1

1

REFLEXIVE STANDARDIZATION2

SIDE-EFFECTS AND COMPLEXITY IN STANDARD-MAKING13

4

Ole Hanseth5Department of Informatics,6University of Oslo, Norway7

(e-mail) ole.hanseth@ifi.uio.no89

Edoardo Jacucci10Department of Informatics,11University of Oslo, Norway12(e-mail) edoardo@ifi.uio.no13

14Miria Grisot15

Department of Informatics,16University of Oslo, Norway17(e-mail) miriag@ifi.uio.no18

19Margunn Aanestad20

Department of Informatics,21University of Oslo, Norway22(e-mail) margunn@ifi.uio.no23

242526

Abstract27

In this paper, we address the general question proposed by the call for papers of this special 28

issue: “What historical or contingent events and factors influence the creation of ICT 29

standards, and in particular, their success or failure?” Based on a case study conducted over 30

1A previous version of this paper was presented at the MISQ Workshop on "Standard-Making: A Critical Research Frontier for Information Systems," Seattle 2003.

2

a period of three years in a Norwegian hospital on the standardization process of an 1

electronic patient record (EPR), the paper contributes to the current discussion on the 2

conceptualization of standard-making in the field of Information Systems. By drawing upon 3

the concepts of logics of ordering adopted from Actor-Network Theory and upon reflexivity 4

and unexpected side-effects adopted from reflexive modernization the paper makes three5

key contributions: 1) it demonstrates the socio-technical complexity of IS standards and 6

standardization efforts; 2) it reports of an empirical case study that shows how the7

complexity can generate reflexive processes that undermine standardization aims; and 3), it8

suggests a theoretical interpretation of standardization complexity by using of ideas from9

complexity theory and the theory of reflexive modernization. These research questions are10

addressed by offering an historical and contingent analysis of the complexity dynamics 11

emerging from the case.12

13

14

Keywords: standards, reflexive modernization, side-effects, socio-technical theory, 15

electronic patient records16

17

18

19

INTRODUCTION20

The research presented in this paper explores the borders and limitations of modern 21

standardization in the context of developing a pan Norwegian standard for electronic patient 22

3

record systems (EPR). An EPR is a computer-based information system for storing and 1

presenting patient clinical data in hospitals.2 We interpret the failed effort to replace the 2

fragmented (mostly paper-based) patient record and information system collage with one 3

integrated electronic record system as an inherent element and outcome of the complexity of 4

the standard setting. Moreover, we show that standardization processes can be reflexive-5

they result in outcomes which are antagonistic to the original aims. For example the 6

standard setting in EPR ended up producing a more fragmented record and IS portfolio.7

8

We will interpret this case and narrative contained therein by highlighting the associated9

complexity of the standardization effort. Our theoretical tool in this interpretive act is Actor-10

Network Theory (ANT) combined with the concept of reflexivity adopted from the theories of 11

risk and reflexive modernization (Giddens 1991; Beck et al. 1994; Beck 1986; Beck 1994;12

Beck, 1999; Beck et al. 2003). The mobilized concept of reflexivity reveals unexpected side-13

effects and how such side-effects can trigger new actions which will have their own side-14

effects, and so on. Initial actions with good intents may thus lead to self-destructive 15

processes whereby side-effects propagate ways that are “reflected” back on their origin and 16

cause the end result to be the opposite of what was initially intended.17

18

The paper makes three key contributions. Firstly, it demonstrates the socio-technical 19

complexity of IS standards and standardization efforts. Secondly, it provides an empirical 20

2 We have chosen to use the term “patient health record” or “medical record” used by core standardization organizations such as CEN TC251, HL7, or ASTM indicates a wider scope of the system that may go beyond single organizations.

4

case showing how this complexity may generate reflexive processes that undermine the 1

initial aims of standardization. Finally, the paper suggests a theoretical interpretation of this 2

phenomenon by means of complexity theory and the theory of reflexive modernization.3

4

The paper is structured as follows. In the first section we show how the development and 5

implementation of an EPR can be seen as a standardization process and how such a6

standard can be considered a complex system. In the second section we present our7

theoretical framework, conceptualizing standards as complex socio-technical systems. In the 8

third section our research design and methodology are outlined. In the fourth section our 9

case is presented, followed by analysis and discussion in the fifth section, including 10

implications and conclusions.11

12

EPR STANDARDIZATION AND ITS COMPLEXITIES13

EPR systems can be used by individual doctors, as a common system in a clinical 14

department, or as a shared and common system in an entire hospital or even among a set of15

interconnected hospitals. EPRs can be an off-the-shelf product, a proprietary system, or (as 16

in our case) a system co-developed between a group of hospitals and a vendor. An EPR 17

system is used to specify, routinize, and uniformize the type and format of clinical 18

information to be collected. Moreover, it is meant to support coordination and cooperation 19

between departments, professions and medical specialities, and hospitals. A hospital-wide 20

