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ai

    Introduction
    Artificial intelligence can help transform healthcare by improving diagnosis, treatment, and the delivery of
    patient care. Researchers in academia, the private sector, and government have gained increasing access to
    large amounts of health data and high-powered Al-ready computing systems. These powerful tools can greatly
    improve doctors’ abilities to diagnose their patients’ medical issues, classify risk at a patient level by drawing on
    the power of population data, and provide much-needed support to clinics and hospitals in under-resourced
    areas. Al can also expand the operational capacity of different organizations, identify potentially fraudulent
    health claims, and streamline manual tasks to boost productivity.
    Much of this progress depends on sharing and utilizing large amounts of health data, which informs the
    development of algorithms and machine learning. While the private sector has driven much of the innovation in
    this field, the federal government and its partners can play a major role by both sharing their own data and
    addressing challenges across the sector. HHS, private sector stakeholders, and academic and clinical
    researchers can support this transformation by collaborating to apply Al both inside and outside of
    government.
    Researchers and practitioners now face multiple challenges in using Al to improve healthcare. These challenges
    include limited access to data, poor data quality, concerns over data governance, and the ethical use of data,
    including accountability and liability for data applications. Multiple stakeholders will need to work together to
    address these challenges as new technical applications emerge.
    The HHS Office of the CTO is now exploring the potential for a department-wide Al strategy to help realize the
    potential of Al, and to establish policies and practices for facilitating Al development. This strategy comes in
    tandem with the February 2019 “Executive Order on Maintaining American Leadership in Artificial
    Intelligence” and The State of Data Sharing at the U.S. Department of Health and Human Services report, published
    by the HHS Office of the CTO in September 2018."
    The Roundtable on Sharing and Utilizing Health Data for Al Applications was designed to bring together HHS
    leaders, and experts in Al and health data from other federal and state government agencies, industry,
    academia, and patient-centered research organizations. The Roundtable began with calls to action by Mona
    Siddiqui, the HHS Chief Data Officer, and Ed Simcox, the HHS Chief Technology Officer. Following these
    keynotes, several speakers gave lightning talks on high-priority use cases for Al in healthcare, including
    representatives from Verily, Amazon Web Services, Health Catalyst, and the Michael J. Fox Foundation. The
    second part of the Roundtable transitioned into possibilities for Al strategies, where representatives from
    Pfizer, the Center for Medicare and Medicaid Innovation (CMMI), the Government Accountability Office
    (GAO), and the Assistant Secretary for Preparedness and Response at HHS outlined possible paths forward.
    The day also featured a keynote address from Eric Hargan, the Deputy Secretary of HHS, who spoke about how
    Al is being deployed within the department.
    Throughout the day, Roundtable participants engaged in three in-depth breakout sessions. These sessions
    focused on the following topics: (1) Identifying high-priority Al applications, (2) Improving and using data for Al
    applications, and (3) Outlining key issues and objectives for an HHS Al strategy. The day concluded with a
    presentation of highlights and actionable recommendations for HHS to advance its own Al strategy across the
    department.
    ? The White House, “Executive Order on Maintaining American Leadership in Artificial Intelligence,” February 11, 2019,
    Retrieved from
    bttps: bitehouse.gov/presidential-actions/executive-order-maintaining-american-leadership-artificial-intelligence
    3 U.S. Department of Health and Human Services Office of the Chief Technology Officer, ‘The State of Data Sharing at the
    U.S. Department of Health and Human Services,” September 2018, Retrieved from
    bttps: bhs. gov/sites/default/files/HHS StateofDataSharing 0915 pdf
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    Background and Key Concepts
    Artificial intelligence has gained significant attention in recent years, particularly in the context of improving
    health and well-being. The following section presents an overview of key concepts and terminology related to
    artificial intelligence. For more information on the use of Al in healthcare, please refer to the briefing paper that
    CODE developed in preparation for the Roundtable on Sharing and Utilizing Health Data for Al Applications*
    At the core of artificial intelligence is the need for high-quality, clean and accurate data to fuel the development
    of algorithms. Researchers emphasize the need for large, multifaceted datasets that allow machine learning
    processes to incorporate as many factors as possible into analysis.° Artificial intelligence also demands clear,
    accountable data governance with defined data elements and processes for ensuring data quality and access.®
    Researchers are now attempting to tap large troves of health data - from electronic health records (EHRs) to
    data collected from wearable devices and sensors - to improve diagnostics and predictive analytics. More
    connected and interoperable data in the healthcare system will enable more transformative Al applications in
    the future.
    Most Al applications depend on algorithms, which describe a logical process that follows a set of rules.
    Computers can be taught a series of steps in order to process large amounts of data to produce a desired
    outcome. There are two forms of algorithm:
    1. Supervised algorithms use ‘training datasets’ in which the input factors and output are known in
    advance. Supervised processes can produce highly accurate algorithms because the ‘right answers’ are
    already known. For example, scientists may feed a dataset of retina images into the algorithm in which
    board-certified physicians have already identified and agreed upon diagnoses for each image.
    2. Unsupervised algorithms are developed through a process whereby data is fed into the algorithm and
    the computer has to ‘learn’ what to look for. Unlike the training datasets fed into supervised
    algorithms, the data fed into unsupervised algorithms does not necessarily include the ‘right answers.’
    Unsupervised algorithms are adept at finding clusters of relationships between observations in the
    data, but may identify erroneous relationships because they are not instructed what to look for.
    Machine learning is the process by which computers are trained to ‘learn’ by exposing them to data. Machine
    learning is a subset of Al, and deep learning is a further subset of machine learning. Deep learning is the process
    by which algorithms can learn to identify hierarchies within data that allow for truly complex understandings of
    data. Natural language processing (NLP) refers to the subfield of machine learning designed to allow computers
    to examine, extract, and interpret data that is structured within a language.
    Augmented Intelligence is a form of Al that enhances human capabilities rather than replacing physicians and
    healthcare providers. Augmented Intelligence has been embraced as a concept by physician organizations to
    underscore that emerging Al systems are designed to aid humans in clinical decision-making, implementation,
    *The Center for Open Data Enterprise, Briefing Paper: Roundtable on Sharing and Utilizing Health Data for Al Applications, April
    2019, Retrieved from bttp://reports opendataenterprise ore/RI 1470 Briefing 2420 Paper pdf
    Nick Ismail, “The Success of Artificial Intelligence Depends on Data,” Information Age, April 23, 2018. Retrieved from
    bttps: information-age.com/success-artificial-intelligence-data-17347160
    ® Rob Thomas, “The Road to Al Leads through Information Architecture.” VentureBeat, January 12, 2018. Retrieved from
    bttps:-//venturebeatcom/?018/01/17 he-road-to-ai-leads-through-information-architecture
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    and administration to scale healthcare.’ In a 2019 white paper, Intel framed augmented intelligence as the Al
    tools that perform specific tasks and are designed to support users, rather than replacing human experts.®
    Stages of Al Development
    Existing and potential Al applications vary in their level of sophistication, ranging from simple augmentation of
    common tasks to full automation of systems and processes. Experts have begun categorizing these stages of Al
    development. Among them, venture capitalist and author Kai-Fu Lee has characterized four “waves” of Al
    applications:’
    Wave 1 | Internet Al
    Wave 2 | Business Al
    Wave 3 | Perception Al
    Wave 4 | Autonomous Al
    Figure 1. “The Four Waves of Al”
    Adapted from Kai-Fu Lee (2018)
    According to Lee, the first wave of Al applications uses data generated on the Internet to better understand
    the habits, interests, and desires of an individual or population.*° The second wave of Al applications uses
    algorithms to inform and improve decision making. Clinical researchers, for example, can construct treatment
    plans by using algorithms “to digest enormous quantities of data on patient diagnoses, genomic profiles,
    resultant therapies, and subsequent health outcomes.”** The third wave of Al applications relates to the
    proliferation of sensors and devices that collect data about the physical world such as smart watches and
    virtual assistants. The fourth wave of Al applications integrates all previous waves and gives machines the
    ability to make decisions without human intervention.?? This includes technologies such as automated vehicles.
