FDA Rules for Healthcare Apps

Michele Warg
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The FDA has, at long last, set down its final rules for the approval and regulation of healthcare apps. These apps, which turn your mobile device into a piece of medical equipment for either diagnosis or treatment, constitute a huge share of the mobile app market. Until the final rules were published, these apps had been in a kind of legal limbo pending the two-year FDA approval process. Now that the guidelines for regulation and enforcement have been made public, the makers of healthcare apps can breathe a sigh of relief, as nothing much seems to have changed. The agency will still regulate healthcare apps, but the way the rules will be enforced is interesting.

First, some perspective is in order. There are currently over forty thousand active healthcare apps available for download through iTunes, the most popular app retailer. Most of these apps have counterparts that are optimized to run on competing platforms such as Android. Each app, and each version of each app, has its peculiarities, making the FDA approval process, which healthcare professionals know all too well, prohibitively slow, even for the currently available healthcare apps. Given the speed of development for new apps, the prospect of an individual review for each of them threatened to put a chill on the entire market.

The FDA's decision in this matter is being hailed as a masterstroke of compromise. After an approval process that spanned two years and included briefs and input from over 140 sources, the FDA decided to exercise "regulatory discretion" over the market. What this means is that, while the agency reserves the right to regulate and approve every single app on the healthcare market, it will focus investigations and enforcement exclusively on those healthcare apps that have the potential to cause real harm to the consumer if they malfunction or otherwise fail.

In practice, this decision provides adequate protection to the consumers of healthcare apps, while sparing the FDA the headache of tracking down forty thousand apps for quality inspection. The decision also eliminates the risk of stifling innovation with endless red tape. The FDA has opted to focus on diagnostic apps, apps that convert your device into an EKG or other monitoring device, and treatment apps such as those that centrally regulate diabetes equipment and drug dosages. A malfunction, miscalibration, or other failure of any of these devices has the potential to cause real harm to trusting users, while a simple heartbeat sensor or calorie counter is unlikely to need such close supervision.

The industry is hailing the FDA for showing an admirable blend of caution and restraint. The agency is prudently choosing to focus its attention on areas where real harm is possible and is letting go of apps that are basically harmless, even when they malfunction. For years, there has been uncertainty about the ultimate position of the FDA with regard to healthcare apps. With the new rules, the agency has shown that it's been listening.


(Photo courtesy of freedigitalphotos.net)


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