Medical Device Link.

Originally Published MX March/April 2005

IT IN HEALTHCARE

The national move toward interoperable electronic health records is a train medtech manufacturers can't afford to miss.

Ken Terry

Thomas W. Smith, chief information officer for Evanston Northwestern Healthcare (Evanston, IL), is feeling frustrated. For an entire year, his department and GE Healthcare (Waukesha, WI) tried to figure out how to transfer images from the hospital's GE Marquette electrocardiographs (ECGs) into the healthcare system's Epic electronic health record (EHR) system. The ECGs can send typed reports into the system, and the reports even contain links that allow doctors to view electrocardiograms on-line. But the method GE finally came up with to transfer the images was too cumbersome for the floor nurses to use. Also, the printed electrocardiograms don't scan well into the electronic record, says Smith.

Thomas W. Smith

A different kind of interface problem has emerged at Borgess Medical Center (Kalamazoo, MI). Borgess recently installed a virtual intensive-care unit (ICU) that allows critical-care specialists and nurses to monitor patients in the actual ICU from a remote location. Bedside monitors, as well as Borgess's picture-archiving communications system (PACS) and lab information system, transmit data to a Web-based Cerner EHR that the off-site intensivists view when they monitor patients.

Photo by W. Cody/CORBIS; insets (from front) courtesy Inovise Medical, Ethicon Endo-Surgery, CHF Solutions, and Baxter Healthcare. (click to enlarge)

Borgess implemented this virtual ICU not only to increase surveillance of its own patients, but also to provide a service to nearby community hospitals. The problem is that none of the neighboring hospitals are on the Cerner platform for which the device interfaces were written. Paul Lange, MD, director of critical-care services for Borgess, wonders whether these other hospitals might have to fax data into the virtual ICU. In that case, the data would have to be entered manually into the system—a big disincentive to Borgess.

Evanston Northwestern and Borgess are on the cutting edge of health information technology (IT). If they are finding it difficult to get computer programs to talk to each other, then surely most of the nation's other healthcare providers face far more daunting challenges as they try to gear up for the national move to interoperable electronic health records.

President Bush accelerated this process last year when he called for all Americans to have access to EHRs within a decade. His appointment of David J. Brailer, MD, PhD, as national coordinator for health information technology was another catalyst of change. Since May 2004, Brailer has helped generate an impressive amount of public- and private-sector activity related to EHRs and the development of healthcare information networks. Although Congress defunded the Office of the National Coordinator for Health Information Technology (ONCHIT) last year, the President recently announced that the Department of Health and Human Services (HHS) would transfer $50 million to Brailer's office. Bush is also seeking to double funding for his health IT plan to $100 million in the current fiscal year, and he will request $125 million for it in fiscal 2006.

While these are piddling amounts by federal government standards, the collaborative public and private efforts to promote health IT and connectivity across healthcare systems are starting to generate a real head of steam. National standards for data exchange will inevitably affect all healthcare players, including medical device manufacturers. So will an increase in the number of hospitals and physicians that have EHRs. Right now, only about 20% of hospitals and 15% of doctors do. When more of them acquire EHRs, hospitals will want to connect their bedside monitors and other devices to those systems. And as physician practices recognize the benefits of EHRs and automated devices in their offices, they'll want to connect the two.

What follows is a rundown of what government agencies and their private-sector affiliates are doing in the health IT arena, and how the changing landscape will change how medtech manufacturers do business.

Regional Health Information Organizations

Last July, when then-HHS Secretary Tommy Thompson and Dr. Brailer launched the national health IT initiative at a Washington, DC, conference, they both emphasized the importance of regional health information organizations—RHIOs, as they've become known. These are locally developed networks of hospitals, doctors, and other providers that are implementing various forms of electronic connectivity. While there are around 100 such projects across the country, many amount to little more than a few hospitals trying to exchange patient data on-line.

Among the most significant RHIOs are the Indiana Health Information Exchange, encompassing most hospitals and many physician offices in Indianapolis; the Santa Barbara County Care Data Exchange, involving 75% of the leading providers in that California county; and the Connecting Colorado Communities eHealth Initiative, which includes four Denver healthcare systems. Massachusetts and Delaware also have announced plans for statewide healthcare connectivity programs.

The Agency for Healthcare Research and Quality (AHRQ; Rockville, MD) within HHS has been charged with providing seed money for RHIO development and testing and for demonstrating the value of healthcare IT. It recently dispensed $139 million in contracts and grants, including five state contracts worth $25 million over five years to develop statewide networks. Colorado, Indiana, Rhode Island, Tennessee, and Utah won these awards.

AHRQ gave grants to a wide variety of researchers and organizations, including hospitals, rural medical clinics, and academic institutions. Many of the projects focus on connectivity between hospitals and community physicians. Others have to do with sharing patient data across the continuum of hospitals, nursing homes, and other outpatient settings.

