1.    Overview

Enabled in part by major industry data exchange standards and architecture initiatives, physicians’ offices and hospitals, and other healthcare facilities (such as Military Treatment Facilities – MTFs), have accelerated their adoption and use of patient electronic health records (EHRs) and other health information technology (HIT) in recent years. As an example, a comparison of results from The Commonwealth Fund’s two national surveys of federally qualified health centers (FQHCs) in 2009 and 2013 show that HIT adoption has grown substantially among providers of care in poor and underserved communities. The surveys found that “nearly all surveyed FQHCs (93%) now have an EHR system, a 133 percent increase from 2009, the year federal “meaningful use” incentives for HIT were first authorized. Three-quarters of health centers (76%) reported meeting the criteria to qualify for incentive payments.” We believe that this technology adoption trend has further accelerated since that study was published.

However, that study and other similar studies reported by the U.S. Department of Health and Human Services (HHS), Office of the National Coordinator for Health Information Technology (ONC), have found that among the most significant challenges for health centers are achieving greater interoperability of EHR systems and ensuring patient access to their records. Therefore, this paper focuses on major trends in the adoption and use of interoperable health information technology across the care continuum. It describes the major industry data exchange standards and architecture initiatives and their beneficial products, and further provides an overview and our rationale as to why interoperability is so important to EHR system evolution. Based on our review of key standards organizations and their initiatives, we have concluded that interoperability is improving and is contributing more significantly to improved patient care. Six representative standards organizations and their initiatives, described below, are setting the recent important trends:

  • Health Level Seven (HL7) - Health Level Seven (HL7) is an American National Standards Institute (ANSI) Accredited Standards Developer. The mission of HL7 is to provide a comprehensive framework and related standards for the exchange, integration, storage, and retrieval of health information that support clinical practices and the management, delivery and evaluation of health services. This mission encompasses the complete ‘life cycle’ of a standard’s specification – development, adoption, market recognition, utilization and adherence. HL7’s Version 2.x (V2) Messaging Standard is the most referenced electronic data exchange in the clinical domain and likely the most widely implemented standard for healthcare in the world; 95% of US healthcare organizations use HL7 V2.x. This messaging standard allows the exchange of clinical data between systems. It is designed to support a central patient care system as well as a more distributed environment where data resides in departmental systems. Other key HL7 standards that are defining the trend in data exchange standardization and architecture include: Electronic Health Record System Function Model Release 2, and HL7 Version 3 Clinical Document Architecture (CDA®).
  • Object Management Group (OMG) - The OMG is an international, open membership, not-for-profit computer industry specifications consortium. OMG member companies write, adopt and maintain the organization’s standards following a mature, open process. Published health information standards include: Patient Identification, Provider Identification, Provider Directory, Record Locator, Data Retrieval, hData, Health Services Directory, Terminology Management, Access Control, Clinical Decision Support, Provider Directory, Services Directory, Medication Statement. Projects underway include: Audit, Care Coordination, Event Publication and Subscribe, Immunization Profile, Ordering Service, SOA Ontology for Health, and Unified Communication Service.
  • Integrating the Healthcare Enterprise (IHE) - IHE is an initiative by healthcare professionals and industry to improve the way computer systems in healthcare share information. IHE promotes the coordinated use of established standards, such as Digital Imaging and Communications in Medicine (DICOM) and HL7, to address specific clinical needs in support of optimal patient care. Systems using DICOM developed in accordance with IHE communicate with one another better, are easier to implement, and enable care providers to use information more effectively. IHE is organized by clinical and operational domains. In each domain users with clinical and operational experience identify integration and information sharing priorities and vendors of relevant information systems develop consensus, standards-based solutions to address them. The active IHE domains are: Anatomic Pathology; Cardiology; Dental; Eye Care, IT Infrastructure; Laboratory, Patient Care Coordination, Patient Care Devices; Pharmacy, Quality, Research and Public Health; Radiation Oncology; Radiology; Mammography; and Nuclear Medicine.
  • Standards and Interoperability (S&I) Framework - The ONC S&I Framework is a collaborative community of participants from the public and private sectors who are focused on providing the tools, services and guidance to facilitate the functional exchange of health information. The S&I Framework uses a set of integrated functions, processes, and tools that enable execution of specific value-creating initiatives. Each S&I Initiative addresses a critical interoperability challenge through a rigorous process. The NwHIN 1.0 Portfolio is a collection of standards, services, and policies that form the foundation for meaningful electronic exchange of health information. It is important for implementing EHR solutions that meet Meaningful Use objectives and other national healthcare priorities. Through this framework, ONC is a trend setter in the initiative areas of Transitions of Care, Laboratory Results Interface, Provider Directories. Query Health, Data Segmentation, esMD, Certificate Interoperability, Longitudinal Coordination of Care, and Public Health Reporting.
  • Open Health Tools - Open Health Tools is a not-for-profit trade association, with the technical goal of assembling and/or developing a comprehensive harmonized tool suite to enable the definition, development and deployment of interoperable Electronic Health Records. This organization is considering merging with HL7 in the near future.
  • Health Informatics Service Architecture (HISA) (ISO 12967-1:2009)- HISA provides guidance for the description, planning and development of new systems, as well as for the integration of existing information systems, both within one enterprise and across different healthcare organizations, through an architecture integrating the common data and business logic into a specific architectural layer (i.e., the middleware), distinct from individual applications and accessible throughout the whole information system through services. This standard was derived from the European Committee for Standardization (CEN) Standard Architecture for Healthcare Information Systems (ENV 12967) HISA effort.

