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Curr Hypertens Rep (2016) 18: 49

DOI 10.1007/s11906-016-0650-9

HYPERTENSION AND EMERGENCY MEDICINE (T RAINER, SECTION EDITOR)

New Approaches to Evaluating and Monitoring Blood Pressure


Elizabeth M. Goldberg 1 & Phillip D. Levy 2

Published online: 30 April 2016


# Springer Science+Business Media New York 2016

Abstract Digital health innovations for hypertension include


cuffless blood pressure sensors, wireless smartphone-enabled
upper arm blood pressure monitors, mobile applications, and
remote monitoring technologies. Wearable trackers have
drawn interest from medical professionals and patients alike.
They have the potential to improve hypertension control and
medication adherence through easier logging of repeated
blood pressure measurements, better connectivity with
health-care providers, and medication reminder alerts. With
increasing emphasis on home and ambulatory blood pressure
monitoring to confirm hypertension prior to treatment, such
devices also can help improve the diagnostic landscape.
However, privacy, accuracy, and cost concerns have prevented
widespread clinical uptake. To foster implementation, device
designers and clinical researchers should collaborate on development of rigorous clinical trials that test cardiovascular outcomes associated with emerging technologies. We review the
current literature on mobile health technologies and novel diagnostic and management protocols and make recommendations on how to incorporate these innovations into practice.
This article is part of the Topical Collection on Hypertension and
Emergency Medicine
* Elizabeth M. Goldberg
Elizabeth_goldberg@brown.edu
Phillip D. Levy
plevy@med.wayne.edu
1

Department of Emergency Medicine & Center of Gerontology and


Healthcare Research, Brown University, 55 Claverick Street,
Providence, RI 02903, USA

Department of Emergency Medicine and Cardiovascular Research


Institute, Wayne State University School of Medicine, Integrated
Biosciences Center, 6135 Woodward Ave, Detroit, MI 48202, USA

Keywords Hypertension . Emergency department .


Screening . Measurement . mHealth . Digital health . Sensors

Introduction
The model of office-based hypertension diagnoses and management is changing with the emergence of mobile health care
(mHealth) and increasing acceptance of home blood pressure
monitors as a diagnostic and monitoring tool [13]. New biomedical technologies can monitor heart rate, blood pressure,
activity level, and various other indices of health. Mobile apps
simplify the logging and trending of blood pressures, sync
with electronic health records, and allow for better remote
monitoring by health-care providers. Developers and early
adapters are optimistic that these innovations will lead to cost
savings and improved chronic disease management, while
reducing the care burden of physicians. Venture funding of
digital health companies reached $4.5 billion in 2015 and
wearable technologies are likely to become more ubiquitous
[4]. However, current clinical practice still relies heavily on
traditional office-based blood pressure monitors and protocols, due in part to uncertainty regarding the reliability and
safety of newer technologies.
The most recent hypertension guidelines have
deemphasized office-based hypertension diagnoses and recommended home blood pressure and ambulatory blood pressure monitoring prior to starting antihypertensive treatment [5,
6]. Despite evidence-based validation protocols, hypertension
guidelines have yet to address emerging wearable technologies [7, 8]. Given the widespread enthusiasm for disease
self-management, it is critical to further evaluate the efficacy,
safety, and privacy concerns of new technologies in rigorous
studies. We review the current literature on mHealth technologies and novel diagnostic and management protocols and

Cost, insufficient accuracy


Measure blood pressure using sensors
Cuffless blood pressure devices

Less bothersome for patients than devices


with cuffs, particularly when needing
measurements during sleep

Provides feedback on blood pressure


measurements
Remote monitoring

Useful in resource limited areas

Cost, requires physician oversight

Home blood pressure monitor


measurement self interpretation
through text messaging [30]
SIMCARD study achieves lower systolic
blood pressure using smartphones and
community health workers [27]
Examples that are FDA approved
include Sotera, Somnotouch-NIBP
Cost, requires physician oversight
Sends messages to remind users to take
medication
Text messaging

