 |
Page History
| Scrollbar | ||
|---|---|---|
|
...
| Page info |
|---|
...
|
The section includes information about CBIIT internal initiatives and other standards that affect Semantic Infrastructure 2.0.
...
| Table of Contents |
|---|
...
|
...
|
Office of the National Coordinator and National Health Standards
The US Office of the National Coordinator for Health Information Technology (ONC),
...
is
...
developing
...
a
...
set
...
of
...
...
...
...
...
...
...
...
...
.
...
The
...
NHIN
...
is
...
a
...
set
...
of
...
standards,
...
services
...
and
...
policies
...
that
...
enable
...
secure
...
health
...
information
...
exchange
...
over
...
the
...
Internet.
...
The
...
NIHN
...
provides
...
a
...
foundation
...
for
...
exchange
...
of
...
health
...
information
...
across
...
diverse
...
entities,
...
within
...
communities
...
and
...
across
...
the
...
country,
...
helping
...
to
...
achieve
...
the
...
goals
...
of
...
the
...
Health
...
Information
...
Technology
...
for
...
Economic
...
and
...
Clinical
...
Health
...
(HITECH)
...
Act.
...
Because
...
of
...
the
...
convergence
...
of
...
federal
...
agencies
...
and
...
local,
...
regional
...
and
...
state-level
...
Health
...
Information
...
Exchange
...
Organizations
...
(HIOs),
...
the
...
NHIN
...
is
...
setting
...
a
...
strong
...
precedent
...
for
...
semantic
...
interoperability
...
in
...
the
...
United
...
States.
...
Many
...
of
...
the
...
recommendations
...
are
...
likely
...
to
...
become
...
part
...
of
...
future
...
meaningful
...
use
...
specifications.
...
With
...
a
...
growing
...
number
...
of
...
organizations
...
becoming
...
part
...
of
...
the
...
NHIN,
...
it
...
is
...
evident
...
that
...
the
...
more
...
Semantic
...
Infrastructure
...
2.0
...
aligns
...
with
...
NHIN,
...
the
...
less
...
need
...
there
...
will
...
be
...
for
...
multiple
...
semantic
...
interoperability
...
strategies.
...
HL7
The Health Level Seven International Standards Development Organization (HL7)
...
is
...
an
...
international
...
community,
...
working
...
together
...
towards
...
a
...
common
...
goal
...
of
...
improving
...
patient
...
care
...
through
...
technology.
...
HL7
...
interoperability
...
protocols
...
include
...
messaging
...
standards,
...
decision
...
support
...
standards,
...
clinical
...
document
...
standards,
...
Electronic
...
Health
...
Record
...
(EHR)
...
functional
...
requirements,
...
drug
...
product
...
labeling
...
standards,
...
and
...
more.
...
Many
...
of
...
these
...
protocols
...
are
...
specifically
...
called
...
out
...
in
...
the
...
meaningful
...
use
...
final
...
rules
...
for
...
the
...
HITECH
...
Act.
...
In
...
addition,
...
HL7
...
defines
...
Electronic
...
Health
...
Record
...
(EHR)
...
and
...
Personal
...
Health
...
Record
...
(PHR)
...
functional
...
requirements,
...
which
...
provide
...
a
...
reference
...
list
...
of
...
functions
...
that
...
may
...
be
...
present
...
in
...
an
...
EHR.
...
The
...
function
...
list
...
is
...
described
...
from
...
a
...
user
...
perspective
...
with
...
the
...
intent
...
to
...
enable
...
consistent
...
expression
...
of
...
system
...
functionality.
...
In
...
2009,
...
the
...
HL7
...
EHR-System
...
Functional
...
Model
...
became
...
an
...
...
...
...
...
...
...
...
...
...
...
...
...
,
...
setting
...
the
...
stage
...
to
...
achieve
...
common
...
functionality
...
of
...
EHRs
...
globally.
...
At
...
the
...
heart
...
of
...
many
...
HL7
...
specifications
...
is
...
the
...
...
Information Model (on the HL7 site) (RIM).
...
An
...
object
...
model
...
created
...
as
...
part
...
of
...
the
...
HL7
...
Version
...
3
...
methodology,
...
the
...
RIM
...
is
...
a
...
large,
...
pictorial
...
representation
...
of
...
the
...
HL7
...
clinical
...
data
...
(domains)
...
and
...
identifies
...
the
...
life
...
cycle
...
that
...
a
...
message
...
or
...
groups
...
of
...
related
...
messages
...
will
...
carry.
...
It
...
is
...
a
...
shared
...
model
...
between
...
all
...
domains
...
and,
...
as
...
such,
...
is
...
the
...
model
...
from
...
which
...
all
...
domains
...
create
...
their
...
messages.
...
The
...
RIM
...
is
...
an
...
American
...
National
...
Standards
...
Institute
...
(ANSI)
...
approved
...
standard.
...
The
...
Clinical
...
Document
...
Architecture,
...
a
...
V3-based
...
standard,
...
provides
...
an
...
exchange
...
model
...
for
...
clinical
...
documents
...
(such
...
as
...
discharge
...
summaries
...
and
...
progress
...
notes)
...
-
...
and
...
brings
...
the
...
healthcare
...
industry
...
closer
...
to
...
the
...
realization
...
of
...
an
...
electronic
...
medical
...
record.
...
CDA
...
leverages
...
the
...
use
...
of
...
XML,
...
the
...
HL7
...
Reference
...
