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Effective clinical communication is two-way (or multi-way if between teams), structured and continuous communication that results in timely, accurate and appropriate transfer of information. It is tailored, open, honest and respectful, and there is the opportunity for clarification and feedback.
It is 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. Health data exchange architectures, application interfaces and standards enable data to be accessed and shared appropriately and securely across the complete spectrum of care, within all applicable settings and with relevant stakeholders, including the individual. Health information exchange, or HIE, provides the capability to electronically move clinical information among disparate healthcare information systems and maintain the meaning of the information being exchanged. The goal of health information exchange is 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 HIE is generally used as either a verb or a noun. In the European Union, the act of information exchange is often referred to as data sharing. The European Commission’s Support Centre for Data Sharing uses the term to refer to the collection of practices, technologies, cultural elements and legal frameworks that are relevant to transactions in any kind of information digitally, between different kinds of organizations. This term is more broadly applied to all types of data sharing, but can also be specifically used for health-related data. Back to top Standards provide a common language and a common set of expectations that enable interoperability between systems and/or devices. In order to seamlessly digest information about an individual and improve the overall coordination and delivery of healthcare, standards permit clinicians, labs, hospitals, pharmacies and patients to share data regardless of application or market supplier. A standards organization, standards body, standards development organization (SDO) or standards setting organization is focused on developing, coordinating, promulgating, revising, amending, reissuing, interpreting, or otherwise producing standards that are intended to address the needs of some relatively wide base of affected adopters. In order to be recognized as an SDO, an organization may be accredited by the American National Standards Institute (ANSI) or the International Organization for Standardization (ISO). Standards are also developed by other groups such as trade unions or associations. The development and adoption of open, consensus-based standards can be a complex process involving many different stakeholders and subject matter experts. There are over 40 different SDOs in the health IT arena. Some entities create standards, such as Health Level Seven (HL7), Systematized Nomenclature of Medicine (SNOMED) International, and the Clinical Data Interchange Standards Consortium (CDISC). Others, like Integrating the Healthcare Enterprise (IHE), do not develop new standards, but rather bundle complementary base standards into IHE profiles that are used to define a specific function or use case, and then are balloted. This creates a scenario that helps drive adoption of the base standards by providing implementation guidance that describes how multiple standards can be used together to support interoperable health information exchange. The different SDOs and profiling organizations have varying compositions and processes, but generally follow shared principles based on developing standards through a multi-stakeholder, consensus-based process to respond to specific industry or market needs. Types of StandardsIn order to understand the types of health data standards available for use, informatics professionals organize these standards into the following specific categories: vocabulary/terminology, content, transport, privacy and security, and identifiers. Vocabulary/Terminology StandardsVocabulary/terminology standards address the ability to represent concepts in an unambiguous manner between a sender and receiver of information, a fundamental requirement for effective communication. Health information systems that communicate with each other rely on structured vocabularies, terminologies, code sets and classification systems to represent health concepts. Some common vocabulary standards currently used in the marketplace include:
Content StandardsContent standards relate to the data content within exchanges of information. They define the structure and organization of the electronic message or document’s content. This standard category also includes the definition of common sets of data for specific message types.
Transport StandardsTransport standards address the format of messages exchanged between computer systems, document architecture, clinical templates, user interface and patient data linkage. Standards center on “push” and “pull” methods for exchanging health information.
Privacy and Security StandardsPrivacy standards aim to protect an individual's (or organization's) right to determine whether, what, when, by whom and for what purpose their personal health information is collected, accessed, used or disclosed. Security standards define a set of administrative, physical and technical actions to protect the confidentiality, availability and integrity of health information. In the U.S., the Health Insurance Portability and Accountability Act (HIPAA) outlines standards that safeguard the privacy and security of protected health information.
In Europe, the General Data Protection Regulation (GDPR) outlines privacy and security regulations for all processing and storage of data relating to data subjects—or people—in the European Union (EU). This regulation extends to health information and any organization that may process or store data on these subjects, meaning it has extensive reach to many organizations worldwide and related to the sharing of data across organizations. Identifier StandardsEntities use identifier standards to uniquely identify patients or providers.
