FDASIA Report on Regulating HIT

On September 4, 2013, the FDASIA mandated workgroup presented their recommendations to the Health IT Policy Committee in Washington, D.C. Some reporting on the meeting cast the draft report as downplaying potential FDA regulation of healthcare IT applications (HIT), while others emphasized the uncertainty (subscription required) of the process and ultimate outcome. Such news stories are, by necessity, short and can’t cover all the issues but this one from iHealthBeat provides a good summary. The final report (links to all draft documents) was submitted September 4, 2013 and was basically unchanged from the preliminary report. The question to be answered by the workgroup was how to regulate HIT. I think we’re past the question of whether or not HIT should be regulated:  there have been reports of patient deaths starting in 2005 (here and here), and that’s with almost zero reporting requirements on the part of providers or vendors, and the proliferation of HIT vendor non-disclosure and hold harmless agreements to supress reporting (see reports here and here). The report, also called the “Section 618 report” for the section of FDASIA that mandates the workgroup and their report, is extremely concise and to the point – perhaps too concise for those outside the world of regulated medical devices. Of the three entities, FDA, ONC and FCC that are the focus of the report, by far the most focus was on the FDA. ONC and FCC received minor recommendat...
Source: Medical Connectivity Consulting - Category: Technology Consultants Authors: Tags: Healthcare IT Standards & Regulatory Source Type: blogs