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IHE / DEV.SDPi

IHE Devices Service-oriented Device Point-of-care Interoperability (SDPi) profiles supplement specification materials and related tooling.
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HL7 2024-Jan: SES Section Clarification as Non-Comprehensive #271

Open ToddCooper opened 9 months ago

ToddCooper commented 9 months ago

Section Number

1:2.2 Safety, Effectiveness & Security Considerations and Requirements

Priority

Issue

HL7 JAN2024 Ballot Comment: OTHER-2769 "Point out SES section is incomplete".

Add comment to SES discussion that the framework only calls out some SES considerations and that manufacturers and integrators need to perform their own analysis.

Proposed Change

Include a statement to indicate that the SES sections in the document are not intended to be comprehensive, and that any implementers must perform appropriate risk management processes.

JavierEspina commented 3 weeks ago

SDPi Developers Workshop #4 -

Add proposed statement to end of 2nd paragraph in 1:2.2