Dov Greenbaum, "Avoiding Regulation in the Medical Internet of Things"

Collecting
Big
Data
via
the
Internet

of
Things,
overcoming
regulatory

and
other
limitations.
Dov
Greenbaum
JD
PhD

Zvi
Meitar
Institute
The
Institute
aims
to
examine
the
Legal
Ethical

and
Social
Implications
of
New
and
Emerging

Technologies
with
a
focus
on
issues
relating
to

Disruptive
Technology.

Four
Facets
of
the
Institute

IoT
The
IoT includes
consumer-‐facing devices,
as
well

as
products
and
services
that
are
not
consumer-‐
facing,
such
as
devices
designed
for
businesses
to

enable
automated
communications
between

machines.

For
example,
the
term
IoT can
include
the
type
of

Radio
Frequency
Identification
(“RFID”)
tags
that

businesses
place
on
products
in
stores
to
monitor

inventory;
sensor
networks
to
monitor
electricity

use
in
hotels;
and
Internet-‐connected
jet
engines

and
drills
on
oil
rigs.
Experts
estimate
that,
as
of
this
year,
there
will

be
25
billion
connected
devices,
and
by
2020,
50

billion.

IoT
The Internet of Things is the network of physical objects that
contain embedded technology to communicate and sense or
interact with their internal states or the external
environment.

IoT
The
Internet
of
Things
(IoT),
which
excludes
PCs,
tablets
and

smartphones,
will
grow
to
26
billion
units
installed
in
2020

representing
an
almost
30-‐fold
increase
from
0.9
billion
in

2009,according
to
Gartner,
Inc.

Gartner
said
that
IoT product
and
service
suppliers
will

generate
incremental
revenue
exceeding
$300
billion,
mostly

in
services,
in
2020.
It
will
result
in
$1.9
trillion
in
global

economic
value-‐add
through
sales
into
diverse
end
markets.

FTC’s
Regulatory
Approach
to
the
IoT
“The
only
way
for
the
Internet
of

Things
to
reach
its
full
potential
for

innovation
is
with
the
trust
of

American
consumers.
“We
believe
that
by
adopting
the

best
practices
we’ve
laid
out,

businesses
will
be
better
able
to

provide
consumers
the
protections

they
want
and
allow
the
benefits
of

the
Internet
of
Things
to
be
fully

realized.
FTC
Chairwoman
Edith
Ramirez

FTC’s
Regulatory
Approach
to
the
IoT
• Security
and
Minimal
Data
Collection
• Consumer
Notice
of
Data
Collection
• Consumer
Choices
re:
Data
Collection
Critics
see
this
as
too
overbearing,

less
-‐permissionpreferring
more

innovation

Its
not
Just
the
Americans

IoT with
some
health
benefits:

Quantified
Self

Quantified
Self
with
a
very
ambitious

health
orientation:
The
Snyderome

A
bit
more
mainstream:
IoT-‐MD
Succinctly:
the
IoT-‐MD
provides
an
environment
where
a
patient’s
vital

parameters
get

• transmitted
by
medical
devices

• via
a
gateway
onto
secure
cloud
based
platforms

• where
it
is

– stored,

– aggregated
and

– analyzed.
Today,
it
has
become
increasingly

possible
to
remotely
monitor
a

patient’s
health
with
the
use
of

network
of
sensors,
actuators
and

other
mobile
communication

devices:
the
Internet
of
Things
for

Medical
Devices
(IoT-‐MD).

Early
adopter
of
IoT-‐MD?

Obama’s
PMI
• Creation
of
a
voluntary
national
research
cohort:
NIH,
in
collaboration
with
other
agencies
and
stakeholders,

will
launch
a
national,
patient-‐powered
research
cohort
of

one
million
or
more
Americans
who
volunteer
to
participate

in
research. Participants
will
be
involved
in
the
design
of
the

Initiative
and
will
have
the
opportunity
to
contribute
diverse

sources
of
data—including
medical
records;
profiles
of
the

patient’s
genes,
metabolites
(chemical
makeup),
and

microorganisms
in
and
on
the
body;
environmental
and

lifestyle
data;
patient-‐generated
information;
and
personal

device
and
sensor
data

A
growing
market
for
IoT-‐MD:
Telemedicine
“Telemedicine
is
the
use
of

medical
information
exchanged

from
one
site
to
another
via

electronic
communications
to

improve
a
patient’s
clinical
health

status.

Telemedicine
includes
a
growing

variety
of
applications
and
services

using
two-‐way
video,
email,
smart

phones,
wireless
tools
and
other

forms
of
telecommunications

technology.”

