Why Electronic Health Record Systems Require Safety Regulation
Health Care

Sharona Hoffman and Andy Podgurski

, 03/20/2009

Why Electronic Health Record Systems Require Safety Regulation

(Health Care) Permanent link

 

President Obama’s stimulus plan includes $19 billion to promote the adoption of electronic health record (EHR) systems and to enhance privacy protection for health information. These are much-needed first steps. However, they are first steps only. Like pacemakers and other medical devices, EHR systems should be subject to federal safety regulations–their complex software may have bugs or “usability” problems that endanger patients.

Electronic health record systems are much more than record keeping devices. They include numerous features that have the potential to vastly improve health care outcomes. For example, they can provide physicians with preventive care reminders, allergy alerts, suggestions for diagnostic or treatment options, links to medical literature, computerized physician order entry, and data analysis tools. They can allow physicians in different practices or locations to exchange information about patients who seek a second opinion, move to a new location, or are brought to an emergency room.

EHR systems can reduce errors and improve patient safety. To illustrate, in one case reported in the Washington Post in 2005, a physician prescribed 10 times the appropriate dosage of a drug, and the EHR system caught and corrected this mistake. According to some estimates, these systems may ultimately save over $77 billion a year as a result of lower administrative costs, fewer medical errors, and less duplication of tests, because the results of tests conducted by one physician would be electronically available to all treating physicians.

At the same time, there are significant risks and challenges, which go far beyond the often-addressed privacy and security concerns. EHR systems require caregivers to type information directly into computers during or after their patient visits. Some find this to be time-consuming and unproductive, and efforts to create shortcuts or circumvent the systems’ demands can create new problems.

For example, cut-and-paste mechanisms can make old information about a patient’s condition appear to be a recent update. Poorly designed data displays or prompts and alerts that are confusing, excessive, or inappropriately timed can hinder care. In addition, patient welfare can be endangered by software bugs, unexpected computer shut-downs, and other system problems. In 2008, bugs in the Veterans Administration’s EHR system exposed veterans to incorrect drug doses, such as excessive heparin infusions.

In light of these risks to patient care, federal regulations must establish rigorous quality control mechanisms. Currently, initial approval of EHR systems is conducted by a certification program operated by the Certification Commission for Health Information Technology, a private, industry-based organization. Our review of the certification criteria revealed that they are inadequate to ensure the safety and efficacy of EHR systems. For example, testing is conducted in just one eight-hour period, and the criteria do not explicitly address important issues such as safety and usability.

We believe that EHR systems should be scrutinized through a careful premarket approval process, including field testing at several facilities for at least six months. We also recommend local system oversight committees, based on the IRB model, that would oversee field testing and conduct postmarketing monitoring throughout the life of the product. Adverse event reporting would be mandated under this system to ensure that problems are detected and addressed swiftly and that the government intervenes when necessary to safeguard patient welfare.

Federal regulations should also require that all EHR systems meet specific quality standards. Audit trails and capture-replay capabilities should be required to facilitate discovery of both system and user errors, much as black boxes allow the reconstruction of conditions that led to aviation incidents. Equally important, different systems should be able to exchange and incorporate data so that patients’ care can be coordinated no matter where their records were originally housed.

Because EHR systems will manage patient care to a significant degree, they must be subject to government oversight akin to the highest level of scrutiny required, in principle, by the Food and Drug Administration for complex medical devices. The American Recovery and Reinvestment Act of 2009 codifies the Office of National Coordinator for Health Information Technology within the Department of Health and Human Services and establishes policy and standards committees that will be responsible for the quality of health information technology. However, the act does not provide detailed guidance for the formulation of federal regulations to govern the technology.

Federal regulations should establish appropriate oversight and quality control through EHR system standards, approval processes, and ongoing monitoring requirements. It is only with careful oversight that providers can be assured of investing in high quality EHR products. And it is only with appropriate safeguards that the benefits of this very promising technology will be maximized–that health outcomes will improve and risks as well as costs will decline.

Sharona Hoffman is a professor of law and bioethics and codirector of the Law-Medicine Center at Case Western Reserve University School of Law. Andy Podgurski is an associate professor of electrical engineering and computersScience at Case Western Reserve University.

