How will the FDA regulate health IT?

Even if reports are just made mandatory, it could prove a fertile ground for fishing by the plaintiff's bar. Assuming reporting is mandated, then, it seems reasonable that manufacturers take all due care to keep their stuff from being reported.

The AMA has a FUD-filled piece out today warning that the FDA is about to come for your doctor's iPhone apps.

The FDA does not have any formal authority over health IT. But it could acquire some by listing applications as medical devices.

Many are.

Software is now used to monitor all sorts of bodily functions -- in hospitals, at clinics, and in the home. Why shouldn't such tools have the protection regulation affords, some assurance of a quality process that may keep the maker from being sued if someone dies from its use?

The question isn't whether health IT will be regulated, or should be regulated. It's what types of heath applications will be regulated, and how.

Contrary to what politicians tell you regulation is not something governments want to do. It costs money, and it puts an agency on the hook for results. If an approved device proves later to be a killer, it's not just the maker that's at fault.

If a program has direct contact with a patient, if it controls the device's interface, it obviously needs to be controlled itself. But what if the software is at some remove from the patient -- if it's a smartphone app that takes data from that interface and reports it to a doctor or other caregiver?

CompassX Group of Irvine, Calif. told the AMA a regulated device will cost three times more than an unregulated one to develop. The estimate seems reasonable. But pre-approval does not appear to be what Jeffrey Shuren (above, from the FDA), who heads the FDA's device regulation unit, is looking at.

Instead he seems to be moving toward some sort of tracking mechanism, and a requirement that producers adhere to the FDA's Quality Systems Regulation in producing their products.

This would represent the smallest possible carrot and stick, given that Shuren told a Congressional committee in February that his office had gotten 260 reports on problems with health IT over the past two years, resulting in 44 injuries and six deaths. Since current reporting is voluntary, that may be just the tip of the iceberg.

Even if reports are just made mandatory, it could prove a fertile ground for fishing by the plaintiff's bar. Assuming reporting is mandated, then, it seems reasonable that manufacturers take all due care to keep their stuff from being reported.

Pre-market clearance is the nuclear option in this debate. It would indeed force up costs, and could drastically limit innovation. But if software is going to be given the power of life-or-death over you don't you want it to be at least as good as the hardware it's connected to?

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