Chronic
Disease
Management

Another
area
ripe
for
IoT-‐MD:
Chronic
Disease
Management

ALSO:

Developing
Nation
Health
Care
“Telemedicine
is

the
use
of
medical

information

exchanged
from

Problems
with
Unregulated
Innovation
in
the

IoT-‐MD
• Privacy

• Hacking/Safety
• Interoperability

• Accessibility

• Usability/reusability
• standardization

Regulating
the
IoT-‐MD
Mixed
bag.
Sporadic
FDA
regulation
For
purposes
of
this
guidance,
CDRH
defines

general
wellness
products
as
products
that
meet

the
following
two
factors:
(1)
are
intended
for
only

general
wellness
use,
as
defined
in
this
guidance,

and
(2)
present
a
very
low
risk
to
users’
safety.
General
wellness
products
may
include
exercise
equipment,
audio
recordings,

video
games,
software
programs
and
other

products
that
are
commonly,
though
not

exclusively,
available
from
retail
establishments

…that
do
not
make
any
reference
to
diseases
or

condition.

Medical
Device
Data
Systems

Medical
Device
Data
Systems
(MDDS)
are
hardware
or

software
products
that
transfer,
store,
convert

formats,
and
display
medical
device
data.

An
MDDS
does
not
modify
the
data
or
modify
the

display
of
the
data,
and
it
does
not
by
itself
control

the
functions
or
parameters
of
any
other
medical

device.
MDDS
are
not
intended
to
be
used
for
active

patient
monitoring.
Examples
of
MDDS
include:
• software
that
stores
patient
data
such
as
blood

pressure
readings
for
review
at
a
later
time;
• software
that
converts
digital
data
generated
by
a

pulse
oximeter
into
a
format
that
can
be
printed;

and
• software
that
displays
a
previously
stored

electrocardiogram
for
a
particular
patient.

Medical
Device
Data
Systems

The
United
States
Food
and
Drug

Administration
(FDA)
issued
a
final
guidance

document
describing
the
Agency’s
intention

not
to
enforce
regulatory
controls
applicable

to
medical
device
data
systems
(MDDS),

medical
image
storage
devices,
and
medical

image
communication
devices,
due
to
the

low
risk
such
devices
pose
to
patients
and

their
importance
in
advancing
digital
health.

The
guidance,
which
finalizes
draft
guidance

issued
by
the
Agency
in
June
2014,
reflects

FDA’s
continued
efforts
to
apply
a
risk-‐based

framework
that
avoids
over-‐regulation
of

certain
low-‐risk
medical
software
products

On February 15, 2011, the FDA issued a
regulation down- classifying MDDS from Class
III (high-risk) to Class I (low-risk)(“MDDS
regulation”)
Class I devices are subject to general controls
under the Federal Food, Drug, and Cosmetic
Act (FD&C Act). Since down-classifying
MDDS, the FDA has gained additional
experience with these types of technologies,
and has determined that these devices pose a
low risk to the public. Therefore, the FDA does
not intend to enforce compliance with the
regulatory controls that apply to MDDS
devices, medical image storage devices, and
medical image communications devices
.

More
Related
Regulation

FDA
MMA
Regulation
is
Limited
The
FDA
defines
a
‘mobile
medical
app’
as
a
mobile
app
that
is
intended
to

either

– Be
used
as
an
accessory
to
a
regulated
medical
device;
or
– Transform
a
mobile
platform
into
a
regulated
medical
device.
What
is
a
regulated
medical
device?
The
FDA
guidance
states
that:
When
the
intended
use
of
a
mobile
app
is
for:
• the
diagnosis
of
disease
or
other
conditions,
• or

– the
cure,

– mitigation,

– treatment,
or

– prevention
of
disease,

• or
is
intended
to
affect
the
structure
or
any
function
of
the
body
of
man,

the
mobile
app
is
a
device.

MMAs
for
FDA
discretionary
regulation

The
problem:

What
is
collecting
all
this
information?

There
are
thousands
of
apps…
Health is the fastest growing of all app categories, and the number of
health and fitness apps has more than doubled over the last 2 years.
The Apple App Store and Google Play each feature more than
100,000 health apps.
HealthTap provided doctors
with access to a special app
review dashboard where
they could find, download,
try, and review all health and
medicalapps.
http://venturebeat.com/2015/01/21/doctors-‐tap-‐myfitnesspal-‐weight-‐watchers-‐as-‐top-‐health-‐apps/

Too
many
apps:
MMA’s

MMA’s
– What
was
submitted
to
the

FDA
will
likely
quickly
change…

Who
is
developing
MMA’s?

