Introduction

Our vision is to enable high-value, health-based data services, such as patient identity management, machine-guided-diagnosis, and secure health-record storage, for underserved communities primarily in countries in the Global Alliance for Vaccines and Immunizations (GAVI).

The vision can be realized by empowering local integrators to develop healthcare solutions at scale, by selecting and combining existing software and hardware modules without the need or capability to develop the modules themselves. We believe that the explosive adoption of digital networks, mobile phone and computing technologies has put this vision within reach even in the most underserved communities.

A core step in achieving this vision is the specification and adoption of data standards that enable interoperability or communication between data services from different vendors or that perform different functions. We believe that existing standards such as OpenHIE and DHIS2 can be supplemented with newly-developed FHIR©-based standards to provide enabling capabilities for use cases unique to underserved communities in GAVI countries, resulting in solutions that are best suited for the bandwidth and reliability limitations of mobile phone networks in such locations. We believe that the identification and adoption of such FHIR-based standards for underserved communities can be greatly accelerated by leveraging the recent progress and adoption of FHIR-based standards developed primarily for use cases in the US and Europe.

In a specific example, it is anticipated that FHIR will accelerate the adoption, and increase the value of easy-to-use, low-cost, point-of-care (PoC) diagnostics for diseases in underserved communities. Our vision for the PoC diagnostics ecosystem includes integration of solutions from different vendors for specific use cases. Examples include: devices that measure vitals, or that can be used to administer laboratory tests, as well as systems that can use artificial intelligence/machine learning (AI/ML) to provide assessments and treatment plans based on diagnoses. These systems are also referred to as machine-guided-diagnostic (MGD) systems. The diverse point-of-care diagnostics ecosystem will require seamless orchestration and data exchange between systems and devices. Previously, this has been done through proprietary protocols and data structures. This increases the cost of adding new MGD systems to point-of-care diagnostics eco-systems and, moreover, leads to isolated systems that are rarely interoperable. The use and adoption of HL7 FHIR© can reduce the cost of adding new devices and applications, and can enable the point-of-care diagnostics ecosystem in underserved communities.

This FHIR-based Implementation Guide (IG) gives a first example of how FHIR standards relevant to use cases in underserved communities can be developed as a step towards a point-of-care diagnostics ecosystem that is interoperable, scalable and adaptable to local conditions/markets. When complete, the IG using the HL7 FHIR standard will specify data models, APIs and tools that will enable the integration and interoperability of a variety of devices, sensors, mobile applications, patient portals, electronic medical record (EMR) systems, payer and other healthcare systems relevant to underserved communities primarily in the GAVI countries.

Whitepaper on Applicability and Feasability of FHIR for APIs to support Gates Innovation Projects

Implementation Guide Sections

The paragraph identifies the different sections present in the IG along with its summary.

The main sections of this IG are:

• Background - Provides business context for the implementation guide and information that implementers should be familiar with before reading the remainder of the IG. This section will help business people get an idea of the purpose of the IG.
• Detailed Specification - The actual requirements that developers are expected to implement. This section is important to all the vendors providing solutions for Point-of-Care Diagnostics.
• Downloads - Allows downloading a copy of this implementation guide and other useful information. This section is important to all the vendors providing solutions for Point-of-Care Diagnostics.