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    April 30, 2021

    Friday Feature | The Role of Governance in Health IT Standardization

    Group therapy in session sitting in a circle in a bright roomBookZurman is proud to share a recent post featuring the insights from guest author, Ron Parker

    The Role of Governance: Realizing Desired Outcomes of Healthcare Interoperability Standardization
    Part 1 | published 04/15/2021

    Interoperability, at its simplest, is the ability for information systems, and the people who use them, to securely and appropriately access and contribute information for a shared collective purpose, with a shared understanding.

    Achieving interoperability at scale in a sector such as healthcare requires standardization on the use of standards-based interoperability across a broad range and numbers of systems, disciplines, workflows, and people in varied roles.

    Only through standardization in the use of consensus-based standards do we achieve the best possible benefits and outcomes latent in the standards themselves. While standards are important, achieving standardization should be a primary goal in governing interoperability.

    Standardization vs. Standards

    Achieving the benefits of interoperability requires the consistent application of consensus-based informatics standards by public and private sector participants across the health sector. However, this requires standardization, not just standards – which are a necessary component of standardization, but don’t provide outcomes in-and-of themselves.

    While the process of defining and managing standards requires skill and tremendous rigor, working to achieve standardization (where the large majority is on the same page with room for exceptions) is more difficult than agreeing on what standards are appropriate in different contexts. There will likely be an appropriate (small, ~5%) level of variation.

    Standardization achieved in an environment where all participants have confidence that participating in a consolidated governance ecosystem enables them to meet their respective goals with the assurance that necessary and inevitable change is anticipated and well managed.

    Also, this differentiation between standardization and standards informs us of the necessary participants in interoperability governance across many organization levels and spanning local facilities to national and international bodies. Alignment on key principles of governance is critical to the success of best-case outcomes.

    The Scope of Standardization: Health and Care Services

    A few years ago, there was an important insight introduced to me by a privacy specialist, inspiring me to develop a habit of using the phrase “health and care” rather than “healthcare.” This phrasing broadens the traditional definition, allows the opportunity to distinguish between services for health promotion and illness avoidance from treating illness, and considers services that address social determinants of health.

    This distinction is an important one, as it necessarily refines and expands the scope of the types of disciplines, roles, information systems, service-delivery locations, and organizations that need to be part of the standardization process and should be represented in any governance model.

    Best Possible Outcomes of Effective Governance?

    The below outlines the short list of initial outcomes and benefits of governance in regard to health informatics and interoperability standardization. Starting with the end in mind, this bottom-up visualization begins with more granular or direct consumers and beneficiaries of standardization and concludes with the meta-level benefits and enablers that make the previous ideas possible.

    • Standardization at a sector level provides a broader market base and incentive for vendor innovation in the functionality and utility of solutions that are more likely to be valued by the end consumer, resulting in product and revenue sustainability for the vendor (empowering further innovation).
    • Innovation allows for greater choice by health service consumers and providers in the software applications they use. Now, innovation does not ensure applications are of sufficient quality and efficacy, but standardization makes this more possible, and allows innovative application of good quality and a sound value proposition to be recognized and valued in the marketplace, while less valuable applications will decline.
    • Improved patient safety for health service consumers and correspondingly reduced professional liability to their service providers.
    • Increased health service consumer engagement and contribution of meaningful information in terms of their overall digital health “picture.” This helps shift cultural and notional realities so that consumers feel they are a central participant in contributing information to their care, rather than feeling disenfranchised and subject to processes they don’t understand or participate in.
    • Availability, continuity, and consistency of information is visible to – and valued by – the client-patient and their service providers as it flows across and between service settings and organizations.
    • Increased confidence of health and care service providers across the varied health and care disciplines that wherever they choose to practice their discipline across the sector, their skills, the nature of the information tools they use, and the quality, breadth, and depth of the information they create and consume is consistent with their training and standards of professional practice.
    • Increased confidence in health service providers that they are operating at peak effectiveness for their clients and peak efficiency in remuneration for provided services. This confidence can be gained through the use of analytics, based on standardized information, that correlates their activities with those of their peers, at a discipline level, and in assessing and negotiating fee schedules based on actual effort and value to the health system; for example, in the U.S., Medicare setting the standard for reimbursement moving from Fee for Service (FFS) to value/outcomes-based care is a rocky road. This will be made much easier if both payors and payees are to use comparable and accurate data that help identify good outcomes, what it takes to achieve them, and subsequently how health and care services should be valued.
    • Avoidance of duplication of effort and closure of gaps by managing controlled vocabularies, since use of (underlying) structured terminologies in the standardized notation to document observations, results, and procedures service delivery is inherently considered best practice by clinical and administrative disciplines.
    • More reliable and predictable procurement of information systems that actually meet requirements, through the specification of standards and the inclusion of standardization processes and activities in the planning, funding, acquisition, and implementation of health informatics systems and solutions.
    • Community and stakeholder agreement on mandated requirements of conformance criteria for standards and standardization for those participating in the governing body(s), jurisdictionally and at the health sector level.
    • Reduction of risk, cost, and time-to-implementation of IT solutions for vendors and their customers across the spectrum of health care by assessing and demonstrating conformity to standards through assessments completed by neutral third parties. These value-added services should be required by system procurers and supported by private-sector solution providers to demonstrate that their products are fit-for-purpose and conformant with health sector specifications.

