Patient Participation in Electronic Medical Records

EDITOR’S NOTE

Electronic Medical Records: Saving Trees, Saving Lives

Dena E. Rifkin

Coeditors CONSIDER THIS IRONY OF MODERN LIFE: IN A MEDICAL CRISIS, EMERGENCY Alison J. Huang, MPhil University of California physicians would have an easier time accessing a patient’s bank San Francisco account using his or her automatic teller machine card than they would School of Medicine Stefan C. Weiss, MHS finding critical medical history using his or her medical insurance card. Duke University Medical records, including crucial electrocardiograms, drug aller- School of Medicine gies, or medical conditions, are typically stored on paper and are Deputy/Reviews Editor Eric P. Wilkinson often inaccessible in emergencies. Stanford University The ability to access medical charts electronically, in emergency School of Medicine situations or in routine medical settings, has not paralleled the growth Senior Editor Catherine S. Magid ON THE COVER of financial networks or indeed of the Internet. Although several University of Pennsylvania Evelina Krieger, commercial sites are now selling space for individuals to put their School of Medicine Tulane University medical records online and numerous institutions have local elec- Senior/New Media Editor School of Medicine, Stuart P. Weisberg Beneath. Acrylic. tronic medical records (EMRs) in place, most clinical records are still Columbia University 76.2ϫ101.6 cm. kept in paper charts that are stored at a single location. College of Physicians and Surgeons The challenge of building an integrated EMR system has proved to Associate Editors Schuyler W. Henderson be more than technological; 25 years of attempts to formalize the terms University of Illinois at Chicago and concepts of medical practice has exposed some fascinating philo- College of Medicine Pam Rajendran sophical conundrums. What belongs in a medical record, and how Boston University should medical conditions or ideas be encoded? Which tasks are best School of Medicine Dena Rifkin performed by physicians, and which by the computer? Is it possible Yale University to encapsulate the medical encounter in digital form? School of Medicine 1 Hobart W. Walling, PhD A number of centers have had local EMRs available for decades, Saint Louis University providing evidence that thoughtfully implemented EMRs improve medi- Health Science Center JAMA Staff cal care through adjunct technology like error checking and allow easier Stephen J. Lurie, MD, PhD study of trends in a clinic population. New links are being forged be- Managing Editor tween individual patient data and the information in digital libraries Juliana M. Walker 2 Assistant Editor or the tools of computerized decision support. While the potential AMA-MSS Governing Council for ease of access and error reduction seems obvious, new technolo- Savita Srivastava, Chairperson gies should be held to the same standards of evidence as new treat- Michael H. Shannon, Vice Chairperson Angela Siler-Fisher, Delegate ments are. Research in this field has started to look not only at effi- Kimberly Nestor, Alternate Delegate ciency and institutional satisfaction but also at health outcomes and Sara Wasserbauer, At-Large Officer impact on the patient-physician relationship. Brad G. Butler, Speaker Andre Biuckians, Vice Speaker As researchers measure the gains made by using EMRs, they should Sunny G. Mistry, Student Trustee also consider potential losses. Will physicians rely too heavily on the safety Ryan J. Grabow, MD, Past Chairperson nets of automatic warning systems, losing the ability to think through

MSJAMA is prepared by the MSJAMA editors the problem—just as many who rely on calculators cannot compute an- and JAMA staff and is published monthly from September through June. It provides a forum swers on their own? With full histories available at the touch of a but- for the news, ideas, and opinions that affect ton, will tired interns and residents cut corners, neglecting to ask their medical students and showcases student writing, research, and artwork. The articles and own questions? EMRs must be a tool for improving patient care rather viewpoints in MSJAMA are not necessarily the than a crutch or a hindrance to the primary work of caring for patients. policy of the AMA or JAMA. All submissions must be the original unpublished work of This month, MSJAMA examines the legal, ethical, and technical chal- the author. Submitted work is subject to review and editing. lenges of EMRs. With a new generation of physicians accustomed to Address submissions and inquiries to: working with computer technology, we may see some of the promise MSJAMA, Stefan C. Weiss, Coeditor, of the past 3 decades of research in this field come to fruition in the 2614 Cedar Creek Dr, Durham, NC 27705; phone (919) 309-4185; coming years. e-mail: [email protected] www.msjama.org REFERENCES 1. McDonald CJ, Overhage JM, Tierney WM, et al. The Regenstrief Medical Record System: a quarter century experience. Int J Med Inf. 1999;54:225-253. 2. Shortliffe EH. The evolution of electronic medical records. Acad Med. 1999;74:414-419.

