Download File - Eric Chavez MD MMI

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2013 Fall MED_INF_405-DL_SEC55
Interoperability and Health Information Exchange for Mobile Health Monitoring
Devices
Team Project Group 4
November 24, 2013
Team Project Group 4:
Eric Chavez
Kenneth Mahung
David West
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Introduction
Group Project Team 4 chose to do a literature review on mobile health device standards. The term “mobile
devices” includes personal health care devices that directly measure one or more physiological parameters by remote
action often outside of a health care setting. Examples of devices included in this scope are glucometers, weight
scales, peak flow meters, and cardiac rhythm monitors, though other devices could qualify by this definition.
Examples of devices that would not be included in this scope include diary recording devices, medication
compliance devices educational devices. The literature review examines the standards that apply to transmitting data
to remote health care settings by both wireless and wired configurations.
Specific questions that the literature review seeks to address will include: what are the breadth and type of
mobile medical devices and what data are being exchanged? What are the current mobile medical device
interoperability standards and what are the organizations developing them? What is the status of mobile device
interoperability standards adoption? What are the security concerns for mobile devices? What are future directions
and concerns for mobile health device standards?
Mobile medical devices are becoming more and more common in healthcare. The ability to passively
acquire and transmit data has great potential appeal for patients. They would not have to transcribe or otherwise
take steps to transmit data. There is great potential appeal for health care providers also. They would not have to
worry about authenticity or latency in the data. In order to make these devices more useful and to improve patient
safety, it is necessary for these devices to communicate with applications that can organize and present the data in a
useful manner to clinicians, and in addition have the data integrated and trended with like data from other sources.
Connecting devices developed and manufactured by different organizations can be a huge task. Interoperability
standards are necessary to build the interfaces that can link these devices to larger information systems.
According to Moorman (2010), “the ultimate goal of interoperability is a seamless flow of information
between many disparate devices over a network to and from the intended recipients. The key word is disparate such
that different vendors can communicate over different networks to different recipients.”
Once mobile devices are linked to larger systems, two-way communication can allow data collected from
the mobile devices to be stored in an electronic health record and information from the hospital information system
can be used to control the device. The exchange of data can be used to influence the function of other mobile
devices using decision support systems. Central hospital management systems can control the functions of the
mobile devices, recognize when they are malfunctioning, and remotely repair and configure them. Even though
mobile devices are more prevalent in healthcare and interoperability standards are the foundation for making these
devices more functional and safe, traditional standards development organizations and agencies such as Health
Level Seven (HL7), the Food and Drug Administration (FDA), the Federal Communication Commission (FCC), and
the Federal Trade Commission (FTC) are just starting to recognize the need for oversight and greater
interoperability (Brandt, 2012).
Research Hypothesis
The research hypothesis is that mobile medical device standards for interoperability are neither wellestablished nor adopted. There are few standards development organizations (SDO) that are focusing on mobile
medical devices. When mobile medical device standards for interoperability do exist, they are often overlooked by
those organizations that are currently producing and using mobile medical devices. This may be because the rate of
introduction of new mobile devices is very great and because there is relatively little government oversight and
regulation of mobile medical devices. Also there may be some debate about what actually qualifies as a mobile
medical device. Lack of mobile medical device interoperability standards may create safety issues when these
devices are used by patients both in remote settings and in medical facility settings.
Methods
A literature review was conducted using multiple sources including peer-reviewed journal articles,
technical white papers, technology web sites, and news articles.