Information
...
Model
...
(RIM)
...
and
...
coded
...
vocabularies.
...
RIM
...
is
...
the
...
basis
...
for
...
the
...
Clinical
...
Document
...
Architecture
...
standard
...
being
...
adopted
...
internationally.
...
Common
...
Message
...
Element
...
Types
...
(CMETs)
...
are
...
standardized
...
model
...
fragments
...
intended
...
to
...
be
...
building
...
blocks
...
that
...
individual
...
content
...
domains
...
can
...
"include"
...
in
...
their
...
designs.
...
These
...
blocks
...
reduce
...
the
...
effort
...
to
...
produce
...
a
...
domain-specific
...
design
...
and
...
assure
...
that
...
similar
...
content
...
across
...
multiple
...
domains
...
is
...
consistently
...
represented.
...
The
...
Model
...
Interchange
...
Format
...
(MIF)
...
is
...
a
...
set
...
of
...
XML
...
formats
...
used
...
to
...
support
...
the
...
storage
...
and
...
exchange
...
of
...
HL7
...
version
...
3
...
artifacts
...
as
...
part
...
of
...
the
...
HL7
...
Development
...
Framework.
...
It
...
is
...
the
...
pre-publication
...
format
...
of
...
HL7
...
v3
...
artifacts
...
used
...
by
...
tooling.
...
It
...
is
...
also
...
the
...
formal
...
definition
...
of
...
the
...
HL7
...
metamodel.
...
The
...
MIF
...
can
...
be
...
transformed
...
into
...
derived
...
forms
...
such
...
as
...
UML
...
XMI
...
or
...
OWL.
...
The
...
HL7
...
Version
...
3
...
Development
...
Framework
...
(HDF)
...
is
...
a
...
continuously
...
evolving
...
process
...
that
...
seeks
...
to
...
develop
...
specifications
...
that
...
facilitate
...
interoperability
...
between
...
healthcare
...
systems.
...
The
...
HL7
...
RIM,
...
vocabulary
...
specifications,
...
and
...
model-driven
...
process
...
of
...
analysis
...
and
...
design
...
combine
...
to
...
make
...
HL7
...
Version
...
3
...
a
...
methodology
...
for
...
development
...
of
...
consensus-based
...
standards
...
for
...
healthcare
...
information
...
system
...
interoperability.
...
The
...
HDF
...
is
...
the
...
most
...
current
...
edition
...
of
...
the
...
HL7
...
V3
...
development
...
methodology.
...
The
...
HDF
...
documents
...
the
...
processes,
...
tools,
...
actors,
...
rules,
...
and
...
artifacts
...
relevant
...
to
...
development
...
of
...
all
...
HL7
...
standard
...
specifications,
...
not
...
just
...
messaging.
...
The
...
growing
...
adoption
...
of
...
HL7
...
standards
...
(for
...
example,
...
the
...
Healthcare
...
Information
...
Technology
...
Standards
...
C32
...
(HITSP/C32)
...
specification
...
called
...
out
...
in
...
the
...
meaningful
...
use
...
final
...
rule)
...
throughout
...
the
...
world
...
suggests
...
that
...
aligning
...
Semantic
...
Infrastructure
...
2.0
...
around
...
these
...
specifications
...
will
...
streamline
...
attainment
...
of
...
Semantic
...
Infrastructure
...
2.0
...
objectives.
...
CDISC
Clinical Data Interchange Standards Consortium (CDISC)
...
is
...
a
...
global,
...
open,
...
multidisciplinary,
...
non-profit
...
organization
...
that
...
has
...
established
...
standards
...
to
...
support
...
the
...
acquisition,
...
exchange,
...
submission
...
and
...
archive
...
of
...
clinical
...
research
...
data
...
and
...
metadata.
...
The
...
CDISC
...
mission
...
is
...
to
...
develop
...
and
...
support
...
global,
...
platform-independent
...
data
...
standards
...
that
...
enable
...
information
...
system
...
interoperability
...
to
...
improve
...
medical
...
research
...
and
...
related
...
areas
...
of
...
healthcare.
...
CDISC
...
standards
...
are
...
vendor-neutral,
...
platform-independent
...
and
...
freely
...
available
...
via
...
the
...
CDISC
...
website.
...
CDISC
...
defines
...
standards
...
to
...
be
...
used
...
or
...
reused
...
in
...
the
...
definition,
...
development,
...
and
...
execution
...
of
...
clinical
...
trials
...
as
...
well
...
as
...
the
...
submission
...
of
...
the
...
clinical
...
trial
...
data
...
to
...
regulatory
...
agencies
...
(for
...
example,
...
FDA)
...
for
...
drug,
...
device
...
or
...
procedure
...
approval.
...
CDISC
...
is
...
currently
...
focused
...
on
...
constructing
...
a
...
Shared
...
Health
...
and
...
Research
...
Electronic
...
Library
...
(SHARE)
...
and
...
would
...
like
...
to
...
use
...
the
...
NCI
...
Knowledge
...
Repository
...
as
...
the
...
basis
...
for
...
SHARE.
...
The
...
CDISC
...
SHARE
...
project
...
is
...
attempting
...
to
...
map
...
CDISC
...
standards
...
(for
...
example,
...
Study
...
Data
...
Tabulation
...
Model
...
(SDTM)
...
and
...
Clinical
...
Data
...
Acquisition
...
Standards
...
Harmonization
...
(CDASH)
...
to
...
