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MEDICAL MALPRACTICE LIABILITY IN THE AGE OF ELECTRONIC HEALTH RECORDS Health care providers, policymakers, patients, a payers share

the vision of a health care syste powered by information technology. The Health Information Technology for Economic and Clinic Health (HITECH) Act of 2009 authorizes grants and incentives totaling an estimated $14 billion to $27 billion to promote meaningful use of electronic health rec ords (EHRs) by providers. In the excitement over health information technology, some of the potential risks associated with it have received less attention, such as the possible effects of this technology on medical malpractice liability. Yet even now, the potential for EHRs to ameliorate some sources of stress related to liability while reinforcing others is apparent. We explore the implications for malpractice liability of four core functionalities of EHR systems: documentation of clinical findings, recording of test and imaging results, computerized providerorder entry, and clinical-decision support. We also discuss the ramifications of secure messaging capabilities integrated into EHR systems and the overall effects that may occur as comprehensive EHR systems become standard. Our analysis is based on a review of the limited available lit- erature on the liability implications of EHRs and a much larger body of literature on the effects of EHRs on quality of care and the role of clinical practice guidelines in malpractice litigation. The legal implications of EHRs extend beyond changes in malpractice liability. Other important consequences include potential liability under privacy and confidentiality laws, disputes over ownership of health data, and heightened vulnerability to Medicare or Medicaid fraud claims as a result of improved information on the match between services rendered and services billed. Be- cause others have covered such concerns well, we confine our analysis to malpractice issues. Major EHR Functionalities and Their Prevalence An array of electronic information systems is used in health care today. Basic EHR systems facilitate electronic access to clinical information such as patient demographic characteristics, patient encounters, and laboratory and imaging results, with some systems permitting clinicians notes. Basic EHR systems also permit computerized provider- order entry of medications, and many systems that include computerized provider-order entry check orders against patient information to flag potential drug interactions, allergic reactions, and errors. Comprehensive EHR systems include these functionalities as well as more extensive capabilities for computerized provider-order entry (such as entry of laboratory test orders and nursing orders) and clinical-decision support. Clinical-decision support may include information about relevant clinical practice guidelines, clinical reminders, and guidance and safety alerts with respect to drug doses. Sophisticated systems scan patient data to provide individualized clinical recommendations. In 2008, a total of 11% of nonfederal U.S. hospitals had implemented basic EHR systems, and less than 2% had implemented comprehensive systems in at least one clinical unit. A much larger proportion of hospitals had implemented or begun implementation of key EHR functionalities; for example, 56% had implemented or initiated implementation of electronic systems for entry of physicians notes, and 52% had implemented or initiated implementati on of clinical-decision support systems involving practice guidelines. Among physicians whose primary practice setting was not a hospital, 21% had a basic system and 6% had a comprehensive system in 2009.

The future of EHRs lies in greater linkages to external systems. Many EHR systems provide electronic communication among providers within the same organization; others also allow secure messaging between providers and patients. These patientprovider communications vary from routine requests to ref ill prescriptions to reports of symptoms requiring prompt assessment. In some instances, systems maintained by different organizations share information about patients through health information exchange networks (HIEs). Although currently these networks are rare, they are likely to become more common owing to the federal governments recent commitment to help states fund the development of HIEs. The liability implications of EHRs are likely to vary over the life cycle of the adoption of these systems. We begin by examining the period of initial transition to EHRs, during which predictable implementation snags may heighten providers liability risk. After this initial period, EHRs have the potential to reduce injuries and malpractice claims but will also create opportunities for error and will alter the context for proving and defending malpractice claims with the use of electronic information. Finally, the long-term effects of widespread adoption of EHRs include potential shifts in the legal standard of care that may not favor providers Medico legal Risks during Implementation of EHRs Implementing new information systems may initially elevate, rather than decrease, providers mal- practice risk (Table 1). As with any new technology, the risk of error increases during the implementation chasm, as providers move from a familiar system to a new one. Several studies have documented increases in computer-related errors, and in one case an increase in mortality, shortly after implementation of computerized provider-order entry systems. Medical errors and adverse events may result from individual mistakes in using EHRs (e.g., incorrectly entering information into the electronic record) or system wide EHR failures or bugs that create problems in care processes (e.g., crashes that prevent access to crucial information). The interface between paper and electronic records may also create documentation gaps or other problems that affect clinical care. As an illustration of such risks, one recent study showed a higher rate of failure to inform patients of abnormal test results in outpatient practices in which a hybrid of paper and electronic records was used than in practices in which paper or electronic records alone were used. Effective training and tailoring of new systems to existing technology can minimize the incidence of such errors, and organizations that have sufficient resources can monitor problems after implementation and adjust systems to minimize the persistence of errors. However, these measures may not prevent errors entirely, and system failures may recur long after implementation, leaving clinicians to practice blind until functioning is restored. At least one legal case suggests that providers have a duty to minimize such risks during the transition period. A federal court held that a hospital that switched from a paper to an electronic system for delivering test results had a duty to implement a reasonable procedure du ring the transition phase to ensure the timely delivery of test results to physicians. The court did not elaborate on what elements are sufficient to constitute a reasonable procedure, but it found that the hospital had met its duty by establishing a protocol for the period before all physicians had completed training on the new system that required radiologists to inform the requesting physician of abnormal results by telephone and that included a procedure whereby the results were automatically printed in two locations. Liability Risks and Benefits as Health Information Technolog y Systems Mature

After the initial implementation stage, it is unclear whether the use of EHRs is likely to increase or decrease malpractice liability overall (Tables 1 and 2). EHRs have frequently been touted for their potential to reduce liability, with some malpractice insurers offering discounts to providers who make the switch from paper records to EHRs. One recent study showed that physicians who used EHRs reported a lower number of paid malpractice claims than did those who did not use EHRs, al- though the association did not persist in multivariate analysis. However, EHR systems also create new legal risks. Table 1. Potential Medical-Liability Risks of Electronic Technologies*. During initial implementation Transition from paper to electronic record may create documentation gaps. Failure to implement procedures that a prudent or reasonable provider would implement to avoid errors during the transition period may leave providers vulnerable in tort. Inadequate training on EHR systems may create new error pathways. Errors by new system users may create incorrect or missing data entries. Failure of clinicians to use EHRs consistently may lead to gaps in documentation and communication. Systemwide EHR bugs and failures could adversely affect clinical care, leading to injuries and claims. As systems mature in place E-mail advice multiplies the number of clinical encounters that could give rise to claims and may heighten the risk of claims if advice is offered without thorough investigation and examination of the patient. More extensive documentation of clinical decisions and activity creates more discoverable evidence for plaintiffs, including metadata. Temptation to copy and paste patient histories instead of taking new histories risks missing new information and perpetuates previous mistakes. Failure to reply to patient e-mails in a timely fashion could constitute negligence and raise patient ire. Information overload may cause clinicians to miss important pieces of information. Departures from clinical-decision support care guidelines could bolster plaintiffs case. As EHRs and HIEs become widespread Better access to clinical information through EHRs could create legal duties to act on the information. Widespread use of clinical-decision support may solidify standards of care that might otherwise be subject to debate. Rise of HIEs may heighten cli nicians duties to search for patient information generated by other clinicians. Failure to adopt and use electronic technologies may itself constitute a deviation from the standard of care. * EHR denotes electronic health record, and HIE health information exchange. Effects on Care Processes EHRs hold considerable promise for preventing harmful medical errors and associated malpractice claims. They promote complete documentation and timely access to patient information, facilitating sound clinical decision making. The use of electronic intermediaries may decrease transcription errors, improve communication among providers, and limit the duplication of tests. Clinical-decision support systems may offer a safety net by reminding harried providers of clinical guidelines and catching errors before they cause harm. Empirical evidence suggests that comprehensive EHR systems can improve adherence to clinical guidelines and reduce rates of medication errors. EHR users overwhelmingly report improvement in the quality of care they provide. On the other hand, despite experts optimism, there is currently no evidence that the use of EHRs reduces diagnostic errors.

