MEDICINEAND BIOLOGYIEEE ENGINEERING IN

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VOLUME 26 • NUMBER 1 ■ http://EMB-Magazine.bme.uconn.edu ■ JANUARY/FEBRUARY 2007

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interoperability: the cure for what ails us

While working in the areaof pacemakers almostthree decades ago, I recalldiscussing the artificial

heart with some fellow biomedicalengineers. At first the discussion wasstrictly devoted to the physiological,mechano-electrical, and systems levels.Slowly, however, the technical discus-sion moved into the matter of econom-ics and the cost-effectiveness of thedevice as it related to the entireprocess. At a point in that debate, itbecame clear that there was a chasmbetween the wonderful opportunitiesthat such devices could offer withrespect to saving or prolonging some-one’s life and the stark economic reali-ties as related to affordability, nomatter where in the world a patientlived. Part of this discussion dealt withthe fact that for the price of a singleartificial heart, 100 people could have apacemaker implanted or replaced.

Today, as we examine the risingoperational costs in the U.S. healthcareindustry (i.e., malpractice insurance,administrative costs, pharmaceuticals,managed care, hospitals, changingtechnologies, etc.), we can easilyunderstand how these runaway costsnot only hold a plethora of negativerepercussions for our national economybut also impact healthcare at the locallevel, such as affecting just how well alocal hospital’s emergency department(ED) can properly allocate its capaci-ties and capabilities. The same thoughtmust be extended to the prospect ofoperating effectively during a majorcrisis. It has come to light, for example,that the 41 million individuals withoutmedical insurance in the United Statesnow look to use these same EDs as theprimary providers of their healthcare.Naturally, having to extend care to theuninsured degrades normal ED opera-tional capabilities and capacities—to

the point that about once every minutean ambulance is turned away from ahospital and sent to another [1]. Ofcourse, rising costs produce other cas-cading, unanticipated, and possiblyundesirable effects. For instance, theydrive consumers to more desirable out-lets and venues—in this case, makingmedical outsourcing [2] a viable choicefor the consumer.

Additionally, this now flattenedworld a la Friedman [3] purports tohave opened up unique, worldwidecost-controlling opportunities to many.Friedman describes the role of informa-tion technology as a social and econom-ic equalizer for the “have nots” of theworld. Particularly in the United States,the complexity involved in the exten-sion of healthcare to both the “haves”and “have nots” is ever increasing, fromthe sheer volume of tests administeredto the number of specialists that arelikely to be involved in a case to theadministration of therapies. At everyjuncture, information technologies (IT)have become a powerful decisive forcein the administration and quality ofcare. Given this area of immense impor-tance, there is one associated problemarea that very few have focused on todate. For the uninitiated, it is importantto highlight that this one area throws animposing shadow not only over the U.S.healthcare system and public health butover national and international securityas well. That vastly mysterious area isinteroperability. As an example ofinteroperability, imagine an individualwho has had an electronic healthrecord (EHR) in his or her private lifefor 20 years. This individual proceedsto have a career in the armed forces fora period of 25 years, and after retire-ment becomes a part of the VeteransAdministration (VA)’s health record-keeping system. Today, there is a needfor this veteran’s EHR to transition

smoothly from one system to the next[civilian, Department of Defense(DoD), and VA], and to do so withoutsuffering any exceptions (missing orinaccurate records) in the process. Yet,there is little that anyone can offer inthe way of knowledge or assurancethat this expectation can be met!

A Turning of the TideRecently, at a seminal IEEE-sponsoredJune meeting in Cambridge,Massachusetts, titled “Special Sessionon Integration and Interoperability ofNational Security InformationSystems,” a fundamentally intellectualturning of the tide on the nature of unin-teroperability took place. Discussionsthere served to confirm that de factoadoption of any preexisting definitionsof interoperability, such as the oneinked by the DoD, amounted to a viola-tion of intellectual due-process whendiscussing the perennially intractableproblem of uninteroperability.

The special session—a veritablegathering of the world’s who’s who incomputing, communications, innova-tions, and policymaking—succeededimmensely in spotlighting the array ofmisunderstandings and complexitiesrelated to interoperability. Gene Amdahl,Simon Ramo, Marcian “Ted” Hoff, Jr.,James Treybig, Gordon Bell, William J.Harris, Rona Stillman, Jeffrey Hunker,and Brenton Greene were some of theluminaries featured at this event. Theystressed a systems approach, which is asyet absent from all efforts thus far toachieve interoperability.

