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

小型企业创新研究(SBIR)第一阶段项目旨在满足对移动健康应用程序(APP)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)，允许应用程序开发人员进行严格的评估。通过市场驱动的行为和计算机科学基础研究的设计和应用，该平台将克服成本、技术和智力障碍，进行严格的评估，从而加快将行为和医学发现转化为商业上可行的、被证明在改善健康方面有效的在线应用。以用户为中心的敏捷设计平台将针对可进化性进行编程？鉴于快速变化的技术和监管格局，在保护人类主体(他们的安全、隐私和机密性)的同时，还必须采取行动。重点将放在帮助无法获得临床、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。该项目的更广泛影响/商业潜力是加速提供经过验证的有效和有用的数字应用程序，以改善人类健康。目前有超过4万个数字健康应用程序可用，其中大多数几乎没有科学基础或对安全性、有效性或效率的评估，付款人、提供者和监管机构要求提供证据。据估计，新应用程序的增长市场将需要通过FDA的严格评估，到2018年，数字健康市场总额估计将达到102亿美元。通过加速通过网络广泛提供的经评估的、商业上可行的健康促进和疾病管理在线应用程序的商业化，该软件产品可以减少在获得高质量卫生资源方面的差距。将创造经济发展、就业和利润。这一产品和伙伴关系将促进两个国家目标：(1)加强美国的创新生态系统(促进健康和健康的技术)和(2)创建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.