Interoperability Primer and Playbook for Public Health and Healthcare Organizations

For standards-based interoperability readiness and safe, secure electronic health information exchange.

EXECUTIVE BRIEF

Analyst Perspective

Health and healthcare organizations prioritizing interoperability will improve data exchange capacity and capability. This will ensure rapid, safe, and secure gathering, sharing, analyzing, and reporting of electronic health information, resulting in reduced costs and improved health at both the individual and population level.

What is interoperability and why is it important?

Overview

Interoperability refers to the ability of two or more computer systems to exchange, communicate, and make use of information to optimize health outcomes for individuals and populations.

To achieve interoperability, we must adopt and optimize electronic health record (EHR) technology and health information exchange (HIE) services. For health and healthcare organizations, standards-based interoperability enables authorized users from multiple locations to access, gather, integrate, and share electronic health information quickly and securely. Outcomes include better care coordination among healthcare organizations and improved nowcasting, forecasting, and scenario modeling among health and human services organizations.

We have reached the tipping point. Nearly 90% of providers use EMR/EHR technology and 72% use certified EMR/EHR technology. Nearly 70% are recording social determinants of health information. Across all hospital types, more than 95% have certified EHR technology and 70% are integrating data into their EHRs from sources outside their health systems. Like EHRs, HIE services must also be optimized, adopted, standardized, and used by healthcare providers, their patients, and public health practitioners in order to advance interoperability.

It will take time for all types of health IT to be fully interoperable. When interoperability is achieved across health and healthcare systems, and the widespread exchange of information becomes standard practice, providers and health and human services organizations will have the infrastructure to deliver patient-centric and population-centered, value-driven accountable care that improves health outcomes while reducing costs.

The Vision

Working diligently to move closer to a streaming 360-degree view of the patient and population and to foster a health and healthcare system that can attend to patient and population needs in real-time – especially during a crisis like the COVID-19 pandemic. Interoperability is the critical diagnostic and assessment/policy development/assurance/facilitating tool required to achieve these goals.

Neal Rosenblatt
Principal Research Director
Info-Tech Research Group

Executive Summary

Your Challenge

Public health and healthcare response and preparedness will be driven by real-time data that allow health and healthcare organizations to quickly identify when and where infectious disease outbreaks and chronic diseases occur and maintain insights about health system capacity (ONC 2021).

The challenge CIOs and their IT leadership teams are facing today include:

• No single source of truth for data integration and curation.
• Multiple copies of data in different formats.
• Large movement of unstandardized data and system capacity to handle it.
• Increased pressure for faster and more efficient data integration and sharing.

Focus on standards-based interoperability to provide timely, safe, and secure access, integration, and exchange of electronic health data so that it can be used to optimize health outcomes for individuals and populations automatically and in real time.

Common Obstacles

Business landscapes and models are rapidly evolving, and users and stakeholders are becoming more data-centric, with maturing expectations and demands for data access and automated, real-time analytics, reporting, and sharing.

Primary barriers or obstacles that prevent organizations from improving or addressing those challenges include:

• Weak alignment with core functions and essential services business capabilities.
• Lack of awareness or knowledge of the importance of interoperability – definitions, types, standards, and standards implementation.
• Infrastructure immaturity and lack of preparedness for participation in interoperable health information exchange networks at the state, provincial, and national levels.

Common Obstacles

Effective approaches to interoperability will result in better outcomes for population health and improved efficiencies – including cost reductions and maturity of infrastructure, platform, and data exchange services – across health and healthcare organizations.
Enterprise-wide operational improvements will be realized by:

• Building awareness and knowledge of interoperability definitions, types, and standards.
• Gauging the impact of interoperability through capabilities mapping by assessing the defining, supporting, and enabling capabilities for interoperability readiness.
• Learning about interoperability and how it affects both your organization as a whole and IT specifically, including challenges and opportunities.

Info-Tech Insight

This research is designed to help public health and healthcare organizations overcome several challenges by focusing on standards-based interoperability to optimize health outcomes for the individuals and populations they serve.

Your challenge

Interoperability challenges experienced today by health and healthcare organizations including providers, researchers, and public health professionals, continue to present difficulties with the usability of health information systems due to their shortcomings in supporting core function capabilities, the provision of essential services, and addressing stakeholder needs.

Source: AHIMA 2017

This research is designed to help health and healthcare organizations overcome these challenges by focusing on standards-based interoperability to optimize health outcomes for the individuals and populations they serve at foundational, structural, semantic, and organizational levels.

Source: ONC and CMS, 2020: Survey Results: Readiness for the ONC and CMS Interoperability Rules

Common obstacles

If creating an interoperable health IT ecosystem is the key to unlocking the future of health and healthcare, and with so many benefits, why is it so difficult to accomplish?

• Competing interests
• E.g. financial, staff, and other resources
• Complexity
• Cost
• Lack of coordination between health systems, organizations, and agencies
• Inconsistent and lack of technical standards
• Numerous software systems with varying data standards
• Divergent health information privacy policies
• Differing approaches to gaining patient/individual consent
• Difficulty getting major EHRs to coordinate with each other
• Data gaps across different EHR applications and networks
• Data silos across the ecosystem that would inform the most urgent and impactful patient and/or population interventions
• The regulatory landscape continues to become increasingly complex:
• Rule revisions for government-sponsored programs occurring on a yearly basis
• Adds to providers' doubts as to whether technologies like machine learning can adapt to these constant regulatory changes

Source: Philips, 2022: The Future Health Index 2022 report

Info-Tech's approach

Unlock the value of interoperability.

