Expanding HL7 FHIR to support post-marketing research and surveillance within multi-source, chronic disease registries

项目总结/摘要 传统临床研究试验模型的可扩展性和及时性的改善越来越依赖于 纳入“真实的世界数据”（RWD）的新增来源-来自电子健康记录系统的数据 （EHR）、观察性研究和疾病登记以及患者和/或护理人员报告。同样地， 观察性上市后药物安全性监测工作在能力和成本方面也仍然有限， 有效性，直到这些其他重要的，增加的RWD来源能够被纳入一个简单的， 高效及时的方式传统的数据交换标准，如HL 7 v3和临床数据 交换标准联盟（CDISC）标准，例如操作数据模型（ODM-XML），定义XML， Data-XML没有得到很好的采用，通常在适用性方面受到限制，并且没有专注于基于API的现代交换 的RWD。该项目的总体目标是开发和演示新的FHIR 扩展、配置文件、资源和实施，支持符合FDA 21 CFR 11的工作流程， 疾病登记为基础的信息交换，从而提供了重要的优势，目前，非FHIR， 为开展此类研究提供基础。我们利用专业知识和丰富的经验， 正在收集和使用RWD进行IV期安全性监测的参与研究者和机构 活动，以及已经在使用FHIR存储这些数据的人。具体来说，我们的目标是两个高- 价值，容易实现，并广泛相关的领域应用FHIR数据交换标准， 领域：（1）使用以下方法将患者报告结局（PRO）数据纳入符合21 CFR 11的工作流程 FHIR，以及（2）在FHIR中启用标准化方法以查询和提供可再现的数据集 支持21项适用于上市后安全性监测的CFR 11合规性分析。作为其中的一部分 项目，我们将提交这些改进HL 7纳入FHIR，使我们的实施 公开提供，并制作一份白色文件，总结已完成的工作，潜在的途径 使用产品的最佳实践或关注点，以及在后续工作中应该解决的问题。

Project Summary/Abstract Improvements in the scalability and timeliness of traditional clinical research trial models increasingly rely upon incorporation of added sources of `Real World Data' (RWD) – data from electronic health record systems (EHRs), observational studies and disease registries, and patient and/or caregiver report. Similarly, observational, post-marketing drug safety surveillance efforts also remain limited in capability and cost- effectiveness until these other important, added sources of RWD are able to be incorporated in a facile, efficient, and timely fashion. Conventional data interchange standards such as HL7 v3 and Clinical Data Interchange Standards Consortium (CDISC) standards, e.g. Operational Data Model (ODM-XML), Define-XML, Data-XML, are not well-adopted, often limited in suitability, and not focused on modern API-based interchange of RWD. The overall goal of this proposed project is the development and demonstration of new FHIR extensions, profiles, resources, and implementations that support FDA 21 CFR 11-compliant workflows for disease registry-based information exchange, thereby providing important advantages over current, non-FHIR- based approaches for conducting such studies. We leverage the expertise and extensive experience of the participating investigators and institutions, who are collecting and using RWD for Phase IV safety surveillance activities, and who are already utilizing FHIR for warehousing of this data. Specifically, we target two high- value, readily achievable, and broadly relevant areas for application of FHIR data interchange standards to this domain: (1) Incorporation of patient-reported outcomes (PRO) data into 21 CFR 11-compliant workflows using FHIR, and (2) Enablement of a standardized approach within FHIR to query and deliver reproducible data sets supporting 21 CFR11-compliant analyses suitable for post-marketing safety surveillance. As part of this project, we will submit these improvements to HL7 for incorporation into FHIR, make our implementations publicly available, and also produce a white paper summarizing the work accomplished, potential paths forward for using the products, and best practices or concerns that should be addressed in subsequent work.