By Jason Keller
Many people have caught wind of the recent FDA draft social media guidance that was announced that addresses character limits and correction of misinformation. But there hasn’t been as much stirring on the other guidance that was recently posted.
And what draft guidance would that be?
According to FDA’s blog, the FDA has come to the conclusion that “medical device data system products pose little risk.” Essentially, the FDA is doing some serious deregulation on certain medical devices “to encourage greater innovation in the development and maturation of these systems.”
So what is a “Medical Device Data System” (also known as MDDS)? According to the FDA, an MDDS is a device that “transfers, stores, converts, and displays a variety of information from medical devices critical to understanding an individual’s health.”
Some heavy hitters in the technology space, like Apple, Samsung, and Google have been announcing their play in the MDDS space. Deregulation of MDDSs will help these tech giants connect the monitor function of their devices with the display function without having to worry about federal oversight.
This news from the FDA could be a strong catalyst in an already emerging health monitor market. Whether you refer to it as a “fitness app,” a “health monitor,” or “wearable technology,” it is being talked about… a LOT. In May, these terms came up in Twitter conversation nearly 100 thousand times!*
There’s good reason for all the commotion – As the FDA says, “doctors and their patients are more frequently using computer systems to collect medical data that can provide useful information on a patient’s health.” This is a trend that isn’t going anywhere, and one that will likely impact how you manage your personal health in the extreme near future.