EPR could reduce redundancy and inconsistency of patient information, as the information 21

would be stored in one single location accessible from any place at any time. 22

Standardization activities have aimed at defining the appropriate design of the EPR as an 23

information system, e.g., with respect to fundamental architecture, access control and data 24

storage. In order to allow new users to get quickly into work or to avoid fumbling in 25

5

emergency situations, standardization of user interface and data presentation is also 1

advocated. However, an EPR can be also be conceptualized as a “package” of standards. It 2

builds on existing technical standards, e.g., with respect to operating systems, databases3

and network standards. It embeds clinical procedural and performance standards as well as 4

numerous classification schemes and terminologies (Timmermans and Berg 2003). These 5

standards go beyond the EPR system as such.6

7

We conceptualize the EPR standardization attempt as a process of alignment. Successful 8

standardization entails the achievement of stabilization and closure in the definition and 9

boundaries of the standard (Law & Bijker 1992; Bijker 1993; David and Greenstein1990). 10

This is not easily achieved, because of the socio-technical nature of standards, as well as 11

the number and variety of standards and their interrelations (Fomin et al. 2003; Bowker and 12

Star 1999; Brunsson and Jakobsson 2000). In our case a number of different actors were 13

involved, both within the individual hospitals and inside and outside the consortium or 14

national project.15

16

Delineating the intricacies involved in standard development processes, de Vries (2003) 17

defines standardization as:18

the activity of establishing and recording a limited set of solutions to actual or 19

potential matching problems directed at benefits for the party or parties involved 20

balancing their needs and intending and expecting that these solutions will be 21

repeatedly or continuously used during a certain period by a substantial number of 22

the parties for whom they are meant (p.155)23

24

6

Taking this definition as a reference, we submit that the observed phenomenon reported in 1

the case study can be seen as a process of standardization (ibid. p. 156) for the following 2

reasons: (1) the activity was aimed at finding a common set of information needs to be 3

addressed by balancing possible differences and views; (2) the clear aim was to create a 4

single solution (with the possibility of some degree of adaptation) to be shared by hospitals, 5

and, internally, by clinical departments; (3) the intended solution was aimed at addressing a 6

set of matching problems, that is, at harmonizing the problem of collecting, presenting, and 7

sharing clinical information between departments and possibly hospitals; (4) the 8

development was a clear long-term investment aiming at achieving a shared and long-lasting 9

electronic solution to recording, storeing, and sharing clinical information.10

11

We also propose that it is appropriate to conceptualize the EPR standard as a complex 12

system. We do so by means of Schneberger and McLean’s (2003) definition of complexity 13

as dependent on a system’s number of different types of components, number of types of 14

links and its speed of change. As noted above, a standardized EPR system includes or 15

builds on a large number of different standards which define very different types of objects. 16

These individual standards embed a large range of different work practices, and they are 17

developed by many different standardization “bodies” involving a large range of different 18

user groups and technical expertise. Further, the standards contain a huge number of 19

different types of links and relations between these elements, and, as will be demonstrated 20

later in this paper, many of the individual components and their relations are rapidly 21

changing. The EPR system standard is also in line with Paul Cillier’s (1998) more detailed 22

definition of a complex system as one made up of a large number of elements interacting in 23

a dynamic and non-linear fashion, forming loops and recurrent patterns which involve both 24

positive and negative feedback; it is open in the sense that it is difficult to define the borders 25

7

between it and other systems; it has “history”: its past is co-responsible for its present as 1

well as its future; and each element is ignorant of the system as a whole, responding only to 2

information available locally. This broad definition will underlie our conceptualization of the 3

systemic nature of the EPR throughout the paper.4

5

STANDARDS, SOCIO-TECHNICAL COMPLEXITY AND REFLEXIVITY6

The socio-technical complexity of IS standards has been studied from a variety of 7

perspectives. One strand has primarily addressed the role of network externalities – in 8

particular focusing on how these make standards increasingly difficult to change as their 9

installed base grows (Shapiro and Varian 1999). Another strand has focused on the 10

complexity - including local specificity and variety - of work practices and organizational 11

structures, and their embedding into standards (Bowker and Star 1999; Forster and King 12

