"In an ideal world, you could claim that's a good approach. But everything in life is actually a trade-off," he said.

"There's a degree of saying, the FDA probably needs to accept that in society going forward, patients need to take more responsibility for their own health care, and that means they're going to need to be allowed to use devices that might potentially do them harm," he said, much as they do with their (unregulated) diets.


When asked whether Hunn's ideas of a united front of business and patient groups lobbying for loosening FDA oversight would succeed, FDA law expert Thompson was cautious.

"Frankly, companies that have a collective interest in a given regulatory scheme would be wise to collaborate with one another on the regulatory environment," he said.

But he warned, "If their goal is simply to declare that their subject area is too important to regulate, too vital for the future of health care, I think their efforts are probably misplaced."

"The fact of the matter is, the FDA regulates an enormous amount of innovation. That's their job. That's what they do," he said.

He thinks the important question is not whether the technologies it is regulating have the potential to be truly innovative, but whether there is a "risk profile that necessitates" intervention.

And he thinks that in many ways the public likes what they perceive as the protective powers of the FDA.

"The challenge is where to draw the line," he said. "The question is, if something went wrong, would someone get hurt? That's the exact place where they tend to regulate, and society, frankly, wants them to regulate."

Radiology apps in practice
Aside from theoretical concerns, how have radiology apps actually worked in practice?

DOTmed News spoke with executives from Hartland, Wisc.-based Merge Healthcare, whose mobile eFilm application bowed at the Radiological Society of North America annual meeting nearly two years ago. Now available on the market, the app, which lets users check out radiology images, was never designed to be a diagnostic viewer, according to Merge. Feedback from radiologist and their customers after its debut made them take the path of turning it into what its promotional materials have dubbed a "workflow enhancement solution."

Part of Merge's concern is that radiology has, in the words of the blogger Hunn, some "particular issues."

"There have been instances in the past with some imaging, where facets of an image that was designed to be displayed on a high quality medical imaging system have been looked at on a computer screen, which has resulted in detail being missed because the resolutions were different, or compressions along the way had removed some of the artifacts," he said.

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