Scott Young, MD

Aside from the telemedicine context, medical devices are hardly mentioned in the AHRQ-funded project descriptions. But Scott Young, MD, the agency's director for healthcare IT, says that AHRQ has looked at how devices connect with EHRs. "We did some work last year around one of the communication interoperability standards for devices," he notes. "We invested about $100,000 in that, knowing it would become increasingly important, and that getting those standards right and making them available would be critical."

National Health Information Network

The government's long-term goal is to build a national health information network that will tie together the RHIOs and federal agencies involved in healthcare. Since nobody knows how to create a national network from scratch, the government is encouraging the regional networks to evolve while trying to develop technical and policy standards for them.

Last fall, ONCHIT put out an official request for information about building a national health information network. When the public comment period ended on January 18, the office had received more than 500 responses.

One response came from 13 leading healthcare provider and healthcare IT groups under the banner of the Connecting for Health program sponsored by the Markle Foundation (New York City). That coalition's proposal stressed the need for open, consensus-driven, and nonproprietary standards and for patient control over access to health records.

There were also responses from consortia such as the Liberty Alliance (San Francisco), whose 150 members include many big corporations outside of healthcare. Another group consisting of eight large tech companies—among them IBM, Microsoft, and Oracle—agreed to embrace open, nonproprietary standards to speed development of a national health information network.

John Quinn

John Quinn, a principal of the consulting firm Capgemini (Cleveland) and chief technology officer of its health division's provider practice, is skeptical about the ability of these business archrivals to work together. But if the government initiative succeeds, he notes, the amount of U.S. investment in healthcare IT could double in the next 10 years. As a result, he says, "A lot of players who haven't been in the health IT space are suddenly very interested in it."

Quinn believes that many medtech companies seeking to enter the healthcare IT market will do so by acquiring existing players. Both GE Healthcare (Chalfont St. Giles, UK) and Siemens Medical Solutions (Erlangen, Germany) have been active buyers of healthcare IT firms. In 2002, GE purchased electronic health records company MedicaLogic, and added its outpatient EHR—used by about 20,000 physicians—to GE's Centricity system for hospitals. In 2001, Siemens acquired Shared Medical Systems, a large provider of enterprise healthcare IT systems, giving Siemens a significant share of the hospital IT market.

Meanwhile, the government has formed a private-sector advisory group to help it plan overall strategy in this area. The Commission on Systemic Interoperability (CSI) includes 11 members, eight appointed by congressional leaders and three by President Bush. CSI must report its findings to Congress by October 31 of this year.

Scott Wallace

"We're charged with developing a strategic plan for the nation's healthcare IT, to help the Congress and the administration focus on what logical next steps the nation should be taking," says Scott Wallace, CSI's chairman and also leader of the National Alliance for Health Information Technology (NAHIT; Chicago), an educational group consisting of providers, payers, device manufacturers, and government agencies.

High on the commission's—and ONCHIT's—agenda is the need for interoperability among healthcare IT systems, which CSI will try to define for Congress. "The simplest description I've heard is that interoperable systems are systems that allow information to be put in once and made available wherever it's needed and authorized," says Wallace.

Certification of EHRs

Before any of these grand plans can be carried out, of course, healthcare data must be on-line. Now, the bulk of it is still on paper. One major obstacle to getting EHRs into hospitals and doctors' offices is the expense; therefore, the government is looking at ways to ease the financial pain. The Centers for Medicare and Medicaid Services (CMS; Baltimore) has already set one plan in motion: later this year, it will launch a pilot to pay doctors extra for acquiring EHRs and using them to improve care of Medicare patients.

Another barrier to EHR adoption, notes CSI's Wallace, is confusion. Healthcare providers, he says, "are faced with buying an incredibly complex product without a whole lot of information about what that product delivers." To address this problem, the newly established Certification Commission for Healthcare Information Technology (CCHIT) is setting minimum requirements for EHR functionality, interoperability, security, and reliability. CCHIT will begin certifying products on the market this summer.

Mark Leavitt, MD

Although created at the urging of Brailer's office, CCHIT is a private-sector organization formed by the American Health Information Management Association (AHIMA; Chicago), the Healthcare Information and Management Systems Society (HIMSS; Chicago), and NAHIT. In addition to IT experts, commission members include representatives of the software vendor, healthcare provider, and payer communities. Mark Leavitt, MD, CCHIT chairman and medical director of HIMSS, notes that for the certification approach to succeed, it must satisfy all three of these constituencies.

"The providers have to feel that a certified product lowers their investment risk," he says. "The vendors have to feel that getting certified makes it easier for them to make and sell their products. And the payers have to feel that if providers are getting incentives for adoption of IT, it's going to be a certified product, and they won't have to conduct audits of individual systems. All three stakeholders have to feel there's value in it, and then it'll take off."

