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MEDICAL DATA,
INFORMATION ECONOMY
AND FEDERATIVE NETWORKS
THE CONCEPTS UNDERLYING
THE COMPREHENSIVE ELECTRONIC CLINICAL
RECORD FRAMEWORK
RINALDI GIOVANNI
ANTONIO GADDI
AND
FABIO CAPELLO
Nova Science Publishers, Inc.
New York
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Extraction from manuscript
Contents
Foreword....................................................................................................................................... 1
SECTION ONE: OVERVIEW .................................................................................................. 7
1.1 Different Medical Records for various applications: descriptions, features and models .... 8
1.1.1 The early Medical Records and the Hospital patient treatment ....................................... 8
1.1.2 Clinical Trial and Medical Research EHRs ............................................................ 13
1.1.3 Genomic Data in EHR................................................................................................ 15
1.1.4 The General Practitioner Medical Records ............................................................ 17
1.1.5 The empowerment of the patient ............................................................................... 19
1.1.5.1 Patient-self-management tools ................................................................................ 20
1.1.5.2 e-Disease management ....................................................................................... 20
1.1.5.3 Personal Health Records or Personal Controlled Health Records ..................... 21
1.1.6 Medical Records: a complex living object .......................................................... 23
1.1.6.1 the comprehensive purpose of EHR ........................................................................ 25
1.1.7 Frameworks for reaching the interoperability ................................................... 29
1.1.7.1 DICOM ................................................................................................................... 30
1.1.7.2 HL7 framework ....................................................................................................... 30
1.1.7.3 IHE Platform ........................................................................................................... 31
1.1.7.4 GEHR/OpenEHR initiative ..................................................................................... 31
1.1.7.5 CEN/TC251............................................................................................................. 32
1.1.8 Conclusions ......................................................................................................... 32
1.2 Looking at the world. Experiences from national e-Government projects: assessments and
trends........................................................................................................................................... 36
1.2.1 The National EHR Programs ......................................................................................... 36
1.2.2 A broad discussion about medical records .................................................................... 45
1.3 Electronic Health Records for Doctors, for Researchers, for Patients .............................. 61
1.3.1 EHR classification according to the actors .................................................................... 61
1.3.2 Darwinian evolution or “driven choices” for the medical record systems? .................. 62
1.3.3 Determinants of Medical Record choice policy in the last decade ................................ 65
1.4 Conclusions .......................................................................................................................... 69
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SECTION TWO: Clinical methodology, healthcare and EHR: theories, problems and
solutions ...................................................................................................................................... 73
2.1 The present Medical Records: the point of view of the clinicians ...................................... 75
2.1.1 Sharing of data: the patient-oriented proposal .............................................................. 78
2.2 Medical information: main features and aims .................................................................... 80
2.2.1 The researchers’ Point of View ...................................................................................... 84
2.2.2 The Health Care Workers’ point of view ........................................................................ 84
2.2.3 The patients’ point of view ............................................................................................. 86
2.3 Ontological approach and contents definition: who makes what?..................................... 89
2.3.1 Introduction .................................................................................................................... 89
2.3.2 Contents definition ......................................................................................................... 91
2.3.3 Who makes what? ........................................................................................................... 93
2.4 The formal t visual communication The formal theories of conversation in the logic of
care .............................................................................................................................................. 96
2.4.1 EHR: the information model .......................................................................................... 97
2.4.1.1 Time, space and functions ..................................................................................... 100
2.4.1.2 The nature of an information model ...................................................................... 101
2.4.2 the theory of communication and the clinical approach to the patient ........................ 104
2.4.3 Information from clinical trial ..................................................................................... 107
2.4.3.1 Data and information paradigms in EHR and Electronic Data Collection ............ 108
2.4.3.2 a proposal platform for clinical trial. The point of view of the researchers .......... 108
2.4.4 Role, instruments and behaviors .................................................................................. 109
2.5 The Doctor-Patient encounter and the Patient-Doctor relationship ................................ 111
2.5.1 Seeking Health Information in the Internet and the patient-doctor relationship: some
considerations ....................................................................................................................... 111
2.5.2 Patient and the Internet: a source of discrepancy between demand and supply and
confounding factor in patient-doctor relationship ................................................................ 114