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Results
Definition of Mobile Health Devices and Data
As we approached this topic, we thought it important to provide background as to what constitutes mobile
health devices and what types of data are typically shared in an interoperable setting. To lay this foundation, it is
worth noting that the Office of the National Coordinator of Health Information Technology (ONC) contracted with
The Health Information Technology Standards Panel (HITSP) headed by John Halamka MD to “advance the
widespread interoperability and adoption of electronic health records” (Blumenthal, 2010). The HITSP is a
cooperative partnership between public and private sectors. The Panel was formed for the purpose of harmonizing
and integrating standards that will meet clinical and business needs for sharing information among organizations and
systems (HITSP website). The HITSP had several working groups highlighted by this diagram:
Figure 1 HITSP Workgroups
The Consumer Perspective Technical Committee addressed mobile medical devices in a document called the
“HITSP Remote Monitoring Interoperability Specification” which was subsequently released on December 18, 2008
(Consumer Perspective Technical Committee, 2008). Within it are contained the types of devices being focused on
and a set of specifications that help to describe the types of data which are currently expected to be exchanged from
these devices. The devices are categorized as follows:
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Blood Glucose Meter
Blood Pressure Monitor
Brain Activity
Cholesterol
Esophageal pH
Heart Rate
Heart Rhythm
Implantable Cardioverter Defibrillator (ICD) Monitoring
Lung Function
Oxygen Saturation (Pulse Oximeter)
Respiration Rhythm
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

Temperature (Thermometer)
Weight (Weighing Scale)
Data elements described for each of these devices contain not only the physiological parameters (e.g. blood
glucose, weight, etc.) but also many contextual parameters such as tester id, device id, date and time, and sample
location. The list above is not intended to be in any way limiting to future activities, but simply represents the scope
of remote home monitoring devices commercially available at the time of the report. What they all share is the
ability to digitally record direct measurements of physiology and/or biological condition. Personal devices like
smart phones are viewed as intermediary devices in this context as they are one step removed from the sensor itself.
However, that gap is diminishing with new types of sensory devices that may be attached to an iPhone. Even with
just its light feature, an iPhone can easily measure a pulse. An iPhone is not, however, equipped by itself to record,
store, and transmit this data. For now it is not among the devices that fit in these categories, but the lines will likely
get greyer and greyer. One might imagine when medical devices start to become more integrated into more
consumer goods such as clothing, automobile seats or furniture.
Mobile Health Device Interoperability Standards and Standards Development Organizations
A review of the literature of mobile medical devices shows that there are relatively few organizations that
are focused on the development and dissemination of interoperability standards for mobile medical devices. Some of
these organizations are very well-known standards development organizations such as the Institute of Electrical and
Electronics Engineers (IEEE), the International Organization for Standardization (ISO), the European Committee for
Standardization (CEN), the National Institute of Standards and Technology (NIST). Some are well-known health
information technology (HIT) standards organizations such as Health Level Seven (HL7) and Digital Imaging and
Communications in Medicine (DICOM). The most commonly referenced organizations devoted to mobile medical
device interoperability standards and those which were listed as the four most important organizations according to
Moorman in her 2010 article are: the Continua Health Alliance, Integrating the Healthcare Enterprise (IHE),
American Society for Testing and Materials-Integrating the Clinical Environment (ASTM-ICE), and the Health
Information Technology Standards Panel (Moorman, 2010). See Table 1 for a summary.
CEN ISO/IEEE 11073: The most commonly referenced set of standards in the literature review of mobile
medical device interoperability standards is the CEN ISO/IEEE 11073 Health Informatics – Medical/Health Device
Communication family of standards. A good review of this family of standards can be found on Wikipedia
(ISO/IEEE 11073 at http://www.wikipedia.org/wiki/ISO/IEEE_11073). The standards provide for automatic data
capture from devices including physiologic data from monitoring sensors on patient and data about the operational
status of the device itself. The standards allow for two-way communication between the mobile devices and larger
information systems. This family of standards is so ubiquitous in the literature about mobile medical devices
because these standards provide the solution for device connection through all layers of the Open Systems
Interconnection (OSI) model. In particular the ISO/IEEE 11073 Personal Health Data standards are targeted for
small mobile devices such as weighing scales, pulse oximeters, blood glucose monitors, blood pressure monitors,
peak flow meters, thermometers, medications monitors, and others.
