Sep 7, 2016
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.
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.
For the second time in two years, members of the US House of Representatives have drafted legislation to expand reimbursement of mobile medical technologies used for remote patient monitoring under the Medicare national health system.
The US Food and Drug Administration has published final guidances on the agency’s regulatory approach to medical device data systems (MDDS) and mobile medical technologies that pose low risk to patients and users.