I-Corps: Digital Health Information Infrastructure

这个I-Corps项目更广泛的影响/商业潜力是开发改善医疗保健数据基础设施的技术。数字健康已经到了一个拐点。FDA最近发布了“软件即医疗器械”（SaMD）的新指南，该指南正在加速临床级连接设备的开发。最近几个月，投资者向数字健康和健康传感器初创公司投入了8.15亿美元。数字生物标志物和生物传感器的兴起为医疗监测和提供方式的重大改变提供了机会。一些相对便宜的收集健康数据的工具可以使“精准医疗”成为现实。然而，目前的工具并没有针对大量数据的涌入进行优化，需要更好的基础设施来安全地存储和访问数据，并在这些新数据集上开发算法。这个I-Corps项目使用区块链衍生的协议来改善数字健康信息的存储和访问方式。区块链是一个开放的数据库（例如，分布式账本）由独立参与者的网络维护。这种区块链协议是为无信任的点对点交换而设计的，没有中央权威。每个数字连接的传感器都是协议中的一个单独节点（参与者）。当患者生成新数据时，传感器会记录信息，并在分布式账本中创建带有时间戳的摘要。区块链保证了研究查询是防篡改的，并且在系统中的各种参与者中具有可审计的历史记录。参与I-Corps的目标是最好地了解临床数据科学家在开发下一代临床决策和算法时所期待的系统和功能。

The broader impact/commercial potential of this I-Corps project is to develop technology that improves healthcare data infrastructure. Digital health has reached an inflection point. The FDA recently issued new guidelines for "Software as Medical Device" (SaMD) which is accelerating the development of clinical-grade connected devices. In recent months, investors poured $815 million into digital health and health sensor startups. The rise in digital biomarkers and biosensors present an opportunity to make significant changes in the way that care is monitored and delivered. Some relatively inexpensive tools that collect health data can make "precision medicine" a reality. However, current tools are not optimized for a large influx of data and there is a need for better infrastructure to be able to securely store and access data and to develop algorithms on these new datasets.This I-Corps project uses blockchain-derived protocols to improve the way digital health information is stored and accessed. A blockchain is an open database (e.g., a distributed ledger) maintained by a network of independent participants. This blockchain protocol is designed for trustless, peer-to-peer exchange without a central authority. Each digitally-connected sensor is a separate node (participant) in the protocol. As a patient generates new data, the sensor records the information, and creates a time-stamped summary in the distributed ledger. The blockchain provides assurance that the research queries are tamper-proof and have an auditable history across a wide range of actors in the system. The goal for the I-Corps participation is to best understand the systems and features the clinical data scientists are looking to as they develop next-generation clinical decisions and algorithms.