Biomedical
...
Research
...
Integrated
...
Domain
...
Group
...
(BRIDG)
...
concepts
...
and
...
then
...
have
...
these
...
concepts
...
reused
...
by
...
CDISC
...
participants
...
(for
...
example
...
care
...
delivery
...
organizations,
...
pharmaceutical
...
companies),
...
who
...
create
...
their
...
own
...
local
...
concepts.
...
BRIDG
...
already
...
incorporates
...
a
...
number
...
of
...
CDISC
...
standards
...
(for
...
example,
...
SDTM)
...
and
...
is
...
working
...
to
...
harmonize
...
other
...
CDISC
...
standards.
...
CDISC
...
SHARE
...
will
...
contain
...
the
...
existing
...
CDISC
...
standards
...
and
...
will
...
provide
...
machine
...
readable
...
element
...
(variables)
...
within
...
those
...
standards.
...
This
...
will
...
allow
...
a
...
range
...
of
...
applications
...
used
...
within
...
other
...
organizations
...
(for
...
example
...
Clinical
...
Research
...
Organizations
...
(CROs),
...
pharmaceutical
...
companies,
...
and
...
other
...
agencies)
...
to
...
automatically
...
access
...
those
...
definitions.
...
ISO
...
21090
...
Harmonized
...
Data
...
Types
...
for
...
Information
...
Exchange
...
The
...
NCI
...
CBIIT
...
Enterprise
...
Conformance
...
and
...
Compliance
...
Framework
...
(ECCF)
...
document
...
requires
...
that,
...
in
...
order
...
to
...
achieve
...
Computable
...
Semantic
...
Interoperability
...
(CSI),
...
each
...
attribute
...
of
...
a
...
static
...
information
...
model
...
should
...
be
...
bound
...
to
...
a
...
robust
...
data
...
type
...
specification.
...
The
...
ISO
...
21090
...
standard
...
provides
...
a
...
harmonized
...
set
...
of
...
data
...
type
...
definitions
...
used
...
for
...
representing
...
and
...
exchanging
...
basic
...
concepts
...
that
...
are
...
commonly
...
encountered
...
in
...
support
...
of
...
information
...
exchange
...
in
...
a
...
healthcare
...
environment.
...
These
...
data
...
type
...
definitions
...
represent
...
a
...
culmination
...
of
...
a
...
large
...
scale
...
joint
...
effort
...
among
...
the
...
standard
...
bodies
...
such
...
as
...
HL7
...
and
...
ISO,
...
and
...
have
...
been
...
reviewed
...
by
...
experts
...
in
...
the
...
field.
...
Additionally,
...
this
...
standard
...
is
...
currently
...
being
...
adopted
...
by
...
Canada
...
Health
...
Infoway
...
and
...
Australia’s
...
National
...
E-Health
...
Transition
...
Authority
...
(NEHTA).
...
Hence,
...
it
...
is
...
important
...
for
...
NCI
...
CBIIT
...
to
...
join
...
the
...
adoption
...
activity
...
at
...
this
...
time
...
and
...
provide
...
leadership
...
in
...
the
...
area.
...
Guidelines
...
on
...
use
...
of
...
the
...
emerging
...
ISO
...
21090
...
data
...
type
...
standard
...
for
...
projects
...
funded
...
by
...
CBIIT
...
have
...
been
...
approved
...
by
...
the
...
CBIIT
...
Enterprise
...
Composite
...
Architecture
...
Team
...
(ECAT).
...
SAIF
SAIF (the
...
HL7
...
Service-Aware
...
Interoperability
...
Framework)
...
provides
...
HL7
...
with
...
an
...
Interoperability
...
Framework,
...
that
...
is,
...
a
...
set
...
of
...
elements
...
including
...
but
...
not
...
limited
...
to
...
constructs,
...
best
...
practices
...
and
...
processes
...
that
...
enable
...
HL7
...
specifications
...
to
...
achieve
...
cross-specification
...
consistency
...
and
...
coherency
...
irrespective
...
of
...
the
...
chosen
...
interoperability
...
paradigm
...
(messages,
...
documents,
...
or
...
services).
...
SAIF
...
consists
...
of
...
four
...
core
...
"frameworks":
...
- Information
...
- (including
...
- RIM,
...
- data
...
- types,
...
- and
...
- vocabulary
...
- bindings),
...
- Behavior
...
- (subsuming
...
- the
...
- existing
...
- Dynamic
...
- Model),
...
- Enterprise
...
- Conformance
...
- and
...
- Compliance
...
- (including
...
- existing
...
- HL7
...
- Implementation
...
- and
...
- Conformance
...
- standards),
...
- and
...
- Governance.
...
SAIF
...
should
...
be
...
regarded
...
as
...
an
...
adjunct
...
to
...
any
...
EAF
...
(Enterprise
...
Architecture
...
Framework)
...
which
...
focuses
...
on
...
Working
...
Interoperability
...
(WI).
...
It
...
is
...
a
...
framework
...
which
...
brings
...
from
...
service-oriented
...
architecture
...
(SOA)
...
practice,
...
two
...
critical
...
constructs
...
which
...
significantly
...
enhance
...
the
...
path
...
to
...
WI,
...
that
...
is:
...
- Separation
...
- of
...
- concerns
...
- (static
...
- versus
...
- behavioral
...
- semantics)
...
- Formal
...
- notion
...
- of
...
- contracts
...
