Premom Fertility App Faces Wrongful Data-Sharing Suit
The app allegedly shared sensitive customer information with three China-based data analysis and collection firms.
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With the increasing concern for people’s mental health as they cope with the COVID-19 crisis, the US agency has relaxed regulations for apps that are intended to treat disorders such as anxiety, depression and insomnia. Certain digital health products would not require a 510(k) clearance during the crisis to enter the market under an immediately-in-effect 15 April guidance document.
Manufacturers faced with an increasingly complex landscape of state patient-privacy laws may opt to comply with federal Health Insurance Portability and Accountability Act regulations instead, attorney Brad Rostolsky tells Medtech Insight.
The special controls are to include biocompatibility, sterility and performance testing, as well as physician training and warning labels.