Self-use wireless upper


Blood pressure devices that can upload
arm blood pressure monitors
data to mobile phones or computers

Smartphone applications allow


for manual or automatic BP logging
Hypertension apps for mobile
devices

May increase willingness to perform


frequent blood pressure checks, may make
physician oversight easier
Improves medication adherence

Poorly regulated, most do not share data


with physician offices, may encourage
unwarranted self-titration of medication
or provide factitious blood pressure
measurements
Cost, bluetooth technology often requires
troubleshooting

Drawbacks
Benefits
Method
Device

New technologies for blood pressure monitoring and management


Table 1

The major device innovations for out of office use include


wireless upper arm blood pressure cuffs and cuffless devices
(Table 1). Wireless upper arm cuffs are automated
oscillometric devices that sync via bluetooth technology to a
computer or smartphone. These function like automated devices in current clinical use by recording vibrations in the
arterial wall to establish systolic and diastolic pressure.
Blood pressures are automatically logged and saved. Many
are user friendly and can improve the accuracy of recording
by avoiding transcription errors, while saving time. However,
most are marketed between US$100 and US$140, which may
be prohibitory for some patients. Additionally, these devices
require some basic knowledge of mobile and computer use,
including the need for regular software updates, and depend
on wireless connectionsa requirement that may not always
work flawlessly. One recent study found 28 % of users experienced device malfunctions that required technological assistance [9].
A second group of emerging devices is cuffless and applied
to the wrist or finger. Traditional teaching has been that blood
pressure monitors should be applied close to the heart, specifically the upper arm, to be most accurate [1012]. Similar to
fitness trackers, these new wearable devices track vital signs
via optical sensors. These wrist and finger sensors use beat-tobeat variability to compute systolic and diastolic readings.
Using computerized mathematical modeling, corresponding
systolic and diastolic blood pressures are computed and data
are indicated on some form of visual interface. For instance,
one such device, Somnotouch-NIBP, uses finger
photoplethysmography and three ECG leads connected to a
watch-like control unit to obtain systolic and diastolic blood
pressure via pulse wave velocity measurements [13]. The interval between the R wave on the ECG and the arrival of the
corresponding pulse wave from the finger is recorded and
translated into blood pressure readings. However, many devices that utilize pulse wave velocity require initial calibration
using an oscillometric brachial cuff, making the accuracy of
the technology somewhat dependent on traditional methods.
The benefits of these blood pressure sensors include the
ability to monitor continuously and avoid sleep-disrupting
cuff inflations when measurements are required at night.
Additionally, their greater ease of use makes them particularly
attractive in the elderly or immobilized patients that may be
most vulnerable to overtreatment and undertreatment with antihypertensives. The trade-off for this convenience lies in the
accuracy of the devices. Although many wireless sensors have
been validated and FDA approved for clinical use,

Notes

Device Innovation

May increase patient engagement and selfmanagement, may be helpful when there
is a long latency to follow-up visits

make recommendations on how to incorporate these innovations into physician practice.

Examples of validated devices include


Withings, QardioArm, iHealth [29]

Curr Hypertens Rep (2016) 18: 49

Only 3 % of reviewed hypertension


management apps were developed
by health-care agencies [19]

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Curr Hypertens Rep (2016) 18: 49

measurements can vary as much as 20 mmHg from blood


pressures derived using brachial cuff. When they are inaccurate, they tend to underestimate blood pressure [12] particularly at the higher end of the scale (i.e., greater than
160 mmHg systolic) [14].
Other cuffless devices include apps that work by application of a finger to the touch screen of the smartphone. Several
of these are listed in Table 2 and are among the highest rated
apps for blood pressure; however, none have been scientifically validated or recommended for clinical use. To the contrary, as evidenced by a study of Instant Blood Pressure
(AuraLife), an app that was purchased by nearly 150,000 individuals, such technology may be highly inaccurate, with
readings that are within 15 mmHg of brachial cuff measured
systolic and 10 mmHg diastolic blood pressures only 59 and
70 % of the time, respectively [15].
While there is insufficient evidence to recommend cuffless
devices to patients at present, there are over 1000 clinical trials
currently registered with www.clinicaltrials.gov to evaluate
the feasibility, accuracy, and safety of various sensor
technologies [16]. Collaborations between researchers and
device innovators will be critical to moving such
technologies forward prior to integrating them into clinical
practice.