The ISO/IEEE 11073 standards allow for a high degree of interoperability. Once connected, mobile devices
send information which informs the larger system about the mobile device and how to communicate with it. The
standards allow for two-way data transmission simultaneously among several devices. All data is time correlated
and can be retrieved, displayed, and stored automatically and nearly instantaneously. Systems built with these
standards are capable of capturing data at the point-of-care and transforming the data so that it can be retrieved,
processed, and archived by a variety of different applications. The standards provide syntactic interoperability
through defined message structures and semantic interoperability through a core nomenclature (Brandt, 2012).
Galarraga (2007) describes how the 11073 standards might be used in a home health monitoring scenario.
Several small devices with sensors to monitor the patient’s physiologic parameters will be integrated and connected
via a Body Area Network (BAN) or Personal Area Network (PAN). The BAN or PAN is then connected to an
integrated compute engine through a Local Area Network (LAN). The compute engine is connected with a
telemedicine server. The telemedicine server is then connected to the larger hospital information system or EHR.
The most critical need for interoperability standards is in homogenizing the interface between the disparate mobile
medical devices and the compute engine (Galarraga, 2007). This is the role of the ISO/IEEE 11073 family of
standards. Different standards within the family allow for device connection to a network via a wired or wireless
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medium, inter-device communication, and communication between the devices and the EHR, all while maintaining
syntactic and semantic interoperability.
Continua Health Alliance: The Continua Health Alliance is not a standards development organization. It
is a group of more than 200 companies from the healthcare, communications, and technology industries (Continue
Health Alliance website). It produces guidelines for mobile medical devices based on current interoperability
standards and certifies mobile devices to be interoperable. Devices certified by Continua allow nearly plug-and-play
compatibility. The organization aims to establish systems of interoperable devices for chronic disease management
and telehealth. Continua-certified products rely on the ISO/IEEE 11073 family of standards and protocols for data
exchange in the upper layers of the OSI model and on Bluetooth and USB standards for data transmission in the
lower layers.
Integrating the Healthcare Enterprise: Integrating the Healthcare Enterprise (IHE) is an international
organization based in the U.S. It is primarily concerned with initiatives which help to improve the way computer
systems share information by identifying interoperability standards and developing technical guidelines that
manufacturers can use when developing new products (IHE website). IHE divides itself into several specialty
domains. The Patient Care Device (PCD) domain is concerned with defining standards for interfaces between pointof-care medical devices such as infusion pumps, ventilators, implantable cardiac devices, and anesthesia equipment
and the larger healthcare enterprise such as electronic health records. Some example profiles can be found on their
website (www.ihe.net/Patient_Care_Devices) and are mentioned below:
 Alarm Communication Management Profile helps to ensure proper dissemination and
prioritization of alarm messages from devices.
 Infusion Pump Event Communication profile allows an infusion pump to send detailed
information to a larger care management system.
 Implantable Device Cardiac Observation profile allows two-way communication for interrogation
and modification of cardiac devices.
 Rosetta Terminology Mapping profile allows mapping and correlation of disparate vendor terms
and units of measure to ISO/IEEE 11073 standards.
ASTM F2761: The official name for the ASTM F2761 standard is “Medical Devices and Medical
Systems—Essential Safety Requirements for Equipment Comprising the Patient-Centric Integrated Clinical
Environment” and is better known as ICE (Quigley, 2009). The standard aims to outline requirements so that
devices produced by various manufacturers that are used in high acuity environments will be fully integrated and
interoperable. The standard also extends to such monitoring devices that can be used in a patient’s home or other
location outside of a hospital environment. Objectives of the standard include development of ICE network
controllers that can send an alarm if the device is malfunctioning, ICE network supervisors which perform functions
such as record keeping and clinical decision support, and ICE network interfaces which connect the devices with
network controllers (Quigley, 2009).
