“AI is revolutionizing healthcare delivery and management, demanding a paradigm shift in how we approach technology implementation,” stated Lauren Riplinger, JD, American Health Information Management Association (AHIMA) Chief Public Policy & Impact Officer. “Health IT end-users, whether they be HI professionals or providers, are on the front lines of deploying AI tools and therefore are acutely aware of the opportunities and risks associated with deploying such technologies. AI solutions must be developed and deployed with a focus on safety, transparency, and the experience. The Alliance’s consensus statement is representative of the end-user community coming together to develop a set of common principles to inform ongoing policy discussions within the Administration and the US Congress.

The HITEU Alliance AI Consensus Statement identifies critical areas requiring immediate attention including:

• Clear Regulation & Oversight: Emphasizing that AI should augment, not replace, human expertise, the statement calls for policymakers to establish risk-based regulations that ensure AI tools are rigorously validated, safe, and equitable.
• Transparency & Trust: Advocating for transparency in AI systems, the statement underscores the need for patients and providers to understand how AI operates, how decisions are made, and how data is utilized.
• End-User Participation & Leadership: Highlighting the importance of engaging the health IT end-user community, the statement calls for engaging end-users throughout the entire lifecycle of AI tool development, use, implementation, and post-market surveillance.
• Privacy & Security: Prioritizing data protection and cybersecurity, the statement calls for AI tools to adhere to stringent privacy standards.
• Reducing Administrative Burden: Aiming to enhance efficiency, the statement advocates for AI solutions that simplify workflows rather than adding unnecessary complexity.

“The family medicine experience is based on a deeply personal physician-patient interaction that requires support from technology, including AI,” said Jen Brull, MD, FAAFP, President of the American Academy of Family Physicians. “As a result, family physicians know the importance of responsible and secure AI development, training implementation and monitoring in our health care system. We’ve seen how AI can reduce administrative burdens, allowing more focus on patient care, but also recognize that it cannot replace a physician or our relationships with patients. We continue to partner with policymakers and health care leaders to ensure AI preserves and enhances primary care.”

Representing the voices of health information professionals, physicians, hospitals, and other front-line health care providers and organizations, the Health IT End-Users Alliance, remains steadfast in its commitment to improving healthcare policies and technology standards that reflect the real-world end-user experience.

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About the HITEU Alliance

The Health IT End-Users Alliance seeks to advance end-user perspectives in health IT policy and standards development and provides a collective voice to move beyond end-user involvement to end-user leadership. Members include, the American Academy of Family Physicians (AAFP), American College of Physicians (ACP), American Health Information Management Association (AHIMA), , Medical Group Management Association (MGMA), OCHIN and Premier, Inc.

RE: RIN 0955–AA06, Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing and Public Health Interoperability (HTI-2) Proposed Rule

Dear Dr. Tripathi:

The Health IT End-Users (HITEU) Alliance appreciates the opportunity to provide the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) with feedback on the Health Data, Technology and Interoperability: Patient Engagement, Information Sharing and Public Health Interoperability (HTI-2) Proposed Rule (RIN 0955-AA06), as published in the August 5 Federal Register.

The HITEU Alliance brings together health information professionals, physicians, hospitals, and other front-line health care providers and organizations that use health IT in the provision of care to ensure that policy and standards development activities reflect the complex web of clinical and operational challenges facing those who use technology tools for care. By working collaboratively across settings of care, the Health IT End-Users Alliance is focused on priorities for how technology can best support clinical care and operations.^[1]

Our comments are grounded in the HITEU Alliance’s Consensus Statements on Data to Support Equity[2] and Real-World Testing, [3] as well as the Alliance Roadmap[4] that highlights the growing set of federal mandates faced by health IT end-users. Our comments focus on:

• Proposed changes to the information blocking exceptions
• Proposed prior authorization application programming interfaces (APIs)
• Pace of change in regulatory requirements and need for greater end-user input/education

Information Blocking

The HITEU Alliance appreciates and supports ASTP’s proposals to ensure access to care and accommodate requestor preferences. However, we believe that certified health IT should include functionality to support providers in complying with information blocking rules.

Protecting Care Access. The HITEU Alliance supports the proposed addition of a Protecting Care Access Exception, with a request to simplify the conditions under the exception. The exception would allow practices that would otherwise be considered information blocking, based on the actor’s good faith belief that sharing electronic health information (EHI) indicating that any person(s) sought, received, provided, or facilitated the provision or receipt of reproductive health care that was lawful under the circumstances in which it was provided, could result in a risk of potential exposure to legal action for those persons.

This exception would provide needed clarity that physicians and other actors may withhold access, exchange, or use of EHI to protect patients, providers, and others in accordance with the Office of Civil Rights’ (OCR) policies on protecting reproductive health information under the Health Insurance Portability and Accountability Act (HIPAA).

Physicians and other providers are committed to protecting their patients from all forms of harm, yet the lack of clear federal policies on the intersection of reproductive health information and information blocking requirements has placed them in serious ethical dilemmas and at risk of federal penalties.

The HITEU Alliance also requests that ASTP limit the burden of using the exception when acting in good faith. As currently constructed, actors must work through a range of conditions in order to satisfy the exception’s requirements, creating uncertainty and documentation burden.

Requestor Preferences. The HITEU Alliance supports the proposed addition of a Requestor Preferences Exception. This exception is appropriate for circumstances when a patient or other requestor asks for only certain information or asks for a delay in receiving information. For example, physicians and other health care professionals have expressed concerns that some patients do not want to receive life-changing diagnoses or lab results in advance of a clinical encounter, and experience real harm when they do not have appropriate guidance or context for understanding clinical information.

The HITEU Alliance urges ASTP to modify the proposed requirement that the preferences of a patient or other requestor be provided in writing. This requirement is overly restrictive and does not recognize that patient preferences, in particular, may be expressed verbally, such as during a clinical visit. We recommend that ASTP instead require that the preferences be documented by the actor.

Support from Certified Electronic Health Record (EHR) Technology. While the newly proposed exceptions provide additional flexibility for clinicians to protect their patients and other providers from inappropriate legal actions and to respect the preferences of patients and other requestors, we caution that the information blocking rules are generally overly complex, leading to confusion among end-users and conservative behavior by providers and vendors. Furthermore, ASTP has not included certification criteria that would result in EHR functionality that supports the use of these exceptions or limit the need for them by advancing technical tools for segmenting data.

To ease the burden of regulatory compliance through technology, the HITEU Alliance encourages ONC to accelerate efforts to advance digital tools that support data segmentation for privacy. This would allow  physicians and other providers to have more confidence that they can engage in information sharing without revealing sensitive information, including reproductive health data, that could negatively impact patients or lead to noncompliance with local, state, or federal privacy laws. We also recommend that ASTP require certified EHR functionality that supports health care providers in recording patient-level information that is needed for compliance with information blocking, such as patient preferences for the release of data to be withheld or delayed, or specific concerns about preventing harm or protecting privacy.