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Patient Participation in Electronic Medical Records

Christopher C. Tsai, BA and Justin Starren, MD, PhD, College of Physicians and Surgeons, Columbia University, New York, NY

ELECTRONIC MEDICAL RECORDS (EMRS) HOLD GREAT PROMISE tem (WebCIS) and to customized case management soft- for improving the practice of medicine by facilitating commu- ware. Patients can also view and enter other data including nication between members of the health care team. The most diet, medication, and exercise information through the EMR. profound influence of EMRs may lie in their ability to encour- Patients and diabetes case managers can communicate age patients’ involvement in their own care. Potentially, pa- through a secure clinical email system as well as via video- tients could use EMRs to access their medical records online, conferencing; case managers also receive alerts when pa- learn about their health conditions, communicate with phy- tients’ transmitted values exceed set thresholds. By allow- sicians, and even contribute to the chart itself. Certain hurdles ing direct patient interaction with the EMR, case managers to such access have yet to be overcome, such as ensuring pri- and physicians have much more accurate and up-to-date in- vacyofpersonalmedicaldataanddeterminingthewaysinwhich formation for managing therapy. Patients learn to monitor patients should be able to influence their charts; once these their own condition by receiving immediate feedback after challenges are met, patients can look forward to a future of in- finger sticks and comparing blood glucose values over time. creased participation in and control over their own care. No new health care technique will be implemented unless Prior innovations in telemedicine provide the founda- it is demonstrated to be cost-effective, whether by improving tion for interactive EMR projects. Telemedicine uses re- health outcomes, or decreasing costs, or both.7 Several stud- mote transmission of video, audio, and text data to provide ies have suggested that telemedicine is able to decrease costs subspecialist care or consultation to patients who might not while maintaining quality in the management of congestive otherwise have access to it. In teleradiology, for example, a heart failure, chronic obstructive pulmonary disease, cere- neuroradiologist working remotely can diagnose brain pa- bral vascular accident, cancer, diabetes, and anxiety.8 thology by looking at a digital image.1 Telemedicine can also Patient interaction with EMRs has the potential to re- facilitate the practice of cardiology, orthopedics, dermatol- duce the frequency of clinical visits and improve health out- ogy, and psychiatry.2 Telemedicine has been used to pro- comes. Yet, one concern is that telemedicine interactions vide medical care to underserved rural communities, disas- will replace clinical encounters, thus deteriorating the patient- ter areas, and military operations.3 physician relationship. It remains to be seen whether the Interactive EMR builds on the telemedicine framework face-to-face clinical