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European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013)
October 17-18 2013, Windsor, United Kingdom
Inas Ezz
Electronic Records in Healthcare: The Need for Quality Standards 1
ELECTRONIC RECORDS IN HELATHCARE: THE NEED
FOR QUALITY STANDARDS
Inas Ezz, Sadat Academy for Management Sciences, Cairo, Egypt; Brunel University, London, UK,
[email protected], [email protected]
Abstract
This paper has investigated the issue of standardization of electronic records in healthcare,
required to facilitate shareability and interoperability concerning patient data. The literature as
the practice has even shown that some basic terms do not mean the same thing to different
researchers and stakeholders. This paper has discussed the need for a balance between
standardization and understanding the variable nature of healthcare information systems and
patients. These arguments have been investigated in the context of an exploratory case
addressing one of the advanced oncology centres in the US. This paper concludes to that there
is a need to suggest a maturity model for electronic records in healthcare information systems
and achieve an appropriate balance between standardization and flexibility.
Keywords: Healthcare Information Systems, Electronic Patient Records, Electronic Health
Records, Electronic Medical Records, Maturity Models
1 INTRODUCTION
Electronic patients records (EPR) are part of the underlying infrastructure supporting healthcare
information systems. Thus, in this section, we are going to provide a brief overview about what is
meant by information systems in healthcare. The use of information systems and its underlying
technologies have been addressed in the literature using different terms such as health information
technologies (Furukawa et al., 2006), healthcare information systems (Johnson, 2011; Teixeira et al,
2010) the use of IT in healthcare (Haux et al., 2002), IT applications in healthcare (Chiasson and
Davidson, 2004) etc. In this paper, we use the term healthcare information systems to combine all
these terms, or others that address the use of ICT to support healthcare applications.
According to Paul and Ezz (2011), it is postulated that healthcare information systems can also offer
economic benefits through efficiency savings; for example by providing the data that helps to identify
potential bottlenecks in the provision and administration of care (Johnson, 2011). Perera et al. (2011)
add that health information sharing between patients and their heath care providers may improve
diagnoses, increase patient education and promote self-care. Analyses of de-identified healthcare
utilization data have proven useful to assess patterns of care, therapy effectiveness and safety.
Although there are multiple potential benefits of healthcare information systems, there are already
several high profile failures (Johnson, 2011; Teixeira et al, 2010; Pai and Huang, 2011; Jha et al,
2009). Some works report how difficult it is to successfully introduce ICTs in this domain Haux et al.
(2002) and Rigby et al. (2000).
European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013)
October 17-18 2013, Windsor, United Kingdom
Inas Ezz
Electronic Records in Healthcare: The Need for Quality Standards 2
The use of EPRs as the primary source of patient medical information is still relatively rare, but
increasing from a slow start in Canadian, British and American primary care. In addition to improved
legibility, the organized note structure of many EPRs supports high quality patient summaries
desirable for shared clinical care. Similarly the detailed healthcare information in EPRs makes them
important sources of information for clinical, research and policy (Jha et al, 2009).
The aim of this research is to investigate the issue of standardization of electronic records in
healthcare. The research is willing to investigate whether there are specific standards being followed
in this context to facilitate the shareability and interoperability concerning patient data. The question
here is if this is not the case can we reach this standardization?
In order to investigate this matter,, section 2 section will discuss the different types of electronic
records as discussed in the literature and popular European and American quality standards. Section 3
provides an attempt to answer the question whether electronic records in healthcare can be
standardized, while section 4 discusses different maturity models related to electronic records in health
care. Section 5 presents the findings of the US oncology medical centre case under investigation.
Finally, the paper ends up with some concluding remarks in section 6.
2 ELECTRONIC RECORDS IN HEALTHCARE
According to De Veer and Francke (2010) more and more health care organizations are introducing
electronic systems to store patient information. These are known as electronic patient records (EPR),
although the systems can be labelled differently locally, using terms such as electronic nursing
records, electronic health records (EHR), or computer-based patient record systems. The
functionalities of these systems may differ, e.g. some are used by nursing staff only, whereas others
are also used by physicians and other professionals. Characteristics of the professionals themselves
play an important role in whether new work routines are implemented and actually used (Fleuren et
al., 2004; Francke et al., 2008). This matter discussed by De Veer and Francke (2010) is an important
factor that adds to the complexity of the EPR issue. In this context, they suggested a model to predict
the attitude of nursing staff (as one of the EPR stakeholders) towards using EPR. This incorporates
some factors that affect the attitude towards using the EPR including for example, the educational
level, job experience and other factors.
The literature almost unanimously proposes that electronic health records (EHR) or electronic patient
records (EPR) have the potential to improve patient care (Teixeira et al., 2010). Others such as Jha et
al. (2009) emphasise the gains to be made from efficient and effective health care provision. The
potential benefits of EPR systems are claimed to be organizational issues such as improving the
exchange of information between healthcare facilities and the support of standardized procedures that
can help to increase consistency between different service providers. Further, EPR should be able to
ensure minimum standards across the trajectory of care when patients move between different
specializations.
The question here is, are EPRs and EHRs interchangeable terms as been presented in the literature?
This matter will be discussed in this section, through referring to the literature as well as some quality
standards.
European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013)
October 17-18 2013, Windsor, United Kingdom
Inas Ezz
Electronic Records in Healthcare: The Need for Quality Standards 3
2.1 Basic Terminologies
As Ken and Kalra (2008) discuss, the importance of the EHR has been obvious through the European
Union’s Health Telematics Framework Programmes, which started with its third Framework
Programme in 1992 and continuing through to its seventh in 2007. Considerable research has been
undertaken over the past 15 years to explore the user requirements for adopting EHRs (for example,
published by the Good European Health Record Project (Ingram et al., 1992; Heard et al., 1993) and
the EHCR Support Action (Dixon et al., 2001). EHR demonstrators have been established in many
European countries, through these R&D projects and subsequently through national programmes, as
the strategic importance of EHRs has grown (Kalra, 2004).
The American College of Obstetricians and Gynaecologists(2010) argue that the electronic health
record (EHR) has the potential to improve the quality, safety, and efficiency of patient care when fully
implemented (Bates, 2003). Further, the use of the EHR can improve communication among health
care providers and increase team effort among providers. Its use can assist with medication safety,
tracking, and reporting and eliminate concerns about the legibility of paper medical records. Most
importantly, its use has been shown to have an effect on quality of care through optimized compliance
with guidelines (Classen, 2010).