    7ACT | The App Association, “Appendix: Key Terminology for Al in Health,” Connected Health, Retrieved from
    bitp://actonline org/wp-content/uploads/Artificial- Intelligence-in-Health-Appendix pdf
    ® Intel, “Intel's Recommendations for the U.S. National Strategy on Artificial Intelligence,” Retrieved from
    bttps://newsroom,intelL.com/wp-content/uploads/sites/11/2019/03/intel-ai-white-paper pdf.
    ; er iu Lee, “The Four Waves of Al.” “Fortune, October 22, 2018, Retrieved from
    bttp: fortune com/?018/10/22, artificial- intelligence- ak deep- learning- kai-fu-lee/
    1 Kai-Fu Lee, “The Four Waves of Al.” Fortune, October 22, 2018, Retrieved from
    bttp.//fortune.com/7018/10/9 2 /artificial-intelligence-ai-deep-learming-kai-fi-lee,
    ? kai-Fu Lee, “The Four Waves of Al.” Fortune, October 22, 2018, Retrieved from
    bttp.//fortune.com/7018/10/9 2 /artificial-intelligence-ai-deep-learming-kai-fi-lee,
    18 Kai-Fu Lee, “The Four Waves of Al.” Fortune, October 22, 2018, Retrieved from
    bttp.//fortune.com/7018/10/9 2 /artificial-intelligence-ai-deep-learming-kai-fi-lee,
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    Al Applications in Healthcare
    The following section outlines five general uses of Al in healthcare, including examples of existing and
    near-term applications. These applications, while not mutually exclusive, are examples of cross-cutting themes
    that emerged from the Roundtable discussions.
    Roundtable participants emphasized the value of Al in improving clinician and administrative workflows.
    Through NLP and other Al tools, machines can rapidly process EHRs and automatically transcribe medical
    notes. Automation can free up time and reduce costs by eliminating manual data entry. Moreover, participants
    noted that Al helps reduce administrative burden by correcting human errors in billing processes.
    e Interpreting handwritten medical records. Amazon Web Services has used NLP to extract and
    interpret handwritten notes and text from medical records.’* NLP is particularly well-suited to
    deciphering physician input since EHRs do not follow a single, unified structure, yet contain important
    information for understanding diagnostic trends and risk profiles of individuals.’
    e Detecting fraud and improper payments. The Centers for Medicare and Medicaid Services (CMS)
    uses statistical analysis to identify fraudulent and improper payments made to healthcare providers. In
    2018, CMS determined that 8.12 percent of all Medicare payments were improper. In order to
    address this problem, CMS employs a testing methodology called Comprehensive Error Rate Testing
    (CERT) and uses Al to engage in predictive analysis of fraudulent and improper healthcare payments.
    This process has saved the government approximately $42 billion, according to CMS.*6
    Roundtable participants emphasized the value of using Al to connect patients with available resources and
    care, especially in rural areas. Examples include:
    e Providing patients with personalized healthcare recommendations. Sage Bionetworks launched
    mPower as a study using surveys and phone sensors to track symptoms of Parkinson's Disease.” The
    results can help patients, doctors, and caregivers better understand changes over time and the impact
    of exercise or medication. Using artificial intelligence, data from mPower could also be used to develop
    specific healthcare recommendations for patients.
    e Creating virtual care programs for patients with chronic conditions. Verily Health's Onduo project,
    which combines a smart device and mobile application, offers virtual care for people with type 2
    diabetes. Onduo can measure blood glucose levels as well as provide information on nutrition and
    medication management. The app also offers a coaching dimension that identifies lifestyle patterns and
    gives patients feedback to improve their health.
    * Rachel Arndt, “Amazon Technology Deciphers Text in Electronic Health Record,” Modern Healthcare, November 27, 2018,
    Retrieved from
    https: modernhealthcare.com/article/?0181127/TRANSFORMATIONO1/18112995 1/amazon-technology-deciph
    4 Mike Miliard, “EHR Natural Language Processing Isn't Perfect, but It’s Really Useful,” Healthcare IT News, May 18, 2017.
    Retrieved from ttps: bealthcareitnews. com/news/ebr-natural- language-processing-isnt-perfect-its-really-useful
    46 Jack McCarthy, “CMS Snags $42 Billion in Medicare and Medicaid Fraud with Predictive Analytics.” Healthcare IT News,
    July 22, 2016, Retrieved from
    bttps: bealthcareitnews.com/news/cms-snags-47-pillion-medicare-and-medicaid-fraud-predictive-analytic
    1” Sage Bionetworks, “mPower Parkinson Study and Public Researcher Portal,” Retrieved from
    bttp.//sagebionetworks ore/research-projects/mpower-researcher-portal
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    e Expanding treatment access for rural populations. Through voice assistants and chatbots, Al has the
    potential to improve and increase access to treatment in rural and other resource-constrained
    environments. There is increasing evidence that Al-driven chatbots can address routine patient
    questions and help doctors communicate with patients about their diagnosis and risk evaluations.®
    Informing Population Health Management
    Population health management (PHM) involves using population-level data to identify broad health risks and
    treatment opportunities for a group of individuals or community. Al can contribute to PHM by combining,
    synthesizing, and analyzing datasets from third parties with clinical or patient-generated data. For example,
    researchers and health providers can use Al to aggregate longitudinal patient-generated data into larger
    datasets that tell better stories about the incidence and prevalence of disease.
    e Identifying at-risk populations. Al can be used to identify populations at risk for opioid abuse or
    overdose. One population health management company, for example, integrates data on social
    determinants of health and pharmacy claims to better understand the diverse “spectrum of opioid
    abuse cases.”?
    Improving Diagnosis and Early Detection
    Diagnostic errors are a major problem in the healthcare system, with most patients experiencing at least one
    diagnostic error in their lifetime.2° Al promises to help physicians accurately diagnose medical conditions in
    their patients and treat disease at an early stage. Al algorithms draw upon large datasets on medical and social
    determinants of health to better identify patterns and assist physicians in making diagnoses and developing
    treatment plans.*?
