4. Science fiction is turning into science fact. One question White brought up: How should we regulate critically important technologies going forward? "What does this mean from a market standpoint?" he asked. "Think about it – the pace of IT is fast and furious, and the pace has dramatically increased since the 510(k) process was instituted." To illustrate this growth and rapid pace, he said the industry is bringing science fiction to science fact. "In 2009, there was an Italian company that inserted an electrode in [a patient's] back to leverage their neurological system and the patient can make a bionic hand move," he said. "This isn't science fiction; this is happening. The question is, where do mind-control devices fit within the 510(k) structure? We need to think about this because technology is thinking about solving issues in a different way, and regulators need to be thinking about if the structure fits anymore, or are we trying to jam a square peg into a round hole?"

[See also: Mobile health app market in growth mode.]

5. Technology has lapped th regulatory framework. It's easy to see how health IT has lapped the regulatory framework when thinking about the amount of IT introduced since the Draft Guidance was released. "Retinal scanners, for example," said White. "Another example is cloud computing. Under FDA Draft Guidance, I don't know if they envision the movement t the cloud in a way that's picked up by the regulation, but in the final, that's something they'll have to take into account." White when on to question if Congress has a role in rebooting policy — something he believes, should happen. "If Congress set the 510(k) process, we need Congress to get involved in setting the new regulatory framework for the new technologies," he said. "What expertise is available to make informed decisions, scientific decisions? Where's the regulatory science? If it's not in the agencies, we better get up to speed quickly to promote innovation and promote safety."

6. We need a new regulatory structure. Internally, White said, he and his team believe the industry needs a new regulatory 2.0 structure to deal with all the emerging technologies. "The market is exploding; it's incredibly creative and innovative, and the regulatory structure has to match that speed." An example, he said, could be similar to what the ONC is using to certify EHR products. "They have experts, external to the government, [whom they] partner with, and they test it," he said. "It should be expert-based. Software folks and engineers, they're incredibly creative, and they're coming up with stuff on the fly. The innovation is incredible, and we need to rely on that expertise in developing innovation and safety outputs."