The use of preassembled ordering and documenting tools within an EHR may simplify the
documentation process, although care must be taken when using templates to avoid importing previous
notes without updating data, assessment, and plans. When using templates, the record must be
reviewed and edited to ensure that it accurately documents the patient encounter. Record uniformity
may reduce practice variations and can standardize health care, procedures, and follow-up (Brokel and
Harrison, 2009). In addition, a more complete record can be created by offering staff additional
questions, information, or alerts (Bernstein and Merkatz, 2007). However, like paper medical records,
EHRs are only as accurate as the information entered into them. Electronic health records provide the
benefit of improving the legibility of prescriptions, potentially reducing the risk of some medication
errors. Healthcare providers have the benefit of accessing information from an online formulary,
assuming that it is updated on an ongoing basis, as well as providing real-time medication alerts. It
also can aid with medication reconciliation for each patient (The American College of Obstetricians
and Gynaecologists, 2010).
The ability of an EHR to store and retrieve data makes it a logical tool to improve the quality of
patient care. Using an EHR can consolidate patient information, such as diagnoses, medications, and
test results, which may enable providers to deliver safer, more effective health care. Decision-making
support, such as prompts and reminders when tests are due or when specific care does not meet
guidelines, provides the clinician with a tool to provide quality care (The American College of
Obstetricians and Gynaecologists, 2010). .
As discussed by the American College of Obstetricians and Gynaecologists (2010), electronic health
records can open communication with patients through online secure portals and reception area kiosks.
These encourage patient partnering by allowing patients to enter personal or medical history
information, make appointments, request refills on prescriptions, or obtain laboratory results. These
kiosks and web portals can also be made interactive so patients may receive targeted education materials and other information (Gill, 2009).
One of the most important features of EHR that distinguishes it from other terms, is that the
acceptance of its implementation within an institution is facilitated when a single, specific program is
installed across a network of computers, along with the establishment of an information technology
support department provided by the organization. This allows uniformity of communication and a
complete interface between group practices and the institution. More importantly, it allows the
institution to provide an information technology support department, through partnership with a
particular vendor. The members of the information technology department can meet with clinicians
regularly to review usage, navigation, and updates to the system. Also, the information technology
European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013)
October 17-18 2013, Windsor, United Kingdom
Inas Ezz
Electronic Records in Healthcare: The Need for Quality Standards 4
support department should be available, at any time, for immediate consultation to troubleshoot any
system problems, such as retrieval of lost data due to power outages, or to assist the clinician in
efficiently using the system. The efficiency of the department is dependent on how well it can train
and assist clinicians, along with upgrading the system as problems or inefficiencies are discovered (The American College of Obstetricians and Gynaecologists, 2010)..
2.2 Electronic Records in Healthcare and Quality Standards
Concerning standardisation of EHR as Ken and Kalra (2008) mention, CEN is the principal legislative
standardisation body for Europe; Technical Committee 251 has responsibility for health informatics
(interoperability) standards. Since 1990 CEN TC/251 has regarded the Electronic Healthcare Record
as one of the most important and most urgent areas for the establishment of European standards. In
2002 CEN TC/251 launched a new Task Force to update the 1999 pre-standard for Electronic
Healthcare Record Communications, to produce a first full standard (EN 13606). One In 2003 ISO
Technical Committee 215 (Health Informatics) agreed to collaborate with CEN on a parallel
standardisation path for EHR Communications, under the same lead, and it is anticipated that these
two bodies will each endorse the 13606 .
2.2.1 European Quality Standards
Investigating the recent popular European quality standards in the context of these terms we found
some relationships and differences. For example, according to BSI (2011) the BS ISO 18308: 2011
the EHR is defined as one or more repositories, physically or virtually integrated, of information in
computer processable form, relevant to the wellness, health and healthcare of an individual, capable of
being stored and communicated securely and of being accessible by multiple authorized users,
represented according to a standardized or commonly agreed logical information model. Its primary
purpose is the support of life-long, effective, high quality and safe integrated healthcare. This means
that on one hand the scope of the EHR is recognized as being broader than the documentation of
illnesses and their prevention and treatment. The systems and services that are deemed potential
contributors to an EHR will increasingly include systems capturing complementary therapy, wellness,
and home care information in addition to the conventional clinical systems within healthcare provider
organizations.
According to the BSI (2012a) PD ISO/TR 14639-1:2012 standard, the EHR should:
enable the consistent capture, processing, retention, protection and communication of health
information such that interoperability is achieved in support of shared care, improved quality
of care, effective resource management, providing evidence of actions taken in health(care),
and in support of the uses of anonymized information for health system management.
enable authorized users to access health information that is relevant, intact, appropriate to
their permissions and within a timeframe that is appropriate to the context.
enable authorized users to access health information seamlessly and as originally organized,
independently of the EHR systems and of the physical formats in which it was originally
stored.
enable the communication of all health information between care settings, subject to
appropriate consent and access rights, to a sufficient quality to support safe shared clinical
care.
help ensure that subjects of care receive the most appropriate care as quickly and safely.
Further, the EHRA shall support integrated care including collaborative multi-disciplinary
care and case management across different healthcare sectors and settings (e.g. primary care,
acute hospitals, allied health, home-based care).
European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013)
October 17-18 2013, Windsor, United Kingdom
Inas Ezz
Electronic Records in Healthcare: The Need for Quality Standards 5
On the other hand, the notion of the personal health record (PHR)2 (this is the term being used for
EPR according to this standard) is also maturing internationally and, and its requirements have been
deliberately worded to be inclusive of the PHR in general terms, i.e. most of these EHR requirements
will also apply to the PHR.
Further The British Standards Institution BSI (2012a), provides some definitions of relevant terms as
based on the PD ISO/TR 14639-1:2012 standard. For example, the electronic medical record EMR is
electronic record of an individual in a physician’s office or clinic, which is typically in one setting and
is provider-centric, while the electronic patient record EPR is an electronic record of an individual in a
hospital or health care facility, which is typically in one organisation and is facility-centric.
The BSI (2012b) provides further clarification in its BS ISO 16527 Personal Health Record System
Functional Model, where the difference between Personal Health Record (PHR) versus a Personal
Health Record System (PHR-S) is discussed. The PHR WG makes a clear distinction between a PHR
and a PHR System (PHR-S). The PHR is the underlying record (e.g., data, information, pictures,
sounds, graphs, or videos) that the software functionality of a PHR-S maintains. There has been much
discussion surrounding the definition of a personal health record. The PHR-S FM does not attempt to
define the PHR, but rather to identify system features and functions necessary to create and effectively
manage PHRs. The PHR-S FM offers examples of data elements, but is not intended to provide details
necessary to specify a data model.
The overarching theme of a PHR-S involves a patient-centric tool that is controlled, for the most part,
by the individual PHR Account Holder. A PHR-S should be immediately available electronically and
able to link to other systems. The PHR-S provides functionality to help an individual maintain a
longitudinal view of his or her health history, and may be comprised of information from a number of
sources – e.g., from providers and health plans, as well as from the individual. Data collected by the
system is administrative and/or clinical, and the tool may provide access to health-related forms (e.g.,
Advance Directives) and advice (e.g., diet, exercise, or disease management). A PHR-S might also
help the individual collect behavioral health, public health, patient-entered and patient-accessed data
(including medical monitoring devices), medication information, care management plans and the like,
and might be connected to providers, laboratories, pharmacies, nursing homes, hospitals and other
institutions and clinical resources (BSI, 2012b).
