Outside FDA, Inside the Crosshairs: Cybersecurity Risks for General Wellness and Fitness Products

This final installment explains that even when a product qualifies as a low‑risk general wellness product outside FDA premarket cybersecurity regulation, developers remain subject to significant cybersecurity and privacy scrutiny — notably the FTC Health Breach Notification Rule, HIPAA, and state breach-notification laws — and must meet overlapping timelines and “reasonable security” expectations to avoid enforcement risk.