Smartphone Applications
Mobile or mHealth is heralded as a panacea for many major
public health problems including poor blood pressure awareness and control. Enthusiasm is warranted as 2/3 of US adults
now own smartphones that are equipped with cameras and
light and motion sensors. By 2017, half of the 3.4 billion
smartphone users worldwide will be using mobile health apps
[17]. Currently, over 100,000 mobile health apps are available, many of which are marketed to the consumer to address
hypertension control or medication adherence; although 42 %
of these require some payment, many come at no additional
cost. Most are developed for patients, but 15 % are primarily
for health-care professionals and offer continuing medical education (CME) credit, remote monitoring, and the ability to
perform telehealth management.
Current hypertension apps offer many consumer-facing
uses including automated blood pressure logging by syncing
to wireless blood pressure devices, medication adherence
alerts, and communication with health-care providers. Some
apps can assist the user in interpreting blood pressure values
and will alert the patient to contact their physician when blood
pressures are alarmingly high or low. Others provide detailed
lifestyle management recommendations in concordance with
clinical practice guidelines [18]. In a 2014, in a review of the
top 100 applications related to blood pressure offered on
Google Play and Apple iTunes, 72 % of apps had tracking

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functions, 22 % had tools to enhance medication adherence,


37 % contained general information on hypertension, and 8 %
contained information on dietary lifestyle modifications such
as the Dietary Approaches to Stop Hypertension (DASH) diet.
However, nearly 1 in 7 also made claims that they could transform the smartphone into a medical device to measure blood
pressure, though none had documentation of validation nor
were any paired with a blood pressure cuff to obtain actual
measurements [19]. Not surprisingly, there are growing concerns that, if left unchecked, mHealth-based hypertension
apps may be misleading to users providing false and potentially dangerous information.
Beyond this, results on the efficacy of mHealth for hypertension control are mixed with some data supporting an improvement in health with a decrease in health-care utilization
[18, 20], while other studies show no benefit [9]. In a recent
meta-analysis of over 3000 patients, mobile phone text reminders increased medication adherence from 50 to 68 %
[21]. Computerized message management systems make this
option scalable and inexpensive. However, few health systems
are providing reimbursement for these services and outcomes
such as cardiovascular disease prevention are uncertain. In a
prospective, randomized-control trial of patients with hypertension using smartphone-enabled wireless blood pressure
cuffs in combination with remote monitoring by nurses, there
was no difference between intervention and control groups in
health-care utilization indices including the frequency of
emergency department visits, office visits, and inpatient stays.
Both groups averaged approximately 150 blood pressure measurements over a 6-month period and had an overall decline in
diastolic blood pressure, but there was no difference in systolic blood pressure and no difference between groups was seen
[9]. The intervention group did report a significant improvement in health self-management as characterized by a decrease in the propensity to view health status as due to chance.

Research and Regulation of mHealth Innovations


While mHealth developers are spearheading much innovation, several promising initiatives are being lead by researchers. The National Institute of Health (NIH) has
established national Big Data Centers of Excellence as part
of a Big Data to Knowledge initiative. This allows for the
funding of interdisciplinary groups to develop the necessary
infrastructure, methods, software, and tools to advance human
health with new technologies. Major areas of research include
improving the reliability and accuracy of devices, exploring
how to best utilize the vast amount of data collected, and
improving safekeeping of physiological measurements and
patient data.
Currently, any blood pressure device that is brought to
market must pass a validation protocol [8]. Noninvasive blood

Company

Evolve Medical Systems, LLC

Taconic System LLC


Qardio, Inc.

