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ONC-REACHNet Collaborate to Use FHIR for Patient EHR Consent

A collaborative pilot project between ONC and REACHNet is looking to FHIR as a means of streamlining patient consent, health data exchange.

Health Data Exchange

Source: Thinkstock

By Kate Monica

- ONC is collaborating with the Research Action for Health Network (REACHNet) on a pilot program to create an electronic patient consent form for more efficient patient EHR exchange. 

The goal of the collaborative effort will be to develop a patient consent form using the Fast Healthcare Interoperability Resources (FHIR) specification for standardized exchange.

The pilot — called Standardizing Consent for REACHNet’s Pediatric Research Registry — will test research on patient consent exchange based on use cases developed by The Patient Choice Technical Project Phase 2: Basic Choice for Research Consent.

“The aim is to assist the healthcare ecosystem by analyzing and developing technical standards to fulfill the technical capability for implementing and sharing individual consent (basic and granular choice) for the sharing of health information in healthcare settings and in a research environment,” stated ONC on the project’s home page.

The Patient Choice Technical Project consists of three phases.

Phase one aims to achieve the following objectives: 

  • To develop Basic Consent Use Cases and Functional Requirements which can be used to guide a Piloting process
  • Conduct pilots which test the functional requirements and scenarios described in the Use Case Development Phase
  • Develop a best practices implementation guide based on lessons learned from piloting efforts.
  • Align work efforts with Standards Developing Organizations (SDO) when possible
  • Develop implementation guidance in form of a standard or artifact

During phase two and phase three, researchers will build upon the artifacts and lessons gleaned from phase one and repeat the phase one process focusing instead on research consent and granular choice.

Phase one of the project kicked off in December of 2015 with a presentation by project leaders, including Jeremy Maxwell of ONC.

“The increased capacity of data sharing has led to additional questions, such as when and how should patients consent to sharing their information electronically for purposes where consent was traditionally captured on paper or health information was not shared at all,” stated Maxwell in the pilot program presentation. “This project seeks to address patient trust of health information exchange as the way health care providers and participants share and access health information.”

Each phase of the project aims to streamline health data exchange for different purposes.

Phase one — basic choice — focuses on patients and the ways efficient health data exchange improves the quality of their treatment. 

“Basic choice is the choice offered to an individual to prevent his or her PHI from being available for electronic exchange when it otherwise would be for purposes of treatment, payment and operations,” he said.

Phase two focuses on research consent and seeks to enable automated information sharing between providers and research teams.

Improving standardization to automate health data exchange between providers and researchers will enable patients to more easily lend their information to research projects.

Granular choice aims to improve patient consent for health data sharing related to more sensitive information including behavioral health.

“Granular Choice is the choice an individual makes regarding the distinctions between legally sensitive clinical conditions, such as mental health or HIV/AIDS status, and evolves over time to enable choice about disclosure to specifically identified participants in the health care system,” stated Maxwell.

Workgroups part of the Patient Choice Technical Project have so far developed several use cases for phase two, with use cases for phase three forthcoming.

REACHNet is funded through the Patient-Centered Outcomes Research Institute (PCORI) through September 2018 and is managed by the Louisiana Public Health Institute (LPHI). 



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