2.5.3 EHR and patient-doctor encounter .............................................................................. 118
2.5.4 EHRs and Doctor-Patient relationships ....................................................................... 123
2.6 The composition of clinical information: gathering information, composing data, caring
patient ....................................................................................................................................... 124
2.6.1 Composition of Clinical Information ........................................................................... 124
2.6.2 The process: intelligent gathering information, composing “universal human” data,
caring consequently the patient ............................................................................................. 132
2.6.3 Practical clinical approach: some considerations ....................................................... 138
2.6.3.1 Data recovery: a review of some models at present used...................................... 140
2.6.4 Other issues on the management of clinical information ............................................. 143
2.6.4.1 Errors and quality check ........................................................................................ 143
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2.6.4.2 Resource-limited settings and neglected cohorts .................................................. 144
2.6.4.3 Ethical issues ......................................................................................................... 145
2.6.5 Caring the patient and raising wellness among citizens .............................................. 145
2.7 Conclusions ........................................................................................................................ 148
SECTION THREE: Records and Information Space ......................................................... 149
3.1 The socio-technical complexity of medical record ............................................................ 151
3.1.1 The actors ..................................................................................................................... 152
3.1.2 The setting .................................................................................................................... 152
3.1.3 The systems ................................................................................................................... 154
3.1.3.1 Traditional systems, different settings and Web 2.0 approach .............................. 156
3.1.3.2 Web 2.0 and Semantic Web .................................................................................. 157
3.1.3.3 the complexity of medical records ........................................................................ 159
3.1.4 A Methodological Note: The Co-Production ............................................................... 165
3.1.4.1 Features of multi-agency care ............................................................................... 166
3.1.4.2 System user and system design ............................................................................. 167
3.1.5 Expertise, knowledge and practice ............................................................................... 167
3.2 Record Care and Information Economy ........................................................................... 170
3.2.1 The Clinical Information Economy .............................................................................. 173
3.2.1.1 The policy context in which we are operating ...................................................... 174
3.2.1.2 self assessment process ......................................................................................... 175
3.2.1.3 care planning ......................................................................................................... 175
3.2.1.4 Care Commissioning ............................................................................................. 177
3.2.1.5 Records and Information Spaces ........................................................................... 178
3.2.2 Principles of Governance and ethics of Clinical Information ...................................... 178
3.3 Publishing Intentional Data and extracting Accidental Information .............................. 180
3.3.1 Characteristics ............................................................................................................. 182
3.3.1.1 Collaboration ......................................................................................................... 182
3.3.1.2 Awareness ............................................................................................................. 183
3.3.1.3 Educational and Training ...................................................................................... 183
3.3.1.4 Community Of Practice ......................................................................................... 184
3.3.1.5 Knowledge Localization ....................................................................................... 184
3.3.1.6 Communication and Collaboration ....................................................................... 184
3.3.1.7 Innovation Management ........................................................................................ 185
3.3.1.8 Collective Intelligence .......................................................................................... 185
3.3.2 Medical data grows on the network and clinical knowledge evolves ........................... 186
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3.3.3 Information grouping and pattern recognition ............................................................ 187
3.3.3.1 virtual health community produces and make available clinical knowledge ........ 187
3.3.3.2 tracking and mapping of digital content ................................................................ 188
3.3.3.3 virtual communities and new technologies ........................................................... 189
3.3.4 Classification of information ........................................................................................ 189
3.3.5 Information accessibility for consuming purposes ....................................................... 191
3.3.6 Information life-cycle over the time, over the places over the concepts ...................... 191
3.3.7 The needs of a collaborative information architecture ................................................ 192
3.4 Conclusions ........................................................................................................................ 194
SECTION FOUR: Technical issues: sharing information caring people .......................... 196
4.1 The data sharing concept and the medical records notion ............................................... 198
4.1.1 Why medical records issue needs an architectural infrastructure discourse? ............. 204
