CODE for Healthcare

Background

The Continua Design Guidelines provide implementation guidance to system integrators and medical device manufacturers to help them unleash the massive amounts of medical-grade data that enables a more holistic perspective, empowering people and clinicians with expert insight to deliver far greater health services. Product integrations take days instead of months freeing engineers to focus on applications that provide value add and differentiate their offering in the market.

The Continua Open Development Environment (CODE) Project accelerates commercial adoption of products that employ the Continua interfaces in order to support ubiquitous delivery of medical-grade device data into health systems. Commercial ready source code is being developed that implements the Continua Design Guidelines while providing documentation and tools to help expedite regulatory approvals.

Project Quality Plan

To streamline FDA acceptance the CODE project operates in the context of an ISO 13485 (Medical Devices -- Quality management systems -- Requirements for Regulatory Purposes) quality management system, and includes the associated documentation with the source code that simplifies its use in products being developed in accordance with IEC 62304 (Medical Device Software – Software Life Cycle Processes).

Commercial Ready Software Development Project

Continua has already developed and released commercial ready Health & Fitness Service software.  This early release implements the FHIR Observation Reporting Server as defined in the Continua Design Guidelines H.812.5 FHIR Observation Upload Trial Implementation.

PCHAlliance is currently seeking sponsors to fund development of additional commercial ready source code that implements key capabilities defined in the Continua Design Guidelines while providing documentation and tools to help expedite regulatory approval.

The Service Interface: FHIR Observation Upload Capability for Personal Health Gateway Request for Proposal seeks development of source code to provide IEEE 11073 mapping to a FHIR data model, support for capability exchange, OAuth service and FHIR-based observation uploads.

Personal Health Devices Interface: Bluetooth LE Manager for Personal Health Gateway Request for Information seeks development of source code to provide a Bluetooth LE manager, device connection, user notification, authentication, and transcoding. Tests shall be created for the existing CODE for Healthcare testing framework.

Questionnaire & Questionnaire Response Capability for Personal Health Gateway Request for Information seeks development of source code to implement Questionnaires per the HL7 Implementation Guide for Questionnaire Form Definition document HL7 CDA QFD and Questionnaire Responses per the HL7 Implementation Guide Questionnaire Response document HL7 CDA QRD.

Questionnaire & Questionnaire Response Capability for Health & Fitness Service Request for Information seeks development of source code to implement Questionnaires per the HL7 Implementation Guide for Questionnaire Form Definition document HL7 CDA QFD and Questionnaire Responses per the HL7 Implementation Guide Questionnaire Response document HL7 CDA QRD.

Delivery of PHMR Using XDR for the Health & Fitness Service Request for Information seeks development of source code to implement the delivery of a PHMR using XDR to a Health Information Service as defined in the H.813 Health Information System Interface Continua Design Guidelines.

Open Source Software Project

It is envisioned that Commercial Ready Source Code effort will move into the open source environment to rally a community of users and developers to expedite evolution of this commercial software and better enable healthcare IT industry.

Open Source Software is software with source code that anyone can inspect, modify, or enhance. It is not to be confused with closed source software that may be available as a free download.

There are a number of critical tasks to enable, support, and help ensure the success of any open source software development effort. They include initial baseline software with which to launch the project, technical infrastructure providing a development environment, social infrastructure to ensure operational health and leadership, communication that reaches diverse participants, volunteer management, software development and release processes, IPR policy, financial plan, and a conformity assessment scheme suitable for a continuous build environment.

Closed Source Software Project

Closed Source is software that only the organization that created and maintains exclusive control over it can modify, as opposed to open source that anyone can modify.  The Closed Source Software Project develops the technical infrastructure, process administration, release processes and conformity assessment that enables Continua and its members an opportunity to develop and demonstrate key capabilities essential to a successful open source software project in a more controlled development environment.

While the software will be developed using the technical infrastructure, process administration and release process as defined in this project plan, the funding of the software development itself is outside the scope of this project. All software developed and released through this closed source software project shall be compliant with FreeBSD open source software license