On Monday morning, Apple held their “Let Us Loop You In” town hall event at their Cupertino headquarters, and while much of the attention will go towards product releases and updates, perhaps the most important and innovative work Apple is doing is in the realm of health.The tech giant announced the release of CareKit, an open source framework for developing apps that “help individuals take a more active role in their own well-being.” In other words, CareKit provides a tool for developers to make iOS apps with therapeutic and diagnostic purposes. The apps collect data from enabled devices (e.g., iPhone, Apple Watch, Fitbit) which can then be shared with care providers to help monitor and inform treatment.For example, Parkinson’s disease patients can complete tasks on their phone (e.g., finger tapping) that will help doctors determine the efficacy of the current treatment program. Post-surgical patients can share movement data with their physician and receive reminders to take medications and do exercises. In both instances, the care provider can update the plan of care based on patient-shared data.This isn’t Apple’s first foray into mobile health. Since late 2014, the Health app has been the default hub for tracking personal health and fitness metrics. In March 2015 Apple released ResearchKit, a software framework that facilitates the development of apps for medical research purposes (e.g., discovery of physiological markers of an imminent epileptic seizure).ResearchKit has been a great resource for researchers around the globe; studies relying on ResearchKit have been conducted at such institutions as Harvard, UCSF, and Oxford. One cardiovascular study at Stanford was able to recruit >10,000 patients in just 24 hours, a feat that normally would require efforts across 50+ medical centers over the course of a year. The framework simplifies the development of apps by providing modules for obtaining consent, collecting participant demographic data, and tracking performance across key tasks. Distribution is handled by the App Store, and because the project is open source, individual improvements and developments can be easily shared within the community.

CareKit will take a similar approach to ResearchKit, but focused on the interaction between patients and caregivers for therapeutic purposes. The first modules available will allow for tracking care plan progress, monitoring symptoms and measurements, visualize insights, and connect patients, loved ones, and caregivers.So what does CareKit mean for mobile health? The most obvious result is an increase in available mobile health applications, given the ease of medical app development provided by the framework.Another advantage of Apple-based health applications is the large install base and pre-existing familiarity of the platform. While other telemedicine companies have emerged (e.g., InTouch, VGo Communications), none are nearly as ubiquitous as the iPhone, which has ~100M users in the U.S. alone. This widespread presence means that nearly a third of the U.S. population will soon have access to a broad range of mobile applications, and as with any major healthcare development, will invite scrutiny of the presently ambiguous regulatory and reimbursement landscape.In terms of regulation, Apple has positioned themselves such that any potential burden of FDA approval lies solely in the hands of 3rd-party app and accessory developers. Last year, the FDA released updated guidance for mobile medical applications, in which it was clarified that apps or devices that only perform routine clinical calculations, enable patient-caregiver communication, or track and access health information are subject to discretionary (i.e., limited) Federal Food, Drug, and Cosmetic Act requirement enforcement. Should any app or add-on hardware go beyond these functions, Apple would not be subject to any regulatory oversight because they only provide the tools to develop and run the apps.(Contrast this with Alphabet, which has two separate companies in the thick of life science research, Verily and Calico, and a dedicated life science & health division at Google Ventures.)Even so, there are plenty of potential applications that would not be subject to significant regulatory oversight, as they would not “pose a risk to a patient’s safety if the mobile app were to not function as intended.”The larger barrier to mobile health reaching its maximum potential is reimbursement. Tools that enable patient autonomy or improved health information management don’t require any additional caregiver input, but for active Parkinson’s disease treatment management or post-surgical care plan adjustment, regular physician participation is crucial. Payers haven’t reached a consensus as to how to characterize remote physician visits; Medicare only covers telehealth visits for patients outside of Metropolitan Statistical Areas or who live in Health Professional Shortage Areas, while private payers’ policies run the gamut of benefit possibilities. In theory, payers would be strong advocates for mobile health and telemedicine, given their recent pressure to move patients to lower acuity settings as quickly as possible (see below). But until reimbursement guidelines are clearly established, it is difficult to predict how physicians will prioritize remote health consultations when their own waiting room is overflowing.

Additionally, the clinical benefits of remote patient monitoring vary by disease indication, and there isn’t clear consensus as to what distinctions, if any, should be made between telehealth, telemedicine, remote patient monitoring, and mobile health, making it even more difficult to accurately characterize the associated risks and benefits.Regardless, telemedicine and mobile health will certainly play an increasingly important role in the coming years. Patients, caregivers, and payers alike will likely opt in as clinical and economic advantages become more evident. At the core of the major barriers towards adoption seems to be a lack of unification and consensus. The release of CareKit by Apple, a major tech player with a massive install base and comprehensive ecosystem, could very well be a major step towards resolving some of these issues.The IT-enabled healthcare market is expected to reach ~$210B by 2020, so as tablet and smartphone markets approach saturation, health isn’t a bad place to look for growth opportunities. The company has strategically leveraged their current products to slowly enter the healthcare IT space, starting with general health and fitness tracking via the Health app and moving into research and therapy with ResearchKit and CareKit.CareKit is planned for released in April, with apps for Parkinson’s disease, diabetes, post-surgery care, chronic disease management, mental health, and maternal health already announced. Apple joins the list of companies such as Illumina, 23andme, (embattled) Theranos, and many others that are pushing for healthcare consumerization.Watch the full event video below (the CareKit announcement starts at 19:23):

Disclaimer: Some of the companies listed above may be DeciBio clients or customers.

Author: Anthony DeBenedetti, Senior Analyst at DeciBio Consulting, LLCdebenedetti@decibio.comConnect with Anthony on LinkedInwww.linkedin.com/in/addebenedetti/en