A War on Patients: Panel Says EHRs Should Not Be Vetted Before Marketing and Deployment

Joe Conn and Modern Healthcare published the following article:Work group says OK to some HIT safety regs (link), Joe Conn, Modern Healthcare, Aug. 7, 2013What is important is what safety regs the Workgroup said "no" to.  It comes as no surprise:A federally chartered special work group with representatives from three federal agencies has submitted its draft recommendations on establishing a regulatory framework for health information technology. Chief among those recommendations is that health IT should not be subjected to pre-market federal regulation, but there were a few exceptions.The exceptions are narrow, and are likely already covered as Class III medical devices by FDA (see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/):The exceptions under which there should be FDA regulation, according to the work group, include medical device accessories to be defined as such by the FDA; certain forms of “high risk” clinical decision support systems, such as “computer aided diagnostics,” also to be defined by the FDA; and some “higher risk software” use cases to be defined by the committee's own safety work group.They did acknowledge the need for postmarket surveillance:... The group also recommended: developing a federally supported, post-market surveillance system for health IT products “to ensure safety-related decision support is in place,” creating a process for gathering information on safety issues,...

Source: Health Care Renewal - August 9, 2013 Category: Health Medicine and Bioethics Commentators Tags: healthcare IT risk FDA Safety Innovation Act work group premarket approval postmarketing sureveillance Joseph Conn healthcare IT regulation Modern Healthcare David Bates health IT extremism Source Type: blogs