    Al can deploy technologies like image recognition, NLP, and deep learning to quickly detect life-threatening
    conditions and assess risk for diseases like brain cancer or heart disease. Roundtable participants noted that it
    may be more accurate to think of these applications as “augmented intelligence” rather than artificial
    intelligence. The goal is not to replace the doctor’s clinical judgment, but to help physicians rapidly prioritize
    patient symptoms and assess a range of diagnostic possibilities rather than ask patients a standard slate of
    questions. Examples from the Roundtable include:
    e Diagnosing diabetic retinopathy through image recognition. Al can help doctors diagnose diabetic
    retinopathy, the world’s leading cause of blindness, by using image recognition. Researchers at Google
    have trained algorithms to analyze images of retinas and diagnose this disease with over 90 percent
    accuracy.**
    18 Rachel Arndt, “Healthcare providers are teaming with chatbots to assist patients,” Modern Healthcare, December 8, 2018,
    Retrieved from
    bttps: modernhealthcare.com/article/70181708/TRANSFORMATIONO1/181709977//healthcare-providers-are-te
    aming-with-chatbots-to-assist-patient
    ZeOmega, “ZeOmega Launches Jiva Opioid Al to Stem Drug Abuse Crisis,” May 28, 2019, Retrieved from
    bttp: eomega,com/zeomega-media-center/press-releases/?019-press-releases/7zeomega-launches-jiva-opioid-ait
    22 The National Academies of Sciences, Engineering, and Medicine (2015) Improving Diagnosis in Health Care, Washington,
    DC: The National Academies Press, Retrieved from bttps://daotore/10.1/276/91/94
    1 | aura Landro, “The Key to Reducing Doctors’ Misdiagnoses,” The Wall Street Journal, September 13, 2017, Retrieved from
    bttps: jcom/articles/the-key-to-reducing-doctors-misdiagnoses-1505276691.
    22 Rohit Varma, “Using Artificial Intelligence to Automate Screening for Diabetic Retinopathy,” Ophthalmology Times,
    October 22, 2018, Retrieved from
    bttps: opbthalmologytimes.com/article/using-artificial intelligence-automate-screening-diabetic-retinapath
    8 of 20
    e Predicting brain deterioration using advanced machine learning. Al can be used to analyze a
    diverse array of datasets and identify potential biomarkers that can indicate the onset of deterioration
    in cases that range from concussion to coma”?
    Drug development is a costly and time-consuming process. Al can help improve drug development through the
    entire development lifecycle, from identifying gaps in current therapeutics to bringing new products to market.
    Pharmaceutical researchers can use Al to sort through huge numbers of research papers and patents, as well as
    comprehensive lists of chemical compounds and their properties, to suggest opportunities for drug
    development. By analyzing the growing databases of biomarker data, they can then work to target different
    treatments to different types of patients. And when drugs or other treatments reach the clinical trial stage, Al
    can help match ideal patients to the right trials. Examples include:
    e Improving clinical trial participation. HHS recently completed a “tech sprint” engaging external
    experts, such as TrialX and Intel, to develop Al applications to match patients to appropriate clinical
    trials. This kind of matching can help researchers find appropriate subjects for their studies and help
    patients find potentially valuable treatments at the same time. “
    e Supporting precision medicine. The National Institutes of Health (NIH) defines precision medicine as
    “an emerging approach for disease treatment and prevention that takes into account individual
    variability in genes, environment and lifestyle for each person.””? Researchers at startups like Lam
    Therapeutics and Lantern Pharma are using supervised machine learning strategies to generate new
    correlations between genomic biomarkers and drug activity to pilot individualized cancer treatments.
    3 Suzanne Leigh, “Artificial Intelligence Aids Scientists in Uncovering Hallmarks of Mystery Concussion,” University of
    California San Francisco Blog. Retrieved from
    bttps: ucsfedu/news/2017/03/405297 6/artificial-intelligence-aids-scientists-uncovering-hallmarks-mystery-concu
    200.
    * Gil Alterovitz and Kristen Honey, “TOP Health’ Tech Sprint Unleashes the Power of Open Data and Al,” U.S. Department
    of Health and Human Services Office of the Chief Technology Officer Blog, January 17, 2019, Retrieved from
    https: bhs.gov/cto/blog/?019/1/17/top-health-tech-s print-unleashes-the-power-of-open-data-and-ai html
    25 National Institutes of Health, “All of Us Research Program,” Retrieved from bttps://allofus nihov/
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    Health Data for Al Applications
    Data is the foundation of all Al applications. During the Roundtable, participants identified a number of
    high-value health data types that can be used for Al development. Building on the expert feedback gathered at
    the Roundtable and subsequent research, this section provides a summary of six major health data types and
    the challenges associated with their use.
    High-Value Health Data Types
    Clinical Trials Data
    EHR Data
    lol Data
    Social Media Data
    Registry Data
    Survey Data
    Vitals Data
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    Administrative and Claims Data generally comes from federal, state, and local government agencies as well as
    healthcare providers and insurers. This can range from hospital discharge summaries to payment records
    between insured patients and the healthcare system.
    Clinical Data is a broad term that encompasses different kinds of data generated “in a clinical setting and
    controlled by aclinician, as opposed to a patient or caregiver.’*”
    e Clinical Trials Data includes registries and results from publicly and privately funded clinical studies.
    Large amounts of data, including sensitive information about participants, are generated over the
    course of a clinical trial. Researchers must obtain regulatory approval to collect and use this data.
    e EHR Data is focused on individual patients, and can include information on routine checkups,
    prescriptions, and medical procedures. Physicians can draw upon EHR data to develop individual
    treatment plans and diagnose conditions. This data can also be combined with social determinants of
    health to develop rich longitudinal profiles of individual patients and populations.
    Genomic Data can include many different characteristics, ranging from full DNA sequences to individual DNA
    variants.2° Recent advances have made it possible to analyze and store data on a person's entire genome
    sequence. According to the National Institutes of Health, “Genome-based research is already enabling medical
    researchers to develop improved diagnostics, more effective therapeutic strategies, evidence-based
    approaches for demonstrating clinical efficacy, and better decision-making tools for patients and providers.”@”
    Genomic data is considered highly sensitive and must be shared and used under carefully controlled conditions.
    Patient-Generated Data includes “health-related data created and recorded by or from patients outside of the
    clinical setting to help address a health concern.”*° This data type is becoming increasingly prevalent through
    the creation of mobile health applications and wearable health devices.
    e = loT Data includes data from mobile software applications, voice assistants, and wearable devices such
    as smart watches. These technologies are part of the “internet of things,” or loT, which refers to the
    growing system of machines and devices connected to the internet. This data is generally collected
    under “terms of service” agreements and has the potential to provide important information on a
    variety of critical health indicators, such as heart rate, sleep cycles, and diet.
    e Social Media Data includes interactions on social media platforms such as Facebook and Twitter.
    Researchers have noted that “Social media may offer insight into the relationship between an
    individual's health and their everyday life, as well as attitudes towards health and the perceived quality
    of healthcare services,” among other opportunities.*! Like loT data, social media data is collected under
    “terms of service” agreements.
