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CODE RFP PHG FHIR Observation Upload 20180117 DRAFT Request for Proposal Continua Design Guidelines Implementation Software Services Interface: FHIR Observation Upload Capability - Personal Health Gateway January 2018 This is a DRAFT RFP being circulated solely for the purpose of seeking sponsors to fund the development work described herein. It is not a solicitation to respond. This Request for Proposal (RFP) contains proprietary and confidential information of the Personal Connected Health Alliance, which is provided for the sole purpose of permitting the recipient to respond to this RFP. Version 20180117 DRAFT Executive Summary The Personal Connected Health Alliance (PCHAlliance) works collaboratively with health, technology and life sciences, public policy, research and advocacy groups to support a new norm of personal health engagement, positive behavior change and improved wellbeing and health outcomes. The PCHAlliance is working to accelerate commercial adoption of products that employ the Continua Design Guidelines in order to support ubiquitous delivery of Continua device data and patient information into health systems. Proposals are currently being accepted to develop commercial ready source code that implements a part of the Continua Design Guidelines while providing documentation and tools to help expedite regulatory approval. The requirements outlined herein are for a component of an overall system called Continua Open Development Environment (CODE) for Healthcare, and the supplied component(s) must be designed to integrate in a consistent manner with the existing CODE for Healthcare system. Suppliers planning to bid shall report their intent by 11:59 PM Eastern Time Zone on 15 January 2018. Proposals will be accepted by 11:59 PM Eastern Time Zone 15 April 2018. Proposals will be held in confidence by PCHAlliance Officers and Staff on a need-to-know basis. Procurement is expected to begin no later than the third quarter of calendar year 2018. The CODE for Healthcare project operates under a Project Quality Plan that is based off requirements specified in the Quality Management System designed in accordance with the IEC 62304 specification. All software that is to be developed shall be developed in accordance with this Project Quality Plan. The goal of the project is to accelerate commercial adoption of products that employ the Continua Interfaces by developing and providing commercial ready source code that implements the Continua Design Guidelines. The architecture employed strikes an effective balance between a turn-key system and software components that can be used in other systems. Personal Health Gateway software shall run on both Android and iOS devices. The primary deliverable of this project is source code, along with the associated build, validation, and regulatory artifacts, that when used can create software services for the current commercial release of both the iOS and Android platforms. Key functionality includes IEEE 11073 mapping to a FHIR data model, supporting capability exchange, OAuth service and FHIR-based observation uploads. Tests shall be created for the existing CODE for Healthcare testing framework. The payment schedule is based on 50% of the total cost being invoiced over the expected duration of the project, and the balance being invoiced upon final acceptance of the deliverables. The supplier shall submit a fixed price contract that covers all costs of delivering products and services as defined in this RFP. All software developed and delivered shall be compliant with FreeBSD open source software license. PCHA Confidential 1 DRAFT Table of Contents 1 Project Overview ............................................................................................................................................... 1 2 Administration ................................................................................................................................................... 1 3 Quality System Requirements ..................................................................................................................... 3 4 Technical Requirements ................................................................................................................................ 4 4.1 Continua Architecture Overview ....................................................................................................... 4 4.2 Commercial Ready Software Architecture Overview ............................................................... 5 4.3 PHG architecture guiding principles ................................................................................................ 5 4.4 PHG architecture overview .................................................................................................................. 7 4.5 Goals and Deliverables for this Project ........................................................................................... 8 4.6 Software Requirements ...................................................................................................................... 10 5 Management Requirements ...................................................................................................................... 10 6 Supplier Qualifications ................................................................................................................................. 11 7 Suppliers’ Section ........................................................................................................................................... 11 8 Contracts and Licenses ................................................................................................................................ 12 9 Appendices ........................................................................................................................................................ 12 9.1 Acronyms & Abbreviations ............................................................................................................... 12 PCHA Confidential 1 DRAFT 1 Project Overview The Personal Connected Health Alliance (PCHAlliance) works collaboratively with health, technology and life sciences, public policy, research and advocacy groups to support a new norm of personal health engagement, positive behavior change and improved wellbeing and health outcomes. The PCHAlliance is focused on driving the agenda, creating an evidence base and mobilizing collective action to achieve personal connected health for all. For more information, please visit http://www.pchalliance.org/. The PCHAlliance publishes and promotes the global adoption of the Continua Design Guidelines, the only secure end-to-end ICT framework for personal connected health and care using open standards, to create a secure and interoperable health data exchange in personal connected health. The CDG provide a set of clearly defined interfaces that enable the secure flow of medical data among sensors, gateways, and end services, removing ambiguity in underlying standards to ensure a consistent and interoperable ecosystem of personal connected health devices. To enable reliable interoperability it also contains additional implementation guidelines that further clarify these standards and specifications by reducing options in the underlying standard or specification or by adding a feature missing in the underlying standard or specification. The PCHAlliance is working to accelerate commercial adoption of products that employ the Continua interfaces in order to support ubiquitous delivery of Continua device data into health systems. Proposals are currently being accepted to develop commercial ready source code that implements the Continua Design Guidelines while providing documentation and tools to help expedite regulatory approvals. This Request for Proposal (RFP) will be used to solicit written proposals from various candidate organizations to develop and deliver specific functional blocks of source code software per the qualifications and requirements defined herein. 2 Administration Proposals will be accepted on or before 11:59 PM Eastern Time Zone 15 April 2018. Procurement is expected to begin no later than the third quarter of calendar year 2018. Failure to comply these requirements may be grounds for disqualification. Instructions are mandatory requirements and should be treated as such. Suppliers planning to bid shall report their intent by 11:59 PM on 15 January 2018 Eastern Time Zone. All proposals submitted shall conform to the following format requirements. A transmittal letter signed by a person authorized to engage your company in a contract shall accompany your proposal. PCHA Confidential 1 DRAFT Volume 1: Technical Proposal • Section 1: Cover letter or letter of transmittal • Section 2: Proposal executive summary • Section 3: Response to Administrative Requirements • Section 4: Response to Quality System Requirements • Section 5: Response to Technical Requirements • Section 6: Response to Test Requirements • Section 7: Response to Management Requirements • Section 8: Response to Supplier Qualifications • Appendix A: Additional supporting information Volume 2: Price Proposal • Section 1: Pricing Response • Section 2: Contract The PCHAlliance is interested in obtaining a complete solution to the stated requirements. Proposals will be evaluated using a number of factors as described below. Technical Solution – Primary consideration will be given to meeting the mandatory functional requirements listed in this RFP. Key factors include: • Fulfillment of requirements stated in this
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