mHealth Intelligence April 21, 2020
The US Food and Drug Administration is easing pre-market certification requirements for new mHealth apps and telehealth tools designed to help patients and providers access mental health resources during the COVID-19 emergency.
With the Coronavirus pandemic putting a strain on the mental health of both patients and providers, federal officials are easing up on regulations for mHealth and apps and telehealth services to push more telemental health services to market.
Earlier this month, the US Food and Drug Administration issued new guidance in the wake of the COVID-19 emergency that relaxes pre-market certification on certain Class 2 prescription-only connected health tools, such as apps and devices, that are designed to treat depression, anxiety, insomnia and other conditions. The guidance also...