tag:blogger.com,1999:blog-22539915.post6069129270180337054..comments2023-09-01T08:09:10.282-05:00Comments on Change Doctor: FDA Considers Regulating Safety of Electronic Health Systems - Now that would shake up the industry!Lyle Berkowitz, MDhttp://www.blogger.com/profile/16542742012919536155noreply@blogger.comBlogger1125tag:blogger.com,1999:blog-22539915.post-33594688997830183602010-03-03T03:55:05.447-06:002010-03-03T03:55:05.447-06:00Lyle,
Thanks for picking up this topic and offeri...Lyle,<br /><br />Thanks for picking up this topic and offering the links, as well as your validation of the issues.<br /><br />Seven Proposed EHR Safety Steps:<br /><br />For those interested in more than sound bites, Jim Walker et al's 2008 article, "EHR Safety: The Way Forward to Safe and Effective Systems" is thoughtful and prescriptive. (J Am Med Inform Assoc. 2008;15:272–277. DOI 10.1197/jamia.M2618.) Their approach is highly informed and outlined in 7 steps, elaborated in the paper.<br /><br />Ross Koppel's work has been important. Perhaps more informative for me was his (Koppel's) recent presentation at Harold Lehmann's Informatics Grand Rounds series from the Bloomberg School of Public Health at Johns Hopkins in December of 2009. The video is freely available here: <br /><br />http://real.welch.jhu.edu/ramgen/DHSI/Dec182009.rm<br /><br /><br />I've done both formal and informal root-cause analyses on EHR safety issues across several vendors; my results validate parts of Jim Walker's articulated model in his Hazard Manager. From my experience, there are almost always 1) product design/architectural design contributors, 2) poorly-implemented (client-side) of products that have been proven to work more safely at other clients, 3) contributing business issues in provider organization with some component of the "New" problem, 4) contributing business issues from the structure of the vendor, be they corporate, home-grown, or federal parent of the software, and 5) technology platform reliability challenges.<br /><br />Root-cause and FMEA is the only way to mitigate these risks. Most experiences authors say, either publicly or privately, that FDA or related government regulation alone produce responses that tend to be anti-quality. Despite the intent of creating transparency, they more often lead to "bad apple" approaches, driving quality problems further underground. This phenomena is well understood by all of us who have worked in Quality Improvement.JoeBeehttps://www.blogger.com/profile/05389682410791855882noreply@blogger.com