U.S. Food and Drug Administration Archives

FDA-approved mHealth substance abuse treatment app now available

11/29/201811/29/2018 Amanda Giasson

The reSET mHealth platform is available for healthcare providers to prescribe to their patients. A mHealth substance abuse treatment app called reSET is the first digital therapeutic treatment for substance abuse disorder to be granted approval by the U.S. Food and Drug Administration (FDA). This unique digital treatment platform can now be prescribed to patients by their medical providers. The prescription-based digital therapeutic offers a 12-week treatment plan. Developed by Pear Therapeutics, the mHealth substance abuse treatment app offers patients a 90-day (12-week) treatment plan. The plan features interactive treatment…

Mhealth will be defined by regulatory issues in 2013

01/01/201304/11/2014 L. Green

Attorneys are cautioning that this year will face significant changes in rules. With 2012 behind us, the first year in which mhealth played an important role in patient education and care has come to a close, and this year will open up new opportunities for both the use of the technology and for its regulation. There were already regulatory issues for mobile health in 2012 and these will carry over into this year.