Dr. Robert Mathews, distinguishedsenior research scholar on nationalsecurity affairs and U.S. industrial pre-paredness at the Center for StrategicAdvancement of Telematics andInformatics, and perhaps the world’sleading authority on interoperability,has said that the manner in which we

Luis KunGovernment Affairs

88 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE JANUARY/FEBRUARY 2007

Government Affairs (continued)

have been studying the interoperabilityof information systems for more thanhalf a century is in essence incorrect.He suggests that we are ignoring keymultidisciplinary and interdisciplinaryaspects of the problem in our considera-tions in addition to not using a systemsapproach. Dr. Mathews, who organizedthis historic IEEE gathering, includingits intellectually compelling mix of sub-jects and themes, added that existingintellectual orientations and the defini-tions for interoperability are profoundlypuzzling and full of equivocations. Hesays that such orientations have at bestserved to wage a disinformation cam-paign against those in the scientific andoperational communities, tearing muchneeded attention and resources awayfrom a holistic (comprehensive) treat-ment of the problem. IEEE-USA hasfundamentally reaffirmed this view,acknowledging the boundless usage ofthe term interoperability, while notingdiscernible vagueness of meaning incommon use [4]. Moving forward witha systems approach has been difficult atbest for the scientific community, forthere is an insufficient appreciation ofthe processes involved.

A Confounding Evolutionary PathThe dawn of the information age hasbrought with it profound societalchanges, to which we humans have notadjusted well. Vast populations of com-putational hardware, communicationsystems, applications, and subordinatedsupport systems make up an intricate,ultracomplex, and highly distributedinterdependent super-infrastructurebehind every decision-making path.While, metaphorically, the oceans ofthe world have been reduced to mereponds, and transcontinental fiber opticbridges have brought the world’s land-masses and their respective populationscloser together and economically moreinterdependent, the curse of the infor-mation age is that the aforementionedsuper-infrastructures must now notonly synchronously cohabitate withhumans everywhere but also must sup-port the way human beings tend tomake decisions.

This complicated “arrangement forcoexistence,” and the process of satis-fying the “man, machine, and theenterprise/support systems” equation,where elaborate processes are involvedin the extension of support towarddecision making by human beings,“have never really been fully under-stood,” according to Mathews. He sub-mits that the “man, machine, and theenterprise/support systems” must bebetter represented in a more fundamen-tal, more holistic (comprehensive)manner.

Course CorrectionAside from the fanciful yet blearydefinitions carved up by many, andthose that exist in popular lore,Mathews attempts to orient us towardinteroperability, defining it as “thatability for people to interact with eachother, between organizations, acrossdomains of influence and geographical boundaries—supported by the properdecisioning tools and services—toachieve a goal/objective/decision, with-in set/accepted limits of performance.”He suggests that interoperability cannotbe hurriedly consigned to the realm ofany technology or any of the systemcomponents alone. Rather interoperabil-ity must factor in all aspects of theequation that concerning the establish-ment, maintenance, and improvementof synchrony among all parties that arerequired to interact to achieve a com-mon goal, objective, or decision.Therefore, Mathews says “every aspectof the man, machine, and enterprise/support system must be properlyaccounted for, considered, and treatedto solve the uninteroperability prob-lem.” According to the HonorableRobert Cresanti, Under Secretary ofCommerce for Technology, at the spe-cial session,” Dr. Mathews has definedinteroperability in a most fundamentalway—as being about people and orga-nizations working together to achievecommon goals; that it is not just aboutthe technology but about how peoplethink and relate to information sharingand the costs of careless or irresponsi-ble handling of that information.”

Role of Interoperability in U.S. Healthcare ReformOn 17 July 2003, a one-year-old baby,Jeanella Aranda, received a transplantedliver from her father at the Children’sMedical Center in Dallas, following asurgical procedure to remove a hamar-toma. Damage to blood vessels sus-tained during the removal of thehamartoma required the surgeons toremove Jeanella’s liver. Jeanella’s par-ents were immediately solicited aspotential donors for a partial liver fortheir daughter; a blood test was quicklyadministered to each parent to deter-mine who was to be the likely trans-plant donor. The laboratory firstreported that Mrs. Aranda was a matchand then subsequently issued a revisedreport stating that Mr. Aranda was theappropriate donor. In truth, the lab’sfirst determination was correct.

Following a partial liver transplantfrom Mr. Aranda, baby Jeanella’s con-dition quickly began to deteriorate asshe developed a postoperative blooddisorder, fever, kidney problems, lunghemorrhages, and severe jaundice. On5 August, 19 days after the transplant,Mrs. Aranda noticed that baby Jeanellawas receiving type O blood transfu-sions, which seemed to be inconsistentwith her husband’s blood type (A), andenquired whether there was a trans-plant-related mismatch. Officials thendetermined that Mrs. Aranda was cor-rect in her observations. By then, it wasalready too late. Baby Jeanella died thenext day, 20 August [5]. This case sur-faced on the heels of another terrible,nationally prominent case of blood typemismatch. Less than six months earlier,17-year-old Jesica Santillán died afterundergoing a heart-lung transplant atDuke University Hospital in NorthCarolina [6].