Prior Authorization APIs

ASTP proposes to adopt standards and certification criteria for Prior Authorization API functionality, which would deploy Fast Healthcare Interoperability Resources (FHIR)-based exchange using a set of implementation guides (IGs) developed by the Health Level Seven International (HL7) Da Vinci Project. These APIs are designed to allow providers to request coverage requirements, submit needed documentation for authorizations, and receive notification back from the payer on authorization status. ASTP proposes to include these functions in the Base EHR definition, which means that eligible hospitals and clinicians must implement them in order to comply with the Medicare Promoting Interoperability Program and Merit-Based Incentive Payment System (MIPS) requirements to use certified EHR technology (CEHRT), with no additional regulatory action by the [5]

The HITEU Alliance is concerned that there is no similar requirement on payers and health plans to adopt certified technology. In fact, CMS does not even require regulated plans use the Da Vinci Project IGs for the prior authorization APIs, but only recommends their use.[6] We urge ASTP and CMS to only require providers to use certified, standards-based APIs for prior authorization if payers are required to also do so, and on the same timeline. Having both parties use conformant, certified technology will increase the likelihood of success.

The HITEU Alliance generally supports solutions to the prior authorization challenges that currently face clinicians and are hopeful that technology can play a key role. In addition to the growing administrative burden of managing a very complex and often manual prior authorization process, providers and others have noted that prior authorization can delay access to care, result in patients abandoning a recommended treatment, and lead to higher out-of-pocket costs.[7]

However, we are concerned that the Da Vinci Project APIs may not have undergone sufficient real-world testing to date. Consistent with our Real-World Testing Consensus Statement, the IGs must undergo timely, real-world testing that provides transparent information to assess maturity and support adoption. The testing should create an understanding of whether the IGs will:

• Be implementable by health care organizations without significant effort beyond the value incurred by adoption;
• Be effective at achieving the desired goal;
• Encompass a complete solution to achieve the desired goal;
• Not result in unintended consequences that would harm individuals (caregivers, patients, physicians, and other clinicians);
• Respect and accommodate the privacy needs of individual patients;
• Not add extraneous work to the care team;
• Ensure sufficient return on investment to justify the health IT spend; and
• Not disparately impact providers who care for communities that are underserved/ marginalized.

It is encouraging that CMS approved a HIPAA exceptions process for voluntary use of the Da Vinci Project prior authorization APIs that included requirements for reporting on the outcome. We are concerned, however, that ASTP is moving ahead with these certification proposals before the findings of the exceptions process have been released to the public, or even referenced in this rulemaking. CMS specifically stated in its approval letter that “[t]he goal of the test is to determine whether FHIR based standards will reduce the cost, complexity, and reduce the burden of the prior authorization transaction” and required a report with findings to be provided to CMS by mid-July 2024.[8]

Pace of change in regulatory requirements and need for greater end-user input and education

As noted in the HITEU Alliance Roadmap, those who use technology tools for care – health IT end-users – face a growing set of federal mandates over the next four years. While each rule addresses important objectives, understanding the complete regulatory landscape highlights implementation challenges, areas of overlap, and even potential conflict.

The HTI-2 proposed rule includes a vast array of regulatory proposals that must be considered within the full context of other regulatory requirements. We applaud ASTP for addressing some areas of regulatory challenge or conflict through policies such as the proposed Protecting Care Access Exception to information blocking. However, many of the proposed new policies will add to existing requirements, including those first introduced in the HTI-1 Final Rule, which was published on January 9, 2024 – barely six months before ASTP released HTI-2 (July 10). In fact, many, if not most, of the provisions in HTI-1 have yet to be implemented (such as adoption of United States Core Data for Interoperability (USCDI) v3 or the Decision Support Interventions, among others).

It is challenging for end-users, and particularly those on the front lines of care delivery, to adequately absorb and assess the proposals in HTI-2 given the many other demands on their time and other regulatory proposals yet to be implemented (HTI-1) or under consideration (such as those contained in CMS payment rules). However, the ASTP rules have a significant impact on the tools available to end-users, their workflows, and their technology costs, thus meriting substantive review. This impact is even more direct given recent CMS rulemaking that leads to automatic alignment of ASTP’s definition of the Base EHR with Medicare’s definition of CEHRT that eligible hospitals and clinicians must use to avoid penalties under the Promoting Interoperability Program (PIP) and meet performance thresholds for MIPS.

The HITEU Alliance recommends that ASTP take a step back and reconsider how the proposals in the HTI-1 and HTI-2 rules fit together, where it makes sense to learn from implementation of HTI-1 provisions before advancing new requirements, and what bandwidth end-users have to update their systems to accommodate these priorities. For example, ASTP has proposed to include in the definition of the Base EHR for providers both a set of prior authorization APIs and a public health API even before payers and public health agencies are required to use certified health IT to communicate with providers.

The HITEU Alliance would be pleased to be a resource and engage in discussions of priorities, timelines, and the need for sub-regulatory guidance and education for physicians and other health care providers that must buy, deploy, and use certified systems to care for patients.

Conclusion

The HITEU Alliance applauds ONC for taking steps to improve the standardization and sharing of health information in support of clinical care. We stand ready to work with ONC to ensure that the end-user perspective is taken into account as the public and private sectors collaborate to make further progress.

[1] https://hitenduser.org

[2] Data to support equity consensus statement (hitenduser.org)

[3] Real-world testing consensus statement (hitenduser.org)

[4] EndUsersAllianceRoadmap-Digital-FINAL.pdf (hitenduser.org)

[5] Calendar Year 2024 Program Requirements | CMS

[6] https://www.cms.gov/priorities/key-initiatives/burden-reduction/interoperability/policies-and-regulations/cms-interoperability-and-prior-authorization-final-rule-cms-0057-f

[7] Consumer Problems with Prior Authorization: Evidence from KFF Survey | KFF and https://www.ama-assn.org/system/files/prior-authorization-survey.pdf.

[8] Da Vinci HIPAA Exception – Da Vinci – Confluence (hl7.org)

The Health IT End-Users Alliance (the Alliance) appreciates the opportunity to provide the Office of the

National Coordinator for Health IT (ONC) with feedback on the Advancing Health Equity by Design and Health Information Technology: Proposed Approach, Invitation for Public Input, and Call to Action white paper, as published on ONC’s website on April 5, 2024.

