In a letter to HHS Secretary Kathleen Sebelius, the Electronic Health Record Association, a coalition of more than 40 EHR vendors, declared its support for the draft recommendations for Food and Drug Administration oversight of medical software and equipment.
The currently proposed regulations would not consider EHRs to be medical devices, and would not be regulated as such. The EHRA supports this decision: "We agree… regulation of health IT beyond what is currently in place is not appropriate until further analysis of data and the establishment of a risk-based framework have been completed," states the letter.
Additionally, the letter expresses EHRA's support for no additional health IT-specific regulation or oversight for technology with low or lower risk, including software with mainly administrative or financial functionality.
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