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）第一阶段项目旨在解决移动医疗应用程序（app）评估的新需求。我们项目的目标是？打破医学学术研究的象牙塔？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。通过以市场为导向的设计和应用行为科学和计算机科学的基础研究，该平台将克服成本、技术和智力障碍，进行严格的评估，从而加速将行为和医学发现转化为商业上可行的在线应用，证明这些应用对改善健康是有效的。以用户为中心和敏捷设计的平台将是什么？为进化而编程？鉴于快速变化的技术和监管环境，同时保护人类受试者（他们的安全、隐私和机密性）。重点将放在协助非研究软件工程师和数字健康应用程序分销商，他们无法获得临床、监管或研究专业知识，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已证明有效和有用的数字应用程序，以改善人类健康。目前有4万多个数字卫生应用程序，其中大多数几乎没有科学基础，也没有对安全性、有效性或效率进行评估。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FDA的严格评估，到2018年，整个数字健康市场预计将达到102亿美元。通过加速将经评估的、商业上可行的在线健康促进和疾病管理应用程序商业化（这些应用程序可通过Web广泛获得），该软件产品可以减少在获取高质量卫生资源方面的差距。经济发展，就业和利润将被创造出来。该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（以技术促进健康和福祉）；(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.