Welcome back to our series of interviews with our in-house experts where we talk about the most important standards and guidelines across different industries. And today’s topic is HL7 — a foundational protocol that has significantly impacted healthcare data interchange.
As healthcare systems have rapidly evolved over the last few decades, so too has the need for standardized communication between different systems and platforms. HL7 serves as a beacon in this vast sea of data exchange, ensuring consistency and clarity in the way patient information and healthcare data are communicated.
But what exactly is HL7? Why is it so important in the modern healthcare landscape? And how has it evolved to meet the changing demands of the sector? Elinext experts are here to unpack these questions and offer an insightful perspective on the significance of the HL7 standard.
Let’s start with an overview of HL7. What does HL7 stand for?
Short for Health Level Seven, HL7 is a set of internationally recognized and most frequently used compatibility standards. These standards define how electronic medical information is transmitted between medical applications, that is how information is:
HL7 offers a range of adaptable international standards, guidelines, and methodologies that allow various medical systems to share data while ensuring that information is distributed and processed consistently.
Why does the healthcare industry need HL7?
HL7 standards are recognized as the most frequently used in the world, and rightfully so. First and foremost, HL7 standards:
- determine the method of packaging and transmitting information between parties, setting the language, structure, and data types crucial for system integration;
- support clinical practices and the delivery of medical services;
- serve as a bridge connecting modern medical services with advanced information technologies.
- are recognized as the most frequently used in the world.
To emphasize, HL7 centers on a range of flexible standards and guidelines through which different healthcare systems can interact with each other. These guiding principles and data standards form a framework that ensures consistent and uniform information exchange and processing. Moreover, this ability to seamlessly share information helps minimize the tendency towards isolation and high variability in healthcare delivery.
What organization is responsible for HL7?
Health Level Seven International, a non-profit organization, handles the development, advancement, implementation, and accumulation of medical knowledge. The organization was founded in 1987, with its headquarters located in the state of Michigan. The mission of the organization is to provide standards that expand the data interoperability capabilities in the healthcare industry.
The organization develops healthcare standards based on the consensus of all interested parties. Health Level Seven International consolidates various message types and relevant clinical standards, outlining the optimal format and representation for clinical information exchange.
Health Level Seven International stands as a leading global authority on standards for the seamless integration of medical information systems. While it has received accreditation from the American National Standards Institute (ANSI), a U.S.-centric body, numerous HL7 specifications have gained global acceptance. A substantial number of these HL7 standards have not only been approved by ANSI but also embraced as international ISO standards.
Health Level Seven International also has numerous international branches that contribute to the development of HL7 standards and adapt these standards to the conditions of specific countries. Almost all the work in HL7 International is carried out by volunteer participants. Participation is open to all, and the organization welcomes a wide range of stakeholders — software developers and providers, physicians, patients, academics, insurers, government representatives, and other interested parties.
HL7 International encompasses about 40 working groups that span various healthcare domains, from pharmaceuticals to public health to scientific research. These working groups are entities that take on the responsibility for the development and maintenance of standards and they are open to anyone interested in contributing to their objectives. HL7 International has more than 1600 members in 50 countries, including over 500 corporate members:
- representatives of Medical Information Systems (MIS) manufacturers;
- governmental organizations;
- pharmaceutical companies;
- consulting firms
As a global standards development organization, does HL7 provide training to learn straight from the source?
Health Level Seven International creates and promotes educational initiatives focused on providing knowledge and bolstering the global healthcare sector by effectively deploying HL7 standards, such as Version 2 (V2), Version 3 (V3), Clinical Document Architecture (CDA), and Fast Healthcare Interoperability Resources (FHIR).
That said, HL7 International offers both individual and corporate training. Individual training is expert-led instruction for individuals around the world in various formats, including:
- online classes and webinars;
- self-paced courses;
- customized training upon request;
- in-person events.
As for corporate training, HL7 International provides instruction tailored for corporations, governments, and academic circles. Training can be conducted on-site at the client’s institution or in real-time with qualified instructors and practicing professionals from HL7 International.
What about certification? How can one become HL7-certified?
Health Level Seven International admits that the healthcare information technology industry is complex. In this intricate landscape, having a highly qualified team is crucial, and hiring specialists certified by HL7 ensures expertise and specialized skills.
Health Level Seven International offers certification testing to assist professionals in achieving an industry-recognized level of qualification and experience, furthering their careers. A complete list of certified participants, with details of their certification type, country, and date, is available on the organization’s official website (the list is publicly accessible).
