Bradley Merrill Thompson: The Need for More Balanced Enforcement of Mobile Medical App Regulations

The Need for More Balanced Enforcement of Mobile Medical App Regulations In this 2-minute audio snippet, Bradley Merrill Thompson, Member of the Firm at Epstein Becker &amp Green and General Counsel to the mHealth Regulatory Coalition, describes a urine analysis mobile app that illustrates why the mobile health app industry needs more consistent and balanced FDA enforcement of mobile regulations.

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Thompson points out that the app declared itself NOT to be a medical device. “If only it were that simple,” said Thompson.”

Other resources:

• How Did the uChek iPhone Urine Analysis App “Come to FDA’s Attention?” – Blog post
• Beyond Mobile Medical App Guidance: What to Worry About After FDA Publishes Its “Final” Guidelines – PMT podcast