but many of them have been answered, thanks in large part to the work of the American Telemedicine Association and others in this space.
In fact, the regulatory environment proved to be the most popular discussion point doing our panel. The FDA is still struggling to keep up with the pace of technological change and how it affects the delivery of healthcare. The recent publication of guidelines on Mobile Medical Applications has been a good start, but the FDA’s stand on clinical-decision support software is still in limbo with no guidance expected for at least another year. This is causing problems for a large number of companies, ranging from those developing big data algorithms to better predict heart attacks to companies like ours that are trying to increase compliance with current standards of care.
Uncertainty is the absolute worst thing for an industry to be facing, and in order for technology to move forward clear regulatory guidance will need to be given—and soon. We need answers to basic questions such as, how will the FDA classify software that uses algorithms to treat patients? At what level of complexity do these algorithms start to require clinical trials?
Electronic Medical Record (EMR) systems have historically been exempt from FDA regulation, but as companies begin to create applications that manipulate all of this data for clinical support, do they open themselves up to regulatory scrutiny?
Technology now allows us to do business around the world. But if you are delivering healthcare remotely, how does liability change when the physician is in one legal jurisdiction while the patient is in another?
In the end, perhaps the reason the concept of telemedicine seems dated is because the technologies that make it possible have now evolved to such an extent that these innovations are simply part of daily life. One of my co-panelists, Jan Odegard at Rice University, said these technologies are so ubiquitous that they are essentially invisible. He’s right. Fifteen years ago, we assumed that the practice of telemedicine would require specialized and expensive video-conferencing hardware, customized monitoring equipment, and a hugely expensive data connection. Now, we just Instagram a picture of that funny mole and e-mail it to our dermatologist friend to take a look.
The telemedicine industry has advanced to a point where much of it is no longer recognizable as such, or that it has evolved to expand into a number of sectors, aided by technological advancements on the Web, the cloud, and in mobile. What had been specialized technology has now become mainstream.
Glenn Hammack, president and CEO of NuPhysicia in Houston, which specializes in web video-enabled telemedicine, and an active member of the American Telemedicine Association, said the group’s mission has always been to achieve its own obsolescence. “The goal is for it to stop being referred to as ‘telemedicine’ because it has become simply medicine,” he said.