Although computerized provider-order entry systems can decrease some kinds of medication ordering errors, they may create vulnerability to new kinds of errors. For example, discontinuities between information systems may cause prescribed medications to be automatically and un- expectedly canceled. Poorly designed systems that default to a potentially dangerous drug dose by failing to consider clinical changes such as renal or hepatic failure can lead to harmful ordering errors if physicians fail to recalculate the dose. Fuller access to electronic patient information may tempt providers to rely on previously recorded patient histories, test results, and clinical findings rather than collect new information. Although this may reduce duplication of effort and expenditures, it may perpetuate errors and omissions from earlier encounters. Overreliance on the copying and pasting function of many documentation systems can also perpetuate earlier mistakes. Table 2. Potential Medical-Liability Benef its of Electronic Technologies.* After successful implementation EHR systems may reduce discontinuities and errors in care, reducing adverse events and claims. EHR systems including integrated clinical-decision support may improve clinical decisions, reducing adverse events and claims. Better documentation of clinical decisions and activity, through both user-entered data and metadata, may improve the ability to defend against malpractice claims when care was appropriate. Compliance with clinical-decision support care guidelines may constitute helpful evidence that the legal standard of care was met. Secure messaging may improve patient satisfaction, improve communication, and reduce propensity to sue. Secure messaging may improve patient communication of clinically significant information, reducing adverse events and claims. As EHRs and HIEs become widespread Adherence to clinical-decision support recommendations may protect providers from liability. Rise of HIEs may facilitate sharing of information about cases, leading to better care and fewer claims. * EHR denotes electronic health record, and HIE health information exchange. Secure messaging systems and other electronic communications also have both liability risks and liability benefits. Offering medical advice without conducting a physical examination or taking a history increases the risk of an erroneous diagnostic or treatment decision. Moreover, courts have held that telephone communications between a physician and a patient can be sufficient to establish the physicianpatient relationship necessary for malpractice liability. The same is likely to be true for electronic communications. Once such a relationship is established, failing to respond to patient e-mails within a reasonable period of time could constitute a violation of the standard of care. In addition, e-mail may create a written record of negligent advice. It may even constitute negligence to e-mail advice to a patient rather than examine him or her in person. Alternatively, messaging systems may help prevent medical errors and adverse events by allowing patients to easily vocalize clinically significant concerns that they do not believe warrant an off ice visit. Messaging systems also affect liability risk by shaping patients perceptions of their physician. E-mails that are responded to slowly, are answered with boilerplate language from staff members, or are otherwise unresponsive to patients concerns are likely to provoke ire and dissatisfaction. Conversely, highly responsive physicians may strengthen their relationships with

patients. This may have medicolegal benefits, since research has linked a propensity to sue with patients satisfaction with their physician and the physicians communication skills. To assist providers, the American Medical Association (AMA) and the American Medical Informatics Association have established ethics policies and guidelines on the use of electronic communications in clinical practice. The AMA policy states that physicians should not use electronic communications to establish physicianpatient relationships only to supplement other, more personal, encounters. Both sets of guidelines recommend that physicians develop their own guidelines for such matters as the appropriate use of and turnaround time for e-mails. The AMA guidelines further suggest establishing a protocol for terminating e-mail relationships with patients who repeatedly violate the rules. Before initiating an e-mail relationship, providers should notify patients of their guidelines and obtain informed consent for the use of electronic communications. Effects on the Litigation Process In addition to affecting the risk of a lawsuit, implementation of EHRs may affect the course of malpractice litigation by increasing the availability of documentation with which to defend or prove a malpractice claim. Unlike telephone conversations, e-mail creates a written record. To the extent that the use of EHRs facilitates the entry of more extensive notes, it too may bolster the written rec- ord. Finally, EHRs record all electronic transactions, from the input of orders to time stamps of clinical activity, although they vary in their ability to produce reports of these data on demand. This information, called metadata, provides a permanent electronic footprint that can be used to track physician activity. Under federal law, metadata are discoverable in civil trials, which means that defendants must surrender them to a plaintiffs law- years on request. State law, which governs most malpractice litigation, varies as to the discoverability and permissibility of metadata. In some malpractice cases, the documentation within EHRs may establish a providers culpability, whereas in others it may help mount a defense. For instance, in one case, a patient with a catastrophic operative outcome sued his surgeon for negligence. Electronic data monitors from the operating room showed that there were more than 90 minutes of gaps in the anesthesia record. The legal inquiry turned to the anesthesiologist. A deeper examination of the electronic record uncovered further discrepancies. Though it was un- clear whether errors were made in patient treatment, the collective weight of the discrepancies became difficult to defend in court, and the anesthesiologist settled the case. Metadata can be used to authenticate the EHR for example, to verify that an EHR was modified at the time of treatment rather than later. Typically, this should bolster the defendants ability to rely on the EHR when defending against a malpractice claim. However, if the record was modified at an inappropriate time, metadata can raise questions about falsification of records, even in the absence of actual wrongdoing. In the afore- mentioned case, metadata revealed that the anesthesiologist wrote his postoperative note minutes after the operation began. This appearance of impropriety probably helped the plaintiff se- cure a settlement. The hospital later discovered that its anesthesiologists commonly recorded standard notes, such as their presence at the patients emergence from anesthesia, during less hectic parts of the procedure. Whereas in the pre-electronic age such a practice posed little risk of liability, the availability of metadata changes the game. Long - Term Effects on the Standard of Care To prove medical malpractice, a plaintiff must establish the applicable standard of care and prove that the defendant caused injury by falling short of that standard. As the use of EHRs

spreads, it may reshape medical liability by altering the way in which courts determine the standard of care and by changing the standard of care itself. Clinical-decision support systems may help drive this transformation. In a malpractice suit, each side presents expert testimony to define the applicable standard of care. Expert witnesses may rely solely on their own judgment and experience or invoke external evidence of the standard of care, such as clinical practice guidelines. Courts have permitted this use of practice guidelines and would probably also admit clinical-decision support systems as evidence of the standard of care, if an expert attests that they reflected reasonable and customary care. A physicians departure from the clinical-decision support protocols could then be used as evidence of negligence. Like practice guidelines, clinical-decision sup- port protocols could establish a more accurate definition of the standard of care than would emerge from the clash of expert opinions alone. However, they have limited ability to anticipate the myriad clinical scenarios that physicians encounter. Physicians routinely override even relatively simple clinical-decision support protocols, such as drug-allergy alerts, for clinically appropriate reasons. Overriding a system default that arguably represents the standard of care creates an electronic record that physicians may need to justify in court. For example, in some clinical-decision support systems, simultaneous use of clopidogrel and aspirin requires physicians to overrule safety protocols protecting against excessive anticoagulation, even though the simultaneous use of the two drugs is generally indicated for patients with myocardial infarction. In the rare case in which a hemorrhage develops in a patient, a deliberate suspension of safety protocols could resonate poorly with juries. Overreliance by courts and juries on recommendations embedded in clinical-decision support systems could result in increased and sometimes inappropriate liability when providers depart from clinical-decision support protocols. Some, but not all, EHR systems prompt clinicians to document their reasons for overriding clinically significant alerts. The growth of HIEs and the subsequent accessibility of external medical records may also substantively change the standard of care. Without HIEs, a provider has limited ability to examine a patients records from another provider. Perhaps recognizing this, at least two courts have declined to impose a legal duty to obtain and review prior medical records. HIEs provide easy access to this information, possibly increasing the liability risk for providers who fail to take advantage of that access. It is unclear whether courts would require physicians to routinely perform comprehensive reviews of external EHRs, but in cases in which a patient mentions a relevant piece of his or her medical history and the provider fails to review an easily accessible external EHR, liability could well result. This prospect reflects a deeper concern about health information technology: will the practice environment evolve along with the information environment to allow physicians to make use of the available information resources? The time constraints of typical off ice visits, for example, may hinder a thorough examination of voluminous EHRs. Under such constraints, key information may be missed in a sea of new electronic data, much of which is of dubious clinical significance. The legal standard of care in malpractice cases is meant to reflect reasonable care, but what appears to be reasonable may differ from the perspective of a layperson, who is convinced of the easy accessibility of electronic information, and the physician, who has the challenge of examining both the patient and his electronic dossier in a 15-minute visit. Finally, as the use of EHRs grows, failure to adopt an EHR system may constitute a deviation from the standard of care. The standard of care is usually defined by reference to what is customary among physicians in the same specialty in similar settings. Once a critical mass of providers adopts EHRs, others may need to follow. If EHRs do indeed improve quality of care,