1995; Hanseth and Monteiro 1997). A third strand has addressed the increased 13

heterogeneity of the actors involved in standardization on the one hand, and increased 14

speed of technical change on the other, and the challenges this leads to regarding the 15

organization of standards setting. These issues have caused a change from traditional 16

formal standardization bodies towards industry consortia as a preferred institutional 17

framework for standards setting (Vercoulen and Weberg 1998; Hawkins 1999; Shapiro et al. 18

2001).19

20

Overall, these studies have pointed at different aspects of complexity in relation to IS 21

standards and standardization dynamics. We suggest now to move one step further by 22

looking at the interdependencies and interactions between these forms of complexities 23

which, we argue, (sometimes) lead to reflexive, i.e. the combination of self-reinforcing and 24

self-destructive, processes. We will now present the theoretical framework we will draw 25

8

upon. The framework is primarily based on Actor-Network Theory (ANT). ANT has by and 1

large been developed and used to analyze the alignment of social networks or what we may 2

call the making of order in a complex world. This world has been seen as including humans 3

and non-humans, or technological and non-technological, elements. The kind of order-4

making that has been studied includes the development and acceptance of scientific 5

theories (Latour and Woolgar 1986), working technological solutions (Law 1987) and 6

organizational structures and strategies (Law 1994). Standardization is order-making par 7

excellence.8

9

Central concepts in early ANT research are closure (Law and Bijker 1992), stabilization (e.g.,10

Bijker 1993) and enrollment and alignment (e.g. Callon 1991). Specifically, closure indicates 11

a state where consensus emerges around a particular technology. Closure stabilizes the 12

technology by accumulating resistance against change. It is achieved through a negotiation 13

process and by enrolling actors/elements of various kinds into a network and translating (re-14

interpreting or changing) them so that the elements are aligned in a way that supports the 15

designers’ intentions. 16

17

The early ANT studies can be said to have focused on complexity in the sense that they 18

spelled out the rich and complex relations between the scientific and the technological on the 19

one hand, and the social on the other, related to the making of scientific theories and 20

technological solutions. ANT has been used in research on the negotiation of IS standards 21

and the embedding of their local context of development and use (Bowker and Star 1994, 22

1999; Timmermans and Berg 1997; Star and Ruhleder 1996; Hanseth and Monteiro 1997; 23

Fomin et al 2003).24

25

9

Since their emergence in the early 1980s, ANT and ANT research have evolved beyond1

their (so-called) “managerial” approach which focuses on how a single actor-network is 2

aligned by a dominating central actor (Law 2003b). Complexity has been addressed more 3

explicitly as the focus has turned to the dynamics unfolding when independent actors try to 4

align different but intersected actor-networks (Latour 1988; Star and Griesemer 1989; Law 5

and Mol 2002; Law 2003a; Law and Urry 2003). This has happened as has attention moved 6

towards more complex cases where order and universality can not be achieved in the 7

classical way.3 These cases are described as “worlds” which are too complex to be closed 8

and ordered according to one single mode or logic. There will only be partial orders which 9

are interacting in different ways, or interconnected and overlapping sub-worlds which are 10

ordered according to different logics.4 The interconnectedness of the sub-worlds means that 11

when one is trying to make order in one subworld by imposing a specific logic, the same 12

logic is making dis-order in another - an order also has its dis-order (Law 2003b; Berg and13

Timmermans 2000). Rather than alignment, stabilization and closure, the keywords are now 14

multiplicities, inconsistencies, ambivalence, ambiguities (Law 2003a, Law and Mol 2002). 15

Mastering this new world is not about achieving stabilization and closure, but rather about 16

more ad hoc practices - “ontological choreography” of an ontological patchwork (Cussins 17

1998). This approach has been applied to studies of cases such as train accidents (Law18

3 John Law and Annamarie Mol (2002, p. 1) define complexity as follows: “There is complexity if things relate but don’t add up, if events occur but not within the process of linear time, and if phenomena share a space but cannot be mapped in terms of a single set of three-dimensional coordinates.” This definition is very brief and rather abstract, but is in perfect harmony with Cillier’s definition presented above.

4 For more extensive demonstration of the logics of EPRs, see also (Gregory 2000, 2004).

10

2003a), a broad range of high-tech medical practices (Mol and Berg 1998), interdisciplinary 1

research [Star and Griesemer 1989]). This approach to complexity has also been applied to 2

analyzing the challenges, not to say impossibility, of achieving closure and stabilization in 3

relation to complex IS, and IS standards (Aanestad and Hanseth 2000).4

5

The evolution of ANT has brought it to closer affinity with the theory of reflexive 6

modernization (Beck et al 2003). The similarities between ANT and reflexive modernization 7

are observed by Bruno Latour when he states that a “perfect translation of ‘risk’ is the word 8

