In a bid to promote access to healthcare data, officials from the FDA’s Center for Devices and Radiological Health (CDRH), reiterated Tuesday during a webinar covering the final guidance on medical device data systems (MDDS), that technologies that receive, store or display data from medical devices are of such low risk that they no longer need to be strictly regulated by the agency.
The FDA in 2011 had already issued a final rule reclassifying MDDS from class III (high risk) to Class I (low risk) devices. Tuesday, Bakul Patel, CDHR’s associate director for digital health, said that in “taking a harder look” at medical device data system and medical image storage and communication device rules, the FDA concluded:
- These types of products included in the regulations are really considered low-risk, and are already classified as Class I.
- Systems that record, share, and use medical device data have become a significant portion of a connected healthcare system.
- Inter-communication functionality is foundational in an interoperable digital health ecosystem.
Consequently, Patel explained, in June 2014 FDA proposed a guidance that “basically said we will take a hands off approach to these types of devices that are identified in medical device data systems, and medical image storage and communication regulations.”
The final MDDS guidance was issued February 9. In it the FDA pointed out that since it has determined that these devices pose a low risk to the public, it “does not intend to enforce compliance with the regulatory controls that apply to MDDS devices, medical image story devices and medical image communications devices.”
In a blog accompanying the posting of the final guidance, Patel and CDRH Director Jeffrey Shuren, M.D., wrote “we hope that finalization of this policy will create an impetus for the development of new technologies to better use and display this data.”
At the same time the FDA updated its guidance for mobile medical applications in order for it to be consistent with the MDDS guidance document.
According to the updated mobile medical application guidance, mobile apps that are not intended for diagnostic image review (for example, an image display for a patient consultation) will be considered medical image communications devices, which the MDDS guidance now puts under enforcement discretion—meaning the FDA won’t regulate them.
“FDA is certainly sticking to its word, working to down-classify or altogether exempt low-risk software-based technologies,” said Bradley Merrill Thompson, an attorney with the firm Epstein, Becker & Green in Washington D.C, who counsels medical device, drug and combination product companies on FDA regulatory, reimbursement, and clinical trial issues. “The implications are profound, both for MDDS type software, but also for what it suggests about the future for health information technology generally.
“FDA is quite earnestly working to ensure that it uses the lightest regulatory touch appropriate for software,” Thompson added. “It's exciting, because it means that innovation in this space can truly flourish. This is a very natural extension from the recent FDA guidance on accessories where FDA acknowledges that the risk associated with an accessory is not necessarily the same as the risk of the parent medical device.”