many legal scholars would applaud this development, since it exemplifies the ability of tort law to spur providers to practice more safely. This deterrence notion, ho wever, assumes that the cost benefit ratio of technology is reasonable, so that injuries are prevented at an efficient cost. Empirical evidence evaluating this assumption is mixed. Conclusions Providers can expect a varied and shifting land- scape of medical liability risks and benefits as the adoption of EHRs unfolds. Whether these developments improve the performance of the medical liability system remains to be seen. Electronic documentation is likely to bolster the accuracy of courts in determining liability by enhancing the evidence available to evaluate claims. Less clear at this early stage is whether EHRs will lead courts to recognize changes in the legal standard of care and if so, whether these changes are socially desirable. It is also unknown how the law may evolve to allocate liability fairly among individual clinicians, EHR developers, and provider organizations that select and implement EHR systems. Liability that arises primarily because of poorly designed EHR systems arguably should rest with those in control of system architecture and implementation, not end users. However, in many cases, suboptimal design may set the stage for user errors, complicating the assignment of fault. In addition, some contracts between provider organizations and EHR developers reportedly include provisions protecting the developer from liability arising from the use of the EHR system. Health care professionals and provider organizations can actively manage EHR-associated risks. First, they can decline to sign contractual provisions that immunize the system developer. Second, they can select systems that are designed to minimize the risk of user error or misuse and maximize the ease of record retrieval. This requires that organizations invest effort early to ensure that the EHR system is customized to the practice patterns of their clinical staff for example, ensuring that clinical-decision support alerts and medication-dose defaults are sensible. Third, organizations that adopt EHRs can ensure that clinicians receive thorough training, including education about organizational expectations regarding the use of the system. Hospitals can monitor the use of the system after implementation for obvious problems. Physicians, for their part, must be willing to climb the learning curve. Understanding how using EHRs may help protect them from liability, and how misuse or nonuse may increase liability risk, should motivate them to do so. Fourth, organizations can ensure that practice conditions are such that the use of the new technology can be maximized. Identification of appropriate practice conditions will require organizations to work closely with their care teams to identify existing barriers to the optimal use of EHRs, whether these involve the length of office visits, the placement of computer terminals, problems accessing external records, or other factors. Fifth, managing patients expectations about secure messaging and accessing of EHRs is pivotal. Finally, when physicians serve as experts in malpractice litigation, they can educate liability insurers and courts about the limitations of clinical decision support systems and the appropriateness of departures from them in certain situations. In evaluating whether to invest in EHR technologies, provider organizations must weigh the substantial up-front cost and possible risks against the potentially sizeable, but uncertain, longrun benefits. The malpractice implications of EHRs should be included in future discussions of risks and benefits. Although there is currently little re- search quantifying the risks and benefits with respect to liability, we are optimistic that they will ultimately weigh in favor of the implementation of EHRs. Regardless, it is likely that EHRs are here to stay. As the use of EHRs becomes common- place, the legal standard of care will evolve, and latecomers to the EHR table may be called to account.

Supported in part by an Investigator Award in Health Policy Research from the Robert Wood Johnson Foundation, Princeton, NJ (to Dr. Mello). Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. We thank Ashish Jha for comments on an early draft of the manuscript.

MEDICAL MALPRACTICE LIABILITY IN THE AGE OF ELECTRONIC HEALTH RECORDS Health care providers, policymakers, patients, a payers share the vision of a health care syste powered by information technology. The Health Information Technology for Economic and Clinic Health (HITECH) Act of 2009 authorizes grants and incentives totaling an estimated $14 billion to $27 billion to promote meaningful use of electronic health records (EHRs) by providers. In the excitement over health information technology, some of the potential risks associated with it have received less attention, such as the possible effects of this technology on medical malpractice liability. Yet even now, the potential for EHRs to ameliorate some sources of stress related to liability while reinforcing others is apparent. We explore the implications for malpractice liability of four core functionalities of EHR systems: documentation of clinical findings, recording of test and imaging results, computerized provider- order entry, and clinical-decision support. We also discuss the ramifications of secure messaging capabilities integrated into EHR systems and the overall effects that may occur as comprehensive EHR systems become standard. Our analysis is based on a review of the limited available lit- erature on the liability implications of EHRs and a much larger body of literature on the effects of EHRs on quality of care and the role of clinical practice guidelines in malpractice litigation. The legal implications of EHRs extend beyond changes in malpractice liability. Other important consequences include potential liability under privacy and confidentiality laws, disputes over ownership of health data, and heightened vulnerability to Medicare or Medicaid fraud claims as a result of improved information on the match between services rendered and services billed. Because others have covered such concerns well, we confine our analysis to malpractice issues. Major EHR Functionalities and Their Prevalence An array of electronic information systems is used in health care today. Basic EHR systems facilitate electronic access to clinical information such as patient demographic characteristics, patient encounters, and laboratory and imaging results, with some systems permitting clinicians notes. Basic EHR systems also permit computerized providerorder entry of medications, and many systems that include computerized provider-order entry check orders against patient information to flag potential drug interactions, allergic reactions,

RESPONSABILIDAD MDICA DE NEGLIGENCIA EN LA ERA DE registros electrnicos de salud


Los proveedores sanitarios, los responsables polticos, los pacientes, a los contribuyentes comparten la visin de un syste cuidado de la salud basado en la tecnologa de informacin. La Tecnologa de la Informacin para la Salud Econmica y Clnica de la Salud (HiTech) Ley de 2009 autoriza a las subvenciones y los incentivos por un total de aproximadamente $ 14 mil millones para 27 mil millones dlares para promover el "uso significativo" de los registros electrnicos de salud (EHR) de los proveedores. En el entusiasmo por la tecnologa de informacin de salud, algunos de los riesgos potenciales asociados con ella han recibido menos atencin, como los posibles efectos de esta tecnologa en materia de responsabilidad por negligencia mdica. Sin embargo, incluso ahora, el potencial de los EHR para mejorar algunas fuentes de estrs relacionadas con la responsabilidad al tiempo que refuerza los dems es evidente. Se exploran las implicaciones de la responsabilidad por negligencia de las cuatro funciones bsicas de los sistemas de HME: documentacin de los hallazgos clnicos, registro de resultados de las pruebas y de imagen, entrada de proveedor de orden informtico y apoyo clnico-decisin. Tambin se discuten las implicaciones de las capacidades de mensajera seguras integradas en los sistemas de HCE y los efectos generales que pueden ocurrir como sistemas de HME integrales se convierten en norma. Nuestro anlisis se basa en una revisin de la escasa literatura disponible sobre las consecuencias de responsabilidad de los EHR y un cuerpo mucho ms grande de la literatura sobre los efectos de los EHR sobre la calidad de la atencin y el papel de guas de prctica clnica en juicios por mala praxis. Las implicaciones legales de los EHR extienden ms all de los cambios en la responsabilidad por negligencia. Otras consecuencias importantes incluyen la posible responsabilidad bajo las leyes de privacidad y confidencialidad, las disputas sobre la propiedad de los datos de salud, y mayor vulnerabilidad frente a las denuncias de fraude de Medicare o Medicaid como resultado de la mejora de la informacin sobre el partido entre los servicios prestados y los servicios facturados. Por-que otros han cubierto bien esas preocupaciones, limitamos nuestro anlisis a las cuestiones de mala praxis. Las principales prevalencia funcionalidades de HME y su

Una serie de sistemas electrnicos de informacin se utiliza en el cuidado de la salud hoy en da. Sistemas EHR "Basic" facilitar el acceso electrnico a la informacin clnica, como las caractersticas del paciente demogrficos, encuentros de pacientes y de laboratorio y resultados de imagen, con algunos sistemas que permiten notas clnicos. SUS sistemas bsicos tambin permiten computarizado de entrada de pedidos del proveedor de medicamentos, y muchos sistemas computarizados que incluyen proveedor de

and errors. Comprehensive EHR systems include these functionalities as well as more extensive capabilities for computerized provider-order entry (such as entry of laboratory test orders and nursing orders) and clinical-decision support. Clinical-decision support may include information about relevant clinical practice guidelines, clinical reminders, and guidance and safety alerts with respect to drug doses. Sophisticated systems scan patient data to provide individualized clinical recommendations. In 2008, a total of 11% of nonfederal U.S. hospitals had implemented basic EHR systems, and less than 2% had implemented comprehensive systems in at least one clinical unit. A much larger proportion of hospitals had implemented or begun implementation of key EHR functionalities; for example, 56% had implemented or initiated implementation of electronic systems for entry of physicians notes, and 52% had implemented or initiated implementation of clinical-decision support systems involving practice guidelines. Among physicians whose primary practice setting was not a hospital, 21% had a basic system and 6% had a comprehensive system in 2009. The future of EHRs lies in greater linkages to external systems. Many EHR systems provide electronic communication among providers within the same organization; others also allow secure messaging between providers and patients. These patientprovider communications vary from routine requests to ref ill prescriptions to reports of symptoms requiring prompt assessment. In some instances, systems maintained by different organizations share information about patients through health information exchange networks (HIEs). Although currently these networks are rare, they are likely to become more common owing to the federal governments recent commitment to help states fund the development of HIEs. The liability implications of EHRs are likely to vary over the life cycle of the adoption of these systems. We begin by examining the period of initial transition to EHRs, during which predictable implementation snags may heighten providers liability risk. After this initial period, EHRs have the potential to reduce injuries and malpractice claims but will also create opportunities for error and will alter the context for proving and defending malpractice claims with the use of electronic information. Finally, the long-term effects of widespread adoption of EHRs include potential shifts in the legal standard of care that may not favor providers

