Who Is Liable When Your Health App Gets It Wrong

Episode 20 of The Digital Health Podcast explores a growing legal tightrope: who pays when a wearable or an algorithm misses a diagnosis? Lucas and Luna break down the 2025 case of a consumer-grade ECG patch that failed to flag a cardiac event, and how the FDA, device makers, and doctors are all pointing fingers. They walk through the distinction between software as a medical device and general wellness products, and why the liability gap is widening as more health data flows through apps, not clinics. Specific focus on a Florida lawsuit where a patient sued a smartwatch maker and a telehealth platform after a missed arrhythmia — and how the court ruled. No hot takes, just the legal architecture that every startup building health software needs to understand. #DigitalHealth #HealthTech #MedicalLiability #FDA #Wearables #ECG #Telehealth #SoftwareAsMedicalDevice #GeneralWellness #ProductLiability #HealthData #StartupRisk #Business #Technology #FexingoBusiness #BusinessPodcast #HealthSoftware #Regulation Keep every episode free: buymeacoffee.com/fexingo