encounters that supplement interac- by making the medical chart, traditionally the province of tive EMR will be more productive and satisfying because of the health care provider, a shared document that patients the long-term connection between physician and patient that can access and update themselves. Numerous projects al- can be provided by the EMR system. ready allow patients to read specified portions of their charts As telemedicine becomes incorporated into chronic dis- online, manually enter data, and verify their medication dos- ease management across the United States, patient-oriented ages or track what doses they have taken. The Patient Clini- EMRs may become a part of the standard of care of outpa- cal Information System (PATCIS) project provides patient management in all medical specialties. Soon, third- tients with the ability to view laboratory results and text year clerks may spend part of their ambulatory care rotation reports through a Web interface and to enter data such as videoconferencing with patients and reviewing EMRs with vital signs.4 The Patient Centered Access to Secure Systems them remotely. Online (PCASSO) project focuses on developing a robust 5 security architecture for direct patient access to an EMR. REFERENCES The largest project combining telemedicine with patient 1. Allen A, Patterson JD. Annual survey: teleradiology service providers. Telemed access to an EMR is the Informatics for Diabetes Education Today. 1997;5:24-25. 6 2. Abt Associates’ national survey of rural telemedicine. Reported in: Department And Telemedicine project (IDEATel). Begun in February of Commerce, Telemedicine Report to the Congress, p 16 ( January 13, 1997). 2000, the IDEATel project is a 4-year, $28-million random- 3. Garshnek MS, Burkle JR. Applications of telemedicine and telecommunica- tions to disaster medicine: historical and future perspectives. J Am Med Inf Assoc. ized clinical trial designed to maximize Medicare patients’ 1999;6:26-37. control of their diabetes by providing them with a comput- 4. Cimino J. Patient access to clinical information: the PatCIS project. Dec 31, 2000. erized link to their caregivers. Patients use a home tele- National Library of Medicine Final Report, National Information Infrastructure Con- tract N01-LM-6-3542. medicine unit (HTU) that allows them to interact in mul- 5. Baker DB, Masys DR. Assurance: the power behind PCASSO security. JAmMed tiple ways with their online charts. When patients measure Inf Assoc. 1999;6(fall symp suppl): 666-670. 6. Informatics for Diabetes Education and Telemedicine (IDEATel) home page. Avail- blood pressure or fingerstick glucose with devices con- able at: www.ideatel.com. Accessed January 31, 2001. nected directly to the HTU, the results are automatically en- 7. Masys DR. Telehealth: The need for evaluation. J Am Med Inf Assoc. 1997;4: 69-70. crypted and transmitted securely over the Internet into the 8. Johnston B, Wheeler L, Deuser J, Sousa K. Outcomes of the Kaiser Perman- Columbia University Web-based Clinical Information Sys- ente tele-home health research project. Arch Fam Med. 2000;9:40-45.

