“Last Friday, we argued that the Feds are obligated to assure the safety and effectiveness of electronic health records, since they are using taxpayer dollars to accelerate their dissemination (via HITECH).
We also argued that pre-market approval–the regulatory strategy used by the FDA to assure safety and effectiveness of medical devices–is not a viable strategy to use in the case of EHRs, since it would interfere with the HITECH-mandated goal of rapidly deploying EHRs throughout our health system.”
Article
Glenn Laffel, EHR Bloggers, 1 March 2010
