Swedish Health Authority Says Beware of Unapproved Apps

Sweden’s Medical Products Agency is asking consumers to check whether their mobile medical apps are CE Mark approved.

The reminder comes after reports that certain mobile apps that should be regulated as a medical device are being marketed unlawfully without the required CE Mark.

In a statement, the regulator notes there is a growing number of health and lifestyle apps, many of which offer tips on exercise and training, that are not considered medical devices. However, others are marketed as a way to diagnose or treat a disease or injury, or to examine a physiological process. Examples include those for conception and pregnancy and those for helping with a functional impairment. These should bear the CE Mark.

The MPA is assessing the boundaries between medical and nonmedical apps and will work with international regulatory bodies on the issue. Earlier this year, U.S. regulators cracked down on two companies that claimed their apps could help diagnose skin cancer. The Federal Trade Commission announced settlements with New Consumer Solutions, developer of the Mole Detective, and Health Discovery, which markets MelApp, both of which purport to check moles for melanoma symptoms. (IDDM, Feb. 27). ― Elizabeth Hollis