orden de entrada de pedidos de verificacin contra la informacin del paciente para poder marcar posibles interacciones medicamentosas, reacciones alrgicas, y los errores. SUS sistemas "completos" incluyen estas funcionalidades, as como ms amplias capacidades para la entrada del proveedor para computarizada (tales como la entrada de pedidos de pruebas de laboratorio y las rdenes de enfermera) y el apoyo clnico-decisin. Apoyo clnico-decisin puede incluir informacin acerca de las directrices pertinentes de prctica clnica, recordatorios clnicos y alertas de orientacin y seguridad con respecto a la dosis de los medicamentos. Sistemas sofisticados escanean los datos del paciente para proporcionar recomendaciones clnicas individualizadas. En 2008, un total de 11% de los hospitales no federales de Estados Unidos ha puesto en marcha los sistemas de HME bsicos, y menos del 2% haba implementado sistemas completos de al menos una unidad clnica. Una proporcin mucho mayor de los hospitales haba realizado o iniciado la implementacin de funcionalidades clave EHR, por ejemplo, el 56% haba implantado o iniciado la implementacin de sistemas electrnicos para el ingreso de notas de mdicos y el 52% tienen implantado o iniciado la implementacin de sistemas de apoyo de decisin clnica involucrando las guas de prctica. Entre los mdicos cuya configuracin prctica principal no era un hospital, el 21% tena un sistema bsico y el 6% tena un sistema completo en 2009. El futuro de la HCE se encuentra en una mayor vinculacin con los sistemas externos. Muchos sistemas de HME proporcionan la comunicacin electrnica entre los proveedores dentro de la misma organizacin, mientras que otros tambin permiten mensajera segura entre los proveedores y los pacientes. Estas comunicaciones paciente-proveedor puede variar en las solicitudes de rutina de ref recetas enfermos a los informes de los sntomas que requieren evaluacin inmediata. En algunos casos, los sistemas mantenidos por diferentes organizaciones compartir informacin acerca de los pacientes a travs de "intercambio de informacin" redes de salud (HIE). Aunque actualmente estas redes son poco frecuentes, pueden llegar a ser causa ms comn el reciente compromiso del gobierno federal para ayudar a los estados financian el desarrollo de HIE. Las implicaciones de responsabilidad de los EHR tienden a variar durante el ciclo de vida de la adopcin de estos sistemas. Comenzamos examinando el perodo de transicin inicial a los EHR, durante el cual engancha implementacin predecibles pueden aumentar el riesgo de responsabilidad de los proveedores. Despus de este perodo inicial, EHR tienen el potencial de reducir las lesiones y reclamos por mala praxis, sino tambin crear oportunidades de error y van a alterar el contexto para demostrar y defender las demandas por negligencia en el uso de la informacin electrnica. Por ltimo, los efectos a largo plazo de la adopcin generalizada de los EHR incluyen posibles cambios en la norma legal de la atencin que pueden no

favorecer a los proveedores

Medico legal Risks during Implementation of EHRs


Medico Riesgos legales durante la ejecucin de la HCE

Implementing new information systems may initially elevate, rather than decrease, providers malpractice risk (Table 1). As with any new technology, the risk of error increases during the implementation chasm, as providers move from a familiar system to a new one. Several studies have documented increases in computer-related errors, and in one case an increase in mortality, shortly after implementation of computerized providerorder entry systems. Medical errors and adverse events may result from individual mistakes in using EHRs (e.g., incorrectly entering information into the electronic record) or system wide EHR failures or bugs that create problems in care processes (e.g., crashes that prevent access to crucial information). The interface between paper and electronic records may also create documentation gaps or other problems that affect clinical care. As an illustration of such risks, one recent study showed a higher rate of failure to inform patients of abnormal test results in outpatient practices in which a hybrid of paper and electronic records was used than in practices in which paper or electronic records alone were used. Effective training and tailoring of new systems to existing technology can minimize the incidence of such errors, and organizations that have sufficient resources can monitor problems after implementation and adjust systems to minimize the persistence of errors. However, these measures may not prevent errors entirely, and system failures may recur long after implementation, leaving clinicians to practice blind until functioning is restored. At least one legal case suggests that providers have a duty to minimize such risks during the transition period. A federal court held that a hospital that switched from a paper to an electronic system for delivering test results had a duty to implement a reasonable procedure during the transition phase to ensure the timely delivery of test results to physicians. The court did not elaborate on what elements are sufficient to constitute a reasonable procedure, but it found that the hospital had met its duty by establishing a protocol for the period before all physicians had completed training on the new system that required radiologists to inform the requesting physician of abnormal results by telephone and that included a procedure whereby the results were automatically printed in two locations.

Nuevos sistemas de informacin de ejecucin podrn elevar inicialmente, en lugar de disminuir, el riesgo de mala prctica de los proveedores (Tabla 1). Como con cualquier nueva tecnologa, aumenta el riesgo de error durante la "brecha de aplicacin", como proveedores de pasar de un sistema familiar para una nueva. Varios estudios han documentado aumentos en los errores relacionados con la informtica, y en un caso un aumento de la mortalidad, poco despus de la implementacin de sistemas de entrada de proveedor de orden computarizados. Los errores mdicos y eventos adversos pueden ser resultado de errores individuales en el uso de los EHR (por ejemplo, entrar en la correcta informacin en el registro electrnico) o el sistema de fallas de HME ancho o "bichos" que crean problemas en los procesos de atencin (por ejemplo, "accidentes" que impiden el acceso a la informacin esencial). La interfaz entre el papel y documentos electrnicos tambin puede crear brechas de documentacin u otros problemas que afectan a la atencin clnica. Como ejemplo de este tipo de riesgos, un estudio reciente mostr una mayor tasa de fracaso para informar a los pacientes de los resultados anormales de las pruebas de las prcticas externas en los que se utiliz un hbrido de papel y documentos electrnicos que en las prcticas en las que se utilizaron solo papel o archivos electrnicos. La capacitacin efectiva y la adaptacin de los nuevos sistemas a la tecnologa existente puede reducir al mnimo la incidencia de este tipo de errores, y las organizaciones que cuentan con recursos suficientes pueden controlar los problemas despus de la implementacin y ajuste de sistemas para minimizar la persistencia de errores. Sin embargo, estas medidas no pueden evitar errores por completo, y los fallos del sistema pueden reaparecer tiempo despus de la aplicacin, dejando a los mdicos a "practicar ciego" hasta que se restablezca su funcionamiento. Al menos en un caso legal sugiere que los proveedores tienen la obligacin de minimizar los riesgos durante el perodo de transicin. Un tribunal federal sostuvo que un hospital que pas de un documento a un sistema electrnico para la entrega de resultados de la prueba tena la obligacin de "poner en prctica un procedimiento razonable durante la fase de transicin" para asegurar la entrega oportuna de los resultados de las pruebas a los mdicos. El tribunal no dio detalles sobre qu elementos son suficientes para constituir un procedimiento razonable, pero encontr que el hospital haba cumplido con su deber mediante el establecimiento de un protocolo para el perodo anterior a todos los mdicos que han completado la formacin en el nuevo sistema que los radilogos deben informar al solicitante mdico de los resultados anormales por telfono y que inclua un procedimiento mediante el cual los resultados se imprimen automticamente en dos lugares.

Liability Risks and Benefits as Health Information Technolog y Systems Mature Riesgos de responsabilidad civil y ventajas como Health

Information va tecnologa sistemas maduros

After the initial implementation stage, it is unclear whether the use of EHRs is likely to increase or decrease malpractice liability overall (Tables 1 and 2). EHRs have frequently been touted for their potential to reduce liability, with some malpractice insurers offering discounts to providers who make the switch from paper records to EHRs. One recent study showed that physicians who used EHRs reported a lower number of paid malpractice claims than did those who did not use EHRs, al- though the association did not persist in multivariate analysis. However, EHR systems also create new legal risks.
Table 1. Potential Medical-Liability Risks of Electronic Technologies*. During initial implementation Transition from paper to electronic record may create documentation gaps. Failure to implement procedures that a prudent or reasonable provider would implement to avoid errors during the transition period may leave providers vulnerable in tort. Inadequate training on EHR systems may create new error pathways. Errors by new system users may create incorrect or missing data entries. Failure of clinicians to use EHRs consistently may lead to gaps in documentation and communication. Systemwide EHR bugs and failures could adversely affect clinical care, leading to injuries and claims. As systems mature in place E-mail advice multiplies the number of clinical encounters that could give rise to claims and may heighten the risk of claims if advice is offered without thorough investigation and examination of the patient. More extensive documentation of clinical decisions and activity creates more discoverable evidence for plaintiffs, including metadata. Temptation to copy and paste patient histories instead of taking new histories risks missing new information and perpetuates previous mistakes. Failure to reply to patient e-mails in a timely fashion could constitute negligence and raise patient ire. Information overload may cause clinicians to miss important pieces of information. Departures from clinical-decision support care guidelines could bolster plaintiffs case. As EHRs and HIEs become widespread Better access to clinical information through EHRs could create legal duties to act on the information. Widespread use of clinical-decision support may solidify standards of care that might otherwise be subject to debate. Rise of HIEs may heighten clinicians duties to search for patient information generated by other clinicians. Failure to adopt and use electronic technologies may itself constitute a deviation from the standard of care.
* EHR denotes electronic health record, and HIE health information exchange .

