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September 06, 2016 – Apple has updated it’s App Store guidelines on health and medical Apps. Developers of health and medical apps will now have strict rules to abide by with Apple’s new App Store Guidelines that establish a high bar for any app aimed at health and wellness. Previous iterations of the guidelines already laid out the proper protocol for human research subjects and avoiding physical harm, but the new rules carry much more detailed and specific language, ranging from privacy protection to warnings about inaccurate data that could potentially cause physical harm. With a whole section on physical harm (previously a short line in the rules). Apple’s new guidelines aren’t letting anything slide. “If your app behaves in a way that risks physical harm, we may reject it,” the guidelines state, and go on to describe in detail possible pitfalls. Apple is also snuffing out any marijuana related apps and those that encourage people to place their iPhones under a mattress or pillow while charging, such as sleep-tracking apps.
Potential issues include medical apps that could provide inaccurate data or information, or those that could be used in diagnosing or treating patients. If the app has received FDA clearance, the developers must submit a link to the documentation. Previously allowable apps, such as the super popular Instant Blood Pressure app, were subsequently shown to be inaccurate, and wouldn’t make the cut under today’s guidelines. Of course, from the patient point of view, such an application, popular or not, would be an absolute no go. Apple is also cracking down on drug dosage apps, which it has been enforcing the past year already. “Drug dosage calculators must come from the drug manufacturer, a hospital, university, health insurance company, or other approved entity, or receive approval by the FDA or one of its international counterparts,” the guidelines state. “Given the potential harm to patients, we need to be sure that the app will be supported and updated over the long term.”
Aside from potential harm for patients, the potential future capabilities of health and medical apps call also for their fitness with respect to validation by and through international organisations such as ICH and/or regulatory agencies, similar to regulations in place for Computerised Systems under Good Laboratory Practices (GLP), Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GVP). The validated absolute reliability of clinical data collected in health and medical apps under any circumstance at any place worldwide may become crucial in the fields of applied theragenomic and personalized medicine. Some vital parameters defining clinical endpoints (i.e., apparent phenotypes), which can already be recorded today from each individual patient carrying a smart device, may help to classify patients into patients subgroups who actually carry the same genetic background (i.e., genotypes) giving rise to the very vital parameter measured by the device. Such phenotypes may apply to patients worldwide and make them amenable for targeted (i.e., genotype-based) modern and effective therapies. In this context, it is even imaginable that smart devices may become medical devices, as already briefly discussed by thasso in the case of iPad’s use as sedatives for kids in pre-surgery settings.
In any case, with the hundreds of thousands of health and medical apps, it’s tough for regulators to keep up. The FDA recently released new guidelines and the FTC also offered up tools to help developers of health apps, but they still aren’t the de facto gatekeeper of the app store, like Apple is. While the FDA’s guidelines seek to clarify the regulatory process and encourage device and app makers to share data with patients, the App Store rules could potentially curb problematic apps faster and right at the source. Moreover, it may well be that one day, Apple (in the case of iOS-based medical apps) will have to team up with regulators worldwide, not only the FDA, in a true glocalisation effort. The screening guidelines could then stop questionable apps from even getting to the market – at least on iOS – and put additional pressure on developers to also make their policies (i.e., concerning patient data safety), product information (i.e., product performance), and the product regulatory approval status (i.e., can data derived from the device legally be used reliably for individual patient-concerning therapy decisions) openly available. This for the benefit of the patient.