Count on changes as IHE implementation progresses—get involved now, and let your voice be heard

Integrating the Healthcare Enterprise (IHE) is an initiative by health care professionals and industry to improve the way computer systems and medical devices are used in sharing health care-related clinical- and process-oriented information. The IHE initiative was originally sponsored by the Radiological Society of North America (RSNA) and the Healthcare Information and Management Systems Society (HIMSS) in 1998. They have since been joined by the American College of Cardiology (ACC), as the third major sponsor.

While there has been much focus on the development of a National Health Information Network (NHIN) since President George W. Bush’s executive order of April 27, 2004, and the establishment of the Office of National Coordinator for Health Information Technology (ONCHIT), much of the groundwork that will make this a reality by 2014 is being laid down by the IHE.

IHE promotes the coordinated use of established standards, such as DICOM, HL7, and IEEE 1073, to establish vendor-independent protocols for the functional and semantic communication of clinical data between devices, systems, and the electronic health record (EHR). In addition, IHE ensures automatic transfer of patient-care-process data, such as procedure and staff/resource scheduling, invoicing, and intersystem messaging. IHE creates “enterprise interoperability,” which is key to establishing a new era of open system communications to replace proprietary clinical and functional silos that prevent efficient, reliable information exchange.

Recognizing the Benefits
The benefits of this infrastructure include freed-up vendor resources for innovation, users’ ability to seek “best-of-application” devices and systems, and, ultimately, critically needed reductions of costs and errors. IHE envisions a day when vital information can be passed seamlessly from system to system within and across departments and made readily available at the point of care.

IHE enables vendors to cooperate in implementing standards for communication among information systems while giving users—medical practitioners, information technology (IT) professionals, and clinical engineers—an important management, oversight, and advisory role in that process. IHE is not merely an academic exercise that creates paper. Vendors actually gather together at technical-compatibility events called “connectathons,” where they work together to interactively test, demonstrate, and debug their systems.

This is a novel and important real-world contribution of IHE, in that vendors’ best and brightest engineers make the unique commitment to collaborate in overcoming problems that traditionally rested on the purchasers’ shoulders and pocketbooks. These connectathons add value to the vendors, too, as they reduce risks and re-engineering costs, allow them to document IHE compliance for customers, and set the stage for successful product demonstrations at large medical trade shows like those run by the sponsoring societies.

In fact, during the past 5 years, more than 20,000 attendees have participated in IHE demonstrations at the annual meetings of the sponsoring societies. In these demonstrations, established IHE profiles are used to communicate relevant patient and operational process information among dozens of systems from a large variety of vendors.

Setting Priorities
The IHE’s organizational structure is by user groups or clinical specialties, referred to as domains. Examples of these domains are radiology, IT, clinical laboratory, and cardiology. In the 2005 Annual IHE Survey conducted by HIMSS, more than 50% of respondents indicated that medical devices should be given a priority for inclusion in the IHE. This is not surprising, because:

• For every network-connected IT device in the hospital, there are four patient care devices (PCDs) that are not connected to the network—yet;
• There are more than 1,500 PCD manufacturers and more than 3,500 make-model combinations;
• PCD’s hardware and software are constantly changing with updated and upgraded technology; and
• PCDs are becoming “smarter” as software—firmware—hardware complexity increases.

Since 2001, a task force of the American College of Clinical Engineering (ACCE) has been working with IHE’s overall strategic development committee (SDC) to develop a plan to support medical devices. In February 2005, the IHE SDC reviewed and ratified ACCE’s proposal to address medical devices; and shortly thereafter, the sponsoring organizations appointed ACCE as the “domain sponsor” for new PCDs. ACCE is charged with leveraging the successful profiles that IHE has developed for radiology, IT, and cardiology, extending the library of IHE profiles to encompass all of the medical devices typically used at the point of care. The long-term goal of the PCD domain is to facilitate the integration of physiologic data from patients, including measurements, diagnostic test results, and waveforms into the EHR, for application in automated charting, analysis, medical-error prevention, etc. In addition, over time, the PCD profiles will enable the integration of important process-related data, such as radio-frequency identification patient and device location; drug-infusion billing and refill scheduling; available-bed notifications for the emergency department; outpatient surgery resource management; and medical-device recall, location, and scheduling.

Objectives of the PCD Domain
The overall objectives of the PCD domain are to promote the work of the domain through papers and presentations; to organize the stakeholders’ resources to develop a technical framework, based on specific use cases and workflows that vendors’ products are measured against in the connectathon; and to participate in demonstrations at the ACC, HIMSS, and RSNA Annual Meetings and other forums.

