Interoperability challenges in the health management of patients with implantable defibrillators

Abstract

Patient empowerment frameworks engage citizens in their healthcare. Heart patients undergo implantation of Cardiovascular Implantable Electronic Devices (CIEDs) that support remote monitoring hoping to live a longer healthier life. Electronic Health Records (EHR), remote device monitoring, and lifestyle data can supply patient context to computerized guidelines so that health events are timely assessed and effectively treated, before they become life-threatening. In this way, lives may be saved, health care resources be optimized, and hospital visits be reduced saving time, hassle, and money. iCARDEA aims to provide health professionals with such an adaptive care planner offering decision support through semi-automated clinical guidelines integrating data from CIEDs, EHRs and Personal Health Records (PHRs). The enabling standards and interoperability initiatives are presented underlining barriers that need to be overcome, before such eHealth innovations become widely adopted.

Full text

Interoperability Challenges in the Health Management of Patients with
Implantable Defibrillators
Catherine Chronaki1, Manuela Plößnig2, Fulya Tuncer3, Mustafa Yuksel3, Gökçe Banu Laleci
Ertürkmen3, Christian Lüpkes4, Marco Eichelberg4, Xavier Navarro5, Wolfgang Pecho6, Asuman Dogac3
1FORTH-ICS, Heraklion, Crete, Greece, 2Salzburg Research, Salzburg Austria, 3SRDC, Ankara,
Turkey, 4OFFIS, Oldenburg,Germany,5Medtronic, Barcelona, Spain, 6St Jude, Vienna, Austria
Abstract
Patient empowerment frameworks engage citizens in
their healthcare. Heart patients undergo implantation of
Cardiovascular Implantable Electronic Devices (CIEDs)
that support remote monitoring hoping to live a longer
healthier life. Electronic Health Records (EHR), remote
device monitoring, and lifestyle data can supply patient
context to computerized guidelines so that health events
are timely assessed and effectively treated, before they
become life-threatening. In this way, lives may be saved,
health care resources be optimized, and hospital visits be
reduced saving time, hassle, and money. iCARDEA aims
to provide health professionals with such an adaptive
care planner offering decision support through semi-
automated clinical guidelines integrating data from
CIEDs, EHRs and Personal Health Records (PHRs). The
enabling standards and interoperability initiatives are
presented underlining barriers that need to be overcome,
before such eHealth innovations become widely adopted.
1. Introduction
An increasing number of patients choose to accept
implantation of a Cardiovascular Implantable Electronic
Device (CIEDs) to alleviate the risk of life-threatening
conditions such as dangerous arrhythmias, sudden death,
and heart failure. Technology empowered patients and
their families access online educational resources,
maintain PHRs, engage in social networking relating to
their condition, using activity and lifestyle monitoring
devices. Hospital records and decision support tools
assist cardiologists in follow-up of CIED patients
typically three times per year based on current clinical
guidelines [1,2]. Recent CIED models support remote
monitoring and preliminary results from clinical trials
show reduction of in-office visits and improved quality of
care [3,4]. Typically, the CIED transfers via GSM or
through a dedicated home gateway, data on the status of
the device and cardiac events of the patient to the data
center of the implant manufacturer on a preset schedule or
on patient request. Attending cardiologists may sign up to
receive alerts and can remotely access the portal of the
implant manufacturer to review relevant reports. When an
event is reported for a patient, the attending cardiologist
needs to evaluate the condition of the patient and decide
whether to reschedule the next patient visit, call the
patient’s home, or just make a note for future reference.
However, the relevant patient data are not readily
available. In the hospital, patient information is typically
distributed in heterogeneous legacy systems, even paper.
Data on lifestyle, medication compliance, emotions,
stress, physical activity, etc. may be part of a health
journal or PHR, but no access to that information is
available, even if the nurse calls the patient’s home.
iCARDEA [5] aims to change this situation. Health
professionals will be able to use an adaptive care planner,
a decision support tool that will semi-automatically
execute computerized clinical guidelines rapidly
assessing all the relevant clinical information for the
patient available in the EHR, the PHR or provided by the
implant through remote monitoring. The guideline for
Atrial Fibrillation has already been defined based on
available clinical guidelines and in collaboration with
leading cardiology centers [2, 6]. Besides the challenge of
turning hundreds of guideline pages into a computer-
interpretable form, a significant challenge for iCARDEA
is retrieving health and lifestyle data of the patient from
disparate sources and converting them into a semantically
interoperable format usable to the adaptive care planner
without violating the security policy of the hospital, or the
privacy of patients and health professionals (see Fig. 1).
Figure 1: The challenge of semantic interoperability.
ISSN 0276−6574 225 Computing in Cardiology 2010;37:225−228.

