No matter how hard the Food and Drug Administration tries to find a middle ground between too much and too little regulation, it's usually seen as the villain. When it implements strict rules on drug approval, for example, it's condemned for slowing down the pipeline of lifesaving remedies. And when the agency loosens its grip, it's blamed for deaths from unsafe drugs.
The FDA's new guidelines on mobile medical apps are likely to put it into a similar position. Some software developers will complain that the regs, which are still in the draft stage, will make it impossible for them to bring valuable products to market. But had the FDA done nothing, other critics would question whether the agency is protecting the public from unsafe or ineffective software.
Before jumping to either conclusion, it's important to take a closer look at exactly what the FDA is proposing.
One of the most important distinctions the agency makes is between apps that promote wellness and good health versus those that are involved in the diagnosis, treatment, cure, or mitigation of a disease. The former group of apps doesn't need FDA approval.
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Among the wellness-related mobile health applications that are off the hook are those that log, record, or track eating habits or exercise. Similarly, a medical reference app such as the Physicians' Desk Reference doesn't require approval. Other safe bets are mobile apps that perform the function of an electronic health record or personal health record. Apps to determine medical billing codes and perform other medical business functions are also exempt.
On the other hand, Mobile MIM, which lets clinicians view full-resolution medical images, does require FDA approval--which the vendor has already secured. As the FDA draft guidelines explain, "a mobile medical app that displays radiological images for diagnosis transforms the mobile platform into a class II PACS [picture archiving and communication system]," and such systems require clearance.
Similarly, an app like AirStrip OB, which displays real-time fetal heart rate monitor data, requires FDA approval.
The FDA guidelines also suggest that certain clinical decision-support tools may come under scrutiny. Among the apps considered medical devices and thus subject to FDA clearance are "mobile medical apps that allow the user to input patient-specific information and--using formulae or a processing algorithm--output a patient-specific result, diagnosis, or treatment recommendation that is used in clinical practice or to assist in making clinical decisions."
That sounds an awful lot like IBM's Watson supercomputer. So while Watson itself isn't a mobile app, what happens when someone builds an app to tap into Watson's diagnostic engine? It's clear many mobile app developers are in for a bumpy ride. But in the end, it's worth it.
The FDA's blessing will mean credibility, proven effectiveness, reimbursement from insurers, and safer patients.