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

这个小企业创新研究（SBIR）第一阶段项目旨在满足对移动健康应用程序（应用程序）进行评估的新需求。我们项目的目标是？打破学术医学研究的象牙塔墙并设计一个平台即服务（PaaS），让应用程序开发人员进行严格的评估。通过行为和计算机科学基础研究的市场驱动设计和应用，该平台将克服严格评估的成本，技术和智力障碍，从而加速将行为和医学发现转化为商业上可行的在线应用程序，并证明可以有效改善健康。以用户为中心和敏捷设计的平台将是什么？是为了进化吗考虑到技术和监管环境的快速变化，同时保护人类受试者（他们的安全、隐私和保密性）。该项目的重点将是帮助没有临床、监管或研究专业知识的非研究软件工程师和数字健康应用程序分销商对其新技术进行严格的健康结果评估。该项目更广泛的影响/商业潜力是加速提供经证明有效和有用的数字应用程序，以改善人类健康。目前有超过40，000种数字健康应用程序，其中大多数几乎没有科学基础或安全性，有效性或效率评估付款人，提供商和监管机构需要证据。据估计，新应用程序的增长市场将需要通过FDA进行严格的评估，到2018年，数字健康市场总额估计将达到102亿美元。这一软件产品通过加速将经评估的、商业上可行的、可通过网络广泛获取的健康促进和疾病管理在线应用程序商业化，可以减少在获取高质量保健资源方面的差距。经济发展，就业和利润将被创造。该产品和合作伙伴关系将促进两个国家目标：（1）加强美国创新生态系统（技术促进健康和保健）和（2）创造一个所有人都能健康长寿的社会。

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.