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Electronic Medical Records: A Decade of Experience

Charles Safran, MD, Chief Executive Officer, Clinician Support Technology, Framingham, Mass and Harvard Medical School, Boston, Mass

MY COLLEAGUES AND I ORIGINALLY BUILT AN ELECTRONIC 1367450 prescriptions for more than 53000 patients.3 Cli- patient record at the Beth Israel Deaconess Medical Center nicians have also documented health promotion and disease (BIDMC) in 1989 simply to facilitate sharing of information prevention tasks, such as recording a patient’s blood pres- over geographically dispersed practice locations.1 However, sure. Confidence in the well-published security measures is the introduction of an electronic patient record has funda- so great that even psychiatric notes are kept online.7 mentally changed the practice of medicine in ways that we With such a heavily used system in place, we had the op- never foresaw. This type of highly interactive program tai- portunity to change medical practice as McDonald8 and oth- lored to medical workflow improves the quality of care,2 ers have done. We developed computer programs to alert reduces medication errors,2 saves physician and nurse time,3 the clinician about clinical events, to help the clinician to improves resident and medical student clinical precepting,4 act on the information, and to document the clinician’s and supports collaboration in complex organizations.5 response in the medical record. A nonrandomized, con- While the electronic patient record seems to be the holy trolled, prospective trial performed during an 18-month grail of clinical computing, the idea is straightforward: take period found that the presentation of a set of alerts and re- the physician’s paper chart and make it electronic. Of course, minders as part of computer-based medical record resulted since paper records are not standardized neither are elec- in significantly faster and more complete adoption of prac- tronic records. An informal count finds more than 400 com- tice guidelines by a group of clinicians treating patients with panies that claim to have such programs for physicians. Any human immunodeficiency virus infection.2 implementation of an electronic medical record requires cer- With fully functioning electronic patient record systems tain decisions about how medicine is practiced, and mak- to monitor care, computers can perform many care coordi- ing such a system work is not as simple as taking a paper nation and documentation functions, freeing people to con- chart and making it electronic. For instance, can 2 people centrate more on interpersonal interactions and provision of in the same office look at a patient’s chart at the same time? health care services.4,5 With shared electronic patient records, Is the physician part of a health system that needs to share busy health care providers can collaborate and asynchronously patient records more broadly? How well can the data col- update plans and progress; for instance, several specialists lected by the system support quality improvement with alerts participating in the care of a patient can share medication lists, or reminders? How do the data get into the record? exchange notes, and alert each other to problems. BIDMC is served by the Center for Clinical Computing Thepromiseoftheelectronicpatientrecordisrealandproven, (CCC) system, a mature system that began to evolve in the buttherealityforphysiciansintheUnitedStateshasbeenlargely late 1970s to support the clinical information needs of staff unrealized. Perhaps the emerging generations of physicians and the administrative needs of the hospital.6 This system with computer skills and consumers of health care who de- is now one of the most widely used in the United States. Phy- mand digitally ensured quality will spur adoption of a tech- sicians use the computing system to look up the results of nology that saves lives and improves the quality of care. all diagnostic studies, to send and receive electronic mail, and to perform a variety of decision support tasks, includ- Financial Disclosure: Dr Safran has an equity interest in Clinician Support Tech- ing online literature searching, computer-assisted expert nology, an e-health application service provider. consultation, and online clinical calculation. As a part of this heavily used CCC system, in 1989 col- REFERENCES leagues and I at the CCC developed an extensive online medi- 1. Safran C, Rury C, Rind D, Taylor WC. A computer-based outpatient medical record for a teaching hospital. MD Comput. 1991;8:291-299. cal record (OMR) for use in an ambulatory primary care prac- 2. Safran C, Rind DM, Davis RB, et al. Guidelines for the management of HIV tice with the goals of facilitating workflow, supporting infection in a computer-based medical record. Lancet. 1995;346:341-346. 3. Safran C, Sands DZ, Rind DM. Online medical records: a decade of experi- collaborative practice models, delivering clinical practice guide- ence. Method Inf Med. 1999;38:308-312. lines, and making the ambulatory office paperless. Clini- 4. Patel VL, Cytryn KN, Shortliffe EH, Safran C. The collaborative health care team. cians interact directly with the computer system, increasing Teaching Learning Med. 2000;12:117-132. 5. Safran C, Jones PC, Rind D, Bush B, Cytryn KN, Patel VL. Electronic commu- the accuracy of data capture and providing an opportunity nication and collaboration in a health care practice. Artif Intell Med. 1998;12: for education, documentation, and action. 139-153. 6. Bleich HL, Beckley RF, Horowitz GL, et al. Clinical computing in a teaching hos- Since the system was first introduced, more than 1000 pital. N Engl J Med. 1985;312:756-764. different staff physicians, nurses, resident physicians, and 7. Safran C, Rind D, Citroen M, Bakker AR, Slack WV, Bleich HL. Protection of confidentiality in the computer-based patient record. MD Comput. 1995;12:187-192. psychiatric social workers have entered 1278484 progress 8. McDonald CJ. Protocol-based computer reminders, the quality of care, and the notes and 391897 medical problems and written online non-perfectibility of man. N Engl J Med. 1976;295:1351-1355.