Naturally, the scope of the PCD spans virtually all clinical disciplines, including emergency medicine, anesthesia, intensive care, surgery, intravenous (IV) therapy, and others. In establishing the PCD under ACCE, the IHE recognized some fundamental differences between PCDs and devices in other domains, such as radiology and cardiology.

PCDs are unique in that many devices are used in multiple clinical contexts, so the acquired data may have different implications depending upon the clinical setting. Also, PCDs provide life-critical signals and alarms that directly impact patient safety and well being in real time, and these messages must be accorded appropriate priority and integrity assurance.

Because more and more devices are designed to be portable and/or to accompany ambulatory patients throughout a facility, PCD connectivity now often includes wireless- and wired-network connections, and emerging web-app-based Internet systems are becoming feasible, and these network and Internet connections must comply with Health Insurance Portability and Accountability Act confidentiality, integrity, and availability regulations.

Finally, the largest health care enterprise value of PCD will come from devices that can provide data that is automatically and accurately incorporated directly into the information stream that feeds the emerging EHR. Once the PCD domain profiles allow automatic data transfer to the EHR, the following major benefits will emerge for the health care enterprise:

1) Clinicians will finally be able to see all relevant intra-­organizational clinical- and process-related patient data as soon as it is available, improving the reliability and safety of decision-making and reducing the likelihood of redundant or conflicting service orders;

2) Enterprises will begin to have the ability to transfer data to and from the Regional Healthcare Information Organizations that are part of the NHIN and ONCHIT plans, finally offering interenterprise clinical- and process-oriented data sharing, which should multiply the benefits described in Item 1 above; and

3) Government and private health care managers and payors, as well as consumers (such as Medicare, insurers, the Department of Health and Human Services, and patients and their families), will begin to have timely access to local, regional, and national clinical and process data that will allow more accurate and timely intervention in expensive chronic-care situations or a dangerous pandemic.

To accomplish its objectives, ACCE has organized the IHE PCD domain into two primary committees, directed by a leadership team of cochairs. The domain leadership team includes Todd Cooper of Breakthrough Solutions (Poway, Calif), Jack Harrington of Philips Medical Systems (Bothell, Wash), Elliot Sloane, PhD, of Villanova University (Villanova, Pa), and Raymond Zambuto of Technology in Medicine (Holliston, Mass). Emanuel Furst, of Imptech Improvement Technologies (Tucson, Ariz) serves as technical coordinator for the domain, and Elliot Sloane, PhD, serves as the liaison to the IHE SDC. Two top-level committees have been formed. The Planning Committee is responsible for high-level planning, surveying the industry, and developing a 5-year road map for the domain. The Technical Committee is responsible for taking the use cases of the Planning Committee and translating these into working documents that the vendors can use to design IHE-compliant systems.

Mapping Out a Plan
The plan for 2006 is to develop two “profiles.” One profile will be to bind the correct patient identifier to the device and its data, and the other profile will be to communicate asynchronous patient data to the EHR. Examples of asynchronous data would be periodic vital-signs data or point-of-care laboratory test results, as opposed to waveforms. These two profiles will be tested at the January 2007 connectathon and demonstrated live at the HIMSS Annual Meeting in February 2007. The testing will be done on three classes of medical devices: vital-signs monitors, IV pumps, and ventilators. Participation by a minimum of three vendors is required to certify interoperability for a given profile.

The Planning Committee is also developing a 5-year plan. Interest in the PCD is running high. Vendors are participating because they see strong value in being able to develop standard interfacing and to reduce their development risks through the connectathons. This permits vendors to concentrate resources on the innovations that differentiate them from their competitors. Users and purchasers see value in system simplicity, reduced medical errors and waste, and the ability to match up best-of-breed technologies from different vendors. Regulators and government agencies recognize that the IHE can provide a direct path to bringing clinical- and process-oriented data into the regional and national systems envisioned by President Bush and the ONCHIT.

The IHE PCD domain also injects clinical engineering directly into the ongoing medical device/IT-convergence process. Clinical engineers are working side by side with their high-level counterparts in industry, hospital IT departments, and standards and regulatory agency staff and volunteers. This is resulting in a better understanding by all parties of the nature of the interfaces, the pitfalls, the risks, and the opportunities involved in connecting all of the patient’s information and making it broadly available.

Information on the work that ACCE has been doing with the PCD domain is available at www.accenet.org/ihe. Those interested in working on this exciting project can e-mail iheinfo@accenet.org.

Raymond Peter Zambuto, CCE, FASHE, SHIMSS, is president and CEO, Technology in Medicine Inc, Holliston, Mass. Elliot B. Sloane, PhD, is assistant professor of decision and information technologies at Villanova University’s College of Commerce and Finance, Villanova, Pa.