Health IT Safety Center
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Health IT: The Coming Regulation
The Food and Drug Administration has spent decades refining its processes for approving drugs and devices (and is still refining them), so what would happen if they extended their scope to the exploding health software industry? The FDA, and its parent organization, the Department of Health and Human Services, are facing an unpleasant and politically difficult choice.
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CDC on EHR Errors: Enough's Enough
The Centers for Disease Control and Prevention does not routinely get involved in telling hospitals how to run operations, but with increasing reports of EHR deployment problems, the Atlanta-based operation now sees the need to act.
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HHS Publishes FDASIA Health IT Report
HHS released a draft report that includes a proposed strategy and recommendations for a health information technology (health IT) framework, which promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally mandated report was developed in consultation with health IT experts and consumer representatives and proposes to clarify oversight of health IT products based on a product’s function and the potential risk to patients who use it.
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Three Areas Where Health Information Technology Needs to Get its House in Order
Health reform is taking off, thanks to pressure from insurers, the promise with which innovative technologies tease us for low-cost treatments, and regulatory mandates dating back to the HITECH act of 2009. Recent hopeful signs for wider adoption of health technologies include FDA forebearance from regulating consumer health apps, calls for more support for telemedicine, and new health announcements from tech giants such as Apple and Google. While technologists push forward in all these areas, we need to keep in mind that several big unsolved problems remain. Let's not get lost in the details--these major issues have to be tackled head on. Read More »