By Peter MacKay, Solutions Architect, Wind River


2011 is turning out to be an evolutionary year for the growing mobile healthcare industry.  In 2007, the iPhone, while not the first handheld applications platform, arguably revolutionized the way modern consumers use telephones.  Around this time healthcare visionaries also foresaw the integration of what I call “user space” with medical enterprises, and a general change in the way ‘patients’ interact with providers – or even take charge of their own wellness.  In addition, the Continua Healthcare Alliance was born, a consortium uniting healthcare and technology companies to focus on standardizing connected devices.  I predict this standardization will drive commoditization (as the inverse – utilizing consumer platforms in healthcare – takes hold), and the Android platform has accelerated this movement.


What makes 2011 “evolutionary”?  Clearly there are regulatory implications when healthcare applications co-exist with consumer platforms.  In February, the FDA ‘finalized’ guidance on Medical Device Data Systems (MDDS), an initiative it had started in 2008.  On July 21, the FDA released draft guidance on mobile medical applications, perhaps influenced by the mHealth Regulatory Coalition which was created to work with the FDA to write a guidance document that addresses what gets regulated and what does not.


While the February ruling defines MDDS and its intended use, the latest guidance further discerns a “mobile” application.  It calls out two categories of applications: an app intended for use with a regulated device, and an application intended to transform a mobile platform into a healthcare platform – with “intended use” claims being the qualifier.  The guidance excludes app stores and their operators, but expects service providers to cooperate with manufacturers in correction or removal actions.


What the FDA is trying to do with this guidance is encompass anything that poses a threat to the safe and effective operation of medical devices, so if you’re in the business of positioning your mobile apps toward healthcare providers, or even patients as end users, it will be important to pay close attention to this regulation and take the necessary steps.  This new guidance is a draft with 90-day commentary period, so if it affects your business act now or forever hold your peace!



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