May 2011

Winds of Change
By David Yeager
Radiology Today
Vol. 12 No. 5 P. 14

An NIBIB project is using edge servers and PHRs to Replace CDs. It could be a look at the future of image and record sharing.

Transporting images and medical records on CDs once seemed like the height of convenience, but it has turned out to be a bit of a hassle for many imaging facilities. Computer viruses, discs that launch their own viewers, and a lack of formatting standards have provided ample evidence to prove the law of unintended consequences. Multiply those issues by hundreds of thousands of patients across the country, and it becomes clear why importing CDs is eating a growing chunk of manpower in many medical facilities.

A project currently under way may provide a new model for exchanging patient records. It doesn’t use CDs to transport patient records—in fact, it doesn’t use any physical media at all. What it does use is free, open-source computer code to build a framework for sending patient records from hospitals to personal health records (PHRs). From that point on, the patients are in complete control; they can direct their PHR to distribute the records however they see fit, and they don’t need physical copies to send their records where they want to go.

The device that accomplishes this task is called an edge server. It’s the result of a contract from the National Institute of Biomedical Imaging and Bioengineering (NIBIB) that was obtained by a consortium of participating medical centers through RSNA. The project is being conducted among five sites geographically spread across the country: Mount Sinai Hospital in New York, the University of Maryland, the University of Chicago, the Mayo Clinic in Rochester, Minn., and the University of California, San Francisco (UCSF).

“As opposed to other health image exchanges across the country, which are often very local activities, we’re really trying to put in place a platform that is a model that can be extended in the long term and spun off as a national imaging exchange,” says David S. Mendelson, MD, FACR, a professor of radiology and chief of clinical informatics at Mount Sinai Medical Center, who is the principal investigator at Mount Sinai and for the overall project.

One of the project’s goals is to demonstrate that different developers with different philosophies can bridge the image-sharing gap. To that end, Mount Sinai is coordinating the development of the edge server, and each of the other sites is developing components for it. Although there is a lot of optimism surrounding the project, there is still a great deal of work to be done.

“In order to be able to maintain as high a level of security as possible, most hospital security folks and IT folks are not enthusiastic about having connections into their secure networks, including the PACS system and hospital information systems,” says Eliot L. Siegel, MD, a professor of radiology and nuclear medicine and vice chairman of imaging informatics at the University of Maryland Medical Center, who is the principal investigator at the Maryland site. “So the whole purpose is to demonstrate to the NIBIB that, utilizing the IHE standard, there is the capability in a private, safe, secure way to have a viable alternative to CDs where, in a manner analogous to the way that patients are currently being given direct control over their physical CDs, patients now have the capability to direct facilities to give them similar control, electronically, through their own personal health records.”

How Does It Work?
Rather than allow direct contact between institutions, the project relies on the edge server, a clearinghouse (a database that’s considered neutral ground), and PHRs to provide security and confidentiality. The patient encounter begins at a Web user interface. When a patient has an imaging exam, he or she can sign up for the program. The patient is assigned an edge server ID number—called a token—and a PIN, and the images and accompanying report are pulled from the PACS and RIS, respectively.

“When a job is submitted, the edge server bundles up their exams and the reports, wraps it, and encrypts it with that same PIN and then goes ahead and sends it off to the clearinghouse,” says Steve G. Langer, PhD, an associate professor of radiologic physics at the Mayo Clinic and the software architect for the project. “And that communication is all logged, too, for HIPAA compliance, and the success and failures are all tracked in the database so that we know what human and what software did what.”

The clearinghouse then waits to receive a request from a PHR. The likely PHR participants as of this writing are FrontRad Technologies, Microsoft HealthVault in conjunction with lifeIMAGE, and InSite One, which was bought by Dell in December 2010. Using the PIN and token, which are assigned to the specific request rather than the patient, the patient can instruct the PHR to retrieve the information from the clearinghouse, which is being administered by lifeIMAGE. Once the information is in the PHR, the hospital is out of the loop, and the patient can control how the information is shared. The entire series of transactions is guided by the free, open-source IHE (Integrating the Healthcare Enterprise) XDS-I.b standard, which is important because a key goal of the project is to demonstrate the viability of lower-cost alternatives to proprietary image-sharing solutions. But modifying XDS-I.b for the planned volume of images presented some challenges.

“The biggest challenge was the fact that we were sort of pushing the limits of IHE and what it’s been designed to do,” says Wyatt M. Tellis, PhD, an informaticist at UCSF and the system architect for the project. “The XDS transactions are built around the use of Web services, which rely on XML as the transport mechanism. And XML is really designed for moving textual data around. So we’ve been kind of pushing the limits of the technology in being able to move these large data sets.”

Dotting I’s and Crossing T’s
While the technological details have largely been hammered out, there are several legal and business hurdles that need to be cleared before the edge server can begin operating. The first is HIPAA compliance. Because this is a new workflow, the institutions want to be certain they’re meeting HIPAA requirements. Some HIPAA issues are still being addressed.

“Local HIPAA offices at each institution have been very conservative, and we understand why,” says Mendelson. “But they’ve probably attached extra levels of rigor to this project.”

