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Pending Mobile Medical Apps Guidance Provokes Heated Controversy

An impassioned debate brewing about FDA’s planned timing for finalizing mobile medical apps guidance bubbled to the surface at a recent meeting of the HHS workgroup tasked with recommending a health IT regulatory framework. Despite pressure to delay the guidance, FDA says it is still pushing ahead.

An HHS-sponsored workgroup convened a conference call last week to discuss its recently released draft recommendations for a comprehensive regulatory structure for health information technology. They ended up spending more time than expected on one very specific point: the timing of FDA’s release of a final guidance on regulating mobile medical apps.

A debate has been brewing about whether FDA should move full steam ahead in issuing the final guidance establishing its...

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