Patient-mediated digital workflow
Anyone wishing to donate EHR data to research projects, including Precision Medicine Initiative’s All of Us Research Program. Developed in partnership with major EHR vendors.
Currently being tested at seven HPOs.
Because this is designed for use by individual volunteers or health provider organizations and will be released as open source software, anyone wishing to stand up a project requiring participant recruitment will be able to download and use this from github. A full national campaign will be used to present this tool whose first application will be for the PMI All of us Project.
Because this workflow has been developed in partnership with the major EHR vendors for use with All of Us, the commercial sector has already endorsed the application and will be using it to provision patient data to the All of Us Coordinating Center which will solicit the first 1M cohort. Presentations planned for AMIA and other professional societies as S4S comes on line.
S4S offers a streamlined, ecommerce-like user experience for donating data from any EHR system by making use of HL7 FHIR to represent clinical data and OAuth 2.0 for authorization. S4S leverages the HIPAA requirement that patients must be able to access their own EHR data, and the Meaningful Use Stage 3 and 2015 EHR Certification programs that require patients be able to share a Common Clinical Data Set with software apps of their choice. S4S design incorporates input from the NIH, the ONC, and Office for Civil Rights to be sure it satisfies rigorous technical, operational, ethical, and legal requirements for patients to release their personally identifiable health information to research studies.
Relationship to the Commons
To the extent that the Commons imagines itself serving as the repository of PHI for general access by the research community, S4S will provide the gold standard for doing so.