At its core, the PHR-S should provide the ability for the individual to capture and maintain
demographic, insurance coverage, and provider information. It should also provide the ability to
capture health history in the form of a health summary, problems, conditions, symptoms, allergies,
medications, laboratory and other test results, immunizations and encounters. Additionally, personal
care planning features such as Advance Directives and care plans should be available. The system
must be secure and have appropriate identity and access management capabilities, and must use
standard nomenclature, coding and data exchange standards for consistency and interoperability. A
host of optional features have been addressed over the course of this initiative, including secure
messaging, graphical presentation of test results, patient education, guideline-based reminders,
appointment scheduling and reminders, drug-drug interactions, formulary management, health care
cost comparisons, document storage and clinical trial eligibility. The effective use of a PHR-S is a key
point for improving healthcare in terms of effective self-management, patient-provider communication
and quality objectives (BSI, 2012b). Table 1 sums up the differences between the EPR, EHR, and
EMR definitions according to the recent BSI PD ISO/TR 14639-1:2012 (BSI, 2012 a).
European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013)
October 17-18 2013, Windsor, United Kingdom
Inas Ezz
Electronic Records in Healthcare: The Need for Quality Standards 6
Electronic health record
EHR
Electronic medical record
EMR
Electronic patient record
EPR
information relevant to the
wellness, health and healthcare of
an individual, in computer-
processable form and represented
according to a standardized
information model, or the
longitudinal electronic record of an
individual that contains or virtually
interlines to data in multiple EMRs
and EPRs, which is to be shared
and/or interoperable across
healthcare settings and is patient-
centric
Adapted from ISO 18308:2011 and
the European 2011 eHealth
Strategies Final Report, January
2011.
electronic record of an individual in
a physician’s office or clinic, which
is typically in one setting and is
provider-centric
[European 2011 eHealth Strategies
Final Report, January 2011]
electronic record of an individual in
a hospital or health care facility,
which is typically in one
organisation and is facility-centric
[European 2011 eHealth Strategies
Final Report, January 2011]
Table 1. EHR, EMR, and EPR Comparison (based on BSI, 2012 a)
2.2.2 American Quality Standards
Investigating American quality standards in this context, through reviewing the literature and ranking,
and as conducted during the case study research we have found out that there is no common American
quality standard in the context of healthcare information systems and electronic records. Rather, there
are multiple standards that could be referred to. However, there have been some initiatives in the
context of standardization such as the ‘The Accountable Care Organization 2013 Program’, which is
attempting to promote standardization through a Medicare or Medicaid Electronic Health Record
(EHR) Incentive Program. The American Recovery and Reinvestment Act of 2009 (ARRA) provides
incentive payments for Medicare and Medicaid providers who “adopt, implement, upgrade, or
meaningfully use [MU] certified electronic health records (EHR) technology.” These incentives are
intended to significantly improve health care processes and outcomes, and are part of the larger Health
Information Technology for Economic and Clinical Health (HITECH) Act. One other of this initiative
to define the relationship of data coming from diverse source systems (for example, clinical laboratory
information management systems, order entry systems, pharmacy information management systems,
dictation systems), and the data stored in the Electronic Health Record. Recalling that the EHR is the
primary repository for information from various sources, the structure of the EHR is receptive to the
data that flow from other systems. Further, in order to accelerate the adoption of EHRs, this guide
provides a common vocabulary, perspective, and references for those developing, purchasing, and
implementing EHR systems, but it does not deal either with implementation or procurement. (RTI
International, 2012). However, it is not clear, what the electronic records should exactly contain.
Further initiatives as discussed by Blumenthal ( 2011) has started in February 2009 by the U.S.
government when it has launched an unprecedented effort to reengineer the way the country collects,
stores, and uses health information. This effort was embodied in the Health Information Technology
for Economic and Clinical Health (HITECH) Act. The HITECH Act set aside up to $29 billion over
10 years to support the adoption and “meaningful use” of electronic health records (EHRs) (i.e., use
intended to improve health and health care) and other types of health information technology.
European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013)
October 17-18 2013, Windsor, United Kingdom
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Electronic Records in Healthcare: The Need for Quality Standards 7
One of the American standards that have been introduced since the late 90s lists some basic contents
that such records should contain. For Example, according to the ASTM (1999) standard, electronic
Health Record (EHR), the record carries all health related information about a patient over time. It
includes such things as observations or descriptions of the patient (for example, the physician’s or
nurse practitioner’s history and physical, laboratory tests, diagnostic imaging reports), provider’s
orders for observations and treatments, documentation about the actions carried out (for example,
therapies or drugs administered), patient identifying information, legal permissions, and so on. While
this standard describes the EHR more like the BSI definition of EPR, it further continues to describe
the input which is primary record (paper oriented record). As mentioned they depict the full range of
data that will compose the EHR but described in familiar terms. Table 2 shows a sample of the data in
such records. However here they entitle it as patient record EPR rather than EHR.
European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013)
October 17-18 2013, Windsor, United Kingdom
Inas Ezz
Electronic Records in Healthcare: The Need for Quality Standards 8
Category Subcategory Examples and Components
Patient registration
information
Identifying information Sex, birth date, race
Locating information Home address, home phone, work phone
Insurance information Name of plan
Guarantor information
Patient problem list
Problem number
Problem name
Date of onset, status
Patient extended
encounters
Hospitalization admission
records
Insurance information (for current encounter),
guarantor information (for current encounter), chief
complaint, diagnoses, clinical variables(observations,
tests, measurements), final diagnosis/problem,
corrections to registration information, procedures
performed, etc.