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Privacy Protections for Cybercharts: An Update on the Law

Julie D. Cantor, MA, JD, Yale University School of Medicine, New Haven, Conn

THE AGE OF COMPUTERS HAS HERALDED THE SLOW REPLACE- While the rule has been widely praised, it has also been ment of the paper medical chart. Although it may be irra- roundly criticized as onerous, costly, overreaching, and in- tional to fear more for the privacy of a cyberchart than that complete. Patients do not own their records, and they have of its paper cousin, in recent years concerns about protect- no new right to sue those who illegally obtain and use their ing electronic medical records have mounted. Perhaps the medical information. Plaintiffs are still limited to theories based unease is this: the paper records were tangible, locked away on, for example, a constitutional right to privacy or a common- in an office or a basement, while with a few mouse clicks, law duty of confidentiality. Also, there is an exception for us- computerized records could be bouncing all over the Inter- ing identifiable chart excerpts in direct-to-patient marketing. net into the hands of anyone, from an employer to a teacher Rather than require written informed consent for that disclo- to a friend. At least, that may be a common fear. When even sure, the rule employs a different mechanism—companies may Microsoft’s “impenetrable” databases are vulnerable to hack- contact a patient at least once about a product, at which time ers, abstract concerns about an inviolate chart seem closer the patient may exercise a right to “opt out” of future mail- to a disturbing reality. ings. While direct marketing may be an effective way to alert Patients, not surprisingly, are worried about how their patients to new and useful products, this loophole could stamp medical information will be used—so worried that they the federal government’s imprimatur on a practice that, with- may withhold details from providers or forgo medical care out stringent safeguards, may be ethically problematic.6 altogether.l Today, national protections for electronic medical re- Legislators, too, are concerned. At the state level, legis- cords float in a kind of nether world, somewhere between latures have begun to map the largely uncharted terrain at the proposed rule, a Bush administration review, and its en- this intersection of medical records and technology.2 Yet, actment. Meanwhile, researchers have recognized the need in the “laboratory of the states,” these laws are inherently for standards and have created secure record-keeping sys- varied and may offer spotty coverage.3 tems based on the National Research Council guidelines.7 Federal legislators have also been struggling to provide Still, ethical questions remain. How should physicians bal- uniform protections for computerized medical records. As ance the need for record keeping and data collection against electronic medical records gained prominence, policymak- patients’ pleas to leave medical histories, physical findings, ers began to notice legal oddities in the current protections or test results out of the electronic chart? Who should be for computerized records. Notably, the law protected vid- responsible for confidentiality breaches, from the loudly whis- eotape rental records, but it left electronic medical records pered elevator gossip to the discriminatory uses of ill- vulnerable. In 1996, partly in response to that “Block- gotten information? Where can patients turn for recourse? buster phenomenon,” Congress included a provision to cre- Federal protections for cybercharts may eventually be- ate strong federal privacy protections, with a 3-year dead- come as comprehensive and as balanced as those on the front line for congressional action, in the Health Insurance lines would like, but the evolution of law is often a slow, Portability and Accountability Act.4 When ensuing legisla- even maddening process. The medical community may need tive proposals became mired in genuine disagreements over to address issues of privacy on its own, without waiting for language and substance, as well as partisan politics, Con- a perfected federal mandate to safeguard a seemingly simple gress missed that target date. The task of creating compre- ideal: that patients will be able to share their most intimate hensive legislation to guard the nation’s medical records fell secrets with physicians, confident that they will remain safe to the US Department of Health and Human Services (HHS). within a very private world. At the twilight of the Clinton administration, HHS of- fered its Final Rule on Standards for Privacy of Individu- REFERENCES ally Identifiable Health Information and effectively created 1. Health Privacy Project Polling Data, Georgetown University Law Center: Cali- 5 fornia HealthCare Foundation survey conducted by Princeton Survey Research As- the first extensive federal regulations for medical records. sociates, January 1999. Available at http://www.healthprivacy.org. Accessed Janu- The rule, which would preempt only weaker state laws, of- ary 23, 2001. fered sweeping protections for electronic and paper re- 2. Cal. Civ. Code § 56, et seq. (2000). 3. Hodge JG, Gostin LO, Jacobson PD. Legal issues concerning electronic health cords, as well as spoken communication. Some key provi- information: privacy, quality, and liability. JAMA. 1999;282;1466-1471. sions: patients may inspect their medical chart and request 4. 42 USC §1320d-2 (West 2000). 5. Federal Register, December 28, 2000 (65 FR 82462). Div 2000). corrections; health plans and physicians must obtain writ- 6. Lo B, Alpers A. Uses and abuses of prescription drug information in pharmacy ten consent in many instances before disclosing identifi- benefits management programs. JAMA. 2000;283;801-806. 7. Halamka JD, Szolovits P, Rind D, Safran CS. A WWW Implementation of na- able information; civil and criminal penalties may follow com- tional recommendations for protecting electronic health information. JAmMed pliance failures and wrongful disclosures. Inf Assoc. 1997;4;458-464.

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Grassroots Computing: Palmtops in Health Care

