EHR disadvantages disappear from Wikipedia

According to the Health Care Renewal blog, which chronicles some of the myriad problems in American healthcare, editors of the Wikipedia page for “electronic health record” keep deleting or changing the section about EHR disadvantages. Drexel University medical informatics professor Scot Silverstein, M.D., who contributes to the Health Care Renewal blog, says that the following text has been removed from the Wikipedia page in the past week:


===Software quality and usability deficiencies===
EHR software is unregulated, unlike computer systems used both in the development and production of, and as a part of pharmaceutical products, medical devices, food, blood establishments, tissue establishments, and clinical trials. Other life-critical industries also have strict software validation and testing standards, e.g., Federal Aviation Administration, NASA.

As a result, EHR software quality and usability is often suboptimal. For example, in “A study of an Enterprise Health information System”, March 2011, a Medical Informatics researcher at [[University of Sydney]] in Australia found that a major EHR system for Emergency Departments slated for deployment in the public hospitals of [[New South Wales]] has serious deficiencies in software architecture and fit with clinician workflow. These deficiencies make it difficult to use and unreliable in terms of data integrity and loss, in one of the most demanding of clinical environments .

The [[Healthcare Information and Management Systems Society]] (HIMSS), a very large U.S. healthcare IT industry trade group, observed that EHR adoption rates “have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available.”

Serious reliability and usability problems with the U.S. Department of Defense’s [[AHLTA]] EHR system have been reported to the Congress.

The U.S. [[National Institute of Standards and Technology]] (NIST) issued a Sept. 2011 report on deficient usability of current EHR systems, with recommendations for usability evaluation, testing and validation.

===Unintended adverse consequences===
EHRs can introduce new unintended consequences, compared to paper records, and adverse outcomes, including patient injury and death, according to regualtory and governmental agencies, researchers, and others; for example, in an internal 2009 FDA memorandum of Feb. 23, 2010 obtained and released by the Huffington Post Investigative Fund, EHR-related medical errors are categorized as: errors of commission (EOC), errors of omission or transmission (EOT), errors in data analysis (EDA), and incompatibility between multi-vendor software applications or systems (ISMA).

The [[National Health Service]] (NHS) in the UK reports specific examples of EHR-caused patient harms in a 2009 document on guidance on the management of clinical risk relating to the deployment and use of health software, Annex A “Examples of potential harm presented by health software.”

Also, in “Research in Ambulatory Patient Safety 2000–2010: A 10-year review”, Dec. 2011, the American Medical Association reports:

:While health IT may confer benefits, some research has also suggested that health IT systems can create new issues or exacerbate existing problems. Wachter noted that, “[i]n both professional and lay publications, concerns have been raised that today’s electronic health records promote the copying and pasting of clinical information, instead of its thoughtful analysis; foster a focus on completing computerized checklists and templates rather than detailed probing of the patient’s history, and support less thoughtful diagnostic reasoning and more automatic behavior on the part of caregivers.” Research indicates that a great deal depends on the design of the health information technology system, with poorly designed systems contributing to instances of errors (Ash et al). Where user interface designs are cumbersome to use and do not fit into the clinician’s natural work context, some have noted the potential for “cognitive overload,” among other reactions, and ultimately the possibility of increasing errors in data entry and retrieval as well as errors in the process of communication and coordination (Ash et al, Singh et al).

In the U.S., FDA’s MAUDE (Manufacturer and User Facility Device Experience) database many reported EHR problems, some of which could result in patient injury or death Both FDA (in the 2010 memo referenced above) and the [[Institute of Medicine]] of the National Academies in a 2011 study reveal that EHR-related injuries and deaths are real, but the true extent is likely understated, they report, due to numerous factors impeding diffusion of knowledge such as contractual gag and hold harmless clauses and lack of familiarity by users of where to report EHR-related adverse events (per aforementioned 2009 FDA internal memo). A Medical Informatics researcher in the U.S. has compiled a well-referenced teaching site that covers unintended consequences of EHRs, health IT project difficulties and failure and related issues{{cite web | last=Silverstein| first=Scot| year=2012 | url= | title=Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties| publisher=Drexel University |accessdate=2012-01-26}}.

The literature is conflicting on benefits and harms of EHRs, and as in the Jan. 2009 U.S. National Academies study “COMPUTATIONAL TECHNOLOGY FOR EFFECTIVE HEALTH CARE: IMMEDIATE STEPS AND STRATEGIC DIRECTIONS”, EHR’s ultimate success will depend upon accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering.

===Regulatory controversy===
FDA’s Jeffrey Shuren, MD JD, Director of the [[Center for Devices and Radiological Health]] (CDRH), has explicitly declared EHRs are a medical device. So has the [[Medical Products Agency (Sweden)]]; Swedish law for medical devices is based on EU Directives. In medicine, legal and ethical standards such as the NIH Guidelines for Conduct of Research Involving Human Subjects and the World Medical Association Declaration Of Helsinki restrict introduction of new drugs and medical devices without informed consent, and without extensive preclinical and clinical testing and post-marketing surveillance, especially when risks of the technology are unknown. As in the 2011 U.S. [[Institute of Medicine]] study “Health IT and Patient Safety: Building Safer Systems for Better Care”, there are calls for formal governmental regulation of the technology.

Indeed, as I write this, there is no “disadvantages” section “of the Wikipedia page for electronic health record” at all. It’s disingenuous to suggest that EHRs have zero disadvantages. The vendors certainly know this. In fact, Silverstein has chronicled many cases where EHRs have caused patient harm and other “difficulties.”

It’s also disingenuous for someone to delete an entire section that addresses some of the issues EHR developers, implementers and users still have with the technology. Sure, EHRs can improve patient care and save money, but poorly implemented systems can increase risk. Wikipedia is supposed to present multiple sides of an issue in an objective manner. Deleting potentially embarrassing text runs counter to the spirit of a wiki, and it makes the page incomplete. Don’t paper over those problems as you work to create a better EHR and a better health system.