FDA Works Toward Regulating Medical Apps

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In recent years, people are turning more and more to the Internet for health information and to “self-diagnose.” With an increasing variety of medical apps available for the iPhone, iPad, Android, and other mobile platforms, self-diagnosis has become even more accessible. Unfortunately, however, checking the boxes next to a variety of symptoms and waiting for a mobile device to spew forth a litany of potential ailments lacks the sensitivity and accuracy of a human diagnostician. Further, those who are not trained in medicine may misinterpret symptoms as erroneously relevant or erroneously irrelevant, leading to misdiagnosis.

In an attempt to prevent mishap as much as possible without limiting the public’s access to information, the Food and Drug Administration (FDA) — the same organization responsible for approving and regulating over-the-counter and prescription pharmaceuticals — is attempting to regulate apps that claim to diagnose medical conditions or offer medical advice. The overarching philosophy behind the FDA’s move to regulate is that the medical apps — like any other medical devices — must be shown safe and effective before receiving the organization’s stamp of approval. Information content aside, the FDA notes that there are concerns specific to mobile platforms, as they note in a draft guidance:

As is the case with traditional medical devices, mobile medical apps can pose potential risks to public health. Moreover, mobile medical apps may pose additional or different risks due to the unique characteristics of the platform. For example, the interpretation of radiological images on a mobile device could be adversely affected by the smaller screen size, lower contrast ratio, and uncontrolled ambient light of the mobile platform; FDA intends to take these limitations into account in assessing the appropriate regulatory oversight for these products.

There are, as yet, no hard and fast rules regarding mobile apps; the FDA is still working to finalize their guidelines. However, in all likelihood, apps will need to identify a target audience — that is, healthcare practitioners or laypeople — and may need to modulate their claims accordingly.

Source: FDA