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Work FG‐SSC SDO work‐ Document Corresponding Standardization Future needs
area deliverable(s) ing on this number document title gap in this area and suggestions
related to this area released by to SG5
work area this SDO
ISO/TR Information security man‐
11633‐ agement for remote mainte‐
1:2009 nance of medical devices and
medical information systems –
Part 1: Requirements and risk
analysis
ISO/TR Information security man‐
11633‐ agement for remote mainte‐
2:2009 nance of medical devices and
medical information systems ‐
Part 2: Implementation of an
information security
management system (ISMS)
ISO Guidelines on data protection
22857:2013 to facilitate trans‐border flows
of personal health data
ISO Digital imaging and communi‐
12052:2006 cation in medicine (DICOM)
including workflow and data
management
ISO/TR Clinical document registry
13128:2012 federation
ISO Health cards – General charac‐
20301:2014 teristics
ISO 21549 Patient healthcard data – Part
1: General structure (2013);
Part 2: Common objects
(2014); Part 3: Limited clinical
data (2014); Part 4: Extended
clinical data (2014); Part 5:
Identification data (2008);
Part 6: Administrative data
(2008); Part 7: Medication
data (2007); Part 8: Links
(2010)
ISO Health indicators conceptual
21667:2010 framework
ISO/TS Classification of safety risks
25238:2007 from health software
ISO/HL 7 Individual case safety reports
27953 (ICSRs) in harmacovigilance –
Part 1: Framework for adverse
event reporting; Part 2:
Human pharmaceutical
reporting requirements
for ICSR
ISO Health informatics – Messages
10159:2011 and communication – Web
access reference manifest
ISO/IEEE Health informatics – Personal
11073‐ health device communication
00103:2015 – Part 00103: Overview

1002 ITU‐T's Technical Reports and Specifications