    What Needs to Be True to Achieve the Benefits of Standards-Based Interoperability at Scale?

    While the best-possible outcomes of effective interoperability governance are very desirable, achieving these benefits across the scope and scale of the health and care services sector is an ambitious goal, and requires formalisms and enablers to be in place if those benefits are to be achieved. Here are some recommendations:

    • Formalized governance of health informatics standardization within the jurisdiction of agencies at federal and state levels:
      • Keep in mind there should ultimately be an “end-in-mind goal” to be standardized up to the international level so that each smaller unit (community, city, county, state, and country) endeavors to align with the consensus-based standardized use whenever possible.
      • Agencies hold the authority to require standards-based solutions and give procurement priority to those conformant with health sector specifications by identifying constructive metrics/solutions aligned with outcomes. This may very well be left to the community for adoption as the outcome is the key, not necessarily how you get there.
      • Where health sector standards are absent or problematic, agencies or organizations bring standards developed “locally” to the health sector governance body for consideration as standards at that level – accepting input from the field and incorporating improvements into supported solutions.
      • Where there are requirements for new or additional standards, agencies/organizations bring those requirements forward to the health sector governance body as requests-for-change (RFC).
        • Governance must include processes and mechanisms to support submission of requests-for-change, validation of requirements, and the dispositioning of those RFCs by appropriate stewards of those standards, typically the originating standards development organizations.
      • Before making changes to existing standards, further analysis is required to determine if change is actually needed or, rather than create a new standards, if the standardized application of an existing standard and associated conformity assess meets the functional need.
      • As part of their role in the health sector governing body, agencies or health service delivery organizations provide:
        • Stakeholders who have governance participants and officially represent their organization’s requirements and perspectives, with the premise of adoption of, health sector consensus-based standards before development or use of local or project-specific standards. Bear in mind project-specific standards in innovative or emerging situations, like COVID-19, HIV, etc. may set the standard for use in the way that extensions are used to account for new or unaddressed areas and get normalized to a standard for use.
        • Trained representatives who are empowered, and enabled, to commit their organizations to consensus decisions at the health sector level when the obligations for due diligence have been met.
    • Governing body representation of health-and-care clinical and administrative disciplines by individuals from the colleges or associations that set standards-of-practice for their respective communities. These individuals officially bring the needs of their communities, as well as knowledge of their current policies and practices, to the standardization consensus process in the spirit of best approach versus an individual approach.