Maxwell Software
Little Green Software
Codulis
Codulis

Name

iOS applications
Smart Blood Pressure (Smart BP)
BP Tracker

Blood Pressure MonitorFamily Life

Qardio Heart Health, Weight


and Blood Pressure Monitor

Blood Pressure Companion Free


Heart Star Blood Pressure Monitor

Blood Pressure Lite


Blood PressureBP Tracker for
Hypertension Management
Hello Heart

Cufit, Inc.
Fruct
Leading Edge Apps LLC
TriStar Apps
Dr. Tomasz Jan Zlamaniec
NumbersMatter2Me
KDSsuriyo
Ufone Apps
Freshware

Blood Pressure (BP) Report Lite

Blood Pressure Log


Blood Pressure (BP) Watch
Blood Pressure Monitor Pro
Perf. Blood Pressure (BP) Monitor

Blood Pressure

FDA approved and validated

BP

Achtgrad AG

Blood Pressure Diary


Blood Pressure Diary Pro
iBP Blood Pressure

BP, weight
BP
BP

Leading Edge Apps, LLC

Android applications
Hypertension eDiary

BP, HR, medication, weight

BP
BP, HR, weight
BP
BP

BP

BP

Taconic System, LLC

Blood Pressure Monitor


Family Lite
IBP Blood Pressure

Hello Doctor, Ltd.

BP
BP (with improved graphics/charting
from lite version)
BP, HR, weight; reminders and easy
sharing of results with doctor, easy
import of lab results, HIPAA compliant
BP, HR, weight, medication

BP, HR, MAP, weight


BP

BP, HR, weight, height, medication


tracking, and correlation with BPs
BP, HR, weight, height

BP, heart rate (HR), weight

Functionality

Top-rated iOS and Android smartphone applications for hypertension

Table 2

Manual
Manual
Manual
Measures pressure from thumb
placed on screen
Manual

Syncs with bluetooth monitors


Manual
Syncs with Withings Blood
Pressure Monitor and Scalea
Manual

Manual

Manual

Manual

Manual entry, syncs with many


devices including apple watch

Manual
Manual

Syncs with QardioArma wireless blood pressure


monitor and/or QardioBase smart scale
for weight measurement
Manual logging
Syncs with bluetooth-enabled monitors

Manually logs, syncs with many commercially


available devices via HealthVault including
A&Da, Omrona, Withingsa, and QardioArma
Manual logging

Processing method

Free

Free
Free
Free
Free

Free

Free
$2.19
$0.99

Free

$0.99

Free

$59.99

Free
$4.99

Free
Free

Free

$2.99

$1.99

Cost (US$)

Jul. 30, 2014

Nov. 22, 2015


Jul. 24, 2015
Jul. 6, 2015
Oct. 29, 2015

Feb. 8, 2012

Jan. 4, 2016
Feb. 12, 2016
Nov. 29, 2014

Oct. 15, 2015

Apr. 6, 2015

Nov. 20, 2015

Dec. 6, 2015

Mar. 3, 2016
Mar. 3, 2016

Oct. 29, 2015


Dec. 1, 2015

Feb. 2, 2016

Nov. 20, 2015

Feb. 27, 2016

Last update

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Curr Hypertens Rep (2016) 18: 49

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pressure measurement systems fall under the 510(k) Food and


Drug Administration (FDA) submission type and may not be
marketed to consumers prior to FDA approval. Given the
shear volume of new health applications and technologies, it
is not feasible for the FDA to provide sufficient oversight.
However, the FDA-released recommendations in February
2015 [22] for developers and distributors that stated its agency
would enforce regulatory requirements over apps that are used
to diagnose, treat, or prevent a medical condition.

foreseeable future, physicians may be able to establish


whether a hypertensive patient who presents to the ED
with elevated blood pressure has underlying noncompliance or truly refractory and potentially dangerous hypertension. Given recent data from SPRINT showing the
benefit of lower blood pressure goals, this may be an
issue of increasing importance in an era that espouses
organizational accountability for hypertension control
[26].

