Medical Device Link.

Originally Published MX September/October 2004

SPECIAL REPORT: IT IN HEALTHCARE

Medtech manufacturers should play a more active role in developing products for clinical connectivity.

Art Kerley

Information technology (IT) in the healthcare sector is making a lot of headlines these days. President Bush has called for the nationwide implementation of electronic health records within 10 years, while Secretary of Health and Human Services Tommy Thompson has appointed an IT healthcare czar to coordinate and expedite the effort.

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Healthcare has been at best a marginal participant in the IT revolution that has brought profound productivity gains to large and small commercial and industrial businesses over the past 25 to 30 years. While IT has made significant inroads in the administrative area (billing, scheduling, and the like), implementation on the clinical side—which, after all, is the business of healthcare—has been lackluster.

Healthcare's Slow Response

Until recently, the drive to digitize clinical information was not seen as a high priority. Hospital departments pursued clinical connectivity on an ad hoc basis, largely depending on the interest and perceived need of the particular medical specialty or department. In the early years, no centralized force within the hospital was setting IT policy or operational standards as was happening in the business sector. At the same time, physicians exercised tremendous power in terms of determining which equipment and systems were purchased by hospitals. Some sought out the latest advances, while others were largely content with the status quo.

Hardware and software thus were ordered and installed on a department-by-department basis. This scenario resulted in the establishment of islands of automation that functioned in isolation within an uncharted sea of specialty-specific networks. These islands often featured the latest advances in onboard computer technology, but commonly lacked the networking ability to share and exchange information between and across departments. This lack severely undercut their potential to improve patient care, productivity, and efficiency. Further complicating clinical data exchange, these proprietary or legacy systems were typically complemented by paper-based recordkeeping, particularly at the critical point of care.

But the connectivity problem is not just a hospital networking issue. Many medical devices are still being designed without any communications capability.

Take a typical visit to the doctor's office. Within the first few minutes, the patient is likely to be weighed on a digital scale, have their temperature taken with an in-the-ear infrared probe, and—in offices with the latest equipment—have their blood pressure monitored with an electronic sphygmomanometer, complete with sensor control for optimum arm positioning to ensure the most reliable reading. All of these devices feature state-of-the art electronics, including advanced microcircuitry, LED displays, and auditory feedback upon successful completion of the measurement. Some feature onboard memory for recall of the last 10 or 20 readings. Yet, the vast majority are designed as stand-alone devices. That means that the healthcare practitioner must enter the device's clinical data in the patient's chart manually—via handwriting.

Spencer Stiles

The market future for such stand-alone devices may be very limited. "Medtech manufacturers will not be able to survive selling stand-alone equipment—no matter how advanced," says Spencer Stiles, marketing manager for Stryker Endoscopy (San Jose). "Network integration is key, and it's absolutely essential to work with hospital IT specialists in order to have a shot at getting your equipment in the door."

Healthcare Information Standards. Historically, healthcare IT has been hampered by the lack of industrywide technology standards, which left many providers, payers, software developers, and equipment manufacturers wary of adopting a standard that might later be orphaned. While there have been many false starts and missteps, however, the healthcare industry now appears to be serious about adopting and implementing standards. A number of industry, government, and advocacy groups have coalesced in order to move healthcare IT to center stage. More than 100 standards development organizations (SDOs) and supporting groups are working to adopt and promote universal healthcare communications protocols, policies, and methodologies.

The most widely used standard for integrating administrative and clinical information across the healthcare enterprise is Health Level 7 (HL7). Other standards tend to focus on a particular medical specialty, like radiology's Digital Imaging and Communications in Medicine (DICOM) standard, or on a particular category of devices, like the electrical and electronics engineers' IEEE 1073 medical information bus for point-of-care devices in acute-care settings. By contrast, HL7 is concerned with the interface requirements of the entire healthcare organization.

The HL7 organization (Ann Arbor, MI) has established working groups with many other SDOs in an effort to ensure reliable data exchange between and among different healthcare information standards. It is important to note that different standards are designed for different medical applications and are not, strictly speaking, competitors. Moreover, in a move toward interoperability, most standards now provide a common port to ubiquitous Ethernet-based local-area and wide-area networks (LANs, WANs) and to the Internet via a transmission control protocol/ Internet protocol (TCP/IP) gateway.

Interoperability

The realization of universal healthcare data exchange standards still does not ensure that the information sent from one device or network will be received by another in its original and meaningful format. Application incompatibilities at one time caused major disruptions between different computer operating systems. Healthcare IT will need to overcome similar barriers if it is to achieve widespread adoption and use.