The Alliance brings together health information professionals, physicians, hospitals, and other front-line health care providers and organizations that use health IT in the provision of care to ensure that policy and standards development activities reflect the complex web of clinical and operational challenges facing those who use technology tools for care. By working collaboratively across settings of care, the Alliance is focused on priorities for how technology can best support clinical care and operations.

The Alliance appreciates ONC’s commitment to prioritizing health equity as a throughline in the design, build, and implementation of health IT policies, programs, and workflows. We share ONC’s vision of Health Equity by Design (HEBD) designing and building for the diversity of uses and end-users, including using health IT to leverage health data into action by identifying and reducing disparities. The Alliance strongly agrees with ONC that HEBD cannot be limited to part of the health care ecosystem – it must be incorporated into every facet of health care for true health equity to be achieved. We see end-users playing a role in all components of HEBD and have identified areas of opportunity for collaboration below.

Priorities for Health Equity by Design

Data Collection and Use to Operationalize Health Equity

Achieving equity in health and health care is a shared priority for health care end-users that includes the collection of needed data to identify disparities and work towards improving care delivery for better patient outcomes. The Alliance strongly encourages ONC to consider how the standardization, collection, and reporting of data, particularly social drivers of health (SDOH) data, can best be leveraged within its HEBD approach. Collecting SDOH data in a way that is culturally appropriate, favors self-reporting, and

aligns with individual preferences requires specific skills, and connecting individuals with appropriate services to address SDOH needs requires significant effort. We believe federal support will be required to create and test standardized and validated data elements and data collection tools, and we encourage ONC to work with CMS, end-users, and other health care stakeholders in the development of these tools.

The Alliance appreciates ONC’s recently published draft 2024-2030 Federal Health IT Strategic Plan (the draft Plan) containing objectives related to advancing the collection and use of standardized SDOH data; ensuring data collection involves appropriate consent for and understanding of secure sharing and use of this information; and encouraging equity, safety, and user-centered design principles in the development and use of health IT. While flexibility in screening tools and processes can allow end-users to best collect these data within existing workflows and environments, the lack of standard approaches can lead to inconsistent data classifications and collection, struggles to track progress over time, and the inability to share this data across organizations and care settings to efficiently coordinate care.

The Alliance acknowledges there can be great uncertainty for end-users in terms of operationalizing health equity throughout health IT systems, including how the technology that powers those systems supports (or hinders) that process. Health IT tools cannot be fully evaluated in isolation; they must be considered in the context of a health care facility’s operations and clinical workflow and their ability to deliver in that environment. We believe ONC’s vision for HEBD should emphasize the importance of developing the necessary technology supports and operations from the outset, because those health IT tools and operations can then find and collect health equity data, which will help create more understanding of health equity within an end-user’s organization.

As ONC identifies areas to expand its work in HEBD, the Alliance encourages the inclusion of the Office of Management and Budget’s (OMB) Directive No. 15: Standards for Maintain, Collection, and Presenting Federal Data on Race and Ethnicity1 in future workplans. Directive No. 15 combines the collection of race and ethnicity information into one question on the census and other federal forms. This change implemented by OMB creates a technical need for end-users as how and where they collect this data will now shift. As we discussed above, we encourage ONC to identify standardized approaches with the inclusion of end-user feedback while developing HEBD compliance materials.

Improved collection and use of relevant demographic and social factor data to identify and guide efforts to address disparities can positively impact health care delivery and operations. Collecting duplicative data or reporting it to government programs without realistic opportunities to connect the data to care improvements only increases burden and may be seen by patients as overly intrusive. The Alliance’s Data to Support Equity Consensus Statement references several principles to guide efforts to ensure the collection of this data prioritizes health equity, is used optimally and appropriately, is actionable, and remains purpose-driven:

• • Prioritize continued development of standardized and validated SDOH data elements to be collected in a consistent, comparable fashion for priority domains.
• • Align selected domains across federal and state health care programs and reporting requirements, and by commercial health plans.
• • Develop consensus on validated instruments to be used for data collection.
• • Recognize the shared obligation across providers, public programs, payers, and community-based organizations to collect and appropriately share SDOH data, with appropriate compensation for data collection and management of health-related social needs, as well as ensuring the availability of data for providers to support clinical and social care delivery.
• • Keep the primary focus on collecting demographic and SDOH data to meet patient needs.
• • Support patient privacy through the adoption of comprehensive data privacy practices for all health care stakeholders.
• • Federal, state, and local governments and health plans should actively provide funding, technical resources, and infrastructure to support training, implementation, and care coordination.
• • Continue and expand research to improve SDOH data collection to optimize improved equity, including appropriate use of demographic and SDOH data in artificial intelligence tools to ensure disparities are identified and addressed alongside mitigating bias and harm.

Artificial Intelligence

When examining the many opportunities for incorporating HEBD into the health care ecosystem, the Alliance recommends ONC specifically consider the role of artificial intelligence (AI) tools within health IT. Research has shown that using AI can increase the accuracy of imaging studies, improve the safety of some medical devices, support clinical diagnosis, and optimize the scheduling of operating rooms. However, those who design these tools are generally not the people using them to provide care, which can lead to serious gaps in the design and intent of these tools compared to their implementation and impact. These design gaps can unintentionally exacerbate disparities and perpetuate inequities within health care. We support federal standards and guidelines that incorporate both risk management approaches and transparency measures to support safe, equitable, and appropriate use of AI tools in health care.

Real-World Testing

Over the past decade, end-users have found that new technical approaches to gathering and sharing health information—that are then included in regulatory requirements—are not sufficiently grounded in real-world experiences and do not adequately consider the implementation pathway for health care. This includes issues such as how new approaches work within existing infrastructure, engaging with and educating patients on their role in utilizing the technology, and how new tools and requirements will fit into the array of regulatory requirements that health IT end-users face. The Alliance’s Real-world Testing Consensus Statement references several principles that support ONC’s HEBD goals, as real-world testing of standards prior to mandated adoption would allow for more comprehensive, equitable standards to be designed, built, and implemented:

• • Real-world testing should inform and investigate whether the standard (or health IT policy) will encompass a complete solution to achieve the desired goal, respect and accommodate the privacy needs of patients, or disparately impact clinicians who care for underserved or marginalized communities.
• • Health IT end-user engagement should be supported to maximize the end-user’s ability to provide effective input, including prioritizing clinicians who care for the underserved and providing those clinicians resources in order to facilitate their participation.
• • The health IT community should work together to identify expectations for rigorous real-world testing, including needed metrics, methods of accountability, external expert review, impact on health equity, and public reporting of the outcome.
• • Standards and health IT policies must ensure equity and embrace diversity by including end-user involvement, conducting real-world testing, and creating resources for standards development.