4.2. Information services .......................................................................................................... 207
4.2.1 Role and relationship ................................................................................................... 211
4.2.2 Medical Records Enterprise Model .............................................................................. 214
4.3 The architectural discourse: the federative platform for sharing information ................ 216
4.3.1 Outline of the architecture principles of the clinical records infrastructure: the hub
concept .................................................................................................................................. 216
4.3.1.1 EHR Core Functions The Functional Model ...................................................... 223
4.3.2 outline of the architecture principles of the clinical records infrastructure: the
federation concept ................................................................................................................. 233
4.3.3 The Physical Resources ................................................................................................ 238
4.3.4 EHR Technology Model ............................................................................................... 242
4.4 Shaping the structure of clinical records: data and information ..................................... 247
4.4.1 Organization of Information and Logic Issues ............................................................. 250
4.4.1.1 Folders ................................................................................................................... 251
4.4.1.2 Transactions .......................................................................................................... 252
4.4.2 Basic Framework Concepts.......................................................................................... 253
4.4.3 Subjects about the Structured Content of Clinical Information ................................... 259
4.4.3.1 Clinical Data Item ................................................................................................. 260
4.4.3.2 Clusters .................................................................................................................. 263
4.5 Building services in web environment and beyond: concepts overview ........................... 267
4.5.1 The technical features of the ecosystem ....................................................................... 269
4.5.2 Metadata, automatic aggregation and tools for the generation of knowledge ............ 271
4.5.3 Mash-up ........................................................................................................................ 273
4.5.4 Rich Internet Applications ............................................................................................ 275
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4.5.5 Blogs ............................................................................................................................. 277
4.5.6 Syndication ................................................................................................................... 277
4.5.7 Signaling....................................................................................................................... 278
4.5.8 Service Annotation and Semantic Web ......................................................................... 279
4.5.9 Ontologies .................................................................................................................... 281
4.5.10 Medical records and the tools managing structured knowledge ................................ 284
4.5.11 Grid computing .......................................................................................................... 286
4.6 Conclusions ........................................................................................................................ 293
Conclusions .............................................................................................................................. 296
Acknowledgements .................................................................................................................. 309
Bibliography ............................................................................................................................ 310
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FOREWORD
The scope of this book is to present some fundamental pillars that must be necessarily taken into
account for the design and the construction of a medical record system, with the introduction of
different points of views to address the issue.
The ideas discussed here are the result of a work done over the last decade, in which technology
has done great steps and at the same time, doctors, patients and medical researchers have put their
expectations in medical record systems contributing at different levels. Nevertheless the work does
not claim to be exhaustive, as the spirit of the book is to propose to reason out on some issues that
have to be considered as the main features to take in consideration in the design and deployment of
medical record systems.
I have noted that whereas medical record systems are supposed to be “living complex objects”,
in which different professionals are involved in a collaborative work, the reality shows that they
often are mere technical tools that collect information often used for administrative tasks,
accompanying medical actions, without the expression of the empowering that they can emanate.
This is mainly due to the bias related to each one of the solutions proposed; whether proposed
by doctors, or by technicians, or by policy makers or by software industries. Each solution tends to
be incomplete, as it generally resolves only part even if in the optimal way of the complex
problems related to the medical information of the patients, the individuals, and the population.
Publications about some of the subjects of this book have almost often treated these arguments
in a excellent way, but from each specialistic point of view, leaving the others aside, with the claim
to be the only exhaustive ones. Though, the result has not always been conveniently applicable, if
not under obligations or incentives, so that only a little part of a great problem was solved. It
consequently brings to the production of disaffection and tensions among the stakeholders, as the
literature widely demonstrates.
Avoiding the traditional method for designing medical record systems in which experts are
involved in a linearization process where clinicians describe the health world and then technicians
translate it in technical languages and software codes, whereas policy makers at the starting point
defines the organizational ties I wanted to engage from the onset in this adventure the medical
experts, working in co-production with the technicians.