Despus de la etapa inicial de la aplicacin, no est claro si es probable que aumentar o disminuir la responsabilidad negligencia general (Tablas 1 y 2) el uso de la HCE. EHR han sido frecuentemente elogiado por su potencial para reducir la responsabilidad, con algunas compaas de seguros por mala praxis que ofrecen descuentos a los proveedores que hacen que el cambio de los registros en papel de EHR. Un estudio reciente mostr que los mdicos que utilizan los EHR reportaron un menor nmero de demandas por negligencia pagados que aquellos que no usaron los EHR, si bien la asociacin no persisti en el anlisis multivariado. Sin embargo, los sistemas de HME tambin crean nuevos riesgos legales.
Tabla 1. Los posibles riesgos mdicos-Responsabilidad de Tecnologas Electrnicas *. Durante la implementacin inicial La transicin del papel a documento electrnico puede crear brechas de documentacin. La no aplicacin de procedimientos que un proveedor prudente o razonable sera aplicar para evitar errores durante el perodo de transicin puede dejar a proveedores vulnerable en el agravio. La capacitacin inadecuada de los sistemas de HME puede crear nuevas vas de error. Errores de los nuevos usuarios del sistema pueden crear entradas de datos incorrectos o faltantes. El fallo de los mdicos a usar los EHR constantemente puede dar lugar a lagunas en la documentacin y la comunicacin. Systemwide EHR "bugs" y fallas podran afectar negativamente a la atencin clnica, dando lugar a lesiones y reclamaciones. Como los sistemas maduran en su lugar Consejos E-mail multiplica el nmero de encuentros clnicos que pueden dar lugar a reclamaciones y puede aumentar el riesgo de reclamaciones si se ofrece asesoramiento sin una investigacin exhaustiva y el examen del paciente. Ms amplia documentacin de las decisiones y la actividad clnica crea una evidencia ms visible para los demandantes, incluidos los metadatos. La tentacin de copiar y pegar historias de los pacientes en lugar de tomar nuevas historias corre el riesgo de falta de nueva informacin y perpeta los errores anteriores. La falta de respuesta de los pacientes e-mails en el momento oportuno puede constituir negligencia y aumentar la ira del paciente. La sobrecarga de informacin puede hacer que los mdicos de perder datos importantes. Salidas de directrices clnicas de decisin de atencin de apoyo podran reforzar caso demandantes. Como EHR y HIEs se generalizan Un mejor acceso a la informacin clnica a travs de los EHR podra crear obligaciones legales para actuar sobre la informacin. El uso generalizado de apoyo clnico-decisin puede consolidar los estndares de atencin que de otra manera podran ser objeto de debate. Rise of HIEs puede aumentar los derechos de los clnicos para la bsqueda de informacin de los pacientes generada por otros mdicos. No adoptar y utilizar tecnologas electrnicas tal, puede constituir una desviacin de la norma de atencin. * EHR denota historia clnica electrnica, y el intercambio de informacin de salud HIE.

Effects on Care Processes

Efectos sobre los procesos de atencin prometedores considerable para la

EHRs hold considerable promise for preventing EHR

harmful medical errors and associated malpractice claims. They promote complete documentation and timely access to patient information, facilitating sound clinical decision making. The use of electronic intermediaries may decrease transcription errors, improve communication among providers, and limit the duplication of tests. Clinical-decision support systems may offer a safety net by reminding harried providers of clinical guidelines and catching errors before they cause harm. Empirical evidence suggests that comprehensive EHR systems can improve adherence to clinical guidelines and reduce rates of medication errors. EHR users overwhelmingly report improvement in the quality of care they provide. On the other hand, despite experts optimism, there is currently no evidence that the use of EHRs reduces diagnostic errors.

prevencin de errores mdicos nocivos y reclamos por mala praxis asociados. Promueven la documentacin completa y el acceso oportuno a la informacin del paciente, facilitar una buena toma de decisiones clnicas. El uso de intermediarios electrnicos podra reducir los errores de transcripcin, mejorar la comunicacin entre los proveedores, y limitar la repeticin de ensayos. Los sistemas de apoyo de decisin clnica puede ofrecer una red de seguridad, recordando los proveedores apresurados de guas clnicas y detectar errores antes de que causen dao. La evidencia emprica sugiere que los sistemas de HME integrales puede mejorar la adherencia a las guas clnicas y reducir el ndice de errores de medicacin. Usuarios HME abrumadoramente reportan mejora en la calidad de la atencin que prestan. Por otra parte, a pesar del optimismo de los expertos, actualmente no hay evidencia de que Although computerized provider-order entry el uso de la HCE reduce los errores de diagnstico. systems can decrease some kinds of medication ordering errors, they may create vulnerability to Aunque los sistemas de entrada de pedidos por new kinds of errors. For example, discontinuities proveedor computarizados pueden reducir algunos between information systems may cause tipos de errores de pedidos de medicacin, pueden prescribed medications to be automatically and un- crear vulnerabilidad a nuevos tipos de errores. Por expectedly canceled. Poorly designed systems that ejemplo, las discontinuidades entre los sistemas de default to a potentially dangerous drug dose by informacin pueden hacer que los medicamentos failing to consider clinical changes such as renal or recetados sean de forma automtica y sin hepatic failure can lead to harmful ordering errors if esperarse, cancelado. Sistemas mal diseados physicians fail to recalculate the dose. Fuller que el incumplimiento de una dosis de droga access to electronic patient information may tempt potencialmente peligrosa al no considerar los providers to rely on previously recorded patient cambios clnicos, como la insuficiencia renal o histories, test results, and clinical findings rather heptica puede conducir a errores pedido than collect new information. Although this may perjudiciales si los mdicos no pueden volver a reduce duplication of effort and expenditures, it calcular la dosis. Fuller acceso a la informacin may perpetuate errors and omissions from earlier electrnica paciente puede tentar a los encounters. Overreliance on the copying and proveedores que depender de historias grabadas pasting function of many documentation systems anteriormente de pacientes, resultados de pruebas can also perpetuate earlier mistakes. y hallazgos clnicos en lugar de recopilar nuevos datos. Aunque esto puede reducir la duplicacin de Table 2. Potential Medical-Liability Benef its of Electronic esfuerzos y gastos, puede perpetuar los errores y Technologies.* omisiones de los encuentros anteriores. La After successful implementation dependencia excesiva de la funcin de copiar y EHR systems may reduce discontinuities and errors pegar de muchos sistemas de documentacin in care, reducing adverse events and claims. tambin puede perpetuar los errores anteriores.
EHR systems including integrated clinical-decision support may improve clinical decisions, reducing adverse events and claims. Better documentation of clinical decisions and activity, through both user-entered data and metadata, may improve the ability to defend against malpractice claims when care was appropriate. Compliance with clinical-decision support care guidelines may constitute helpful evidence that the legal standard of care was met. Secure messaging may improve patient satisfaction, improve communication, and reduce propensity to sue. Secure messaging may improve patient communication of clinically significant Tabla 2. Potencial Benef Mdico y Pasivos de la Electronic Technologies. * Despus de la implementacin exitosa SUS sistemas pueden reducir discontinuidades y los errores en la atencin, la reduccin de eventos adversos y reclamos. Sistemas EHR, incluyendo apoyo clnico-decisin integrada pueden mejorar las decisiones clnicas, la reduccin de eventos adversos y reclamos. Mejor documentacin de las decisiones y la actividad clnica, tanto a travs de los datos introducidos por el usuario y los metadatos, puede mejorar la capacidad de defenderse contra demandas por negligencia cuando la atencin era apropiado. Cumplimiento de las directrices clnicas de decisin de atencin de apoyo puede constituir prueba para mejor resolver que la norma legal de la atencin se cumpli. Mensajera segura puede mejorar la satisfaccin del paciente,

information, reducing adverse events and claims. As EHRs and HIEs become widespread Adherence to clinical-decision support recommendations may protect providers from liability. Rise of HIEs may facilitate sharing of information about cases, leading to better care and fewer claims.
* EHR denotes electronic health record, and HIE health information exchange.

