FDA to Help Clarify E-health Records

• Date: April 07, 2010
• Source: Admin

Paul Egerman, healthcare software entrepreneur and co-chair of the adoption and certification group believes that their association with the FDA will certainly provide a fruitful result in improving patient safety. However, seemingly not all share the same view.

Carl Dvorak, executive VP at EHR system provider Epic Systems and a workgroup member, opposing Egerman’s view believes that FDA will not be best organization to make people feel comfortable in coming forward to report incidents. In fact, he strongly believes that FDA’s QSR process will fail to resolve the problems mentioned by people in a recent workgroup testimony.

Speaking in favor of FDA association, Egerman reminds ONC’s restricted access to governing EMR certification and he insists that FDA’s probe into the certification will help them to use software which enables them to help pharmacies that can't process cancellations or give compliance data back to physicians. Accepting the pros, Egerman acknowledges that there are a few cons also associated with their association with FDA. First of all, Egerman knows that some FDA processes might be disincentives to innovation and will add a whipping "a six-figure cost" to the company.  

According to the other members of the workgroup committee, FDA’s functioning begins only after death or serious injury of the customers whereas ONC tries to develop a system that attempts to resolve mere unsafe conditions also.

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