Relevance to Emergency Care

Recommendations for Adaptation of mHealth


into Physician Workflow

Mobile technologies addressing hypertension diagnosis and


management are particularly relevant to emergency department physicians. As reported by McNaughton et al., 23.6 %
of all adult emergency department (ED) visits are
hypertension-related [23], with almost 1 % carrying a primary
diagnosis of hypertension. Clinical guidelines recommend
discharge for ED patients who have elevated blood pressure
without signs or symptoms of end organ damage, with referral
to outpatient, primary care for follow-up, and further testing as
needed [24]. Unfortunately, timely follow-up is not always
feasible and a process that incorporates home blood pressure
monitoring post-ED discharge using validated devices to track
blood pressure readings in advance of a primary care visit may
decrease the latency to a hypertension diagnosis or help primary care physicians better titrate medications. Many device
innovators offer remote monitoring capabilities that sync with
the physician office electronic health records. Patients with
particularly difficult to control blood pressures may benefit
most from these technologies. Even patients with poor medication adherence can be helped with mobile reminders to take
their medication. While there are many potential applications
for blood pressure sensors and hypertension-related mHealth
technologies in the emergency department setting, to date,
there is no research in this realm.
As such, mHealth apps and other devices become more
ubiquitous in the consumer environment, emergency physicians are also likely to encounter patients who present to the
ED solely based on concern for elevated blood pressure readings. While some of these patients may indeed be justified in
their reasoning, many more may be prompted by erroneous
values. Accordingly, emergency physicians should be prepared to provide reassurance based on knowledge of aforementioned measurement inaccuracies.
Additional technology that may be relevant to emergency care includes methods to measure patient compliance using ingestible tracers that are attached to daily
medications. These FDA-approved devices provide a direct measure of medication adherence by transmitting
time-stamped messages to a cloud-based server [25].
Currently, their cost is prohibitory, but in the

Many new blood pressure devices, apps, and remote


monitoring systems are available to patients and
health-care systems that may improve hypertension control, medication compliance, and physician access to repeated blood pressure measurements. While mHealth interventions still require rigorous evaluation through clinical trials, patient acceptance and interest in mHealth are
increasing. Subpopulations that may benefit the most
from these technologies include those in resourcelimited areas [27], with poor medication adherence,
and those on multiple medication [28]. Physicians
should encourage patients to use websites with independent physician reviews, such as iMedicalApps, and read
the entire app descriptions before downloading apps for
health maintenance. Some app descriptions may have a
disclaimer Bfor entertainment purposes only.^ Blood
pressure devices that are validated are available on the
dabl Educational Trust website and can be freely
searched by patients. Home blood pressure monitors
using upper arm cuffs and ambulatory blood pressure
devices that are validated can be used to establish a
diagnosis of hypertension and aid in drug titration and
monitoring; however, pending further study, existing
sensor-based and cuff-free devices should not be used
in clinical practice.

Conclusions
Wireless blood pressure monitors and hypertension apps may
improve blood pressure control and drug adherence in patients. Stakeholders including policy makers, physicians, device manufacturers, and patients must work together to ensure
that data from new technologies is kept private and benefits
patients. While technology continues to evolve, more research
that examines long-term health outcomes, costs, and risks is
necessary before cuff-less blood pressure monitors and other
mHealth-based hypertension apps can be recommended in
clinical practice.

49 Page 6 of 7
Compliance with Ethical Standards
Conflict of Interest Dr. Goldberg declares no conflict of interest. Dr.
Levy declares personal fees and non-financial support from The Medicine
Company and Chiesi USA.
Human and Animal Rights and Informed Consent This article does
not contain any studies with human or animal subjects performed by any
of the authors.
Funding Dr. Goldberg received research funding for this work from the
Center of Gerontology and Healthcare Research, Brown University,
AHRQ T32 post-doctoral training grant (PI: Mor, Grant No. T32
HS000011). Dr. Phillip Levy is currently funded by the National
Institute on Minority Health and Health Disparities (PI: Levy - MD 5
R01 MD005849-05).

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