SAIF
...
is
...
open
...
enough
...
to
...
be
...
implemented
...
for
...
all
...
or
...
one
...
or
...
a
...
few
...
types
...
of
...
interoperability
...
paradigms
...
(messages,
...
documents,
...
or
...
services).
...
Intended
...
usea
...
of
...
SAIF
...
include
...
enterprise
...
interoperability
...
projects
...
including
...
those
...
building
...
large-scale
...
integrated
...
health
...
IT
...
infrastructures
...
at
...
the
...
national
...
level.
...
The
...
main
...
benefits
...
that
...
will
...
be
...
derived
...
from
...
developing
...
specifications
...
using
...
SAIF
...
include:
...
- Consistency
...
- of
...
- specifications
...
- Enhanced
...
- ability
...
- to
...
- manage
...
- loosely-coupled
...
- complex
...
- interactions
...
- between
...
- multiple
...
- trading
...
- partners
...
- Increased
...
- cross-organization
...
- reuse
...
- of
...
- architecture
...
- primitives
...
- (realizing
...
- the
...
- value
...
- proposition
...
- of
...
- common
...
- message
...
- element
...
- types
...
- (CMETs)
...
- and
...
- extending
...
- that
...
- proposition
...
- to
...
- include
...
- behavioral
...
- as
...
- well
...
- as
...
- static
...
- semantic
...
- constructs).
...
Implementations
...
include:
...
- National
...
- Cancer
...
- Institute
...
- (NCI)
...
- Canada
...
- Health
...
- Infoway
...
- (CHI)
...
- Open
...
- Health
...
- Tools
...
- (OHT)
...
- Architecture
...
- Project
...
- team
...
caBIG®
...
Semantic
...
Infrastructure
...
v2
...
-
...
Initiatives
...
The
...
initiatives
...
proposed
...
below
...
are
...
intended
...
to
...
support
...
production
...
operation
...
of
...
caBIG®
...
semantics
...
while
...
evolution
...
toward
...
a
...
national-scale
...
capability
...
begins.
...
In
...
addition
...
to
...
its
...
legacy
...
obligations,
...
caBIG®
...
and
...
caGrid
...
are
...
expected
...
to
...
inform
...
the
...
design
...
and
...
initial
...
implementations
...
supporting
...
personalized
...
medicine
...
(BIGHealth),
...
improvement
...
of
...
health
...
care
...
quality,
...
value
...
and
...
affordability
...
through
...
the
...
National
...
Health
...
Informatics
...
Network
...
(NHIN),
...
and
...
more
...
immediately
...
support
...
cancer-oriented
...
initiatives
...
such
...
as
...
the
...
cancer
...
aware
...
extension
...
to
...
the
...
national
...
standard
...
electronic
...
medical
...
record
...
(EMR),
...
and
...
a
...
number
...
of
...
other
...
rapidly
...
emerging
...
initiatives
...
that
...
will
...
require
...
capabilities
...
well
...
beyond
...
our
...
traditional
...
focus
...
on
...
cancer
...
and
...
on
...
static
...
data
...
semantics.
...
The
...
need
...
for
...
all
...
semantic
...
metadata
...
to
...
be
...
formally
...
recorded
...
in
...
a
...
single
...
central
...
repository
...
would
...
limit
...
or
...
preclude
...
application
...
of
...
the
...
semantic
...
infrastructure
...
to
...
very
...
large,
...
diverse
...
communities
...
such
...
national
...
health
...
care.
...
Distributed,
...
federated
...
metadata
...
resources
...
will
...
clearly
...
be
...
required.
...
Also,
...
support
...
for
...
behavioral
...
semantics
...
describing
...
the
...
business
...
context
...
of
...
messages
...
and
...
services
...
contracts,
...
metadata
...
creation
...
via
...
processing
...
of
...
line-of-business
...
artifacts,
...
support
...
for
...
ontology
...
based
...
semantics
...
and
...
support
...
for
...
semantically
...
aware
...
service
...
oriented
...
architecture
...
(SOA)
...
capabilities
...
and
...
some
...
form
...
of
...
grid-to-grid
...
semantic
...
interoperability
...
all
...
appear
...
to
...
be
...
capabilities
...
that
...
the
...
emerging
...
semantic
...
infrastructure
...
will
...
have
...
to
...
provide
...
in
...
order
...
to
...
scale
...
to
...
national
...
levels.
...
The
...
caBIG®
...
Semantic
...
Infrastructure
...
and
...
its
...
operational
...
model
...
will
...
be
...
extended
...
to
...
provide
...
integrated
...
support
...
for:
...
- Initiative
...
- 1.
...
- Distributed,
...
- federated
...
- metadata
...
- repositories
...
- and
...
- model
...
- repositories
...
- and
...
- operations
...
- Initiative
...
- 2.
...
- Automated
...
- generation
...
- of
...
- metadata
...
- from
...
- line-of-business
...
- artifacts
...
- Initiative
...
- 3.
...
- Rules
...
- management
...
- and
...
- contracts
...
- support
...
- (behavioral
...
- semantics)
...
- Initiative
...
- 4.
...
- Semantics
...
- support
...
- for
...
- W3C
...
- service
...
- oriented
...
- architecture
...
- resources
...
- Initiative
...
- 5.
...
- HL7
...
- Common
...
- Terminology
...
- Services
...
- 2
...
- (CTS
...
- 2)/
...
- Object
...
- Management
...
- Group
...
- Model
...
- Interchange
...
