Apple issues more explicit guidelines for mobile medical and health app developers

By Stewart Eisenhart, Emergo Group
Apple has published updated guidelines for how the company reviews applications submitted for sale via its App Store, with an expanded section focused on safety requirements for health and medical apps.

Under a longer “Physical Harm” section, the guidelines provide several examples of user risk issues that may lead to rejection of an app.

• For instance, medical apps intended for diagnosis or treatment or that run the risk of generating inaccurate health data “may” undergo more vigorous review by Apple; apps that have received regulatory clearance should provide links to appropriate documentation, as well.
• Any app designed to perform as a drug dosage calculator must be submitted to Apple by a manufacturer, healthcare facility, university or insurer, according to the guidance, or have received regulatory clearance or approval by the FDA or another regulatory entity.
• Apps should avoid usage recommendations that contradict Apple’s hardware safety documentation.

Developers submitting such apps for review should also ensure that their support contact details and Wallet passes are up to date and maintained regularly.

Although the FDA has issued its own guidance on mobile medical and health apps, Apple’s latest recommendations also warrant careful attention from developers since the App Store serves as a major access point for these tools.

For more information on US regulatory requirements for mobile medical technologies, download our whitepaper on the topic.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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