Building on the work and efforts of the above listed organizations, standards and initiatives, this paper will further refine the problem/gap analysis, standards integration, and specification development. We address this in further detail following the graphic below, which is an overview of the S & I Framework that is integrating the various initiatives and work products from the HHS/ONC perspective.

 Figure 1 graphic

Figure 1: Overview of the S & I architecture refinement and management activities that are integrating the various initiatives and work products from the HHS/ONC perspective.

2.    Key Frameworks and Tools Driving Trends In The Adoption and Use of Health IT

We discussed key government and industry-wide trends in the use and adoption of health IT in the overview section above. Several important frameworks and tools for both ongoing and future efforts in architectural specification, modeling, development, and demonstration/deployment of next-generation certified EHR solutions include:

a.    Service Specification Development Framework

Based on the HL7 Development Framework (HDF), the Healthcare Services Specification Project (HSSP) Service Specification Development Framework (SSDF) is a methodology used for producing service specifications for Healthcare. The SSDF Methodology is a product of theHSSP, a joint endeavor between HL7 and the OMG organizations. The Electronic Health Records Technical Committee chartered the HSSP, and the Board of Directors of both organizations subsequently validated the HSSP. The project has several objectives:

  • To facilitate open industry input for collaborating organizations interested in supporting this process;
  • To gauge broader interest in healthcare computational services within the HL7 community;
  • To facilitate the development of a set of implementable interface standards supporting agreed-upon services specifications to form the basis for provider purchasing and procurement decision;
  • To stimulate the adoption and use of standardized “plug-and-play” services by healthcare software product vendors;
  • To validate the HL7 Development Framework in its use for the development of services specifications, recommending enhancements if appropriate; and
  • To complement and not conflict with existing HL7 work products and activities, leveraging content and lessons learned from elsewhere within the organization.

Within the process, HL7 has primary responsibility for identifying the functional requirements, mapping those requirements to the EHR Functional Model, enumerating the valid information for the services, and establishing conformance criteria.

The OMG uses this content to develop Requests for Proposals (RFPs) that are the basis of the OMG standardization process. This process allows vendors and other submitters to propose solutions that satisfy the mandatory and optional requirements expressed in the RFP while leaving design flexibility to the submitters and implementation flexibility to the users of the standard. HL7 will be involved in the RFP creation and evaluation process.

b.    IHE Technical Frameworks

The IHE Technical Frameworks are a resource for users, developers and implementers of healthcare imaging and information systems. They define specific implementations of established standards to achieve effective systems integration, facilitate appropriate sharing of medical information and support optimal patient care. The IHE Technical Committees expands the IHE Technical Frameworks annually, after a period of public review, and maintains them through the regular identification and correction of errata.

c.    Testing Tools

IHE has developed a growing body of software tools to facilitate testing and implementation of IHE Integration Profiles in healthcare information technology systems. These tools are available for download and are licensed by their developers for free use. The links below point to sources with further information and direct access to download the tools. IHE Europe assembled additional useful tools and tool kits, many of which are used for as part of IHE testing, as part of the Healthcare Interoperability Testing and Conformance Harmonization (HITCH) project. This is described briefly below.

d.    HITCH Roadmap for Sustainable and Effective Deployment of Testing and Certification of eHealth Systems

The HITCH project made important recommendations in their report to the EU Commission on how to proceed with eHealth interoperability testing and certification/labeling in Europe. HITCH proposed a way forward balancing the urgency to defragment the current approach by eHealth projects, reduce cost of testing, raise the level of quality, and remain sufficiently flexible to account for local needs.

HITCH considers testing and certification related, but distinct processes. While testing represents the way one assesses/measures the level of interoperability, certification is a process where a certifying entity uses the positive test results. If profile specifications and testing tools are robust, certification becomes a formality and high‐level of eHealth interoperability are realized.

In the area of testing, HITCH stressed the need to continue and amplify the progress accomplished in the last few years with initiatives such as IHE “Connectathons.” HITCH identified two areas that need further improvement and more formalism. First, there is a need for a widely-accepted quality guide for interoperability testing based on existing quality standards (such as ISO 9001 and 17025). Second, an organized collaboration is needed to reduce the fragmentation and lack of maturity in interoperability test tools and test plans in specific areas.

In the area of certification, HITCH surveyed various certification strategies and concluded that different variants would need to coexist and evolve with profile specification stability and market maturity.

e.    Trends from Large-Scale Multi-Agency Government Initiatives

In addition to industry groups and standards organizations, relevant leading-edge trends in shareable data architectures are also being established through government interoperable “operational” EHR databases and supporting systems.

Healthcare system analysts and architects are providing services in support of the Virtual Lifetime Electronic Records (VLER), Defense Healthcare Management System Modernization (DHMSM), and Interoperable Electronic Health Record (iEHR) initiatives. The Department of Defense is developing a modern iEHR designed to facilitate data exchange with a comparable Veterans' Administration health record, as well as undertaking the DHMSM effort to upgrade their entire electronic health record (EI-IR) infrastructure. This interoperability program also incorporates a variety of critical data quality tasks, including correction, enrichment, standardization and de-duplication of data.

3.    Conclusion

This paper has described the most significant challenges for healthcare organizations (particularly those within the Federal government) in achieving greater interoperability of EHR systems and ensuring improved patient access to their records. Specifically, it has focused on major trends in the adoption and use of interoperable health information technology (IT) across the care continuum, including the major industry data exchange standards and architecture initiatives. This paper has provided an overview and our rationale as to why interoperability is so important to EHR system evolution. Based on our review of key standards organizations and their initiatives, we have concluded that interoperability is accelerating, and is contributing more significantly to improved patient care and lower costs to healthcare organizations.