The Info-Tech difference:

• Building awareness and knowledge of interoperability definitions, types, and standards.
• Gauging the impact of interoperability through mapping and assessing defining, supporting, and enabling capabilities for interoperability readiness.
• Learning about interoperability and how it affects both your organization as a whole and IT specifically, including challenges and opportunities.

1. Capability Mapping
• Use the Capability Mapping tool as an interoperability readiness assessment process.




2. Interoperability Assessment
• Identify interoperability types (foundational, structural, semantic, and organizational) across your organization.




3. Interoperability Implementation

• Build types and standards into your organization's interoperability ecosystem one use case at a time.

• Interoperability Ecosystem

Executive brief case study

The future enablement of health interoperability outcomes 2030.

In May 2021, the Office of the National Coordinator for HealthIT (ONC) launched a project called "Health Interoperability Outcomes 2030." The project asked health and healthcare practitioners (n ≈ 700), "What should 2030 look like because of interoperability?" Outcome statements were collected and analyzed for trends, groupings, and combinations. The result was a prioritized set of interoperability outcomes focused on the end state of individuals having internet-based access to their electronic health information, setting the course for aspirational and achievable goals by 2030.

INDUSTRY: Government/ HealthIT
SOURCE: The Office of the National Coordinator for HealthIT

An aspirational vision of interoperable health systems by 2030

• The health system will enable evidence-based, precision care that accounts for the social and health conditions of each patient, including links between health and human services.
• The health system will more quickly identify high-risk conditions, chronic diseases, and disparities in health equity.
• The data used for clinical and administrative processes will be electronically integrated to support decisions about payment, eligibility, and benefits.
• Public health response and preparedness will be driven by real-time data that allow public health agencies to quickly identify when and where infectious disease outbreaks occur and maintain insights about health system capacity.
• Reporting for public health, quality measurement, and safety will all be completed automatically and electronically.
• Researchers will be able to use inclusive, representative datasets to compare the real-world performance of treatments, procedures, devices, and drugs.
• Research and testing for new decision support, workflows, and other work processes will be able to be conducted across multiple sites and among different technologies.
• Researchers and health professionals will spend little to no time normalizing data for research and quality activities.
• Preventable data-related safety events will be reduced to zero.
• Health professionals will spend less time on administrative tasks and more time caring for their patients.
• Duplicate diagnostic tests and procedures will be reduced.

Source: ONC 2021 | Synthesized statements that reflect respondents' overall sentiment about what health systems should look like in 2030 because of interoperability.

Insight summary

Overarching insight

This research is designed to help health and healthcare organizations overcome several challenges by focusing on standards-based interoperability to optimize health outcomes for the individuals and populations they serve.

1 Insight – Definitions and Levels

1.0 Standards-based Interoperability in health and healthcare organizations provides timely, safe, and secure access, integration, and use of electronic health data so that it can be used to optimize health outcomes for individuals and populations.

1.1 Health and Healthcare organizations prioritizing interoperability and standards will see improvements in data access, integration, management, retrieval of data and documents, scientific staff productivity, IT efficiencies, cost optimization, and data exchange capabilities. This ensures quick, safe and secure gathering, analyzing, and sharing of electronic health information in ways that follow all industry and HIPAA protocols.

1.2 Standards-based interoperable HIT solutions are becoming fundamental building blocks driving digital transformation, enabling financial efficiencies, and supporting standards development as well as the implementation, operation, and use of standards-based HIT solutions – specifically for services integration, cloud computing, cybersecurity, and information safety.

2 Insight – Standards Development

2.0 Standards provide a common vocabulary, code sets, structure, and guidelines that enable interoperability between systems and/or devices.

2.1 In order to seamlessly ingest and curate information without effort, standards permit clinicians, labs, hospitals, pharmacies, payors, patients, health information exchanges, healthcare services, and public health organizations to share data regardless of application or market supplier.

2.2 Interoperability standards development works to increase the adoption of emerging and mature health IT standards to further align existing and emerging standards and implementation guidance with strategic healthcare policy goals to achieve improved health outcomes for people everywhere.

2.3 With the expansion of data and information exchange partners, along with the shift to value-based care, a broader range of data types have become available to inform on more complex and integrated health and care decisions, including data pertaining to the social determinants of health.

3 Insight – Standards Implementation

3.0 Health and healthcare organizations seeking to acquire or improve their health information systems need a convenient, reliable way of specifying a level of compliance to standards sufficient to achieve efficient interoperability for digital and data modernization.

3.1 Some standards development organization (SDO) entities create standards. Others bundle complementary standards into profiles that are used to define a specific function or use case. This provides implementation guidance that describes how multiple standards can be used together to support interoperable information exchange.

3.2 The different SDOs generally follow shared principles based on developing standards through a multi-stakeholder, consensus-based process to respond to a specific industry or market need.

4 Insight – Testing and Conformance

4.0 Organizations like the Global Consortium for eHealth Interoperability, which was co-founded by HIMSS, IHE International, and HL7 International, work to amplify and align the work of organizations like IHE and HL7 to increase the adoption of emerging and mature health IT standards. The consortium's primary goal is to coordinate work with governments and national ministries of health to further align existing and emerging standards and implementation guidance with strategic healthcare policy goals to achieve improved health outcomes for people everywhere.

5 Insight – Interoperability Ecosystem

5.0 An efficient interoperability ecosystem provides an information infrastructure that uses technical standards, policies, and protocols to enable seamless and secure capture, discovery, exchange, and utilization of health information.

Interoperability Playbook

Follow these best practices to make sure your standards-based implementation requirements are solid.