Standards, Implementation Guides and ProfilesStandards on their own are helpful because they describe and constrain what data moves. Implementation guides describe how to implement these standards for a specific use case. An implementation guide is a companion to a standard that describes how to use a standard to satisfy a specific healthcare use case. It should specify which way a standard is to be applied in a particular use case—how to structure the data consistently and what vocabulary to use. While you can implement a standard in a number of different ways, when using an implementation guide to integrate a standard into a health IT system, the guide directs one way to constrain the standard for a particular situation, removing ambiguity and achieving consistency. A benefit to the use of implementation guides like IHE Profiles is that they provide a common language for purchasers and market suppliers to discuss the integration needs of healthcare sites and the integration capabilities of health IT products. They provide precise definitions of how to implement standards to meet specific clinical needs. They offer developers a clear implementation path for standards that has been carefully documented, reviewed and tested as well as supported by industry partners. They give purchasers a tool that reduces the complexity, cost and anxiety of implementing interoperable systems. IHE profiles, in particular, organize and leverage the integration capabilities that can be achieved by coordinated implementation of communication standards, such as DICOM, HL7 W3C and security standards. Testing and Conformance EffortsThe adoption and implementation of standards involves a testing ecosystem that spans standards development, implementation and feedback from real-world testing into the development process to support continuous improvement. There are various different testing and compliance efforts that support advancing health IT interoperability, including:
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 adoption of emerging and mature health IT standards. The primary goal of the consortium 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. Back to top The health interoperability ecosystem comprises individuals, systems and processes that want to share, exchange and access all forms of health information, including discrete, narrative and multimedia. Individuals, patients, providers, hospitals/health systems, researchers, payers, suppliers and systems are potential stakeholders within this ecosystem. Each is involved in the creation, exchange and use of health information and/or data. 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. Exchange Partners and Data SourcesHistorically, the focus was on the exchange of clinical information between providers and hospitals. As the technology has progressed, these exchange partners have broadened to include individuals, such as patients and caregivers, and organizations, such as long-term care, public health departments, community-based organizations and payers. With this expansion, along with the shift to value-based care, has also come a broader range of data types that are available to inform health and care, including device data, patient-generated data and data pertaining to the social determinants of health. Social determinants of health can include data points such as an individual’s housing status, access to reliable transportation and level of food security. Network ArchitecturesThere are three primary types of exchange network architecture used to coordinate the exchange of health information across entities.
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. Types of HIE OrganizationsAn 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 and governance functions for information exchange. There are several different types of HIEs currently operating across the U.S. and its territories:
U.S. Exchange Initiatives: An Environmental ScanMany organizations are actively working to achieve ubiquitous exchange. This environmental scan provides a curated review of the current landscape of the U.S.-based networks and frameworks which enable interoperable, nationwide health information exchange via a variety of methods and collaborations. International Networks Enabling ExchangeBeyond the examples outlined above, various exchange networks and infrastructure have been established globally.
Back to top Watch the HIMSS TV deep-dive on interoperability. Ultimately, the goal is to be able to share and access information that informs an individual’s full, longitudinal health story. By having and understanding the complete and accurate picture of an individual’s health—including their preferences and other determinants of health—includes a number of benefits. Clinicians can better inform care and decision making, patients can become active participants in their care plans, and health IT developers and implementers can leverage evidence to create and adopt systems that support clinical processes and improve care delivery. A number of benefits can be realized for exchange stakeholders, including: With these benefits in mind, taking a use-case driven approach can frame how information sharing may inform care or business practices and can help frame the potential benefits and drive interoperability forward. The following examples provide a snapshot at how interoperable exchange may occur. Back to top As the HIMSS definition suggests, interoperability goes beyond its technical requirements. Often there are policy changes influencing the value proposition and therefore willingness to exchange. Organizational considerations must align with external organizations and work toward achieving trust across stakeholders to enable meaningful data sharing. The following outlines some of these considerations and the approaches that may be leveraged. Ensuring and communicating patient consent for data sharing activities is critical to abide by regulatory requirements and maintain the trust of the patient. There are several consent models used in information exchange, dependent on regulatory requirements within a jurisdiction.