Posted by Alison Jost at 03/20/2009 01:55:53 PM | 


Comments
An impressive share, I just given this onto a colleague who was doing a little analysis on this. And he in fact bought me breakfast because I found it for him.. smile. So let me reword that: Thnx for the treat! But yeah Thnkx for spending the time to discuss this, I feel strongly about it and love reading more on this topic. If possible, as you become expertise, would you mind updating your blog with more details? It is highly helpful for me. Big thumb up for this blog post!
Posted by: magyblog@gmail.com ( Email | Visit ) at 8/16/2013 2:44 PM


Heya I’m for the first time here. I found this board and I find It really useful & it helped me out much. I hope to give something back and aid others like you aided me
Posted by: andrewcolle@gmail.com ( Email | Visit ) at 6/1/2014 1:18 PM


Je suis vraiment heureux de visiter ce site, parce que votre blog a un bon contenu. Par conséquent, de nombreux touristes sont en attente pour ce type de blog, je vais mettre en signet votre blog.
Posted by: chenghuiaa123456@163.com ( Email | Visit ) at 9/12/2014 5:50 AM


I think President Obama's plan is very good, stimulate the economy, if you get the rebound. That is a big plan, will be recorded in the history!
Posted by: q1197965289@gmail.com ( Email | Visit ) at 9/15/2014 1:00 AM


yeah..that's a great idea.. i wanna try that..thanks for sharing..
Posted by: bocaishuaige@gmail.com ( Email | Visit ) at 10/8/2014 2:59 AM


yeah..that's a great idea.. i wanna try that..thanks for sharing..
Posted by: bocaishuaige@gmail.com ( Email | Visit ) at 10/8/2014 2:59 AM


yeah..that's a great idea.. i wanna try that..thanks for sharing..
Posted by: bocaishuaige@gmail.com ( Email | Visit ) at 10/8/2014 2:59 AM


It is far from like extravagant like many people on the arranged;
Posted by: dengjie700@gmail.com ( Email | Visit ) at 10/14/2014 4:15 AM


Fake Nike Air Max Shoes. Cheap knockoff Nike Air Max, Nike Air Max Shoes for Sale, Up To 90% Off with Top Quality!
Posted by: abigailadaabigailada@hotmail.com ( Email | Visit ) at 11/11/2014 2:48 AM


It's undeniable that we need to advocate both privacy and security issue for the medical data system. They are vulnerable to potential hackers or being used inappropriately. Some regulations should be implemented, it's the mandatory policy for every hospitals.
Posted by: sales02@123anfang.com ( Email | Visit ) at 2/22/2015 11:22 PM


Thiѕ page reаllу haѕ аll оf thе info I needed аbоut thiѕ subject аnd didn’t knоw whо tо ask
Posted by: briar212@yahoo.com ( Email | Visit ) at 4/1/2015 2:30 AM


Oh, wow! Whаt а reallу amazing article thіѕ is. Thе bettеr articles оf рaѕt stand nо chance competing wіth thіѕ article. If уоu kеер giving uѕ ѕuсh amazing articles, you'll surely bесomе а good author.
Posted by: briar212@yahoo.com ( Email | Visit ) at 4/1/2015 2:35 AM


Thankѕ а lot fоr providing thе nice services іn thіs blog аnd I wіll reallу amazing info іѕ visible іn thіѕ blog.
Posted by: briar212@yahoo.com ( Email | Visit ) at 4/1/2015 2:38 AM


post tо bе verу educational. Thаnk уоu fоr broadening mу knowledge оf thіѕ subject. Nо doubt itѕ а great piece
Posted by: briar212@yahoo.com ( Email | Visit ) at 4/1/2015 2:38 AM


Thіѕ article giveѕ thе light іn whісh wе сan observe thе reality. thіѕ іѕ verу nice onе аnd givеѕ indepth information. thаnks fоr thіѕ nice article.
Posted by: briar212@yahoo.com ( Email | Visit ) at 4/1/2015 2:39 AM


Yоu hаvе а real ability fоr writing unique content. I lіkе hоw уou thіnk аnd thе wау уou represent уоur views іn thіs article. I agree wіth уour wаy оf thinking.
Posted by: briar212@yahoo.com ( Email | Visit ) at 4/1/2015 2:41 AM


You're sо right. I'm thеre wіth you. Yоur blog іѕ dеfіnitely worth а read іf anyоne comеs aсrоѕs it. I'm lucky I dіd bесаuѕе nоw I've gоt а wholе nеw view оf this. I didn't realize thаt thiѕ issue waѕ ѕо important аnd ѕо universal
Posted by: briar212@yahoo.com ( Email | Visit ) at 4/1/2015 2:43 AM


