With more than 97,000 mobile medical apps currently available and the industry expected grow to $26 billion by 2017, some are calling for the government to finalize guidance or adopt rules that will regulate the safety and security of this technology. Two types of medical apps are in use: they either allow consumers to take a more proactive approach to their health by, for example, keeping track of calories consumed each day, or serve as remote monitoring and testing devices that can assess heart and breathing rates or provide more sophisticated medical diagnostics by reading self-administered tests.
The Food and Drug Administration (FDA) issued draft guidance in 2011, focusing on apps used for clinical purposes and explaining how the agency interprets its statutory authority as to the apps it can regulate. While some groups have called for the agency to finalize the guidance quickly, others suggest that it should wait until a working group examining a framework for regulating health information technology under the Food and Drug Administration Safety and Innovation Act of 2012 releases its report in early September 2013.
A consumer advocacy organization reportedly conducted a study and reported in July that many medical apps do not encrypt sensitive data and they frequently share data with advertisers or other third parties without users’ knowledge. The Privacy Rights Clearinghouse has apparently recommended that federal regulators step in to oversee the privacy and security of personal information. See CQ Healthbeat News, August 15, 2013; The Kansas City Star, August 26, 2013.