Maulin Shah, MD, PatientKeeper Inc, Cambridge, Mass

PALMTOP COMPUTERS FIRST ARRIVED ON THE MARKET NEARLY sibilities is invaluable. The second is cost. Most palmtop de- 10 years ago. However, it was not until the last few years vices, equipped with all necessary software, cost well un- that they started to be widely used. A combination of tech- der $500. This puts them within the price range for the nological advances, improved form, and diverse applica- traditional early adopters of technology—young physi- tions has led to a 169% increase in sales from 1999 to 2000.1 cians and physicians-in-training—and has further facili- Originally designed as personal organizers—a replace- tated the rapid growth of the palmtop movement. Third is ment for bulky and inefficient day-planners—these pocket- the large breadth of applications available. Individuals can sized devices are quite versatile and can support a wide va- download current reference information that is automati- riety of functions. From medical references, to prescription cally updated to their devices at no additional cost. Fur- writing, to electronic medical records, palmtop computers thermore, there are hundreds of niche applications that can may be key to the ever-elusive adoption of health care in- be used to solve specific clinical problems. formation technology by physicians. However, the biggest hurdle for adoption of palmtop devices In the past, most information technology in health care by individuals and enterprises alike is the ability to connect was imposed on physicians by the institution in which they them directly to clinical information systems. As was the case practiced. This often led to an “us vs them” mentality that with PCs, the technology that most significantly impacted their has severely hampered physician adoption of new technol- adoption and functionality was networking—the ability to con- ogy. In contrast, palmtop computers have been brought into nect to local intranet and global Internet resources. For mo- health care by physicians looking to improve their produc- bile, disconnected devices, the analogous technology to net- tivity. This grassroots movement towards a new technol- working is synchronization—updating new information from ogy is unprecedented in health care. the palmtop to the existing information system, and sending When personal computers (PCs) were first made avail- new information from the existing information system to the able to the general public, they were shunned by large en- palmtop. Palmtop computers will only reach their true poten- terprises, including health care institutions. The enterprises tial when they can connect to any and all clinical information were already entrenched in mainframe-based computing, and systems the physician uses. For example, while in the clinic, personal computers were not seen as suited for the work- the palmtop must connect to the physician’s practice manage- place. However, as PCs became more and more popular with ment system to check patient information and record visits. individual users, large enterprises had to adapt; networking While at the hospital, the device must connect to the hospi- technology was created to connect individuals’ computers and tal’s information systems to obtain lab results or enter orders. to allow them to access server applications. Despite these de- Institutions and companies are now addressing the technical velopments, PCs were never as widely adopted in health care challenge of connecting to these disparate systems. as they were in other industries. Since physicians do not of- Palmtop computing promises to help finally realize the ten practice at their desks, large, immobile desktop PCs did benefits that health care information technology has been not fit into the physician workflow. promising for years. Physicians will be able to perform all The adoption of palmtop computing in health care is in of their information management responsibilities from in- many ways analogous to the adoption of PCs in other individual palmtop devices that are with them at all times. From dustries in the 1980s. In contrast to the PC revolution, nearly prescribing medications and checking formulary restric- 15% of physicians are already using palmtop computers.2 tions, to ordering labs and viewing test results, physicians While most of these individuals are still using their devices will soon be able to interact with both personal and profes- for simple organizational tasks, many are beginning to in- sional information and improve their productivity, their vestigate how to use the devices to improve their profes- income, and ultimately, their patients’ care.

sional productivity. Small group practices and depart- Financial Disclosure: Dr Shah owns stock in PatientKeeper Inc, a company that ments within large health care institutions have even started develops palmtop medical applications. purchasing devices for all of their members.3 There are many reasons palmtop computers have had a REFERENCES larger grassroots movement driving them into health care 1. PDA Sales Soar in 2000. Available at http://cnnfn.cnn.com/2001/01/26 than other technologies. The first is mobility. For physi- /technology/handheld/index.htm. Accessed January 27, 2001. 2. Fisher J, Wang R. The cure is in hand. WR Hambrecht & Co. San Francisco, cians used to wearing white coats filled with reference books, Calif: October 19, 2000. Report available at http://www.wrhambrecht.com index cards, and hundreds of scraps of paper as their ad hoc /research/coverage/ehealth/ir/ir20001019.pdf. Accessed February 8, 2001. 3. Wake Forest School of Medicine Academic Computing Department. Available mobile filing system, the promise of 1 pocket-sized device at http://www.wfubmc.edu/academic_computing/ACAbout.htm. Accessed Feb- that could simplify and organize all of their clinical respon- ruary 8, 2001.

