summary of policy options as well as related opportunities and considerations.Policy Options to Facilitate the Development of Antiviral Drugs for Future PandemicsPolicy option			Opportunities			Considerations					Create a strategy to focus on developing diverse antiviral drugs to respond to pandemics caused by the most dangerous pathogens (report p. 33).			&nbsp;			Policymakers could ensure focus on pathogens and pathogen families, such as flaviviruses and bunyaviruses, that are most likely to cause severe future pandemics, with an emphasis on pathogen families for which no drug candidates are currently in clinical trials.									Designing hypothetical pandemic scenarios could help identify the relative likelihoods that an outbreak could quickly become severe and widespread, indicating which antiviral drugs may need to be stockpiled and which need to be developed only to the point of phase 1 clinical trials.				Focusing attention on viral families with no drug candidates in clinical trials could spur research and development.				Developing drug candidates through phase 1 clinical trials would provide information on the initial safety profile and side effects of different doses in advance of potential pandemics.									Not every possible pandemic scenario can be considered, and a pathogen that may cause a future pandemic might not appear on current lists of potential pandemic pathogens.				It is difficult to predict how a novel pathogen may travel across populations. Therefore, assessing the stage to which each drug candidate should be developed and how much manufacturing might be needed may also be difficult.								Assign to a new or existing entity the authority to lead, implement, and be accountable for identifying and developing antiviral drugs for pathogens or pathogen families of greatest risk (report p. 34).			&nbsp;			Policymakers could ensure that this entity has authority and accountability for making decisions and allocating resources to implement a strategy for addressing pathogens and pathogen families informed by pandemic scenarios and the risks they present.									A single, centralized entity could direct strategic investments for pandemics, increase communication across federal agencies and with drug developers, and facilitate greater accountability for more effective allocation of resources and response to the spectrum of pandemic threats.				A single entity that is explicitly accountable for pandemic preparedness and response could effectively mitigate pandemic risks and enhance government efforts to deal with uncertain but likely pandemic risks. When multiple entities share fragmented responsibilities, no one entity is accountable for the ultimate success of the effort.									Because authorities among HHS entities vary, designating an entity with responsibility and authority may require new directives or legislation.				To be effective, any entity with such authority for identifying and developing pandemic antiviral drugs would need to coordinate or align its efforts with related efforts, such as the development of vaccines, diagnostics, and surveillance.								Implement economic incentives to develop antiviral drug candidates and spur new drug-development technologies (report p. 35).			&nbsp;			Policymakers could use various push and pull economic incentives to encourage the development of pandemic antiviral drugs, based on the economic costs of scenarios, scientific opportunities, and pathogen priorities. They could also consider other policy priorities, such as drug accessibility.			&nbsp;			Policymakers could use economic incentives to stockpile certain drugs in advance as well to ensure sufficient manufacturing capacity.									Economic incentives could address the identified challenges related to critical market failures that have limited investment in pandemic antiviral drugs. Through such actions, economic and societal costs from viral pandemics could be meaningfully reduced.				Manufacturing capacity for pandemic antiviral drugs may be useable for similar antiviral drugs with an existing commercial market.				New drug development technologies spurred by investment in pandemic antiviral drugs may allow for the treatment of nonpandemic infectious diseases, especially diseases caused by pathogens in the same family as those targeted for antiviral development.									Periodic updates to evaluations of pandemic risks would be needed to guide the deployment of economic incentives for new antivirals and drug development technologies and the extent of investment needed as new pandemic pathogens arise.				Evidence of the full range of potential pandemic costs may be unavailable or insufficient for precise determinations of the level of investment needed to achieve certain levels of preparedness.					Source: GAO. | GAO-23-105847Why GAO Did This StudyPandemics impose large human and economic costs on society. According to the World Health Organization, almost 7 million people died worldwide during the COVID-19 pandemic. The International Monetary Fund estimates that by 2024, COVID-19 will have reduced global economic output by $13.8 trillion relative to prepandemic forecasts. Scientists have predicted that another pandemic is highly likely.The CARES Act included a provision for GAO to report on the federal response to the COVID-19 pandemic. This report discusses incentives and strategies to enhance antiviral drug investment.GAO reviewed economic and scientific literature relevant to these areas. GAO also interviewed stakeholders and experts with perspectives on the science and economics of antiviral drug development, including those at HHS. In addition, GAO convened, with assistance from the National Academies of Sciences, Engineering, and Medicine, a 2-day meeting of 16 experts.GAO is identifying policy options in this report.For more information, contact Michael Hoffman at (202) 512-2700, HoffmanME@gao.gov or Candice Wright at (202) 512-6888, WrightC@gao.gov.
- Chemical Weapons: Status of Forensic Technologies and Challenges to Source Attribution What GAO FoundWhen a chemical weapon is used, investigators may use forensic technologies to detect that it was used, identify the chemical, and help attribute it to a likely source. Most technologies for chemical identification are mature. Some technologies for attributing chemical agents based on chemical analyses are under development. For example, a wide variety of laboratory-based and fieldable instruments for chemical identification are in commercial use. Investigators also use data from these instruments to help attribute chemicals to their potential sources, but there are limits to the information existing technologies can provide.Key technologies to identify and attribute chemical weapons to a likely sourceTechnology			Information it provides		Chromatography (Gas or Liquid)			Separates and identifies chemicals in a sample mixture. Mature for identification of chemical agents, can inform attribution.		Nuclear Magnetic Resonance Spectroscopy			Determines arrangement of atoms in a molecule. Mature for identification of chemical agents, developing for complex mixtures. Can inform attribution.		Mass Spectrometry			Measures mass-to-charge ratios to identify chemicals in a mixture. Mature for identification of chemical agents, can inform attribution.		Impurity Profiling			Identifies key impurities to link samples to production process or precursor. In development for attribution.		Isotope Ratio Methods			Measures ratio of stable isotopes in a sample to link to a precursor. In development for attribution.		Source: GAO. | GAO-23-105439GAO found several challenges that can hinder identification and attribution of chemical agents, including the following:Poor samples: In some instances, investigators cannot obtain useful chemical information because samples are too small, dilute, or degraded.	Limited reference data: Generally, chemical identification methods rely on comparison to data from known chemicals, called reference data. However, reference data can be limited because they are resource intensive to collect, analyze, and archive. Additionally, reference data may be challenging to use in some instances, such as if they were developed using different experimental methods or stored in an incompatible format.	Lack of information sharing: Controls on information sharing are needed for national security concerns but can hinder collaboration among researchers in developing technologies and improving understanding of chemicals and their sources.	Limited coordination: Entities may not be aware of individual and laboratory expertise that could assist with identifying a chemical agent or its source. Researchers may unknowingly duplicate work, and opportunities to strengthen capabilities may be missed.GAO identified six high-level policy options in response to these challenges. These policy options are provided to inform policymakers of potential actions to address the challenges identified in this technology assessment. They identify possible actions by policymakers, which include Congress, federal agencies, state and local governments, academic and research institutions, and industry.Policy options to address challenges that hinder identification and attribution of chemical agentsPolicy Option			Opportunities			Considerations		Develop technology to aid with sampling			(report p. 35)Policymakers could encourage development of technologies that allow more rapid sample analysis or that slow sample degradation.						Could reduce likelihood of degradation by shortening time between sampling and analysis.				May reduce cost of analysis by minimizing the number of chemical signatures generated by sample degradation.									Small market size for certain instrumentation may limit industry interest in developing new technologies.				Testing of new technologies can be challenging due to the toxicity and reactivity of chemical agents.					Study known threats			(report p. 36)Policymakers could advance scientific knowledge on known chemical agents and threats.						Could support a faster response to an event and faster attribution to a source.				Could ensure that the U.S. has the appropriate workforce, capabilities, knowledge, and facilities to respond effectively to chemical incidents.									In some cases, additional knowledge is unlikely to help identify a chemical (e.g., due to highly degraded samples) or attribute it to its source (e.g., when there are many possible production processes for a given chemical agent).				Building the necessary body of knowledge could be resource intensive.					Further anticipate emerging threats			(report p. 37)Federal policymakers could foster development of technologies and approaches that help anticipate emerging chemical threats.						Could deter use of chemical agents and support a faster response in the event of use.				Emerging chemical threat assessment and characterization technologies could better prepare U.S. government entities and international partners for the unexpected.									A vast number of chemicals are potential emerging threats, and efforts would require careful prioritization.				Computational approaches would require security considerations to protect potentially classified chemicals.					Standardize data			(report p. 37)Policymakers could encourage standardization of future data collection and support efforts to modernize legacy data on chemical threats.						Could ensure that computational methods work on data from different sources, maximizing efficiency and potential insights.				Modernized legacy data may provide insights that are otherwise expensive or difficult to acquire.									Consensus on standard operating procedures may be difficult to achieve.				Legacy data may be challenging to use in certain circumstances, such as due to changes in experimental design, instrumentation, and analytical techniques over time.					Share information			(report p. 38)Federal and international policymakers could facilitate information sharing to increase collaboration on chemical agent forensic analyses.						Quickly making classification decisions about new and emerging information could improve appropriate research collaboration and information exchange.				Increased understanding of classification guidance could improve handling of classified information and allow researchers to more confidently know what information can be shared.									Classification systems are complex, and creating tools to assist in navigating them could be challenging.				Agencies need to balance facilitating additional information sharing with protecting information critical to national security.					Coordinate on chemical attribution			(report p. 40)Federal and international policymakers could encourage increased coordination between entities involved in chemical attribution.						Clear roles and responsibilities could enable each entity to quickly execute its mission in response to a chemical incident.				Collective development of robust methods and capabilities could increase international confidence in findings.									Federal agencies often have different goals and requirements, so efficiencies may be limited, even with increased coordination.				Coordination activities with multi agency participation could divert resources away from other tasks.					Source: GAO. | GAO-23-105439Why GAO Did This StudyDespite the Chemical Weapons Convention's ban on their use, chemical weapons have been used in the past decade in assassinations and on civilian populations. To identify the use of a chemical weapon and then attribute that weapon back to its source, researchers rely on several technologies for chemical analysis. Chemical analysis is one piece of an overall chemical weapon investigation.This report discusses (1) the status of key technologies available to identify a chemical agent or its source, including their strengths and limitations; (2) challenges researchers and investigators face in trying to identify a chemical agent or its source; and (3) policy options that may help address the challenges of using key technologies to identify a chemical agent and its source.To conduct this technology assessment, GAO reviewed key reports and scientific literature; interviewed government, intergovernmental, and academic representatives; conducted site visits; and convened two meetings of experts with the assistance of the National Academies of Sciences, Engineering, and Medicine. GAO is identifying policy options in this report.For more information, contact Karen Howard at (202) 512-6888 or HowardK@gao.gov.
- Regenerative Medicine: Therapeutic Applications, Challenges, and Policy Options What GAO FoundRegenerative medicine offers the hope of being able to restore or replace cell, tissue, and organ functions affected by disease, injury, or aging. This may eventually help manage or cure many conditions that are currently considered chronic, untreatable, or terminal.Examples of Diseases and Regenerative Medicine Therapies That Might Address ThemGAO identified many challenges that may affect the development and use of regenerative medicine technologies and therapies including:Challenges related to standardization. Standards are rules, conditions, guidelines, or agreed-upon practices that are adopted within an industry to provide developers with a common framework and promote consistency. Developing regenerative medicine standards is challenging because these technologies and therapies are complex and rapidly evolving. In addition, standards require consensus from stakeholders, which may be difficult to obtain.Challenges related to regulation. The Food and Drug Administration (FDA) ensures the safety, efficacy, and security of human medical products in the U.S. through regulation. Regenerative medicine faces challenges related to regulation, including difficulty navigating a complex regulatory framework, uncertainty over which regulatory pathway is most appropriate for certain emerging technologies and therapies, and staffing shortages at FDA and collaborating agencies.Challenges related to manufacturing. Manufacturing is the creation of products from starting materials, in a way that is generally consistent and reproducible. It is a key step for many emerging technologies and therapies, but the cells, tissues, and organs used for regenerative medicine are complex and difficult to manufacture at scale. Other challenges to manufacturing include a lack of infrastructure and difficulty ensuring quality and consistency.GAO developed 11 policy options that could help address the challenges or enhance the benefits of regenerative medicine. These policy options are provided to inform policymakers of potential actions to address the policy challenges identified in this technology assessment. They identify possible actions by policymakers, which include Congress, federal agencies, state and local governments, academic and research institutions, and industry. Policymakers would need to consider the impacts these new technologies will have on existing federal programs that are already strained. We suggested possible federal components for the policy options.Selected Policy Options to Mitigate Challenges Associated with Regenerative Medicine Technologies and TherapiesSelected policy Option			Opportunities			Considerations					Invest in standards development.			(report p. 26)						This policy option could help address the challenge that standards require consensus.									Could streamline standards development, which may, in turn, accelerate innovation, increase product safety and reliability, accelerate regulatory review, and decrease costs of regenerative medicine therapies.									Existing organizations may not include all stakeholders, and stakeholders may hesitate to accept standards created without their input.				Industry stakeholders may hesitate to adopt standards if they perceive it will cost them a controlling position in the market.				Standards should be appropriately flexible to allow for innovation, while still being detailed and specific enough to support manufacturing of consistent, quality products.								Provide opportunities for increased interactions between regulatory experts (at FDA or in industry) and smaller companies, especially early in the development process (report p. 32)						This policy option could help address the lack of access to regulatory expertise.			&nbsp;									May provide more timely advice and avoid unnecessary delays or uncertainty by pursuing the wrong regulatory pathways or submitting data that do not meet regulatory requirements.									May require additional resources to bolster the workforce of regulatory scientists at FDA or public-private partnerships.				FDA may be limited in its ability to advise companies early in the process so as not to create a conflict of interest.								Consider whether changes to the framework for evaluating combination products and medical devices to accommodate emerging technologies and therapies may be necessary. (report p. 33)						This policy option could help address whether current regulatory pathways are sufficient for emerging technologies and therapies.									May encourage innovators, researchers, and developers of new products to provide valuable feedback to regulators.									Coordinating among stakeholders to consider changes to regulatory pathways may be time- and resource-intensive.				If such consideration leads to recommended changes to the framework, statutory and regulatory changes may be necessary.								Provide more oversight and feedback to suppliers to increase consistency in starting materials (report p. 40)						This policy option could help address inconsistency in starting materials for manufacturing.									May accelerate manufacturing by reducing variation in input materials.				May reduce the risk of failure during product development.									Starting material suppliers may lack incentives to follow standards if they lead to higher costs					Source: GAO. &nbsp;| &nbsp;GAO-22-105274Why GAO Did This StudyRegenerative medicine represents a paradigm shift in the medical field because it aims to restore or supplement function, rather than just treating symptoms, and opens the door for personalized therapies. GAO conducted an assessment of current and emerging regenerative medicine technologies and therapeutic applications. This report examines (1) current and emerging regenerative medicine technologies and therapies and their potential benefits, (2) challenges that hinder their development and use, and (3) policy options that could help enhance benefits and mitigate challenges associated with these technologies and therapies. GAO reviewed scientific and policy literature and other key reports; convened a 3-day expert meeting; interviewed subject matter experts and stakeholder groups including government agencies, such as the Department of Health and Human Services, non-government organizations, industry, academia, end user groups such as patient groups; and conducted site visits. GAO is identifying policy options in this report.For more information, contact Karen L. Howard at (202) 512-6888 or howardk@gao.gov.