Encounters
Practitioner hospital notes
Practitioner visit notes
Home healthcare notes
Hospital discharge summary
Office/clinic visit
Home healthcare visit
Practitioner visit within
Extended stay
Emergency room visit
Patient care plans
Clinical roadmaps Assessment data
Chronic disease management
Plans delineating therapy, education, scheduled
appointments
Plans for specific patient
problems
Orders
Medication
orders/prescription
Test orders
(both continuing orders, for example, Hgb QAM,
and point orders, for
example, glucose stat)
Diet orders
Other treatment orders
Physical therapy order
Occupational therapy order
Respiratory therapy order
Nursing treatments order
Other observation orders
Nursing observations (also
independent of orders)
Consults (to variety of
clinical
specialists)
Nursing interventions
Service Instances
Confirmation of receipt of
orders
Documentation of
completion of
each step of process (for
example,
MAR report)
Procedures
Surgical procedure Pre-procedure orders, pre-operative diagnosis, procedure
identifier, provider(s) performing procedures, permissions for
procedure, procedure note, duration of procedure, medication
used, immunizations, complications, final diagnosis, post-
operative orders, after care plans
Table 2. Contents of the Traditional Patient Record (ASTM,1999)
European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013)
October 17-18 2013, Windsor, United Kingdom
Inas Ezz
Electronic Records in Healthcare: The Need for Quality Standards 9
Category Subcategory Examples and Components
Procedures
Outpatient procedures
Invasive diagnostic studies
Bedside procedures
Imaging studies
Thyroid scan, chest X-ray, cardiac echoes, OB ultrasound,
Vascular dopplers, cardiac catheterizations
Physiologic tracings EEGs, EKGs, prenatal monitors, cardiac monitors
Other special studies Glaucoma fields, pulmonary function, sleep studies
Practitioner notes Physicians’, nurses’, physical therapists’, etc., notes
Provider discrete observation
Blood pressure, heart rate, skin fold thickness, eye
tonometry, infant’s head circumference
Identifying information Patient’s name and identifying number
Health history
Chief complaint
Source of history
Present illness
Family Hx
Social Hx
Functional status Hx
Travel Hx
Occupational Hx
Childhood disease Hx
Surgical procedures Hx
Allergy Hx
Medication Hx
Review of systems
Smoking Hx total
Smoking Hx current, etc.
Physical exam
General status Px
Vital signs Px
Skin Px
Head Px
Eyes Px
Ears Px
Nose Px
Mouth/throat/teeth Px
Thorax/lungs Px
Breasts Px
Heart Px, etc.
Toxic exposures
Nursing assessments
Legal documents Surgical releases
Organ donor permissions
Advance directives (release of
documents)
Schedules (surgery/clinic, etc.) Requests for resource Send patient to eye clinic
Assignment of resource
Documentation of delivery to
resource and return
Supplies and equipment Consumables (434’s)
Attachments
Table 2. Contents of the Traditional Patient Record Continued (ASTM , 1999)
European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013)
October 17-18 2013, Windsor, United Kingdom
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Electronic Records in Healthcare: The Need for Quality Standards 10
Further, although as been clarified above by the ASTM (1999) standard, EHR does not only include
all health related information about a patient over time when presenting a table describing the record
content structure data categories, segments and entity relationship, they call it again patient record as
described in Table 3.
Data Category and Segments Entity
Administrative Data
I
II
III
IV
Demographics
Legal agreements
Financial information
Provider/practitioner
Patient
Patient
Patient
Provider
Clinical Data: Problem/Diagnoses
V
Problem list
Problem
Clinical Data: History
VI
VII
VIII
Immunization
Hazardous stressor exposure
Health history
Service instance
Observation
Observation
Clinical Data: Assessments/Exams
IX
*
Assessments
Patient reported data
Observations
Observation
Clinical Data: Care/Treatment
Plans
X
Clinical orders
Orders
Clinical Data: Services
XI
XII
XIII
Diagnostic tests
Medications
Scheduled appointment/ events
Observations
Service Instance
Encounter
Administrative Data: Encounters
XIV
Administrative data
Encounter disposition
Patient
Encounter
Clinical Data: Encounters
Chief complaint/ diagnoses
Clinical course
Therapy/procedures
Observation
Observation
Service
instance
Table 3. Patient Record Content Structure Data Categories,Segments and Entity Relationships ASTM (1999)
3 CAN THE HEALTH RECORD BE STANDARDIZED?
It has to be well understood that the healthcare priorities in different countries is variable. In this
section we are going to provide some examples from BSI PD ISO/TR 14639-1:2012 BSI (2012a)
standard. Although that one of the reasons this standard has been developed was to provide guidance
for developing and emerging countries and for the many international groups that conduct health
programs in the developing and emerging world, we will use this standard in a different way in this
section. We will basically focus on highlighting the differences between healthcare information
systems in general and electronic records in healthcare in particular. As confirmed by this standard,
part of ISO/TR 14639 arises from the recognition that currently there is considerable diversity
internationally in the approach and scope of development and implementation of national health
information systems (HIS).
European, Mediterranean & Middle Eastern Conference on Information Systems 2013(EMCIS2013)
October 17-18 2013, Windsor, United Kingdom
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Electronic Records in Healthcare: The Need for Quality Standards 11
3.1 Healthcare Standards
BSI PD ISO/TR 14639-1:2012 has described the healthcare information systems initiatives in some
selected countries such as Australia, Canada, Brazil, India according to multiple criteria including for
example, the national health system, the focus of the national health system, the components of the
national health system, the national health policies, the electronic health record, vertical systems
(disease centred systems), national datawarehouse, standards in use (clinical vocabulary),
interoperability, security, standards development, insurance systems. The most important issue here is
that as a start, the healthcare systems are not and cannot be exactly standard. One main reason is that
the stakeholders and supporting bodies are different from country to another. Further, the national
health system differs depending on the health threats and their priorities. For example the focus in
Australia is on chronic disease including arthritis and musculoskeletal conditions, asthma, chronic
obstructive pulmonary disorder (COPD) and other respiratory diseases, cancer control, cardiovascular
health, diabetes, mental health, and reducing common risk factors such as smoking, alcohol, substance
abuse, obesity, diet, inactivity, and hypertension. Further, the focus is also on indigenous health as
well as rural and regional healthcare. Comparing this with Canada, we can see that the focus of
national health care systems is mainly, patient safety, quality of care, access and wait time of care, the
supply and distribution of health human resources, increasing incidence of chronic disease, an aging
population and the long term sustainability of the health system (BSI, 2012a).
3.2 Electronic Records in Healthcare
Similarly to what has been discussed in the context of healthcare information systems, and in addition
to the inconsistency of the terms related to electronic in the literature, there is no standardization in the
initiatives concerning electronic records in health care while we have investigated the cases presented
by BSI PD ISO/TR 14639-1:2012. For example, in Australia, the government has supported National
Health and Hospitals Reform (NHHR) package included AUD 466,7 million toward initial
implementation of shared personally–controlled PCEHR capability as a national eHealth priority. Prior
to this initiative, there had been no funded policy aimed at delivery of a national system of electronic
health records, although trials were conducted and proposals put forward under the former
HealthConnect program. The aim is to provide every Australian with a PCEHR that is controlled by
them, ensuring individuals’ privacy, improving efficiency in the healthcare system through
streamlining access to patient information thereby reducing duplication and improving use of scarce
resources, providing continuity of care by enabling access to patient information at the point of care,
and improving safety and quality in healthcare (BSI, 2012a).