CCHIT is focusing initially on certification of ambulatory EHRs, says Leavitt, "because that's where the greatest need is—the most to gain, and the slowest adoption rate." The commission isn't limited to ambulatory care, however. It could later move into inpatient EHR certification, according to Leavitt.

CCHIT plans to address the ability of devices to connect with EHRs, notes the commission chairman, "but people are seeing a lot more urgency to the external connection: for instance, can lab results be imported automatically? It's very nice to be able to get the vital signs and the ECG data, and I'm sure that that interface is going to be a requirement. But the feeling is that it's less urgent now than these other modes of interoperability."

For now, Leavitt suggests that device manufacturers agree on a messaging standard. "It would be great if they said, 'for interfacing vital signs there's this IEEE standard, and we're all going to use it.' When that's established, at some point we'd put it in our requirement and say, 'the EHR has to connect using that standard.'"

Standards for Messaging and Terminology

Messaging standards already have a lot of traction. For example, the U.S. departments of Health and Human Services, Defense, and Veterans Affairs are trying to make their health IT systems interoperable with one another and with those of other federal agencies (see sidebar, this page). Two years ago, the departments announced that all government agencies would adopt the Health Level 7 (HL7) standards for reports and orders, the National Council for Prescription Drug Programs (NCPDP) standards for prescriptions, the Digital Imaging and Communications in Medicine (DICOM) standards for imaging, and the electrical and electronics engineers' IEEE 1073 standards for transmitting data from devices to computer systems.

Paul Schyve

While some of these messaging standards are widely used in hospitals, they're far from universal, says Paul M. Schyve, MD, senior vice president of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (see sidebar, this page). And even if they were used in all information systems, the components of those systems would still not be able to communicate without specially designed interfaces. That is because messaging standards enable computers only to exchange data, not to understand or act upon the information.

"The issue is the semantic meaning of the data we're moving," says John Quinn of Capgemini. "We expect computer systems in healthcare to be able to do something with the data. We're not just sending a lab result; we expect the receiving system to notice that the value's out of range and alert the physician. Or, when a physician orders a drug, we expect other systems to know which drugs a patient is on so they can alert the physician that there's drug interaction potential."

At a more basic level, when data are sent to an EHR from a device or some other external source, the pieces of information must be put into the proper data fields. Tom Smith of Evanston Northwestern Healthcare notes that GE is now writing an interface to make sure that the vital-signs output from bedside monitors will go into the appropriate fields of the Epic EHR system.

To avoid needless expense and consumption of time in translation work of this nature, all parts of the system must use a common terminology. "We have to agree on the nomenclature we're going to draw from," states Leavitt. "For example, take a vital-signs monitor that measures the pulse and says 'regular' or 'irregular' or uses other terms of description; we've got to agree on the nomenclature for those things."

There are several standardized lexicons of medical terms. For instance, federal agencies are supposed to use LOINC (for Logical Observation Identifiers, Names, and Codes), which standardizes the electronic exchange of lab results. And the government has licensed SNOMED (for Systematized Nomenclature of Medicine), a much bigger lexicon, from the American College of Pathology for clinical terminology. Any manufacturer or software vendor can now use this nomenclature for free.

Quinn believes the government will eventually specify terminology standards that will have to be embedded in all healthcare information products. "To device makers, this is an issue because the data coming out of their devices are going to have to move up a notch in terms of how they are encoded so that they meet the newer standards the government is starting to talk about using."

Fortunately, Quinn adds, medical devices use only a small fraction of the 365,000 terms that are now included in SNOMED. But manufacturers will have to start thinking about including the source code for these terms in their devices. "We need to have the data properly encoded at the source, whether it's the lab system or the bedside monitor or whatever. Because what we'll be relying on at the start is the mapping of the data."

Nomenclature is less of a problem for devices than for other sources of EHR data, according to Leavitt. "By and large, the data coming out of a device are better structured than the data coming from another EHR. So it would be much easier to create a standard interface to ECG or vital-signs machines than to create one to other EHRs."

David Lansky, director of the Markle Foundation's health program, thinks it will be years before most EHRs use the same terminology and can communicate without interfaces. But that doesn't mean that device manufacturers should be complacent. With the Bush administration promoting healthcare IT as the panacea for high health costs and medical errors, it's a sure bet that the government will continue to push the private sector to move faster in this area.

Conclusion

Interoperability among electronic health records is now fully recognized as not only a desirable advance in healthcare IT but a necessary one. As can be seen even from this brief review, significant changes are afoot, and all stakeholders are, or should be, involved.

The take-home lessons for device manufacturers are several: Cooperate with other manufacturers on messaging standards. Look at the differences in terminology. Stay abreast of the requirements for interoperability. Device makers that do not do so could be at a serious disadvantage in the long run, because providers won't buy or keep devices that are incompatible with their EHRs.

Ken Terry is technology editor of Medical Economics magazine, a nonclinical publication for physicians.

Copyright ©2005 MX