- Utility-Scale Energy Storage: Technologies and Challenges for an Evolving Grid What GAO FoundTechnologies to store energy at the utility-scale could help improve grid reliability, reduce costs, and promote the increased adoption of variable renewable energy sources such as solar and wind. Energy storage technology use has increased along with solar and wind energy. Several storage technologies are in use on the U.S. grid, including pumped hydroelectric storage, batteries, compressed air, and flywheels (see figure). Pumped hydroelectric and compressed air energy storage can be used to store excess energy for applications requiring 10 or more hours of storage. Lithium-ion batteries and flywheels are used for shorter-duration applications such as keeping the grid stable by quickly absorbing or discharging electricity to match demand. Flow batteries represent a small fraction of total energy storage capacity and could be used for applications requiring 10 or more hours of storage. Metal-air batteries are being evaluated for applications requiring 10 or more hours of storage.Pumped Hydroelectric (left) and Lithium-Ion Battery (right) Energy Storage TechnologiesEnergy storage technologies face multiple challenges, including:Planning. Planning is needed to integrate storage technologies with the existing grid. However, accurate projections of each technology’s costs and benefits could be difficult to quantify. Further, refinement of costs, benefits, and other data are needed to inform the planning process.	Regulation. Rules and regulations vary across regions and states, which forces energy storage project developers to navigate a patchwork of potential markets. Developers that want to deploy storage across multiple markets may need to conduct separate analyses to determine each region’s regulatory outlook and profit potential.	Standardization. Codes and standards may need revising and must keep pace with maturing technologies to minimize public safety and welfare risks. However, the technology’s evolution and deployment is outpacing codes and standards development. As a result, entities seeking to deploy new technologies may face challenges applying existing codes and standards to new technologies.	Valuation. Realizing the potential of energy storage technologies may depend on the ability to value investments. For example, profit potential can vary because regions and states value storage differently, reflecting local market rules and regulations.GAO developed six high-level policy options in response to these challenges. These policy options are provided to inform policymakers of potential actions to address the policy challenges identified in this technology assessment. They identify possible actions by policymakers, which include Congress, federal agencies, state and local governments, academic and research institutions, and industry. The status quo option illustrates a scenario in which policymakers do not intervene with ongoing efforts.Policy Options to Address Challenges to Utility-Scale Energy StoragePolicy options and implementation approaches			Opportunities			Considerations					Status quo (report p. 48)			Policymakers could maintain the status quo through:			Tax credits and funding				Research and development				Previous plans and programs by states would continue, including actions for energy storage.									The federal government has various national capabilities to support energy storage technology incentives and demonstration.				DOE support for storage research and development would continue.									Some policymakers may lack sufficient information to make decisions on evolving storage capabilities.				Storage development, deployment, and use could be left dependent on forces outside policymakers’ control.								Integration (report p. 50)			Policymakers could include clear goals and next steps in plans to help integrate storage, by:			Establishing roadmaps, based on storage costs and benefits				Assessing storage in plans									Storage planning could help policymakers identify and remove barriers to energy storage deployment.				Plans could increase investors’ confidence and help them determine storage investments.									Plans that seek to alter conventional grid planning could be difficult to execute.				Stakeholders have set different goals for low-carbon electric generation.				Planning depends on factors such as location suitability; not every technology is suited for every location.								Regulation (report p. 52)			Policymakers could revise and enact rules and requirements for how storage is defined, used, or owned by:			Identifying market barriers				Establishing targets or mandates				Modernizing ownership models									Could promote energy storage technologies by improving grid efficiency while reducing costs for all customers.				Could help lower costs and reduce the timeline for interconnection.				Could accelerate permit approval timelines.									Regulations differ across states, which could make finding the right regulatory model to achieve energy goals a challenge.				Integrating new technologies with conventional grid planning can be challenging.				Changes to rules and regulations could exclude certain technologies.								Standardization (report p. 54)			Policymakers could update or create new codes and standards and provide education on storage safety risks.									Could help stakeholders operate storage systems more safely.				Standards placed into regulations could help address storage performance requirements.									Codes and standards take time to develop and could be outdated if not adopted in a timely manner.				Standards may be ambiguous, which could make it difficult to design storage systems.								Support manufacturing and adoption (report p. 56)			Policymakers could support actions to help energy storage manufacturing and adoption challenges by:			Enacting battery reuse and recycling policies				Conducting outreach				Targeting activities to support storage development and deployment									Reuse and recycling policies could increase the recovery of products and materials.				Stakeholder outreach and informational programs could help overcome awareness and familiarity challenges.				Federal and state financial support for longer-duration energy storage development and demonstration could be important in a future electricity system powered by wind and solar generation.									Incentives and motivation to invest in new recycling applications is limited.				Funding may fluctuate year to year or favor short-term projects.				Development of new systems could be difficult because of engineering and economic uncertainty, particularly for longer-duration storage.				Low-cost, flexible natural gas generation could make it more difficult for new pumped hydroelectric facilities to compete.								Provide Incentives (report p. 58)			Policymakers could create mechanisms to incentivize storage deployment, by:			Providing incentives, such as loan guarantees or tax credits				Considering policies to encourage the capture of multiple revenue streams									Financial incentives could help developers and companies develop storage technologies.				Technologies with longer durations may benefit from policies that help industry to capture their full value.									Incentives could lead to unintended outcomes for governments or developers, and some stakeholders may not believe they are necessary.				Technology value varies by region, which may affect storage incentives, valuation, and revenue streams.				Environmental and social costs and benefits could be difficult to quantify.				Low-cost, flexible natural gas generation could make it more difficult for new pumped hydroelectric facilities to compete.					Source: GAO. &nbsp;| &nbsp;GAO-23-105583Why GAO Did This StudyThe U.S. electricity grid connects more than 11,000 power plants with around 158 million residential, commercial, and other consumers. Energy storage technologies have the potential to enable several improvements to the grid, such as reducing costs and improving reliability. They could also enable the growth of solar and wind energy generation.GAO conducted a technology assessment on (1) technologies that could be used to capture energy for later use within the electricity grid, (2) challenges that could impact energy storage technologies and their use on the grid, and (3) policy options that could help address energy storage challenges.To address these objectives, GAO reviewed agency documents and other literature; interviewed government, industry, academic, and power company representatives; conducted site visits; and convened a virtual meeting of experts in collaboration with the National Academies of Sciences, Engineering, and Medicine. GAO is identifying policy options in this report (see p. 2).For more information, contact Brian Bothwell at (202) 512-6888 or bothwellb@gao.gov.
- Fusion Energy: Potentially Transformative Technology Still Faces Fundamental Challenges What GAO FoundNuclear fusion, the process that powers the sun and other stars, could produce electric power without carbon emissions, long-lived nuclear waste, or risk of meltdowns. Researchers and companies are pursuing many different concepts for fusion energy and have reported recent progress, such as the development of high-temperature superconducting magnets that could make fusion devices much more compact. Also, in 2022, an experiment at the National Ignition Facility achieved a key scientific milestone, generating more energy from a fusion reaction than the amount of direct energy spent to start the reaction.National Ignition FacilityHowever, several challenges must be overcome to achieve commercial fusion, and stakeholders’ projections of this timeline range from 10 years to several decades. One key scientific challenge is in the physics of plasmas, the state of matter needed for fusion. Researchers do not fully understand the behavior of burning plasmas, those whose main source of heat is from the fusion reaction itself rather than an external source. Researchers have made advancements in this area but lack sufficient experimental data to validate their simulations. One key engineering challenge is the development of materials that can withstand fusion conditions for decades, such as extreme heat and neutron damage, and no facility exists where materials can be fully tested. More generally, the task of extracting energy from fusion to provide an economical source of electric power presents several complex systems engineering problems that have yet to be solved.Public and private sector misalignments, regulatory uncertainty, and other factors also present challenges to fusion energy development. One area of misalignment is research priorities. Public sector efforts prioritize basic science, but fusion energy development requires an additional emphasis on technology and engineering research. Another factor is regulatory uncertainty, which could slow development of fusion energy, although developing appropriate regulations to ensure safety without constraining development is difficult. Doing so may require significant public engagement, but little is known about public perception of fusion energy in the U.S.&nbsp;GAO developed four policy options that could help address these challenges or enhance the benefits of fusion energy. These policy options are provided to inform potential actions to address the public policy challenges identified in this technology assessment. They identify possible actions by policymakers, which include legislative bodies, government agencies, academia, industry, and other groups. See below for a summary of the policy options and relevant opportunities and considerations.Policy Options to Help Address Challenges or Enhance Benefits of Fusion Energy&nbsp;			Opportunities			Considerations		Sustain current efforts (report p. 32)						Some challenges described in this report may be addressed by current efforts.				Could allow policymakers to observe and evaluate the impact of existing efforts, which could limit risk and save money.									Current efforts may not address all challenges described in this report.				Current efforts alone may delay or inhibit the development of fusion energy, which could result in forgone benefits or negative impacts, such as to the environment.								Align public and private efforts (report p. 33)			&nbsp;			Implementation approaches:			&nbsp;			Align programs, missions, and organizational structures with fusion energy development goals			&nbsp;			Expand use of public private partnerships			&nbsp;			Reduce barriers to collaboration			&nbsp;			Leverage international coordination									Could accelerate the demonstration and commercialization of fusion energy by enhancing research on materials, technology, and engineering needs.				Could leverage strengths across sectors and expand programs that, according to experts and interviewees, are underused and have been effective in advancing fusion energy development.				Standardized research and development agreements could accelerate research, encourage knowledge sharing between organizations and countries, and reduce time-intensive negotiation.									Aligning public and private efforts can be time intensive and may require additional resources or legislative action, according to experts.				To achieve fusion energy development timeline goals, policymakers may need to pursue parallel efforts and take more risks, which could incur greater costs.				Could require additional resources or reallocation of existing resources from other programs.								Build shared assets for fusion energy (report p. 34)			&nbsp;			Implementation approaches:			&nbsp;			Support facilities that address scientific and engineering challenges			&nbsp;			Support workforce development			&nbsp;			Assess sources of critical supplies and manufacturing capabilities									Could help fill critical research gaps on the path to fusion energy commercialization.				Could help ensure fusion energy development is not limited by critical workforce or supply shortages.									Test facilities require significant investment and years to build and commission.				Workforce development takes significant time and resources. National lab representatives said that long-term funding is needed for education and training.				Stakeholders may disagree on the best options to support community assets that are usable for a range of fusion energy technologies.								Engage the public in decision-making (report p. 35)			&nbsp;			Implementation approaches:			&nbsp;			Study public opinion through surveys and focus groups			&nbsp;			Educate through cross-sectoral forums			&nbsp;			Include affected communities in decision-making related to fusion facilities									Could help inform policy decisions, such as those related to regulation of and investment in fusion energy.				Could ensure community stakeholders’ views are represented so that decisions do not negatively impact issues of public concern, such as traffic or the environment.				Could ensure that benefits, such as economic development, are shared broadly and inclusively with affected communities.				Alignment between communities and fusion developers could reduce barriers to their success.									Engagement should be proactive, transparent, and should set realistic expectations for benefits, risks, and timelines.				It may be difficult to ensure broad participation and representation.				Engagement should be used to learn about the public’s perspectives about fusion energy rather than to persuade the public to support fusion.					Source: GAO. &nbsp;| &nbsp;GAO-23-105813Why GAO Did This StudyFusion could address many energy challenges by providing abundant, safe, low-carbon energy. Researchers have achieved scientific and technological advancements in recent years. Fusion energy companies have received billions of dollars of private investment in addition to federal grants.GAO conducted a technology assessment on (1) the status, potential benefits, and limitations of fusion energy, (2) challenges that might affect the development or use of fusion energy, (3) policy options that might help enhance the benefits or mitigate challenges associated with fusion energy.GAO reviewed key reports and scientific literature; interviewed stakeholders from government, industry, and academia; held focus groups with members of the public; attended a conference on issues related to fusion energy; and convened a meeting of experts in collaboration with the National Academies of Sciences, Engineering, and Medicine. GAO is identifying policy options in this report.For more information, contact Brian Bothwell at (202) 512-6888 or bothwellb@gao.gov.
