Here's a bit of news sure to be unpopular at the third-annual Health 2.0 Conference that's set to begin Tuesday in San Francisco (without FierceHealthIT present, unfortunately): The FDA has scheduled a November hearing on how manufacturers of regulated medical devices use the Internet and social media, including blogs, social networking sites, wikis and video sharing sites.

"FDA's authority is exceptionally broad," healthcare attorney Bruce Merlin Fried writes in an iHealthBeat column. "This authority, taken to the present, gives FDA authority to regulate certain health IT, specifically regarding its safety."

Fried notes that there are two instances in which the FDA might need to regulate health IT processes for safety reasons: if a process is too complex to be done manually or if the demands of immediate intervention leave clinicians overly reliant on computers. The latter might cover clinical decision support in an emergency department. "One can easily imagine that on a Saturday night in a large urban hospital ED or in the midst of a mass casualty event, an ED clinician may look to the decision support software in making snap clinical decisions," Fried says.

With that in mind, the health IT community might want to plan on sending representation to testify at next month's hearing.

For more:
- read Fried's iHealthBeat column

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