    76 University of Washington Health Sciences Library, “Data Resources in the Health Sciences,” Retrieved from .
    bttp://guides lib uw.edu/hsl/data/findclin
    27 Office of the National Coordinator for Health Information Technology, Conceptualizing a Data Infrastructure for the
    Capture, Use, and Sharing of Patient-Generated Health Data in Care Delivery and Research through 2024, January 2018,
    Retrieved from bttps: healthit gov/sites/default/files/onc pghd final white paperpdf
    78 BHG Foundation at the University of Cambridge, {dentification and genomic data, December 2017, Retrieved from
    bttp: phgfoundationore/documents/PHGF-|dentification-and-genomic-data pdt
    ?? National Institutes of Health National Human Genome Research Institute, “A Brief Guide to Genomics,” Retrieved from
    https: genome.gov/about-genomics/fact-sheets/A-Brief-Guide-to-Genamic
    %° Office of the National Coordinator for Health Information Technology, Conceptualizing a Data Infrastructure for the
    Capture, Use, and Sharing of Patient-Generated Health Data in Care Delivery and Research through 2024, January 2018,
    Retrieved from bttps: healthit gov/sites/default/files/onc pghd final white paperpdf
    3? Kevin Padrez et al, “Linking social media and medical record data: a study of adults presenting to an academic, urban
    emergency department,” BMJ Quality & Safety, 2016, Retrieved from bttp//dxdoiore/10.1136/bmiqs-7015-004489
    11 of 20
    Social Determinants of Health Data represent “conditions in the environments in which people are born, live,
    learn, [and] work...that affect a wide range of health, functioning, and quality-of-life outcomes and risks.”°4
    Examples of these social determinants include access to transportation, education, and job opportunities as
    well as the availability of food and housing options. Social determinants of health data can come from many
    sources inside and outside of government, and can be used to better understand population health.
    Surveillance Data is a broad term that encompasses the “ongoing, systematic collection, analysis, and
    interpretation of health-related data essential to planning, implementation, and evaluation of public health
    practice.”*?
    e Registry Data includes data shared voluntarily by individuals that is generally focused around a
    specific diagnosis or condition such as cancer or cystic fibrosis. This data can be used to track trends
    and better understand conditions over time. According to the NIH, this data “belongs to the sponsor of
    the registry and..may be shared with the participants and their families, and approved health care
    professionals and researchers. However, personal, identifying information is kept private.”™*
    e Survey Data includes the results of surveys and studies conducted to assess population health. This
    data can help stakeholders monitor the spread of disease, track health insurance coverage across
    regions, and assess trends in nutrition and exercise, among other uses.°°
    e Vitals Data is generally collected and exchanged between local jurisdictions and the federal
    government. This data represents “vital events,” such as births, deaths, marriages, divorces, and fetal
    deaths.**
    Roundtable participants identified numerous legal, cultural, and technical challenges associated with sharing
    and utilizing health data for Al applications. While some of these challenges are specific to Al development,
    others are general issues that impact all applications of health data.
    Legal challenges
    e Inconsistent restrictions on data use. Among the legal challenges, participants noted that health data
    types have different legal and regulatory constraints on their use. For example, administrative and
    claims data, clinical data, and certain types of surveillance data, such as survey data, can include
    sensitive, individual-level information.*” The use of these data types is often restricted under existing
    privacy frameworks such as HIPAA. Patient-generated data, such as data collected from mobile
    applications and wearable devices, can also contain sensitive information about individuals ranging
    from fertility treatments to mental health conditions. However, there are relatively few legal guidelines
    that protect this emerging data type from misuse.
    *2 Office of Disease Prevention, and Health Promotion, “Social Determinants of Health,” Retrieved from
    bttps: bealthypeaple gow/7070/topics-objectives/tapic/social-determinants-of-health
    33 World Health Organization, “Public health surveillance,” Retrieved from
    bttps: bojnt/topics/public health surveillance/en
    * National Institutes of Health, “List of Registries,” Retrieved from
    bttps: nibgov/health-information/nih-clinical-research-trials-you/list-registrie
    °° National Center for Health Statistics, “Resources for Survey Participants,” Retrieved from
    https: cdcgov/nchs/nchs for you/survey participants htm
    %¢ National Center for Health Statistics, “National Vital Statistics System,” Retrieved from
    bttps: cdcogov/nchs/n Index btm
    3” Amy Bernstein and Marie Haring Sweeney, Marie Haring, “Public Health Surveillance Data: Legal, Policy, Ethical,
    Regulatory, and Practical Issues,” Morbidity and Mortality Weekly Report. Retrieved from
    https: cdcgov/mmwr/preview/mmwrhtml/sué 10337 btm
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    Concerns about intellectual property. Roundtable participants also discussed the challenges of using
    and sharing proprietary data and algorithms. Data collected in drug development trials, through
    private-sector health surveys, or in other ways could benefit researchers and organizations in the
    health sector developing Al applications, and proprietary Al models could be developed for greater
    accuracy if the algorithms they use were shared. But while all parties stand to benefit from sharing
    data and algorithms, it is difficult to balance that benefit against companies’ need to protect their
    intellectual property for competitive advantage.
    Cultural challenges
    Underlying bias in health data. Some Roundtable participants highlighted concerns about bias and
    lack of diversity in health data, which can have serious consequences when utilized for Al development.
    As one expert notes, “If the data are flawed, missing pieces, or don’t accurately represent a population
    of patients, then any algorithm relying on the data is at a higher risk of making a mistake.”?
    Data silos and administrative hurdles. While HHS is developing more efficient ways for its operating
    agencies to share data - for example, by developing common data use agreements (DUAs) - it is still
    difficult for HHS agencies to share data with each other, and can be difficult for organizations outside
    of government to obtain data from HHS. Roundtable participants said that tt can take 12 to 18 months
    to get access to data from various agencies and offices within HHS. Culture changes are needed to
    reduce the administrative hurdles that prevent timely data sharing.
    Overly restrictive interpretations of HIPAA. Some Roundtable participants noted that fears about
    violating HIPAA have created a risk-averse environment for data sharing. While HIPAA is intended to
    protect patient privacy, it does allow data sharing and use under specific conditions.°*’ Participants
    suggested that HHS could provide more guidance on what is and is not permissible under HIPAA in
    different contexts.
    Technical challenges
    Limited technical capacity for data management and analysis. Roundtable participants inside and
    outside of government noted the need for more staff with data science training. In particular, both
    government and the private sector need more experts in Al and its application to health data and
    issues.
    Inadequate IT infrastructure for hosting and analyzing large datasets. Al applications require large
    quantities of data, and large computational capacity, to train and test algorithms. The increasing
    demand for real-time data adds to these technical requirements. Both HHS and the stakeholders that
    work with the department may need to upgrade their infrastructure to meet these challenges.
    Poor data interoperability. Roundtable participants flagged a number of challenges related to joining
    and combining health datasets. Across the healthcare system, large amounts of data are structured in
    different ways, preventing stakeholders from easily exchanging and integrating this information.