- Pandemic Origins: Technologies and Challenges for Biological Investigations What GAO FoundDetermining the likely origin of pandemics is challenging. Researchers may use several technologies to investigate a pandemic’s origin. For example, researchers use technologies such as genomic sequencing, bioinformatics analysis, and genetic databases to generate, analyze, and compare a pathogen’s genetic makeup against that of other pathogens. A key limitation of these technologies is that some laboratory-based genetic modifications may be indistinguishable from natural variations. Access to samples is critical for conducting genetic sequence analysis, which allows researchers to generate and analyze the data needed to support the likely origin of a pandemic.Examples of technologies for pandemic origin investigationsResearchers also use technologies such as serology (i.e., blood analysis) and epidemiological surveillance—tracking a disease as it moves through a population—to monitor pathogen infection and disease occurrence in human and animal populations. The resulting data can support pandemic origin investigations. However, for these technologies to be effective in determining a pandemic’s likely origin, investigators need access to samples and data from infected or exposed individuals from early in an outbreak to reliably trace the disease back to the first human infection(s). Further, researchers may conduct laboratory-based pathogen studies to generate data to support known natural patterns or unusual patterns of spread indicative of a possible laboratory-related origin. However, some pathogens cannot be easily cultured in a laboratory setting, and some pathogens may require enhanced biosafety-level facilities.However, experts told GAO that technologies are not the limiting factor for determining the likely origin of a pandemic. GAO identified three cross-cutting challenges that hinder pandemic origin investigations. These include a lack of sufficient access to samples and genetic sequence data; a lack of standardized processes for submitting, accessing, and using genetic sequence data stored in databases around the world; and a lack of a sufficient and skilled interdisciplinary workforce.GAO identified five policy options that may help address the cross-cutting challenges. These policy options represent possible actions that policymakers—who may include Congress, federal agencies, state and local governments, academia, industry, and international organizations—could consider taking. See below for a summary of the policy options and relevant opportunities and considerations.Policy Options to Address Three Cross-Cutting Challenges in Pandemic Origin InvestigationsPolicy Option			Opportunities			Considerations					Establish multilateral agreements for accessing and sharing samples and genetic sequence data (report p. 21)						Federal policymakers and others could encourage international preparedness in advance of future outbreaks by establishing multilateral agreements for accessing and sharing samples and genetic sequence data.									Ensuring timely access to genetic information and samples in the critical beginning stages of a pandemic as well as throughout an origin investigation may help in the determination of a pandemic’s origin.				Establishing standing agreements between nations before a pandemic occurs could assist in the determination of a pandemic’s origin.									Countries may be unwilling to participate in multilateral, international agreements because of concerns related to national sovereignty, among other reasons.				Identifying an appropriate responsible entity to determine and monitor whether countries are following agreed upon standard processes may be time consuming and challenging.								Develop standardized processes for genetic sequence database use (report p. 22)						Federal policymakers and others could empower or establish a working group to develop standardized processes for database use to support pandemic origin investigations.									Developing standardized processes for database use could help ensure consistency of submitted data and metadata across multiple databases, improve researchers’ access, and help researchers comprehensively compare genetic sequences.				Implementing leading practices for genetic data integrity and associated metadata could help improve the quality of data in genetic sequence databases.									Standardized processes may be difficult to develop as there are risk-benefit trade-offs. For example, access to certain novel pathogen sequences should be limited to trusted and credentialed individuals with a need to access those sequences.				It may be challenging for multiple stakeholders to agree on what data are important.								Improve current, or develop new, genetic sequence database tools (report p. 23)						Policymakers could encourage the improvement of current, or development of new, genetic sequence database tools.									Improved or new database interfaces could streamline researchers’ data submission, access, and use as well as improve data quality.				Improved or new database interfaces could help address the projected future growth in genetic sequence data.									Building new, or retooling current, database interfaces could be time- and labor-intensive.				It may be challenging for groups of users to agree on what database interface features are important.								Encourage the development, retention, and growth of a workforce with the critical skills needed for pandemic origin investigations (report p. 24)						Policymakers could encourage mechanisms to provide training, workforce development, and capacity-building, including in areas considered hot spots of emerging infectious disease.									Encouraging development of expertise in geographic areas where novel pathogens are likely to emerge could increase the overall global supply of skilled workers and help to ensure the workforce is not concentrated in any geographic region.				A trained workforce skilled in origin investigations could contribute to other areas such as public health, or other types of related activities.									Pandemic origin investigations tend to be episodic. As a result, it may be difficult to adequately plan for and consistently fund staffing in science fields related to pandemic origin investigations.				Researchers may experience unwanted attention or pressure because of their involvement in pandemic origin investigations and leave the field or refuse to participate.								Augment or develop a national strategy to better coordinate and collaborate domestically and internationally on pandemic origin investigations (report p. 25)						Federal policymakers could better coordinate and collaborate with domestic and international partners by augmenting or developing a national strategy for pandemic origin investigations. This could be a standalone strategy or a component of existing strategies such as the National Biodefense Strategy.									A national strategy could help address the challenges that hinder pandemic origin investigations.				Federal coordination and collaboration leadership, guided by a national strategy, could increase preparedness for future pandemic origin investigations.				Understanding pandemic origins could help mitigate health and economic costs associated with pandemics by, for example, facilitating surveillance that could identify future pandemics more quickly.									Allocating resources and defining how federal agencies and others will collaborate may be challenging because of the number and types of entities with relevant expertise.				During nonpandemic periods, other priorities and needs may arise and make it challenging to provide sustained resources and support needed for maintaining a national strategy.					Source: GAO. | GAO-23-105406Why GAO Did This StudyPandemics are global disease outbreaks that can greatly increase morbidity and mortality and cause significant economic and social disruptions. According to the scientific literature, most pandemics where the origin is known were caused by the natural transmission of a virus through animal-to-human contact; however, there is potential for a pandemic to originate from laboratory research.GAO was asked to conduct a technology assessment on pandemic origins. This report describes: (1) key technologies available for pandemic origin investigations, (2) strengths and limitations of these tools and how researchers use them to investigate pandemic origins, and (3) cross-cutting challenges researchers face in trying to determine a pandemic’s origin.GAO reviewed peer-reviewed scientific literature and other documents, including reports from the Centers for Disease Control and Prevention, Office of Director of National Intelligence, Johns Hopkins Center for Health Security, World Health Organization, and select national laboratories; interviewed government, industry, and academic representatives; and convened a meeting of 27 experts in March 2022 with assistance from the National Academies of Sciences, Engineering, and Medicine.GAO is identifying policy options in this report.For more information, contact Karen L. Howard at (202) 512-6888 or howardk@gao.gov.
- Artificial Intelligence in Health Care: Benefits and Challenges of Machine Learning Technologies for Medical Diagnostics What GAO FoundSeveral machine learning (ML) technologies are available in the U.S. to assist with the diagnostic process. The resulting benefits include earlier detection of diseases; more consistent analysis of medical data; and increased access to care, particularly for underserved populations. GAO identified a variety of ML-based technologies for five selected diseases — certain cancers, diabetic retinopathy, Alzheimer’s disease, heart disease, and COVID-19 —with most technologies relying on data from imaging such as x-rays or magnetic resonance imaging (MRI). However, these ML technologies have generally not been widely adopted.Academic, government, and private sector researchers are working to expand the capabilities of ML-based medical diagnostic technologies. In addition, GAO identified three broader emerging approaches—autonomous, adaptive, and consumer-oriented ML-diagnostics—that can be applied to diagnose a variety of diseases. These advances could enhance medical professionals’ capabilities and improve patient treatments but also have certain limitations. For example, adaptive technologies may improve accuracy by incorporating additional data to update themselves, but automatic incorporation of low-quality data may lead to inconsistent or poorer algorithmic performance.Spectrum of adaptive algorithmsWe identified several challenges affecting the development and adoption of ML in medical diagnostics:Demonstrating real-world performance across diverse clinical settings and in rigorous studies.	Meeting clinical needs, such as developing technologies that integrate into clinical workflows.	Addressing regulatory gaps, such as providing clear guidance for the development of adaptive algorithms.These challenges affect various stakeholders including technology developers, medical providers, and patients, and may slow the development and adoption of these technologies.GAO developed three policy options that could help address these challenges or enhance the benefits of ML diagnostic technologies. These policy options identify possible actions by policymakers, which include Congress, federal agencies, state and local governments, academic and research institutions, and industry. See below for a summary of the policy options and relevant opportunities and considerations.Policy Options to Help Address Challenges or Enhance Benefits of ML Diagnostic Technologies&nbsp;			Opportunities			Considerations					Evaluation (report			page 28)			Policymakers could create incentives, guidance, or policies to encourage or require the evaluation of ML diagnostic technologies across a range of deployment conditions and demographics representative of the intended use.			This policy option could help address the challenge of demonstrating real world performance.									Stakeholders could better understand the performance of these technologies across diverse conditions and help to identify biases, limitations, and opportunities for improvement.				Could inform providers' adoption decisions, potentially leading to increased adoption by enhancing trust. 				Information from evaluations can help inform the decisions of policymakers, such as decisions about regulatory requirements.									May be time-intensive, which could delay the movement of these technologies into the marketplace, potentially affecting patients and professionals who could benefit from these technologies.				More rigorous evaluation will likely lead to extra costs, such as direct costs for funding the studies. Developers may not be incentivized to conduct these evaluations if it could show their products in a negative light, so policymakers could consider whether evaluations should be conducted or reviewed by independent parties, according to industry officials. 								Data Access (report			page 29)			Policymakers could develop or expand access to high-quality medical data to develop and test ML medical diagnostic technologies. Examples include standards for collecting and sharing data, creating data commons, or using incentives to encourage data sharing.			This policy option could help address the challenge of demonstrating real world performance.									Developing or expanding access to high-quality datasets could help facilitate training and testing ML technologies across diverse and representative conditions. This could improve the technologies' performance and generalizability, help developers understand their performance and areas for improvement, and help to build trust and adoption in these technologies.				Expanding access could enable developers to save time in the development process, which could shorten the time it takes for these technologies to be available for adoption.									Entities that own data may be reluctant to share them for a number of reasons. For example, these entities may consider their data valuable or proprietary. Some entities may also be concerned about the privacy of their patients and the intended use and security of their data.				Data sharing mechanisms may be of limited use to researchers and developers depending on the quality and interoperability of these data, and curating and storing data could be expensive and may require public and private resources.								Collaboration (report			page 30)			Policymakers could promote collaboration among developers, providers, and regulators in the development and adoption of ML diagnostic technologies. For example, policymakers could convene multidisciplinary experts together in the design and development of these technologies through workshops and conferences.			This policy option could help address the challenges of meeting medical needs and addressing regulatory gaps.									Collaboration between ML developers and providers could help ensure that the technologies address clinical needs. For example, collaboration between developers and medical professionals could help developers create ML technologies that integrate into medical professionals' workflows, and minimize time, effort, and disruption.				Collaboration among developers and medical providers could help in the creation and access of ML ready data, according to NIH officials.									As previously reported, providers may not have time to both collaborate with developers and treat patients; however, organizations can provide protected time for employees to engage in innovation activities such as collaboration.&nbsp; 				If developers only collaborate with providers in specific settings, their technologies may not be usable across a range of conditions and settings, such as across different patient types or technology systems.					Source: GAO. | GAO-22-104629Why GAO Did This StudyDiagnostic errors affect more than 12 million Americans each year, with aggregate costs likely in excess of $100 billion, according to a report by the Society to Improve Diagnosis in Medicine. ML, a subfield of artificial intelligence, has emerged as a powerful tool for solving complex problems in diverse domains, including medical diagnostics. However, challenges to the development and use of machine learning technologies in medical diagnostics raise technological, economic, and regulatory questions.GAO was asked to conduct a technology assessment on the current and emerging uses of machine learning in medical diagnostics, as well as the challenges and policy implications of these technologies. This report discusses (1) currently available ML medical diagnostic technologies for five selected diseases, (2) emerging ML medical diagnostic technologies, (3) challenges affecting the development and adoption of ML technologies for medical diagnosis, and (4) policy options to help address these challenges.GAO assessed available and emerging ML technologies; interviewed stakeholders from government, industry, and academia; convened a meeting of experts in collaboration with the National Academy of Medicine; and reviewed reports and scientific literature. GAO is identifying policy options in this report.For more information, contact Karen L. Howard at (202) 512-6888 or howardk@gao.gov.
- Decarbonization: Status, Challenges, and Policy Options for Carbon Capture, Utilization, and Storage What GAO FoundMany technologies for carbon capture, utilization, and storage (CCUS) are ready for wider demonstration or deployment, but multiple challenges limit their use. Carbon capture includes technologies that separate and purify carbon dioxide (CO2) from a source, which could be an industrial facility (point-source capture) or the atmosphere (direct air capture). Applications of capture technologies at point sources are mature in some sectors (e.g., natural gas processing) but require further demonstration in some of the highest-emitting sectors (e.g., power generation). Direct air capture is not as mature, but has been implemented at pilot scale. Lengthy time to deployment and high costs hinder widespread deployment of both types of carbon capture in the near term.Technologies for transporting, storing, and directly using captured CO2 are mature. Companies are beginning to commercialize utilization technologies that convert captured CO2 into valuable products such as ethanol, sustainable aviation fuel, and mineral aggregates. However, many CO2-based products are not competitive with conventional products, may be excluded from the market by industry standards, and lack a standardized method for ensuring they effectively reduce CO2 emissions.Components of carbon capture, utilization, and storageGAO identified three aspects of CCUS deployment where challenges may arise:Cost. Deploying CCUS is an added cost to doing business but currently offers few opportunities to generate revenue. Incentives such as federal tax credits help offset the high cost of CCUS for some but not all emitters.	Infrastructure development. More widespread deployment of CCUS would require a build-out of infrastructure for each of its components, including transport and storage. Timing of development, negotiating land access, and proximity of facilities are all challenges affecting this build-out.	Community engagement. Deploying CCUS projects relies on acceptance by and effective engagement with local communities. In the past, unsuccessful community engagement and local opposition have contributed to cancellation or relocation of some CCUS projects, while others were well received.GAO identified seven policy options that could help address these challenges or enhance the benefits of CCUS technologies. The policy options are possible actions by policymakers, which may include Congress, federal agencies, state and local governments, academic and research institutions, and industry. In addition, policymakers could choose to maintain the status quo, whereby they would not take additional action beyond current efforts.&nbsp;See below for details of the policy options and selected opportunities and considerations.Policy options to help address challenges or enhance benefits of CCUS technologies, with selected opportunities and considerationsPolicy Option			Opportunities			Considerations					Research, development, and demonstration (report p. 20)			&nbsp;			Policymakers could enhance support for consistent funding of research and development and large-scale demonstrations simultaneously.									Research and development could reduce cost, resolve issues, mitigate risks, and advance emerging technologies.				Demonstrations could reduce cost and establish the viability of carbon capture by promoting learning-by-doing.									Stakeholders have different ideas for research and development priorities.				Requires careful oversight of large-scale demonstrations.								Technology-neutral standards (report p. 34)			&nbsp;			Policymakers could encourage the creation, adoption, or use of technology-neutral standards.									Could incentivize the development or use of products with the best CO2 benefits.&nbsp;				Could incentivize manufacture in the U.S.									Standards development is a resource-intensive and lengthy process.				Could be difficult to compare CO2 benefits of different products without standardized life cycle assessment.								Standardized life cycle assessment guidelines (report p. 34)			&nbsp;			Policymakers could support the creation and use of standardized life cycle assessment guidelines to validate CO2 benefits of CO2-based products.									Could improve accuracy of comparisons between various CO2 utilization pathways or products.									Standards development and life cycle assessment are resource-intensive and lengthy processes.				Coordination of many stakeholders to establish standardized life cycle assessment guidelines may be challenging.								Framework for land access (report p. 44)						Policymakers could support development of legal or regulatory frameworks to manage geologic storage of CO2 at the state level.									Legal or regulatory clarity could facilitate deployment of CO2 storage infrastructure.				Pore-space unitization processes could reduce the time and cost of negotiating land access for storage. &nbsp;									Individual landowners may oppose losing certain property rights due to pore-space unitization.				CO2 storage projects may cross state boundaries, requiring coordination.								Strategic siting (report p. 44)						Policymakers could facilitate strategic siting of CCUS facilities.									Could minimize financial and logistical barriers to CCUS development.				Carbon capture and utilization industries may accelerate deployment if access to infrastructure increases.									Certain geographic regions that are inherently more suited for CCUS could benefit more than others from infrastructure investments.				Some communities may not want CCUS infrastructure for several reasons, including perceptions of environmental and safety risks.								Modify incentives (report p. 55)			&nbsp;			Policymakers could modify existing incentives to facilitate access for CCUS projects.									Could increase the number or kinds of facilities that deploy CCUS.				Could incentivize new technology development to reduce costs of capture.									Modifying tax credits could reduce government tax revenues or increase use of fossil fuels.				Modifying market-based approaches could be subject to uncertainty in carbon prices.								Community engagement (report p. 62)			&nbsp;			Policymakers could support and encourage proactive community engagement around CCUS deployment.									Better understanding of public opinion could guide community engagement and decision-making.				Could build local support and reduce delays.									Well-designed education and public awareness campaigns could be resource-intensive.				May require new funding or reallocation of existing resources to support new efforts.					Source: GAO. &nbsp;| &nbsp;GAO-22-105274Why GAO Did This StudyIn 2021, CO2 reached a record high concentration in the Earth's atmosphere for the modern era. Scientific assessments have shown that reducing CO2 emissions could help mitigate the negative effects of climate change. CCUS is one tool available to help slow, stop, or potentially reverse the rising levels of CO2 in the atmosphere.This report discusses (1) the status of available carbon capture technologies; (2) opportunities for using or storing captured CO2; (3) key challenges that could affect the development, demonstration, and deployment of CCUS technologies; and (4) options policymakers could consider to help address these challenges.In conducting this assessment, GAO interviewed federal officials, academic researchers, industry organizations, private companies, nongovernmental organizations, technology testing centers, and federal advisory committees; In conducting this assessment, GAO interviewed federal officials, academic researchers, industry organizations, private companies, nongovernmental organizations, technology testing centers, and federal advisory committees; convened an interdisciplinary meeting of 27 experts with assistance from the National Academies of Sciences, Engineering, and Medicine; and reviewed relevant literature. GAO is identifying policy options in this report.For more information, contact Karen L. Howard at (202) 512-6888 or howardk@gao.gov.