Summary of Plays

1. Build awareness and knowledge of interoperability definitions, types, standards, standards-based implementation, and standards testing and conformance.
2. Gauge the impact of interoperability by using the capabilities mapping tool for assessing, defining, supporting, and enabling capabilities for interoperability readiness across your organization.
3. Develop an information infrastructure that includes all interoperability types, applicable standards, guides, and profiles.
4. Choose standards that have been vetted by rigorous testing and conformance efforts.
5. Build types and standards into your organization's interoperability ecosystem one use case at a time (e.g. the Info-Tech Social Determinants of Health blueprint).

Blueprint benefits

Developing and deploying world-class interoperating data and analytics exchange to meet today's and tomorrow's health challenges across health and care ecosystem landscapes. This includes all communities served at the individual, patient, and population levels.

Focusing on five key priorities that are interconnected and equally important to reaching the future interoperable state:

1. Building the Right Foundation: Improving data exchange infrastructure, collection, analysis, and sharing across health and healthcare organization information networks.
2. Accelerating Data for Action: Tapping into more data sources, promoting health equity, and increasing capacities for scalable outbreak response, nowcasting, forecasting, scenario modeling, and predictive analytics in real-time.
3. Developing a State-of-the-Art Workforce: Using next-generation skills for actionable health and care insights.
4. Supporting and Extending Partnerships: Breaking down silos, ensuring transparency, addressing policy challenges, and solving problems together.
5. Managing Change and Governance: Making sure resources are used wisely, monitoring progress, and supporting strategic innovation for new ways of thinking and working.

Info-Tech offers various levels of support to best suit your needs

DIY Toolkit

“Our team has already made this critical project a priority, and we have the time and capability, but some guidance along the way would be helpful.”

Guided Implementation

“Our team knows that we need to fix a process, but we need assistance to determine where to focus. Some check-ins along the way would help keep us on track.”

Workshop

“We need to hit the ground running and get this project kicked off immediately. Our team has the ability to take this over once we get a framework and strategy in place.”

Consulting

“Our team does not have the time or the knowledge to take this project on. We need assistance through the entirety of this project.”

Diagnostics and consistent frameworks used throughout all four options

Additional Support

If you would like additional support, have our analysts guide you through other phases as part of an Info-Tech Workshop.

To accelerate this project, engage your IT team in an Info-Tech workshop with an Info-Tech analyst team.

Info-Tech analysts will join you and your team at your location or welcome you to Info-Tech's historic Toronto office to participate in an innovative onsite workshop.

Contact your account representative for more information.
workshops@infotech.com 1-888-670-8889

The following are sample activities that will be conducted by Info-Tech analysts with your team:

Click here to access the Capability Mapping Tool in the Reference Architecture	Click here to access The Role of SDOH in Value-Based Care Delivery blueprint
Capability Mapping	Use Case Implementation
Use the capability mapping tool as an interoperability readiness assessment process.	Build types and standards into your organization's interoperability ecosystem one use case at a time.

Interoperability defined 1.1

What is interoperability...

Leading industry-wide definitions

1. Healthcare Information and Management Systems Society (HIMSS)
• The ability of different information systems, devices, and applications (systems) to access, exchange, integrate, and cooperatively use data in a coordinated manner, within and across organizational, regional, and national boundaries, to provide timely and seamless portability of information and optimize the health of individuals and populations globally.
2. Office of the National Coordinator For Health IT (ONC)
• The ability of two or more systems to exchange health information and use the information once it is received.
3. American Health Information Management Association (AHIMA)
• The ability to communicate and exchange data accurately, effectively, securely, and consistently with different information technology systems, software applications, and networks in various settings, and exchange data such that clinical or operational purpose and meaning of the data are preserved and unaltered.
4. Institute of Electrical and Electronics Engineers (IEEE)
   • The ability of two or more systems or components to exchange information and to use the information that has been exchanged.

01 Info-Tech Play
Build awareness and knowledge of interoperability definitions, types, standards, standards-based implementation, and standards testing and conformance efforts.

…and why is it important?
Info-Tech Insight

Standards-based Interoperability in health and healthcare organizations provides timely, safe, and secure access, integration, and use of electronic health data so that it can be used to optimize health outcomes for individuals and populations.

"You can't manage what you can't measure."
- Peter Drucker

"In public health, we can't do anything without surveillance. That's where public health begins."
- David Satcher, MD, PhD, Director, CDC 1993–1998; qtd. In CDC, Sept. 2022

Interoperability defined 1.2

Four types of interoperability

Source: Healthcare IT News, 2019

Interoperability is a journey, not a destination

1.1 Info-Tech Insight

Health and healthcare organizations prioritizing interoperability and standards at all levels will see improvements in data access, integration, management, retrieval of data and documents, scientific staff productivity, IT efficiencies, cost optimization, and data exchange capabilities, ensuring quick, safe and secure gathering, analyzing, and sharing of electronic health information in ways that follow all industry and HIPAA protocols.

1.2 Info-Tech Insight

Standards-based interoperable HIT solutions are becoming fundamental building blocks driving digital transformation, enabling financial efficiencies, and supporting standards development as well as the implementation, operation, and use of standards-based HIT solutions – specifically for services integration, cloud computing, cybersecurity, and information safety.

02 Info-Tech Play

Gauge the impact of interoperability by using the Info-Tech capabilities mapping tool for assessing defining, supporting, and enabling capabilities for interoperability readiness across your organization.

Interoperability defined 1.3

Are "health information exchange" and "data sharing" the same thing?

