<s>
Medical	B-Application
software	I-Application
has	O
been	O
in	O
use	O
since	O
at	O
least	O
since	O
the	O
1960s	O
,	O
a	O
time	O
when	O
the	O
first	O
computerized	O
information-handling	O
system	O
in	O
the	O
hospital	O
sphere	O
was	O
being	O
considered	O
by	O
Lockheed	O
.	O
</s>
<s>
As	O
computing	O
became	O
more	O
widespread	O
and	O
useful	O
in	O
the	O
late	O
1970s	O
and	O
into	O
the	O
1980s	O
,	O
the	O
concept	O
of	O
"	O
medical	B-Application
software	I-Application
"	O
as	O
a	O
data	O
and	O
operations	O
management	O
tool	O
in	O
the	O
medical	O
industry	O
—	O
including	O
in	O
the	O
physician	O
's	O
office	O
—	O
became	O
more	O
prevalent	O
.	O
</s>
<s>
Medical	B-Application
software	I-Application
became	O
more	O
prominent	O
in	O
medical	O
devices	O
in	O
fields	O
such	O
as	O
nuclear	O
medicine	O
,	O
cardiology	O
,	O
and	O
medical	O
robotics	O
by	O
the	O
early	O
1990s	O
,	O
prompting	O
additional	O
scrutiny	O
of	O
the	O
"	O
safety-critical	O
"	O
nature	O
of	O
medical	B-Application
software	I-Application
in	O
the	O
research	O
and	O
legislative	O
communities	O
,	O
in	O
part	O
fueled	O
by	O
the	O
Therac-25	O
radiation	O
therapy	O
device	O
scandal	O
.	O
</s>
<s>
The	O
development	O
of	O
the	O
ISO	O
9000-3	O
standard	O
as	O
well	O
as	O
the	O
European	O
Medical	O
Devices	O
Directive	O
in	O
1993	O
helped	O
bring	O
some	O
harmonization	O
of	O
existing	O
laws	O
with	O
medical	O
devices	O
and	O
their	O
associated	O
software	O
,	O
and	O
the	O
addition	O
of	O
IEC	B-Application
62304	I-Application
in	O
2006	O
further	O
cemented	O
how	O
medical	O
device	O
software	O
should	O
be	O
developed	O
and	O
tested	O
.	O
</s>
<s>
The	O
U.S.	O
Food	O
and	O
Drug	O
Administration	O
(	O
FDA	O
)	O
has	O
also	O
offered	O
guidance	O
and	O
driven	O
regulation	O
on	O
medical	B-Application
software	I-Application
,	O
particularly	O
embedded	O
in	O
and	O
used	O
as	O
medical	O
devices	O
.	O
</s>
<s>
There	O
was	O
an	O
expansion	O
of	O
medical	B-Application
software	I-Application
innovation	O
with	O
the	O
adoption	O
of	O
electronic	O
health	O
records	O
and	O
availability	O
of	O
electronic	O
clinical	O
data	O
.	O
</s>
<s>
The	O
global	O
IEC	B-Application
62304	I-Application
standard	O
on	O
the	O
software	O
life	O
cycle	O
processes	O
of	O
medical	O
device	O
software	O
states	O
it	O
's	O
a	O
"	O
software	O
system	O
that	O
has	O
been	O
developed	O
for	O
the	O
purpose	O
of	O
being	O
incorporated	O
into	O
the	O
medical	O
device	O
being	O
developed	O
or	O
that	O
is	O
intended	O
for	O
use	O
as	O
a	O
medical	O
device	O
in	O
its	O
own	O
right.	O
"	O
</s>
<s>
Due	O
to	O
the	O
broad	O
scope	O
covered	O
by	O
these	O
terms	O
,	O
manifold	O
classifications	O
can	O
be	O
proposed	O
for	O
various	O
medical	B-Application
software	I-Application
,	O
based	O
for	O
instance	O
on	O
their	O
technical	O
nature	O
(	O
embedded	O
in	O
a	O
device	O
or	O
standalone	O
)	O
,	O
on	O
their	O
level	O
of	O
safety	O
(	O
from	O
the	O
most	O
trivial	O
to	O
the	O
most	O
safety-critical	O
ones	O
)	O
,	O
or	O
on	O
their	O
primarily	O
function	O
(	O
treatment	O
,	O
education	O
,	O
diagnostics	O
,	O
and/or	O
data	O
management	O
)	O
.	O
</s>
<s>
The	O
dramatic	O
increase	O
in	O
smartphone	B-Application
usage	O
in	O
the	O
twenty-first	O
century	O
triggered	O
the	O
emergence	O
of	O
thousands	O
of	O
stand-alone	O
health	O
-	O
and	O
medical-related	O
software	O
apps	O
,	O
many	O
falling	O
into	O
a	O
gray	O
or	O
borderline	O
area	O
in	O
terms	O
of	O
regulation	O
.	O
</s>
<s>
While	O
software	O
embedded	O
into	O
a	O
medical	O
device	O
was	O
being	O
addressed	O
,	O
medical	B-Application
software	I-Application
separate	O
from	O
medical	O
hardware	O
—	O
referred	O
to	O
by	O
the	O
International	O
Medical	O
Device	O
Regulators	O
Forum	O
(	O
IMDRF	O
)	O
as	O
"	O
software	O
as	O
a	O
medical	O
device	O
"	O
or	O
"	O
SaMD	O
"	O
—	O
was	O
falling	O
through	O
existing	O
regulatory	O
cracks	O
.	O
</s>
<s>
Examples	O
of	O
mobile	O
apps	O
potentially	O
covered	O
by	O
the	O
guidance	O
included	O
those	O
that	O
regulate	O
an	O
installed	O
pacemaker	B-Device
or	O
those	O
that	O
analyze	O
images	O
for	O
cancerous	O
lesions	O
,	O
X-rays	O
and	O
MRI	B-Algorithm
,	O
graphic	O
data	O
such	O
as	O
EEG	B-Application
waveforms	O
as	O
well	O
as	O
bedside	O
monitors	O
,	O
urine	O
analyzers	O
,	O
glucometer	O
,	O
stethoscopes	O
,	O
spirometers	O
,	O
BMI	O
calculators	O
,	O
heart	O
rate	O
monitors	O
and	O
body	O
fat	O
calculators	O
.	O
</s>
<s>
IEC	B-Application
62304	I-Application
has	O
become	O
the	O
benchmark	O
standard	O
for	O
the	O
development	O
of	O
medical	O
device	O
software	O
,	O
whether	O
standalone	O
software	O
or	O
otherwise	O
,	O
in	O
both	O
the	O
E.U.	O
</s>
<s>
Leading	O
industry	O
innovation	O
in	O
software	O
technologies	O
has	O
led	O
key	O
industry	O
leaders	O
and	O
government	O
regulators	O
to	O
recognize	O
the	O
emergence	O
of	O
numerous	O
standalone	O
medical	B-Application
software	I-Application
products	O
that	O
operate	O
as	O
medical	O
devices	O
.	O
</s>