Web Language. While the platform-independent Internet has largely nullified the differences between computer operating systems in accessing and viewing information on the World Wide Web, that, too, was largely a function of adopting standards that defined the way individual pages are designed. Hypertext markup language (HTML) is the Web authoring standard that structures pages within a graphical context so that pages developed with HTML will be rendered similarly for any visitor, regardless of the user's particular operating system or Web browser.

While HTML is a powerful authoring language, it is primarily concerned with the consistent display of text and graphics on the Web. Extensible markup language (XML) goes further. It enables data to be defined, transmitted, validated, and interpreted in the same way among heterogeneous applications and different networks or organizations. Since XML treats page content as defined fields, or tags, it has a very robust information search and retrieval capability—but only if industry agrees to and developers adhere to the strict definition of each tag.

XML shows significant promise for addressing the issue of interoperability in numerous business and industrial applications, and is regarded similarly for its healthcare IT potential. The latest version of XML is designed to operate with HL7. XML is not without technical limitations, but, like most standards, it continues to evolve and improve with each revision.

The Electronic Health Record. The healthcare industry, in seeking to emulate the successful information enterprise model of business, recognizes that the era of stand-alone computerized equipment, proprietary systems, and off-line, or paper-based, recordkeeping is over.

The prime mover in the drive for medical interoperability is the electronic health record (EHR), which would track every point of patient contact across the entire continuum of care, from primary care physician through hospitals, clinics, laboratories, and medical specialists. Administrative data pertaining to billing, coding, insurance reimbursement, disposition, and so on would also be a part of the EHR.

The EHR is not a new concept. Early versions date back to the 1980s. A 1991 report from the Institute of Medicine (IOM; Washington, DC) characterized the EHR as an "essential technology for healthcare."¹ IOM's subsequent reports in 2000 and again this year received widespread media attention because of their call for national adoption of EHRs to improve healthcare efficacy, patient safety, and operational efficiency.^2,3 EHRs have the potential to improve the quality and coordination of care, reduce medical errors, and eliminate unnecessary tests and redundant procedures—all while saving costs. The Center for Information Technology Leadership (Wellesley, MA) has estimated that the adoption of EHRs would save the U.S. healthcare system $86.8 billion annually.⁴

Estimates of current EHR use vary greatly. The U.S. Department of Health and Human Services estimates that 13% of hospitals and 28% of physicians' offices are using some form of electronic recordkeeping, but other studies suggest lower numbers.^5,6 More promising is a recent survey conducted by the American Academy of Family Physicians (Leawood, KS), which revealed that nearly 40% of the respondents have completely converted to EHRs or are in the process of doing so.⁷ The annual leadership survey from the Health Information and Management Systems Society (Chicago) indicated that implementing EHRs is the top priority for healthcare executives over the next two years.⁸ Similarly, a joint survey conducted by the Healthcare Financial Management Association (Westchester, IL) and GE Healthcare Financial Services (Chicago) suggested that hospital spending on improving healthcare IT infrastructure is expected to increase by double digits over the next five years.⁹

Like most medical devices, the EHR products currently on the market are designed with proprietary technology and cannot share and exchange clinical information with competing systems. However, most vendors are committed to adopting the universal standards now under consideration.

Trace Devanny

Cerner Corp. (Kansas City, MO), a leading supplier of healthcare information technology and EHR systems, welcomes the call for industrywide standards. Commenting on the government's recently announced goals and initiatives for a seamless healthcare IT infrastructure, Cerner president Trace Devanny says he looks forward to "the national conversation" on what he describes as a critical issue.

"If we are to eliminate error, decrease variance, and cut unnecessary waste, we must take the paper chart out of healthcare," says Devanny. "President Bush and Secretary Thompson have not only championed the creation of a ubiquitous electronic health record, they have set forth specific proposals that will move us in that direction in the decade ahead."

Collecting Electronic Clinical Data

While a great deal of attention has focused on the benefits of EHRs to the end-user, there has been very little discussion about how clinical information will get into electronic recordkeeping systems. This is generally attributed to the fact that medtech product designers and manufacturers have been largely absent from the conversation.

Lorin David Kalisky

"End-users have been the primary force behind the drive to achieve connectivity and interoperability in healthcare information systems," says Lorin David Kalisky, marketing manager for Capsule Technologie (Paris), a supplier of clinical connectivity solutions for medtech manufacturers. "Manufacturers were initially slow on the uptake, but are now responding to the demands from hospitals that their devices and equipment have built-in networking capability." Kalisky's firm provides data translation from a device's communication port to the particular information system running on a hospital's network. The company works with manufacturers on new medical devices as well as developing data translation interfaces for current equipment.

