In a surprise announcement recently, Apple Inc. preceded the debut of its new line of connected watches by unveiling ResearchKit, a medical research platform that has demonstrated its powerful potential with the first five applications. The open-source ResearchKit and evolving HealthKit promise new ways for apps and researchers to gather sensor and health data that will enable faster clinical insights at lower cost.
Digital health and mobile health platforms have been emerging for a number of years, primarily in consumer health, but few with clinical rigor or clearance from the U.S. Food and Drug Administration. As in other product categories, Apple has used thoughtful design and its market strength to create a powerful new platform that lowers the barriers to creating apps. ResearchKit promises to benefit researchers, physicians and patients across a spectrum of diseases, from rare diseases to widespread chronic diseases that make up the majority of healthcare costs.
Apple’s new platform will amplify a broad set of new opportunities we are calling “Digiceuticals” — where software, sensors and apps are standalone treatments for disease and integrated into comprehensive care plans alongside drugs and medical devices. Leading academic groups have already demonstrated that digital tools can improve the effectiveness of drugs and health behavior change. Health platform investments by Apple (aapl), Google (goog) and Samsung (krx) are lowering the barriers for reaching the right patient, time and place with engaging messaging customized for each patient.
Rather than threatening to crush the innovators that have blazed the trail in front of previous Apple releases, ResearchKit and HealthKit promise to amplify the efforts of researchers and startups in digital health. One example is Ginger.io., a pioneering MIT venture enabling large scale clinical trials on smartphones. CEO and founder Anmol Madan is expecting his company to use ResearchKit across many clinical trials. And within the first 24 hours of launching, Stanford University’s cardiovascular research app, which promises to accelerate clinical insights and lower the costs of research, received over 11,000 downloads .
The tremendous enthusiasm for ResearchKit is slightly tempered by concerns from the healthcare community around data privacy, research ethics, and questions around generalizability of its findings. In regards to external validity, it remains to be seen that of the more than 10,000 subjects that have signed up for the MyHeartCounts app, how many fit into the target demographic for such an app. For example, how many of them are middle-to-older age adults (i.e. above 45 years of age) with at least one risk factor for cardiovascular disease.
Similarly, Apple claims that it “will not see your data,” but an independent review of its data storage, privacy, and anonymization methods and policies may provide more reassurance to participants as well as regulatory agencies. Finally, research ethicists are appropriately concerned about the validity of study eligibility criteria, as there is potential for recruiting minors and non-US citizens into the study with limited checks and balances against fraud and impersonation.
Last year a breakout year for digital health investments, as over $4 billion went into health care startups — that's more than the previous three combined years. This is the most exciting time in history for health technology to improve lives around the world, and the smartphone is a core enabler for health communication, education, monitoring, and telemedicine. New technologies and services are extending this impact into diagnosis and simple therapeutic interventions. In an era of dwindling National Institute of Health funding, academic medical research is limited to studies sponsored by pharmaceutical companies with millions of dollars to spend on gathering data.
For those of us active in creating and investing across the future of digital health, 2015 presents a plethora of opportunities to fundamentally change the business models and experiences of healthcare globally. The complexities of proving healthcare efficacy, value, and adoption still exist but the Golden Age of Digiceuticals is now accelerating.
Zen Chu is a Lecturer at the MIT Sloan School of Management and runs Accelerated Medical Ventures, partnering with physicians in Boston and China to found and fund digital health companies. Maulik Majmudar is Chief Clinical Officer for Quanttus, Inc. and a cardiologist at the Massachusetts General Hospital, where he also serves as associate director of the MGH Health Transformation Lab.