So, the first challenge of this book is to face the issues proposed in a co-productive way, in
which the point of views are harmonized in shared visions, where the requirements that inevitably
must be posed and considered, do not become veto but opportunities and challenges to overcame,
also offering different shared solutions based on technology, organizational changes, medical actions
and workflow in a unitary way; and to do this in this adventure it has been needed as well to involve
in different actors in order to present a more shared proposal.
For these reasons this book is proposed to technicians, policy-makers, doctors and medical
researchers, in order to achieve a shared vision of the design, deployment and utilization of the
medical record systems, because it is from different actors that this book has been done.
Following this main consideration, the book cover four sections.
The first explores what is the state of the art of the medical record systems’ exploitation
analyzing their design and implementation and the contexts in which they have been deployed,
pointing also out lights and shadows, including the expectation of Central Governments that have
promoted and started national programs.
The scope is to present, briefly, what have been the main aims and goals that have encouraged
the deployment of medical record systems in relationship with policies constraints, users outlook,
and design principles.
In this section, some definitions will be provided, found in the literature of the sectors, even if
the purpose is not to be exhaustive: literature is very flourishing and in the same way a lot of
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definition have been presented. But the several citation presented in all the book are only a part of
the huge amount that it has been found across different International or National Societies (for
technicians or for doctors) and diverse journals (for technicians or for doctors); it was therefore
impossible to quote each specific definition, experiences or proposals done. The scope is to indicate
the issues to be considered and the trends currently explored around the world. Thus the
bibliography will offer the right direction to deepen and to know the detail of specific issues.
We have noted that many definitions are partial, highlighting only some aspects of the problem
and inevitably the outcomes are evident.
Because of the different definitions and visions, we refer often in the book to medical records or
medical record system if we consider the generic aspect, whereas we use the correct term if we are
treating specific issues. Nevertheless at the end, we want to achieve a complex description of the
subject that overcomes the present definitions.
These reflections have led us to consider the medical record as a complex living object that must
be treated according to different projections, the first being the point of view of the actors.
We intend ideally to group the actors of the healthcare system interested in consuming medical
information from different standpoint in three main clusters: doctors, patients and researchers. With
doctors we intend each professionals interested in medical record managing (we do not treat
expressly of systems for nurse, but we know that professionals apart from doctors, like the nurse are,
are included in the management of system for “professionals”); with patients we mean also family,
neighbor and friendly relationships; with researchers we intend to group all the persons involved in
the medical, pharmaceutical and clinical research at different levels in different settings: research
centers, University, industries. The scope, so, is not to analyze the exact systems for each actors
segmented in different tasks inside the main group, but is to provide the point of view that inevitably
claim to became the requirements.
Policy-makers, to which this book is also directed, have important reasons for being engaged in
the route of definition of the subjects submitting the medical record systems, as we will see in the
third part.
The second sections, in fact, we will explore how the actors of the health context the doctors,
the patients and the researchers through social relationships, produce clinical information, and
what are the mechanisms that transform information into knowledge.
This is the point of view of the actors that express the requirements and it focuses on the
systematic reasoning done by clinicians in the construction of the medical record. Also in this part,
doctors do not want to be exhaustive, but this method of approach poses the basis to define which
kind of information the actors need to treating a patient; or the researchers have to collect to achieve
a goal; or the patient desires to share with other people affected by the same disease or to share with
professionals. Because of this purpose, that is part of the everyday job, the medical information is
treated through the evaluation of doctor-patient-researcher relationships, and through the
mechanisms underlying the route for observation, evaluation, perform actions, and provide
instructions.
But it is interesting to note that a first interesting requirement rises, and it is related to the
intrinsic nature of the medical records that are not only a collection of information, but rather a
complex systems for managing the clinical knowledge on the information collected.
As we have indicated, the complex living object that is the medical record described in a
numbers of definitions and conceived mainly by the actors must also be considered in a more wide
context, as it belongs to a more complex space: the clinical information space, and this poses new
rules.
Healthcare operates in a public sector, and in a political economy, this includes processes of
service planning, commissioning and performance assessment. Therefore the capabilities of the
platform we will present must be shared and reused in many different contexts and for a range of
purposes.