    Participants attributed these challenges to a lack of common data standards and issues with
    enforcement where standards do exist.
    38 Dave Gershorn, “If Al is going to be the world’s doctor, it needs better textbooks,” Quartz, September 6, 2018. Retrieved
    from bttps://q7.com/author/dgershgorna
    % Office of the National Coordinator for Health Information Technology, “How HIPAA Supports Data Sharing,” Retrieved
    from https: bealthit gov/topic/interoperability/how-bipaa-supparts-data-sharing
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    Recommendations and Actionable Opportunities
    The February 2019 “Executive Order on Maintaining American Leadership in Artificial Intelligence” outlined a
    number of strategic objectives for developing Al.° These include (text bolded for emphasis):
    Executive Order Objectives
    A. “Promote sustained investment in Al R&D in collaboration with industry,
    academia, international partners and allies, and other non-federal entities to
    generate technological breakthroughs in Al and related technologies and to rapidly
    transition those breakthroughs into capabilities that contribute to our economic and
    national security.
    B. Enhance access to high-quality and fully traceable federal data, models, and
    computing resources to increase the value of such resources for Al R&D, while
    maintaining safety, security, privacy, and confidentiality protections consistent
    with applicable laws and policies.
    C. Reduce barriers to the use of Al technologies to promote their innovative
    application while protecting American technology, economic and national security, civil
    liberties, privacy, and values.
    D. Ensure that technical standards minimize vulnerability to attacks from malicious
    actors and reflect federal priorities for innovation, public trust, and public confidence
    in systems that use Al technologies; and develop international standards to promote
    and protect those priorities.
    E. Train the next generation of American Al researchers and users through
    apprenticeships; skills programs; and education in science, technology, engineering,
    and mathematics (STEM), with an emphasis on computer science, to ensure that
    American workers, including federal workers, are capable of taking full advantage of
    the opportunities of Al.
    F. Develop and implement an action plan, in accordance with the National Security
    Presidential Memorandum of February 11, 2019 (Protecting the United States
    Advantage in Artificial Intelligence and Related Critical Technologies) (the NSPM) to
    protect the advantage of the United States in Al and technology critical to United
    States economic and national security interests against strategic competitors and
    foreign adversaries.”
    Under the Executive Order, agencies funding and deploying Al are expected to use these government-wide
    objectives to inform their work.
    4° The White House, “Executive Order on Maintaining American Leadership in Artificial Intelligence,” February 11, 2019,
    Retrieved from
    bttps: bitehouse.gov/presidential-actions/executive-order-maintaining-american-leadership-artificial-intelligence
    14 of 20
    The HHS Office of the CTO is exploring the potential for a department-wide Al strategy to help realize the
    value of Al within government, and to establish policies and practices for facilitating its development across the
    health sector. Over the course of the Roundtable, participants outlined a number of recommendations for HHS
    and other stakeholders that align with the objectives of the Executive Order. These recommendations and
    related actionable opportunities are summarized below:
    Al demands a robust information technology (IT) infrastructure, including data infrastructure, and staff
    with the skills to apply it. Both infrastructure and expertise must be able to manage the large amounts of
    data needed to support Al as well as the development of advanced Al applications.
    Actionable Opportunities:
    e Develop comprehensive technology investment plans to support organizational Al
    strategies. Within HHS, this can include improving legacy systems for managing the data
    that will fuel Al applications as well as IT modernization overall. It may also include
    public-private collaboration to reduce the cost to government of technical
    improvements.
    e Build expertise in designing and implementing Al applications. Most federal
    departments, including HHS, have limited organizational knowledge and experience
    needed to develop Al applications with their data. HHS can bridge this gap through
    hiring programs, public-private collaborations, or fellowship programs to bring Al
    experts into government on a temporary basis.
    e Create national testbeds for Al development. |ndustry has led the development of Al
    applications, since commercial companies collect massive amounts of data and have the
    resources, expertise, and technical capacity to apply tt. HHS and other agencies can help
    remove these barriers to entry by creating collaborative environments where data and
    code for Al applications can be tested, stored, and shared.
    Concerns about privacy are paramount in the application of individual health data. While the use of
    health data in EHRs and other medical records is governed by federal and state legislation, other data
    types like loT data are only regulated through “terms of service” agreements developed by the private
    sector. HHS and its partners will need to ensure that sensitive information is not disclosed or misused
    when these data sources are applied. At the same time, researchers need to be able to use sensitive
    data appropriately to develop new insights, diagnostic methods, and treatments. (The challenge of
    balancing privacy with health data access will be the subject of the next Roundtable in this series.)
    Actionable Opportunities:
    e Provide guidance for de-identifying sensitive data. In order to protect privacy, health
    data can be de-identified in different ways before researchers analyze It. Data scientists,
    for example, have utilized codes that make it possible to link data about an individual
    from different sources without revealing the person’s identity. HHS could provide
    additional guidance on de-identification methods to protect data privacy and security
    while encouraging its use for Al applications. This guidance may include updating
    HIPAA’s rules around de-identification to meet modern demands.
    15 of 20
    e Develop credentialing systems for controlled access to sensitive health data. Some
    sensitive data maintained by the federal government, such as collections of genomic
    data, are now available only to qualified researchers only, under agreements that
    prohibit them from sharing the data more widely. HHS could apply this model more
    broadly and develop credentialing systems to determine who should have access to what
    kinds of data and under what conditions.
    Data for Al applications should be clean, timely, accurate, and standardized. Roundtable participants
    identified numerous challenges related to integrating data and metadata from multiple sources.
    Common standards for data collection and management can ensure that data and metadata are
    accurate and consistent across healthcare applications, using a shared library of variables that are
    applied across datasets. Standardization also ensures that datasets will be interoperable between
    agencies within HHS or between HHS and its external partners. The current lack of interoperability is
    amajor obstacle to applying data for Al development.
    Actionable Opportunity:
    e Adopt and expand existing common data models. Many participants noted the value
    of adopting existing common data models for data and metadata, wherever possible.
    Common data models standardize the way information is structured and make it easier
    to use in combination with other data. Examples of existing common data models include
    Patient Centered Outcome Research Network (PCORNet) model and the Observational
    Medical Outcomes Partnership (OMOP) model. Participants also mentioned ICD-10,
    which is a widely used coding system that could be expanded to improve health data
    quality and interoperability nationwide.
    Al applications are most effective when they can integrate large amounts of data about diverse facets
    of health. However, researchers inside and outside of HHS often have difficulty accessing the data
    they need. To share data from other sources, researchers must have DUAs that abide by HIPAA
    regulations, whether HHS is sharing data with outside researchers or whether different operating
    divisions within HHS are sharing data with each other. Drawing up and approving separate DUAs can
    take time and administrative resources that are a burden on researchers and slow down the research
    process.
    Actionable Opportunity:
    e Update and standardize data use agreements. A set of standard DUAs, using common
    terms and conditions, could accelerate and simplify data sharing between operating
    agencies within HHS. Revised DUAs could substantially reduce the time it takes for HHS
    researchers to request and receive important, time-sensitive data: Finalizing DUAs can
    now take up to 12 months. Standard DUAs for internal use within HHS could also
    become a model for agreements between HHS and outside partners.
