The federal government, in its new report on creating a risk-based regulatory framework for health information technology, focuses on the functionality of HIT products, not the platform whether it be cloud-based, installed or mobile.
Consequently, the framework from the Food and Drug Administration, Office of the National Coordinator for HIT and Federal Communications Commission identifies three categories of functionality: administrative, health management and medical device functions. Having these categories can help avoid regulatory duplication and prompt discussions to identify and clarify areas of ambiguity where it may be unclear where to categorize a particular function, report authors explain. Electronic health records, for instance, may have functions that span more than one category, as would privacy and security functions.
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