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Technologies for Donating Medicare Beneficiary Claims Data to Research Studies

Allowing Medicare beneficiaries to donate their medical claims data for scientific research studies.
  • Centers for Medicare and Medicaid Services (CMS)
  • National Institutes of Health (NIH)
Start Date
  • 9/7/2017
  • Linking of Clinical and Other Data for Research
  • Use of Enhanced Publically-Funded Data Systems for Research


STATUS: Completed Project


CMS established a Blue Button platform in 2010 to give Medicare beneficiaries access to their own health information. In 2014, CMS was awarded a PCORTF project to develop a plan to redesign the Blue Button to enable it as a Data-as-a-Service platform. In 2016, a second CMS PCORTF project was awarded to implement the Data-as-a-Service platform and to utilize the Health Level Seven International (HL7) Fast Healthcare Interoperability Resources (FHIR®) framework. This allows third party services to build computer applications (apps) and other tools that can easily collect, present, and share the data—in a manner that ensures privacy and security of the data—which would make the data more actionable for patients.


CMS worked with NIH to leverage the Sync for Science (S4S) and Blue Button API (BB API) programs to enable Medicare beneficiaries to donate their medical claims data for scientific research studies using S4S data donation workflow.

Project Objectives:

  • Make source code and documentation publically available.

  • Monitor the BB API system for performance and system issues and generate notifications.

  • Update the S4S reference implementation guide to include CMS BB API.

  • Make documentation, guides, and reference tools publically available.

  • Create and run Developer/Application Validation process to support operations.

  • Create a final report of the pilot, suitable for ASPE PCORTF to publish on their website.

  • Provide digital and printed materials to facilitate outreach and education on BB API and S4S to developers and end users.


  • CMS modified the BB API code to meet the S4S specifications. Specifically, modifications were made to the S4S reference implementation open source test suite for Medicare beneficiary claims data to work with the CMS Blue Button 2.0 developer sandbox.

  • CMS incorporated native mobile app support to the industry-standard OAuth2.0 authorization protocol. In addition, CMS added 30,000 synthetic Medicare beneficiaries to the production environment for production application testing, and increased the frequency of Medicare Part D data updates from monthly to weekly.

  • NIH conducted pilot testing on the S4S App, which was successful in validating the technology and workflow. NIH developed the S4S Discovery App that supports viewing both clinical and CMS Blue Button patient data made available by the S4S Procure App. The NIH-developed S4S Procure App allows developers to obtain data from the CMS Blue Button API.




Below is a list of ASPE-funded PCORTF projects that are related to this project

Improving Beneficiary Access to Health Information: A Plan to Enhance “Blue Button” – “Blue Button” is a service that allows patients to access their own health information in electronic form. CMS established a Blue Button platform in 2010 to give Medicare beneficiaries access to their own health information: however, this initial service had limited functionality and scalability, making it difficult for beneficiaries to use and share their health information. This project aimed to engage a range of stakeholders to define functional requirements for Blue Button as well as develop a plan to improve Blue Button, including an implementation strategy and roadmap for a ‘Data-as-a-Service’ Platform.

Improving Beneficiary Access To Their Health Information Through An Enhanced Blue Button Service – This project built on the project entitled, “Improving Beneficiary Access to Health Information: A Plan to Enhance “Blue Button”. Utilizing the Fast Healthcare Interoperability Resources (FHIR) framework to ensure data is in a structured format that can be accepted by a wide range of applications, the Blue Button on FHIR (BBonFHIR) interface put Medicare beneficiaries in control of connecting their data to third party applications and services they trust. In this model, beneficiaries are empowered to select participation in research based on their preferences (e.g., enrolling in a genetic cancer research study because of a familial history of cancer). This dramatically simplified the acquisition of beneficiary claims data to support beneficiary participation in clinical research studies. Once completed, the BBonFHIR Service application program interface (API) allowed researchers to selectively pull beneficiaries’ Medicare part A, B, and D claims data specific for specific research needs.