The Food and Drug Administration in the US has a lot of responsibility to protect and advocate for consumers. And one department in the FDA, the Center for Drug Evaluation and Research (CDER), regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
The number one issue for aging consumers is the lack of privacy related to sensitive medical information and other data that wearables like Fitbits and heart monitors bring without proper oversight. This is part of the reason for the FDA’s Digital Health Innovation Action Plan (DHIAP), which is meant to speed up the evaluation process for digital health technologies and allow the FDA to better focus on high-risk products.
