IEEE Solid-State Circuits Magazine - Fall 2017 - 36

To correctly define and design a wireless
system for hospital patient monitoring, it
is important to understand the regulatory
requirements when deploying wireless
technology in medical devices.
the selection and performance of
wireless technology
■ wireless quality of service
■ wireless coexistence
■ the electromagnetic compatibility
(EMC) of wireless technology
■ the security of wireless signals
and data.
While all these issues should be
considered when implementing any
wireless system, when designing a
medical device, the burden is on the
manufacturer to show that the impact
of any of these issues has been as-
sessed and appropriate risk control
measures are in place.
■

Selection and Performance
of Wireless Technology
Whether a custom protocol or an
existing standard, the wireless tech-
nology must be shown as suitable
to meet the monitoring application
requirements, e.g., throughput, num-
ber of nodes supported, and com-
munication range.

Wireless Quality of Service
The chosen wireless technology must
meet the monitoring performance

requirements for latency and pro -
b a bi l it y of loss of i n for m at ion
(drop out).

Wireless Coexistence
This technology must meet the
monitoring performance require-
ments in the presence of other ap-
plications operating in the same
frequency spectrum. While interfer-
ence mitigation techniques such as
frequency hopping, forward error-
correction, and data redundancy
can be employed, if they are not
implemented efficiently, these tech-
niques can have a negative impact
on system latency and power con-
sumption. Concerns about interfer-
ence from other devices having a
negative impact on emerging wire-
less patient monitoring systems has
led U.S. and European regulatory
bodies, the Federal Communications
Commissions a nd the Europea n
Telecommunications Standards
Institute, to allocate dedicated fre-
quency spectrum for wearable wire-
less monitoring devices [the Medical
body area networks (MBANS) spec-
trum at 2360-2400 MHz in the United

TABLE 1. WIRELESS PATIENT MONITORING APPLICATION REQUIREMENTS.

36

GENERAL CARE PATIENTS

ICU PATIENTS

Date type

Intermittent, processed vital signs

Continuous, up to 12-lead ECG

Data rate

Low, few b/s

Up to 120 kb/s

Range

~30 m

~3 m

Latency

Few minutes

< 250 ms

Number of nodes

100 s

1

Network topology

Ad-hoc star

Point to point

Network priority

Low

High

Security

High

High

Lifetime

Few days

Few days

Cost

Low

Medium

FA L L 2 0 17

IEEE SOLID-STATE CIRCUITS MAGAZINE

States and 2483.5-2500 MHz in the
European Union] [4].

EMC of Wireless Technology
A wireless medical device must be
shown to continually function as in -
tended in the presence of electro-
magnetic interference (EMI) from
other devices. For medical devices,
EMC/EMI testing is moving away from
being a prescribed set of tests and
frequencies to an individual prod-
uct-based risk analysis and testing;
that is, the manufacturer must declare
which frequencies his product is most
susceptible to and then show by test-
ing that the risks of this interference
have been mitigated.
Regulations to be introduced in
2019 require very high levels of RF
immunity testing for proximity fields
from certain wireless transmitters
that are expected to become com-
monplace in hospitals, namely global
system for mobile communications/
code division multiple access/long-
term evolution (LTE) at 00.8-0.9 GHz
and Bluetooth/wireless local area
network/RF identification/LTE at
2.4-2.57 GHz [5]. The EMI testing lev-
els for medical devices are orders of
magnitude higher in field strength
and closer in frequency than RF
immunity testing required for con-
sumer products, and it is very likely
that low-power RF communication
systems will face tough challenges
in meeting these requirements. For
medical devices, this will neces-
sitate the careful system design and
mitigation at RF protocol and ap -
p l i cation levels to ensure robust
operation in presence of these high-
level interferers.

Security of Wireless Signals
and Data
Concern about the vulnerability of
wireless medical devices to hacking
led to the FDA issuing a new guidance
note in 2014, "Management of Cyber
Security in Medical Devices" [6], which
highlighted t wo major concerns:
device hijacking and denial of ser-
vice. Device hijacking occurs when
an attacking device discovers the



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