Medical Device Link.

Originally Published MX September/October 2004

SPECIAL REPORT: IT IN HEALTHCARE

To stay in step, medtech manufacturers will have to begin developing their products to meet increasing demand for integration and interoperability.

Brad Burg

There's no way to sugarcoat this news: when it comes to making use of the tools developed by the information technology (IT) revolution, the world's healthcare systems are lagging behind nearly every other industry.

There's no dearth of arguments in favor of the adoption of such systems. Among the most frequently adduced grounds for implementing IT systems are the potential for improving patient safety, gaining greater efficiency, and reducing overall healthcare costs. But these terms themselves incorporate a wide variety of potential benefits—and they're just a part of the picture.

Adoption of advanced IT systems is essential if the world's healthcare systems are to take advantage of new therapies emerging from the biotechnology revolution, including advances in molecular diagnostics, personalized medication planning, robotic surgery, and home-based care. Moreover, the flat fact is that without such technologies in place—and soon—the world's healthcare systems are in serious danger of collapsing under the weight of their own costs and inefficiencies.

With so much riding on the adoption of advanced IT systems, why have the world's healthcare systems made such little progress? Once again, analysts have pointed to a variety of obstacles to explain the shortfall. The cost of purchasing, implementing, and maintaining such systems is certainly one factor of importance—particularly for countries in which corporately owned hospitals are also expected to return a profit to their investors. But government-managed hospitals and healthcare systems have fared little better, burdened as they have been with the rising costs of caring for rapidly aging populations. The difficulty of getting trained physicians to adopt such IT systems, the absence of uniform standards, and the rapid obsolescence of technologies have all contributed to the failure of the world's healthcare systems to adopt IT-based systems.

One contributing factor not usually recognized has been the relative absence of leadership from the medical technology community itself. In spite of the increasing sophistication and complexity of medical technology products, few medtech manufacturers have sought to take a leadership role in advancing the adoption of IT-based systems. Some medtech sectors have been more active than others. Companies with specialties in diagnostic imaging or point-of-care diagnostic instruments, for instance, have been active in developing standards that permit their products to operate and communicate with one another as well as with hospital and laboratory information systems. For the most part, however, medtech companies have so far been content to stay out of the fray, waiting for the right moment and watching for their commercial opportunities.

Now, at last, that may be changing. Industry association AdvaMed (Washington, DC) has recently established a sector for healthcare IT. And recent government initiatives centered on the creation and implementation of an electronic health record system may finally have broken the logjam in government leadership.

But medtech manufacturers will be joining a program that's very much, as they say, "already in progress." Dozens of organizations have already taken encouragement of healthcare IT systems as their major focus, and many have been operating for years with little input from the medtech manufacturing community.

This article looks at some of the key organizations that are already involved in promoting healthcare IT, with special attention to the elements that they see as part of an advanced IT-based healthcare system. Where the medtech manufacturing community may fit in isn't yet known, but the starting point has to be an understanding of the visions that are already circulating.

Tipping the Scale

Blair Childs

"In the area of health information technology, government has reached the tipping point. And now, medical device manufacturers are all tipping," says Blair Childs, executive vice president at AdvaMed, the nation's largest trade association for medical device manufacturers.

Childs' assessment is certainly a reasonable one, in view of recent government initiatives in this area. Earlier this year, President Bush announced a new healthcare technology agenda for the nation, proposing as its centerpiece the goal of creating a national electronic health record (EHR) system for all Americans within 10 years. Shortly thereafter, Tommy Thompson, secretary of the U.S. Department of Health and Human Services (HHS), declared that this is the decade of health information technology, and he appointed a national health information technology coordinator.

At the end of July, that coordinator, David J. Brailer, MD, PhD, joined Thompson in releasing the first installment of the HHS plan to speed progress toward the creation of electronic health records and other benefits of healthcare IT for U.S. patients. The HHS report, "The Decade of Health Information Technology: Delivering Consumer-Centric and Information-Rich Health Care," named four areas in which the federal government intends to support private-sector efforts.

• Informing Clinical Practice. Bring information tools to the point of care, especially by investing in EHR systems in physicians' offices and hospitals.
• Interconnecting Clinicians. Build an interoperable health information infrastructure so that records follow the patient and clinicians have access to critical healthcare information when treatment decisions are being made.
• Personalizing Care. Use health information technology to give consumers more access and involvement in health decisions.
• Improving Population Health. Expand capacity for public health monitoring, quality-of-care measurement, and bringing research advances more quickly into medical practice.

