Why not?  You get the best of both worlds here with the ONC continuing with their area of business and the ability to work with the FDA a bit closer when it comes to “engineered software” products.  As the industryimage changes, so does how regulation takes place.  Again, if the ONC had specific questions or needed certain tests the FDA resources would be there.  Also if the FDA would have the expertise of consulting the ONC as well.  The ONC could be it’s own division and I think the collaboration between the FDA and ONC would probably be very good.

Let’s face it the lines are grayer than they used to be as technology moves forward and collaboration is the name of the game today.  There are some very intelligent sophisticated engineers at the FDA as well and they are already well versed in complex devices so it’s not like this would be brand new entirely but rather a little different focus.  We do have devices now reporting data to medical record systems and those of course still need certification and the meaningful use criteria to meet and what is one of the devices is one under current review at the FDA, would this not make sense?  The records and devices are collaborating with data and are integrated so why not the regulation portions.  I think this would also satisfy and “duplication of efforts” questions out there as well. 

In addition with some devices needing clinical trials, the ONC could certainly have some substantial input here as relates to work flow too.  This is maybe not a perfect answer but I think it would answer a lot of questions and allow the ONC to keep operating with what they are doing and have greater access to those at the FDA when the gray areas or collaboration efforts are needed.  In addition the patient safety would be addressed from 2 different points of view too and that can’t hurt a bit. BD

While the mHealth Regulatory Coalition and several mHealth advocates have asked the FDA to release its long-delayed guidance – which has been in the works since the agency issued preliminary guidelines in late 2011 – a coalition of roughly 120 health IT stakeholders has asked the government to put the brakes on the FDA until a much more wide-ranging study of HIT regulations is finished.

In fact, some are wondering if the FDA is the right agency to oversee mHealth regulation.

Haley pointed out that both the FDA and ONC are "jockeying for jurisdiction" of the mHealth landscape. The FDA recently issued a warning to medical device makers, healthcare providers and other parties about the dangers of cyber attacks on devices – a move that Haley said caught the industry by surprise. More recently, the ONC launched its own Health IT Patient Safety Action & Surveillance Plan, which left some wondering if the two agencies were competing against each other.



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