- Large Constellations of Satellites: Mitigating Environmental and Other Effects What GAO FoundThere are almost 5,500 active satellites in orbit as of spring 2022, and one estimate predicts the launch of an additional 58,000 by 2030. Large constellations of satellites in low Earth orbit are the primary drivers of the increase. Satellites provide important services, but there are potential environmental and other effects that this trend could produce (see figure).Potential effects from the launch, operation, and disposal of satellitesGAO assessed technologies and approaches to evaluate and mitigate the following potential effects:Increase in orbital debris. Debris in space can damage or destroy satellites, affecting commercial services, scientific observation, and national security. Better characterizing debris, increasing adherence to operational guidelines, and removing debris are among the possible mitigations, but achieving these is challenging.	Emissions into the upper atmosphere. Rocket launches and satellite reentries produce particles and gases that can affect atmospheric temperatures and deplete the ozone layer. Limiting use of rocket engines that produce certain harmful emissions could mitigate the effects. However, the size and significance of these effects are poorly understood due to a lack of observational data, and it is not yet clear if mitigation is warranted.	Disruption of astronomy. Satellites can reflect sunlight and transmit radio signals that obstruct observations of natural phenomena. Satellite operators and astronomers are beginning to explore ways of mitigating these effects with technologies to darken satellites, and with tools to help astronomers avoid or filter out light reflections or radio transmissions. However, the efficacy of these techniques remains in question, and astronomers need more data about the satellites to improve mitigations.GAO developed the following policy options to help address challenges with evaluating and mitigating the effects of large constellations of satellites. GAO developed the options by reviewing literature and documents, conducting interviews, and convening a 2-day meeting with 15 experts from government, industry, and academia. These policy options are not recommendations. GAO presents them to help policymakers consider and choose options appropriate to the goals they hope to achieve. Policymakers may include legislative bodies, government agencies, standards-setting organizations, industry, and other groups.Policymakers may be better positioned to take action on this complex issue if they consider interrelationships among these policy options. For example, implementing the fourth option (improving organization and leadership) may improve policymakers’ ability to implement the first and second options (building knowledge, developing technologies, and improving data sharing). Similarly, implementing the first option may help with the third option (establishing standards, regulations, and agreements). More generally, trade-offs between mitigations may emerge, the ongoing increase in new constellations may introduce unexpected changes, and a large and diverse set of interests from the global community may shift over time, all of which present persistent uncertainties. To address these complexities and uncertainties, the full report presents the policy options in a framework, which may help policymakers strategically choose options to both realize the benefits and mitigate the potential effects of large constellations of satellites.Policy options for technologies and approaches to evaluate and mitigate potential effects of large constellations of satellitesPolicy Option			Opportunites			Considerations					Build knowledge and develop technologies (report p. 57)			Policymakers could support research on the extent of potential effects, as well as development of technologies to address them.									Improving knowledge about potential effects of satellite constellations could help policymakers decide which mitigations to implement, if any.				Research on darkening satellites, removing orbital debris, and other technologies could lead to innovative mitigation.									Resources for studying the potential effects of satellite constellations are limited, in both the government and private sectors, which could hamper efforts to build knowledge or develop technologies.				Knowledge of some effects, such as the long-term growth of orbital debris, may already be sufficient. Experts told us that in such cases, leadership and standards, regulations, and agreements could prompt action.								Improve data sharing (report p. 57)			Policymakers could facilitate improved sharing of relevant data about satellite constellations.									The ability to more easily share high-quality data could improve mitigation of potential effects. For example, better satellite position data might help astronomers avoid disruptions or help satellite operators avoid collisions.				Increased data sharing may create opportunities for increased collaboration and awareness across government, academia, and the satellite industry, which could in turn generate additional mitigation approaches.									The ability to effectively share data will depend heavily on the willingness of stakeholders, particularly satellite operators. Some operators are willing to share data with entities that have a demonstrated need but expressed reservations about sharing certain detailed data more openly.				Collecting and updating data on satellite positions or other key information in a common format poses technical and logistical hurdles.								Establish standards, regulations, and agreements (report p. 58)			Policymakers could establish appropriate standards, regulations, and agreements to help mitigate potential effects of satellite constellations.									Establishing formalized standards, regulations, and agreements around potential effects of satellite constellations could help institutionalize successful mitigation approaches and make them standard practices for future operators.				Formalized regulations could provide enforcement avenues to help protect existing satellite operators and stakeholders and provide direction to new entrants.									Regulations on satellite licensing or operation may create incentives for operators to pursue licensing in less-regulated venues.				Authors of voluntary standards and agreements might face difficulties incentivizing private operators to adopt new practices.				Existing laws and accepted practices vary across domains. For example, international law may only address certain types of effects.								Improve organization and leadership (report p. 59)			Policymakers could build national and international organizational and leadership structures that facilitate effective mitigation of the potential effects of satellite constellations.									Centralized leadership and coordination may improve mitigation.				Broader organization and leadership structures could pull together relevant stakeholders to implement mitigations.									Unilateral leadership or mitigation action by one nation could cause satellite operators to license in less-regulated nations.				International agreements on satellite constellations may take longer to implement and may lag behind the need for timely mitigation.				Establishing effective organization and leadership structures may divert resources and personnel from other missions.					Source: GAO. | GAO-22-105166Why GAO Did This StudyEnabled by declines in the costs of satellites and rocket launches, commercial enterprises are deploying large constellations of satellites into low Earth orbit. Satellites provide important data and services, such as communications, internet access, Earth observation, and technologies like GPS that provide positioning, navigation, and timing. However, the launch, operation, and disposal of an increasing number of satellites could cause or increase several potential effects.This report discusses (1) the potential environmental or other effects of large constellations of satellites; (2) the current or emerging technologies and approaches to evaluate or mitigate these effects, along with challenges to developing or implementing these technologies and approaches; and (3) policy options that might help address these challenges.To conduct this technology assessment, GAO reviewed technical studies, agency documents, and other key reports; interviewed government officials, industry representatives, and researchers; and convened a 2-day meeting of 15 experts from government, industry, academia, and a federally funded research and development center. GAO is identifying policy options in this report.For more information, contact Karen L. Howard at (202) 512-6888 or HowardK@gao.gov&nbsp;or Andrew Von Ah at (202) 512-2834 or VonAhA@gao.gov.
- Persistent Chemicals: Technologies for PFAS Assessment, Detection, and Treatment What GAO FoundCurrent and promising technologies and methods could accelerate assessment of human health effects caused by per- and polyfluoroalkyl substances (PFAS) and improve the detection and treatment of PFAS in the environment. However, these technologies and methods face key challenges that hinder effective management of PFAS.Focus of the per- and and polyfluoroalkyl substances (PFAS) technologies discussed in this reportAssessment. Technologies that may accelerate assessment of PFAS health effects include high-throughput assays—automated testing methods that rapidly evaluate a large number of chemicals—and machine learning, which may help improve on technologies that predict health effects based on the effects of similar molecules.Detection. Current technologies for detecting PFAS can reliably quantify about 50 specific PFAS, but these technologies are unable to detect or quantify the thousands of other PFAS known to exist. EPA requires reliable samples, known as analytical standards, to develop PFAS detection methods. However, researchers and agencies are developing new detection methods that do not need analytical standards and can screen for or quantify unknown PFAS. These methods include high-resolution mass spectrometry and total fluorine analysis.Treatment. PFAS treatment can involve removal of PFAS from contaminated media, followed either by disposal in landfills or destruction by incineration. There are full-scale, proven treatment technologies that can remove PFAS from drinking water. But these technologies also leave behind PFAS-contaminated residual materials that must be disposed of or destroyed. Emerging technologies may be more effective, but none have been demonstrated at full scale, and most are still being researched.GAO identified three challenges associated with PFAS assessment, detection, and treatment technologies:PFAS chemical structures are diverse and difficult to analyze for health risks, and machine learning requires extensive training data that may not be available.	Researchers lack analytical standards for many PFAS, limiting the development of effective detection methods.	The effectiveness and availability of disposal and destruction options for PFAS are uncertain because of a lack of data, monitoring, and guidance.GAO developed the following three policy options that could help mitigate these challenges. These policy options involve possible actions by policymakers, which may include Congress, federal agencies, state and local governments, academia, and industry. See below for details on some of the policy options and relevant opportunities and considerations.Policy Options That Could Help Enhance Benefits or Mitigate Challenges of PFAS Assessment, Detection, and Treatment Technologies			Policy option 									Opportunities									Considerations								Promote research (report p. 35)			Policymakers could support development of technologies and methods to more efficiently research PFAS health risks.			This policy option could help address the challenge of limited information on the large number and diversity of PFAS, as well as a lack of standardized data sets for machine learning.									Promoting research on predictive methods could allow researchers to more efficiently assess PFAS classes rather than individually.				Integrating existing PFAS health information from multiple studies could result in more efficient health assessments of the wide range of PFAS.				Supporting technologies for more efficient research could also improve the assessment of alternatives to PFAS.									Computer models for more efficiently researching PFAS may not be sufficient on their own to accurately assess health effects, because of a lack of scientific knowledge on the behavior of PFAS in the human body.				Researchers lack complete data sets to train and validate machine learning models, which are needed before such models can be used for PFAS assessment.								Expand method development (report p. 36)			Policymakers could collaborate to improve access to standard reference samples of PFAS, known as analytical standards and increase the pace of method and reference sample development for PFAS detection.			This policy option could help address the challenges of a lack of validated methods in media other than water, lack of analytical standards, and cost, which all affect researchers’ ability to develop new detection technologies.									Supporting efforts by federal and independent laboratories to develop reference samples for known PFAS could increase access to available and affordable analytical standards for researchers.				Enabling researchers to accelerate development of new detection methods for media other than water could enable researchers to discover and reliably characterize more PFAS.				Enabling development and finalization of a standard method for high resolution mass spectrometry could enable better screening and identification of PFAS in the environment.									Private industry has been reluctant to provide analytical standards, many of which are considered proprietary, hindering the development of detection methods.				High costs for PFAS testing may deter private well owners and smaller water utilities from testing.								Support full-scale treatment (report p. 37)			Policymakers could encourage the development and evaluation of full-scale technologies and methods to dispose of or destroy PFAS.			This policy option could help address the challenges of cost and efficiency of disposal and destruction technologies and a lack of guidance from regulators.									Supporting optimization of full-scale disposal and destruction technologies for PFAS by encouraging finalization of EPA methods could improve PFAS monitoring during incineration.				Encouraging the development of guidance to improve monitoring at landfills could help prevent future contamination.				Accelerating the development and sharing of performance and cost models for disposal and destruction of PFAS and promoting treatment could help stakeholders plan for future costs.									Technologies for destroying PFAS could be difficult to implement at scale, due to the lack of guidance from regulators. 				In the absence of effective controls, landfills may release PFAS into the environment over time.				Guidelines currently vary by a considerable amount across the U.S. and may drive up the cost of PFAS disposal and destruction.					Source: GAO. | GAO-22-105088Why GAO Did This StudyPFAS are a large group of heat and stain resistant chemicals, first developed in the 1940s. PFAS are used in a wide range of products, including carpet, nonstick cookware, waterproof clothing, and firefighting foam used at airports and military bases. PFAS can persist in the environment, including in water, soil, and air, for decades or longer. The Centers for Disease Control and Prevention has found that most people in the U.S. have been exposed to two of the most widely studied PFAS, perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS). Both have been linked to human health problems.GAO was asked to conduct a technology assessment on PFAS assessment, detection, and treatment. This report examines (1) technologies for more efficient assessments of the adverse health effects of PFAS and alternative substances; (2) the benefits and challenges of current and emerging technologies for PFAS detection and treatment; and (3) policy options that could help enhance benefits and mitigate challenges associated with these technologies.GAO assessed relevant technologies; surveyed PFAS subject matter experts; interviewed stakeholder groups including government, non-governmental organizations, industry, and academia; and reviewed key reports. GAO is identifying policy options in this report.For more information, contact Karen L. Howard at (202) 512-6888 or howardk@gao.gov or J. Alfredo Gómez at (202) 512-3841 or gomezj@gao.gov.