In other times, such grand gestures might have been dismissed as election-year grandstanding—but not this year. According to experts, this time the changes are for real. And no matter which candidates gain election this fall, remaking the nation's healthcare system is hardly likely to disappear from the government's agenda.

For medtech manufacturers, the most urgent questions in this field center on how companies can participate in the opportunities generated by the government's rebalancing act. Companies that figure out how to tip the scales in their favor will be implementing change and working with healthcare enterprises to create products that are more integrated—or interoperable, in the current parlance—and will thereby position themselves to generate profits in whole new areas of business. Those that cannot find a position in the emerging IT-based healthcare universe will likely find themselves scrambling to adjust as the scales tip against them.

For this article, MX asked strategists and thinkers at some of the key organizations involved in forwarding healthcare IT to share their insights about the coming changes in the field (see sidebar 1). Along the way, they provided some important observations about what medtech executives should be thinking about and planning for—and how companies can best position themselves for future growth.

The Healthcare Information Management and Systems Society (HIMSS; Chicago), for example, is devoted to encouraging leadership in the use of healthcare information technology (see sidebar 2). HIMSS medical director Mark Leavitt, MD, offers a classic example of the types of inefficiencies that have resulted from a lack of IT integration. "Say you're a hospital that has invested $3 million in an MRI scanner, which does a superb job in just three seconds. But then the scanner's data are printed on paper and jammed into a manila folder, where the doctor has to find them."

Obviously, says Leavitt, such a process is both inefficient and costly. Moreover, he notes, "so far as the end-user is concerned, that inefficiency destroys part of the value of the original product."

Despite the existence of similarly egregious instances on a large scale, however, healthcare providers have rarely pressured manufacturers to develop more-advanced systems that would improve their efficiency. "In fact, the old paper-office inefficiency has certain advantages for providers," says Leavitt. "The difficulty of moving records around often keeps patients returning to the same providers. And that, in turn, produces continuity of care—which is a plus."

But no one should be lulled into inactivity by healthcare providers' previous behavior, says Leavitt. That was then. From now on, everyone involved in healthcare must begin to plan for a much swifter pace.

Rads

David S. Channin

A good vantage point for viewing the changes that have been happening in the field of healthcare IT is offered by the radiology sector, which is generally acknowledged as an IT leader. Radiology manufacturers and their customers were among the first to utilize widely accepted standards for the transfer of healthcare information—because standards are the key to moving data. Such standards, indeed, are structures for data. In effect, they are containers, says David S. Channin, MD, who teaches radiology at Northwestern University (Evanston, IL) and heads its imaging informatics lab. "With those containers we can transport data from one entity to another, then unpack it easily and use it effectively," explains Channin.

In the case of radiology, two such standards are involved. One, called Digital Images for Communication in Medicine (DICOM), governs the transmission of the images themselves, plus accompanying data to make sure they are properly displayed. The other standard, Health Level 7 (HL7), is more general. It is concerned with patient data—including administrative and demographic data—as well as order information and general clinical information.

Building on their experience in using such standards, HIMSS and the Radiological Society of North America (RSNA; Chicago) have joined forces to sponsor an initiative called Integrating the Healthcare Enterprise (IHE). Channin is on the strategic development committee of IHE, which promotes the use of standards to help with data integration in various areas of healthcare. IHE is also involved in developing sector-specific profiles that explain how particular kinds of devices should use existing standards—such as DICOM, HL7, and others—to accomplish complex tasks. Lexicons such as SNOMED (for clinical terminology) and LOINC (for lab results) are then used to precisely specify content for these transactions.

Jon Zimmerman

Each standard has an associated standards-developing organization (SDO); some of these are named after the standards they maintain. Because standards are constantly evolving, manufacturers are wise to stay in close touch with the appropriate entities, says Jon Zimmerman, vice president of Soarian Health Connections at Siemens Medical Solutions (Malvern, PA), one of the radiology sector's largest firms. "Manufacturers should join the SDOs that affect their areas," advises Zimmerman. "That's a crucial way to be alerted to the newest requirements."

Yet that's only the starting point. "Go to the relevant medical specialty societies and ask what their biggest challenges are in accessing data," he adds. "Ask doctors and hospitals who are customers about how they use electronic records, and what data are most useful in daily work." Zimmerman's own involvement in such activities offers a model for other manufacturers. He also serves on the steering group of Connecting for Health, a project cosponsored by the Markle Foundation (New York City) and the Robert Wood Johnson Foundation (Princeton, NJ), two leading organizations promoting healthcare informatics (see sidebar III).

