Last week, FTC Commissioner Julie Brill stated that she was concerned about the nature of health tech, particularly health apps. She is afraid that the data collected by these apps, and their connected devices, might be used to predict future health conditions. Because of this fear, she believes that health tech should be regulated heavier, with her leading a charge to do just that.
Of course, she is right that data-based predictions are a reality, as that is exactly why these products exist. Why else would you gather and record this type of data if you weren't interested in using it to predict possible patterns and health concerns? Fortunately the Food and Drug Administration agrees with me and not the FTC, changing policy on pre-market approvals.
The organization has announced a plan to lift restrictions on several types of health devices, including direct-to-consumer products, many of which are connected with apps. These devices include exercise equipment, fertility diagnostic devices, hearing aids, talking first aid kits, thermometers and stethoscopes. The FDA said in regards to the new plans,
The FDA believes devices... are sufficiently well understood and do not present risks that require premarket 21 notification (510(k)) review to assure their safety and effectiveness.
This advisory does not go into effect immediately; the FDA has opened up a 60 day comment period before it goes from advisory to policy. Hopefully, for the sake of all of the mobile and wearable tech startups out there with unique and interesting ideas, this will not only become policy, but will be opened up even further.