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Finalized Scope Language
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After SDPi Friday review 3 November.
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ToddCooper committed Nov 3, 2023
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Expand Up @@ -60,25 +60,18 @@ In this version, the content is added as 2.3.1, and then the profiles as 2.3.10

The Service-oriented Device Point-of-care Interoperability (SDPi) Profile specifications encompass the following application scope:

#EdNote: Working Draft - KF THC#
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. The SDPi specifications provide detailed instructions for seamless plug-and-play interoperability between ISO/IEEE 11073 SDC-based medical devices (including SaMD), as well as between medical devices and health IT systems based on HL7 FHIR and HL7 Version 2.
Key considerations include safety, security and effectiveness for data reporting, alert notification, device-external control and other high-acuity (e.g., ICU, OR, Step-Down, Emergency response) use cases.
Provision is made for coordination of individual device functional contributions to support Clinical System Functions.
Key considerations include enabling safe, secure and effective interoperability for data reporting, alert notification, device-external control and other high-acuity point-of-care use cases.
Provision is made for coordination of individual device functional contributions to support clinical system functions that are provided by two or more participants.


#EdNote: Original component points ...
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. _Safe, effective and secure medical device interoperability_
. Optimized for high-acuity points of care (e.g., operating room, intensive care, and emergency)
. utilizing services oriented architectures
. providing seamless plug-and-play connectivity
. between medical devices, health software (incl. SaMD), and other health-related systems and technologies
. supporting medical reporting, alerting external control and other capabilities
. and coordination / coupling between multiple devices for achieving clinical system functions
. ecosystem (vendor independent) of ... products ...

Notes: #<add additional explanatory / scoping notes here>#
Notes:

1. High-acuity points of care include operating rooms (OR), intensive care units (ICU), step-down units, and emergency care.
2. Clinical system function example: Physiological monitoring of a patient's condition as they are being weaned off of a ventilator.
3. "SaMD" is Software as a Medical Device, including "clinical apps"; they are a class of Health Software.
4. ISO/IEEE 11073 Service-oriented Device Connectivity (SDC) standards provide a Services Oriented Architecture (SOA) specification for safe, effective and secure medical device interoperability (SES MDI).
[#vol1_clause_sdpi_overview_framework]
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