The Section Three treats these arguments. It starts showing the socio-technical complexity
associated to the medical records, according to the issues presented in the previous sections. In this
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part we will explain within a context of Information Economy, in which space services and products
are offered, as the use and management of information is strictly related to the action to be taken.
In the Information Economy space, in which information has value and is transacted in the
delivery of care, the development of services and the deployment of clinical capabilities and practice
through the conversational relationships among the actors that produce and enrich the medical
information value chain, are inscribed the (co)operations of a set of roles, that came with their own
responsibilities producing Publication, Brokerage and Delivery of clinical information.
We inscribe the complex relationships among the actors in an environment supporting the
operation and governance of a dynamic and participative ecology and economy of care; in which
many actors, belonging to different institutions, agencies, organizations depending on each other,
interacting and transacting in complex ways over the infrastructure and in the real, face-to-face
world and resources and policies emerge and evolve; but because there are hard limits on capacities
and resources, optimization and rationing are realities that must be faced, while costs and demand
are managed.
Clinical information is constructed upon relationships between the actors. The adding value
chain, on which health transactions are based in health information economy, is funded on these acts
of communication and it comprises a set of roles and interactions working together to create and
delivery a service, in which each element provides its own contribution for the benefit of the users
adding “value” inside the ecosystem.
So the construction of information according to the roles and its interpretation assumes a
fundamental role in the design of the information systems.
Clinical information produced in this ecosystem fosters collaboration among users and can be
intentional or accidental, because it is based on the meaning of the information created: social
collaboration among health actors is based on voluntary traditional clinical information sharing, but
there are a great amount of medical information produced for some scopes that can be reused,
revealing hidden connection among data. That promotes accidental collaboration, unthinkable in the
past.
At last but in strict relationships with the previous ones, the technological point of view is
presented in the Section Four. This part explores how the concepts introduced might led to the
construction of information artifacts, and how those resources could exploit the emerging
technologies (web, sharing of data and services, mining and expert systems, mobile, tablets, grid
computing, and so on).
In this section we want to point out that technology is not an appendix to be added to the
requirements “to make” the systems, but on the contrary it is part of the whole design process from
the onset, because it suggests how the solutions must be harmonized with the requirements and how
knowing the new technologies, those requirements assume new perspectives and meanings, leading
the actors, stakeholders and designers to a new and more important views, otherwise unimaginable.
The scope is to present as the new technologies aid to create a collaborative environment in
health context, in which the actors belonging to different organizations and with different roles and
aims can collaborate sharing data and information for creating a virtual community of
stakeholders, also fostering and making available tools for collaboration: making real the pervasive
medical, patient-centered information system.
This aim must face the present medical record systems conceived in “individualform in which,
aiming to resolve partial requirements, data are contained in silos that cannot communicate with the
others, unless in complex ways, introducing different software layers. In these applications data are
hard-wired in the application, in the software workflows; or the meaning of data is connected to the
database schema making in the reality difficult to treat, consume, and analyze the data under the
different perspectives that it contains. For these reasons, a sort of separation between information
models and domain content models is proposed, fostering the definition of minimal unit of
information to which specification and context information must be associated to allow composition
of data items in clusters, mining hiding meaning through the correlation with other data, used in
different guide-lines, or used in different clinical scenarios and so on. Those features otherwise
cannot be achieved using traditional applications.
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But the ecosystem described, in which the relationships among the actors belonging to different
organizations, institutions and agencies live and are nurtured (even if they want to continue to
express their ethos in the collaborative work that medical job requires), promote the realization of
federative platforms, in which clinical information and services are shared, fostering also
collaboration and the inclusion in the care workflow of all the actors including the “empowered”
patient.
Then, according to the concepts expressed in the previous sections, the lines of development of a
federative platform are defined. This will take in account the new paradigms brought by Web 2.0
applied to medical records in health context like: Publishing and Sharing information, Semantic
Web, Syndication, Signalling, Messaging, Mash-ups, Intentional and Accidental clinical
information, mining of data, scenarios creation, Presentation Services.
At last a review of new technologies not directly associated to web environment, but for which
they assume further meaning, is presented: medical ontologies, expert systems and grid computing.
