Authors of the federal governments proposed strategy of a regulatory framework for health information technology take pains to ensure stakeholders that the framework actually wont be heavy on regulation. For instance, there is no call for new or additional areas of Food and Drug Administration oversight. What the report makes clear is that the industry is expected to aggressively regulate itself.
We recommend a limited, narrowly-tailored approach that primarily relies on ONC-coordinated activities and private sector capabilities, report authors from the Food and Drug Administration, Office of the National Coordinator for Health IT and Federal Communications Commission say. For example, we do not recommend the need for any new or additional areas of FDA oversight. Rather, we believe a better approach is to foster the development of a culture of safety and quality, leverage standards and best practices, employ industry-led testing and certification, and selectively use tools such as voluntary listing, reporting and training to enable the development of a transparent learning healthcare environment that fosters continual health IT improvement. We do not believe that regulation should be, or needs to be, the first approach used to reach this outcome.
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