Mobile Medical Apps: A Market on the Move | MIT Technology Review

By MIT Technology Review Custom on November 18, 2014 | In partnership with Sagentia

No question about it: The world wants mobile medical apps (MMAs)—and demand won’t slow down any time soon.“The demand for remote patient monitoring is growing dramatically,” says Jeannette Tighe, from the HealthTech Advisory practice at Sagentia, a global technology advisory and product  development company headquartered in Cambridge, U.K.

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.

Read more: Mobile Medical Apps: A Market on the Move | MIT Technology Review.

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