The "medical app guidance" document is online. It says that "the FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient's safety if the mobile app were to not function as intended." A number of the tasks identified by Gurman as being part of Apple's Healthbook fall under the tasks that FDA says it will regulate, with glucose monitoring specifically named in the document as an example. The agency will exercise only "discretion" regarding a range of simple apps, such as "simple tools to organize and track health information" or "help[ing] patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions."
None of the parties disclosed the topics discussed at the meeting. The Times also noted that Google executives also met with FDA officials that same month.
Gurman and others are undoubtedly correct that Apple has interests and substantial investments in both the fitness and healthcare markets. But those are two very different markets. Apple may be more interested in accessories, user interfaces, and operating system features that make it simpler and easier for iOS users to work with more specialized mobile health and fitness devices. Via Bluetooth Low Energy, an iWatch could become a convenient summarization and display for selected health and fitness data from apps on the iPhone or from iCloud storage or from third-party devices.
In Passbook, Apple doesn't provide the loyalty cards, tickets, or other digital documents: it creates a consistent user experience and centralized "place" for such documents. Healthbook may do the same for fitness and health data.
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