In Canada, according to the BSI PD ISO/TR 14639-1:2012 electronic health records that coordinate
care between professionals, telehealth that offers remote patient monitoring in the home and patient
portals are expected to become increasingly important as means of supporting new and more effective
care in the future. Currently there is a wide range in the adoption of automation of patient health
information in the various practice settings in Canada, where the highest level of adoption and use of
electronic records is in the hospital sector; nearly all larger community and tertiary care centres now
have electronic records systems that span the various clinical services and programs. Smaller hospitals
have a lower level of automation, but nonetheless have generally automated many core functions. In
the ambulatory clinic environment, electronic record usage is still limited. Despite a number of heavily
funded initiatives, physician adoption of electronic medical records in primary care is very low in
Canada compared to many OECD countries (The Commonwealth Fund, 2009). Since early in 2004,
one of the major differentiators of the Canadian health information system landscape has been the
development of a common Electronic Health Record Solution (EHRS) Blueprint and the pan-Canadian
standards necessary to support EHR interoperability (BSI, 2012a).
In Brazil, listed by the as BSI PD ISO/TR 14639-1:2012 in 1999, the Ministry of Health (MoH)
proposed the National Health Card Project aiming at defining standards for uniquely identifying the
individual, the health organization and the healthcare worker as well as defining a core patient dataset
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for registering clinical data. In 2003, the MoH unified the registries of healthcare (HC) providers and
workers, creating a national registry with unique identifiers. The use of this registry is mandatory for
all HC providers in the country no matter whether public or private. These two projects had a major
impact on how health information systems became to be regarded (PAHO, 1997). The national
database of uniquely identified persons holds 180 million people and the national registry of HC
providers has 228 thousand records with 2,7 million HC workers. The standards are to be made
publicly available and updated on the website. The relevant standard chosen in the context of
electronic records is the EHR information model: OpenEHR (BSI, 2012a).
In India, according to the BSI PD ISO/TR 14639-1:2012 even the vocabularies for medical data are
not in place at the moment, but are recognized as important and are part of the country’s strategic plan.
As part of the concern with interoperability, assessment is currently being done on how existing HIS
comply with standards for interoperability in order to help define strategic actions. .In September
2010, the Ministry of Health and Family Welfare of the Government of India formed an Expert
Committee for Standardization of Electronic Medical Records (BSI, 2012a).
To sum up, the initiatives in different countries are at different stages, have variable objectives, and
the terms being used are not standard. For example, as seen above, personally–controlled PCEHR in
Australia, EHR is being used in Canada, in Brazil the national program is called National Health Card
while the standard followed later is the OpenEHR. Finally India is starting to focus on
standardization, while the term being used is Electronic Medical Records.
3.3 Patient Centred View and Electronic Records in Healthcare
According to BARBER et al. (2011), it is argued that user-centered (UC) design and implemented IT
is an unquestionable principle and a golden rule for a technology that is: effective for both users and
organizations, satisfactory for the end-users and, most importantly, safe for patients. Conclusively UC
IT is an ethical call. They support this idea by highlighting Han et al. (2005) point of view concerning
the matter that technology in healthcare can kill, which means that safety should be the number one
priority for any technology used for processes of care. Further, as they emphasize, research in human
factors has demonstrated how user-centered design contributes to a safer technology (DoH and Design
Council, 2003) and therefore, ergonomic principles and UCD methods should be applied to most
informatics and systems development projects. Barber et al. (2011) have seen in their research how
clinicians were asked to use electronic patient record systems implemented with a top-down approach
and very limited user involvement.
Confirming this matter, especially in the context of patients, who are supposed to be the target
beneficiaries of healthcare systems, Gordon et al. (2013) mention that transdisciplinary approaches
have incorporated patient-centered care into research, practice, and health care policy. The Institute of
Medicine (2001) describes patient-centered care as being responsive and respectful of the individual's
needs, preferences, culture, beliefs, and values. These factors guide treatment decisions and influence
communication and goal setting. Treatment is not limited to providing culturally and linguistically
appropriate services, but culturally sensitive communication that reflects understanding, respect, and
appreciation of cultural diversity (U.S. Department of Health and Human Services, 2007).
Health care professionals must determine that the patient is literate and, most importantly, has the
cognitive and language ability to understand and follow a recommended treatment plan. Therefore, an
important application of a transdisciplinary model is intensive, ongoing interaction among team
members from different disciplines enabling an exchange of information, knowledge, and skills in an
effort to work in unison (King et al., 2009). Social and cultural determinants must be seen in the
context of the individual and the community that include the patient's support system. Diversity
includes all aspects of culture, as well as socioeconomic status, religion, disability or ableness, age,
gender, race, and sexual orientation, which all interact in a dynamic manner (Falender & Shafranske,
2004). The consideration of cognitive abilities, language, education, health literacy, as well as
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environmental and financial factors, provides an opportunity to view the patient in a broader context
and leads to a decrease in health disparities. Patient information obtained by the health care team
members must be shared across the various disciplines that are involved in the patient's care. Sharing
information facilitates team member's access to the patient's life situation, which leads to a more
comprehensive plan of care.
Cultural beliefs, social, psychological, and spiritual needs, and values influence patient and
family/support system's concepts of health and illness and the meaning of visible and hidden disability
(e.g., traumatic brain injury (TBI), multiple sclerosis), illness, and loss Gordon & Zaccario, 2010).
For example, an individual with a TBI may be physically independent, but have distressing cognitive
deficits that are not visible to others. Limited knowledge and understanding of these factors can also
affect an understanding of how the patient assigns meaning to and experiences pain. If health care
professionals do not explore cultural, environmental, and economic factors related to each patient,
managing their illness and pain may result in unnecessary readmissions and poor health outcomes. For
example, a patient cannot be expected to adhere to a pain medication regimen if the health care team is
unaware that the patient does not have the means to pay for that medication or there are certain
cultural taboos to taking traditional pain medication.
Identifying and sharing information about cultural nuances (e.g., avoiding eye contact as a sign of
respect for authority, leaving all decision-making to a particular family member, or not reporting pain
because it is a sign of weakness), across the continuum of care can contribute to a successful
transdisciplinary approach to pain management. The integration of the patient's family, community,
and other resources provides the foundation for culturally sensitive transdisciplinary care.
Furter, the idea of starting to focus on healthcare quality and patient satisfaction has been recognized
by several authors as present Al Badri et al. (2009). This included multiple efforts such as (Ygge and
Arnetz, 2001; Jackson et al., 2001; Badri et al., 2005, 2008; Zineldin, 2006; Labarere et al., 2001).
Investigating the patient as a target stakeholder of healthcare systems, add to the complexity of the
system. Patients themselves are complex. When discussing the patient as a target stakeholder of the
healthcare system, we need to discuss the nature of disease itself, which is nonlinear and (Denis, and
Letellier, 2012).
