what is iso in medical informatics about? christian hay, convener tc 215, wg 6 «pharmacy and...
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What is ISO in medical informatics about?Christian Hay, Convener TC 215, WG 6 «pharmacy and medicines business»
12 September 2013
© 2014 GS1
Scope TC 215: Health Informatics
Standardization in the field of information for health, and Health Information and Communications Technology (ICT) to promote interoperability between independent systems, to enable compatibility and consistency for health information and data, as well as to reduce duplication of effort and redundancies
The domain of ICT for health includes but is not limited to:• Healthcare delivery;• Disease prevention and wellness promotion;• Public health and surveillance;• Clinical research related to health service.
© 2014 GS1
Other liaisons
CAG2: Co-ordination Group (CG)
WG 1Ad
hoc
gro
up
Ad h
oc g
roup
Join
t WG
7 w
IEC/
62A
Specific ad hoc tasks
Domain-specific portfolio of items
Permanent underpinning standards work
Technical Committee Plenary (TC Plenary)
NMB NMB NMB NMB….
JICCAG1: Executive Council (EC)
CAG3- xSDOCo-ordination Group
Join
t WG
w
ISO
/TC2
49
WG 4
WG 3
WG 2
WG
-D
WG
-D... ...
TC 215 structure
NMB: National Mirror Body: IPQ - Instituto Português da Qualidade, Rua António Gião, 2 - PT-2829-513 Caparica
IPQ has an “observer” status
© 2014 GS1
Other liaisons
CAG2: Co-ordination Group (CG)
WG 1
Ad h
oc g
roup
Ad h
oc g
roup
Join
t WG
7 w
IEC/
62A
Specific ad hoc tasks
Domain-specific portfolio of items
Permanent underpinning standards work
Technical Committee Plenary (TC Plenary)
NMB NMB NMB NMB….
JICCAG1: Executive Council (EC)
CAG3- xSDOCo-ordination Group
Join
t WG
w
ISO
/TC2
49
WG 4
WG 3
WG 2
WG
-D
WG
-D... ...
TC 215 structure
Liaison: e.g. CEN TC 251, DICOM, GS1, HL7, IHE, IHTSDO (SNOMED)
© 2014 GS1
Other liaisons
CAG2: Co-ordination Group (CG)
WG 1
Ad h
oc g
roup
Ad h
oc g
roup
Join
t WG
7 w
IEC/
62A
Specific ad hoc tasks
Domain-specific portfolio of items
Permanent underpinning standards work
Technical Committee Plenary (TC Plenary)
NMB NMB NMB NMB….
JICCAG1: Executive Council (EC)
CAG3- xSDOCo-ordination Group
Join
t WG
w
ISO
/TC2
49
WG 4
WG 3
WG 2
WG
-D
WG
-D... ...
TC 215 structure
WG1: Architecture, Frameworks and Models
WG2: Systems and Device Interoperability
WG3: Semantic content
WG4: Security, Safety, and Privacy
© 2014 GS1
Other liaisons
CAG2: Co-ordination Group (CG)
WG 1
Ad h
oc g
roup
Ad h
oc g
roup
Join
t WG
7 w
IEC/
62A
Specific ad hoc tasks
Domain-specific portfolio of items
Permanent underpinning standards work
Technical Committee Plenary (TC Plenary)
NMB NMB NMB NMB….
JICCAG1: Executive Council (EC)
CAG3- xSDOCo-ordination Group
Join
t WG
w
ISO
/TC2
49
WG 4
WG 3
WG 2
WG
-D
WG
-D... ...
TC 215 structure
WG
6: P
harm
acy
and
med
icin
es
busi
ness
JWG
1: In
form
atic
s of
T
radi
tiona
l C
hine
se m
edic
ine
JWG
7: A
pplic
atio
n of
ris
k m
anag
emen
t to
IT n
etw
orks
in
corp
orat
ing
med
ical
dev
ices
© 2014 GS1
An example of WG 6 delivery
© 2014 GS1
ISO IDMP – Identificationof Medicinal Products
Substance
Dose FormStrength
Substance
Dose FormStrength
Substance
Dose FormStrength
Substance
Dose FormStrength
Regulated Medicinal Product
Pharmaceutical Product
Substance
Pharmaceutical Dose Form
Units of measurement
Standard Terminology
EN ISO 11615
EN ISO 11616
EN ISO 11238
EN ISO 11240
EN ISO 11239
8All these EN ISO standards have been jointly developed with HL7 and are currently
in implementation by US FDA, European Medicines Agency and other regulators
© 2014 GS1
Contact
9
Christian HayGS1 Global OfficeSr Consultant HealthcareConvenor ISO TC 215, WG 6
Tel +41 21 825 32 19Mob +41 76 369 10 54