The institutions are also working to satisfy their own institutional review boards (IRBs). IRBs often set additional privacy requirements beyond HIPAA’s requirements. Without IRB approval, the institutions would have no access to the patient data, which means they wouldn’t be able to study it. But the IRB issues can’t be addressed until the HIPAA issues are settled.

There are also business associate agreements (BAAs) that need to be signed; however, determining who needs to sign off is an inexact science. Typically in a situation like this, all the hospitals would have to sign BAAs with each other; but if this business model is going to set a precedent for other image-sharing initiatives, a multitude of BAAs will quickly become impractical. The answer may be for each hospital to sign a BAA with just the clearinghouse, but that remains an open question. To date, Mount Sinai is the only institution that has received all the necessary approvals to begin operation of the edge server. The sites hope to be online this spring.

 “This is a really big deal from a national perspective,” says David Avrin, MD, a radiologist and vice chairman for informatics at UCSF and chair of the RSNA informatics committee. “And we need to bring more of the existing business-to-business electronic commerce transactions to radiology, as long as it’s done securely and confidentially with patient control.”

Avrin says the business-to-business aspect of the project is important for the entire medical enterprise, not just radiology. He says one challenge related to sharing medical information is that hospitals tend to view patient information as business assets. He adds that the United States is the only major industrialized nation that doesn’t have a national medical record identifier, which he sees as a significant flaw in the system.

“Our perspective is that any hospital or institution that receives any form of government payment should be compelled, by law, to share their information—under patient control—securely and confidentially. And this has been amazingly difficult from a business side, a philosophy side, and a confidentiality side, much more so than a technical side,” says Avrin. “We’re just making life hard for ourselves—and very expensive. It leads to incomplete information across boundaries of care, repeat studies at expense, and [additional unnecessary] radiation exposure.”

This demonstration project has the potential to be a step toward better collaboration among medical institutions. But even after the legal issues are settled, and there’s no reason to believe they won’t be, there is one more question that needs to be answered: If you build it, will they come? The success of the project hinges on persuading patients to participate.

Paul J. Chang, MD, FSIIM, a professor of radiology and vice chair of radiology informatics at the University of Chicago and principal investigator at the Chicago site, says patients may be reluctant to sign up for the project because of concerns about how their University of Chicago records will be handled at facilities that don’t have access to the edge server, including other hospitals in the Chicago area. He says the hospital also doesn’t want to be seen as favoring one PHR or group of PHRs over another. Chang believes the best way to deal with these issues is to be completely transparent about the process, offer patients as many options as possible, and develop a marketing strategy.

“I want to come up with a marketing strategy where I can encourage people to use it because [that provides a way to] articulate a reason for them to use it,” Chang says. “That’s going to be important and nontrivial as well.”

The Ultimate Goal
Once the business arrangements are finalized, the real test of the project’s effectiveness will begin. It is set up to accommodate as many as 300,000 patient records, and each site is supposed to enroll three local competitors to test whether sharing data in this manner decreases repeat imaging. But success can be measured in different ways. Initially, it will be measured by how many patients sign up and how well it manages their information. But it may also provide an opportunity for facilities to look at their data in new ways.

Although medical facilities are transitioning from paper records to digital records, the digital repositories are still organized in discrete blocs. And facilities are still constrained by having to transfer records on physical media. Siegel says easing the barriers to information sharing and creating a patient-centric record have the potential to not only eliminate physical media but also allow more effective record searches across patient records that are currently stored separately in multiple hospital and outpatient office records, potentially saving time and improving patient care.

“So the next-generation electronic medical record, I think, is going to look very different. It will be much more intelligent, much more interoperable, and much more fluid than what exists now,” says Siegel. “And I think the conclusion that EMRs are going to come to in the long term is going to be creating a patient-centric medical record rather than a hospital- or facility-centric one.”

A more subtle sign of success will occur when image and data sharing are integrated into vendor offerings; the surest sign of technology integration is when it’s taken for granted. Before there were CD players in cars, there were portable CD players with tape deck adapters. Most people probably haven’t seen one of them in a long time.

“I think, like anything else, the real sign of success is when devices like the edge server are obsolete, no longer necessary,” says Chang. “PACS broker and DICOM translator boxes, early on, were necessary to demonstrate that digital image management was feasible but eventually became obsolete because interoperability was incorporated natively within vendor offerings. I think this is exactly the same idea. The only difference is we have a catalyst, and that is meaningful use.”

Chang believes meaningful use rules coupled with normal market forces will speed up the timetable for integration. Although the federal government has yet to set meaningful use guidelines for radiology, the patient-centric model of health information management is an idea that’s not going away. Sometime in the future, meaningful use will come to radiology, and this project may make that transition smoother. If nothing else, the researchers hope it will set a benchmark for future efforts.

“What we wanted was a solution that was based on open standards, so there will be some competition to provide good interfaces, but the solution itself is pretty well defined,” says Mendelson. “And that consumer-driven piece is fairly unique today. Even though that’s what is articulated by the Obama administration and ONC [the Office of the National Coordinator for Health Information Technology], it really is novel to find things that are driven by the consumer.”

— David Yeager is a freelance writer and editor based in Royersford, Pa.