Regardless of the model leveraged, a patient has the right to revoke their consent at any time, and processes to ensure that preference is communicated and enforced is important for data sharing processes. Ensuring Privacy and SecurityRegulations such as GDPR in the EU, HIPAA in the U.S., and various other national and state laws and regulations set forth privacy and security requirements to safeguard health information when it is created, received, transmitted, or maintained by health systems and other organizations. Privacy and security considerations may include the following:
Producing High-Quality DataIn order to ensure that the information received from disparate sources can be trusted that it is accurate and complete, there needs to be efforts by organizations to maintain high-quality data. This can be achieved by ensuring that:
Back to top 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. The following outlines examples of how governments have worked to facilitate exchange both within the U.S. and in countries around the world. With the goal of achieving ubiquitous, 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. Among the health IT provisions outlined in 21st Century Cures, many sections provide directives to the ONC, Centers for Medicare and Medicaid Services (CMS) and other agencies related to improving interoperability. In parallel with the release of the ONC Interoperability and Information Blocking Final Regulation, CMS also outlined an Interoperability and Patient Access Final Regulation, as part of their MyHealthEData Initiative, focused on driving exchange of and patient access to health information by liberating patient data using CMS authority to regulate Medicare Advantage, Medicaid, Children’s Health Insurance Plan, and Qualified Health Plan issuers on the federally facilitated exchanges. The Interoperability Standards Advisory (ISA) process represents a single, public list of standards and implementation specifications published by ONC. ONC coordinates the identification, assessment and determination of these recommended standards and implementation specifications for industry use to fulfill specific clinical health IT interoperability needs. Stakeholders are encouraged to implement and use these recommended standards as applicable to their needs. The ISA is organized into sections with related interoperability needs, each including one or more standards or implementation specifications to accomplish the listed need. Additional characteristics on these standards and implementation specifications are listed to inform stakeholders on maturity and adoption. These include: This ONC project aims to standardize data found outside of traditional care delivery settings. As part of the precision medicine initiative, it focuses on standards in two areas: ONC hosts an open, community platform where individuals and organizations can share and learn from projects occurring in the United States and internationally. HIMSS and PCHAlliance strongly urge prioritization of necessary funding and technical assistance to implement modern health information and technology strategies to ensure timely interoperability and sharing of public health surveillance data. An important component is the work in partnership with the Association of Public Health Laboratories, Council of State and Territorial Epidemiologists and the National Association for Public Health Statistics and Information Systems that support this multi-year effort to modernize public health data systems, surveillance and analytics at the CDC, and state, local and tribal health departments. Funding included in the Fiscal Year 2020 Appropriations Package and the Coronavirus Aid, Relief and Economic Security (CARES) Act, will help address some of the challenges, but in the long term, we need a predictable and sustained funding source to fully tackle this issue. In the U.S., state public health agencies manage and track information for immunizations, infectious diseases and vital statistics, however, they often lack adequate funding to ensure their information systems are updated and conform to national standards and profiles. Health information exchanges—which are public or private entities, depending on the state and region—aim to ensure there is robust and standardized data exchange between and among public health entities and state and local health departments. At an international level, there are a variety of initiatives being led by health ministries and governments to further country-level and cross-border interoperability efforts. The Global Digital Health Partnership (GDHP) is a collaboration of over 40 governments and territories, government agencies and the World Health Organization, formed to support the effective implementation of digital health services. Interoperability is one of the various work streams explored by GDHP. The proposed work stream activities focus on the evolving challenges of sharing patient data between care providers, organizations, caregivers and patients. These challenges are partly a technical problem for health systems, clinicians and patients, however they also pose significant risks for patient safety, and detract from high-quality coordinated care and the efficient delivery of services. A GDHP report outlines a variety of government efforts from 15 participating countries. In Europe, the EU EHR Exchange