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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 oversight plan for health care apps, or should wait for the HHS-wide effort to map out a broader health IT regulatory framework, which, some suggest, could include a lesser role for FDA

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