Comments on: Clinical vs. Clerical Systems – Why FDA Software Regulation is Inevitable http://histalk2.com/2008/01/16/clinical-vs-clerical-systems-%e2%80%93-why-fda-software-regulation-is-inevitable/ Healthcare IT News and Opinion Fri, 19 Mar 2010 15:08:21 -0500 http://wordpress.org/?v=2.8.4 hourly 1 By: The Alchemist http://histalk2.com/2008/01/16/clinical-vs-clerical-systems-%e2%80%93-why-fda-software-regulation-is-inevitable/comment-page-1/#comment-675 The Alchemist Thu, 17 Jan 2008 14:00:59 +0000 http://histalk2.com/2008/01/16/clinical-vs-clerical-systems-%e2%80%93-why-fda-software-regulation-is-inevitable/#comment-675 Dealing with SOA platforms in the clinical arena of data, I often feel that any federated view of legacy data called for a lack of better term, “post-transactional” is a process primarily for disclosure. Transmitting bi-directional clinical immunohematology data through an electronic conduit including group, type, compatibility findings, HLA typing and UNOS over the enterprise SOA platform should be verified and authenticated consistent with FDA 510(k) compliance. I believe that voluntary accreditation of clinical portals with national agencies such as URAC might serve as "deemed" status to that long auguous road to FDA dreamland – Area 510. A functional example of adequate FDA 510(k) compliance was addressed by SCC Soft Computer Genetic Information System Suite, the last of the best-of-breed clinical software companies in the United States. Dealing with SOA platforms in the clinical arena of data, I often feel that any federated view of legacy data called for a lack of better term, “post-transactional” is a process primarily for disclosure.

Transmitting bi-directional clinical immunohematology data through an electronic conduit including group, type, compatibility findings, HLA typing and UNOS over the enterprise SOA platform should be verified and authenticated consistent with FDA 510(k) compliance. I believe that voluntary accreditation of clinical portals with national agencies such as URAC might serve as “deemed” status to that long auguous road to FDA dreamland – Area 510.

A functional example of adequate FDA 510(k) compliance was addressed by SCC Soft Computer Genetic Information System Suite, the last of the best-of-breed clinical software companies in the United States.

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