Investigating the matter of patient centric view from the healthcare standards perspective, we can see
that this matter has been addressed. For example, The British Standards Institution BSI (2012b) has
emphasized that every health care organization has to recognize who is the customer (patient, patient's
relative, payer, another health care unit, authorities etc.) and define the customer's needs and
expectations. Further, as been stressed, in health care the main customer is the patient. The health care
services are then designed and established to meet the patient's needs. Patient satisfaction should be
properly monitored. In further context of customer focus in healthcare, EN ISO 9000:2005
emphasized that organizations depend on their customers and therefore should understand current and
future customer needs, should meet customer requirements and strive to exceed customer expectations.
Thus, in healthcare organizations, top management should ensure that:
- information on patients' rights is available,
- the patient and his/her family are shown consideration and respect,
- the dignity and integrity of the patients are preserved,
- the patient is kept informed and permitted to participate in the care,
- suggestions and complaints from the patients and their families/next of kin are investigated and acted
upon,
- informed consent by the patient is obtained before the health care services are delivered,
- the patient or, when appropriate, their family/next of kin is informed when the patient has suffered an
adverse event,
- the organization has a procedure determining to what extent anonymous and non-anonymous data are
given to interested parties outside the organization,
- cooperation throughout the continuum of care irrespective of the health care provider takes place.
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Further, according to BSI PD ISO/TR 14639-1:2012 all countries identified in their report (Canada,
Australia, Brazil, India, and Kenya) have realized the importance of moving from provider-centric app
roaches to a patient centric approach that will ultimately allow for the construction of a shared
electronic health record Importance of standards All countries recognized the importance of standards
and their adoption to guarantee interoperability between health information systems.
However, the user centred development in general and patient centred development in particular, is
one of the main challenges of standardization of electronic records in healthcare, as each patient is a
unique case that is dynamic and might change over time. . Further, as Barbeer et al. mention,
healthcare IT affects and is affected by a large variety of stakeholders. In their research Lichtner et al.
(2010) have been involved in mapping stakeholders for the evaluation of the English Electronic
Prescription Service where the maps were multiple and complex, with a variety of interested parties
whose business were expected to be affected by the introduction of this new infrastructure.
In more simple models of hospital IT, stakeholders can comprise: direct end-users, such as nurses and
doctors asked to use electronic patient record systems; indirect users, such as clinical coders interested
for billing purposes in using the information recorded by clinicians in these systems; and non-users
such as patients whose information is recorded and exchanged and who are affected by others using
IT. Different users might (and often do) have different views on IT. Which user should be at the center
of UC IT and who is to decide? Should patients be involved in design and implementation of health IT
for the sake of patient-centered care? A ‘pure’ user-centered design is, if not a fairytale, then a vision
almost impossible to achieve. Furthermore, end-users do not have to have been involved in the design
of the technology to find it usable and useful. The implementation of the Picture Archiving systems
(PACS) in the UK is an exemplary success story of this kind. Involving users can be expensive and
time consuming, and it may give rise to hard to fulfil expectations. At times it may also be politically
undesirable. (Barber et al., 2011)
3.4 Importance of Basic Standardization
Although it has been clear that the patient centered view suggests that there are different needs to
patients that need to be recorded and thus one patient case cannot be generalized, there is a need of
basic standardization. For the same reason of being patient centred, we need to allow the patient data
to be transferred to other stakeholders including other medical centered. whenever needed. As
Blumenthal (2011) discusses, the ability to effectively transfer electronic health information between
different information systems in various institutions and practices is underdeveloped in the United
States at this time (Adler-Milstein et al., 2010; Adler-Milstein et al., 2011). Thus, providers are
appropriately concerned that their electronic health information systems may not be able to exchange
health information about their patients with other caretakers. This concern creates a rationale to wait
until some uncertain future time when systems for exchange are working well. However, with
thousands of health information technology products and hundreds of thousands of users of health
information technology, developing such exchange solutions and getting them to work seamlessly are
huge challenges. Overcoming these challenges requires collaboration among vendors and users of
health information technology, but these organizations are often fierce competitors in local and
national markets; so collaboration is unlikely to occur naturally. This lack of collaboration creates a
rationale for government to be an honest broker in facilitating technical and policy approaches to the
exchange of health information (Blumenthal, 2011).
4 HEALTHCARE INFORMATION SYSTEMS MATURITY MODEL
According to SEI (2010), a maturity model contains the essential elements of effective
processes for one or more disciplines and describes an evolutionary improvement path from
ad-hoc, immature processes to disciplined, mature processes with improved quality and
effectiveness (Garzás et al., 2013).
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When talking about maturity models as Wendler (2010) suggests, most people first think of Capability
Maturity Model Integration (CMMI). CMMI is a framework that contains best practices for
developing products and services. Its roots lie in the software industry with the CMM for Software
from 1993. The last instalment of the integrated version, CMMI for Development 1.3, was published
in 2010 and combined concepts from software development, systems engineering, and product
development. Besides this, two additional CMMIs for Acquisition and Services are available, too
(Software Engineering Institute, 2010; Wendler, 2010).Widening the purpose in the evolution of
CMM(I) during the last two decades gives a first impression that the applicability of maturity models
is not just restricted to software-related domains but also to management, as an example. In fact, the
maturity concept emerged out of quality management. The concept of maturity stages building on each
other, and therefore offering a simple but effective tool for analysis and measurement, was introduced
by Crosby (1979). He proposed his so called quality management process maturity grid, which
categorized best practices along five maturity stages and six measurement categories (Wendler, 2010).
In this section, we are going to address some maturity models, which are from our point of view
relevant to healthcare information systems in general, and reflect the need for base minimum standards
of electronic records in healthcare in particular. Other maturity levels could be also referred to from
integrative perspective in the context of future research focusing on this matter in particular. Thus, we
will first introduce the e-Health Architecture Maturity Model, the popular CMM(I) software maturity
models, and the project management maturity model.
4.1 eHealth Architecture Maturity Model
Given the outcomes of previous sections, it is worth investigating the stage of healthcare information
systems. Supported by the findings from of ISO/TR 14639 report, the development of an eHealth
architecture maturity model (eHAMM) is proposed for expressing the extent of development of HIS
and eHealth architecture. The model can be used to direct planning and assess progress of national
healthcare information systems (HIS) towards maturity. The maturity model will be elaborated upon in
ISO/TR 14639-2 and includes a methodology for classifying HIS according to descriptions of
architectural components. International standards are an important part of developing robust and
interoperable health information systems. However, international standards have historically described
mature or highly-evolved systems, making implementation challenging for those seeking an entry-
point into standards for strengthening their eHealth architectures. There is a need for systematic
analyses of eHealth architectures within and across countries. The variety in country HIS described in
this part of ISO/TR 14639 suggests the need for an eHealth Architecture Maturity Model (eHAMM)
and methodology for describing country capacity to provide direction in health system strengthening.
An eHealth architecture model has been developed upon which the maturity model described in
ISO/TR 14639-2 is based. This model can be used for system analysis and development of strategy.