- Blockchain: Emerging Technology Offers Benefits for Some Applications but Faces Challenges What GAO FoundBlockchain combines several technologies to provide a trusted, tamper-resistant record of transactions by multiple parties without a central authority such as a bank. Blockchain can be used for a variety of financial and non-financial applications, including cryptocurrency, supply chain management, and legal records. GAO found that blockchain is useful for some applications but limited or even problematic for others. For example, because of its tamper resistance, it may be useful for applications involving many participants who do not necessarily trust each other. But it may be overly complex for a few trusted users, where traditional spreadsheets and databases may be more helpful. Blockchain may also present security and privacy challenges and can be energy-intensive.Blockchain has a wide range of potential non-financial uses (see figure).Blockchain has many potential non-financial applicationsFor example, it could be used to organize supply chains, create less hierarchical organizations, and document title registries for real estate. However, most such efforts are not yet beyond the pilot stage and face challenges. For example, most blockchain networks are not designed to be interoperable and cannot communicate with other blockchains. Organizations that want to use blockchain also face legal and regulatory uncertainties, and have found it difficult to find skilled workers to implement blockchain.Financial applications of blockchain have the potential to reduce costs and improve access to the financial system, but they also face multiple challenges. Cryptocurrencies, likely the most widely known application, are a digital representation of value protected through cryptographic mechanisms, which facilitates payments. Some are known for volatility (i.e., frequent or rapid changes in value), but a type known as stablecoins may help reduce this risk. Similarly, an emerging area known as decentralized finance offers services such as blockchain-based lending and borrowing, which also face several challenges. For example, blockchain-based financial applications can facilitate illicit activity, may reduce consumer and investor protections compared to traditional finance, and, in some cases, are subject to unclear and complex rules.GAO developed four policy options that could help enhance benefits or mitigate challenges of blockchain technologies. The policy options identify possible actions by policymakers, which may include Congress, federal agencies, state and local governments, academic and research institutions, and industry. In addition, policymakers could choose to maintain the status quo, whereby they would not take additional action beyond any current efforts. See below for details of the policy options and relevant opportunities and considerations.Policy Options That Could Help Enhance Benefits or Mitigate Challenges of Blockchain Technologies&nbsp;			Opportunities			Considerations					Standards (report p. 38)						Policymakers could collaborate to unify standards that focus on the development, implementation, and use of blockchain technologies.									Could simplify fragmented standards and help identify gaps and reduce overlap in standard-setting efforts.				Could identify the areas in which standards would be most beneficial across different sectors of the economy or applications of blockchain.				Could help address challenges around interoperability and data security.									Could require consensus from many public- and private-sector stakeholders, which can be time- and resource-intensive.				May not be clear which entities should take the lead in establishing internationally recognized standards for different technologies and application areas.				May require new funding or reallocation of existing resources to support new efforts.								Oversight (report p. 39)						Policymakers could clarify existing oversight mechanisms, including regulations, or create new mechanisms to ensure appropriate oversight of blockchain applications.									Clear, industry-specific U.S. oversight frameworks could offer the clarity needed for individuals and firms to more successfully engage in blockchain-related commerce in the U.S.				Policymakers, including regulatory entities and developers, could use tools to create oversight mechanisms in addition to testing innovative products and services.				Could provide coordinated and timely clarity to promote safety and soundness, consumer protection, and compliance with applicable laws and regulations to combat illicit activity in blockchain-related commerce.									Policymakers will need to determine the appropriate level of oversight. Aggressive oversight could hamper innovation and competition as the technology matures, whereas too little oversight could leave consumers and businesses unprotected.				Soliciting input across a range of stakeholders in various sectors may be time consuming and challenging.				May require new funding or reallocation of existing resources.								Educational materials (report p. 40)						Policymakers could support the development of educational materials to help users and regulators better understand blockchain technologies beyond existing financial applications.									Could enable instructors to train a workforce skilled in developing, implementing, and using blockchain-based products.				Could increase consumer literacy and help reduce negative public perceptions of blockchain.				Could stimulate critical thinking and innovation, as well as prompt innovative research and development.				Could help prepare policymakers to better use and regulate the latest technologies.									Educational materials will likely need to be tailored to meet a wide variety of learning needs across multiple target audiences.				May be difficult to identify who could most effectively create educational materials for any particular target audience.				May require new funding or reallocation of existing resources, especially to address the need for education regarding innovative uses of blockchain beyond existing financial applications.								Appropriate uses (report p. 41)						Policymakers could support activities designed to determine whether blockchain is appropriate for achieving specific missions and goals or to mitigate specific challenges.									Actively investigating where and when blockchain would be the most useful could allow entities to capture the full benefits the technology might offer.				Supporting blockchain use, where appropriate, could enhance transparency and accountability of existing systems and services.									Legal or regulatory uncertainty may hinder some potential users from benefitting from blockchain.				Could be difficult to revert to a non-blockchain technology once an entity has invested a significant amount of time and resources.				May require new funding or reallocation of existing resources.					Source: GAO. | GAO-22-104625Why GAO Did This StudyEconomies rely on central authorities and trusted intermediaries to facilitate business transactions. Blockchain is a technology that could reduce the need for such entities while establishing a system of verification. It might therefore improve a variety of financial and non-financial applications. However, the use of blockchain technologies raises a variety of ethical, legal, economic, and social concerns.GAO was asked to conduct a technology assessment on the use of blockchain, with an emphasis on foresight and policy implications. This report discusses (1) non-financial applications of blockchain, including potential benefits and challenges, (2) financial applications of blockchain, including potential benefits and challenges, and (3) policy options that could help enhance benefits or mitigate challenges of blockchain technologies.GAO assessed blockchain applications developed for or used in finance, government, supply chain management, and organization management; interviewed a range of stakeholder groups including government, industry, academia, and a venture capital firm; convened a meeting of experts in collaboration with the National Academies of Sciences, Engineering, and Medicine; and reviewed key reports and scientific literature. GAO is identifying policy options in this report.For more information, contact Karen L. Howard at (202) 512-6888 or howardk@gao.gov.
- Vaccine Development: Capabilities and Challenges for Addressing Infectious Diseases What GAO FoundVaccines protect people from disease by preparing the body to respond to an infection. Vaccinations are a key part of individual and community health, but vaccine development remains complex and costly. Innovative technologies and approaches, such as those identified in this report, may enhance the nation’s ability to respond to infectious disease. For example, reverse vaccinology and next-generation platforms—combined with existing research—helped researchers develop some COVID-19 vaccines more quickly and effectively.However, key challenges may hinder the adoption of these innovative technologies and approaches. Some promising technologies face issues and challenges such as inherent technical limitations and high cost. For example, organ chips may facilitate testing, but they are not yet able to replicate many of the complex functions of the human immune system. Similarly, single-use systems may increase the flexibility of vaccine manufacturing facilities, but may require extensive testing to ensure that they do not negatively affect the resulting vaccine. Further, economic challenges may hinder vaccine development. Experts attribute underinvestment in vaccines to market failures (i.e. market interactions that fall short of what would have been socially beneficial). For example, vaccines benefit those who are vaccinated, and, to some degree, those who are not. This additional benefit is not captured in the price, which reduces return on vaccine investment.GAO identified 9 policy options that may help address challenges hindering the adoption of vaccine development technologies and approaches or economic challenges. These policy options involve possible new actions by policymakers, who may include Congress, federal agencies, state and local governments, academic and research institutions, and industry. See below for details for some of the policy options and relevant opportunities and considerations.Selected Policy Options to Address Challenges in Vaccine Development&nbsp;			Opportunities			Considerations					Prioritize infectious disease pathogens (report page 21)			Policymakers could collaborate across sectors (e.g., government, academia, researchers, industry, and nonprofit organizations) to prioritize infectious disease pathogens with pandemic potential for vaccine R&amp;D.&nbsp;For example, policymakers could develop a working group to prioritize pathogens with pandemic potential and work more closely with international organizations to prioritize vaccine development as well as develop monoclonal antibodies.									Prioritizing pathogens with pandemic potential could improve strategic vaccine R&amp;D decision-making and help focus resources on developing and adopting key technologies and approaches that most effectively address those pathogens.				Appropriately matching the technologies and approaches to the prioritized potential pandemic pathogens then leveraging technologies may help address certain technical limitations and cost.				With greater leadership and strategic partnerships, policymakers could more quickly address threats to the U.S. population.									As new threats are identified, priorities may change, which may cause uncertainty for vaccine developers.				Policymakers may have different priorities based on their respective missions.				There may be disagreements as to which key technologies should be prioritized and used, resulting in the need for policymakers to weigh the potential advantages and disadvantages associated with various options.								Improve preparedness (report page 21)			Policymakers could provide support for public-private partnerships to strategically address potential pandemic pathogens identified as priorities. These partnerships could, for example, develop and test vaccine candidates that may provide protection from pathogens with pandemic potential.									This early development could provide a coordinated foundation that can be mobilized in an emergency. Such an approach could speed vaccine development as well as potentially reduce risk for vaccine researchers and developers concerning questions of safety, efficacy, and manufacturability.									The lack of certainty of the commercial market and government funding for vaccines against pathogens with pandemic potential may be too risky for the private sector to undertake.								Further support development of data standards (report page 32)			Policymakers could further support coordinated efforts to obtain the views of all stakeholders and to develop standards for health data and their use in clinical trials.									Integrating researchers’ needs into the standards development process could better ensure the necessary data are available.				Access to high-quality data in a standardized format may allow streamlined patient recruitment for clinical trials.									Expanding access to patient heath data requires attention to ensure privacy.				Developing and implementing standardized data formats and IT infrastructure is time-consuming and costly.								Improve preparedness (report page 41)			Policymakers could provide support for public/private partnerships to strategically develop manufacturing capacity to respond to surge requirements. To maintain this capacity, partnerships could manufacture prototype vaccine candidates against high-priority pathogens.									Manufacturing, testing, and stockpiling vaccines could be mobilized in an emergency and more rapidly mitigate future pandemics.				By leveraging strategic partnerships, policymakers could take steps to increase the availability of vaccines to more quickly address threats to the U.S. population.									May require new resources or reallocation of resources from other efforts.				There may be a risk that the vaccines manufactured, tested, and stockpiled against prioritized pathogen classes miss certain pandemic pathogens.&nbsp;				The stockpiled vaccines would need to be regularly replenished prior to expiration.								Evaluate factors that inhibit vaccine investment and mechanisms to increase it (report page 54)			Policymakers could collaborate across sectors, such as government, academia, and industry, to conduct a systematic evaluation of factors that inhibit developers from investing in new vaccines.									A clear understanding of the range of factors discouraging vaccine investment would provide the basis for effectively addressing those factors.									Collaboration between policymakers and other stakeholders to obtain all relevant viewpoints can be time-consuming and it may be hard to reach a consensus.					Source: GAO. | GAO-22-104371Why GAO Did This StudyThe CARES Act included a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This report discusses technologies, approaches, and associated challenges for vaccine (1) research and development, (2) testing, and (3) manufacturing, as well as (4) the economic factors that affect vaccine investment.GAO conducted literature searches including scholarly articles and government reports relevant to these four areas. GAO interviewed stakeholders and experts with a diverse set of perspectives on the science, administration, and economics of vaccine development. GAO also convened a 3-day meeting of 22 experts with expertise in at least one area related to our four objectives with assistance from the National Academies of Sciences, Engineering, and Medicine. GAO received technical comments on a draft of this report from 1 federal agency and 9 participants at its expert meeting, which it incorporated as appropriate.GAO is identifying policy options in this report.For more information, contact Karen L. Howard at (202) 512-6888 or howardk@gao.gov.
- Quantum Computing and Communications: Status and Prospects What GAO FoundQuantum information technologies aim to use the properties of nature at atomic scales to accomplish tasks that are not achievable with existing technologies. These technologies rely on qubits, the quantum equivalent of classical computer bits. Scientists are creating qubits from particles, such as atoms or particles of light, or objects that mimic them, such as superconducting circuits. Unlike classical bits, qubits can be intrinsically linked to each other and can be any combination of 0 and 1 simultaneously. These capabilities enable two potentially transformational applications—quantum computing and communications. However, quantum information cannot be copied, is fragile, and can be irreversibly lost, resulting in errors that are challenging to correct.Examples of quantum computing hardwareSome quantum computing and communications technologies are available for limited uses, but will likely require extensive development before providing significant commercial value. For example, some small error-prone quantum computers are available for limited applications, and a quantum communications technology known as quantum key distribution can be purchased. According to agency officials and stakeholders, additional quantum technology development may take at least a decade and cost billions, but such estimates are highly uncertain. Quantum computing and communications technologies will likely develop together because of some shared physics principles, laboratory techniques, and common hardware.&nbsp;Quantum computers may have applications in many sectors, but it is not clear where they will have the greatest impact. Quantum communications technologies may have uses for secure communications, quantum networking, and a future quantum internet. Some applications—such as distributed quantum computing, which connects multiple quantum computers together to solve a problem—require both quantum computing and communications technologies. Potential drawbacks of quantum technology include cost, complexity, energy consumption, and the possibility of malicious use.GAO identified four factors that affect quantum technology development and use: (1) collaboration, (2) workforce size and skill, (3) investment, and (4) the supply chain. The table below describes options that policymakers—legislative bodies, government agencies, standards-setting organizations, industry, and other groups—could consider to help address these factors, enhance benefits, or mitigate drawbacks of quantum technology development and use.Policy Options to Help Address Factors that Affect Quantum Technology Development and Use, or to Enhance Benefits or Mitigate Drawbacks			Policy options and potential 			implementation approaches						Opportunities			Considerations					Collaboration (report p. 37)						Policymakers could encourage further collaboration in developing quantum technologies, such as collaboration among:			Scientific disciplines				Sectors				Countries									Collaboration among disciplines could enable technology breakthroughs.				Collaboration could help accelerate research and development, as well as facilitate technology transfer from laboratories to the private sector, federal agencies, and others.				International collaboration could bring mutual benefits to the U.S. and other countries by accelerating scientific discovery and promoting economic growth.									Intellectual property concerns could make quantum technology leaders reluctant to collaborate.				Institutional differences could make collaboration difficult.				Export controls may complicate international collaboration, but are also needed to manage national security risks.								Workforce (report p. 39)						Policymakers could consider ways to expand the quantum technology workforce by, for example:			Leveraging existing programs and creating new ones				Promoting job training				Facilitating appropriate hiring of an international workforce who are deemed not to pose a national security risk									Educational programs could provide students and personnel with the qualifications and skills needed to work in quantum technologies across the private sector, public sector, and academia.				Training personnel from different disciplines in quantum technologies could enhance the supply of quantum talent.				International hiring could allow U.S. quantum employers to attract and retain top talent from other countries.									Efforts to increase the quantum technology labor force may affect the supply of expertise in other technology fields with high demand.				It may be difficult to adequately develop workforce plans to accommodate quantum technology needs.				International hiring could be challenging because of visa requirements and export controls, both in place for national security reasons.								Investment (report p. 41)						Policymakers could consider ways to incentivize or support investment in quantum technology development, such as:			Investments targeted toward specific results				Continued investment in quantum technology research centers				Grand challenges to spur solutions from the public									More targeted investments could help advance quantum technologies. These may include investments in improving access to quantum computers and focusing on real-world applications.				Quantum technologies testbed facility investments could support technology adoption, since testbeds allow researchers to explore new technologies and test the functionality of devices.				Grand challenges have shown success in providing new capabilities and could be leveraged for quantum technologies.									It may be difficult to fund projects with longer-term project timeframes.				A lack of standards or, conversely, developing standards too early, could affect quantum technology investments. Without standards, businesses and consumers may not be confident that products will work as expected.				Developing standards too early may deter the growth of alternative technology pathways.								Supply Chain (report p. 43)						Policymakers could encourage the development of a robust, secure supply chain for quantum technologies by, for example:			Enhancing efforts to identify gaps in the global supply chain				Expanding fabrication capabilities for items with an at-risk supply chain									A robust supply chain could help accelerate progress and mitigate quantum technology development risks by expanding access to necessary components and materials or providing improved economies of scale.				Quantum material fabrication capabilities improvements could ensure a reliable supply of materials to support quantum technology development.				Facilities dedicated to producing quantum materials could help support scalable manufacturing of component parts needed for quantum technology development.									The current quantum supply chain is global, which poses risks. For example, it is difficult to obtain a complete understanding of a component’s potential vulnerabilities.				Some critical components, such as rare earths, are mined primarily outside of the U.S., which may pose risks to the supply chain that are difficult to mitigate.				Quantum manufacturing facilities take a long time to develop and can be costly.					Source: GAO. | GAO-21-104422Why GAO Did This StudyQuantum information technologies could dramatically increase capabilities beyond what is possible with classical technologies. Future quantum computers could have high-value applications in security, cryptography, drug development, and energy. Future quantum communications could allow for secure communications by making information challenging to intercept without the eavesdropper being detected.GAO conducted a technology assessment on (1) the availability of quantum computing and communications technologies and how they work, (2) potential future applications of such technologies and benefits and drawbacks from their development and use, and (3) factors that could affect technology development and policy options available to help address those factors, enhance benefits, or mitigate drawbacks.To address these objectives, GAO reviewed key reports and scientific literature; interviewed government, industry, academic representatives, and potential end users; and convened a meeting of experts in collaboration with the National Academies of Sciences, Engineering, and Medicine. GAO is identifying policy options in this report.For more information, contact Karen L. Howard at (202) 512-6888 or howardk@gao.gov.