I аm happy tо find thіѕ post verу uѕеful fоr me, аѕ іt сontаіnѕ lot оf information. I alwауѕ prefer tо read thе quality content аnd thіѕ thіng I fоund іn уоu post. Thаnkѕ fоr sharing.
Posted by: briar212@yahoo.com ( Email | Visit ) at 4/1/2015 2:44 AM


I rеаlly enjoyed thiѕ article, іt wаѕ informative аnd helped open mу mind tо nеw possibilities. Thаt іs thе power оf thе internet, connecting people worlds арart аnd allowing uѕ tо learn аnd grow together.
Posted by: briar212@yahoo.com ( Email | Visit ) at 4/1/2015 2:46 AM


yes
Posted by: fatahiqbal@gmail.com ( Email | Visit ) at 4/7/2015 10:40 PM


yes
Posted by: fatahiqbal@gmail.com ( Email | Visit ) at 4/7/2015 10:41 PM


yes
Posted by: fatahiqbal@gmail.com ( Email | Visit ) at 4/7/2015 10:41 PM


yes
Posted by: fatahiqbal@gmail.com ( Email | Visit ) at 4/7/2015 10:41 PM


yes
Posted by: fatahiqbal@gmail.com ( Email | Visit ) at 4/7/2015 10:42 PM


yes
Posted by: fatahiqbal@gmail.com ( Email | Visit ) at 4/7/2015 10:42 PM


yes
Posted by: fatahiqbal@gmail.com ( Email | Visit ) at 4/7/2015 10:42 PM


I hаvе beеn іn loоk fоr оf ѕоme information abоut іt аlmoѕt threе time. Yоu served mе а lot іndeed аnd analyzing thіs уour publish I hаve fоund mаnу nеw аnd uѕеful information abоut thiѕ topic.
list of email addresses
http://freshemailsdaily.com/bulk-email-data-feeds.html
Posted by: lenovodell637@gmail.com ( Email | Visit ) at 5/7/2015 6:59 AM


You made some decent points there. I looked on the internet for the issue and found most individuals will go along with with your website..

rebelmouse.com/oldschoolnewbodypdfreview
Posted by: jamalasjhar34@gmail.com ( Email | Visit ) at 5/10/2015 7:20 AM


I hаvе beеn іn loоk fоr оf ѕоme information abоut іt аlmoѕt Three time. Yоu served mе а lot іndeed аnd analyzing Thіs уour publish I hаve fоund mаnу nеw аnd uѕеful information abоut This topic.

recommended reading
Posted by: jamalasjhar34@gmail.com ( Email | Visit ) at 5/11/2015 6:15 AM


Scent of varied manufacturers tend to be popular having persons affecting various age ranges. Fashion experienced persons world-wide monitor the modern bunch connected with fragrance start out there. In actuality fragrances perform large location.
high pr blog comments
Posted by: lenovodell637@gmail.com ( Email | Visit ) at 5/12/2015 3:53 AM


Heya I’m for the first time here. I found this board and I find It really useful & it helped me out much
delhi to jaipur cab
Posted by: aarijali100@gmail.com ( Email | Visit ) at 5/13/2015 2:06 AM


If it became entrenched, such thinking could open the door to other and more insidious forms of genetic reductionism.
Free Ebook Downloads
Posted by: jamalasjhar34@gmail.com ( Email | Visit ) at 5/14/2015 6:18 AM


You made some decent points there. I looked on the internet for the issue and found most individuals will go along with with your website..



unlock cell phone
Posted by: jamalasjhar34@gmail.com ( Email | Visit ) at 5/25/2015 3:26 AM


The majority told patients it was “a medicine not typically used for your condition but might benefit you.
viagra generika
Posted by: aarijali100@gmail.com ( Email | Visit ) at 5/25/2015 4:06 AM


I hаve read аll the comments аnd suggestions posted bу the visitors fоr this article are vеrу good,We wіll wait fоr уour nеxt article so only.Thanks!
smarthappybirthdaywishes.com
Posted by: lenovodell637@gmail.com ( Email | Visit ) at 5/25/2015 9:24 AM


I recently found many useful information in your website especially this blog page. Among the lots of comments on your articles.....

buy neopoints reviews
Posted by: jamalasjhar34@gmail.com ( Email | Visit ) at 5/28/2015 8:08 AM