    Participants also highlighted two areas for action that go beyond the Executive Order:
    16 of 20
    Increasingly, patients are generating data about themselves that can complement research and
    clinical data? Patient-generated data includes data collected through sensors and wearables, and
    through social media and mobile applications. Large amounts of this data are collected under “terms
    of service” agreements and are being used by entities that are not covered by HIPAA.” As interest in
    patient-generated data increases, there is a need for clearer rules around its appropriate use,
    particularly in the context of Al development.
    Actionable Opportunities:
    e Develop specific guidelines for entities not covered by HIPAA. HIPAA applies to
    traditional entities, such as health plans and healthcare providers, but does not apply to
    software development and social media companies that may be collecting
    patient-generated data with sensitive health information? While the HHS Office for
    Civil Rights has developed several informational resources for health app developers,
    entities that are not covered by HIPAA, and the individuals whose data they collect,
    would benefit from further guidance and best practices on appropriate uses of
    patient-generated data.
    Many Al applications that use health data are being developed as a “black box” without clear
    information about the algorithms and data being used to make decisions. Al strategies should include
    steps to address concerns about accountability, bias, and oversight. This will require improved
    transparency for both Al algorithms and the data that supports them.
    Actionable Opportunities:
    e Develop guidelines for mitigating bias in health-related Al applications. Some
    Roundtable participants expressed interest in having HHS and its partners develop
    guidance for identifying and reducing bias inAl applications. Participants also suggested
    including an internal HHS review function to enforce such guidelines and help increase
    transparency.
    e Pilot and implement an FDA regulation for health-related Al applications.
    Roundtable participants expressed similar concerns about a lack of quality assurance
    and oversight for Al development in healthcare. The Food and Drug Administration
    411) S. Department of Health and Human Services, “Patient-Generated Health Data,” Retrieved from
    https: bealthit gov/topic/scientific-initiatives/patient-generated-health-data
    #2 U.S. Department of Health and Human Services, Examining Oversight of the Privacy & Security of Health Data Collected by
    Entities Not Regulated by HIPAA, June 2016, Retrieved from
    bttps: healthit. gov/sites/default/files/non-covered entities report june 17 7016 pdf
    #3 U.S. Department of Health and Human Services, Examining Oversight of the Privacy & Security of Health Data Collected by
    Entities Not Regulated by HIPAA, June 2016, Retrieved from
    bttps: bealthit gov/sites/default/files/non-covered entities report june 17 7016 pdf
    * US. Department of Health and Human Services Office for Civil Rights, “Health app developers, what are your questions
    about HIPAA?” Retrieved from bttps://hipaaqsportalbhs gov/
    17 of 20
    (FDA) has established a set of iterative, agile guidelines to precertify the rapid
    development of Software as a Medical Device (SaMD).*? The FDA should continue its
    efforts to adopt a revised regulatory framework for Al applications in which proposed
    changes to algorithms must be disclosed to the FDA prior to market release. This
    framework should take into account the ability of Al applications to adopt in real time
    and provide ways to assess any risks from those changes.
    e Publish metadata about data sources. Metadata provides information about the
    structure of a dataset, the meaning of each variable within the data, the method of
    collection, and other important characteristics. Metadata can also provide information
    about the source of the data, the way it was collected, and other factors that may
    indicate potential causes of bias. Publishing metadata will make it easier to assess
    whether the data and the algorithms it supports are at risk of being biased in any way.
    “5 US. Food and Drug Administration, “Developing Software Precertification Program: A Working Model,” June 2018,
    Retrieved from
    https: fdagov/downloads/MedicalDevices/DigitalHealth/DigitalHealthPreCertProgram/UCM611103. pdf
    46 US. Food and Drug Administration, “Proposed Regulatory Framework for Modifications to Artificial
    Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,” April 2019, Retrieved from
    https: fda gov/media/177535/download
    18 of 20
    Conclusion
    While the promise of Al in healthcare is significant, a number of challenges can impede its successful
    implementation. The Roundtable on Sharing and Utilizing Health Data for Al Applications was a first step to finding
    solutions by identifying innovative examples of Al applications, high-value data types, and ways that all
    stakeholders can contribute to the successful and appropriate use of Al.
    In the two months since the Roundtable, HHS has demonstrated its commitment to exploring the use of Al
    inside and outside of government. For example, HHS is moving forward with its “Reimagined — Buy Smarter”
    program designed to use Al to conduct strategic comparative analysis of industry pricing to ensure that HHS is
    saving taxpayers as much money as possible.4”7 HHS and CMS are also working to expand their cloud capacity to
    manage the growing data assets that are critical to their daily operations and future Al applications.”
    The Executive Office of the President has also advanced government-wide Al initiatives. In addition to the
    February 2019 “Executive Order on Maintaining American Leadership in Artificial Intelligence,” the National
    Science and Technology Council updated The National Artificial Intelligence Research and Development Strategic
    Plan in June 2019. The Plan recommends that the federal government develop a coordinated approach to
    maximize the impact of Al technology as it grows in scope. The Plan also proposes eight different strategies to
    bolster Al development such as understanding the ethical, legal, and societal implications of Al, adopting
    effective strategies for Al-human collaboration, and supporting the safety and security of Al systems.
    This summary report presents research and diverse stakeholder input from the Roundtable on Sharing and
    Utilizing Health Data for Al Applications that can inform the development of an HHS Al strategy. The report
    outlines a number of ways that HHS can take action that align with the Executive Order and other
    government-wide Al initiatives.
    The same kinds of recommendations and actionable opportunities may be useful to the growing number of
    stakeholders outside of government who are working to develop applications based on health data.
    Private-sector companies, patients and their advocates, academic researchers, healthcare providers, and other
    stakeholders will all play critical roles in the development of health-related Al in the months and years ahead.
    CODE hopes that this report will provide context, perspective, and the beginnings of a framework for the
    important work to come.
    47 Amelia Brust, “HHS wants to use Al to help it ‘Buy Smarter,” Federal News Network, May 17, 2019, Retrieved from
    hitps://federalnewsnetwork.com/ai-machine-learning-month/?019/05/hhs-wants-to-use-ai-to-help-it-buy-smarter,
    8 Joseph Goedert, “CMS works with MarkLogic to expand cloud platforms,” Health Data Management, April 30, 2019,
    Retrieved from https: bealthdatamanagementcom/news/cms-warks-with-marklogic-to-expand-claud-platform
    *? The National Science and Technology Council, The National Artificial Intelligence Research and Development Strategic Plan,
    June 21, 2019, Retrieved from
    https: hitehouse.gov/wp-content/uploads/?2019/06/National-Al-Research-and-Development:-Strategic-Plan-2019
    19 of 20
    Acknowledgements and Appendices
    The Roundtable on Sharing and Utilizing Health Data for Al Applications was
    funded through a Patient-Centered Outcomes Research Institute (PCORI) ry
    Engagement Award Initiative (12667-CODE). This Roundtable is part of the Corl
    Open Data Roundtable Series: Sharing and Utilizing Data to Enhance and Protect °
    Health and Well-Being funded through this award.
    PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE
    CODE would like to thank the HHS Office of the Chief Technology Officer for their partnership in co-hosting
    this Roundtable series. We also thank the Multi-Stakeholder Advisory Committee for this series:
    Lisa Bari, CMS Innovation Center, Centers for Medicare and Medicaid Services
    Sohini Chowdhury, Michael J. Fox Foundation
    James Craver, National Center for Health Statistics, Centers for Disease Control and Prevention
    Gwen Darien, National Patient Advocate Foundation
    Stephanie Devaney, Al! of Us Research Program, National Institutes of Health
    Natalie Evans-Harris, BrightHive
    Jason Gerson, Patient-Centered Outcomes Research Institute
    Joel Gurin, Center for Open Data Enterprise
    William Hoffman, World Economic Forum
    Charles Keckler, Associate Deputy Secretary, HHS
    Lisa Khorey, Allscripts Healthcare Solutions
    Michael Seres, 11 Health
    Mona Siddiqui, Chief Data Officer, HHS
    Paul Tarini, Robert Wood Johnson Foundation
    John Wilbanks, Sage Bionetworks
    The following resources are included as appendices to this report:
    e = List of Participating Organizations
    e Roundtable Agenda
    20 of 20
    Roundtable on Sharing and Utilizing Health Data for Al Applications
    PARTICIPATING ORGANIZATIONS
    Academia
    Dell Medical School, University of Texas at Austin is the graduate medical school of The University of
    Texas at Austin in Austin, Texas. The school opened to the inaugural class of 50 students in the summer of
    2016 as the newest of 18 colleges and schools on the UT Austin campus.
    Duke Margolis Center for Health Policy’s mission is to improve health and the value of health care through
    practical, innovative, and evidence-based policy solutions. Duke-Margolis catalyzes Duke University's
    leading capabilities to inform policy making and implementation for better health and health care.
    Harvard Law School, Petrie-Flom Center founding mission is to promote interdisciplinary analysis and legal
    scholarship in the fields of Health Law Policy, Biotechnology, and Bioethics.
    University of Maryland School of Public Health offers an unusual breadth of expertise to explore complex
    issues through public health disciplines, and lenses as varied as engineering, arts and humanities, business
    and public policy.
    Stanford University, one of the world's leading teaching and research universities, dedicated to finding
    solutions to big challenges and to preparing students for leadership in a complex world.
    Hall Center for Law and Health, Indiana University Robert H. McKinney School of Law was established in
    1987 to expand the curriculum and teaching of health law and provide opportunities for students.
    Civil Society
    ACT | The App Association represents more than 5,000 app companies and information technology firms
    across the mobile economy. ACT advocates for an environment that inspires and rewards innovation, while
    providing the necessary resources to help its members leverage their intellectual assets to raise capital and
    create jobs.
    American Medical Association (AMC) promotes the art and science of medicine and the betterment of
    public health. AMC provides timely, essential resources to empower physicians, residents and medical
    students to succeed at every phase of their medical lives.
    Center for Data Innovation educates policymakers and the public about the opportunities and challenges
    associated with data, as well as technology trends such as predictive analytics, open data, cloud computing,
    and the Internet of Things.
    Center for Open Data Enterprise (CODE) is an independent nonprofit organization based in Washington,
    D.C. whose mission is to maximize the value of open government data for the public good.
    Healthcare Leadership Council (HLC)}, a coalition of chief executives from all disciplines within American
    healthcare, is the exclusive forum for the nation’s healthcare leaders to jointly develop policies, plans, and
    programs to achieve their vision of a 21st century system that makes affordable, high-quality care
    accessible to all Americans.
    World Economic Forum is the International Organization for Public-Private Cooperation. The Forum
    engages the foremost political, business and other leaders of society to shape global, regional and industry
    agendas.
    Government
    The U.S. Department of Health and Human Services is a cabinet-level department of the U.S. federal
    government with the goal of protecting the health of all Americans and providing essential human services.
    The Agency for Healthcare Research and Quality's (AHRQ) mission is to produce evidence to make
    health care safer, higher quality, more accessible, equitable, and affordable, and to work within the
    U.S. Department of Health and Human Services and with other partners to make sure that the
    evidence is understood and used.
    The Centers for Disease Control and Prevention Center (CDC) works to protect America from
    health, safety and security threats, both foreign and in the U.S. Whether diseases start at home or
    abroad, are chronic or acute, curable or preventable, human error or deliberate attack, CDC fights
    disease and supports communities and citizens to do the same.
    The National Center for Health Statistics (NCHS), part of the CDC, compiles statistical
    information to help guide policies to improve the health of Americans. Holds a biennial data
    user conference; consult the NCHS website for date and location. NCHS disseminates data
    and statistics online and in print.
    Center for Medicare and Medicaid Services (CMS) administers the Medicare program and works in
    partnership with state governments to administer Medicaid, the Children's Health Insurance
    Program (CHIP), and health insurance portability standards.
    The Innovation Center with CMS supports the development and testing of innovative
    health care payment and service delivery models.
    Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring
    the safety, efficacy, and security of human and veterinary drugs, biological products, and medical
    devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit
    radiation.
    Health Resources and Services Administration (HRSA) is the primary federal agency for improving
    health care to people who are geographically isolated, economically or medically vulnerable.
    The Immediate Office of the Secretary (IOS) is responsible for operations and coordination of the
    work of the Secretary.
    The National Institutes of Health (NIH) seeks fundamental knowledge about the nature and
    behavior of living systems and the application of that knowledge to enhance health, lengthen life,
    and reduce illness and disability.
    NIH Clinical Center mission is to provide hope through pioneering clinical research to
    improve human health. The center has an Individual and collective passion for high
    reliability in the safe delivery of patient-centric care in a clinical research environment.
    The Office of the Assistant Secretary for Preparedness and Response leads the nation’s medical
    and public health preparedness for, response to, and recovery from disasters and public health
    emergencies.
    The Office of the Chief Technology Officer (CTO) provides leadership and direction on data,
    technology, innovation and strategy across the HHS. Areas of focus include promoting open data
    and its use to create value, driving more efficient operations through technology utilization, and
    coordinating innovation strategy across the Department to improve the lives of the American
    people and the performance of the Department.
    Office of Inspector General (OIG) mission is to protect the integrity of Department of Health &
    Human Services (HHS) programs as well as the health and welfare of program beneficiaries.
    Office of the National Coordinator Improve the health and well-being of individuals and
    communities through the use of technology and health information that is accessible when and
    where it matters most.
    U.S. Government Accountability Office (GAO) examines how taxpayer dollars are spent and provides
    Congress and federal agencies with objective, reliable information to help the government save money and
    work more efficiently.
    Healthcare Insurers and Providers
    HCA Healthcare is committed to the care and improvement of human life. HCA follows a vision of
    healthcare the way it should be: patient-centered, constantly evolving and constantly improving, practiced
    with integrity and compassion.