In this paper we report on the current status of global
interoperability initiatives that facilitate the incorporation
of clinical, personal health, and device data into computer
processable guidelines, in a scalable way that preserves
consistency cultivating trust through appropriate security,
privacy, and consent policies. The iCARDEA
interoperability layer aims to leverage widely adopted
reporting standards such as HL7 CDA R2 constrained
with “Integrating the Healthcare Enterprise” (IHE)
content profiles. At the same time, the technical
framework developed by IHE is used to create an
infrastructure that is scalable and secure. In the context of
patient empowerment, iCARDEA can also benefit from
the work of Continua Health Alliance on design
guidelines and certification processes that enable vendors
to build interoperable devices and monitoring platforms
for wellness and disease management at home.
As for the rest of the paper, the next section “Methods”
presents enabling standards, interoperability initiatives,
and functionality criteria for EHRs and PHRs. In the
“Results” section, the basic principles of the iCARDEA
interoperability layer are presented in association with
well-known barriers to wide adoption. The “Discussion”
section focuses on the ways iCARDEA aims to address
technical and organizational challenges in the deployment
of its architecture, while conclusions summarize our
contribution and future plans.
2. Methods
The iCARDEA interoperability layer implements IHE
integration and content profiles to enable productive use
of CIED, EHR, and PHR data mainly by the adaptive care
planner. IHE profiles prescribe the constrained use of
standards such as DICOM and HL7 through integration
profiles based on actors and transactions for specific
clinical domains as those relating to iCARDEA: Patient
Care Devices (IHE PCD), Patient Care Coordination
(IHE PCC), and IT Infrastructure (IHE ITI).
IHE PCD addresses interoperability issues with
regulated medical devices such as CIEDs. The
Implantable Device Cardiac Observation (IDCO) profile
[7] uses HL7 v2.5/6 and ISO/IEEE11073 standards
including the Rosetta Terminology mapping to facilitate
interoperability at the device level. Adoption of IDCO
will alleviate the problem of attending cardiologists
having to use a different system to follow-up the devices
of each implant manufacturers and enable storage of
clinical information to the Hospital Information System
(HIS) or the EHR.
Part of IHE PCC, the IHE Care Management (CM)
profile [8] enables subscriptions to specific types of
clinical data that conform to HL7 CDA R2 [9], HL7
CCD, ASTM CCR and are constrained by specific IHE
clinical content profiles [10]. Thus, the adaptive care
planner may subscribe to EHR and PHR updates of CIED
patients in the hospital and receive new reports or results
when available. However, it is unlikely that HIS will fully
support IHE CM, largely due to the number of
subsystems that co-exist and carry part the patient’s
fragmented EHR.
IHE ITI offers IHE profiles that address EHR
interoperability issues aiming to leverage provider data
(e.g. diagnostic examinations, lab results, progress
reports) through cross-enterprise sharing of clinical data
in an XDS repository. These include patient identification
(IHE PIX), cross enterprise sharing of clinical documents
(IHE XDS), and security (IHE ATNA).
Figure 2: Overall EHR interoperability infrastructure.
iCARDEA analyzed the state of the art in standards,
technologies, and architectures and selected the most
promising approaches for the design of its interoperability
layer. Designing and implementing these components
engages a multi-disciplinary team. Achieving deployment
of this architecture in a hospital on an efficient workflow
that conforms to the local security policy that redefines
CIED patient followup is certainly a challenge. Moreover,
since no two hospitals are alike, the design of the
interoperability layer has to be flexible and adaptable to
different modes of information exchange that range from
human mediated to automatic updates based on a
subscriber/observer pattern (IHE CM). In addition,
different hospitals adopt different clinical documents
(forms or templates) to document the care procedures.
This requires the creation of converters that translate local
forms into standardized content templates with the help of
a Common Terminology service (Fig. 2).
Importing data from different types of legacy
information systems is not easy. So far, three different
ways have been considered: (a) maintaining a shared
space where clinical data will be exported in the format
that has been agreed upon by a human agent following
the security policy of the healthcare facility, (b) extending
the legacy EHR system to support cross enterprise
document sharing, effectively actively exporting data in
CDA R2, (c) periodically using the native DB interface of
the legacy EHR system to query subscribed patients.
EHR data, personal health and lifestyle data are
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increasingly relevant in the emerging Internet of Things
and smart home environments that aim to provide
unobtrusive care for elderly people. So, while the above
IHE domains concentrate on the extended hospital
environment, the Continua Health Alliance develops
design guidelines to foster the development of
interoperable personal health solutions for the extended
home environment. Here the focus is on disease
management, wellness and independence integrating
devices like weighting scales, thermometers, exercise
monitoring, etc. to PHRs [11]. The focus of Continua’s
design guidelines includes PAN-IF (Interface to Personal
Area Network health devices) and xHR-IF (Interface to
export personal health data from Disease Management, as
for example transmission to an EHR). By June 2010, 15
products were certified including oximeters, glucose
meters, weighing scales, blood pressure monitors,
pedometers, along with collectors of that information. It
is through the PHR that iCARDEA can provide the
adaptive care planner lifestyle data from homecare
devices or sensors if so dictated by the guideline.
The power of iCARDEA is that it takes a collaborative
evolutionary approach where technological innovation