- Exposure Notification: Benefits and Challenges of Smartphone Applications to Augment Contact Tracing Why GAO Did This StudyWith the emergence and rapid global spread of COVID-19, smartphone apps have been developed to supplement manual contact tracing, which is a public health measure used to slow the spread of infectious disease.GAO was asked to conduct a technology assessment of exposure notification apps. This report discusses (1) the benefits of exposure notification apps; (2) the current level of deployment in the U.S.; (3) challenges affecting their use; and (4) policy options that may help address these challenges for future use.To address these objectives, GAO reviewed agency documentation, met with officials from several federal agencies, and conducted a review of technical and policy literature. GAO also interviewed representatives from companies involved in the development of exposure notification apps, public health organizations, federally funded research and development centers, and academic researchers. In addition, GAO analyzed information from a selection of states. GAO is identifying policy options in this report.GAO received technical comments on a draft of this report from five federal agencies and five organizations included in the review, which it incorporated as appropriate.What GAO FoundExposure notification applications (apps)—which determine the proximity of users and notify people who have been in close contact with another user who was likely infectious—are expected to enhance the speed and reach of contact tracing and help slow the spread of infectious diseases such as COVID-19. As of June 2021, almost half (26/56) of U.S. states, territories, and the District of Columbia had deployed an app for COVID-19, all using a system developed jointly by Google and Apple (see figure). In the absence of a national app, states independently launched apps, resulting in a staggered rollout over 10 months beginning in August 2020.Map of deployment of exposure notification apps by U.S. states and territories, as of June 2021Reported app development costs for selected states varied, ranging from no cost (provided by a nonprofit organization) to $700,000. Marketing costs for selected states ranged from $380,000 to $3.2 million. Reported app download levels in the selected states ranged from 200,000 to more than 2 million, as of June 2021.GAO identified several challenges limiting app use and the ability of states and others to determine whether the apps were effective:Accuracy of measurements			Technical limitations to measuring distance and exposure can result in inaccurate exposure notifications.		Privacy and security concerns			The public may lack confidence that its privacy is being protected, in part, due to a lack of independent privacy and security assessments and a lack of federal legal protections.		Adoption			States have faced challenges attracting public interest in downloading and using an exposure notification app.		Verification code delays			States faced challenges in promptly providing people who tested positive for COVID-19 with a verification code necessary to notify other close contacts of potential exposure using the app.		Evidence of effectiveness			Limited data are available to evaluate the effectiveness of the apps.		Source: GAO. | GAO-21-104622GAO developed the following four policy options that could help address challenges related to exposure notification apps. The policy options identify possible actions by policymakers, which may include Congress, other elected officials, federal agencies, state and local governments, and industry. See below for details of the policy options and relevant opportunities and considerations.Policy Options to Help Address Challenges of Exposure Notification Apps for Future Use&nbsp;			Opportunities			Considerations		Research and Development (report page 41)			Policymakers could promote research and development to address technological limitations.						Research on technological limitations could help increase accuracy, encouraging users to download and use the apps.				Research on technologies and architectures other than those used by U.S. states could lead to improvements.				Partnerships with technology companies could spur innovation and help with integrating improvements.									The research needed may be costly.				Improvements may not be cost-effective, since existing apps may already be sufficiently accurate.				Research may result in apps that are not functional for the next pandemic, since the current apps were developed for COVID-19.					Privacy and Security Standards and Practices (report page 42)			Policymakers could promote uniform privacy and security standards and practices for exposure notification apps.						Uniform standards and best practices could help address real and perceived risks to the public’s data, potentially increasing adoption.				Standards developed by a broad coalition of stakeholders could increase the likelihood of stakeholder agreement and buy-in.									Policymakers would need to balance the need for privacy and security with the costs of implementing standards and practices.				Implementation of privacy requirements may need to be flexible, since jurisdictions could use different approaches.				Standards and practices could be challenging to oversee and enforce.					Best Practices (report page 43)			Policymakers could promote best practices for approaches to increasing adoption and to measure the effectiveness of exposure notification apps.						Best practices could help authorities better promote app adoption.				Best practices could help state public health authorities by providing information on procedures and potential approaches for distributing verification codes in a timely manner.				Best practices could help public health authorities establish a more rigorous way to measure the extent of app use and any resulting improvements in notifying exposed people.									Best practices could require consensus from many public- and private-sector stakeholders, which can be time- and resource-intensive.				Current best practices may have limited relevance to a future pandemic.				In some cases, stakeholders may lack sufficient information or the experience to develop best practices.					National Strategy (report page 44)			Policymakers could collaborate to enhance the pandemic national strategy and promote a coordinated approach to the development and deployment of exposure notification apps.						Enhanced national coordination that builds on the underlying infrastructure and lessons learned from COVID-19 could prompt faster deployment of apps in the future.				A future national marketing campaign with cohesive and coherent messaging could result in wider adoption.				Policymakers could recommend a national app that public health authorities could decide to use based on their individual needs. A national app could add more functions by integrating exposure notification capabilities with test scheduling and vaccine delivery coordination.									A coordinated national approach would likely have associated costs and require sustained funding during the pandemic.				Coordination of groups with divergent perspectives and interests may pose challenges to defining outcomes, measuring performance, and establishing a leadership approach.				It is unclear whether potential users would be more or less likely to trust a national exposure notification app than one developed by a state government.					Source: GAO. | GAO-21-104622For more information, contact Karen L. Howard at (202) 512-6888 or howardk@gao.gov&nbsp;or Vijay A. D’Souza, at (202) 512-6240, dsouzav@gao.gov.
- Forensic Technology: Algorithms Strengthen Forensic Analysis, but Several Factors Can Affect Outcomes What GAO FoundLaw enforcement agencies primarily use three kinds of forensic algorithms in criminal investigations: latent print, facial recognition, and probabilistic genotyping. Each offers strengths over related, conventional forensic methods, but analysts and investigators also face challenges when using them to assist in criminal investigations.Latent print algorithms help analysts compare details in a latent print from a crime scene to prints in a database. These algorithms can search larger databases faster and more consistently than an analyst alone. Accuracy is assessed across a variety of influencing factors, including image quality, number of image features (e.g., ridge patterns) identified, and variations in the feature mark-up completed by analysts. GAO identified several limitations and challenges to the use of these algorithms. For example, poor quality latent or known prints can reduce accuracy.Facial recognition algorithms help analysts extract digital details from an image and compare them to images in a database. These algorithms can search large databases faster and can be more accurate than analysts. The accuracy of these algorithms is assessed across a variety of influencing factors, including image quality, database size, and demographics. GAO identified several challenges to the use of these algorithms. For example, human involvement can introduce errors, and agencies face challenges in testing and procuring the algorithms that are most accurate and that have minimal differences in performance across demographic groups.Probabilistic genotyping algorithms help analysts evaluate a wider variety of DNA evidence than conventional analysis—including DNA evidence with multiple contributors or partially degraded DNA—and compare such evidence to DNA samples taken from persons of interest. These algorithms provide a numerical measure of the strength of evidence called the likelihood ratio. To assess these algorithms, law enforcement agencies and others test the influence of several factors on the likelihood ratio, including DNA sample quality, amount of DNA in the sample, number of contributors, and ethnicity or familial relationships. GAO identified two challenges to the use of these algorithms. For example, likelihood ratios are complex and there are no standards for interpreting or communicating the results as they relate to probabilistic genotyping.Generally, three entities test forensic algorithms to ensure they are reliable for law enforcement use.GAO developed three policy options that could help address challenges related to law enforcement use of forensic algorithms. The policy options identify possible actions by policymakers, which may include Congress, other elected officials, federal agencies, state and local governments, and industry. See below for details of the policy options and relevant opportunities and considerations.Policy Options to Help Address Challenges with the Use of Forensic AlgorithmsPolicy option			Opportunities			Considerations					Increased training			(report p. 44)			Policymakers could support increased training for analysts and investigators.									Training on human factors could reduce risks associated with analyst error and decision-making.				Could help users or investigators understand and interpret the results they receive.				For latent print and facial recognition, training on cognitive biases could raise awareness and improve objectivity.				Standards for training or certification of analysts or users could increase consistency and reduce risk of improper use across the various federal and non-federal labs and law enforcement&nbsp;agencies that use algorithms.									Training materials may need to be developed or made more widely available.				May not be clear what entity should establish standards or certifications of training because multiple groups are involved in developing and disseminating training.								Standards and policies on appropriate use			(report p. 45)			Policymakers could support development and implementation of standards and policies on appropriate use of algorithms.			&nbsp;									Standards or policies addressing the quality of data inputs could reduce improper use.				Increased consistency across law enforcement agencies could increase public confidence.				Standards for testing and performance of facial recognition algorithms could help to reassure the public and other stakeholders that algorithms are providing reliable results.				Standards or policies for communicating results could help users to better understand the&nbsp;strength of the evidence and come to an informed conclusion.									May be difficult to implement across different levels of government.				Individual localities or agencies may be reluctant to conform to more universal standards.				May increase the cost of procuring and maintaining forensic algorithms.				Standards creation can be resource- intensive, requiring research and testing as well consensus from public- and private-sector stakeholders.				&nbsp;								Increased transparency			(report p. 46)			Policymakers could support increased transparency related to testing, performance, and use of algorithms.									The public may be more inclined to trust algorithms if officials provide access to the results of testing, and to information about data sources, how algorithms are used, and for what types of investigations.				Increasing the availability of comparative testing results and presenting them in a way that is easy for non-technical users to understand could make it easier for agencies to select the best- performing algorithms.				For facial recognition algorithms, clearly identifying software versions used in testing could improve public confidence and help agencies choose algorithms.				Making more data sets publicly available for facial recognition algorithm training and testing could improve algorithms and minimize demographic effects.									Algorithm developers may not want to divulge proprietary information related to training and testing.				Sharing the source of training and testing data may create risks to privacy.				Law enforcement agencies or crime labs may have difficulty finding peer- reviewed journals interested in publishing validation studies from testing.				&nbsp;					&nbsp;Why GAO Did This Study&nbsp;For more than a century, law enforcement agencies have examined physical evidence to help identify persons of interest, solve cold cases, and find missing or exploited people. Forensic experts are now also using algorithms to help assess evidence collected in a criminal investigation, potentially improving the speed and objectivity of their investigations.GAO was asked to conduct a technology assessment on the use of forensic algorithms in law enforcement. In a prior report (GAO-20-479SP), GAO described algorithms used by federal law enforcement agencies and how they work. This report discusses (1) the key performance metrics for assessing latent print, facial recognition, and probabilistic genotyping algorithms; (2) the strengths of these algorithms compared to related forensic methods; (3) challenges affecting their use; and (4) policy options that may help address these challenges.In conducting this assessment, GAO interviewed federal officials, select non-federal law enforcement agencies and crime laboratories, algorithm vendors, academic researchers, and nonprofit groups; convened an interdisciplinary meeting of 16 experts with assistance from the National Academies of Sciences, Engineering, and Medicine; and reviewed relevant literature. GAO is identifying policy options in this report.For more information, contact Karen L. Howard at (202) 512-6888 or howardk@gao.gov.