A Diverse Workforce

The Alliance strongly believes that a diverse health care workforce reflective of the U.S. population is needed to address health disparities and increase health equity. This is especially true for patients of color,

who tend to be less healthy than the U.S. majority, experience less access to care, and receive a lower quality of care due to systemic racism and accompanying systems of oppression. Achieving a more diverse workforce is essential to improving patient outcomes and society’s overall health.2 A workforce reflective of the population supports all end-users to provide more accessible, inclusive, comprehensive, responsive, and culturally effective care to reduce or eliminate health disparities. We encourage ONC to work with other HHS partners, including the Office of Minority Health (OMH) and the Health Resources and Services Administration (HRSA), to develop strategies to continue increasing the diversity of the clinician workforce as an important aspect of HEBD.

Patient Privacy and Trust

The Alliance agrees with ONC on the importance of protecting patients’ data privacy and that it is an important aspect of HEBD. Patients often don’t understand when their electronic health information (EHI) flows out of Health Insurance Portability and Accountability Act (HIPAA)-covered entities and beyond the protection of HIPAA, and therefore are unlikely to be fully aware or understand how non-covered entities can use and share their EHI. The Alliance recommends ONC provide further education for individuals and work with other federal government partners to ensure appropriate statutes and regulations are in place to protect individuals’ EHI when not covered under HIPAA protections. Providing patients with a baseline understanding of who is responsible for protecting their EHI in various situations would support health equity and reduce disparities in patient health education levels.

Expanding ONC-Stakeholder Engagement on Health Equity

The Alliance appreciates ONC’s desire to hear from the health care community on how best to advance health equity and joins ONC in viewing HEBD as a collaborative partnership that will require all parts of the health care ecosystem to work together in order to achieve its goals. We believe practicing clinicians and health care facility staff are key stakeholders in these discussions and would welcome the opportunity to convene or engage in a meeting between ONC and a diverse group of end-users to build cooperation and understanding for what would make ONC’s vision of HEBD most successful. The Alliance looks forward to connecting further to discuss how we might best facilitate or participate in a meeting that would provide ONC with the most helpful feedback.

Conclusion

The Alliance applauds ONC for taking steps to further its HEBD goals by prioritizing health equity as a key feature during the design, build, and implementation of health IT policies, programs, projects, and workflows. We stand ready to work with ONC to ensure that the end-user perspective is taken into account as public and private sector stakeholders collaborate to make further progress in designing systems centered around health equity.

The Health IT End-Users Alliance (the Alliance) appreciates the opportunity to comment on the Office of the National Coordinator for Health IT (ONC) draft 2024-2030 Federal Health IT Strategic Plan (the draft Plan), published on March 27, 2024.

The Alliance brings together health information professionals, physicians, hospitals, and other front-line healthcare providers and organizations that use health IT in the provision of care to ensure that policy and standards development activities reflect the complex web of clinical and operational challenges facing those who use technology tools for care. By working collaboratively across settings of care, the Health IT End-Users Alliance is focused on priorities for how technology can best support clinical care and operations.

The Alliance appreciates ONC’s commitment to improving health experiences and outcomes for individuals, populations, and communities while also promoting opportunities for improving health equity, advancing scientific discovery and innovation, and modernizing the nation’s public health infrastructure. We share many of ONC’s goals for addressing the policy and technology components essential for meeting the diverse data requirements of all health IT users. While the Alliance sees great alignment in the objectives of goals two – Enhance the Delivery and Experience of Care – and four – Connect the Health System with Health Data; we see end-users playing a role in all components of the draft Plan and have identified areas of opportunity for collaboration below.

Interoperability and Data Sharing Through Real-World Testing

The development of new health IT standards and their adoption into regulatory requirements can bring benefits by addressing specific challenges and creating more uniformity in how health information is gathered, shared, and used. The Alliance appreciates ONC’s intent to collaborate across public and private sectors on health IT standards’ maturity, adoption, and use, as well as improve alignment and automation of data collection and reporting to reduce burden and costs associated with federal requirements. The Alliance also agrees with the need to develop, align, test, and implement data standards to increase interoperability.

Over the past decade, end-users have found that new and compounding regulatory requirements were not sufficiently grounded in real-world experiences and did not adequately consider the implementation pathway before mandated use. Adequate and inclusive testing of standards should be done before they are included in regulation. End-user input should be part of every phase of the development, maturity, testing, and implementation of health IT standards.

We are pleased ONC references real-world performance throughout the draft Plan. We note, however, that while the real-world testing requirements included in ONC’s certification rules are helpful to assess how products perform after implementation, they are not the same as real-world testing in advance of inclusion in regulation. The Alliance’s Real World Testing Consensus Statement outlines several key principles to leverage the input of health IT end-users to ensure standards and policies are efficiently adopted and implemented, keep burden minimal, and accomplish the desired tasks. Key principles include:

• • End-users must be instrumental in establishing goals and priorities for setting standards.
• • End-user input should be included in every phase of standards development from initial standard scoping to real-world testing.
• • Standards and policies to advance standards adoption should prioritize patient care and wellness and public health.
• • Real-world testing should include real-world implementations, production pilots, collection of metrics, training needs for staff, markers of success, and estimated costs and benefits.
• • Standards shouldn’t be considered mature, or included in regulation, until real-world testing has been completed and report outs are made public.
• • Continuous monitoring of standards after deployment.

Standards and policy should ensure equity and embrace diverse end-user involvement.
The Alliance encourages ONC to include a diverse set of end-users from various types, sizes, and settings of healthcare organizations in all phases of real-world testing. We encourage ONC to work with the Centers for Medicare & Medicaid Services (CMS), other relevant federal agencies, and the broader health IT community to identify expectations and needed elements for the successful real-world testing of standards. Again, this testing must happen in advance of inclusion in certification requirements and needs to go beyond what is included in the real-world testing requirements in the certification regulations.

Advancing Health IT in Clinical Workflows with the End-User Perspective

New technologies must be integrated as seamlessly as possible into existing clinical workflows. The Alliance strongly supports ONC’s objectives to promote the use of health IT and other modern technologies in clinical workflows and to provide support for healthcare professionals for easier adoption, implementation, and use of secure health IT.

We commend ONC for recognizing the need for resources and support focused on end-users. We encourage ONC to consider the needs of different clinical settings and organizations of different sizes. Information dissemination through webinars and broad implementation guides is a necessary first step, but end-users would benefit further from tailored assistance that accounts for and builds on the different capabilities of various organizations. We recommend ONC offer forums for end-users to identify needed resources and technical assistance. These feedback processes should bring end-users together with federal agency staff, technology vendors, and other key stakeholders to outline actionable steps for streamlining and improving implementation of health IT.