Perhaps most important, adds Zimmerman, is to connect with those who know systems. "One of the best things device manufacturers can do is to seek out the systems designers, and then work with them," he says. Such designers are in the business of mediating among all the equipment and the parties involved, and thus have an overview of current and future needs—and wish lists.

John Halmka, MD

Indeed, all of the experts stress the need for manufacturers to actively study what others require. John Halamka, MD, has a broad perspective on the topic. Another member of the steering group of Connecting for Health, he's also the CIO of Harvard Medical School (Boston) and of Boston's CareGroup health system—a million-patient multihospital network that is considered a leader in IT implementation. Halamka points to EKGs as a salient example. "Right now, manufacturers of EKG devices all have different standards. The imaging people got together and worked out a way of making their standards universal. Clearly, EKG makers should do the same."

Of course, with an EKG, the need for interfacing is obvious since the device's function is to produce a specific, formatted set of data—precisely the sort of result that suggests it should be transmittable directly into a hospital information system. But the experts emphasize that the ideal of such direct interfacing is increasingly going to be sought in relation to many other kinds of devices, too.

"Manufacturers have looked at things mostly in relation to what their devices do," notes Zimmerman. "But they must focus on the output, too. Many, many devices are putting out data—or could be." Consider hospital-use products such as infusion pumps or home-use products such as blood-glucose monitors and asthma testers. Some such products already gather patient data, at least for temporary readouts. But if made accessible to a broader IT-based treatment management system, that data could help to provide better care, avoid mistakes, and thus save money. The more that medical products facilitate such goals, the more appealing they will be to customers.

As technology develops, customers will be demanding what customers increasingly demand in every area of IT: first, reliability; then simplicity; and finally, interchangeability. As Channin puts it, "hospitals want to be able to buy anyone's monitoring device—HP, GE, Fujitsu—without thinking about it. From their point of view, it should be like buying a printer."

Middleware

Although the experts are comfortable indicating what's needed to improve systems within hospitals and other provider enterprises, they stop short of prescribing any kind of universal system as a solution. Currently, many institutions employ networks that enjoy fairly efficient flows of data internally, but that's as far as their flow goes. "Transfer to outside healthcare systems is very often still manual," says Leavitt. "That's analogous to having a phone system within a company but no outside lines."

Even where standards are used in an otherwise leading-edge way, as in radiology, such digital parochialism is typically the case. "My radiology files here at Northwestern are digital, and so are those at the Mayo Clinic," notes Channin, "but we can't send back and forth. And that's true even though we're both DICOM compliant."

Organizations such as IHE are working to resolve such inter-network issues so that medical product manufacturers will not have to comply with the differing requirements of varied and independent hospital systems. "In fact, we would not want vendors competing on the format of the information or on who might own such formats," says Channin. "We want them to focus on improving the features and functionality of their products—with better displays, better design, and so on. But with regard to format and communication, they should simply use the standards." Doing so, he adds, "solves a vendor headache."

While end-users have an interest in medical products that can be readily integrated with one another, however, such integration does not require universal compatibility in a direct sense. "What is actually needed," explains Halamka, "is the ability to interface with 'middleware,' which can operate between specific equipment and a given system. I've written middleware for various products myself." Using such middleware, Halamka's CareGroup system can now maintain EKGs on-line (see sidebar IV). "We currently have 1.2 million EKGs in our system," he says.

In addition, Halamka has created a middleware-based system through which patients can access their records over the Internet. In effect, this system leverages the Web to create a de facto EHR—at least for the one million patients belonging to CareGroup. Such an approach opens the possibility of an incremental means of developing the digital Holy Grail of patient recordkeeping—the universal EHR. Instead of a single centralized system, there could be numerous systems, each with the ability to access information from the others.

Still, efforts to develop a universal EHR have hardly been abandoned. Indeed, creating such a system is now a national goal. Among healthcare IT experts, however, the EHR is not considered a central challenge. "It's just one part of the picture," notes AdvaMed's Childs.

Paying the Bill

Wherever medtech companies choose to turn their attention, the healthcare system provides plenty of IT challenges. Without question, developing advanced IT-based systems for electronic recordkeeping, transmittability, interoperability, treatment planning, case management, payment processing, and a host of other areas will be enough to keep medtech IT specialists busy for years to come.

The next issue is, of course, how to pay for all this activity.

