Comments on: How Much EHR Oversight is Required to Ensure Patient Safety? http://www.nuesoft.com/blog/how-much-ehr-oversight-is-required-to-ensure-patient-safety/ Just another WordPress site Mon, 09 Jan 2012 14:11:08 +0000 hourly 1 http://wordpress.org/?v=3.3.1 By: Tim Gee http://www.nuesoft.com/blog/how-much-ehr-oversight-is-required-to-ensure-patient-safety/#comment-9945 Tim Gee Mon, 13 Dec 2010 19:15:54 +0000 http://www.nuesoft.com/blog/?p=178#comment-9945 The rub here seems to be that there is a fundamental difference between the core missions of a certification body primarily interested in ensuring a minimum level of functionality and features, and a regulatory agency responsible for ensuring patient safety. While there may be some blurring between the two, as both the FDA and ONC anointed certification bodies might look to certain features that may enhance safety, asking a certification body to assume responsibility for patient safety is way outside such an organization's scope or capabilities -- at least under the current paradigm for ensuring the safety of medical devices. Certification of safety can be done, as exemplified by the FAA and their certification of specific experimental aircraft and aircraft "products" produced by the likes of Boeing and others. Such a transition would be very time consuming and costly, to both industry and the government, bringing innovation and new product development to a virtual standstill during the transition. I see little real chance for such a transition when the FDA's model for ensuring safety through the use of a Quality System, combined with product clearance and approvals continues to show reasonable success. The rub here seems to be that there is a fundamental difference between the core missions of a certification body primarily interested in ensuring a minimum level of functionality and features, and a regulatory agency responsible for ensuring patient safety. While there may be some blurring between the two, as both the FDA and ONC anointed certification bodies might look to certain features that may enhance safety, asking a certification body to assume responsibility for patient safety is way outside such an organization’s scope or capabilities — at least under the current paradigm for ensuring the safety of medical devices.

Certification of safety can be done, as exemplified by the FAA and their certification of specific experimental aircraft and aircraft “products” produced by the likes of Boeing and others. Such a transition would be very time consuming and costly, to both industry and the government, bringing innovation and new product development to a virtual standstill during the transition. I see little real chance for such a transition when the FDA’s model for ensuring safety through the use of a Quality System, combined with product clearance and approvals continues to show reasonable success.

]]> By: ICMCC News Page » How Much EHR Oversight is Required to Ensure Patient Safety? http://www.nuesoft.com/blog/how-much-ehr-oversight-is-required-to-ensure-patient-safety/#comment-6617 ICMCC News Page » How Much EHR Oversight is Required to Ensure Patient Safety? Wed, 17 Mar 2010 09:22:22 +0000 http://www.nuesoft.com/blog/?p=178#comment-6617 [...] Article Nuesoft, 16 March 2010 SHARETHIS.addEntry({ title: "How Much EHR Oversight is Required to Ensure Patient Safety?", url: "http://articles.icmcc.org/2010/03/17/how-much-ehr-oversight-is-required-to-ensure-patient-safety/" }); [...] [...] Article Nuesoft, 16 March 2010 SHARETHIS.addEntry({ title: "How Much EHR Oversight is Required to Ensure Patient Safety?", url: "http://articles.icmcc.org/2010/03/17/how-much-ehr-oversight-is-required-to-ensure-patient-safety/" }); [...]

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