Further, the Alliance supports the ONC objective to engage health IT end-users across the industry in health IT development, optimization, and usability testing so that the needs of end-users are reflected. We also support ONC’s objective to investigate the impact and effectiveness of health IT on care outcomes. As referenced above, a federally supported, collaborative process to engage stakeholders in real-world testing is crucial for success. Real-world testing must be done in advance of regulatory requirements, though it should not end with implementation of technology and standards. A lifecycle approach to product monitoring will help to ensure the goal of improved patient care is being accomplished. Yet, ONC, CMS, developers, and other healthcare stakeholders should endeavor to mitigate or eliminate any monitoring burden that could be placed on providers.

The Alliance appreciates ONC’s continued commitment to streamlining electronic documentation requirements to reduce burden and improve the quality of patient health records, including leveraging health IT to standardize data and processes related to electronic prior authorization. Improving the prior authorization process will require federal support of more robust real-world testing of interoperability standards and implementation guides intended to facilitate automation. Greater engagement with the health IT end-user community will help create a better understanding of the effort needed to operationalize technology solutions and business processes needed to interact with payer systems.

For example, stakeholders would benefit from understanding the scope and outcomes of pilot projects that used the Health Level Seven (HL7) DaVinci Project standards for electronic prior authorization before proposing any requirements that they be supported in certified health IT products. In April 2021, CMS approved a request from the HL7 Da Vinci Project for an “exception from use of adopted standards, as provided under 45 CFR 162.940, to test Fast Healthcare Interoperability Resources (FHIR) based standards. The goal of the test is to determine whether FHIR based standards will reduce the cost, complexity, and reduce the burden of the prior authorization transaction.” CMS required reporting of findings from the pilot not later than July 14, 2024. Before moving forward with any regulations, federal officials and end-users should evaluate those findings to understand whether the pilot was successful, how standards might need to be modified, and whether the results are scalable to other settings of care and across providers and payers of all sizes. Additional real-world testing may also be needed.

Pursuant to stakeholder concerns, CMS recently issued an enforcement discretion statement exempting the industry from the use of the HIPAA mandated prior authorization transaction. We strongly urge that ONC continue to monitor the scalability of FHIR as it relates to prior authorization workflows and the impact of the enforcement discretion on the industry, to include implementation variations and any associated impacts on interoperability.

Social Determinants of Health Data Collection and Use to Address Health Inequities

care is a shared priority of the healthcare field that includes the collection of needed data to identify disparities and work towards improving care delivery for better patient health outcomes. Federal health programs are increasingly incorporating policies that encourage or require screening and the collection of demographic and social determinants of health (SDOH) data. The Alliance supports SDOH programs when needed data are collected and used appropriately. However, standardization and increased uniform collection and reporting of relevant data are necessary to limit burden and ensure that only needed data are collected. This can best be accomplished with more resources for providers to offset the costs of training staff, updating systems, and developing systems to leverage these data to improve care.

Throughout all goals in the draft Plan, the Alliance is pleased to see objectives related to advancing the collection and use of standardized SDOH data; ensuring data collection involves appropriate consent for and understanding of secure sharing and use of this information; and encouraging equity, safety, and user-centered design principles in the development and use of health IT. While flexibility in screening tools and processes can allow providers to best collect these data within existing workflows and environments, the lack of standard approaches can lead to inconsistent data classifications and collection, struggles to track progress over time, and the inability to share this data across organizations and care settings to efficiently coordinate care. We stress that, without appropriate data sharing guardrails (both technical and policy-driven), patients may lose trust in data protection and may refrain from open and honest communication with their providers—impacting care and negating the usefulness of health IT.

Improved collection and use of relevant demographic and social factor data to identify and guide efforts to address disparities can positively impact healthcare delivery and operations. Collecting duplicative data for the sake of collecting data or reporting it to government programs without realistic opportunities to connect the data to care improvements only increases burden and may be seen by patients as overly intrusive. The Alliance’s Data to Support Equity Consensus Statement references several principles to guide efforts to ensure the collection of this data is used optimally and appropriately, is actionable, and remains purpose-driven:

• • Prioritize continued development of standardized and validated SDOH data elements to be collected in a consistent, comparable fashion for priority domains.
• • Align selected domains across federal and state healthcare programs and reporting requirements, and by commercial health plans.
• • Develop consensus on validated instruments to be used for data collection.
• • Recognize the shared obligation across providers, public programs, payers, and community-based organizations to collect and appropriately share SDOH data, with appropriate compensation for data collection and management of health-related social needs, as well as ensuring the availability of data for providers to support clinical and social care delivery.
• • Keep the primary focus on collecting demographic and SDOH data to meet patient needs.
• • Federal, state, and local governments and health plans should actively provide funding, technical resources, and infrastructure to support training, implementation, and care coordination.
• • Continue and expand research to improve SDOH data collection to optimize improved equity.

The Alliance also appreciates the objective to harmonize common data elements for improved interoperability. We support efforts to standardize and increase uniform collection and reporting of relevant data, but more needs to be done to support end-users. In addition to standardization, end-users need training in how best to collect sensitive data, the tools and workflows best equipped to collect and share it effectively, and how to avoid redundant or inaccurate data collection. Federal policies must also reflect the realities end-users face, including the limitations of certified health IT to protect sensitive health information.

The Alliance recommends ONC continue working with CMS to support the development of standardized data elements, including the US Core Data for Interoperability (USCDI). Tools to collect and share SDOH data should undergo real-world testing with input from end-users to increase the likelihood that these technical approaches will succeed. Lastly, providing resources, tools, and training will widen the opportunity for end-users to be able to collect this information and work with community organizations to implement closed referral loops to monitor impacts and interventions on health disparities and health outcomes.

Artificial Intelligence and Decision Support Interventions

The rapid proliferation and advancement of artificial intelligence (AI) tools in healthcare is already impacting end-users. The Alliance appreciates the draft Plan objectives on promoting education, outreach, and transparency about the development and use of AI algorithms, as well as promoting the safe and responsible use of AI tools for care delivery supported by decision support interventions (DSIs). Most end-users will be reliant on AI tool developers and their EHR vendor for integrating the tools. Including the input of end-users and providing transparency throughout the life cycle of AI innovation, technology development, implementation, and use will help contribute to the safe and appropriate use of these technologies.

Building on DSI transparency policies finalized in the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, the Alliance encourages ONC to work with federal partners and industry to identify transparency requirements that provide useful and actionable information for end-users and patients. ONC and other federal agencies should actively engage end-users to identify the most appropriate list of DSI attributes to include in transparency requirements and evaluate how best to share this information with end-users for their use. This must include assessments and guidance to identify and mitigate possible bias. End-users will also need plain language descriptions from tool developers to support patient education efforts. Like electronic prior authorization, we encourage ONC to include consideration of end-users in these efforts as this landscape continues to develop, ensuring a shared responsibility across both end users and DSI developers to prioritize improved patient care while preserving safety and addressing biases. ONC should also encourage certified health IT developers to identify common and effective approaches to presenting or displaying DSI attributes. A wide variation in DSI transparency across developers may encumber provider use of this information and undermine the goals ONC has established.

