TTA Archives 2005-2012

The Washington Post takes a peek into Pandora’s Box…what FDA regulations can mean to companies innovating in the health IT field. There’s nowhere to hide, although many companies may qualify under the MDDS rules [TA 15 Feb] into Class I rather than the more restrictive Class II 510(k) or even Class III. Even so, FDA cannot move quickly, although Bradley Merrill Thompson and the mHealth Regulatory Coalition are trying to help them ‘balance innovation against the patient’s safety’. Merrill Matthews Jr., a health ethicist and visiting scholar at the Institute for Policy Innovation, sums up the conundrum: “Some of these new technologies coming out, you’re on 3.0 or 4.0 before the FDA would even realize you exist and begin to figure out whether [regulation] is going to be applicable.” For health IT firms, regulatory questions abound Hat tip to Kelly Besecker of AFrame Technologies, which wound up in Class II.