STTR Phase I: Enabling an Evidence-Based Digital Health Revolution through Do-It-Yourself (DIY) Evaluation

This Small Business Innovation Research (SBIR) Phase I project is designed to address the emerging need for evaluation of mHealth applications (apps). The goal of our project is to ?break down the ivory tower wall of academic medical research? and design a Platform as a Service (PaaS) to allow app developers to conduct rigorous evaluation. Through market-driven design and application of fundamental research in behavioral and computer science, this platform will overcome cost, technological and intellectual barriers to rigorous evaluation, thereby accelerating translation of behavioral and medical discoveries into commercially-viable, online applications proven effective in improving health. The usercentered and agile designed platform will be ?programmed for evolvability? given the rapidly changing technological and regulatory landscape, while protecting human subjects (their safety, privacy and confidentiality). The focus will be on assisting non-research software engineers and distributors of digital health applications who do not have access to clinical, regulatory or research expertise to conduct rigorous health outcomes evaluation of their new technology. The broader impact/commercial potential of this project is to accelerate the availability of proven effective and useful digital applications that improve human health. With over 40,000 digital health applications currently available, most with little scientific foundation or evaluation of safety, efficacy or efficiency payers, providers and regulatory bodies are demanding evidence. It is estimated that a growth market of new apps will require rigorous evaluation through the FDA and a total Digital Health market estimated to reach $10.2 billion by 2018. Through accelerated commercialization of evaluated, commercially-viable online applications in health promotion and disease management that are broadly available through the Web, this software product can reduce disparities in access to high quality health resources. Economic development, jobs and profits will be created. This product and partnership will promote two national goals: (1) to strengthen the US innovation ecosystem (for technology to promote health and wellness) and (2) to create a society in which all people live long, healthy lives.