An Open Letter to David Bates, MD, Chair, ONC FDASIA Health IT Policy Committee on Recommendations Against Premarket Testing and Validation of Health IT

From http://www.healthit.gov/policy-researchers-implementers/federal-advisory-committees-facas/fdasia:The Food and Drug Administration Safety Innovation Act (FDASIA) Health IT Policy Committee Workgroup is charged with providing expert input on issues and concepts identified by the Food and Drug Administration (FDA), Office of the National Coordinator for Health IT (ONC), and the Federal Communications Commission (FCC) to inform the development of a report on an appropriate, risk-based regulatory framework pertaining to health information technology including mobile medical applications that promotes innovation, protects patient safety, and avoids regulatory duplication.My Open Letter to the Committee's chair speaks for itself:From: Scot SilversteinDate: Mon, Sep 16, 2013 at 9:39 AMSubject: ONC FDASIA Health IT Policy Committee's recommendations on Premarket SurveillanceTo: David BatesSept. 16, 2013David Bates, Chair, ONC FDASIA Health IT Policy Committeevia email    Dear David,I am disappointed (and in fact appalled) at the ONC FDASIA Health IT Policy Committee's recommendations that health IT including typical commercial EHR/CPOE systems not be subjected to a premarket testing and validation process.  I believe this recommendation is, quite frankly, negligent. [1]As you know, my own mother was injured and then died as a result of EHR deficiencies, and nearly injured or killed again in the recuperation period from her initial injuries by more health IT pr...
Source: Health Care Renewal - Category: Health Medicine and Bioethics Commentators Tags: David Bates ECRI Deep Dive Study FDA FDASIA Health IT Policy Committee Workgroup healthcare IT dangers healthcare IT deaths healthcare IT defects healthcare IT risk ONC premarket approval Source Type: blogs