Improving the ability of existing products to communicate data—or developing new generations of products to accomplish IT tasks never previously imagined—will be costly. But such development costs may not be additive to those that device manufacturers are already encountering, says HIMSS's Leavitt. Instead, he suggests, the costs related to developing IT features could simply be a better alternative for investing R&D funding since such features may reduce the marketing significance of other features.

"Given the increasing importance of integrated solutions, in many cases those buying healthcare devices may be more willing to pay for effective standardization than for bells and whistles," says Leavitt. "Such a customer preference would enable manufacturers to devote more of their attention and development money to meeting communication standards—which will, in turn, help to attract new customers."

Adopting IT standards also has advantages for device makers, says Leavitt. "In the long run, such standardization will save manufacturers money," he points out. "They won't have to decide which among various systems to be linkable with or how to connect to different ones. Eventually, every company's products will be able to integrate with those of every other company, and there will be a more-level playing field in that respect." Then, says Leavitt, manufacturers will be able to return to developing proprietary features.

Considering current government initiatives, experts expect that federal programs may provide funding to support some of the costs involved in developing new IT-based products. Siemens' Zimmerman cites the Medicare Modernization Act of 2003 as evidence of increasing collaboration. Under the terms of the act, he says, "the nation's biggest healthcare payer is changing in ways that will improve access to therapy. The bill makes Medicare more open to new technology, for instance in its encouragement of e-prescribing."

AdvaMed's Childs cites other encouraging signs of effective collaboration, such as the new disease-management programs and Council for Technology and Innovation at the Centers for Medicare and Medicaid Services (CMS; Baltimore). "These new programs represent opportunities for increased flexibility in allowing payment for new treatments that incorporate information technology. I expect we'll see even more of that flexibility coming." He anticipates great cooperation, in particular, from Mark B. McClellan, MD, PhD, formerly FDA commissioner and now CMS administrator.

Favorable funding trends are apparent in the private sector, too. Leavitt points to a GE-led program called Bridges to Excellence as an indication of how the various players in healthcare—not just government but insurers and employers—can provide financial encouragement for the use of information technologies. Begun in 2003, the program provides bonus payments to physicians who improve their care, in part based on their use of information systems. "That means more money going directly toward the technical end, which rewards those manufacturers whose products can integrate with other systems," says Leavitt.

Bridges to Excellence involves some some big corporate names besides GE—including Ford, UPS, and Verizon—which increases the chance that others would join or emulate any such initiative that proves effective. Currently, portions of the program are operating in only four market areas: Cincinnati; Louisville; Massachusetts; and Albany/Schenectady, NY.

Professional organizations are also finding new ways to move healthcare IT forward. HIMSS has joined with the American Health Information Management Association (AHIMA; Chicago) and the National Alliance for Health Information Technology (NAHIT; Chicago) in a private effort to certify the compatibility of various IT products (see sidebars V, VI).

According to HIMSS's Leavitt, the organizations intend to focus on how well a product handles incoming and outgoing data—that is, its interoperability. "The compatibility we're looking for will involve certain standards that permit data interchange, the way DICOM works with images in the field of radiology."

In January, IHE will hold its annual "IHE Joint Connectathon," which provides face-to-face compatibility testing for medtech products (see sidebar VII). "Vendors actually bring equipment of all kinds and varied levels of complexity, and they validate its interoperability," explains IHE's Channin. "After focusing on a specific clinical integration problem, IHE produces a technical framework document detailing a standards-based solution, then works with vendors to test such solutions at the meeting." The most recent Connectathon drew participation from 35 manufacturers, including majors such as GE and Philips.

Conclusion

There's a lot going on everywhere in the field of healthcare IT, and much will be demanded of medical product manufacturers. But there's also a lot of help available, and many valuable strategies that are worthy of adoption. To be successful in the emerging IT-based healthcare universe, makers of medical devices must look at their products in new and more critical ways—and ask whether those products can become more flexible. Performing a single task, in isolation, may be only part of what a product is needed to do.

Conversely, making data available to other devices and systems should be more than just an add-on or an afterthought. In a world where phones and personal digital assistants are merging to become videocameras and recorders, healthcare customers will inevitably expect devices to be more intelligent and more communicative. And when they are, such devices will help to make the entire healthcare system safer, more efficient, and less expensive. Like all others involved in the development and use of healthcare IT systems, manufacturers have a lot to get done—and a lot to gain.

Brad Burg is a freelance writer based in Morris Plains, NJ.

Illustration by EYEWIRE

Copyright ©2004 MX