"Health information exchange"
United States/Canada

"Data sharing"
European Union

In the United States and Canada, the sharing of health information between entities is referred to as health information exchange. In the European Union, it is often referred to as data sharing.

Overview: Health information exchange, or HIE, provides the capability to electronically move clinical information among disparate health and healthcare organization information systems and maintain the meaning of the information being exchanged.

The goal: Health information exchange aims to facilitate access to and retrieval of clinical data to provide safe, timely, efficient, effective, and equitable patient-centered care. HIE can also be used by public health authorities to assist in the analysis of the health of populations.

The term: The Healthcare Information and Management Systems Society (HIMSS) generally defines the term HIE as either a verb or a noun.

Verb: The electronic sharing of health-related data between two or more organizations facilitated by applied standards for use by a variety of stakeholders to inform health and care.

Noun: Organizations within the United States that provide health information exchange technology and services at a state, regional, or national level and often work directly with communities to promote secure sharing of health data.

Source: HIMSS, 2020

Standards development

Making sense of so many standards.

Standards Development

• There are over 40 different types of standards development organizations (SDOs) in the health IT arena. Examples include health level seven (HL7) and systematized nomenclature of medicine (SNOMED).

Accreditation

• An organization may be accredited by the American National Standards Institute (ANSI) or the International Organization for Standardization (ISO).

Types of Standards

• In order to understand the types of health data standards available for use, these standards are organized into the following specific categories:
  • Vocabulary/Terminology
  • Content
  • Transport
  • Privacy and Security
  • Identifiers

The Value of Interoperability Standards

2.0 Info-Tech Insight

Standards provide common vocabulary, code sets, structure, and guidelines that enable interoperability between systems and/or devices.

2.1 Info-Tech Insight

In order to seamlessly ingest and curate information without effort about an individual or population and improve the overall coordination and delivery of healthcare services, beneficiary services, or population-based interventions, standards permit clinicians, labs, hospitals, pharmacies, payors, patients, health information exchanges, healthcare services organizations, and public health organizations to share data regardless of application or market supplier.

Which standards do I apply for what purpose?

Associating types of standards with types of interoperability.

Foundational

• Reference Architecture
• Capabilities Mapping
• Enterprise Architecture
  • Business
  • Applications
  • Data
  • Technical
• Infrastructure
  • Example: Data Lakehouse
    • Retrieval
    • Storage
    • Curation
    • Analytics
    • Reporting
    • Exchange

Structural

• Content Standards
• Transport Standards

Semantic

• Vocabulary/Terminology Standards
• Code Sets
• Classification Systems

Organizational

• Privacy and Security Standards
• Identifier Standards
• Governance
  • Shared Consent
  • Trust vs. Commons
  • Workflows
• Other Considerations
  • Policy/Social/Legal

2.2 Info-Tech Insight

Interoperability standards development works to increase the adoption of emerging and mature health IT standards and facilitates the coordination of work with health and healthcare organizations to further align existing and emerging standards and implementation guidance with strategic healthcare policy goals to achieve improved health outcomes for people everywhere.

2.3 Info-Tech Insight

With the expansion of data and information exchange partners, along with the shift to value-based care, has come a broader range of data types that are available to inform on more complex and integrated health and care decisions. This includes data pertaining to the social determinants of health, which can include an individual's housing status, access to reliable transportation and high-quality care, and level of food security.

Foundational interoperability

Also known as simple transport, foundational interoperability is the most basic level and refers to an organization's system or software capability to exchange data with another system. At this level, systems can securely communicate and receive data from other systems assuming a basic level of infrastructure is in place for safe and secure transport. Capabilities mapping provides a process to assess an organization's readiness for interoperable information exchange. While enterprise architecture defines, organizes, standardizes, and documents the entire architecture and key elements of an organization within which interoperability types and standards are identified and specified in the workflow.

Foundational

• Reference Architecture
• Capabilities Mapping
• Enterprise Architecture
  • Business
  • Applications
  • Data
  • Technical
• Infrastructure
  • Example: Data Lakehouse
    • Retrieval
    • Storage
    • Curation
    • Analytics
    • Reporting
    • Exchange

Click Here to Access the Capability Mapping Tool for Foundational Interoperability

Structural interoperability

The standardization of data to a particular format, syntax, and organization of data exchange, including the data field level, to enable machine-readable interpretation by multiple document management systems or devices. At this level of interoperability, data is categorized and organized into a specific order to ensure the receiving system can automatically detect predetermined data fields.

Structural

• Content Standards
• Transport Standards

Not an exhaustive list of standards. For illustrative purposes only.

Semantic interoperability

The ability to automatically interpret the information exchanged accurately, as it was originally intended, and without changing its meaning in order to produce useful results as defined by the end-users of both systems.

Semantic

• Vocabulary/Terminology Standards
• Code Sets
• Classification Systems

Not an exhaustive list of standards. For illustrative purposes only.

Organizational interoperability

Includes governance, policy, social, legal, and organizational considerations to facilitate the secure, seamless and timely communication and use of data both within and between organizations, entities, and individuals. These components enable shared consent, trust, and integrated end-user processes and workflows.

Organizational

• Privacy and Security Standards
• Identifier Standards
• Governance
  • Shared Consent
  • Trust vs. Commons
  • Workflows
• Other Considerations
  • Policy
  • Social
  • Legal

Not an exhaustive list of standards. For illustrative purposes only.

Standards implementation guides and profiles

Standards describe and constrain what and how data moves.