For medtech manufacturers, adoption of a standard EHR will have profound implications. Every electronic medical device will be required to be able to at least send information to the EHR, which will function, in effect, as a large, networked database. Many devices will have to be retrofitted or redesigned to become network-capable. For the medtech industry, the shift will be profound, like the upheaval that came with the change from mechanical to solid-state equipment in the 1970s.

Bill Saltzstein

"Medical devices with clinical connectivity have to fit real-world applications—the way that doctors and healthcare professionals work," says Bill Saltzstein, president of Code Blue Communications Inc. (Woodinville, WA), a supplier of Bluetooth-based technology services for medtech manufacturers.

The adoption of universal, industrywide healthcare IT standards and the EHR should also go a long way toward facilitating the development of a new generation of point-of-care clinical data collection instruments—both wired and wireless.

Wired Devices. On the wired front, many medical devices include an RS-232 serial port that can be bridged into the Ethernet networks typically found in hospitals and medical offices using special interface adapters available from several vendors. While this kind of migratory approach is necessary in the early stages of adoption, it is largely a temporary solution requiring hardware and software updates. Technical compromises often are necessary to ensure communications capability, so this approach is not likely to be a viable long-term option.

Wireless Technology. Suppliers of wireless materials and components are just getting around to seeing the enormous potential of the medical device market, in spite of the fact that untethered movement throughout the workday is characteristic of the healthcare profession. As doctors make rounds in hospitals or go from examining room to examining room in their offices, they need a feature-rich, robust, yet portable data collection and communications device like an EHR system and supporting products.

Wireless standards such as Bluetooth and Wi-Fi (IEEE 802.11x) are finding their way into an increasing number of medical devices. Wi-Fi has the greater range and data rate and is often viewed as a wireless LAN replacement. In contrast, Bluetooth is seen as a shorter-range cable replacement system. It can be ideal in hospital settings where the goal is to prevent interference from competing signals, and in home-care patient monitoring. Wi-Fi is generally chosen for fixed or transportable devices and equipment, which tend to be larger, whereas Bluetooth is more apt to be the wireless mode of choice for smaller, more portable devices. Both Wi-Fi and Bluetooth-enabled medical devices can share and exchange information.

Infrared wireless was used in some early applications, but appears to be losing support. Zigbee is a relatively new wireless standard that is making major inroads in building automation and lighting systems. Its ultralow power consumption shows promise for a number of medical applications, such as monitoring the position and functioning of implanted devices with onboard sensors.

"Creating a gee-whiz device with the latest bells and whistles may be of interest to the developer, but have little market viability," says Code Blue's Saltzstein. "Wireless is a natural environment for medical devices, and more and more products are being introduced. But developers need to match the feature-sets of their wireless products with the particular demands and requirements of medical end-users in hospitals, doctors' offices, and patients in the homecare environment."

Wireless technology is especially well suited for hospital environments, where medical professionals, patients, and equipment are anything but stationary. Which particular wireless technology is employed is typically determined by the application requirements of the device, including data transmission rate, distance range, and power consumption.

Handheld Computers. Personal digital assistants (PDAs) using the Palm and Microsoft Pocket PC operating systems are receiving increasing attention from medtech application developers and manufacturers for use in portable medical device applications. PDAs are already widely used by doctors for referencing medical symptom and disease directories and pharmaceutical formularies. Although some EHR systems have been developed with a PDA interface in mind, the form is generally seen as too limiting for anything but forced-choice responses. This contrasts with the more narrative style of physicians' clinical notes.

When Microsoft Corp. (Redmond, WA) introduced the Tablet PC last year, both the financial and IT industry media questioned the product's market viability. It was slow to take off in traditional IT applications, but many medtech analysts consider it an ideal platform for wireless point-of-care clinical data collection devices.

The Interconnected Future

Opportunities for medtech companies abound as the healthcare industry gears up for clinical connectivity and systems interoperability. Healthcare, like other industries, is rapidly becoming an information-intensive business with the same inherent user demands on its information systems as any other business enterprise.

"Already, 90% of our operating-room deals involve close consultation and collaboration with the people who have the responsibility for ensuring that all medical equipment is fully compatible with hospital information systems," says Stryker Endoscopy's Stiles.