Health Information Technology Standards Panel: As mentioned above, the ONC founded the HITSP in
2005. HITSP is now a cooperative of public and private organizations (HITSP website). Its mission is to set
integration and interoperability standards with the goal of a universal EHR. The guidelines endorsed by HITSP are
meant to be mandatory for any organizations developing products, systems, or software for EHRs used in the U.S.
Interoperability of remote monitoring devices is one focus of HITSP with its Interoperability Standard 77 (IS77).
According to HITSP, the IS77 standard is concerned with data exchange and interoperability requirements
for patient monitoring devices that are physically attached to or worn by a patient that is in a site remote from a
physician (Consumer Perspective Technical Committee, 2008). Much like the ISO/IEEE 11073 standards, the IS77
standards allow for two-way communication between these remote patient monitoring devices and a centralized
hospital information system. The standards define the syntax and semantics of messages regarding measurement of
patient physiologic parameters, and define the messaging protocols for data about the function of the device itself. In
addition, the patient, family member, or caregiver at the remote site may send additional messages to the physician
or provider at the main hospital or medical center.
Also, like the ISO/IEEE 11073 standards, the IS77 standards work in a system that connects the mobile
devices to a device intermediary system. The device intermediary system interfaces with the mobile devices and
collects and stores patient monitoring data. This is then connected to a remote monitoring management system
which allows clinical personnel to select which data should then be forwarded to an EHR. The IS77 protocols allow
for an alternative pathway for flow of information from the mobile devices to a personal health record (PHR) system
or to a health information exchange organization. In this latter design it is assumed that data can then be transmitted
from the PHR or health information exchange organization to the hospital EHR of the physician who ordered the
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remote monitoring. Unlike ISO/IEEE 11073 standards, the IS77 standards only focus on interoperability between
mobile devices and the EHR. They do not regulate the way data is captured on the device or how the data is
transmitted from the device (i.e. Bluetooth, ZigBee, Wi-Fi) to the device intermediary system.
Table 1 Summary of Mobile Device Standards and Standards Development Organizations
Organization
CEN/ISO/IEEE
Standard
11073 family
Continua Health Alliance
multiple standards from
various SDOs
IHE
multiple standards from
various SDOs
ASTM
F2761
HITPS
IS77
HL7
FHIR
Uses
total solution for two-way
communication and data
exchange between remote
mobile devices and larger
information systems
consortium of multiple
health and
telecommunication
enterprises; publishes
guidelines for
interoperability
identifies standards and
publishes guidelines for
interoperability
integration, control, and data
acquisition standards for
heterogeneous devices in
acute care
data exchange for
monitoring devices worn by
patients at remote sites
combines HL7 messaging
standards with web standards
and web services
Benefits
cooperation among large and
well-established SDOs;
complete set of standards;
wide international adoption
concerned with building a
system of interoperable
mobile devices; certified
products using widelyadopted standards offer plugand-play interoperability
concerned with building
interfaces for interoperability
between a single device and
a larger information system
increased patient safety and
workflow efficiency
can transmit data to an EHR,
PHR, or HIE organization
makes HL7 standards easy to
integrate into mobile device
systems
Mobile Health Device Adoption and Security
With all the standards being put into place, the most effective approach to attaining rapid, wide acceptance
for any of these standards in the U.S. is through third-party certification. This is extremely important because early
compliance with the requirements and the security of data are of utmost importance.
Brusco (2012) stated that as a result of the sophisticated devices and apps, accessing and transmitting
patient data has increased dramatically, and, thus, there has been an increased concern about securing patient data
and ensuring compliance with the Health Insurance Portability and Accountability Act (HIPAA) and the FDA
proposed mobile health guidelines. Failure to comply with federal regulations could have significant ramifications,
including fines and/or loss of a professional license.
According to Brusco (2012), the guidelines have a narrow focus and are not intended for apps that address
electronic health record functions, resource materials, general health, or general office operations. Instead, the
guidelines are intended for three types of apps—“a mobile application that acts as an accessory to a regulated
medical device, turns a mobile gadget into such a device or makes suggestions regarding a patient’s diagnosis or
treatment,” (Mobile Devices, 2013).
