Letter of Opposition for the Preventing Regulatory Overreach To Enhance Care Technology (PROTECT) Act of 2014
The Patient, Consumer, and Public Health Coalition strongly opposes the Preventing Regulatory Overreach To Enhance Care Technology (PROECT) Act of 2014. The Act, as drafted, would have the harmful consequence of exempting so-called “health software” and “clinical software” devices from FDA oversight. Also, the Act is premature. Congress is awaiting a study commissioned in 2012 to guide policymakers on this very issue.