- Defense Navigation Capabilities: DOD is Developing Positioning, Navigation, and Timing Technologies to Complement GPS What GAO FoundThe Department of Defense (DOD) plans to keep the Global Positioning System (GPS) at the core of its positioning, navigation, and timing (PNT) solution, using other PNT technology to complement GPS or as an alternative for when GPS is degraded or unavailable. DOD’s alternative PNT science and technology portfolio explores two approaches: improved sensors to provide relative PNT information, and external sources to provide absolute positioning and navigation. Relative PNT technologies include inertial sensors and clocks to allow a platform to track its position and keep track of time without an external signal like GPS. However, relative PNT technologies require another PNT technology to correct errors that can accumulate with such systems. Absolute PNT technologies allow a platform to use external sources of information to determine its position but rely on the availability of those external sources. Absolute PNT technologies include celestial and magnetic navigation as well as the use of very low radiofrequencies or low Earth orbit satellites to transmit information.Technologies that could be used in GPS-denied environmentDOD may use multiple PNT technologies to provide sufficient PNT information to its various military platforms. DOD is pursuing approaches, such as creating common standards and interfaces, to aid in integrating and fielding new PNT technologies faster and at lower cost. DOD is developing its PNT modeling and simulation capabilities to evaluate the performance of new PNT technologies.DOD faces challenges in developing and integrating alternative PNT technologies. Officials from across DOD and experts told GAO that alternative PNT solutions are not prioritized within DOD. For example, there is no central program office responsible for developing the variety of alternative PNT technologies across DOD. DOD’s continued reliance on GPS, despite known GPS vulnerabilities to disruption, presents a challenge for obtaining sufficient support to develop viable alternatives. DOD officials and experts also said challenges in establishing clear PNT performance requirements hinder technology development.GAO developed six policy options that may help address challenges with developing and integrating alternative PNT technologies. The policy options identify possible new actions by policymakers, who may include Congress, federal agencies, and industry groups. See below for details of the policy options and relevant opportunities and considerations. &nbsp;Policy options that may help address challenges with developing and integrating alternative PNT technologies&nbsp;			Opportunities			Considerations					Increase Collaboration			Policymakers could consider mechanisms to coordinate across DOD to clarify responsibilities and authorities in prioritizing the need for alternative PNT technologies.									Increased coordination could allow the military services to leverage one another’s research and development activities.			Prioritization of alternative PNT could increase the technology’s visibility, allowing more programs and platforms within DOD to better understand available technologies.									PNT solutions for a particular mission or platform may still need significant customization, possibly offsetting the benefits from centralized coordination.			Current mechanisms, such as the PNT Oversight Council, may not have the capacity to take on alternative PNT coordination.								Focus on Resiliency			Policymakers could consider selecting the most resilient technologies as the cornerstone of the PNT suite for military missions, rather than defaulting to GPS.									By focusing on resiliency, technologies that add to resilient PNT could receive higher priority for development, even if they are not full replacements for GPS.									A PNT solution will likely need multiple technologies to meet full PNT requirements, because no single alternative PNT technology is currently able to provide all of the required information.			DOD will need to continue maintaining GPS, as it will remain a part of the PNT solution.								Clarify Requirements			Policymakers could consider opportunities for DOD to clarify what level of PNT performance is actually needed for missions, rather than defaulting to requirements that match GPS performance.									With performance requirements that better reflect mission needs, DOD could make more informed decisions (such as savings in cost or integration time) in developing viable alternative technologies that will meet the actual mission needs, but not necessarily have GPS-level performance.			&nbsp;			&nbsp;									GAO previously reported that creating requirements involves appropriately skilled personnel.			Programs may still want GPS-level performance because more precise PNT information is always desired, even when it goes beyond what is needed to complete a specific mission.			&nbsp;								Coordinate with Industry			Policymakers could consider ensuring that DOD and commercial industry coordinate so industry is prepared to meet DOD’s needs, and DOD can leverage industry advances.									DOD clearly communicating its needs to industry could allow industry to be better positioned to meet those needs.			Industry may have alternative PNT technologies that could be applied to defense.			&nbsp;									Commercial industry may not be incentivized to develop and manufacture alternative PNT technologies if the market is too small.			A lack of transparency into proprietary commercial technology may mask vulnerabilities of different PNT technologies.								Institutionalize Open Architecture			Policymakers could consider making the open architecture initiative more permanent, including providing funding.									With appropriate resources, DOD’s open architecture initiative has the potential to greatly reduce integration costs and time for all PNT technologies.			Open architecture could keep DOD ahead of evolving threats to PNT, as it would be easier to field new alternative PNT technologies.									The open architecture initiative will need buy-in across the military services, as well as with commercial industry partners, which may be difficult to achieve.			Once implemented, the open architecture initiative could need continued resources and governance, as the architecture will likely evolve.								Analyze Vulnerabilities			Policymakers could consider having DOD conduct ongoing analysis of vulnerabilities of different PNT systems.			&nbsp;									Given that a future solution will likely require a PNT system comprised of a combination of different technologies, users could be better informed about each combination’s overall vulnerabilities.			Users could better match PNT solutions to the mission and threat.									The complexity of having a unique PNT system for each mission and platform could make this analysis difficult.			If DOD relies more on alternative PNT, the threats will evolve in response to that strategy, which may mean the vulnerability analysis needs to be updated regularly.					Source: GAO. | GAO-21-320SPWhy GAO Did This StudyFor decades, the satellite-based GPS has transmitted PNT data to receivers used by military platforms and personnel worldwide. PNT information is essential in many facets of DOD operations. Given the ubiquity of GPS, the failure, malfunction, or jamming of its signals or equipment could disrupt military activities involving aircraft, ships, munitions, land vehicles, and ground troops. This possibility has led DOD to explore alternatives to GPS.GAO was asked to assess the alternative PNT technologies DOD is developing. This report discusses (1) how DOD plans to meet future PNT needs and the capabilities and limitations of alternative PNT technologies, (2) how alternative PNT technologies integrate with one another and with current PNT capabilities, and (3) policy options that may help address challenges with the development and integration of alternative PNT technologies.To address these objectives, GAO reviewed technical studies, agency documents, and other key reports; interviewed government officials and researchers about alternative PNT technologies; and convened a 3-day meeting of experts from government, non-governmental organizations, academia, and industry. GAO is identifying policy options in this report.For more information, contact Karen L. Howard at (202) 512-6888 or HowardK@gao.gov&nbsp;or Jon Ludwigson at (202) 512-4841 or LudwigsonJ@gao.gov.
- Artificial Intelligence in Health Care: Benefits and Challenges of Technologies to Augment Patient Care What GAO FoundArtificial Intelligence (AI) tools have shown promise for augmenting patient care in the following two areas:Clinical AI tools have shown promise in predicting health trajectories of patients, recommending treatments, guiding surgical care, monitoring patients, and supporting population health management (i.e., efforts to improve the health outcomes of a community). These tools are at varying stages of maturity and adoption, but many we describe, with the exception of population health management tools, have not achieved widespread use.	Administrative AI tools have shown promise in reducing provider burden and increasing efficiency by recording digital notes, optimizing operational processes, and automating laborious tasks. These tools are also at varying stages of maturity and adoption, ranging from emerging to widespread.GAO identified the following challenges surrounding AI tools, which may impede their widespread adoption:Data access. Developers experience difficulties obtaining the high-quality data needed to create effective AI tools.	Bias. Limitations and bias in data used to develop AI tools can reduce their safety and effectiveness for different groups of patients, leading to treatment disparities.	Scaling and integration. AI tools can be challenging to scale up and integrate into new settings because of differences among institutions and patient populations.	Lack of transparency. AI tools sometimes lack transparency—in part because of the inherent difficulty of determining how some of them work, but also because of more controllable factors, such as the paucity of evaluations in clinical settings.	Privacy. As more AI systems are developed, large quantities of data will be in the hands of more people and organizations, adding to privacy risks and concerns.	Uncertainty over liability. The multiplicity of parties involved in developing, deploying, and using AI tools is one of several factors that have rendered liability associated with the use of AI tools uncertain. This may slow adoption and impede innovation.GAO developed six policy options that could help address these challenges or enhance the benefits of AI tools. The first five policy options identify possible new actions by policymakers, which include Congress, elected officials, federal agencies, state and local governments, academic and research institutions, and industry. The last is the status quo, whereby policymakers would not intervene with current efforts. See below for details of the policy options and relevant opportunities and considerations.Policy Options to Address Challenges or Enhance Benefits of AI to Augment Patient CarePolicy Option			Opportunities			Considerations					Collaboration (report p. 32)						Policymakers could encourage interdisciplinary collaboration between developers and health care providers.									Could result in AI tools that are easier to implement and use within a providers’ existing workflow.				Could help implement tools on a larger scale.				Approaches to encourage collaboration include agencies seeking input from innovators. For example, agencies have used a challenge format to encourage the public to develop innovative technologies.									May result in the creation of tools that are specific to one hospital or provider.				Providers may not have time to both collaborate and treat patients.								Data Access (report p. 33)						Policymakers could develop or expand high-quality data access mechanisms.									A “data commons”–a cloud based-platform where users can store, share, access, and interact with data–could be one approach.				More high-quality data could facilitate the development and testing of AI tools.				Could help developers address bias concerns by ensuring data are representative, transparent and equitable.									Cybersecurity and privacy risks could increase, and threats would likely require additional precautions.				Would likely require large amounts of resources to successfully coordinate across different domains and help address interoperability issues.				Organizations with proprietary data could be reluctant to participate.								Best Practices (report p. 34)						Policymakers could encourage relevant stakeholders and experts to establish best practices (such as standards) for development, implementation, and use of AI technologies.									Could help providers deploy AI tools by providing guidance on data, interoperability, bias, and implementation, among other things. Could help improve scalability of AI tools by ensuring data are formatted to be interoperable.				Could address concerns about bias by encouraging wider representation and transparency.									Could require consensus from many public- and private-sector stakeholders, which can be time- and resource-intensive.				Some best practices may not be widely applicable because of differences across institutions and patient populations.								Interdisciplinary Education (report p. 35)						Policymakers could create opportunities for more workers to develop interdisciplinary skills.									Could help providers use tools effectively.				Could be implemented in a variety of ways, including through changing academic curriculums or through grants.									Employers and university leaders may have to modify their existing curriculums, potentially increasing the length of medical training.								Oversight Clarity (report p. 36)						Policymakers could collaborate with relevant stakeholders to clarify appropriate oversight mechanisms.									Predictable oversight could help ensure that AI tools remain safe and effective after deployment and throughout their lifecycle.				A forum consisting of relevant stakeholders could help recommend additional mechanisms to ensure appropriate oversight of AI tools.									Soliciting input and coordinating among stakeholders, such as hospitals, professional organizations, and agencies, may be challenging.				Excess regulation could slow the pace of innovation.				&nbsp;												Status quo (report p. 37)			Policymakers could maintain the status quo (i.e., allow current efforts to proceed without intervention).									Challenges may be resolved through current efforts.				Some hospitals and providers are already using AI to augment patient care and may not need policy-based solutions to continue expanding these efforts.				Existing efforts may prove more beneficial than new options.									The challenges described in this report may remain unresolved or be exacerbated. For example, fewer AI tools may be implemented at scale and disparities in use of AI tools may increase.					Source: GAO.Why GAO did this studyThe U.S. health care system is under pressure from an aging population; rising disease prevalence, including from the current pandemic; and increasing costs. New technologies, such as AI, could augment patient care in health care facilities, including outpatient and inpatient care, emergency services, and preventative care. However, the use of AI-enabled tools in health care raises a variety of ethical, legal, economic, and social concerns.GAO was asked to conduct a technology assessment on the use of AI technologies to improve patient care, with an emphasis on foresight and policy implications. This report discusses (1) current and emerging AI tools available for augmenting patient care and their potential benefits, (2) challenges surrounding the use of these tools, and (3) policy options to address challenges or enhance benefits of the use of these tools.GAO assessed AI tools developed for or used in health care facilities; interviewed a range of stakeholder groups including government, health care, industry, academia, and a consumer group; convened a meeting of experts in collaboration with the National Academy of Medicine; and reviewed key reports and scientific literature. GAO is identifying policy options in this report.For more information, contact Karen L. Howard at (202) 512-6888 or howardk@gao.gov.
- 5G Wireless: Capabilities and Challenges for an Evolving Network What GAO FoundFifth-generation (5G) wireless networks promise to provide significantly greater speeds and higher capacity to accommodate more devices. In addition, 5G networks are expected to be more flexible, reliable, and secure than existing cellular networks. The figure compares 4G and 5G performance goals along three of several performance measures.Note: Megabits per second (Mbps) is a measure of the rate at which data is transmitted, milliseconds (ms) is a measure of time equal to one thousandth of a second, and square kilometer (km2) is a measure of area.As with previous generations of mobile wireless technology, the full performance of 5G will be achieved gradually as networks evolve over the next decade. Deployment of 5G network technologies in the U.S. began in late 2018, and these initial 5G networks focus on enhancing mobile broadband. These deployments are dependent on the existing 4G core network and, in many areas, produced only modest performance improvements. To reach the full potential of 5G, new technologies will need to be developed. International bodies that have been involved in defining 5G network specifications will need to develop additional 5G specifications and companies will need to develop, test, and deploy these technologies. GAO identified the following challenges that can hinder the performance or usage of 5G technologies in the U.S.GAO developed six policy options in response to these challenges, including the status quo. They are presented with associated opportunities and considerations in the following table. The policy options are directed toward the challenges detailed in this report: spectrum sharing, cybersecurity, privacy, and concern over possible health effects of 5G technology.Policy options to address challenges to the performance or usage of U.S. 5G wireless networksPolicy Option			Opportunities			Considerations					Spectrum-sharing technologies (report p. 47)						Policymakers could support research and development of spectrum sharing technologies.									Could allow for more efficient use of the limited spectrum available for 5G and future generations of wireless networks.				It may be possible to leverage existing 5G testbeds for testing the spectrum sharing technologies developed through applied research.									Research and development is costly, must be coordinated and administered, and its potential benefits are uncertain. Identifying a funding source, setting up the funding mechanism, or determining which existing funding streams to reallocate will require detailed analysis.								Coordinated cybersecurity monitoring (report p. 48)						Policymakers could support nationwide, coordinated cybersecurity monitoring of 5G networks.									A coordinated monitoring program would help ensure the entire wireless ecosystem stays knowledgeable about evolving threats, in close to real time; identify cybersecurity risks; and allow stakeholders to act rapidly in response to emerging threats or actual network attacks.									Carriers may not be comfortable reporting incidents or vulnerabilities, and determinations would need to be made about what information is disclosed and how the information will be used and reported.								Cybersecurity requirements (report p. 49)						Policymakers could adopt cybersecurity requirements for 5G networks.									Taking these steps could produce a more secure network. Without a baseline set of security requirements the implementation of network security practices is likely to be piecemeal and inconsistent.				Using existing protocols or best practices may decrease the time and cost of developing and implementing requirements.									Adopting network security requirements would be challenging, in part because defining and implementing the requirements would have to be done on an application-specific basis rather than as a one-size-fits-all approach.				Designing a system to certify network components would be costly and would require a centralized entity, be it industry-led or government-led.								Privacy practices (report p. 50)						Policymakers could adopt uniform practices for 5G user data.									Development and adoption of uniform privacy practices would benefit from existing privacy practices that have been implemented by states, other countries, or that have been developed by federal agencies or other organizations.									Privacy practices come with costs, and policymakers would need to balance the need for privacy with the direct and indirect costs of implementing privacy requirements. Imposing requirements can be burdensome, especially for smaller entities.								High-band research (report p. 51)						Policymakers could promote R&amp;D for high-band technology.									Could result in improved statistical modeling of antenna characteristics and more accurately representing propagation characteristics.				Could result in improved understanding of any possible health effects from long-term radio frequency exposure to high-band emissions.									Research and development is costly and must be coordinated and administered, and its potential benefits are uncertain. Policymakers will need to identify a funding source or determine which existing funding streams to reallocate.					Status quo (report p. 52)						Some challenges described in this report may be addressed through current efforts.									Some challenges described in this report may remain unresolved, be exacerbated, or take longer to resolve than with intervention.					Why GAO Did This StudyGAO was asked to assess the technologies associated with 5G and their implications. This report discusses (1) how the performance goals and expected uses are to be realized in U.S. 5G wireless networks, (2) the challenges that could affect the performance or usage of 5G wireless networks in the U.S., and (3) policy options to address these challenges.To address these objectives, GAO interviewed government officials, industry representatives, and researchers about the performance and usage of 5G wireless networks. This included officials from seven federal agencies; the four largest U.S. wireless carriers; an industry trade organization; two standards bodies; two policy organizations; nine other companies; four university research programs; the World Health Organization; the National Council on Radiation Protection and Measurements; and the chairman of the Defense Science Board's 5G task force. GAO reviewed technical studies, industry white papers, and policy papers identified through a literature review. GAO discussed the challenges to the performance or usage of 5G in the U.S. during its interviews and convened a one-and-a-half day meeting of 17 experts from academia, industry, and consumer groups with assistance from the National Academies of Sciences, Engineering, and Medicine.GAO received technical comments on a draft of this report from six federal agencies and nine participants at its expert meeting, which it incorporated as appropriate.For more information, contact Hai Tran at (202) 512-6888, tranh@gao.gov or Vijay A. D’Souza at (202) 512-6240, dsouzav@gao.gov.