      Conversely, these representatives report back to their respective organizations on how proposed or existing standardization enables or constrains their communities of interest. These individuals are empowered to obtain commitment from their organizations on use of health sector standards in their standards of practice, incorporating critical and rapid feedback loops to correct unintended adverse consequences for other stakeholders.
    • Creation of a health sector, health informatics standards governing body including representation from agency/organizational (federal, state, and territorial) standards bodies or agencies, health service delivery organizations, private sector vendor and consultancy communities, and clinical and administrative organizations and associations. The governing body includes the following divisions:
        1. Standards release center (e.g., libraries) responsible for:
          • licensing, provisioning and maintaining currency of international terminology standards— controlled vocabularies often overlap or underlap and should be harmonized to improve efficiency, reduce redundancy, or close gaps;
          • providing an online repository for referencing and downloading those standards;
          • providing a repository for health sector core standards specifications (e.g., FHIR baseline profiles and implementation guides)—search for existing guides rather than “rolling your own,” and a repository of such information then creates an “easy button;”
          • an interactive tool to assist projects in selecting standards;
          • implementation guidance, national extensions of and distributing terminologies, and standards specifications;
          • boilerplate for specifying standards requirements by procurement organizations.
        2. Definition and execution of governance processes in achieving consensus-based agreement on health sector standards and their application, including:
          • provisioning of online resources and collaboration mechanisms for consumers and creators of health sector standards and specifications for their effective use;
          • providing secretarial and meeting support for the governance body and committees.
        3. Engagement with the standards delivery organizations (SDOs) of the standards being profiled and employed on a health sector level:
          • Including secretarial, expense, and travel support for official representatives to those international SDOs with which the national health sector holds licenses or has endorsed as health sector standards (e.g. HL7, SNOMED Intl, LOINC, DICOM, ISO TC 215, IHE, x12).
    • Commitment to the health sectors standards governing body as an annually funded essential agency to scale digital interoperability. This foundational component ensures fulfillment of the promise and intent of the federal health service delivery regulations in the context of a digital world (as opposed to incremental and ineffective efforts contributing to wasteful health and care spending) where the governing body is:
        1. perceived as a strategic and tactical agency in achieving its mission;
        2. funded as a reportable line item in the annual budget;
        3. subject to auditor oversight in terms of both expenditures and value-for-money.

    Achieving effective interoperability at scale in the health and care services sector requires governance that affords all the participants in the sector confidence that their investment in resources, time, and focus on achieving effective interoperability will be recognized and rewarded.

    This can only be true if governance is transparent, and their respective interests are appropriately represented. That governance and its related processes and mechanisms will have both a maturity and a vitality that will allow planning and managing for change over time that does not undermine past, present, and future investments in working interoperability.

    This article is the result of well over 30 years of experience and insight gained by the author in working in both social services and health sectors, with much of that time engaged in the evolution of standards-based interoperability at a national level. These concepts of sector-level governance of interoperability are a “big idea” that, while daunting in scope, are implementable. The costs to do so would be significant, however would be a small fraction of the costs of national health and care services delivery and should achieve measurable benefits annually of least an order of magnitude of the costs to implement this idea.

    You may feel that the benefits are either over or under-represented, or that many of the enablers already exist or are unnecessary.

    So, your turn. We invite your thoughts – what do you think of this “big idea?”

    Get to know the guest author!

    Ron P Headshot 721x721
    Ron G. Parker

    With over 35 years of experience in architecting integrated IT solution environments in health and social services enterprises, Ron also spent 16 years with a national government agency architecting and supporting the consistent implementation of EHR solutions across the country. In that role, he was also the accountable director and project lead for the establishment of the Canada Health Infoway Standards Collaborative, a national body of key stakeholders focused on the implementation of interoperability standards, and responsible for licensing, maintenance, and provisioning of LOINC, SNOMED CT, HL7 standards in Canada.

    Currently he is a subcontractor working with BookZurman Inc. to develop a blueprint for the maturing of standards-based interoperable systems in the U.S. Veterans Health Administration.

    He has international experience with work in Saudi Arabia and Southern Africa and contributor of the Digital Health Platform Handbook, published jointly by the World Health Organization and the International Telecommunication Union of the United Nations. He is a member of Health Level Seven (HL7) Incorporated, served as a co-chair of their Architecture Review Board and, serves as HL7 Canada Affiliate chair, and also serves as a co-chair of the HL7 International Council.

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