Secure messaging systems and other electronic communications also have both liability risks and liability benefits. Offering medical advice without conducting a physical examination or taking a history increases the risk of an erroneous diagnostic or treatment decision. Moreover, courts have held that telephone communications between a physician and a patient can be sufficient to establish the physicianpatient relationship necessary for malpractice liability. The same is likely to be true for electronic communications. Once such a relationship is established, failing to respond to patient e-mails within a reasonable period of time could constitute a violation of the standard of care. In addition, e-mail may create a written record of negligent advice. It may even constitute negligence to e-mail advice to a patient rather than examine him or her in person. Alternatively, messaging systems may help prevent medical errors and adverse events by allowing patients to easily vocalize clinically significant concerns that they do not believe warrant an off ice visit. Messaging systems also affect liability risk by shaping patients perceptions of their physician. Emails that are responded to slowly, are answered with boilerplate language from staff members, or are otherwise unresponsive to patients concerns are likely to provoke ire and dissatisfaction. Conversely, highly responsive physicians may strengthen their relationships with patients. This may have medicolegal benefits, since research has linked a propensity to sue with patients satisfaction with their physician and the physicians communication skills. To assist providers, the American Medical Association (AMA) and the American Medical Informatics Association have established ethics policies and guidelines on the use of electronic communications in clinical practice. The AMA policy states that physicians should not use electronic communications to establish physician patient relationships only to supplement other, more personal, encounters. Both sets of guidelines recommend that physicians develop their own guidelines for such matters as the appropriate use of and turnaround time for e-mails. The AMA guidelines further suggest establishing a protocol for terminating e-mail relationships with

mejorar la comunicacin y reducir la propensin a demandar. Mensajera segura puede mejorar la comunicacin con el paciente de la informacin clnicamente significativa, la reduccin de eventos adversos y reclamos. Como EHR y HIEs se generalizan La adherencia a las recomendaciones de apoyo clnicodecisin puede proteger a los proveedores de la responsabilidad. Rise of HIEs puede facilitar el intercambio de informacin sobre los casos, lo que lleva a una mejor atencin y un menor nmero de reclamaciones. * EHR denota historia clnica electrnica, y el intercambio de informacin de salud HIE.

Sistemas de mensajera seguros y otras comunicaciones electrnicas tambin tienen tanto riesgos de responsabilidad y los beneficios de responsabilidad. Ofreciendo asesoramiento mdico sin realizar un examen fsico o tomar un historial aumenta el riesgo de una decisin diagnstica o tratamiento errneo. Por otra parte, los tribunales han sostenido que las comunicaciones telefnicas entre un mdico y un paciente puede ser suficiente para establecer la necesaria relacin de responsabilidad por negligencia mdico-paciente. Lo mismo es probable que sea cierto para las comunicaciones electrnicas. Una vez establecida esta relacin, no responder a mensajes de correo electrnico del paciente en un plazo razonable de tiempo podra constituir una violacin de la norma de atencin. Adems, el correo electrnico puede crear un registro por escrito de asesoramiento negligente. Incluso puede constituir negligencia al asesoramiento e-mail a un paciente en lugar de l o ella examinar en persona. Por otra parte, los sistemas de mensajera pueden ayudar a prevenir errores mdicos y eventos adversos, permitiendo a los pacientes a vocalizar fcilmente preocupaciones clnicamente significativos que no creen garantiza una visita de hielo. Los sistemas de mensajera tambin afectan el riesgo de responsabilidad por la configuracin de las percepciones de sus mdicos de los pacientes. Los correos electrnicos que se respondieron lentamente, se responden con un lenguaje repetitivo de los miembros del personal, o son de otra manera que no responde a las preocupaciones de los pacientes son propensos a provocar la ira y el descontento. Por el contrario, los mdicos altamente sensibles pueden fortalecer sus relaciones con los pacientes. Esto puede tener beneficios mdico-legales, ya que la investigacin ha vinculado una propensin a demandar a la satisfaccin de los pacientes con su mdico y las habilidades de comunicacin del mdico. Para ayudar a los proveedores, la Asociacin Mdica Americana (AMA) y la American Medical Informatics Association han establecido polticas y directrices ticas en el uso de las comunicaciones electrnicas en la prctica clnica. La poltica AMA establece que los mdicos no deben utilizar las comunicaciones electrnicas para establecer relaciones mdico-paciente - ". Otras ms personales, encuentros," slo para complementar Ambos conjuntos de directrices recomiendan que los mdicos desarrollen sus propias directrices para cuestiones como la utilizacin adecuada y tiempo de entrega de mensajes de correo electrnico.

patients who repeatedly violate the rules. Before initiating an e-mail relationship, providers should notify patients of their guidelines and obtain informed consent for the use of electronic communications. Effects on the Litigation Process In addition to affecting the risk of a lawsuit, implementation of EHRs may affect the course of malpractice litigation by increasing the availability of documentation with which to defend or prove a malpractice claim. Unlike telephone conversations, e-mail creates a written record. To the extent that the use of EHRs facilitates the entry of more extensive notes, it too may bolster the written record. Finally, EHRs record all electronic transactions, from the input of orders to time stamps of clinical activity, although they vary in their ability to produce reports of these data on demand. This information, called metadata, provides a permanent electronic footprint that can be used to track physician activity. Under federal law, metadata are discoverable in civil trials, which means that defendants must surrender them to a plaintiffs law- years on request. State law, which governs most malpractice litigation, varies as to the discoverability and permissibility of metadata. In some malpractice cases, the documentation within EHRs may establish a providers culpability, whereas in others it may help mount a defense. For instance, in one case, a patient with a catastrophic operative outcome sued his surgeon for negligence. Electronic data monitors from the operating room showed that there were more than 90 minutes of gaps in the anesthesia record. The legal inquiry turned to the anesthesiologist. A deeper examination of the electronic record uncovered further discrepancies. Though it was unclear whether errors were made in patient treatment, the collective weight of the discrepancies became difficult to defend in court, and the anesthesiologist settled the case.

Las directrices de AMA sugieren adems el establecimiento de un protocolo para la terminacin de las relaciones de correo electrnico con los pacientes que repetidamente violen las reglas. Antes de iniciar una relacin por correo electrnico, los proveedores deben notificar a los pacientes de sus lineamientos y obtener el consentimiento informado para la utilizacin de las comunicaciones electrnicas. Efectos sobre el Proceso Contencioso Adems de afectar el riesgo de una demanda, la implementacin de EHR puede afectar el curso de los juicios por mala praxis aumentando la disponibilidad de la documentacin con la que defender o demostrar una demanda por negligencia. A diferencia de las conversaciones telefnicas, el correo electrnico crea un registro escrito. En la medida en que el uso de la HCE facilita la entrada de ms extensas notas, tambin puede reforzar el escrito rec-ord. Por ltimo, los EHR registran todas las transacciones electrnicas, a partir de la entrada de pedidos a los sellos de tiempo de actividad clnica, aunque varan en su capacidad para producir informes de estos datos sobre la demanda. Esta informacin, denominada metadatos, proporciona una huella electrnica permanente que se puede utilizar para rastrear la actividad mdico. Bajo la ley federal, los metadatos se pueden descubrir en los juicios civiles, lo que significa que los acusados deben entregar a la ley de aos de un demandante a peticin. La ley estatal que regula mayora de los juicios por negligencia mdica, vara en cuanto a la detectabilidad y la permisibilidad de los metadatos. En algunos casos de mala prctica, la documentacin dentro de los EHR puede establecer la culpabilidad de un proveedor, mientras que en otros puede ayudar a montar una defensa. Por ejemplo, en un caso, un paciente con un resultado operativo catastrfica demand a su cirujano por negligencia. Monitores de datos electrnicos de la sala de operaciones mostraron que haba ms de 90 minutos de las lagunas en el registro de anestesia. La investigacin judicial se volvi hacia el anestesilogo. Un examen ms profundo del registro electrnico descubierto otras discrepancias. Aunque era poco claro si se haban cometido errores en el tratamiento del paciente, el peso colectivo de las discrepancias se hizo difcil de defender en los tribunales, y el anestesilogo resolvi el caso.