goes hand in hand with developments in evidence based
medicine. As additional lifestyle data become available
from the home of the patient, these data can be readily
used in an automated guideline, assuming the patient
consents. A consent management architecture is needed to
enable patients to grant or revoke permission to access
selected PHR data. In line with this requirement, in
iCARDEA an XACML and SAML based patient consent
management methodology is being implemented.
In the course of guideline execution, health
professionals may need to review diagnostic exams, or
prior ECG traces. The OpenECG network started in 2002
[12], to provide its community with tools for the
integration of resting ECGs in the EHRs according to the
ISO/IEEE 11073-91064 standard (SCP-ECG). SCP-ECG
focuses on the diagnostic ECG and was quite successful
in primary care and telecardiology. Unfortunately to this
date, Continua does not address diagnostic ECG and
some existing IHE profiles do not support SCP-ECG,
selecting DICOM instead. For the future, data from
clinical documents will be correlated with vital signs,
ECG and diagnostic imaging to provide a more accurate
status of a patient’s health.
Recent advances in the area of functional specification/
certification of information systems provide a broader
view on the full potential of the iCARDEA approach as
they take note of all the different kinds of clinical data
that can be made available to the adaptive care planner as
clinical guidelines become more complex. The functional
criteria defined by CCHIT based on the EHR functional
model of HL7 [13] provide a standardized description of
the functions available in a given clinical setting as in a
cardiology department [14].
3. Results
The core of the EHR system interoperability
infrastructure presented in Fig. 3 aims to leverage recent
IHE integration and content profiles in a scalable and
flexible way that permits deployment in any hospital.
The infrastructure for clinical documents/diagnostic
imaging/laboratory results sharing across organizations
(XDS) forms the core of the component. A medical
services registry maintains a list of clinical data sources
along with the preferred way to retrieve clinical data.
Active subscriptions refer to active requests for specific
content profiles as requested by:
• adaptive care planner to meet the needs of
personalized medical care plans of the patient,
• personal health record of the patient to receive reports
or examination results,
• correlation and analysis component for knowledge
discovery.
Through the so called IHE PCC9 and PCC10
transactions an EHR interoperability infrastructure can
provide the adaptive care planner, the PHR, and the data
correlation and analysis component (i.e. an evolving
knowledge database) with dynamic updates on clinical
data of enrolled CIED patients. An IHE XDS repository
can act as an EHR server for CIED patients aggregating
data from different sources within the hospital (Fig. 3).
Relevant ITI transactions are used to register a new
clinical document set and query or retrieve other.
Figure 3: XDS repository acting as a buffer to enable
interoperability with legacy EHR systems.
Empowered individuals would like to assemble all his
medical data in their Personal Health Records. For our
system the PHR is another entity that once authenticated
may subscribe to receive updates on clinical data
registered in the XDS repository using the IHE XPHR
content profile. Beyond iCARDEA, the patient
empowerment framework should be able to interface
personal health devices, and environmental sensors that
provide the contextual awareness relevant to interpret
lifestyle trends.
4. Discussion
Huge amounts of data can be collected at the different
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stages of the health care delivery process and when
combined with data on lifestyle, activity, nutrition the
value of decision support is evident. Building a
sustainable interoperability framework for computerized
clinical guidelines to execute seamlessly using quality
data from different sources within and out of the hospital,
would certainly improve quality of care, reduce errors and
increase productivity.
Although there is significant activity on standards
development and interoperability frameworks that aim to
constraint standards so as to achieve higher levels of
interoperability providing implementation guidance,
adoption rates remain low. This is probably due to gaps in
the maintenance and promotion of standards but maybe
more importantly to the lack of organizational support
and a clear legal and regulatory framework.
iCARDEA portrays a different way of work for the
attending health care professionals, possibly also a
different model of care. Healthcare professionals will no
longer passively wait for patients to come on their
appointments. They reach out proactively through the
graphical interfaces provided by the adaptive care planner
to check the status of patients in response to remotely
reported patient events. Wide acceptance of decision
support tools such as those developed by iCARDEA will
certainly contribute a sense of aptitude to health
professionals and convey feelings of confidence in
technology, safety and trust to patients that have to live
with an implant.
5. Conclusions
The iCARDEA (An Intelligent Platform for
Personalized Remote Monitoring of the Cardiac Patients
with Electronic Implant Devices) project has engaged a
multidisciplinary group in addressing this challenge
offering automated computer interpretable personalized
guidelines based on PHR, EHR, and CIED data. The
resulting Adaptive Care Planner aims to become a
valuable Decision Support tool for attending physicians
hoping to improve quality of life of CIED patients in a
secure, unobtrusive and transparent way.
Acknowledgements
The research leading to these results has received
funding from the European Commission’s 7th Framework
Programme (FP7/2007-2013) under grant agreement no
ICT-248240, iCARDEA Project.
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Address for correspondence.
Catherine Chronaki
FORTH-Institute of Computer Science
PO 1385, Heraklion, Crete, Greece
Email: chronaki@ics.forth.gr
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