In 2016, more than 165,000 health and wellness apps were available through the Apple App Store, but only a small fraction of them are subject to FDA regulation. According to Dr. Ostherr, this should concern the Americans whose data are housed in these apps.
“Members of the general public, including patients, have begun to play a newly important role in collecting data about health and disease,” Dr. Ostherr told Science Daily. “With the rise of mobile apps and the growth of smartphone and wearable-device use, people’s daily lives have become experiments ‘in the wild.'”
Federal and state policies govern how personal health data is shared and also set boundaries between traditional clinical settings and those outside these settings, Dr. Ostherr explained. But depending on how the FDA categorizes an app, the health-related data it collects might not be protected under these policies.
Almost all of these apps — whether they are subject to FDA regulations or not — are “capturing tons of personal data, some of which would be classified as personal health information if it were subject to oversight by [HIPAA],” Dr. Ostherr told Science Daily.
The chance the data from an unregulated app could end up in a clinical setting where a patient could benefit from a physician’s review is “almost nil,” she told Science Daily.
More articles on supply chain:
5 latest FDA approvals
Dr. Reddy’s recalls 500k+ bottles of ulcer drug: 4 things to know
Analysis: Up to 20% of pharma brands are shifting advertising focus to the point-of-care