MMAs
are
not
the
only
things
collecting
our
vitals

Data
Integrity
“As it is right now, all the wearable gear out
there is marching to its own tune, doing its
own thing, and grabbing data in its own way
with marginal accuracy. By and large, these
are closed ecosystems or proprietary
applications within an open architecture that
have limited scalability”
http://www.phonearena.com/news/Samsungs-‐Voice-‐of-‐the-‐Body-‐is-‐an-‐open-‐hardware-‐and-‐software-‐platform-‐for-‐personal-‐health-‐monitoring_id56601

Hardware
&
Software
Variability

Software
Variability

https://en.wikipedia.org/wiki/Android_version_history

Software
Variability

https://en.wikipedia.org/wiki/IOS_version_history

Further
Lack
of
Standardized
Hardware
http://smartphoneworld.me/hello-‐world-‐2/

Further
Lack
of
Standardized
Hardware
https://testingmobileapps.wordpress.com/2016/02/17/smartphones-‐sensors-‐list/

Privacy
and
hijacking
of
data

Lack
of
Encyption in
general…

Malicious
Attackers
http://holykaw.alltop.com/cyber-‐crime-‐statistics-‐and-‐trends-‐infographic

Proposed
Solution:
Something
in
the
middle

Proposed
Solution:
Something
in
the
middle
Top
down
regulatory
v.
Bottom

up
industry
led

The
Middle
Layer
can
be
configured
to:
Dynamically
enforce
appropriate
industry

determined
standards
by
being
the
primary
and

preferred
gateway
for
data
to
travel
through

from
patient
to
provider
Alternatively
one
of
a
handful
of
government

approved
IoT-‐MD
health
data
gateways

(compare
with
credit
reporting
agencies)

The
Middle
Layer
can
be
configured
to:
Enforce
industry
standards:
Passively: by
rejecting
data
that
doesn’t
meet
those

standards
Or
Actively:
interacting
with
IoT-‐MD
devices
through
to

modify
the
data
such
that
it
meets
the
standards

For
example:
The
Middle
Layer
can
be

configured
to
provide:
1. Enforced
Standards
either
via
conversion
of

data
to
a
standardized
format
or
not

accepting
data
that
doesn’t
conform.
2. Enforced
and
standardized
encryption
by
not

accepting
data
that
is
not
encrypted
by
the

standard
3. Enforcing
calibration
of
sensors/adding
fudge

factors
to
standardize
the
sensors

For
example:
The
Middle
Layer
can
be

configured
to
provide:
1. A
secure
Centralized
Repository
for
the
data,

accessible
by
both
designated
health
care

providers
and
the
patient
themselves
2. The
ability
to
track
who
is
accessing
the
data

to
enforce
some
semblance
of
privacy
and

control
by
the
patient
of
their
data

Summary
• The
IoT and
the
IoT-‐MD
have
created
a
new

and
emerging
reality
that
will
be
of
substantial

benefit
to
patients
and
other
consumers
of

healthcare
– Telemedicine
– Chronic
disease
management
– Medicine
in
developing
nations
– Quantified
self
and
other
tracking
of
vitals
and

health
related
data

Summary
• FDA,
FTC
and
other
regulators
are
misguided

in
their
attempts
to
regulate
this
industry
– Too
many
applications
– Too
many
novice
companies
– Too
many
software
and
hardware
versions

Summary
• Nevertheless
there
remain
real
concerns
that

call
out
for
some
form
of
government

intervention

– Privacy

– Hacking/Safety
– Interoperability

– Accessibility

– Usability

Summary
• Potential
solution
could
be
technological
• Some
sort
of
middleware/middle
layer…
– That
provides
• Safety
• Encryption
• Data
collection
and
data
retention
Standardization
• Tracking
• Centralized
data
repositories

Remember
the
V-‐chip?

Obama’s
PMI
• The
Precision
Medicine
Initiative,
a
bold
new
research
effort
to
revolutionize
how

we
improve
health
and
treat
disease.
• Launched
with
a
$215
million
investment
in
the
President’s
2016
Budget,
the

Precision
Medicine
Initiative
will
pioneer
a
new
model
of
patient-‐powered

research
that
promises
to
accelerate
biomedical
discoveries
and
provide
clinicians

with
new
tools,
knowledge,
and
therapies
to
select
which
treatments
will
work

best
for
which
patients.
• Most
medical
treatments
have
been
designed
for
the
“average
patient.”
As
a
result

of
this
“one-‐size-‐fits-‐all-‐approach,”
treatments
can
be
very
successful
for
some

patients
but
not
for
others.
• This
is
changing
with
the
emergence
of
precision
medicine,
an
innovative

approach
to
disease
prevention
and
treatment
that
takes
into
account
individual

differences
in
people’s
genes,
environments,
and
lifestyles.
• Precision
medicine
gives
clinicians
tools
to
better
understand
the
complex

mechanisms
underlying
a
patient’s
health,
disease,
or
condition,
and
to
better

predict
which
treatments
will
be
most
effective.

Problems
Less
of
an
issue
for
large
data
sets…

Dov Greenbaum, "Avoiding Regulation in the Medical Internet of Things"

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