Conclusion

The Alliance supports ONC’s visions and focused, yet comprehensive, goals to improve the health and well-being of individuals and communities using technology and health information that is accessible when and where it matters most. We look forward to engaging with ONC and other federal partners to contribute our diverse expertise to accomplishing these goals and objectives.

The left side of the table is a list of the federal regulatory final rules in no specific order. The 21st Century Cures Act and the ONC HTI-1 Final Rule are divided into specific subparts to demonstrate the different regulatory requirements and various agency involvement.

The collaborative roadmap is available for download here.

January 31, 2024

Dr. Laurie Locascio
Under Secretary of Commerce and Technology
Director of the National Institute of Standards and Technology (NIST)
Submitted electronically to www.regulations.gov

RE: NIST–2023–0309, Request for Information (RFI) Related to NIST’s Assignments Under Sections 4.1, 4.5 and 11 of the Executive Order Concerning Artificial Intelligence

Dear Dr. Locascio:

The Health IT End-Users (HITEU) Alliance appreciates the opportunity to provide the National Institute of Standards and Technology (NIST) with feedback on the Request for Information (RFI) Related to NIST’s Assignments Under Sections 4.1, 4.5 and 11 of the Executive Order Concerning Artificial Intelligence, as published in the December 21, 2023 Federal Register.

The HITEU Alliance brings together health information professionals, physicians, hospitals, and other front-line health care providers and organizations that use health IT in the provision of care to ensure that policy and standards development activities reflect the complex web of clinical and operational challenges facing those who use technology tools for care. By working collaboratively across settings of care, the Health IT End-Users’ Alliance is focused on priorities for how technology can best support clinical care and operations.

Our comments are grounded in the HITEU Alliance’s Consensus Statements on Data to Support Equity and Real-World Testing. They focus on:

• Ensuring that end-users are sufficiently engaged in standards and guidance development, including for complex issues such as generative artificial intelligence (AI); and
• Providing end-users with adequate tools and information to safely and effectively use AI and other technology for care.

Standards and Guidance Development Must Include End-Users

Under Executive Order 14110 – Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence – the National Institute of Standards and Technology (NIST) has been tasked with the crucial role of establishing guidelines and best practices to support the development and deployment of safe, secure and trustworthy AI systems. Among other things, NIST will develop a companion resource to its existing AI Risk Management Framework to address generative AI. NIST has also been tasked with providing guidance to a wide range of federal agencies on their own use of AI, and possible regulatory activities.

As a coalition of those who use technology to provide health care, the HITEU Alliance urges NIST to consider the unique attributes of the health care sector and actively engage the end-users of AI tools as you complete your work.

The development of new health information technologies (IT) can bring benefits to both clinical care and operations. Artificial intelligence is no different – research has shown that using AI can increase the accuracy of imaging studies, improve the safety of drug pumps and other medical devices, support clinical diagnosis, and optimize the scheduling of operating rooms, among other things.

However, those who design these tools are generally not the ones who are using them to provide care. Over the past decade, end-users have found that new technical approaches to gathering and sharing health information that are then included in regulatory requirements are not sufficiently grounded in real-world experiences and do not adequately consider the implementation pathway for health care. This includes issues such as how new approaches work with the existing infrastructure that is deployed, workflow constraints to adopting new technology (including limitations confronting small, solo, and rural medical clinics), technology costs, engaging with and educating patients on their role in utilizing the technology, and how new tools and requirements will fit into the array of regulatory requirements that health IT end-users face.

All of these real-world concerns are likely to also apply to AI tools that will be created and used in the years to come. In addition, we would note that AI tools may also impact the health care workforce by automating some tasks, creating new roles, and resulting in significant additional training needs.

The HITEU Alliance encourages NIST to include in its standards and guidelines both risk management approaches and transparency measures that support safe, equitable, and appropriate use of AI tools in health care.

Health care providers will need information from the developers of AI tools to ensure safe and appropriate use. For example, they will need to know that a developer has undertaken efforts to ensure that an AI tool is accurate and safe for specific populations, and whether it has gone through the Food and Drug Administration’s (FDA) approval process. They will also need information that explains how a model works.

Researchers and others have identified concerns about AI tools in use in health care today that may embed bias or have other unintended clinical consequences. More transparency on the training data and algorithms used to create AI tools, as well as results from analyses and evaluations of AI tools, will support clinicians and other end-users in assessing whether and how to use these tools. The development of model cards or other standardized forms of transparency will be crucial for demonstrating the benefits and limits of a particular tool. For example, in a 2023 survey nearly eight in 10 physicians said a summarization of key points, purpose, capabilities, and limitations along with examples of real-world scenarios would be most useful in providing them information about AI tools. Moreover, in health care, end-users will play a vital role in communicating and sharing information with patients. Therefore, guidelines for AI tool developers should address both what the user of a tool needs to know, as well as the information they will then need to share with patients.

As noted in our Data to Support Equity Consensus Statement, achieving equity in health and health care is a key priority. Given the ways in which AI has been shown to replicate bias in the data used to train and deploy AI tools, we urge NIST to provide guidance on ways to detect and mitigate bias in AI tools, as well as transparency requirements for AI tool developers related to:

• Disclosure of any known concerns and steps to mitigate bias;
• Attributes of the data used to train a tool;
• Specific populations for which a given tool may be appropriate or inappropriate;
• Data use and protection policies; and
• Updates over time on whether a tool is experiencing “drift” that may affect its accuracy.

The HITEU Alliance recommends that NIST actively engage end-users and other stakeholders to identify the most appropriate list of AI attributes to include in any transparency guidelines for health care. Working together, the clinical, operational, and technical communities can identify how best to balance usability and completeness in creating a “nutrition label” for AI tools used in caring for patients.

Conclusion

HITEU Alliance members appreciate the opportunity to comment on this RFI and would welcome the opportunity to collaborate with NIST to share the end-user perspective on IT tools used in health care as this important work continues.

September 11, 2023

Dear Administrator Brooks-LaSure:

The Health IT End-Users (HITEU) Alliance appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) proposed rule entitled Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health Program, as published in the August 7 Federal Register.

The HITEU Alliance brings together health information professionals, physicians, hospitals, and other front-line health care providers and organizations that use health IT in the provision of care to ensure that policy and standards development activities reflect the complex web of clinical and operational challenges facing those who use technology tools for care. By working collaboratively across settings of care, the HITEU Alliance is focused on priorities for how technology can best support clinical care and operations.