By defining indicators against this framework, priorities and gaps can be identified. The countries
described would show different profiles, which would be consistent with their level of maturity and
strategic direction (ISO Health Informatics WIKI, 2011, BSI, 2012a).
Figure 1. presets this schema that usefully identifies and relates the components of an eHealth
architecture framework. It is proposed and discussed in the ISO TC 215 (International Standards
Organisation Technical Committee) Technical Report 14639 while Part 2 is being prepared in
collaboration with WHO. EHR and health information repositories, patient path as well as data
interchange, interoperability and accessibility, and clinical terminology and classification are major
components of this model (ISO Health Informatics WIKI, 2011, BSI, 2012a). However, we suggest that
these matters need to be standardized at a global level, if we are aiming interoperability in the context
of patient data whenever necessary.
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Figure 1. Model of an eHealth Architecture (ISO Health Informatics WIKI, 2011 in BSI, 2012a)
4.2 Software Maturity Models
As healthcare in general and electronic records in healthcare in particular require software as part of its
infrastructure, we are going to refer back to the literature in the context of systems and software
development. The CMM was originally developed by the Software Engineering Institute and it has
been enhanced since then. It was primarily based on the experiences and extensive feedback of
software practitioners and designed to assist the US Department of Defence in software acquisition. It
described an evolutionary software development process improvement path from an ad hoc, immature
process to a mature, disciplined process. The CMM maps organization’s software project process on a
five-level system. The five-levels are defined according to a set of activities described by the SPI
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areas. When combined into the five-level model, each level represents one of five stages of maturity.
The key process areas are summarized in Table 4 (Jiang et al., 2004).
Table 4. Key Process Activities for CMM (Jiang et al., (2004)
A number of software process capability/maturity models have been developed thereafter and these
are being used for software process improvement/assessment by companies (Hauck et al., 2011) At the
moment, the most popular and most widely used certification in the world for cataloging the maturity
of a software development organization is CMMI-DEV (Valdéset al., 2011; Garzás et al., 2013). This
model can be regarded as a further development of the CMM original model, with a lot of similarities.
Suggesting a maturity model for the Spanish software industry based on ISO standards, Garzás et al.
(2013) add an important issue in their model, namely auditing. Further, stakeholder requirement
definition process as well as system requirement analysis process, are considered important tasks in
their model level 2 of maturity. These matters will be discussed in the implications on electronic
records in healthcare in section 4.4.
4.3 Project Management Maturity Model
As Demir and Kocaba (2010) describe, the CMM first refers to project management at level 2, where
the focus is on repeatability, and hence begins the definition of standards for project management. The
PMMM takes these standards to the next level of development by defining a separate model for the
process and practice of project management. The models parallels the CMM as it is described below
(Wysocki, 2004). PMMM helps organizations address fundamental aspects of managing projects,
improve the likelihood of a quality result and successful outcome and reduce the likelihood of risks
impacting projects adversely (OGC, 2006). Reaching an excellence in project management can be
achieved by project management maturity model (PMMM) which is comprised of five levels, as
shown in Figure 1. Each of the five levels represents a different degree of maturity in project
management (Kerzner, 2001; OGC, 2006; Wysocki, 2004; Cleland and Ireland, 2006). These levels,
which can be seen in Figure 2. are (Demir and Kocaba, 2010):
1. Level 1- Common Language (Initial Process): In this level, the organization recognizes the
importance of project management and the need for a good understanding of the basic
knowledge on project management and the accompanying language or terminology. In the
first level, project definition and awareness are important.
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2. Level 2- Common Processes (Repeatable Process): In this level, the organization recognizes
that common processes need to be defined and developed such that successes on the project
can be repeated on other projects.
3. Level 3- Singular Methodology (Defined Process): In this level, the organization recognizes
the synergistic effect of combining all corporate methodologies into a singular methodology,
the center of which is project management. The synergistic effects also make process control
easier with a single methodology than with multiple methodologies. of Excellence (COE) role
deployment.
4. Level 4- Benchmarking (Managed Process): This level contains the recognition that process
improvement is necessary to maintain a competitive advantage. Benchmarking must be
performed on a continuous basis. The company must decide whom to benchmark and what to
benchmark.
5. Level 5- Continuous Improvement (Optimized Process): In this level, the organization
evaluates the information obtained through benchmarking and must then decides whether or
not this information will enhance the singular methodology.
.
Figure 2. The five levels of project management maturity (Demir and Kocaba, 2010)
4.4 Implications of Electronic Records in Healthcare
Comparing what has been described concerning the healthcare information systems and quality
standards and cases presented in section 3 we can see that healthcare information systems is still at the
early stages of maturity. Focusing on the main issue addressed in this paper, namely electronic
records in healthcare, it is clear that regarding the eHealthcare architecture maturity model, EHR and
health information repositories, patient path as well as data interchange, interoperability and
accessibility, and clinical terminology and classification are major components of this model (BSI,
2012a). In order to achieve this, it is highly necessary to standardize some basic terminology such as
EHR, as well as other clinical terms in order to achieve interoperability between different systems.
Concerning the CMM(I), electronic records in healthcare are still at an early stage of maturity, due to
lack of standardization. Other relevant models such that of Garzás et al. (2013) focus on stakeholder
requirement as well as systems requirements, which in our case is necessary for the design of the
system. Thus patient centered design is an issue here, which requires flexibility due to different
patient’s needs. For the sake of patient safety, an auditing process such as that suggested by Garzás et
al. (2013) is needed.
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Level 1 of the project management maturity model focusing on common language emphasizes what
has been recommended above concerning standardization of basic terms.
5 CASE FINDINGS
As mentioned, the aim of this research is to investigate the issue of standardization of electronic
records in healthcare. The research is willing to investigate whether there are specific standards being
followed in this context to facilitate the shareability and interoperability concerning patient data. As
has been seen from the literature and popular quality standards, even some terms do not mean the
same thing to different researchers or stakeholders. There is another important question here, namely
can we reach this standardization? One of the relevant matters here is the patient centric view, which
has shown through the literature, is that each patient is a different case, due to multiple factors, which
are not just limited to the disease, which by itself can change over time. This matter may limit the
standardization issue.
5.1 Research Method
In order to perform this investigation, the research method that has been selected is the case study
research method. This is because it enables in depth investigation required for such a study. Further,
the specific type of case study is exploratory. This type of case study is used to explore those
situations in which the intervention being evaluated has no clear, single set of outcomes (Yin, 2003).
In the context of this research a qualitative approach is more appropriate as such approach can be used
to: (a) investigate little-known (b) examine in depth complex processes; (c) examine the phenomenon
in its natural setting and, (d) learn from practice. In doing so, various data collection methods such as
interviews and documentation were used. This study includes embedded units of analysis. Thus,
separate in depth interviews have been conducted from both medical specialists as well as the IT side.