Implementation guides: Defined

Implementation guides describe how to implement standards for what types of use cases. They specify:

• Which way a standard is to be applied (organizational interoperability).
• How to structure the data consistently (structural interoperability).
• What vocabulary to use (semantic interoperability).

Implementation guides: Benefits

Implementation guides like IHE Profiles and ONC's ISA provide:

• A common language to identify and specify health and healthcare organizations' data integration and health IT needs.
• Precise definitions and implementation path for developers of how to implement standards to align with business needs.
• Standards that have been carefully documented, reviewed, tested, and supported by industry partners.
• IT purchaser tools that reduce the complexity, cost, and anxiety of implementing interoperable systems.

IHE profiles organize and leverage the integration capabilities that can be achieved by the coordinated implementation of communication standards, such as DICOM, HL7 W3C, and security standards.

The Value of Standards Implementation Guides and Profiles

3.0 Info-Tech Insight

Health and healthcare organizations seeking to acquire or improve their health information systems need a convenient, reliable way to specify a sufficient level of compliance to standards to achieve efficient interoperability for digital transformation and data modernization.

3.1 Info-Tech Insight

Some standards development organization (SDO) entities create standards. Others bundle complementary standards into profiles that are used to define a specific function or use case. This provides implementation guidance that describes how multiple standards can be used together to support interoperable health information exchange.

3.2 Info-Tech Insight

The different SDOs generally follow shared principles based on developing standards through a multi-stakeholder, consensus-based process to respond to a specific industry or market needs.

03 Info-Tech Play

Develop an information infrastructure that includes all interoperability types, applicable standards, guides, and profiles.

Standards testing and conformance

Testing and conformance: Defined

The adoption and implementation of standards involve a testing ecosystem that spans standards development, implementation, and feedback from real-world testing into the development process to support continuous improvement.

Testing and conformance: Efforts

The Value of Testing and Conformance

4.0 Info-Tech Insight

Organizations like the Global Consortium for eHealth Interoperability, which was co-founded by HIMSS, IHE International, and HL7 International, work to amplify and align the work of organizations like IHE and HL7 to increase the adoption of emerging and mature health IT standards. The consortium's primary goal is to coordinate work with governments and national ministries of health to further align existing and emerging standards and implementation guidance with strategic healthcare policy goals to achieve improved health outcomes for people everywhere.

04 Info-Tech Play

Choose standards that have been vetted by rigorous testing and conformance efforts.

Roadblocks to interoperability (1)

2 Key Issues

Two key issues, readiness and data sharing challenges, are impeding health and healthcare organizations from achieving interoperability.

3 of the Biggest Challenges

Among stakeholders in the health and healthcare industry, the lack of data standardization, technical interoperability, and data quality were the biggest challenges to health data sharing between data-sharing entities.

Top 5 Barriers

The top five barriers to interoperability readiness and implementation among health and healthcare executive management and senior leadership include competing priorities, time for implementation, lack of staff, knowledge of requirements, and lack of funding.

(1) Source: eHealth Initiative, "Survey Results: Readiness for the ONC and CMS Interoperability Rules," 2020

Incentives to participate

Creating an interoperable health IT ecosystem is the key to unlocking the future of health and healthcare.

Data Exchange Facilitators

Data standardization, technical interoperability, and data quality are the biggest opportunities for health data sharing between data-sharing entities.

Readiness Facilitators

• Moving from a siloed to an ecosystem approach is a significant change in service delivery.
• Interoperability is the key to delivering end-to-end processes in the health ecosystem by integrating multiple solutions across organizational boundaries to deliver the best possible health and care at the individual and population levels.
• It requires changes in health and care service delivery around design, application development, operational support, roles, skills, accountabilities, partnerships, governance, and security.

For illustrative purposes only. Not an exhaustive list of facilitators, benefits, and uses.

Workflow considerations and guidance

Privacy, security, and ensuring data quality.

Ensuring privacy and security

Regulations such as the General Data Protection Regulation (GDPR) in the EU, the Health Insurance Portability and Accountability Act (HIPAA) in the U.S., and various other national and state laws and regulations establish privacy and security requirements to safeguard the creation and receiving, maintenance, and transmittal of health information maintained by health and healthcare organizations and systems.
Privacy and security considerations may include the following:

• Implementing Data Use and Reciprocal Support Agreements (DURSA) – also known as trust agreements – with health systems and other stakeholders.
• Data access and exchange controls.
• Standard privacy and security policies and procedures that govern data protection and use.
• Data encryption guidelines for exchange between data-sharing organizations.
• Administrative, physical, and technical assurances for maintaining confidentiality, integrity, and availability of the data aligned with state and national laws and regulations.

Data quality considerations

In order to ensure that the information received from one or many sources can be trusted and that it is accurate and complete, efforts by organizations to maintain high-quality data may include the following:

• Ensuring structural and semantic interoperability so that data are structured and coded with standardized terminology and styles where possible, to be leveraged in a machine-readable format for analysis and interpretation.
• Documentation communicates in a way such that the clinical or operational purpose and meaning of the data are preserved, unaltered, and understood by human end-users.

Info-Tech Insight

Level 4 organizational interoperability must consider alignment with external organizations and work toward enabling shared consent, trust, and safe, secure, seamless, and timely integrated end-to-end user processes and workflows.

Interoperability Ecosystem

Interoperability ecosystem

Exchange partners and data sources.

The interoperability ecosystem accesses and exchanges all forms of health and health-related information.

Health and healthcare organizations, hospitals, health systems, information exchanges, registries, researchers, payers, providers, laboratories, pharmacies, patients, and suppliers, among a host of others, are potential stakeholders within the interoperability ecosystem. Each is involved in the creation, exchange, and use of data and health information.

