Fitness wearables are all the rage, but the sector is quickly moving into ugly territory. The Food and Drug Administration (FDA) regulates hard-core medical devices, but wearable manufacturers have been pushing the envelope toward health management. It should be no surprise that the FDA is now floating a "General Wellness: Policy for Low Risk Devices," but I think the agency and the medical profession need to chart a third path between no regulation and medical devices.
The FDA's draft guidance in circulation for "nonbinding recommendations" regarding low risk general welfare devices apply to things that have "(1) an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition."
Yah, it's like that. It appears so long as fitness and health wearable manufacturers use the key phrases "may help to reduce the risk" and/or "may help living well with" certain chronic diseases or conditions as a part of a healthy lifestyle, they will not run afoul of the FDA, so long as the device is not invasive – i.e. requiring a needle or implantation – doesn't include technology that may pose a device to a user's safety if device controls are not applied; raise novel questions of usability; or raise questions of bio compatibility.
Bio-hackers looking to implant RFID chips and computers into themselves clearly aren't going to be covered under the “General Wellness Low Risk Devices” policy. Anyone with a Fitbit or other smart device tracking steps, pulse rate and the like, as well as associated apps will be OK.
However, there are already devices out there that could easily go beyond general wellness and into medical applicability without any changes, while more could be added via software or service tweak.
Exhibit ‘A’ for dual-use tech that could be used for both fitness and health is the Fitlinxx (News - Alert) AmpStrip. It's a $149.95 wearable heartrate monitoring strip solution. Weighing in at 0.4 ounces, put AmpStrip on the lower left ribcage to track heart rate and activity around the clock; tracking exercise load, skin temperature and posture. Shower with it, swim with it, sleep, do whatever for three to seven days with its long-lasting adhesive keeping it in place.
Since it is a 24x7 monitor, it provides tracking of things such as resting heart rates and recovery. Data is stored within the single-lead ECG device, with Bluetooth downloading to the phone and the cloud.
While it is not an apples to apples comparison, the stock cardiologist Holter Monitor lists around $1,400 dollars for the hardware alone – you don't buy it; you simply "rent" it, with an average cost of $350 for the test. The monitor provides "better" monitoring data with five to seven different points, but only records data at 24 to 48 hours at a time. But you can't get anything wet and you walk around toting around a device and the assorted wiring for the electrodes strapped along your torso. If you roll over and accidentally pull one of the leads, you have to start the test over again—so another day or two without bathing.
Clearly, from an ease-of-use standpoint, the AmpStrip wins big-time. It's cheap enough that you could give anyone checked into the hospital for most any invasive procedure to provide pre and post-surgical heartrate monitoring. And, attending staff can download data according.
Would this low-cost effort save lives and increase catching post-surgery cardiac irregularities? Nobody's done a study. It will probably take five to seven years to even get a study together, get the results gathered, published in one or more journals and finally lead to FDA certification trials. In that same time, the AmpStrip will probably be into its third hardware iteration.
The FDA and/or the medical establishment should propose a protocol for "off-label/acceptable use" of wearable fitness devices for diagnostic and therapeutic applications. While this will be viewed as a threat to existing (and expensive) medical device manufacturers, it also has the potential to lower the cost of medical care and result in improved outcomes – saved lives, and shorter hospital stays.