MedCity Influencers

Safety and Efficacy in mHealth

Haptique just released their long awaited released its final standards for testing and certifying mobile health apps. While it represents a good start I was disappointed that it doesn’t do more. Haptique wants to help “healthcare providers and consumers easily identify medical, health and fitness apps that deliver credible content, contain safeguards for user data […]

Haptique just released their long awaited released its final standards for testing and certifying mobile health apps. While it represents a good start I was disappointed that it doesn’t do more. Haptique wants to help “healthcare providers and consumers easily identify medical, health and fitness apps that deliver credible content, contain safeguards for user data and function…” It tries to do this in a fashion that’s consistent and doesn’t compete with the FDA and guidance for regulation of mobile medical apps. What I’m afraid it won’t do is help much in understanding whether the apps actually do some good.

The standards have been divided into four sections: Operability Standards, Privacy Standards, Security Standards and Content Standards. The first three, while Important, speak to demonstration of baseline acceptability for an application that deals with those information that is related to health and/or healthcare.

It’s the Content Standards that leave me wanting more. They do speak to consistency with basing the application with credible and up to date information (C1 – C4, C6, and C7), that the application is consistent with established practices and appropriate to its intended audience (C8-C11). Only one standard (C5) speaks to the requirement that any results it produces are accurate and consistent.

All of this is better than not having standards but there is nothing in these standards that speak to whether or not the apps actually do any good. mHealth can’t indefinitely exist as a promising concept. It needs to start delivering actual substance and that requires an infrastructure that helps define value and provides methods for demonstrating that value. My concern is that app developers may start using adherence to the Haptique standards as evidence of value.

The Haptique standards speak in large part to safety but it barely touches on efficacy. Yet, if mHealth is to succeed in helping transform health and healthcare, it needs to show a demonstrated and reliable delivery of value.

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