Thursday, March 12, 2015

Well -- Apple Moves At Lightning Speed, It Seems: UPDATED "Informed Consent" Guidelines For Stanford Med App

Barely eight hours ago, we wrote about the "brave new world" of clinical trial recruiting. . . via an ingeniously simple and elegant iPhone App -- released just Monday. Tonight, AppleInsider is reporting that Apple has already tightened its developer guidelines to address the patient confidentiality and informed consent concerns that FDA and other regulators around the globe might justifiably articulate.

From those just-revised Apple Developer Guidelines, then:

. . .27. HealthKit and Human Subject Research

27.1 Apps using the HealthKit framework or conducting human subject research for health purposes, such as through the use of ResearchKit, must comply with applicable law for each Territory in which the App is made available, as well as Sections 3.3.28 and 3.3.39 of the iOS Developer Program License Agreement

27.2 Apps that write false or inaccurate data into HealthKit will be rejected

27.3 Apps using the HealthKit framework that store users’ health information in iCloud will be rejected

27.4 Apps may not use or disclose to third parties user data gathered from the HealthKit API or from health-related human subject research for advertising or other use-based data mining purposes other than improving health, or for the purpose of health research

27.5 Apps that share user data acquired via the HealthKit API with third parties without user consent will be rejected

27.6 Apps using the HealthKit framework must indicate integration with the Health app in their marketing text and must clearly identify the HealthKit functionality in the app’s user interface

27.7 Apps using the HealthKit framework or conducting human subject research must provide a privacy policy or they will be rejected

27.8 Apps that provide diagnoses, treatment advice, or control hardware designed to diagnose or treat medical conditions that do not provide written regulatory approval upon request will be rejected

27.9 Apps conducting health-related human subject research must obtain consent from participants or, in the case of minors, their parent or guardian. Such consent must include the (a) nature, purpose, and duration of the research; (b) procedures, risks, and benefits to the participant; (c) information about confidentiality and handling of data (including any sharing with third parties); (d) a point of contact for participant questions; and (e) the withdrawal process. . . .

Oh my -- it isn't often that I get caught completely slack-jawed by the advancing pace of tech, but tonight I confess -- I am agape. Maybe I'm just getting old, but it sure seems that the world moves so quickly these days. [Not entirely rhetorically -- I wonder whether both Stanford and Apple received calls from FDA staffers today, post the Bloomberg story and the AppleInsider note, earlier in the week.] Sleep well, one and all!

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