By MIT Technology Review Custom on November 18, 2014 | In partnership with Sagentia
The Regulatory Pathway
The U.S. Food & Drug Administration (FDA) has created three categories of MMAs:
1. Unregulated: This lowest tier consists of wellness-focused apps such as exercise trackers and heart-rate monitors that many consumers use in their fitness regimens.
2. Enforcement discretion: This middle category includes disease-focused apps that work as simple professional calculators (for instance, measuring and calculating mean arterial pressure, or assessing a Glasgow Coma Scale score); or that provide coaching for patients with conditions such as cardiovascular disease, hypertension, diabetes, and obesity.
3. Regulated: This highest tier consists of specific patient- or disease-monitoring and treatment-responses, such as infusion pumps, which act as medical devices and could cause harm to patients if faulty.