- Format
...
- (OMG
...
- and
...
- HL7
...
- Model
...
- Interchange
...
- Format
...
- (MIF))
...
- compliant
...
- federated
...
- terminology
...
- services
...
- Initiative
...
- 6.
...
- Controlled
...
- biomedical
...
- terminology,
...
- ontology
...
- and
...
- metadata
...
- content
...
- Initiative
...
- 7.
...
- Assessment
...
- of
...
- semantic
...
- unification
...
- of
...
- compositional
...
- and
...
- derivational
...
- models
Terminology and Data Types
Terminology and data type standards referred to during requirements gathering processes have included:
SNOMED CT (Systematized Nomenclature of Medicine--Clinical
...
Terms),
...
a
...
comprehensive
...
clinical
...
terminology,
...
originally
...
created
...
by
...
the
...
College
...
of
...
American
...
Pathologists
...
(CAP)
...
and,
...
as
...
of
...
April
...
2007,
...
owned,
...
maintained,
...
and
...
distributed
...
by
...
the
...
International
...
Health
...
Terminology
...
Standards
...
Development
...
Organisation
...
(IHTSDO),
...
a
...
non-for-profit
...
association
...
in
...
Denmark.
...
SNOMED
...
CT
...
is
...
one
...
of
...
a
...
suite
...
of
...
standards
...
designated
...
\for
...
use
...
in
...
U.S.
...
Federal
...
Government
...
systems
...
for
...
the
...
electronic
...
exchange
...
of
...
clinical
...
health
...
information
...
and
...
is
...
also
...
a
...
required
...
standard
...
in
...
interoperability
...
specifications
...
of
...
the
...
U.S.
...
Healthcare
...
Information
...
Technology
...
Standards
...
Panel.
...
SNOMED
...
CT
...
is
...
also
...
being
...
implemented
...
internationally
...
as
...
a
...
standard
...
within
...
other
...
IHTSDO
...
member
...
countries.
...
UCUM
...
(Unified
...
Code
...
for
...
Units
...
of
...
Measure),
...
a
...
code
...
system
...
intended
...
to
...
include
...
all
...
units
...
of
...
measures
...
being
...
used
...
in
...
contemporary
...
international
...
science,
...
engineering,
...
and
...
business.
...
The
...
purpose
...
is
...
to
...
facilitate
...
unambiguous
...
electronic
...
communication
...
of
...
quantities
...
together
...
with
...
their
...
units.
...
The
...
Unified
...
Code
...
for
...
Units
...
of
...
Measure
...
is
...
inspired
...
by
...
and
...
heavily
...
based
...
on
...
ISO
...
2955-1983,
...
ANSI
...
X3.50-1986,
...
and
...
HL7
...
extensions
...
called
...
“ISO+”.
...
WHO
...
Drug
...
Dictionary,
...
an
...
international
...
classification
...
of
...
medicines
...
created
...
by
...
the
...
WHO
...
Programme
...
for
...
International
...
Drug
...
Monitoring
...
and
...
managed
...
by
...
the
...
Uppsala
...
Monitoring
...
Centre.
...
WHO
...
Drug
...
Dictionary
...
is
...
used
...
by
...
pharmaceutical
...
companies,
...
clinical
...
trial
...
organizations
...
and
...
drug
...
regulatory
...
authorities
...
for
...
identifying
...
drug
...
names
...
in
...
spontaneous
...
adverse
...
drug
...
reaction
...
(ADR)
...
reporting,
...
pharmacovigilance,
...
and
...
clinical
...
trials.
...
MedDRA
...
(Medical
...
Dictionary
...
for
...
Regulatory
...
Activities),
...
a
...
clinically
...
validated
...
international
...
medical
...
terminology
...
used
...
by
...
regulatory
...
authorities
...
and
...
the
...
regulated
...
biopharmaceutical
...
industry
...
throughout
...
the
...
entire
...
regulatory
...
process,
...
from
...
pre-marketing
...
to
...
post-marketing
...
activities,
...
and
...
for
...
data
...
entry,
...
retrieval,
...
evaluation,
...
and
...
presentation.
...
MEDDRA
...
is
...
also
...
the
...
adverse
...
event
...
classification
...
dictionary
...
endorsed
...
by
...
the
...
International
...
Conference
...
on
...
Harmonisation
...
of
...
Technical
...
Requirements
...
for
...
Registration
...
of
...
Pharmaceuticals
...
for
...
Human
...
Use
...
(ICH).
...
MedDRA
...
is
...
used
...
in
...
the
...
US,
...
European
...
Union,
...
and
...
Japan.
...
Its
...
use
...
is
...
currently
...
mandated
...
in
...
Europe
...
and
...
Japan
...
for
...
safety
...
reporting.
...
The
...
US
...
Food
...
and
...
Drug
...
Administration
...
(FDA)
...
has
...
committed
...
to
...
keeping
...
current
...
on
...
MedDRA,
...
and
...
it
...
has
...
become
...
the
...
standard
...
for
...
adverse
...
event
...
reporting
...
in
...
the
...
United
...
States.
...
RxNorm
...
terminology
...
released
...
by
...
the
...
National
...
Library
...
of
...
Medicine
...
(NLM).
...
RxNorm
...
provides
...
normalized
...
names
...
for
...
clinical
...
drugs
...
and
...
links
...
its
...
names
...
to
...
many
...
of
...
the
...
drug
...
vocabularies
...
commonly
...
used
...
in
...
pharmacy
...
management
...
and
...
drug
...
interaction
...
software,
...
including
...
those
...
of
...