    UnitedHealth has a mission to help people live healthier lives and make the health system work better for
    everyone and are working to create a system that delivers high quality care, responsive to the needs of each
    person and the communities in which they live.
    New York Presbyterian Hospital is one of the nation’s most comprehensive, integrated academic health
    care delivery systems, dedicated to providing the highest quality, most compassionate care and service to
    patients in the New York metropolitan area, nationally, and throughout the globe.
    Nonprofit & Philanthropic Organizations
    Michael J. Fox Foundation is dedicated to finding a cure for Parkinson's disease through an aggressively
    funded research agenda and to ensuring the development of improved therapies for those living with
    Parkinson's today.
    Robert Wood Johnson Foundation (RWJF) is the nation’s largest philanthropy dedicated solely to health.
    RWJD supports research and programs targeting some of America’s most pressing health issues—from
    substance abuse to improving access to quality health care.
    Patient Advocacy
    National Patient Advocate Foundation (NPAF), the advocacy affiliate of the Patient Advocate Foundation,
    represents the patient voice, both the powerful stories of individuals and the collective needs of the
    community. The NPAF’s primary objective is to prioritize the patient voice in health system delivery reform
    to achieve person-centered care.
    Patient-Centered Outcomes Research Institute (PCORI} helps people make informed healthcare decisions,
    and improves healthcare delivery and outcomes, by producing and promoting high-integrity,
    evidence-based information that comes from research guided by patients, caregivers, and the broader
    healthcare community.
    Patient Privacy Rights’ purpose is to honor and empower the individual’s right to privacy through personal
    control of health information wherever such information is collected and used. They educate, collaborate
    and partner with people to ensure privacy in law, policy, technology, and maximize the benefits from the use
    of personal health information with consent.
    Private Sector
    Allscripts is a leader in healthcare information technology solutions that advance clinical, financial and
    operational results. Its innovative solutions connect people, places and data across an Open, Connected
    Community of Health.
    Amazon Web Services is a subsidiary of Amazon that provides on-demand cloud computing platforms to
    individuals, companies and governments, on a metered pay-as-you-go basis.
    Apple is an American multinational technology company headquartered in Cupertino, California, that
    designs, develops, and sells consumer electronics, computer software, and online services.
    Blackfynn helps the neuroscience and neurology communities make optimal use of data by powering an
    innovative platform that integrates and puts complex data in context.
    Booz Allen Hamilton provides management and technology consulting and engineering services to leading
    Fortune 500 corporations, governments, and not-for-profits across the globe. Booz Allen partners with
    public and private sector clients to solve their most difficult challenges through a combination of consulting,
    analytics, mission operations, technology, systems delivery, cybersecurity, engineering, and innovation
    expertise.
    Epic hires smart and motivated people from all academic majors to code, test, and implement healthcare
    software that hundreds of millions of patients and doctors rely on to improve care and ultimately save lives
    around the globe.
    Flatlron Health is a healthcare technology and services company focused on accelerating cancer research
    and improving patient care. Their mission is to improve lives by learning from the experience of every
    cancer patient.
    Geisinger Healthcare is a coordinated intersection of services and providers - primary care and specialists,
    hospitals and trauma centers, insurance, medical education and research. Geisinger has expanded and
    evolved to meet regional needs and developed innovative, national programs in the process.
    Google LLC is an American multinational technology company that specializes in Internet-related services
    and products, which include online advertising technologies, search engine, cloud computing, software, and
    hardware.
    Google Al conducts research that advances the state-of-the-art in the field, applying Al to products and to
    new domains, and developing tools to ensure that everyone can access Al.
    Health Catalyst is dedicated to enabling health care organizations to fundamentally improve care by
    building the most comprehensive and fully integrated suite of healthcare data warehousing and process
    improvement solutions available.
    IBM Research is a community of thinkers dedicated to addressing some of the world’s most complex
    problems and challenging opportunities for the benefit of all. They are one of the world’s largest and most
    influential corporate research labs, with more than 3,000 researchers in 12 labs located across six
    continents.
    Intel Corporation invents at the boundaries of technology to make amazing experiences possible for
    business and society for everyone. Leading on policy, diversity, inclusion, education and sustainability, we
    create value for our stockholders, customers, and society.
    KB Stack Consulting helps government and non-profit organizations develop creative strategies for using
    data, evidence, and innovation to improve the impact of government social programs.
    Mathematica Policy Research is dedicated to improving public well-being by bringing the highest standards
    of quality, objectivity, and excellence to bear on public policy. It advances its mission through objective,
    evidence-based standards, superior data, and collaboration.
    Microsoft is an American multinational technology company with headquarters in Redmond, Washington. It
    develops, manufactures, licenses, supports and sells computer software, consumer electronics, personal
    computers, and related services.
    Mpirica Health is a digital health company that uses machine learning, backed by a robust methodology, to
    scores hospitals and surgeons based on objective clinical outcomes. Our cloud-based platform and API helps
    patients and payers, especially self-insured employers, avoid surgery risks and costs.
    Oncology Analytics, Inc. provides health plans with an evidence-based, technologically driven approach to
    utilization management, which is purpose-built for oncology. They provide a technology enabled service to
    ensure cancer patients get the right treatment at the right time, and at an affordable price.
    Pfizer’s purpose is grounded in their commitment to fund programs that provide public benefit, advance
    medical care and improve patient outcomes. Their belief is that all people deserve to live healthy lives. This
    drives their desire to provide access to medicines that are safe, effective, and affordable.
    TrialX brings researchers and patients together, accelerating clinical research to find cures for millions.
    They put the patient at the center and build solutions that work together seamlessly to meet the patient
    where they are, helping them find the trials they are looking for and connect with investigators close by.
    Verily Life Science’s mission is to bring together technology and life sciences to uncover new truths about
    health and disease. As an independent company, they are focused on using technology to better understand
    health, as well as prevent, detect, and manage disease.
    Viz.ai’s world class team of technologists, doctors, executives, and advocates has developed an Al-driven
    approach to care that is fast, effective, collaborative, and sustainable.
    11 Health and Technologies have a complete care management platform that is the new gold standard in
    healthcare for both patients and clinicians by combining Smart Technology with the world's first one to one
    Patient Coach Program that provides both technical and emotional support to patients.
    Roundtable on Sharing and Utilizing Health Data for Al Applications
    U.S. Department of Health and Human Services | April 16, 2019
    Purpose: Identify high-priority health applications of Al and key issues for an HHS Al strategy to address.
    Registration and Light Breakfast
    Welcome
    Mona Siddiqui, Chief Data Officer, U.S. Department of Health and Human Services (HHS)
    Opening Remarks
    Ed Simcox, Chief Technology Officer, HHS
    Structure of the Day
    Joel Gurin, President, Center for Open Data Enterprise (CODE)
    Lightning Talks: Emerging Applications of Al
    Sohini Chowdhury, Deputy Chief Executive Officer, Michael J. Fox Foundation
    Jason Jones, Chief Data Scientist, Health Catalyst
    Vivian Lee, President of Health Platforms, Verily Life Sciences
    James Wiggins, Senior Solutions Architect for Academic Medical Centers, Amazon Web Services
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