Metadata can be used to authenticate the EHR for Los metadatos se pueden usar para autenticar la HCEexample, to verify that an EHR was modified at the por ejemplo, para verificar que un HME se modific en time of treatment rather than later. el momento del tratamiento en lugar de ms tarde. Typically, this should bolster the defendants ability to rely on the EHR when defending against a malpractice claim. However, if the record was modified at an inappropriate time, metadata can raise questions about falsification of records, even in the absence of actual wrongdoing. In the aforementioned case, metadata revealed that the anesthesiologist wrote his postoperative note minutes after the operation began. This appearance of impropriety probably helped the plaintiff se- cure
Normalmente, esto se debe reforzar la capacidad del acusado de confiar en la HCE en la defensa contra una demanda por negligencia. Sin embargo, si el registro fue modificado en un momento inadecuado, los metadatos pueden plantear preguntas acerca de la falsificacin de documentos, incluso en ausencia de delito real. En el caso anteriormente mencionado, los metadatos revel que el anestesilogo escribi sus notas postoperatorias minutos despus del inicio de la operacin. Esta apariencia de impropiedad probablemente ayud a que el demandante se-curar a un acuerdo. El hospital ms

a settlement. The hospital later discovered that its anesthesiologists commonly recorded standard notes, such as their presence at the patients emergence from anesthesia, during less hectic parts of the procedure. Whereas in the preelectronic age such a practice posed little risk of liability, the availability of metadata changes the game. Long - Term Effects on the Standard of Care

tarde se descubri que sus anestesilogos comnmente registran notas estndar, como su presencia en la emergencia del paciente de la anestesia, durante partes menos agitadas del procedimiento. Mientras que en la era pre-electrnica esta prctica plantea poco riesgo de responsabilidad civil, la disponibilidad de los cambios en los metadatos del juego. Efectos a largo plazo en el nivel de atencin - Larga Para demostrar la negligencia mdica, el demandante debe demostrar la norma aplicable de la atencin y demostrar que el acusado caus lesiones al caer por debajo de ese nivel. A medida que el uso de los diferenciales de EHR, puede cambiar la forma de la responsabilidad mdica, alterando la forma en que los tribunales determinan el nivel de atencin y por el cambio de la norma de la propia atencin.

To prove medical malpractice, a plaintiff must establish the applicable standard of care and prove that the defendant caused injury by falling short of that standard. As the use of EHRs spreads, it may reshape medical liability by altering the way in which courts determine the standard of care and by changing the standard of care itself. Sistemas de apoyo clnico-decisin pueden ayudar a Clinical-decision support systems may help drive this transformation. In a malpractice suit, each side presents expert testimony to define the applicable standard of care. Expert witnesses may rely solely on their own judgment and experience or invoke external evidence of the standard of care, such as clinical practice guidelines. Courts have permitted this use of practice guidelines and would probably also admit clinical-decision support systems as evidence of the standard of care, if an expert attests that they reflected reasonable and customary care. A physicians departure from the clinical-decision support protocols could then be used as evidence of negligence.

impulsar esta transformacin. En una demanda por negligencia, cada parte presenta el testimonio de expertos para definir la norma aplicable de la atencin. Los peritos pueden confiar exclusivamente en su propio juicio y experiencia, o invocar la evidencia externa de la calidad de la atencin, como las guas de prctica clnica. Los tribunales han permitido la utilizacin de guas de prctica y probablemente tambin admitir que los sistemas de apoyo de decisin clnica como prueba de la calidad de la atencin, si un experto confirma que reflejan un cuidado razonable y de costumbre. Salida de un mdico de los protocolos de apoyo clnico-decisin podra ser utilizado como evidencia de negligencia. Al igual que las guas de prctica, los protocolos de apoyo clnico-decisin podra establecer una definicin ms precisa del nivel de atencin que surgira del choque de opiniones de expertos solo. Sin embargo, tienen una capacidad limitada para anticipar los escenarios clnicos mirada de que los mdicos encuentran. Los mdicos tienen prioridad rutinariamente protocolos an relativamente simples clnico-apoyo a la decisin, tales como alertas de medicamentos de alergia, por razones clnicamente apropiados.

Like practice guidelines, clinical-decision sup- port protocols could establish a more accurate definition of the standard of care than would emerge from the clash of expert opinions alone. However, they have limited ability to anticipate the myriad clinical scenarios that physicians encounter. Physicians routinely override even relatively simple clinical-decision support Anulacin de un defecto del sistema que representa sin protocols, such as drug-allergy alerts, for clinically duda el nivel de atencin crea un registro electrnico que los mdicos pueden tener que justificar ante el appropriate reasons. Overriding a system default that arguably represents the standard of care creates an electronic record that physicians may need to justify in court. For example, in some clinicaldecision support systems, simultaneous use of clopidogrel and aspirin requires physicians to overrule safety protocols protecting against excessive anticoagulation, even though the simultaneous use of the two drugs is generally indicated for patients with myocardial infarction. In the rare case in which a hemorrhage develops in a patient, a deliberate suspension of safety protocols could resonate poorly with juries. Overreliance by courts and juries on recommendations embedded
tribunal. Por ejemplo, en algunos sistemas de soporte de decisin clnica, el uso simultneo de clopidogrel y aspirina requiere que los mdicos hacer caso omiso de los protocolos de seguridad que protegen contra la anticoagulacin excesiva, a pesar de que el uso simultneo de los dos frmacos se indica en general para los pacientes con infarto de miocardio. En el raro caso en el que se desarrolla una hemorragia en un paciente, una suspensin deliberada de los protocolos de seguridad podra resonar mal con los jurados. La dependencia excesiva de los tribunales y jurados sobre las recomendaciones incluidas en los sistemas de apoyo clnico-decisin podra dar lugar a responsabilidad mayor ya veces inapropiada cuando los proveedores salen de protocolos de apoyo clnicodecisin. Algunos, pero no todos, los sistemas de HME mdicos inmediatas para documentar sus razones para

in clinical-decision support systems could result in increased and sometimes inappropriate liability when providers depart from clinical-decision support protocols. Some, but not all, EHR systems prompt clinicians to document their reasons for overriding clinically significant alerts. The growth of HIEs and the subsequent accessibility of external medical records may also substantively change the standard of care. Without HIEs, a provider has limited ability to examine a patients records from another provider. Perhaps recognizing this, at least two courts have declined to impose a legal duty to obtain and review prior medical records. HIEs provide easy access to this information, possibly increasing the liability risk for providers who fail to take advantage of that access. It is unclear whether courts would require physicians to routinely perform comprehensive reviews of external EHRs, but in cases in which a patient mentions a relevant piece of his or her medical history and the provider fails to review an easily accessible external EHR, liability could well result. This prospect reflects a deeper concern about health information technology: will the practice environment evolve along with the information environment to allow physicians to make use of the available information resources? The time constraints of typical off ice visits, for example, may hinder a thorough examination of voluminous EHRs. Under such constraints, key information may be missed in a sea of new electronic data, much of which is of dubious clinical significance. The legal standard of care in malpractice cases is meant to reflect reasonable care, but what appears to be reasonable may differ from the perspective of a layperson, who is convinced of the easy accessibility of electronic information, and the physician, who has the challenge of examining both the patient and his electronic dossier in a 15-minute visit. Finally, as the use of EHRs grows, failure to adopt an EHR system may constitute a deviation from the standard of care. The standard of care is usually defined by reference to what is customary among physicians in the same specialty in similar settings. Once a critical mass of providers adopts EHRs, others may need to follow. If EHRs do indeed improve quality of care, many legal scholars would applaud this development, since it exemplifies the ability of tort law to spur providers to practice more safely. This deterrence notion, however, assumes that the cost benefit ratio of technology is reasonable, so that injuries are prevented at an efficient cost. Empirical evidence evaluating this assumption is mixed.

