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.
More Articles on FDA regulation:
HIMSS Weighs in on FDA Regulation for Health IT
SOFTWARE Act Gets Mixed Industry Response
New Bill Would Clarify FDA Regulation of Medical Software
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