The corpus of technologies presented must be taken in consideration, to respond to the
requirements expressed. Or, better, those technologies produce new meanings to the requirements
and open new directions to explore, inside the ecosystem described in which actors, roles and
relationships are inscribed.
In this context, in which issues about data and services sharing are presented as base for the
pervasive and holistic medical record systems construction, becomes fundamental to explore also the
principle of “infrastructural governability”.
It is an important argument related to the sharing of the clinical information, the pervasive
“mission” of web, the possible uncontrolled “empowering” of the patient and the natural request to
conserving the privacy of the individuals.
The Internet world has allowed that the complexity of managing resources and responsibilities
associated with the allocation of rights and responsibilities over their use could be simply ignored.
The philosophy of Web 2.0 is that anyone can do anything! This approach has brought patients to
overcome the health organization and in some cases has allowed the following of “do-it-yourself
healthcare” proposals.
The Internet was established and has achieved critical mass by ignoring the logics and principles
of the information governance; and having established itself and becoming pervasive, it is now the
principal channel and medium for health information.
But how can this be safe in the absence of governance and where mechanisms of control are
inaccessible and ineffective?
The conversation theory, applied to the information service value chain, can help us to
understand this question and direct us toward strategies in which governance is one of the most
important features that the pervasive design of medical record system must take in consideration.
So, finally, nevertheless considering positive all the efforts done so far, in this book we assert
that medical record issue is a complex living object, and its design, construction and deployment
must be faced considering different aspect of the problem in a co-productive fashion. Starting from
the patient-doctor-researcher relationships must be considered the human perspective of the
information collection because the patient-centered gathering of medical information must be done
for human aims, for which the term “patient-centered”, often used, must be considered not only by a
technical perspective but first of all by considering the human point of views. These information live
and are nurtured in the information spaces, in which clinical information value chain is composed
through voluntary acts of “publication, brokerage and delivery” of clinical information, necessary
for making available medical records and for creating a virtual community of actors, making
effective and real the collaboration among the individuals interested in the healthcare context,
therein included the patient. These transactions among the relationships among the actors, produce
value and enrich the whole information ecosystem in which actors, institutions, agencies and
organizations share medical information, build collaborations and create virtual communities. And
we do not have to forget that these opportunities and challenges, unthinkable some years ago, are
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made possible by the new development of technology, that allows pervasive computing, shared
information and distributed knowledge, collaborative tools, sophisticated and complex algorithms
for information analysis, across agencies, institutions and nations, making effective the creation of
virtual communities of actors engaged in the treatment of clinical information for the individuals.
But at the same time we are also aware that a certain usage of technology can brought to a drift,
making possible the arousing of incorrect forms of “do-it-yourself healthcare”; for this reason
technology must be governed in healthcare context; and this assertion is not in contrast with the new
development of technology.
The description of medical record, so, must take in consideration all these aspects described in
the previous sentences, in a unitary fashion, aside from the risk to be partial. Then the construction
must be only according the idea of “co-production” in which actors, policy-makers and technicians
must be engaged in a co-production approach, in which they must be empowered to be participants
and to negotiate their contributions in the process of construction of shared visions of socio-
technical systems of care, without the division into experts and clients.
At last I wish to thanks the professor Mike Martin, Visiting Professors at Newcastle University
(UK), because his work done in the last decade and the fruitful discussions about these issues have
given the birth, in my head, to the idea to systemize some suggestions and to propose this book as a
further contribution to the research in the field of Medical Record Systems.
Giovanni Rinaldi
ResearchGate has not been able to resolve any citations for this publication.
165 3.1.4.1 Features of multi-agency care
  • A Methodological Note
A Methodological Note: The Co-Production............................................................... 165 3.1.4.1 Features of multi-agency care............................................................................... 166 3.1.4.2 System user and system design............................................................................. 167
281 4.5.10 Medical records and the tools managing structured knowledge
  • .......... . Ontologies
Ontologies.................................................................................................................... 281 4.5.10 Medical records and the tools managing structured knowledge................................ 284