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Can a Phone App Calculate an Incorrect Drug Dosage?

David W. Hodges
Partner at Kennedy Hodges LLP practicing pharmacy error, medical malpractice and personal injury law
Posted on Oct 19, 2013

People love their smartphones and can use them to do just about anything, with phone apps being all the rage these days. Consumers are even using apps to monitor their own health. In fact, medical apps for cellphones are quite popular, causing the Food and Drug Administration to take notice and get involved in order to protect patient safety.

While there are some apps that aren’t harmful to consumers, like those that allow consumers to log and track health data, there are other medical apps that could pose a threat to patients. For example, if an app calculates the wrong drug dosage due to a malfunction, patients could suffer harm.

While some of these apps allow patients with diabetes to easily monitor their blood sugar and allow consumers and even doctors and nurses to perform a variety of tasks, they can lead to patients receiving an incorrect prescription dosage or needless medical treatment upon malfunction. This is why the FDA is looking to review phone apps in the same manner as they monitor as other medical devices—for patient safety.

The FDA has already approved approximately 100 mobile medical apps; however, more apps are being created to help patients take part in their own health care. The FDA recently released guidelines for creators of these apps. “Mobile apps are unleashing amazing creativity, and we intend to encourage these exciting innovations,” said FDA Senior Policy Adviser Bakul Patel. “At the same time, we have set risk-based priorities and are focusing FDA’s oversight on mobile apps that are devices for which safety and effectiveness are critical.”

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