First
...
Databank,
...
Micromedex,
...
MediSpan,
...
Gold
...
Standard
...
Alchemy,
...
and
...
Multum.
...
By
...
providing
...
links
...
between
...
these
...
vocabularies,
...
RxNorm
...
can
...
mediate
...
messages
...
between
...
systems
...
not
...
using
...
the
...
same
...
software
...
and
...
vocabulary.
...
RxNorm
...
now
...
includes
...
the
...
National
...
Drug
...
File
...
-
...
Reference
...
Terminology
...
(NDF-RT)
...
from
...
the
...
Veterans
...
Health
...
Administration,
...
which
...
allows
...
for
...
classification
...
of
...
the
...
RxNorm
...
terms
...
into
...
their
...
chemical
...
and
...
physiological
...
effect
...
categories.
...
NDF-RT
...
is
...
a
...
terminology
...
used
...
to
...
code
...
clinical
...
drug
...
properties,
...
including
...
mechanism
...
of
...
action,
...
physiologic
...
effect,
...
and
...
therapeutic
...
category.
...
Unique
...
Ingredient
...
Identifier
...
(UNII).
...
The
...
overall
...
purpose
...
of
...
the
...
joint
...
FDA
...
and
...
United
...
States
...
Pharmacopeia
...
(USP)
...
Substance
...
Registration
...
System
...
(SRS)is
...
to
...
support
...
health
...
information
...
technology
...
initiatives
...
by
...
generating
...
unique
...
ingredient
...
identifiers
...
(UNIIs)
...
for
...
substances
...
in
...
drugs,
...
biologics,
...
foods,
...
and
...
devices.
...
The
...
UNII
...
may
...
be
...
found
...
in:
...
- NLM's
...
- Unified
...
- Medical
...
- Language
...
- System
...
- (UMLS)
...
- National
...
- Cancer
...
- Institute
...
- Enterprise
...
- Vocabulary
...
- Services
...
- USP
...
- Dictionary
...
- of
...
- United
...
- Stated
...
- Adopted
...
- Name
...
- (USAN)
...
- and
...
- International
...
- Drug
...
- Names
...
- (future)
...
- FDA
...
- Data
...
- Standards
...
- Council
...
- website
...
- VA
...
- National
...
- Drug
...
- File
...
- Reference
...
- Terminology
...
- (NDF-RT)
...
- FDA
...
- Inactive
...
- Ingredient
...
- Query
...
- Application
...
NDC
...
(National
...
Drug
...
Code),
...
a
...
unique
...
product
...
identifier
...
used
...
in
...
the
...
United
...
States
...
for
...
drugs
...
intended
...
for
...
human
...
use.
...
The
...
Drug
...
Listing
...
Act
...
of
...
1972
...
requires
...
registered
...
drug
...
establishments
...
to
...
provide
...
the
...
FDA
...
with
...
a
...
current
...
list
...
of
...
all
...
drugs
...
manufactured,
...
prepared,
...
propagated,
...
compounded,
...
or
...
processed
...
by
...
that
...
establishment
...
for
...
commercial
...
distribution.
...
Drug
...
products
...
are
...
identified
...
and
...
reported
...
using
...
the
...
NDC.
...
FDA
...
MedWatch,
...
the
...
Food
...
and
...
Drug
...
Administration
...
reporting
...
system
...
for
...
adverse
...
events,
...
founded
...
in
...
1993.
...
An
...
adverse
...
event
...
is
...
any
...
undesirable
...
experience
...
associated
...
with
...
the
...
use
...
of
...
a
...
medical
...
product.
...
The
...
MedWatch
...
system
...
collects
...
reports
...
of
...
adverse
...
reactions
...
and
...
quality
...
problems,
...
primarily
...
with
...
drugs
...
and
...
medical
...
devices,
...
but
...
also
...
for
...
other
...
FDA-regulated
...
products
...
(for
...
example,
...
dietary
...
supplements,
...
cosmetics,
...
medical
...
foods,
...
and
...
infant
...
formulas).
...
NLM
...
DailyMed,
...
which
...
provides
...
high
...
quality
...
information
...
about
...
marketed
...
drugs.
...
Drug
...
labeling
...
and
...
other
...
information
...
in
...
the
...
Structured
...
Product
...
Labeling
...
(SPL)
...
is
...
what
...
has
...
been
...
most
...
recently
...
submitted
...
by
...
drug
...
companies
...
to
...
the
...
Food
...
and
...
Drug
...
Administration
...
(FDA)
...
as
...
drug
...
listing
...
information.
...
OMG
Object Management Group (OMG)
...
is
...
a
...
consortium,
...
originally
...
aimed
...
at
...
setting
...
standards
...
for
...
distributed
...
object-oriented
...
systems,
...
and
...
is
...
now
...
focused
...
on
...
modeling
...
(programs,
...
systems
...
and
...
business
...
processes)
...
and
...
model-based
...
standards.
...
Model-driven
...
architecture
...
(MDA)
...
is
...
a
...
software
...
design
...
approach
...
for
...
the
...
development
...
of
...
software
...
systems.
...
It
...
provides
...
a
...
set
...
of
...
guidelines
...
for
...
the
...
structuring
...
of
...
specifications,
...
which
...
are
...
expressed
...
as
...
models.
...