As interoperability gains a foothold—particularly through the government-mandated development and implementation of the EHR—healthcare professionals will soon come to expect location-independent 24/7 information access, Internet gateways with e-mail and voice capability, device portability, graphic-rich content, streaming video, interactive systems, and, of course, the highest level of data encryption for bulletproof security.

This is not expected to be accomplished overnight. But connectivity initiatives will usher in a new era of intelligent medical devices. These will incorporate a wide array of digital technologies, including real-time operating systems, flash memory and other information storage devices, smart cards, biometrics, embedded microprocessors, digital signal processing, broadband, voice-over-Internet protocol, speech recognition systems, device relationship management for remote troubleshooting and repair of medical equipment, and many more.

Yet, medtech manufacturers are not as involved in healthcare IT initiatives as they could be. Some of the largest medtech companies are active participants, but the industry generally is not well represented in either standards development or policy setting. The coming transformative advances in healthcare IT will shape the course of product development for years to come, however. These advances, therefore, argue for greater manufacturer involvement in policy decisions regarding connectivity.

Many IT application markets are fully mature and in maintenance mode. Thus, healthcare IT is increasingly seen as the growth engine of the industry in the future, and a source of unparalleled opportunities for properly poised and positioned medtech manufacturers.

Conclusion

Hospitals have long been aware of the potential for integrated IT systems to improve healthcare efficacy and patient safety. Now, they are increasingly beginning to see the ROI benefits of investing in network-capable equipment and enterprisewide interoperability.

"Simply stated, it's about increased patient throughput," says Stryker Endoscopy's Stiles. "Implementing fully integrated information systems means that more patients can be seen since the hospital is avoiding duplication of services, eliminating redundant tests and procedures, and making better use of its facility and staff." In addition, says Stiles, hospitals are aware that if they don't invest in full-featured clinical connectivity, staff and patients will go elsewhere—to healthcare facilities that do.

End-users are developing wish lists and prioritizing feature sets for the next generation of IT-enabled medical products. Many of these medical devices will require, for example, onboard data storage systems. Will the specs call for a hard drive, flash memory, or a removable solution?

There will be equivalent questions with regard to power supplies, input devices, wired versus wireless, and interface ports. And every option will also need to be tested against the paramount need to safeguard the integrity and privacy of medical information. Manufacturers making these decisions may find that they are producing better devices cost-efficiently if design and manufacturing considerations are part of the IT standards conversation.

Discussion and debate about healthcare IT has been dominated and shaped by healthcare providers, payers, standards organizations, hospital management information systems personnel, software developers, advocacy groups—and now the government. Manufacturers have not been a high-visibility force or an influential presence. But now, the time for the medtech industry to become a full participant in scripting the development of next-generation, network-capable, clinically connected medical devices and equipment has clearly come.

References

1. Institute of Medicine, The Computer-Based Patient Record: An Essential Technology for Health Care, ed. RS Dick and EB Steen (Washington, DC: National Academy Press, 1991).
2. Institute of Medicine, To Err Is Human: Building a Safer Health System, ed. LT Kohn, JM Corrigan, and MS Donaldson (Washington, DC: National Academy Press, 2000).
3. Institute of Medicine, Patient Safety: Achieving a New Standard of Care, ed. P Aspden, JM Corrigan, J Wolcott, and SM Erickson (Washington, DC: National Academy Press, 2004).
4. B Middleton, "Center for Information Technology Leadership, The Value of Healthcare Information Exchange and Interoperability," presented to the Health Information and Management Systems Society (HIMSS) Annual Conference, Orlando, FL (2004).
5. TG Thompson and DJ Brailer, The Decade of Health Information Technology: Delivering Consumer-Centric and Information-Rich Healthcare, Framework for Strategic Action (Washington, DC: U.S. Department of Health and Human Services, 2004); available from Internet: www.hhs.gov/onchit/framework/hitframework.pdf.
6. U.S. Electronic Medical Records Markets for Inpatient and Ambulatory Care (Palo Alto, CA: Frost & Sullivan, 2004).
7. Membership Survey on the Adoption of Electronic Health Records (Leawood, KS: American Academy of Family Physicians, 2004).
8. Health Information and Management Systems Society (HIMSS), 15th Annual Leadership Survey (Chicago: HIMSS, 2004).
9. How Are Hospitals Financing the Future?: The Future of Capital Spending (Westchester, IL: Healthcare Financial Management Association, 2004).

Illustration by EYEWIRE

Copyright ©2004 MX