What types of standards does HL7 include?
HL7 standards can be divided into the following categories:
- Primary Standards: These include the most frequently used standards related to system integration, functional interoperability, and compliance requirements.
- Foundational Standards: These standards define the primary tools and building blocks used to create standards, as well as the technological infrastructure to adhere to.
- Clinical and Administrative Domains: These standards contain messaging and documentation exchange guidelines for clinical specialties and groups.
- EHR Profiles: These standards provide functional models and profiles that allow for the effective management of electronic health records.
- Implementation Guides: These guides Include auxiliary documents and supplementary materials.
- Rules and References: These include technical specifications, software frameworks, and guidelines for software and standard development;
- Education & Awareness: These standards contain valuable resources and tools for enhancing understanding and application of HL7 standards.
Let’s dive a bit deeper into HL7 primary or core standards.
HL7 International considers the following standards as its core, meaning that they are most frequently used:
- Message Exchange Standards of two versions (v2.x and v3.0): These standards define how to transmit information between participants.
- Clinical Document Architecture (CDA): This framework comprehensively defines the format, organization, and meaning of clinical documents. CDA utilizes the XML language foundation. When drafting a clinical document, its layout, organization, and interpretation are derived from the CDA guidelines. A document created under the CDA represents a holistic information entity with clearly delineated elements. It also can incorporate text, graphics, audio, and various multimedia elements.
- Structured Product Labeling (SPL): Structured product labeling encompasses all published materials accompanying a drug, for example, prescription information which contains extensive details about the medication.
- Clinical Context Object Workgroup (CCOW): This provides guidelines for the visual integration of user-oriented applications.
- Continuity of Care Document (CCD): These are U.S.-specific guidelines for sharing medical summaries built upon the CDA framework. The CCD specification contains specific U.S. requirements, so its use is limited to the U.S.
What does the timeline for HL7 standard development look like?
The first version of HL7 (HL7 v1) was released in 1987 and was intended only for concept verification and defining the standard’s content and structure.
However, its practical application began with version 2. By 1990, the HL7 v2 (2.1, 2.2, 2.3, 2.3.1, 2.4, 2.5, 2.5.1, 2.6, 2.7, 2.8, 2.8.1, 2.8.2, 2.9), became an instrumental tool for the electronic exchange of clinical data. This standard focused on exchanging financial, administrative, and clinical information in the form of text messages.
Currently, version 2 is the most widely adopted and used standard, although it has certain limitations like the inability to add extended information without introducing a new version, which explains numerous releases. Version 2.9, the most recent update of the v2 standard, was published in 2019.
Interestingly, among all its releases, versions 2.3 and 2.3.1 are the most widespread today. As the organization itself notes, owing to its extensive adoption, version 2 will remain integral to healthcare communication with the release of version 3 and the development of CDA and FHIR. HL7 aims to support and expand version 2 alongside other products, and statistics further back v2’s dominance: 95% of U.S. healthcare entities and organizations in over 35 countries globally utilize this version.
The shortcomings of the second version along with technological advancements led to the development of the third version (HL7 v3) in 1995. This version was anchored in the HL7 Reference Information Model (RIM), integrated data type models, terminological dictionaries, and a refreshed standard development methodology.
Although version 3 was theoretically and conceptually well-thought-out, the development of specific domains experienced prolonged delays, leading to serious criticism and several calls for simplification.
In 2001, to standardize structure and promote semantic compatibility across medical systems, the HL7 Clinical Document Architecture (CDA) was launched. While its first release was in 2001, it’s the second release from 2005 that remains popular today, with a third version currently in the development and review phase.
Fast forward to 2011, there was a collective push within the HL7 community to explore the possibility of creating a new compatibility standard from scratch, leveraging modern technology and insights. This initiative resulted in the development of the Fast Healthcare Interoperability Resources (FHIR) project. Adopting cutting-edge information and communication technologies like XML, JSON, Web 2.0, HTTP, and REST, FHIR saw its first release in 2014. Its fourth version, released in 2019, remains pertinent and widely adopted today.
In conclusion, the significance of the HL7 standard in the realm of healthcare can hardly be overstated. It plays a pivotal role in data structuring, streamlining system design, and ensuring consistency in data transmission. Furthermore, HL7 is vital for maintaining data security and enhancing accessibility. At Elinext, a leading healthcare software development company, we stay on top of relevant industry standards to make sure we deliver the most efficient solutions to our clients that help them navigate the complexities of modern healthcare.