Mobile Medical App Regulations On the Move – Proposed Bills to Further Alter the Regulatory Landscape of Mobile Medical Apps

Mobile Medical App Regulations On the Move – Proposed Bills to Further Alter the Regulatory Landscape of Mobile Medical Apps

Apple’s apps store lists close to a 100,000 health apps.  Together with wearable technology, direct-to-consumer testing services, and greater consumer participation in the decision to purchase health insurance, the healthcare market in the United States is undergoing a significant transformation.

Mobile Medical App Regulations On the Move – Proposed Bills to Further Alter the Regulatory Landscape

By | FDA Law Update | April 1, 2014
Mobile Medical App Regulations On the Move – Proposed Bills to Further Alter the Regulatory Landscape

Apple’s apps store lists close to a 100,000 health apps.  Together with wearable technology, direct-to-consumer testing services, and greater consumer participation in the decision to purchase health insurance, the healthcare market in the United States is undergoing a significant transformation.

FDA Delivers Its First Mobile Medical App Inquiry

The Food and Drug Administration has taken its first action against a mobile app maker for failure to obtain pre-marketing clearance. Late last week the FDA sent a letter to Biosense Technologies Private Limited, asking the company to either identify an FDA clearance for its uChek urine analyzer app or explain why it does not believe that FDA clearance is required.