Model-driven
...
architecture
...
is
...
a
...
kind
...
of
...
domain
...
engineering,
...
and
...
supports
...
model-driven
...
engineering
...
of
...
software
...
systems.
...
NCI
...
chose
...
to
...
use
...
MDA
...
because
...
it
...
is
...
a
...
set
...
of
...
standards
...
that
...
have
...
worked
...
well
...
in
...
other
...
areas.
...
The
...
advantage
...
to
...
this
...
approach
...
is
...
that
...
MDA
...
allowed
...
NCI
...
to
...
use
...
available
...
tools
...
to
...
automatically
...
generate
...
some
...
of
...
the
...
code,
...
while
...
giving
...
the
...
flexibility
...
to
...
tailor
...
the
...
code
...
to
...
specific
...
needs.
...
In
...
the
...
future,
...
when
...
the
...
system’s
...
requirements
...
change,
...
NCI
...
can
...
update
...
models
...
and
...
quickly
...
regenerate
...
the
...
appropriate
...
code.
...
MDA
...
is
...
related
...
to
...
multiple
...
standards,
...
including
...
Unified
...
Modeling
...
Language
...
(UML),
...
Meta-Object
...
Facility
...
(MOF),
...
and
...
XML
...
Metadata
...
Interchange
...
(XMI).
...
Of
...
particular
...
importance
...
to
...
model-driven
...
architecture
...
is
...
the
...
notion
...
of
...
model
...
transformation.
...
A
...
specific
...
standard
...
language
...
for
...
model
...
transformation
...
has
...
been
...
defined
...
by
...
OMG
...
called
...
Query
...
View
...
Transformation
...
(QVT).
...
The
...
specifications
...
produced
...
by
...
HL7
...
target
...
multiple
...
facets
...
of
...
the
...
interoperability
...
challenge,
...
include
...
specification
...
of
...
information
...
models,
...
data
...
types,
...
and
...
vocabularies;
...
messaging,
...
clinical
...
documents,
...
and
...
context
...
management
...
standards;
...
and
...
implementation
...
technology,
...
profile,
...
and
...
conformance
...
specifications.
...
Despite
...
the
...
diversity
...
in
...
depth
...
and
...
scope
...
of
...
HL7
...
specifications
...
a
...
common
...
thread
...
is
...
the
...
use
...
of
...
a
...
model
...
driven
...
methodology
...
and
...
the
...
derivation
...
of
...
specifications
...
and
...
interim
...
work
...
products
...
from
...
a
...
common
...
set
...
of
...
reference
...
models.
...
The
...
models
...
used
...
in
...
the
...
Healthcare
...
Development
...
Framework
...
(HDF)
...
development
...
methodology,
...
use
...
the
...
Unified
...
Modeling
...
Language
...
(UML)
...
as
...
the
...
preferred
...
syntax.
...
The
...
HDF
...
closely
...
aligns
...
the
...
underlying
...
meta
...
model
...
governing
...
well-formed
...
HL7
...
models
...
with
...
the
...
meta
...
model
...
of
...
UML
...
and
...
applies
...
the
...
model
...
driven
...
process
...
to
...
all
...
of
...
the
...
technical
...
specifications
...
of
...
HL7,
...
not
...
just
...
messages.
...
The
...
Ontology
...
Definition
...
MetaModel
...
(ODM)
...
is
...
an
...
Object
...
Management
...
Group
...
(OMG)
...
specification
...
to
...
make
...
the
...
concepts
...
of
...
model-driven
...
architecture
...
applicable
...
to
...
the
...
engineering
...
of
...
ontologies.
...
It
...
links
...
Common
...
Logic
...
(CL),
...
the
...
Web
...
Ontology
...
Language
...
(OWL),
...
and
...
the
...
Resource
...
Description
...
Framework
...
(RDF).
...
The
...
Object
...
Constraint
...
Language
...
(OCL)
...
is
...
a
...
declarative
...
language
...
for
...
describing
...
rules
...
that
...
apply
...
to
...
any
...
Meta-Object
...
Facility
...
(MOF)
...
Object
...
Management
...
Group
...
(OMG)
...
meta-model,
...
including
...
UML.
...
The
...
Object
...
Constraint
...
Language
...
is
...
a
...
precise
...
text
...
language
...
that
...
provides
...
constraint
...
and
...
object
...
query
...
expressions
...
on
...
any
...
MOF
...
model
...
or
...
meta-model
...
that
...
cannot
...
otherwise
...
be
...
expressed
...
by
...
diagrammatic
...
notation.
...
OCL
...
is
...
a
...
key
...
component
...
of
...
the
...
OMG
...
standard
...
recommendation
...
for
...
transforming
...
models,
...
the
...
Query
...
View
...
Transformation
...
(QVT)
...
specification.
...
HL7
...
Static
...
models
...
are
...
not
...
strictly
...
UML
...
diagrams.
...
Although
...
they
...
have
...
some
...
similarity
...
in
...
presentation,
...
they
...
are
...
actually
...
statements
...
of
...
constraints
...
against
...
a
...
formal
...
UML
...
model,
...
which
...
is
...
the
...
RIM.
...
In
...
a
...
static
...
model,
...
each
...
of
...
the
...
"clones"
...
is
...
actually
...
a
...
statement
...
of
...
constraints
...
on
...
a
...
properly
...
defined
...
RIM
...
class
...
(properly
...
defined
...
in
...
the
...
RIM
...
sense).
...