- Covid-19: Data Quality and Considerations for Modeling and Analysis What GAO FoundThe rapid spread and magnitude of the COVID-19 pandemic have underscored the importance of having quality data, analyses, and models describing the potential trajectory of COVID-19 to help understand the effects of the disease in the U.S. The Centers for Disease Control and Prevention (CDC) is using multiple surveillance systems to collect data on COVID-19 in the U.S. in collaboration with state, local, and academic and other partners. The data from these surveillance systems can be useful for understanding the disease, but decision makers and analysts must understand their limitations in order to interpret them properly. For example, surveillance data on the number of reported COVID-19 cases are incomplete for a number of reasons, and they are an undercount the true number of cases, according to CDC and others.There are multiple approaches to analyzing COVID-19 data that yield different insights. For example, some approaches can help compare the effects of the disease across population groups. Additional analytical approaches can help to address incomplete and inconsistent reporting of COVID-19 deaths as well. For example, analysts can examine the number of deaths beyond what would normally be expected in the absence of the pandemic. Examining higher-than-expected deaths from all causes helps to address limitations in the reporting of COVID-19 deaths because the number of total deaths is likely more accurate than the numbers of deaths from specific causes. The figure below shows actual deaths from the weeks ending January 1 through June 27, 2020, based on data from CDC’s National Center for Health Statistics, compared with the expected deaths based on prior years’ data. Deaths that exceeded this threshold starting in late March are considered excess deaths that may be related to the COVID-19 pandemic.Higher-Than-Expected Weekly Mortality for 2020, as of July 14, 2020Analysts have used several forecasting models to predict the spread of COVID-19, and understanding these models requires understanding their purpose and limitations. For example, some models attempt to predict the effects of various interventions, whereas other models attempt to forecast the number of cases based on current data. At the beginning of an outbreak, such predictions are less likely to be accurate, but accuracy can improve as the disease becomes better understood.Why GAO Did This StudyThe COVID-19 pandemic has resulted in significant loss of life and profoundly disrupted the U.S. economy and society, and the Congress has taken action to support a multifaceted federal response on an unprecedented scale. It is important for decision makers to understand the limitations of COVID-19 data, and the uses and limitations of various methods of analyzing and interpreting those data.The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) includes a provision for GAO to, in general, conduct monitoring and oversight of the authorities and funding provided to address the COVID-19 pandemic and the effect of the pandemic on the health, economy, and public and private institutions of the U.S. This technology assessment examines (1) collection methods and limitations of COVID-19 surveillance data reported by CDC, (2) approaches for analyzing COVID-19 data, and (3) uses and limitations of forecast modeling for understanding of COVID-19.In conducting this assessment, GAO obtained publicly available information from CDC and state health departments, among other sources, and reviewed relevant peer reviewed and preprint (non-peer-reviewed) literature, as well as published technical data on specific models.For more information, contact Timothy M. Persons, PhD at (202) 512-6888 or PersonsT@gao.gov, SaraAnn Moessbauer at (202) 512-4943, or MoessbauerS@gao.gov, or Mary Denigan-Macauley, PhD at (202) 512-7114 or DeniganMacauleyM@gao.gov.
- Forensic Technology: Algorithms Used in Federal Law Enforcement What GAO FoundFederal law enforcement agencies GAO reviewed are primarily using three types of forensic algorithms to help assess whether or not evidence collected in a criminal investigation may have originated from an individual: probabilistic genotyping, latent print (fingerprint and palm print) analysis, and face recognition. To a lesser extent, agencies also use algorithms to compare iris images, speech, and handwriting. Each type of algorithm uses different characteristics in its assessment. For example, probabilistic genotyping uses statistics to analyze biological samples found during a criminal investigation to assist in comparisons to a known DNA sample taken from a suspect, or to DNA data profiles from a database of known persons. The Federal Bureau of Investigation currently uses probabilistic genotyping and latent fingerprint algorithms to help assess whether or not evidence collected in a criminal investigation may have originated from an individual and face recognition to generate investigative leads. The National Institute of Standards and Technology and other organizations have developed standards to facilitate transmission of data between agencies.Potential Uses of Forensic Algorithms to Examine Evidence from a Crime SceneWhy GAO Did This StudyForensic algorithms help forensic experts partially automate the process of assessing whether or not evidence collected in an investigation may have originated from an individual, potentially increasing the speed of investigations and reducing human bias and error.GAO was asked to conduct a technology assessment on the use of forensic algorithms in federal law enforcement. GAO is conducting this assessment in two phases. The first phase describes algorithms being used by federal law enforcement agencies and how these technologies work. The second phase will assess the approaches and challenges related to how federal law enforcement agencies apply these technologies and will identify policy options for addressing these challenges going forward.In conducting this assessment, GAO obtained information from the National Institute of Standards and Technology, the Department of Justice, the Department of Homeland Security, and the Department of Defense; convened an interdisciplinary panel of 16 experts with assistance from the National Academies of Sciences, Engineering, and Medicine; interviewed additional stakeholders, including nonprofit groups and legal experts; and reviewed relevant literature and case law.For more information, contact Karen L. Howard, PhD at (202) 512-6888, howardk@gao.gov.
- Artificial Intelligence in Health Care: Benefits and Challenges of Machine Learning in Drug Development [Reissued with revisions on Jan. 31, 2020.] What GAO FoundMachine learning—a field of artificial intelligence (AI) in which software learns from data to perform a task—is already used in drug development and holds the potential to transform the field, according to stakeholders such as agency officials, industry representatives, and academic researchers. Machine learning is used throughout the drug development process and could increase its efficiency and effectiveness, decreasing the time and cost required to bring new drugs to market. These improvements could save lives and reduce suffering by getting drugs to patients in need more quickly, and could allow researchers to invest more resources in areas such as rare or orphan diseases.Machine learning could accelerate drug development This set of technologies could screen more chemical compounds and zero in on promising drug candidates in less time than the current process.Examples of machine learning in the early steps of drug development include:Drug Discovery  :   Researchers are identifying new drug targets, screening known compounds for new therapeutic applications, and designing new drug candidates, among other applications.	Preclinical Research  :   Researchers are augmenting preclinical testing and predicting toxicity before testing potential drugs in humans.	Clinical Trials:  Researchers are beginning to improve clinical trial design, a point where many drug candidates fail. Their efforts include applying machine learning to patient selection, recruitment, and stratification.GAO identified several challenges that hinder the adoption and impact of machine learning in drug development. Gaps in research&nbsp;in biology, chemistry, and machine learning limit the understanding of and impact in this area. A shortage of high-quality data, which are required for machine learning to be effective, is another challenge. Accessing and sharing these data is also difficult, due to costs, legal issues, and a lack of incentives for sharing. Furthermore, a low supply of skilled and interdisciplinary workers creates hiring and retention challenges for drug companies. Lastly, uncertainty about potential regulation of machine learning used in drug development may limit investment in this field.GAO developed six policy options in response to these challenges. Five policy options are centered around research, data access, standardization, human capital, and regulatory certainty. The last is the status quo, whereby policymakers—federal agencies, state and local governments, academic and research institutions, and industry, among others—would not intervene with current efforts. See below for details of the policy options and relevant opportunities and considerations.Policy Options to Address Challenges to the Use of Machine Learning in Drug Development &nbsp;						Opportunities 									Considerations 								Research  (report page 27)			Policymakers could promote basic research to generate more and better data and improve understanding of machine learning in drug development.									Could result in increased scientific and technological output by solving previously challenging problems.			Could result in the generation of additional high-quality, machine readable data.									Basic research is generally considered a long term investment and its potential benefits are uncertain.			Would likely require assessment of available resources and may require reallocation of resources from other priorities.								Data Access  (report page 28)			Policymakers could create mechanisms or incentives for increased sharing of high-quality data held by public or private actors, while also ensuring protection of patient data.									Could shorten the length of the drug development process and reduce costs.			Could help companies identify unsuccessful drug candidates sooner, conserving resources.									Would likely require coordination between various stakeholders and incur setup and maintenance costs.			Improper data sharing or use could have legal consequences.			Cybersecurity risks could increase, and those threats would likely take additional time and resources to mitigate.			Organizations with proprietary data could be reluctant to participate.								Standardization  (report page 29)			Policymakers could collaborate with relevant stakeholders to establish uniform standards for data and algorithms.									Could improve interoperability by more easily allowing researchers to combine different data sets.			Could help efforts to ensure algorithms remain explainable and transparent, as well as aid data scientists with benchmarking.									Could be time- and labor-intensive because standards development typically requires consensus from a multitude of public and private-sector stakeholders. This process can result in standards development taking anywhere from 18 months to a decade to complete and require multiple iterations.								Human Capital  (report page 30)			Policymakers could create opportunities for more public and private sector workers to develop appropriate skills.									Could provide a larger pool of skilled workers for agencies, companies, and other research organizations, allowing them to better leverage advances in the use of machine learning in drug development.			Interdisciplinary teamwork could improve as workers with different backgrounds learn to better communicate with one another.									Data science-trained workers could exit the drug development field in search of higher-paying opportunities.			Would likely require an investment of time and resources. Companies and agencies will need to decide if the opportunities and challenges justify the investment or shifting of existing resources and how best to provide such training.								Regulatory Certainty  (report page 31)			Policymakers could collaborate with relevant stakeholders to develop a clear and consistent message regarding regulation of machine learning in drug development.									Could help increase the level of public discourse surrounding the technology and allow regulators and the public to better understand its use.			Drug companies could better leverage the technology if they have increased certainty surrounding how, if at all, regulators will review or approve the machine learning algorithms used in drug development.									Would likely require coordination within and among agencies and other stakeholders, which can be challenging and require additional time and costs.			If new regulations are promulgated, compliance costs and review times could be increased.								Status Quo  (report page 32)			Policymakers could maintain the status quo (i.e., allow current efforts to proceed without intervention).									Challenges may be resolved through current efforts.			Companies are already using machine learning and may not need action from policymakers to continue expanding its use.									The challenges described in this report may remain unresolved or be exacerbated.					Source: GAO.Why GAO Did This StudyDeveloping and bringing a new drug to market is lengthy and expensive. Drug developers study the benefits and risks of new compounds before seeking Food and Drug Administration (FDA) approval. Only about one out of 10,000 chemical compounds initially tested for drug potential makes it through the research and development pipeline, and is then determined by FDA to be safe and effective and approved for marketing in the United States. Machine learning is enabling new insights in the field.GAO was asked to conduct a technology assessment on the use of AI technologies in drug development with an emphasis on foresight and policy implications. This report discusses (1) current and emerging AI technologies available for drug development and their potential benefits; (2) challenges to the development and adoption of these technologies; and (3) policy options to address challenges to the use of machine learning in drug development.GAO assessed AI technologies used in the first three steps of the drug development process—drug discovery, preclinical research, and clinical trials; interviewed a range of stakeholder groups including, government, industry, academia, and nongovernmental organizations; convened a meeting of experts in conjunction with the National Academies; and reviewed key reports and scientific literature. GAO is identifying policy options in this report.For more information, contact Timothy M. Persons, Ph.D., at (202) 512-6888 or personst@gao.gov.
- Irrigated Agriculture: Technologies, Practices, and Implications for Water Scarcity What GAO FoundIn the United States, irrigation accounts for more than 40 percent of freshwater use. Several areas in the nation are both heavily irrigated and considered water stressed. Farmers can select irrigation technologies and water conservation practices to better manage freshwater, an increasingly limited natural resource. Farmers have access to multiple irrigation technologies that could increase efficient use of water. Irrigation technologies include micro irrigation, which applies small amounts of water close to the plants; sprinkler systems, which spray water through nozzles; and gravity systems, where water floods the field or runs down furrows. In addition, practices such as irrigation scheduling may help farmers avoid over-irrigation. Farmers can also use precision agriculture technologies, such as soil moisture sensors, computer or smartphone decision support tools, and remote control of irrigation equipment to help optimize irrigation scheduling.Irrigated areas (2012) and water stressed areas (2015) across the contiguous United StatesFarmers adopt and use efficient irrigation systems to maximize farm-level profitability, through improved crop yields and decreased costs and other inputs. Drivers of farmer adoption of irrigation technology include increasing profits and reducing risks, but we did not find much evidence that conserving water was a factor in adoption of technology. Barriers limiting adoption of more efficient technology include small farm size, large capital investments, and lack of available information on the technologies. For precision agriculture technologies, lack of connectivity, such as access to broadband, can be a barrier, particularly in rural areas.Farmers’ use of efficient irrigation technologies alone may not conserve water. GAO’s modeling of an illustrative irrigated watershed shows farmers’ use of efficient irrigation scheduling—such as using data from soil moisture sensors to schedule irrigation—can reduce the amount of water applied to the field, resulting in less water withdrawn from a source, which in this model was groundwater. At the same time though, GAO’s modeling shows water that is consumed through evapotranspiration does not change with efficient irrigation scheduling, while return flows to the source bodies of water may be reduced. While, in some instances, reduced return flows may be beneficial, as such flows can convey pollutants downstream, reduced return flows may also result in less water available to downstream users.Simulated impact of switching to efficient irrigation schedulingGAO’s analysis of survey data on farms that converted to more efficient irrigation systems shows there is no change in the amount of water farmers apply to a field with more efficient technology, except for a few technologies and crop types. One such exception is in orchards and vineyards, where switching to micro irrigation was associated with less water applied per acre. Efficient technology may actually increase water use, as it provides farmers with additional flexibility to expand irrigated land or to switch to more water-intensive crops.Policy Options The request for GAO to conduct this study specified a policy goal of reducing the impact of irrigated agriculture in locations facing water scarcity in the United States. With that goal in mind, GAO identified the following options federal policymakers could consider:(1) Promote the use of more efficient irrigation technology and practices, such as irrigation scheduling.(2) Promote the use of precision agriculture technologies, such as soil moisture sensors and weather stations.However, in light of GAO’s findings, these options may need to be combined with appropriate agreements in order to enable and encourage water savings. Such agreements could include incentives to farmers for conserving water. Both policy options have the potential benefit of reducing the amount of water applied during irrigation. However, challenges include ensuring that water savings on the farm translates to water conservation on the larger watershed level.Why GAO Did This StudyDemand for freshwater surpasses the amount naturally available in some areas of the United States. The agriculture sector competes for this limited resource, and withdraws and consumes the most freshwater of any user in the nation. GAO was asked to conduct a technology assessment around agricultural water use.This report provides an overview of irrigation technologies and on-farm water conservation practices, factors influencing the adoption of these technologies, and implications of their use for water scarcity.In conducting this assessment, GAO reviewed scientific literature; convened an expert meeting with the assistance of the National Academies; visited farmers, academics, and industry representatives; interviewed officials from federal agencies; modeled water use in an illustrative watershed; and performed a regression analysis on U.S. Department of Agriculture irrigation, crop, and technology data.GAO describes two policy options that federal policymakers could consider relating to irrigation technology and discusses their benefits and challenges.For more information, contact Timothy M. Persons at (202) 512-6412 or personst@gao.gov&nbsp;or Steve D. Morris at (202) 512-3841 or morriss@gao.gov.