The analysis technique utilised in this research is pattern matching. The bias that is considered to be a
danger in using qualitative research approach is overcome in this research by data triangulation.
5.2 Case Description and Results
The case under investigation is one of popular centers in the United States. It incorporates multiple
networks of centers in different specializations one if which is its cancer center, which is nationally
recognized for quality, with accreditations from the American College of Surgeons Commission on
Cancer, National Accreditation Program for Breast Centers (NAPBC) and American College of
Radiology for our Breast Imaging Center of Excellence. With the opening of their new Cancer
Resource and Support Center (CRSC), patients at risk for cancer, the newly diagnosed patient, those in
treatment and those in survivorship have the availability of a full continuum of services in an
environment of patient comfort and dignity. Among the services offered are: American Cancer
Society-trained cancer resource volunteers to provide educational information and guidance, new
patient orientation classes, nurse navigators, financial navigator, genetic counselor, survivorship nurse
practitioner, registered dietitian, integrated therapy, support groups and community forums. Patients
have access to a broad array of clinical research trials in the country. Their multi-disciplinary team of
cancer specialists meets weekly to coordinate the most appropriate treatment plan, which is
individualized to meet the physical, mental and spiritual needs of the patients, their families and the
community.
The medical centers under investigation do not use in-house development, but like most of others they
rely on vendor dependant software. These are CERNER and EPIC EPR vendors, However when
describing what they perform with such software, it is more like BSI EHR definition rather than EPR.
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While developing such packages, most of the USA vendors in general do not rely on patient centred
development, or even the practitioners want. However, lately due to multiple Governmental initiatives,
the software providers are starting to have some focus groups which might be including some
specialists. In general, we cannot consider that such applications have reached an advanced level of
maturity, because of the reason that has just been mentioned, and the matter that it lacks a degree of
in-house development that allows appropriate stakeholder analysis.
Investigating the suggested American Standard patient record contents discussed above with the
medical party, has shown that the suggested fields are useful, but they need additional fields to be
added including for example legal document consent, mental status, neurological (physical exam),
extremities, abdomen, previous treatment. It has been clear through the discussion that a due to the
disease nature some specific fields are necessary. One other challenge concerning the standardization,
is that the procedures might be different from a medical center to another. Electronic records for
patients are vital, as they have been facing situations, where the diagnosis and consequently the
treatment has not been as desired due to the matter that the patient does not remember to mention
some important issue to the specialist such as some side effects they had from some medication, a
previous disease or a medical process they went through. So although the challenges of
standardization it is important to share the patient records and history. When sharing the patient record
with other medical centers, a hard-copy subject to patient consent and signature can be provided.
It has been confirmed that the focus of the American Government aims to promote standardization and
patient safety. An example is the Medicare or Medicaid Electronic Health Record (EHR) Incentive
Program mentioned above. The American Recovery and Reinvestment Act of 2009 (ARRA) provides
incentive payments for Medicare and Medicaid providers who “adopt, implement, upgrade, or
meaningfully use [MU] certified electronic health records (EHR) technology.” Further, the main
focus of the and the integrated medical centers under investigation in this case, is patient safety and
interoperability development efforts rather than patient centric development. There is a fear of
developing web applications allowing the patient accessibility to the medical data without an
intermediary, who need to be a medical party to perform proper explanation of the results. The current
systems used provide a degree of standardization with some degree of flexibility to allow customizing
patient data.
In order to understand who exactly a patient from their perspective and thus requires to have a record,
it has been confirmed that a patient is one who visits the center with a complaint, or someone who is
doing regular check-up, or those who are under management. Clearly, each of those categories needs
different types of support where specific data is required incorporating multiple processes, which adds
to the complexity of healthcare. Although that the data gathered in the first visit for all categories is
almost the same (management phase) but thereafter changes happen depending on the case (follow
up), which means that the patient status might change from a status to another. This will require new
management methods for the patient. On one hand, once a patient has been registered, the relationship
with the primary care usually doesn’t end; on the other hand the relationship with specialists might
end. This means that the patient status is never static, and might change its status over time,
especially that the treatment process may trigger side effects or even secondary disease. Further, the
main disease of the patient might be cured and the major case would be related to another specialist, so
this means that shareability of patient records are vitally required. As each patient might be seeing
more than one specialist especially due to the complications of the cancer therapy, data can be shared
between medical stakeholders as hardcopies (lack if electronic integration is due to privacy issues),
where the patient consent is mandatory. This is considered as one of the challenges of integration. A
patient may suffer from multiple diseases, which can be classified as primary, secondary, surgical, and
diagnosis.
Although that the importance issue of patient centricity and healthcare information systems
development, which is adds to the complexity of healthcare information systems multiple issues that
have been referred to in the literature have been confirmed, the patient centric view is not the highest
priority as safety. As a starting point, it has been confirmed from the medical specialist’s point of view
that technology in healthcare can kill, which means that safety should be the number one priority for
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Electronic Records in Healthcare: The Need for Quality Standards 21
any technology used for processes of care. This can occur with computer assisted radiation devices, or
unreliable patient records, as examples. However, it has been agreed that multiple issues are important
to understand concerning each individual patient case. Diversity includes all aspects of culture, as well
as socioeconomic status, religion, disability, age, gender, race, environment etc.
6 CONCLUSIONS
This paper has investigated the issue of standardization of electronic records in healthcare. The
research is willing to investigate whether there are specific standards being followed in this context
to facilitate the shareability and interoperability concerning patient data. As has been seen from the
literature that although a great effort has been performed from some quality standards institutions
such as British standards and ISO some terms do not mean the same thing to different researchers
or stakeholders. Although the dynamic nature of patients and that that each patient is a specific
case, which may require different data fields to be stored, there are basic fields that need to be
standardized, especially concerning each disease category. This needs to be supported by a degree
of flexibility of the system to change the patient status in an ongoing manner. Unless a degree of
basic standardization is reached, the healthcare information systems will remain in a primitive
maturity level. We understand that such a degree of lack of standardization to the patient and the
environment will remain. This paper concludes to that there is a need to suggest a maturity model
for electronic records in healthcare information systems and achieve an appropriate balance
between standardization and flexibility. This requires transdisciplinary integration efforts from
practitioners, patients, quality standards organizations, governments, WHO and others to identify
such standards and vocabulary preferably classifying according to disease or at least medical
specialization. An integrated maturity model for electronic records in healthcare information
systems including but not, limited to project management, infrastructure, and architecture need to
be developed. For the sake of patient safety, auditing is an important matter that needs to be
considered in such a model.
7 ACKNOWLEDGMENT
The author would like to thank Prof. Ray J Paul Emeritus Professor at Brunel University for the
continuous discussions and collaboration in the area of healthcare information systems. This includes
multiple topics including electronic records in healthcare; which is an ongoing issue in our
collaboration and we are working on another paper on this topic to appear fairly soon.
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