Today, the U.S. Food and Drug Administration indicated their current thinking, which considers lowering the enforcement compliance with regulatory controls on certain technology by deregulating the space between medical devices and information systems.
This is a big deal, and follows a balanced approach to regulation outlined through the FDASIA process, where risks are weighed against their potential benefit, indicating the agency is continuing to take a thoughtful approach to regulation.
The FDA issued draft guidance on its intent to effectively deregulate the space between medical devices and information systems – those interfacial pieces formally considered under the Medical Device Data System (MDDS), medical image storage devices and medical image communication devices.
What does this mean in the real world?
Imagine you are a small medical device company building a display for data flowing from an implanted glucometer, or other monitor of patient’s vital signs. Per FDA’s draft guidance, the agency is proposing that software can now send that information directly to a cell-phone for display, saving many months and lots of development dollars, without concern that the cellphone would become part of the regulated device. And the phone doesn’t have to be categorized and cleared as a Class I medical device, meaning we could see more rapid innovation and more cost-effective products.
This change will also help enable medical device interoperability, as under the prior framework, any device or software construct that created interoperability by moving medical device data to achieve interoperability between systems would have been regulated by the FDA as a Class I device.
We at West Health applaud the FDA’s current thinking on this topic for two reasons. First, it recognizes the low risk and high potential benefit of the intersection between IT and medical devices. We are “allin” when it comes to creating medical device interoperability, for all of the savings in time, money and lives that it can enable. Having the Internet replace the ‘sneakernet,’ where nurses and clinicians are forced to transfer data manually between devices and systems, will be a welcome change in healthcare.
Second, the proposals under this draft guidance honor the open, stakeholder-driven FDASIA process and the resultant risk-based framework. It would be hard to imagine getting such a talented and dedicated group together again if their good work was not reflected in subsequent action.
This guidance is also very timely, as it is released just days in advance of the House Energy and Commerce meeting on using emerging digital technology to unleash 21st century cures. When looking for ways for the government to foster innovation, judicious de-regulatory actions and iterative adjustments in guidance such as this represent an effective and expedient means for the government to support innovation.
It is worth noting that this action is completely in line with the White Houses’ Todd Parks’ familiar battle cry of ‘data liberacion.’ Isn’t it time we let the Internet that has changed everything else, change healthcare?