ignorar las alertas clnicamente significativos. El crecimiento de HIEs y la posterior accesibilidad de los registros mdicos externos tambin puede cambiar sustancialmente el estndar de cuidado. Sin HIEs, un proveedor tiene una capacidad limitada para examinar los registros de un paciente a otro proveedor. Tal vez reconociendo esto, al menos, dos tribunales se han negado a establecer un derecho legal para obtener y revisar los registros mdicos anteriores. HIEs facilitar el acceso a esta informacin, posiblemente incrementando el riesgo de responsabilidad para los proveedores que no pueden beneficiarse de ese acceso. No est claro si los tribunales requerira a los mdicos realizar rutinariamente exmenes exhaustivos de los EHR externos, pero en los casos en que un paciente menciona un dato relevante de su historial mdico y el proveedor no revisar un EHR externo de fcil acceso, la responsabilidad bien podra resultar . Esta perspectiva refleja una preocupacin ms profunda sobre la tecnologa de la informacin de salud: el entorno de la prctica evolucionar junto con el entorno de la informacin para permitir a los mdicos a hacer uso de los recursos de informacin disponibles? Las limitaciones de tiempo de las visitas de hielo apagado tpico, por ejemplo, puede dificultar un examen completo de los EHR voluminosos. En estas limitaciones, la informacin clave se puede perder en un mar de nuevos datos electrnicos, mucha de la cual es de importancia clnica dudosa. La norma legal de la atencin en casos de negligencia pretende reflejar un cuidado razonable, pero lo que parece ser razonable puede diferir de la perspectiva de un laico, que est convencido de la fcil accesibilidad de la informacin electrnica, y el mdico, que tiene el reto de examinar tanto el paciente y su expediente electrnico en una visita de 15 minutos. Por ltimo, como el uso de los EHR crece, la no adopcin de un sistema de HME puede constituir una desviacin de la norma de atencin. El tratamiento estndar es generalmente definida por referencia a lo que es habitual entre los mdicos de la misma especialidad en entornos similares. Una vez que una masa crtica de proveedores adopta EHR, otros pueden necesitar seguir. Si EHR de hecho mejorar la calidad de la atencin, muchos juristas aplauda este desarrollo, ya que es un ejemplo de la capacidad de la ley de responsabilidad civil para estimular a los proveedores practican de forma ms segura. Esta nocin de "disuasin", sin embargo, asume que la relacin costobeneficio de la tecnologa es razonable, por lo que las lesiones se impide a un costo eficiente. La evidencia emprica evaluar esta hiptesis es mixto. Conclusiones Los proveedores pueden esperar de un variado y cambiante de paisaje de los riesgos de responsabilidad mdica y beneficios de la adopcin de la HCE se desarrolla. Si estos desarrollos mejoran el rendimiento del sistema de responsabilidad mdica est por verse. Documentacin electrnica es probable que reforzar la veracidad de los tribunales en la determinacin de la responsabilidad mediante la mejora de los datos

Conclusions Providers can expect a varied and shifting landscape of medical liability risks and benefits as the adoption of EHRs unfolds. Whether these developments improve the performance of the medical liability system remains to be seen. Electronic documentation is likely to bolster the accuracy of courts in determining liability by enhancing the evidence available to evaluate claims. Less clear at this early stage is whether EHRs will lead courts to recognize changes in the legal standard of care and if so, whether these changes are socially desirable. It is also unknown how the law may evolve to allocate liability fairly among individual clinicians, EHR developers, and provider organizations that select and implement EHR systems. Liability that arises primarily because of poorly designed EHR systems arguably should rest with those in control of system architecture and implementation, not end users. However, in many cases, suboptimal design may set the stage for user errors, complicating the assignment of fault. In addition, some contracts between provider organizations and EHR developers reportedly include provisions protecting the developer from liability arising from the use of the EHR system. Health care professionals and provider organizations can actively manage EHR-associated risks. First, they can decline to sign contractual provisions that immunize the system developer. Second, they can select systems that are designed to minimize the risk of user error or misuse and maximize the ease of record retrieval. This requires that organizations invest effort early to ensure that the EHR system is customized to the practice patterns of their clinical staff for ex- ample, ensuring that clinical-decision support alerts and medication-dose defaults are sensible. Third, organizations that adopt EHRs can ensure that clinicians receive thorough training, including education about organizational expectations regarding the use of the system. Hospitals can monitor the use of the system after implementation for obvious problems. Physicians, for their part, must be willing to climb the learning curve. Understanding how using EHRs may help protect them from liability, and how misuse or nonuse may increase liability risk, should motivate them to do so. Fourth, organizations can ensure that practice conditions are such that the use of the new technology can be maximized. Identification of appropriate practice conditions will require organizations to work closely with their care teams

disponibles para evaluar los reclamos. Menos claro en esta primera etapa es si EHR conducirn tribunales para reconocer los cambios en la norma legal de la atenciny en caso afirmativo, si estos cambios son socialmente deseables. Tampoco se sabe cmo la ley puede evolucionar para asignar responsabilidad equitativamente entre los mdicos individuales, desarrolladores de HME, y organizaciones de proveedores que seleccionan e implementan los sistemas de HME. Responsabilidad que surge principalmente debido a los sistemas de HME mal diseados duda debe recaer en quienes tienen el control de la arquitectura y la implementacin del sistema, no a los usuarios finales. Sin embargo, en muchos casos, el diseo ptimo puede sentar las bases para los errores del usuario, lo que complica la asignacin de culpa. Adems, algunos contratos entre las organizaciones de proveedores y desarrolladores de HME informes incluyen disposiciones que protegen el desarrollador de la responsabilidad derivada de la utilizacin del sistema de EHR. Profesionales de la salud y organizaciones de proveedores pueden gestionar activamente los riesgos EHR-asociados. Primero, pueden negarse a firmar las clusulas contractuales que inmunizan el desarrollador del sistema. En segundo lugar, se pueden seleccionar los sistemas que estn diseados para reducir al mnimo el riesgo de error del usuario o el mal uso y maximizar la facilidad de recuperacin de registros. Para ello es necesario que las organizaciones invierten esfuerzo temprano para asegurar que el sistema EHR se adapta a los patrones de la prctica de su personal clnico - por ejemplo, asegurndose de que las alertas de apoyo de decisin clnica y los valores predeterminados medicamentos de dosis son razonables. En tercer lugar, las organizaciones que adoptan los EHR pueden asegurar que los mdicos reciban una slida formacin, incluida la educacin sobre las expectativas de la organizacin con respecto a la utilizacin del sistema. Los hospitales pueden monitorear el uso del sistema despus de la implementacin de los problemas obvios. Los mdicos, por su parte, deben estar dispuestos a subir la curva de aprendizaje. La comprensin de cmo el uso de los EHR puede ayudar a protegerlos de la responsabilidad, y cmo el mal uso o falta de uso puede aumentar el riesgo de responsabilidad civil, debe motivar a que lo hagan. En cuarto lugar, las organizaciones pueden asegurar que las condiciones de la prctica son tales que el uso de la nueva tecnologa puede ser maximizada. Identificacin de las condiciones de prctica apropiados requerir a las organizaciones a trabajar en estrecha colaboracin con sus equipos de atencin para identificar las barreras existentes para el uso ptimo de los EHR, si stos implican la duracin de las visitas al consultorio, la colocacin de terminales informticos, problemas de acceso a los registros externos, u otros factores. En quinto lugar, la gestin de las expectativas de los pacientes sobre la mensajera segura y el acceso de la HCE es fundamental. Por ltimo, cuando los

to identify existing barriers to the optimal use of EHRs, whether these involve the length of office visits, the placement of computer terminals, problems accessing external records, or other factors. Fifth, managing patients expectations about secure messaging and accessing of EHRs is pivotal. Finally, when physicians serve as experts in malpractice litigation, they can educate liability insurers and courts about the limitations of clinical decision support systems and the appropriateness of departures from them in certain situations.

mdicos actan como expertos en juicios por mala praxis, pueden educar a las aseguradoras de responsabilidad civil y de los tribunales acerca de las limitaciones de los sistemas de apoyo de decisiones clnicas y la adecuacin de las salidas de los mismos en determinadas situaciones. Al evaluar la posibilidad de invertir en tecnologas de HME, organizaciones de proveedores deben sopesar el costo inicial considerable y los posibles riesgos frente a los beneficios potenciales importantes, pero incierto, a largo plazo. Las consecuencias por mala praxis de los EHR deben incluirse en los futuros debates sobre los riesgos y los beneficios. Aunque en la actualidad poco de investigacin cuantificacin de los riesgos y beneficios con respecto a la responsabilidad, somos optimistas de que en ltima instancia, pesa a favor de la implantacin de la HCE. No obstante, es probable que los EHR estn aqu para quedarse. A medida que el uso de la HCE se convierte en un lugar comn, el criterio jurdico de la atencin va a evolucionar, y los recin llegados a la mesa EHR puede ser llamado a rendir cuentas.

In evaluating whether to invest in EHR technologies, provider organizations must weigh the substantial up-front cost and possible risks against the potentially sizeable, but uncertain, longrun benefits. The malpractice implications of EHRs should be included in future discussions of risks and benefits. Although there is currently little research quantifying the risks and benefits with respect to liability, we are optimistic that they will ultimately weigh in favor of the implementation of EHRs. Regardless, it is likely that EHRs are here to Apoyado en parte por un premio de Investigador en la stay. As the use of EHRs becomes common- place, Investigacin de Polticas de Salud de la Fundacin Robert Wood Johnson, Princeton, NJ (el Dr. Mello). the legal standard of care will evolve, and latecomers to the EHR table may be called to account. Supported in part by an Investigator Award in Health Policy Research from the Robert Wood Johnson Foundation, Princeton, NJ (to Dr. Mello). Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. We thank Ashish Jha for comments on an early draft of the manuscript.