Posted by:Richard Smith February 17th, 2014
There has been much made of the FDA’s announcement that they will regulate custom mobile apps used in healthcare settings. Along with HIPAA regulations surrounding privacy of patient information, this threat of regulation caused some confusion and hesitation for developing mobile apps to be used for health care purposes.


The FDA issued guidelines last September. They segregated mobile apps into two categories, one which would be regulated, the other which they did not intend to regulate.

Apps the FDA will regulate:
  • Apps that are an extension of a medical device by connecting to such devices for purposes of controlling the device or displaying, analyzing or transmitting patient-specific medical data. An example is an app that might control an insulin pump.
  • Apps that convert the mobile device into a regulated medical device by using attachments, display screens or sensors similar to those of currently regulated devices. An example would be attaching a blood glucose strip reader for the mobile phone to function as a glucose meter or an app that uses the built-in accelerometer to collect motion information for monitoring sleep apnea
  • Apps that provide patient-specific analysis, diagnosis or treatment recommendations.
Apps the FDA does not intend to regulate:
  • Apps that provide or facilitate clinical care by coaching or prompting patients to manage their health in their daily living environment
  • Apps that provide patients with simple tools to organize and track their health information
  • Mobile apps that provide easy access to patients’ health conditions or treatments
  • Apps that help patients document, show or communicate to providers potential medical conditions
The regulated apps are in a position of trust and that the apps is counted on to either deliver medicine, monitor the patient’s vitals or make a medical decision about patient care. In the non-regulated category, the app supports communication between patient and provider and humans are in control, the app is just facilitating communications.

Regardless of the kind of app, mHealth apps are turning to be a gamechanger for healthcare today. I welcome your thoughts

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