Sleep Wearables and Athletes: Legal Questions in the Digital Age
Sleep wearables fall into two large categories. Those that are regulated and those that are not. When a sleep wearable (an actigraph) is marketed and sold as a medical device, it must be FDA approved or cleared. These are often referred to as medical grade actigraphs and are usually about 92 percent accurate. Consumer-grade actigraphs are not or are not supposed to be marketed as a medical device, (e.g. WHOOP and Fitbit). They are not regulated by the FDA and are not subject to the rules for medical grade actigraphs. Validation studies are normally not published for these devices.
A team or athlete’s choice of actigraph is important, as unregulated actigraphs could be inaccurate. This could lead teams and athletes to draw erroneous conclusions, and even take inappropriate actions based on the data. For example, an inaccurate actigraph could show a sleep problem in an athlete where none actually exists, and vice versa.
Who interprets the data is also important as most of the people employed by sports teams have little or no training in sleep science and the interpretation of sleep data from actigraphs. Athletes’ “sleep files” often falls into the laps of strength and conditioning coaches who have no formal training in that area. Further, the strength coaches share this information with team management which has its own implications for the athletes.
Privacy of the data collected is an important and complex issue. If the sleep data is considered medical data, then it can be subject to HIPPA and state and local laws and the team needs explicit written consent to collect sleep data and share it with anyone besides the athlete. However, since most professional teams require broad health information waivers all team personnel can have access to all the sleep information.
In other words, if an athlete is not sleeping well everyone in management will know about it. Additionally, since actigraphs monitor movement 24/7 there is a lot more information that can be inferred about the athlete beyond how he or she sleeps. Athletes have often complained it gives team management a window into everything they are doing outside of team requirements. Consequently, all of this information has the potential to leak into contract negotiations with possible adverse consequences to the athlete. Some players’ associations have tried to protect athletes from this possibility through their collective bargaining agreements, but it is difficult to unsee such information.
Lastly, the ownership of the sleep data is also an important consideration that is usually overlooked. Suppliers of actigraphs normally require user agreements so that they can own, and/or sell the data collected. This can be individual data about a specific athlete or general data from all wearers of the type of actigraph. Teams and athletes are generally not even aware that their data can be used or owned in that manner.
Obviously, collecting, analyzing and using sleep data in a team environment is complex, although it is not always treated that way. Regardless of these issues though, I think that athletes and teams will continue to use sleep technology because they will continue to find sleep monitoring beneficial to their performance. And at the end of the day, that is the most important thing.
However, teams who currently collect sleep data or who are contemplating collecting such data should obtain appropriate legal advice and devise policies and procedures to protect both the team and the athlete.
Nothing in this article should be construed as legal advice. Please contact a lawyer in your state to obtain legal advice on these issues.
This is Part Two of AAST's The Technology of Sleep blog series. To read Part One, click here.