Page 262 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING Research Administration PROCEDURE
SOP No: Q016 SOP Title: Standard Review Assessment
4.2 Research Administration Quality Specialists
As part of review, QS team members will assess the type of data being collected (PHI, No PHI) and how the device will interact with the Children’s Health network.
Quality Specialists will first query members of the research team with the following questions:
1. Is Children’s protected health information (PHI) being accessed, collected, stored, or transmitted (e.g. ePHI, PHI, HR, Financial, ePII, PII, etc.) outside of the covered entity (to external collaborators)?
2. Will the system, device, or interface connect to the Children’s Health internal network? If no, the system or device will need to connect to the Guest/Business Guest networks.
3. Is technology (software, applications) being installed onto the Children’s Health environment?
4. Are non-Children’s systems/devices that produce Radio Frequency (RF) being provisioned within the Children’s environment? Examples of RF devices include: 1) wireless medical telemetry systems generally used to monitor a patient’s vital signs (e.g. pulse, and respiration) using radio frequency (RF) communication and 2) cellular/mobile phone to support health care delivery.
5. Are there any architectural changes or uses of an existing implementation or a previously reviewed request?
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