In February 2013, a set of standards for mobile applications were announced by Happtique. Happtique is an
mHealth solutions company with the goal of integrating mobile health into patient care and daily life (PR Newswire
2013). They offer a suite of certified applications through mRx™ which gives a physician or other provider the
ability to “prescribe” one or more mobile health applications appropriate to a patient’s condition. The patient “fills
the prescription(s)” by uploading the recommended applications or acquiring the necessary devices.
After publishing a final set of standards, Happtique will certify apps under the Happtique Health App
Certification program (HACP). As mentioned in the PR Newswire article (2013), “HACP will help healthcare
providers and consumers easily identify medical, health, and fitness apps that deliver credible content, contain
safeguards for user data, and function as described”.
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HACP is promising because it is already widely accepted due to the collaboration that it has garnered. For
example, “the Association of American Medical Colleges (AAMC), CGFNS International, and Intertek will serve,
according to their respective subject matter expertise, as HACP Partners responsible for the evaluation of health
apps against the Certification Standards” (PR Newswire, 2013).
Future Directions
A future direction for mobile device interoperability standards is HL7’s Fast Healthcare Interoperability
Resources (FHIR). This new standard that is now being developed by HL7 is meant to make implementing HL7
standards easier and more compatible with mobile standards (Brandt, 2012). According to the HL7 website, FHIR
combines features of HL7 version 2, HL7 version 3, and the Clinical Document Architecture and web standards
such as eXtensible Markup Language (XML), HTTP-based protocols and other web services protocols (HL7 FHIR
website). With this combination of services and protocols it is hoped that FHIR will make HL7 healthcare standards
interoperable with a wide variety of systems and devices and that implementation of systems using the standard can
be deployed rapidly.
Conclusions
After conducting the various literature reviews, our research hypothesis stating that “mobile medical device
standards for interoperability are neither well-established nor adopted” has not been disproven. There may be many
contributing factors to this lag in adoption of standards for data exchange, but one significant factor is likely to be
the highly competitive and growing consumer marketplace for medical devices which are marketed directly to
consumers. As a result, manufacturers of mobile medical devices continue to focus on the device and not necessarily
on the ability to exchange data with central health care systems. Despite this challenge, there could be steps taken to
encourage interoperability in the near future. One approach to encouraging adoption of interoperability standards
would be to incorporate a branded third-party certification and incorporate this requirement into prerequisites for
reimbursement, mimicking the strategy used by the Meaningful Use program for encourage use and adoption of
certified EHR’s.
One candidate for a certification body is Happtique. Happtique has garnered the most global support by
adopting an interoperability standard that includes the widely accepted HL7 version 3, the Clinical Document
Architecture, and web standards such as XML and seems to have garnered the most global support. Happtique has
focused on ensuring that both the mobile medical device and the mobile application that operates the device meet
the requirements for interoperability. However, it may be difficult for Happtique to shed its image as a proprietary
standard simply through participation of independent bodies. Many private companies have produced platforms that
become de facto standards (Apple, Microsoft, et al), but they are frequently challenged at becoming a truly
ubiquitous standard.
As long as the use of mobile medical devices continues to grow and evolve, so will the proliferation of
mobile health applications that take the incoming feed of data and try to convert it into a meaningful user interface.
The biggest expectation of standardized mobile medical devices and their operating systems or mobile applications,
is the potential in cost reduction for medical care. This potential will be difficult to fully realize without
interoperability and extending beyond the individual user interface. If this type of interoperability is to be branded
and certified as an important feature to the consumer, and therefore lead to adoption, privacy and security must be an
important and explicit consideration. Patients must be confident that even with interoperability, they still have
control over their data. Without this level of confidence, adoption of widespread interoperability will be a
significant challenge.
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