05 Info-Tech Play

Build types and standards into your organization's interoperability ecosystem one use case at a time (e.g. the Info-Tech Social Determinants of Health blueprint).

The value of an interoperability ecosystem

5.0 Info-Tech Insight

An efficient interoperability ecosystem provides an information infrastructure that uses technical standards, policies, and protocols to enable seamless and secure capture, discovery, exchange, and utilization of health information. With the expansion of data and information exchange partners, along with the shift to value-based care, has come a broader range of data types that are available to inform on more complex and integrated health and care decisions, including device data, patient-generated data, and data pertaining to the social determinants of health, which can include an individual's housing status, access to reliable transportation and high-quality care, and level of food security.

Network architectures for interoperability

There are three primary types of exchange network architecture used to coordinate the exchange of health information across entities.

Centralized

Patient data are collected and stored in a centralized repository, data warehouse, or other databases. The exchange organization has full control over the data, including the ability to authenticate, authorize, and record transactions among participants.

Federated

Interconnected but independent databases allow for data sharing and exchange and grant users' access to the information only when needed.

Hybrid

Incorporates variations of federated and centralized architectures to harness the advantages of both. These are becoming common as various combinations of available services are implemented.

An important technical development that has expanded exchange partners and data sources is the emergence of healthcare APIs. APIs outline a set of clearly defined specifications to allow for one software application to build on the data and functionality of another application, without needing to understand its system design. APIs are already ubiquitous in today's web economy and will play an essential role with respect to fueling healthcare interoperability for person-centered care.
Source: HIMSS 2022

Interoperability modernization – data lakehouse

Solution Architecture

Data, Application, and Technology Layers

Info-Tech Insight

A data lakehouse is a modern hybrid, open data management architecture that takes the best concepts from both the data science focus of a data lake and the analytics power of a data warehouse and puts them together while trying to eliminate the unsupported and proprietary limitations of both models. A data lakehouse offers one single source of truth for analytics and simplifies enterprise data infrastructure at a time when machine learning is poised to disrupt every industry.

Interoperability modernization – network architecture

Solution Architecture

Data, Application, and Technology Layers

Info-Tech Insight

A data lakehouse infrastructure provides a modern architected, single-source platform solution for safe, secure, and governed data ingestion, unified data analytics, and manual, automated, and streaming data sharing and accessibility.

Public health and healthcare interoperating information exchange system

Managed interoperability

"Advancing interoperability is now an essential part of most health care activities ranging from health equity to public health emergency response."
– Healthit.gov, "Interoperability," 2019

Types of HIE organizations

There are several different types of health information exchanges (HIEs) currently operating across the US and its territories.

An HIE organization oversees and governs the exchange of health-related information
among organizations according to nationally recognized standards. The purpose of a health information exchange organization is to perform oversight, governance, and data curation functions for information exchange.

Forms of health information exchange
Accessing and securely sharing medical information electronically.

Electronic health information exchange (HIE) allows doctors, nurses, pharmacists, other healthcare providers, and patients to appropriately access and securely share a patient's vital medical information electronically – improving the speed, quality, safety, and cost of patient care.

There are currently three key forms of health information exchange:

1. Directed Exchange
• Ability to send and receive secure information electronically between care providers to support coordinated care.
2. Query-Based Exchange
• Ability for providers to find and/or request information on a patient from other providers, often used for unplanned care.
3. Consumer Mediated Exchange
   • Ability for patients to aggregate and control the use of their health information among providers.

Click here to learn more about the forms of Health Information Exchange

Source: ONC, "What is HIE?," 2020

Use cases
Sources and examples

Standards and Technology:

• Office of the National Coordinator (ONC) Interoperability Standards Advisory (ISA)
• US Core Data for Interoperability (USCDI)
• ONC Health IT Certification Program

Investments:

• The Sequoia Project Interoperability Matters Initiative
• LEAP in Health IT

Investments/Policy:

• ONC Trusted Exchange Framework and Common Agreement (TEFCA)

Policy:

• Information blocking

Trends:

• Interoperability participation and methods of exchange among hospitals

STANDARDS AND TECHNOLOGY

Use Case: ONC Interoperability Standards Advisory

Identification, assessment, and public awareness of interoperability standards and implementation specifications.

INDUSTRY: U.S. Government
SOURCE: Office of the National Coordinator for Health Information Technology (ONC)

Interoperability Standards Advisory (ISA)

The Interoperability Standards Advisory (ISA) process represents the model by which the Office of the National Coordinator for Health Information Technology (ONC) coordinates the identification, assessment, and public awareness of interoperability standards and implementation specifications that can be used by the United States healthcare industry to address specific interoperability needs including, but not limited to, interoperability for clinical, public health, and research purposes. ONC encourages all stakeholders to implement and use the standards and implementation specifications identified in the ISA as applicable to the specific interoperability needs they seek to address. Furthermore, ONC encourages that further pilot testing and industry experience be sought with respect to standards and implementation specifications identified as "emerging" in the ISA. For historical background on the ISA please review prior ISA publications.
Source: ONC 2019, 2022

STANDARDS AND TECHNOLOGY

Use Case: US Core Data for Interoperability

Standardized health data classes and elements for interoperable health information exchange.

INDUSTRY: U.S. Government
SOURCE: Office of the National Coordinator for Health Information Technology (ONC)

US Core Data for Interoperability (USCDI)

The United States Core Data for Interoperability (USCDI) is a standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange. Review the USCDI Fact Sheet to learn more.