Our comments below focus on the section of the proposed rule that supports collecting and using data to address social determinants of health (SDOH). Specifically, CMS proposes to add codes and payment rates for three services that support the needs of individuals when social and other factors affect the ability of physicians and other clinicians to create and carry out a plan of care. The proposals include:

• Two new G codes for Community Health Integration (CHI) Services (initiating visit and subsequent services) that are incident to a professional service and that can be provided by certified or trained auxiliary personnel, which may include a community health worker. These services would allow for the identification of and services to address particular SDOH needs that are interfering with, or presenting a barrier to, diagnosis or treatment of a patient’s problem. These codes would support both conducting a person-centered assessment, as well as coordinating receipt of needed services from health care practitioners, home- and community-based services, social services, and caregivers, as well as care transitions.
• One new stand-alone G code to support the administration of a standardized, evidence-based Social Determinants of Health Risk Assessment that can be billed on the same day as an evaluation and management visit. The assessment would include the domains of food insecurity, housing insecurity, transportation needs, utility difficulties, and any other relevant factors.
• Adding the SDOH risk assessment to the annual wellness visit as an optional, additional element with an additional payment.
• New coding for Principal Illness Navigation (PIN) Services focused on patients with a serious, high-risk illness. Parallel to the proposed CHI services, PIN services could be incident to a professional service and provided by certified or trained auxiliary personnel, which may include a community health worker or care navigator.

The HITEU Alliance supports the Agency’s goal of improving the ability of physicians and other clinicians to gather information on social determinants of health and to involve community health workers, care navigators, and peer support specialists in furnishing medically necessary care. We commend CMS for recognizing the need to reimburse clinicians for the costs associated with identifying and addressing the social and other non-clinical factors that affect the health of individuals. Collecting this information in a way that is culturally appropriate, favors self-reporting, and aligns with individual preferences requires specific skills, and connecting individuals with appropriate services to address SDOH needs requires significant effort. We caution, however, that achieving the Agency’s goals will require federal support to create and test standardized and validated data elements and data collection tools, as well as mechanisms to share these types of data with semantic interoperability. We encourage CMS to work with end users in the clinician community as well as standard development organizations such as HL7 in informing these tools.

While we understand the urgency to address SDOH needs today and encourage CMS to finalize its proposals, we also recommend that CMS work with the Office of the National Coordinator for Health IT (ONC) and other agencies to support the development of standardized data elements and tools that can be tailored to the needs of a given setting or specialty. Without standardization, it will be challenging to share data across care providers and community-based organizations (CBOs) with common understanding, and providers may find that they need to collect data that others have already collected, leading to burden for both the care team and the individual. Most CBOs will not be able to easily document CHI or PIN services in patients’ health records and will have to find alternate ways to share information with a patient’s care team, slowing care coordination and adding administrative burden. CMS is well positioned to work with ONC and other stakeholders to advance solutions that better enable interoperable data between the traditional health care system and CBOs.

In our Consensus Statement on Data to Support Equity, the HITEU Alliance identified eleven principles to guide public and private sector efforts to ensure that relevant demographic and social factor data are available to advance equity. They include, among others, the need to:

• Develop consensus on validated instruments to be used for data collection (as appropriate for a given setting, context, or domain), with a preference for self-reporting of race, ethnicity, and other factors.
• Develop and support adoption of validated technical tools to support both the collection and electronic sharing of these data, as well as technical tools to protect privacy and maintain autonomy over how personal information is used, consistent with individual preferences.
• Keep the primary focus for collecting demographic and SDOH data on meeting patient needs versus secondary uses of the data.
• Retain individuals’ privacy through the adoption of comprehensive data privacy practices by CBOs and other entities.
• Governmental and health plan funding, technical resources, and infrastructure to support coordination between health care organizations and CBOs to connect individuals to resources that will meet their needs.
• Continued and expanded research on how best to collect and leverage SDOH data in ways that are clinically relevant, linked to care plans, and respectful of patient attitudes toward and preferences for the collection of SDOH data.

Tools to collect and share SDOH data should also undergo real-world testing, consistent with the HITEU Alliance’s Consensus Statement on Real-World Testing. Engaging with end users to conduct real-world testing of standardized instruments and tools to collect, share, and use SDOH data in ways that are respectful of individual preferences will increase the likelihood that these technical approaches will succeed and achieve the goals of improving health by addressing the social drivers of health.

Conclusion

The HITEU Alliance supports CMS’ proposals to advance the ability of physicians and other clinicians to identify and address SDOH and related challenges that affect the health of individuals. We look forward to engaging with the Agency and other federal partners on how to advance the development of standardized data elements, evidence-based collection tools, and semantic interoperability in this area.

June 20, 2023

RE: RIN 0955–AA03, Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency (HTI-1) Proposed Rule

Dear Dr. Tripathi:

The Health IT End-Users (HITEU) Alliance appreciates the opportunity to provide the Office of the National Coordinator (ONC) for Health IT with feedback on the Health Data, Technology and Interoperability: Certification Program Updates, Algorithm Transparency (HTI-1) Proposed Rule (RIN 0955-AA03), as published in the April 18, 2023 Federal Register.

The HITEU Alliance brings together health information professionals, physicians, hospitals, and other front-line health care providers and organizations that use health IT in the provision of care to ensure that policy and standards development activities reflect the complex web of clinical and operational challenges facing those who use technology tools for care. By working collaboratively across settings of care, the HITEU Alliance is focused on priorities for how technology can best support clinical care and operations.^[1]

Our comments are grounded in the HITEU Alliance’s Consensus Statements on Data to Support Equity and Real-World Testing. They focus on:

• Adoption of the U.S. Core Data for Interoperability version 3 (USCDI v3) standard
• Patient-requested restrictions certification criterion and the related request for information (RFI) on data segmentation
• Proposals to enhance transparency and risk management for decision support interventions (DSI)

USCDI v3

The USCDI contains the minimum data needed for interoperability and is composed of critical data elements and vocabulary standards used in clinical care. ONC first adopted the USCDI v1 in the 21^st Century Cures Act Final Rule (2020) and proposes to advance to the larger USCDI v3. Among other advances, USCDI v3 will include additional data on social drivers of health (SDOH), including SDOH assessments, goals, and interventions.

The HITEU Alliance supports the ONC proposal to adopt USCDI v3. Adopting USCDI v3 will advance efforts to standardize and increase uniform collection and reporting of relevant data on race, ethnicity, preferred language, and social drivers of health. However, more needs to be done to support physicians, hospitals and other health care providers given Congress’ and the Biden-Harris Administration’s focus on the collection, use, and sharing of this data for public and private programs.

