- Two of the FDA's thought leaders on mHealth and health IT have mapped out how all of the FDA's recent guidance—proposed and finalized—fits together into a less-regulated, more innovative mHealth marketplace for patients, according to a new blog item on the FDA site. The blog was co-written by Bakul Patel, Associate Director for Digital Health in FDA's Center for Devices and Radiological Health and Jeffrey Shuren, MD, JD, Director of FDA's Center for Devices and Radiological Health.
- The agency has finalized its guidance on medical device data systems, confirming its intention to give a free regulatory pass for technologies that "receive, transmit, store or display data from medical devices." Further, the agency proposed not to examine regulatory compliance for low-risk devices that are "designed to maintain or encourage a general state of health and may associate a healthy lifestyle with reducing the risk or impact of certain diseases or conditions," stated the blog.
- Combined with last month's draft guidance that distinguished between parent devices and accessories for those devices for the purpose of rating the risk of both, the agency believes it has crafted a regulatory roadmap that it hopes will "advance public health by promoting innovation and development in this area by continually adapting our regulatory approach to technological advances to meet the needs of patients and consumers."
The FDA's laissez-faire attitude toward mHealth can't be addressed without mentioning the agency's critics who complain that it has given a free pass to Big Pharma for the last six years. Whether those same criticisms can be applied here is still up for debate.
The technology industry is not used to the level of regulatory scrutiny given to the healthcare industry. The regulations that healthcare executives regard as another day at the office would be seen as draconian, almost medieval rules of engagement designed to choke off innovation and development cycles in Silicon Valley. So, while the FDA's approach is not a surprise, but its attention to detail is.
In distinguishing between parent devices and accessories, the bloggers wrote, "For example, an accessory to a Class III parent device may pose lower risk that could be mitigated through general controls or general and special controls and thus could be regulated as Class I or Class II." In other words: You can have an iPad, but buying aftermarket hardware or extensions that turn that iPad into an EHR portal makes the parent device a different device than it was before the accessory.
Meanwhile, privacy advocates would like the leash to be tighter. Congress may well pick that up in its 21st Century Cures legislation, so the door isn't closed on privacy concerns just yet.