The FDA, in conjunction with other administrative agencies, has released a new report that describes its strategic plan for regulating health IT devices. The report suggests three different categories of health IT, based on the risks associated with each type. The lowest-risk category is administrative health IT functions. This includes software for admissions, scheduling, and practice management. The FDA has indicated that health management health IT functions pose a slightly higher risk. These include clinical decision support and medication management tools. Finally, the FDA identified medical device health IT functions, such as robotic surgical control and computer-aided detection software, as high risk areas.
The FDA has indicated that it will focus its attention on medical device health IT functions, and does not see a need for further regulatory oversight over the other two areas at this time.
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