Format developed the EU’s eHealth Network to support the digital transformation of health and care in the EU by seeking to unlock the flow of health data across borders, and support implementation of the Cross-Border Health Care Directive. The recommendation seeks to facilitate the cross-border exchange of EHRs in the EU by supporting member states in their efforts to ensure that citizens can securely access and exchange their health data wherever they are in the EU. It will help citizens to quickly access and share their health data with healthcare professionals, for example, when consulting a specialist or receiving emergency treatment in another EU country. The backbone infrastructure for the EHR exchange is the EHDSI. The EHDSI consists of services and infrastructure that use information and communication technologies to enable cross-border healthcare services. Initial focus is on enabling the exchange of baseline health information, including:
A number of EU countries are already exchanging the ePatient summaries and ePrescriptions. As part of the EHDSI, Finland and Estonia were among the first to implement infrastructures to support the exchange of patient summaries, leveraging the X-Road platform, a free and open-source data exchange layer solution that enables organizations to exchange information securely over the internet. Future phases will include lab results, medical imaging and reports, and hospital discharge letters. The European Commission also outlined priorities for 2019-2024 EU Digital Strategy, which included the creation of a European Health Data Space (EHDS) to foster the exchange and sharing of different kinds of health data (electronic health records, genomics, registries, etc.) in Europe. It aims to not only support exchange for the delivery of primary care, as well as, the development of new treatments, medicines, medical devices and services. Beyond the citizens, this would help meet the needs of different users and actors in the health system, while simultaneously protecting citizens’ data. The commission is currently working with the member states and stakeholders to define the best governance structure and set up the appropriate infrastructure for the EHDS. Additionally, some existing regulatory gaps regarding member states implementation of the GDPR for the secondary use of data are being addressed. The European Interoperability Framework (EIF) gives specific guidance on how to set up interoperable digital public services. It offers public administrations 47 concrete recommendations on how to improve governance of their interoperability activities, establish cross-organizational relationships, streamline processes supporting end-to-end digital services, and ensure that both existing and new legislation do not compromise efforts. In an effort to ensure secure and federated access to genomic data, the European 1+ Million Genomes Initiative aims to create a technical infrastructure to improve disease prevention, allow for more personalized treatments and provide a sufficient scale for new clinically impactful research. In addition to the technical foundation for this effort, the signatory countries will also assess ethical and legal implications of genomics, and data storage, security and ethical uses. Beyond these broader initiatives occurring across Europe, many countries are also leading specific regional and national efforts to expand exchange abilities./p> The Nordic Interoperability Project is a consolidated grassroots effort to demonstrate the value for the patient from a seamless cross-border exchange of health data. The consortium includes organizations from all five Nordic countries—Denmark, Finland, Iceland, Norway, Sweden—and works to enable patients to live and act in an open, seamless, cross-border healthcare ecosystem, by showcasing and implementing solutions and innovations from the Nordics. The goal is to enable the Nordics by 2030 to be the most sustainable and integrated health region in the world, providing personalized healthcare for all its citizens. In Portugal, the Shared Services of the Ministry of Health (SPMS) is a state-owned enterprise that manages the Portuguese Health Ministry Central Purchasing and serves as the national IT authority and the Portuguese representative for eHealth cross-border affairs. SPMS provides shared services in the areas of purchasing and logistics, financial services, human resources, and information and communication technologies to health and care entities to centralize and optimize the procurement of goods and services within the Portuguese National Health System. In Asia and the South Pacific, many governments are also adopting digital health strategies to encourage interoperable exchange. For example, India’s The Ministry of Health and Family Welfare (MoHFW) publishes EHR standards and created a Centre for Health Informatics under the eHealth Division of MoHFW as part of their Digital Health Strategy to initiate several digital health initiatives in the country, and started the National Health Portal as a citizen portal with the objective of improving the health literacy of the masses in India. New Zealand’s health agencies, organizations and individuals signed a Commitment to New Zealand Health Interoperability to outline principles to drive the adoption of exchange infrastructures and processes in their health sector. Back to top |