A USCDI "data class" is an aggregation of various data elements by a common theme or use case.

A USCDI "data element" is the most granular level at which a piece of data is exchanged.

For example, date of birth is a data element rather than its component day, month, or year, because date of birth is the unit of exchange.

Source: ONC 2022

USCDI v3 Summary of Data Classes and Data Elements

STANDARDS AND TECHNOLOGY

Use Case: ONC Health IT Certification Program

ONC Health IT Certification Program Progress

Use • Empowerment • Interoperability

INDUSTRY: Government
SOURCE: Office of the National Coordinator for Health Information Technology (ONC)

About the Program

The Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program is a voluntary certification program established by the ONC to provide for the certification of health IT. Requirements for certification are established by standards, implementation specifications, and certification criteria adopted by the Secretary of the Department of Health and Human Services (HHS).

INVESTMENTS

Use Case: The Sequoia Project Interoperability Matters Initiative

Interoperability Matters Initiative

Creating practical solutions to health data exchange challenges.

INDUSTRY: Government
SOURCE: The Sequoia Project

Important interoperability issues to tackle Additional call-out areas: Implementation of TEFCA Payer to provider, payer to payer, payer to patient Supporting health equity Integrating modalities for interoperability, data access, and data exchange regardless of source Collaboration with the right stakeholders Consumerism Scale Data Quality

INVESTMENTS

Use Case: LEAP in Health IT

Addressing fast emerging challenges that inhibit the development, use, and advancement of interoperability in health IT.

INDUSTRY: US Government
SOURCE: Office of the National Coordinator for Health Information Technology (ONC)

Leading Edge Acceleration Projects (LEAP) in Health Information Technology (Health IT)

LEAP in Health IT projects tackle the creation of new standards, methods, and tools to improve care delivery and advance research capabilities. The LEAP in Health IT program addresses fast emerging challenges that inhibit the development, use, and advancement of interoperable health IT.

Source: ONC, "Leading Edge Acceleration Projects in Health Information Technology"

INVESTMENTS & POLICY

Use Case: ONC TEFCA

A universal policy and technical floor for nationwide interoperability.

INDUSTRY: US Government
SOURCE: Office of the National Coordinator for Health Information Technology (ONC)

Trusted Exchange Framework Common Agreement (TEFCA)

The Trusted Exchange Framework and Common Agreement (TEFCA) establishes a universal policy and technical floor for nationwide interoperability; simplifies connectivity for organizations to securely exchange information to improve patient care, enhance the welfare of populations, and generate health care value; and enables individuals to gather their healthcare information.

The Common Agreement establishes the infrastructure model and the governing approach for users in different networks to securely share basic clinical information under commonly agreed-upon expectations and rules.

Source: ONC, Trusted Exchange Framework and Common Agreement (TEFCA), 2022

Additional Resources

• A User's Guide to Understanding TEFCA
• Common Agreement for Nationwide Health Information Interoperability - Version 1
• Trusted Exchange Framework – Final
• Data Use and Reciprocal Support Agreement (DURSA)
• 21st Century Cures Act (Cures Act)

Glossary of Terms

• Recognized Coordinating Entity (RCE)
• Qualified Health Information Network (QHIN)

POLICY
Use Case: Information Blocking

Identifying reasonable and necessary activities that do not constitute information blocking.

INDUSTRY: US Government
SOURCE: Office of the National Coordinator for Health Information Technology (ONC)

Information blocking

Information blocking is a practice by a healthcare "actor," except as required by law or specified in an information blocking exception, that is likely to interfere with the access, exchange, or use of electronic health information (EHI).
– 21st Century Cures Act, 2016
Source: ONC, Information Blocking, 2022

To whom does information blocking apply?

The 21st Century Cures Act (Cures Act) applies the law to healthcare providers, health IT developers of certified health IT, and health information exchanges (HIEs)/health information networks (HINs).

The Cures Act also establishes two different "knowledge" standards for actors' practices within the statute's definition of "information blocking." For health IT developers of certified health IT and HIEs/HINs, the law applies the standard of whether they know, or should know, that a practice is likely to interfere with the access, exchange, or use of EHI. For healthcare providers, the law applies the standard of whether they know that the practice is unreasonable and is likely to interfere with the access, exchange, or use of EHI.

Information blocking exceptions

Eight information blocking exceptions were established in the 2020 Cures Act Final Rule. The exceptions are divided into two categories:

1. Exceptions that involve not fulfilling requests to access, exchange, or use EHI
   • Preventing Harm
   • Privacy
   • Security
   • Infeasibility
   • Health IT Performance
2. Exceptions that involve procedures for fulfilling requests to access, exchange, or use EHI
   • Licensing
   • Fees
   • Content and Manner

Additional Resources

• Learn more about Electronic Health Information (EHI)
• Learn More About Information Blocking Exceptions
• Learn More About the Cures Act Final Rule

Trends
Use Case: Interoperability Participation and Methods of Exchange among U.S. Hospitals

The current state of interoperability among hospitals and trends on participation in local, state, regional, or national information exchange networks.

INDUSTRY: Healthcare
SOURCE: American Hospital Association

Trends show progress in interoperable health information exchange among hospitals in the U.S.

Interoperable exchange of health information is critical for delivering appropriate care, reducing healthcare costs, and making healthcare more efficient.

Methods of information exchange include sending, receiving, querying/finding, and integrating patient health information.

Nearly all hospitals (91%) are now participating in some form of patient health information exchange and more than six in ten (62%) are participating in all forms of exchange via local, regional, state, and/or national health information exchange networks.