In a report titled “To Err Is Human:Building a Safer Health System” [7],the Institute of Medicine of the NationalAcademies reported that medical errorsclaim more lives in the United Statesthan motor vehicle accidents, breastcancer, or AIDS and that “adverseevents” directly related to medicalerrors cost the nation on the order of

IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE JANUARY/FEBRUARY 2007 89

US$37.6 billion a year, of which US$17billion are completely preventable(These figures represent the lowest esti-mate as presented by the Institute.). In amore recent report [8], also by theInstitute of Medicine, a study conductedat the Brigham and Women's Hospitalin Massachusetts revealed 70 separateincidents of adverse drug events(ADEs) and 194 potential ADEs. Thereport also notes that, upon furtheranalysis of the data, a system analysisgroup found 334 errors associated withthe documented 264 events in total.

The system analysis group discov-ered that defects in drug knowledgedistribution, dose and identity check-ing, availability of patient information,order transcription, allergy defense sys-tems, medication order tracking, andinterservice communications presentedkey problem areas, accounting for over75% of the errors identified. They con-cluded that there were pervasive sys-tem-of-systems problems that led to themany errors.

In mulling over this information, Dr.Mathews reminded us that “whenever asystem-of-system problem has beenidentified as such, what people are reallyreferring to is an interoperability prob-lem. We must remember that the verynotion of interoperability presupposes asynchronous interworking of all compo-nents in constituting systems to achievethe desired goal. When the many stepsin the interoperability processes aren’tproperly qualified, quantified, associat-ed, monitored, assessed, and improved,things are bound to go wrong. All rela-tionships–however subtle in composingsystems—must be properly accountedfor.” He continued to state that hewasn’t surprised by these statistics, andalarmingly questioned whether the actu-al numbers may indeed be much higherthan those declared by the Institute ofMedicine. According to Matthews,"since most aren’t able to properlydefine the processes as (it) pertains tointeroperability, let alone qualify andquantify the many aspects of anydomain of concern well—in this particu-lar case of Brigham and Women’sHospital—there may very well be many

dimensions that go either unreported orunderreported as a result.”

After reviewing the prepublicationcopy of the Institute’s latest report, Dr.Mathews’s observations seem to havebeen proven accurate. A second studyconducted at the Brigham andWomen’s Hospital in fact uncoveredADEs at a higher rate than certain otherstudies involving computerized surveil-lance. This was due to the fact that thecomputerized surveillance system usedin the new study was adjusted to bemore sensitive and was undeniably ableto detect milder ADEs, as the surveil-lance system was governed by a newlyminted set of rules for identifying awider range of ADEs. As Dr. Mathewssaid, in this case, improving qualifica-tion and quantification of the domainand translating that knowledge toimprove the computerized surveillancesystem then permitted the discovery ofadditional ADEs that would otherwisehave gone unnoticed or unreported.

The Future of Interoperability Dr. Noah Porter, president of Yale,once said “few persons are so familiarwith each of the several lines of argu-ment in which lies its strength if it betrue, and its weakness if it is false, as tobe able to judge of any considerablenumber. Fewer still are competent topronounce upon the relation of eachpart to every other, and the cumulativeforce of all as they bear upon the grandconclusion.” [10] If I had to account forjust one extraordinarily brilliant mes-sage that the IEEE Special Session onIntegration and Interoperability ofNational Security Information Systemsuncovered, it was that thus far inter-operability has been studied andapproached quite incorrectly, and that itmust be viewed with an interdiscipli-nary and multidisciplinary perspective(holistic) using a systems approach.With the cerebral assistance of geneti-cists, seismic engineers, electrical engi-neers, bridge builders, computerscientists, biologists, structural engi-neers, metallurgists, economists, physi-cists, management scientists, policymakers, and analysts, Dr. Mathews both

THE MILITARY ANDINTEROPERABILITYComputers were born of war, and

they are still at war. The American

military has had the longest tenure

and the most diversified experi-

ence with computers and elec-

tronic communications technology

in the United States federal govern-

ment, and indeed the world.

Therefore, it would appear logical

that a definition for information sys-

tems’ interoperability per a U.S.

DoD dictate should become ubiq-

uitously acceptable as an intellec-

tual point of departure for

discussions relating to uninteroper-

ability, and indeed it has.

