The FDASIA report described a risk-based regulatory framework by which health IT regulation would be approached. Rules issued by the FCC outlined how dedicated medical body area networks will be built and managed.
The FDA and FCC recently announced plans to establish medical wireless test beds that would allow novel connected health solutions to be tested under a variety of conditions. They will be holding a public workshop, in conjunction with the Connect2HealthFCC Task Force, to discuss these test beds as well as a “medical testing license” that will allow health care facilities to conduct clinical trials of novel medical devices.
As Robert Primosch, attorney at Wilkinson Barker Knauer, LLP in Washington, D.C. and Co-Chair of the Federal Communications Bar Association’s Telemedicine Committee, described the event,
The FCC has envisioned that wireless medical devices could be tested both “on site” at medical facilities, and elsewhere. For example, the medical testing license will permit testing when patients are confined to their homes, or are ambulatory but using implanted or body-worn medical devices. In the FCC’s view, “this flexibility is necessary to ensure critical functions for many medical devices – such as remote monitoring, device tolerance to potential interference sources, and patient ability to use devices without the benefit of assistance as critical aspects of experiments conducted outside of medical campuses.”
Additional topics may include the need for and scope of wireless medical device test beds, an overview of current public and private test bed programs and initiatives, a discussion of ideal features, functions and gaps of such programs, and how best to drive innovation and safe co-existence of wireless medical technologies.
One thing we often hear are statements from our colleagues and readers that generally start with “wouldn’t it be great if…” and then go on to describe how currently silo’ed devices could communicate with each other or capture novel types of physiologic data remotely on a patient. The policies being set by federal agencies like the FCC and FDA will ultimately shape what those systems will look like, which ones are feasible, and how patients are protected as they are rolled out.
For more information on this public event, check out the announcement from the FCC.