OCL
...
constraints
...
express
...
additional
...
rules
...
that
...
apply
...
to
...
the
...
clone.
...
In
...
HL7
...
static
...
models,
...
OCL
...
statements
...
are
...
applied
...
to
...
the
...
clone
...
-
...
in
...
other
...
words,
...
OCL
...
statements
...
are
...
applied
...
to
...
the
...
RIM
...
class
...
only
...
when
...
it
...
is
...
subject
...
to
...
the
...
constraints
...
defined
...
in
...
the
...
clone.
...
In
...
order
...
to
...
use
...
OCL
...
with
...
HL7
...
static
...
models,
...
a
...
new
...
binding
...
mechanism
...
must
...
be
...
described
...
by
...
HL7.
...
This
...
is
...
an
...
expected
...
extension
...
to
...
the
...
OCL
...
langauge.
...
The
...
Common
...
Terminology
...
Services
...
2.0
...
(CTS2)
...
Specification
...
will
...
be
...
an
...
extension
...
the
...
HL7
...
CTS
...
Specification.
...
World
...
Wide
...
Web
...
Consortium
...
(W3C)
...
Recommendations
| Info | ||||||
|---|---|---|---|---|---|---|
| =
|
| ||||
| } A W3C recommendation is the final stage of a ratification process of the World Wide Web Consortium (W3C) working group concerning the standard. This designation signifies that a document has been subjected to a public and W3C-member organization's review. It aims to standardise the Web technology. It is the equivalent of a published standard in many other industries. {info} |
XML
...
Schema
...
(XSD),
...
published
...
as
...
a
...
W3C
...
recommendation
...
in
...
May
...
2001,
...
is
...
one
...
of
...
several
...
XML
...
schema
...
languages.
...
Like
...
all
...
XML
...
schema
...
languages,
...
XSD
...
can
...
be
...
used
...
to
...
express
...
a
...
set
...
of
...
rules
...
to
...
which
...
an
...
XML
...
document
...
must
...
conform
...
in
...
order
...
to
...
be
...
considered
...
'valid'
...
according
...
to
...
that
...
schema.
...
However,
...
unlike
...
most
...
other
...
schema
...
languages,
...
XSD
...
was
...
also
...
designed
...
with
...
the
...
intent
...
that
...
determination
...
of
...
a
...
document's
...
validity
...
would
...
produce
...
a
...
collection
...
of
...
information
...
adhering
...
to
...
specific
...
data
...
types.
...
The
...
Resource
...
Description
...
Framework
...
(RDF)
...
is
...
a
...
family
...
of
...
World
...
Wide
...
Web
...
Consortium
...
(W3C)
...
specifications
...
originally
...
designed
...
as
...
a
...
metadata
...
data
...
model.
...
It
...
has
...
come
...
to
...
be
...
used
...
as
...
a
...
general
...
method
...
for
...
conceptual
...
description
...
or
...
modeling
...
of
...
information
...
that
...
is
...
implemented
...
in
...
web
...
resources,
...
using
...
a
...
variety
...
of
...
syntax
...
formats.
...
RDF
...
Schema
...
(variously
...
abbreviated
...
as
...
RDFS,
...
RDF(S),
...
RDF-S,
...
or
...
RDF/S)
...
is
...
an
...
extensible
...
knowledge
...
representation
...
language,
...
providing
...
basic
...
elements
...
for
...
the
...
description
...
of
...
ontologies,
...
otherwise
...
called
...
Resource
...
Description
...
Framework
...
(RDF)
...
vocabularies,
...
intended
...
to
...
structure
...
RDF
...
resources.
...
The
...
Web
...
Ontology
...
Language
...
(OWL)
...
is
...
a
...
family
...
of
...
knowledge
...
representation
...
languages
...
for
...
authoring
...
ontologies.
...
The
...
languages
...
are
...
characterized
...
by
...
formal
...
semantics
...
and
...
RDF
...
and
...
XML-based
...
serializations
...
for
...
the
...
Semantic
...
Web.
...
OWL
...
is
...
endorsed
...
by
...
the
...
World
...
Wide
...
Web
...
Consortium
...
(W3C)
...
and
...
has
...
attracted
...
academic,
...
medical
...
and
...
commercial
...
interest.
...
SPARQL
...
(pronounced
...
"sparkle")
...
is
...
an
...
RDF
...
query
...
language;
...
its
...
name
...
is
...
a
...
recursive
...
acronym
...
that
...
stands
...
for
...
SPARQL
...
Protocol
...
and
...
RDF
...
Query
...
Language.
...
It
...
was
...
standardized
...
by
...
the
...
RDF
...
Data
...
Access
...
Working
...
Group
...
(DAWG)
...
of
...
the
...
World
...
Wide
...
Web
...
Consortium,
...
and
...
is
...
considered
...
a
...
key
...
semantic
...
web
...
technology.
...
SWRL
...
(Semantic
...
Web
...
Rule
...
Language)
...
is
...
a
...
proposal
...
for
...
a
...
Semantic
...
Web
...
rules-language,
...
combining
...
sublanguages
...
of
...
the
...
OWL
...
Web
...
Ontology
...
Language
...
(OWL
...
DL
...
and
...
Lite)
...
with
...
those
...
of
...
the
...
Rule
...
Markup
...
Language
...
(Unary/Binary
...
Datalog).
...
| Include Page | ||||
|---|---|---|---|---|
|
| Scrollbar | ||
|---|---|---|
|
