2.3 Scope
The Corporation Registry will accept patient data from a variety of sources and formats related to the diagnosis and treatment of patients with disease. The Registry will initially focus on pandemic/ disease, with plans to incorporate
additional diseases aligning with scientific priorities as the Registry matures.
Data collected through the Registry will support:
1. Research (basic, clinical, epidemiological)
2. Generating cohorts of well-characterized patients
3. Identifying phenotypic clinical features of patients with disease
4. Improving and/or assisting with clinical trial recruitment processes
5. Identifying biomarkers correlated with disease
6. Appropriate secondary uses of the aggregated data (e.g., benchmarking, quality improvement, regulatory requirements)
3.4 Project Milestones, Deliverables, and Deadlines
Upon selection of vendors, corporate Registry staff will assemble a Project Team consisting of internal staff and staff representing each vendor. The Project Team will develop a Project Plan specifying deliverables, milestones, timeframes,
deadlines, and resource requirements for each stage.
3. Requirements
The requirements for the corporate registry project are detailed in the table below.
Vendors are expected to respond to these requirements by replying in a survey format with additional details that at a minimum indicate the requirement is met, partially met, requires customization, or cannot be met, as well as any comments that will explain the response.
The requirements include the following groupings for specific features:
1. Business and System
2. Regulations and Policies
3. Constraints
4. Information System Design & Integration
5. Performance, Availability & Contingency Plan
1. Business and System Specification
1.1 The system will include the ability to directly integrate with multiple data sources, including electronic health records, billing systems, other registries, among others.
1.2 The system will include the ability to handle data collection for at least two points of care with integration of multiple entries for the same episode of care.
1.3 The system will include the ability to generate exportable data sets for use by corporate staff.
1.4 The system will be configurable, with the ability to modify and add data elements as needed for data collection.
1.5 The system will include canned and custom reports. Vendor comment should include details of the format (e.g. pdf, xls, csv, etc.)
2. Regulations and Policies
2.1 The system will conform to the federal laws and regulations that are planned for at the time of go-live related to health IT, privacy and security.
2.2 The system will conform to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and related regulations.
3. Constraints
3.1 The vendor will demonstrate the ability to import legacy data in a defined format inclusive of all required fields.
3.2 The vendor will demonstrate the ability to incorporate different types of data (i.e. structured, semi-structured, unstructured)
4. Information System Design & Integration
4.1 The system will integrate with PersonnelHR, corp’s association management system to pull user-specific permissions and information through single-sign on.
4.2 The vendor will demonstrate the ability to host the clinical data registry. Please explain your approach in some detail.
4.3 The vendor will demonstrate the ability to support scaling the hardware and software.
4.4 The vendor will demonstrate the ability to provide technical assistance to support multiple registries .
4.5 The vendor will demonstrate the ability to have scheduled and routine periodic import(s) of the data that have been collected and which need to be imported. (Specify real-time, hourly, and daily).
4.6 The system will incorporate responsive design in application front-end to allow for multi-platform and device accessibility.
4.7 The vendor will provide data collection and reporting services with secure certificate (HTTPS) implementation if corporation will not host the solution.
4.8 For DaaS, SaaS or hosted environments, the Vendor will provide details of the scheduled backups of data and system environments (include details of how often and when).
5. Performance, Availability & Contingency Plan
5.1 The system will be available online 24 hours per day, 365 days per year with the exception of scheduled and pre-notified system maintenance downtimes.
5.2 The vendor will provide adequate tools to investigate any performance issues and system delays/outages that might be reported by users.
5.3 For DaaS, SaaS and hosted software, the Vendor will provide details of scheduled and routine updates and outages that will occur.
5.4 For SaaS and hosted solutions, in the event of an unscheduled outages that might occur (such as a natural disaster), the Vendor will provide details of how a continuity plan (e.g. a tested disaster and recovery plan, and solution(s)
in place that will restore system availability).
5.5 The vendor will demonstrate that system resources are adequate for timely report generation and that response times are acceptable.
5.6 The vendor should include details of their ability and preferred means of providing
Help Desk and service support, including non-business hours.
Confidential,

Ai Development Lab In Public and Primary Healthcare. - Blood &
Brain Disease Research Center

Centre For Blood Research and Genomic /inherited Blood Disease Research

Centre for Exta-Pathological Collaboration- Inter industry Data Share

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