Percent of U.S. non-federal acute care hospitals engaging in electronic sharing of patient health information	Hospital participation rates in national, state, regional, or local information exchange networks
Sources: AHA Annual Survey Information Technology Supplement; ONC Data Brief, No. 64, "Interoperability and Methods of Exchange among Hospitals in 2021" Notes: National network consists of hospital participation in CommonWell Health Alliance, e-Health Exchange, Sequoia Project's Carequality, Strategic Health Information Exchange Collaborative (SHIEC), as well as EHR vendor's network.

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APPENDIX 1.0

Key Initiative Planning for Interoperability Readiness

Goals | Challenges | Solutions | Proposed Support and Tools

APPENDIX 1.0 Key Initiative Planning for Interoperability Readiness

Goals | Challenges | Solutions | Proposed Support and Tools

APPENDIX 1.0 Key Initiative Planning for Interoperability Readiness

Goals | Challenges | Solutions | Proposed Support and Tools

APPENDIX 1.0 Key Initiative Planning for Interoperability Readiness

Goals | Challenges | Solutions | Proposed Support and Tools

APPENDIX 2.0

Public Policy and Government Efforts

US and Global

APPENDIX 2.0

Public Policy and Government Efforts

US and global: A list of significant initiatives

How governments are working to facilitate exchange both within the US and in countries around the world.

United States Policies and Initiatives

• 21st Century Cures Act (2016) and ONC Final Rule (2020)
• Interoperability Standards Advisory (ISA)
• ONC Health IT Certification Program
• Data: Elemental to Health
• National Health IT Priorities for Research
• Precision Medicine Initiative
• Patient-Centered Outcomes Research (PCOR)
• Accelerating Application Programming Interfaces (APIs) for Scientific Discovery
• Health Information Technology Workflow Automation Policy Development
• Advancing Health Data and Metadata Standards
• Leading Edge Acceleration Projects (LEAP) in Health Information Technology (Health IT)

Global Government Policies and Initiatives

At the international level, there are a variety of initiatives being led by health ministries and governments to further country-level and cross-border interoperability efforts.

• Global Digital Health Partnership
• European EHR Exchange Format
• General Data Protection Regulation (GDPR)
• e-Health Digital Service Infrastructure (eHDSI)
• European Reference Networks (ERNs)
• European Health Data Space (EHDS)
• European Interoperability Framework (EIF)
• National Digital Health Strategy and Framework for Action
• NHS England: NHS Standard Contract
• New Zealand: Interoperability Roadmap

For illustrative purposes. Significant US and Global initiatives. Not an exhaustive list.

"Achieving interoperability to date has required government involvement, guidance, and regulation. Public policy efforts have the potential to drive forward frameworks for trusted exchange, align and educate stakeholders on existing and emerging standards, and broaden stakeholder participation to ensure an inclusive exchange ecosystem for care coordination and continuity."

HIMSS, 2020

APPENDIX 2.0

US Policies and Government Effort

Goal: Achieving Interoperable Nationwide Exchange

The U.S. Department of Health and Human Services (HHS) has enacted and implemented a variety of legislation, regulations, and guidance to further the adoption of standards-based approaches to interoperability.

For illustrative purposes. Significant US initiatives. Not an exhaustive list.

APPENDIX 2.0

Global Policies and Government Effort

An annotated list of significant global interoperability initiatives

Goal: Facilitate country-level and cross-border interoperability.

At the international level, there are a variety of initiatives being led by health ministries and governments to further country-level and cross-border interoperability efforts.

For illustrative purposes only. Significant Global initiatives. Not an exhaustive list.

APPENDIX 3.0

Health and Health-Related Stakeholders and Data Sources

An alphabetical listing of stakeholders and data sources by industry or stakeholder category.

APPENDIX 3.0

Health and Health-Related Stakeholders and Data Sources

An alphabetical listing of stakeholders and data sources by industry or stakeholder category

APPENDIX 4.0

US Exchange Initiatives

An environmental scan of us exchange initiatives: who they are and what they do.

APPENDIX 4.0

US Exchange Initiatives

US exchange initiatives come in many shapes and sizes. Some are non-profit organizations. Others are private or public/private collaborations. Some are nationwide in scope and others are global. Regardless of their operating framework and scope, many organizations are actively working to achieve ubiquitous exchange.

Environmental Scan of Exchange Initiatives

This environmental scan summary provides an annotated review of the current landscape of the US-based networks and frameworks which enable interoperable, nationwide and global health information exchange via a variety of methods and collaborations.

Click here to access HIMSS' fully curated review of the current US-based landscape

APPENDIX 5.0

International Networks Enabling Exchange

Digital health continues to expand at a rapid pace toward strengthening health and healthcare systems worldwide.

APPENDIX 5.0

International Networks Enabling Exchange

International digital health leaders from 33 nations and territories and three international organizations that represent over 2.8 billion people. Efforts are focused on working to provide opportunities for worldwide participants to exchange best practices for data sharing, electronic health records exchange, patient access, among other important opportunities.

International Networks

Digital health continues to expand at a rapid pace toward strengthening health and healthcare systems worldwide. Interoperability is a major focus area in:

• Overcoming patient data sharing challenges between health care providers, health organizations, caregivers, and patients.
• Determining the path forward for addressing interoperability challenges through standards and technology.

For illustrative purposes only. Significant international exchange initiatives. Not an exhaustive list.

Source: GDHP, "Connected Health: Empowering Health Through Interoperability," 2019

Click here to access the Global Digital Health Partnership's white paper on interoperability and key findings