As noted in our Data to Support Equity Consensus Statement, achieving equity in health and health care is a key priority that requires collection of data to identify disparities and monitor efforts to improve. In addition to agreed-upon and validated standards and instruments to support interoperability, end-users need training in how best to collect sensitive data, and the development of tools and workflows to efficiently collect and share data, avoid redundant or inaccurate data collection, and minimize burden on individuals, clinicians, and other providers. Collection of data should be actionable, purpose-driven and supported by appropriate and accessible technology and other resources that support connection to social services and other interventions. The nine principles laid out in our consensus statement address factors such as:

• Aligning domains of SDOH data collection across federal and state healthcare program and reporting requirements;
• Recognizing the shared obligation among public programs, payers, community-based organizations (CBOs), and providers to collect and appropriately share relevant demographic and SDOH data;
• Keeping the primary focus on collecting demographic and SDOH data on meeting patient needs versus secondary uses of the data;
• Supporting the adoption of technical tools to protect privacy and share information consistent with patient preferences; and
• Acting on the need for federal, state, and local governments and health plans to provide funding, technical resources, and infrastructure to support training, hardware and software implementation and maintenance, evaluation and quality improvement, and coordination between health care organizations and CBOs.

HITEU Alliance members would be pleased to work with ONC and other policymakers to continue to advance policy and practice to ensure that we have the necessary data to support equity.

Patient Requested Restrictions and Data Segmentation

The proposed rule includes three provisions related to data segmentation:

• Within the certification criteria, ONC proposes that a health IT developer must enable a provider (or other user) to flag whether any data element in the USCDI should be restricted from use or disclosure and prevent any flagged data from subsequent use or disclosure. ONC does not point to specific standards to achieve this functionality, which would support health care providers in being responsive to patient-requested restrictions that are included as a right in the HIPAA Privacy Rule (45 CFR 164.522(a)(1)(i)(A).
• Within the certification criteria, ONC also proposes that health IT developers must provide the ability for “patients (and their authorized representatives) [to] be able to use an internet-based method to request a restriction to be applied for any data expressed in USCDI.” ONC does not specify how this functionality would be provided but states it could be built into a patient portal, an API, or other method.
• In the information blocking portion of the proposed rule, ONC includes an RFI on health IT capabilities for data segmentation, including discussion of the HL7 standards on Data Segmentation for Privacy (DS4P) and the related HCS Security Label Vocabulary.

As the front line in providing care, HITEU Alliance members believe there is an urgency to solve the issue of data segmentation. End-users need these tools not only to support patient-requested restrictions, but also to navigate the ever-more-complex web of state and federal requirements regarding health information management and privacy, comply with the information blocking rules, and, above all else, maintain the trust between patients and providers that is a bedrock of medicine.

Therefore, in addition to moving ahead with the proposed certification criteria to support patient-requested restrictions, the health IT community must come together and engage in the hard work to further develop and engage in real-world testing of a standardized approach to data segmentation that will support end-users without adding undue burden.

To that end, we urge ONC and other federal agencies to act quickly to deploy a federally supported process to engage stakeholders, including end-users, and establish a collaborative process to both define the needs for data segmentation and evaluate, pilot test, and improve the HL7 DS4P Implementation Guides (IGs) for CCDA and FHIR.

Consistent with our Real-World Testing Consensus Statement, the IGs must undergo timely real-world testing that provides transparent information to assess maturity and support adoption. The testing should create an understanding of whether the IGs will:

• Be implementable by health care organizations without significant effort beyond the value incurred by adoption;
• Be effective at achieving the desired goal;
• Encompass a complete solution to achieve the desired goal;
• Not result in unintended consequences that would harm individuals (caregivers, patients, physicians, and other clinicians);
• Respect and accommodate the privacy needs of individual patients;
• Not add extraneous work to the care team but would reduce burden;
• Ensure sufficient return on investment to justify the health IT spend; and
• Not disparately impact physicians and other providers who care for communities that are underserved/ marginalized.

ONC and other federal agencies should work with the broader health IT community to identify expectations for rigorous real-world testing of data segmentation solutions, such as the needed metrics, methods of accountability, assurance that testing results are impartial, external expert review of testing methods and results, impact on health equity, and public reporting of the outcome. Standards should not be considered mature until real-world testing has been completed and comprehensive report-outs on the testing are made public. Inclusion of standards and IGs in regulation should also not be considered a mark of maturity.

Engaging with end users to conduct real-world testing will increase the likelihood that technical solutions will succeed and achieve the goals of automating appropriate data segmentation without undue burden for patients and providers. Given the importance of this issue, the Alliance looks forward to collaborating with ONC and the broader health IT community to ensure that the end-user perspective is well represented in advancing data segmentation and encourage end-users to engage in real-world testing.

Decision Support Interventions (DSI) and Algorithmic Transparency

ONC proposes to build from the existing certification requirements related to clinical decision support tools to create a broad range of transparency and risk management measures related to DSI, and particularly Predictive DSI, which ONC proposes to define as: “Technology intended to support decision-making based on algorithms or models that derive relationships from training or example data and then are used to produce an output or outputs related to, but not limited to, prediction, classification, recommendation, evaluation, or analysis.”

The HITEU Alliance generally supports ONC’s efforts to create better transparency and risk management around DSI. As noted in the preamble to the proposed rule, researchers and others have identified concerns about DSI tools in use today that may embed bias or have other unintended consequences. More transparency on the training data and algorithms used to create DSIs, as well as results from analyses and evaluations of DSI tools, will support clinicians and other end-users in assessing whether and how to use these tools.

However, the HITEU Alliance is concerned that ONC has cast too broad of a net in creating a proposal that would apply to all predictive DSI, regardless of who created it (health IT developers, health systems, clinicians, and third-party developers). At a minimum, the HITEU Alliance would recommend that ONC exclude from its transparency and risk management requirements any DSI tools that are created by a health care provider organization for its own use, with no intent to commercialize.

Providers already engage in significant research and internal review processes to ensure that the tools they create are evidence-based and will meet their needs. They would not gain any additional information by sharing that information with their EHR vendor for the purpose of having it shared back to them. For example, ONC specifically mentions order sets as a type of DSI that would be included in its regulatory approach. Many provider organizations regularly develop custom order sets that are deployed through their EHR, based on the specific expertise, and needs of their clinicians.

The HITEU Alliance also recommends that ONC and other federal agencies actively engage end-users and other stakeholders to identify the most appropriate list of DSI attributes to include in the transparency requirements. Working together, the clinical, operational, and technical communities can identify how best to balance usability and completeness in creating a “nutrition label” for DSI.

Conclusion

 The HITEU Alliance applauds ONC for taking steps to improve the standardization and sharing of health information in support of clinical care. We stand ready to work with ONC to ensure that the end-user perspective is taken into account as the public and private sectors collaborate to make further progress.