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The Patient-Owned, Population-Based Electronic Medical Record: A Revolutionary Resource for Clinical Medicine

Jem Rashbass, MD, PhD, MRCPath, Clinical Director of Biomedical Computing, Cambridge University, Cambridge, England

THE INTEGRATED ELECTRONIC MEDICAL RECORD (EMR) IS THE infrastructure and the general level of acceptance by clini- next step in the evolution of health care delivery. There have cians of the value of information gathering in clinical prac- been many attempts to create this tool. Nevertheless, an EMR tice. Unfortunately, in the United States, health record that contains all of a patient’s health data and allows infor- systems are focused around the financial drivers in health mation to be extracted for anonymous population-based care and consequently the clinical population data are bal- epidemiologic studies remains elusive. kanized among individual health care providers. In con- Inevitably, this record will change the everyday practice trast, in the United Kingdom, as in much of Europe, a uni- of medicine both for the individual and the population, but fied health care system in the National Health Service has it will also revolutionize clinical research. It will allow re- led to the introduction of a unique patient identifier for searchers to ask questions about diseases that were previ- everyone in the population. New European legislation en- ously been impossible to ask, and it may well lead to the suring patient empowerment mandates that there is spe- discovery of tens or even hundreds of new diseases and al- cific consent obtained for how clinical information may be low reclassifications of existing ones. Although smaller sub- used both in medical care and research.3 This, when com- sets of data have been extremely useful and form the basis bined with a number of British government imperatives of traditional epidemiology, the real value of the integrated establishing data communication standards and the Health EMR is the ability to ask these types of questions on rou- and Social Care Bill currently before the UK Parliament to tinely collected clinical data from whole populations of address the issue of control of anonymized access to popu- millions of people. Gene chip–based molecular analyses of lation data,4 serves to create the ideal environment to de- patients with complex clinical phenotypes will soon be- velop an integrated EMR. come commonplace, and researchers will need to be able The United Kingdom has begun to capitalize on these to search across the EMRs of all patients to find those with opportunities with a number of initiatives at the local level the same subtle constellation of clinical features. coordinated nationally by the National Health Service In- It is essential that there be an open and informed debate formation Authority, which will develop and test the nec- to determine where the balance lies between the use of pa- essary prototypes.5 The Electronic Record Development and tient data for research and public health management and Implementation Programme and others such as the East- the right of the individual to control personal privacy of ern Region Electronic Health Record Consortium,6 a part- the medical record. Much has been written on both sides nership of academics, industry, and the health service led of the argument; legislation has in general empowered the by the University of Cambridge, are closely linked with na- individual and caused anxiety among researchers. Never- tional public debates on the ethical use of data for clinical theless, objective studies of patients’ views are sparse and studies and patient care. These can succeed only by com- find that most patients realize the value of well-controlled bining public debate with the introduction of technology. access to records. For example, a study of more than 200000 It is still early, but during the next decade some form of patients at the Mayo Clinic, conducted in response to new patient-owned EMRs for entire populations will likely be in- legislation in Minnesota in 1997, found that more than 95% troduced. The impact this will have on clinical practice and of patients, when fully informed, were willing to have their our understanding and classification of disease could possi- clinical information used in EMRs.1 Health care communi- bly be greater than the effect that molecular biology has had ties in industrialized countries are confronted by the tech- on medicine during the last 10 years. nical, ethical, and social challenges created by these issues.2 Standards that support data integration and security REFERENCES and are inherently scalable to the size of a whole popula- 1. Melton JL. The threat to medical-records research. N Engl J Med. 1997;337: 1466-1470. tion will need to be developed. These standards must also 2. European Telematics Health Observatory. Available at http://www.ehto.org be able to evolve quickly to embrace new technology or statu- /ehto/ehealthrecord.html. Accessed February 8, 2001. tory changes in data access control rules. Researchers will 3. Data Protection Act 1998: Protection and Use of Patient Information. Depart- ment of Health. Available at http://www.doh.gov.uk/dpa98. Accessed February require new search tools with algorithms capable of trawl- 8, 2001. ing this type of relatively “messy” clinical data. 4. Health and Social Care Bill, UK House of Commons. Available at http://www .parliament.the-stationery-office.co.uk/pa/cm200001/cmbills/009/2001009 Researchers, clinicians, and health care providers are seek- .htm. Accessed February 8, 2001. ing a suitable social and political environment in which to 5. Electronic Record Development and Implementation Programme. Available at http://www.nhsia.nhs.uk/erdip. Accessed February 8, 2001. develop a prototype population-based, patient-owned rec- 6. The Eastern Region Electronic Health Record Consortium. Available at http:// ord. The United States leads in the overall investment in www.cl.cam.ac.uk/Research/SRG/opera/nhs/EREHRC. Accessed February 8, 2001.

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