Government wide, the DoD defini-

tion for interoperability has given

rise to similar definitions, with a hint

of familiar DoD phraseology. The

DoD defines interoperability as that

“ability of systems, units, or forces

to provide data, information, mate-

rial, and services to and accept

the same from other systems, units,

or forces and to use the data, infor-

mation, material, and services so

exchanged to enable them to

operate effectively together.

According to the DoD, “interoper-

ability is more than just information

exchange. It includes systems,

processes, procedures, organiza-

tions, and missions over the life

cycle and must be balanced with

information assurance.” [9] And

according to the IEEE Standards

Computer Dictionary, interoper-

ability is defined as that “ability of

two or more systems or compo-

nents to exchange information and

to use the information that has

been exchanged.”

Government (continued)

cleverly and uniquely proved that if human beings and information tech- nologies are to have an arrangement of coexistence to be interoperable-for the purpose of successfully attaining com- mon goals in a timely, efficient, and effective manner-then going forward we must have a very intimate under- standing of any such arrangement for coexistence.

Let's go back to the example used earlier-an individual with an electronic health record in the civilian, military, and VA sectors-and imagine the con- sequences of having an interoperable and longitudinal "unique" record throughout the individual's lifetime. This individual's life may be saved a few times by having the right informa- tion in the right place at the right time. The quality of life may improve, and the number of potential medication or aller-

bined with personal genetic information (while, of course, protecting the rights of privacy), will allow us to move into true disease prevention. True interoper- ability will help improve the quality of our healthcare and public health systems while significantly reducing expenses.

References [ I ] "The future of emergency care in the United States health system," Institute of Medicine, June 14, 2006. [2] J. Lancaster, "Surgeries, side trips for 'medical tourists': Affordable care at India's private hospitals draws growing number of foreigners," Washington Post Foreign Service, October 21, 2004 [Online]. Available: http://www.washingtonpost.com/wp- dyn/articles/A49743-20040ct20.html; B. Simon, "Vacation, adventure and surgery? Elective surgeries by world-class doctors at third-world prices," 60 Minutes [CBS], September 4, 2005 [Online]. Available: http://www.cbsnews.com/stories/2005/ 04/21/60minutes/main689998.shtml; and "UK to send heart patients to India," Press Trust of India, June 29, 2003 [Online]. Available: http://economic- times.indiatimes.com/cms.dll/html/uncomp/arti- cleshow?msid=49583

[5] D. Grady and L.K. Altman, "Suit says transplant error was cause in baby's death," NY Times, March 12, 2003 [Online]. Available: http://query.nytimes.com/ gst/fullpage.html?res=9805E7DB 153EF93 1A25750CO A9659C8B63&sec=health&pagewanted=print [6] E. Bradley, "Anatomy of a mistake," CBS Broadcasting Inc., Sept. 7, 2003 [Online]. Available: http://www.cbsnews.com/stories/2003/03/16/ 60minutes/main544 162.shtml [7] T. Kohn, J.M. Corrigan, and M.S. Donaldson, Eds., "To err is human: Building a safer health sys- tem," Institute of Medicine's Committee on Quality of Health Care in America, Washington, D.C., 1999. [8] P. Aspden, J. Wolcott, J. Lyle Bootman, and L.R. Cronenwett, Eds., "Preventing medication errors" (Quality Chasm Series), Institute of Medicine's Committee on Identifying and Preventing Medication Errors-Board on Health Care Services, Washington, D.C., 2007 [prepublication copy]. [9] "Interoperability and supportability of informa- tion technology (IT) and national security systems (NSS)," Department of Defense Directive 4630.5, May 5,2004. [lo] N. Porter, "Physiological metaphysics; or, the apotheosis of science by suicide," The Princeton Review, vol. 2, July-Dec. 1878, and N. Porter, Science and Sentiment with Other Papers Chiefly Philosophical, New York: Charles Scribner's Sons, Franklin Press, 1882.

EY errors may be eliminated. The r31 T.L. Friedman, The World Is Flat: A Brief

knowledge stored could also provide H'Sto" of the Twenty-First l s t ed., The views expressed in this York: Farrar, Strauss & Giroux, 2005.

information related to environmental [41 IEEE, IEEE-rlSA pos i t ion statement on editoriallpaper are those of the author factors (e.g., quality of the water and "Interoperability for the national health information and do not reflect the official policy or air), as well as short- and long-term network," approved by Board of Directors, position of the National Defense

Piscataway, NJ, November 11, 2005 [Online]. effects of diet, exercise, and vaccines. In Available: [https~llwww,ieeeusaorg/policyl University, the Department of Defense, my view, all these factors, when com- positions/NHWinteroperability.html] or the U.S. Government.

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