‘network’ in the ANT sense, referring to whatever deviates from the straight path of reason 9

and of control to trace a labyrinth, a maze of unexpected associations between 10

heterogeneous elements, each of which acts as a mediator and no longer as a mere 11

compliant intermediary” (Latour 2003, p. 36).5 From Beck’s perspective, the recent change of 12

focus within ANT signals a move from the first modernity to a second reflexive modernity,613

which is reflexive in the way that modern society itself is now modernized: the change is 14

happening not within social structures but to them. This leads to a “pluralization of 15

modernities” (Beck et al. 2003, p. 2): “ ‘meta-change’ of modern society results from a 16

critical mass of unintended side-effects … resulting from … market expansion, legal 17

5 The most substantial difference between the two is maybe the status they attribute to theories. Reflexive Modernization is presented as a theory in the classical sense which describes the world “as it is”, while ANT has adopted the ethnomethodological position and sees itself just as one “ethnotheory” having the same status as other such theories (Latour 2003).6 According to Beck two processes of modernization of our society can be distinguished: a first one called “first” or “simple” modernization, characterized by a stable system of coordinates as, for instance, the nation state, the gainful employment society - a concept of rationality that emphasizes instrumental control; a second one called “reflexive modernization,” characterized by a fundamental societal transformation within modernity which revolutionizes its very coordinates and calls into question its own basic premises (Beck 1999).

11

universalism and technical revolution“ (ibid. p. 2, emphasis in original)–what we normally 1

refer to as globalization. Beck defines “side-effect” more precisely as “effects that were 2

originally intended to be more narrow in their scope than they turned out to be” (ibid. p.2).3

4

The term “reflexive” connotes, in Bruno Latour’s interpretation, that “the unintended 5

consequences of actions reverberate throughout the whole of society in such a way that they 6

have become intractable” (Latour 2003, p. 36). Side-effects can thus be reflexive to the 7

extent they propagate through multiple, separate networks and finally become reflected -8

hence the term reflexive- back onto what initially triggered them. The end result can be one 9

that is the opposite of what was originally intended.7 In ANT terms, the propagation of side-10

effects results in the dis-ordering of networks created by an initial ordering action. 11

12

Standardization forms a key feature of modernization. Consequently, if the theories of Beck 13

and Giddens are valid, we should find reflexive processes unfolding in standardization. And 14

indeed, such examples are not hard to find – standardization is prone to escalated 15

processes of dis-ordering Hanseth et al. (2001), Ciborra et al. (2000), Ciborra and Osei-16

Joehene (2003), Rolland (2003). Hanseth and Braa (2001) in the context of corporate IT 17

standards, denote standardization vividly as “chasing the rainbow.”18

19

7 Reflexivity may be seen as a form of path-dependence. This concept has more recently emerged as influential within broader discussions of complexity theory. It has diffused from economics into other scientific fields – first historical sociology (Mahoney 2000), then sociology and social sciences more broadly (Urry 2003). Path-dependency in terms of self-reinforcing processes leading to lock-ins has been widely studied in relation to standards.

12

By the following case, we will narrate efforts to standardize an EPR system. This process1

qua standardization unfolded as a prototypical narrative of modernity, It can be interpreted2

as a control seeking process where the actors attempt to create a universal order by 3

enrolling heterogeneous elements, and thereafter translating and aligning them into one 4

closed and stabilized network. We will show how the orders that actors sought to create 5

were linked to multiple “worlds.” The ordering effects originating from each of these worlds 6

created disorders in others. The end effect was the undermining of the order-making and 7

increased disorder. This is what we will call “reflexive standardization”-that efforts and 8

actions taken toward standardization and stability lead to an opposite result. We standardize 9

in order to integrate, order and control a fragmented world, and to reduce its complexity – to 10

forge order out of chaos. Reflexive standardization, then, shows that when we try to achieve 11

order, and closeness, we get chaos, openness and instability.12

13

RESEARCH APPROACH AND SETTING14

The paper addresses the following research question suggested by the call for papers of the 15

special issue: what historical or contingent events and factors influence the creation of ICT 16

standards and in particular, their success and failure? By addressing this question, the 17

research focuses, in particular on three aspects, of standardization: 1) socio-technical 18

perspective on IS standards and standardization as outlined above, 2) identification and 19

analysis reflexive standardization processes, and, 3) interpretation of these processes with 20

the theory of reflexive modernization as discussed above.21

22

The socio-technical perspective provided us with conceptual lens that was valuable in 23

understanding and interpreting complexity associated with standardization. In particular, the 24

concepts of logics of ordering, orders, and dis-orders, provided a helpful sensitizing device to 25

13

interpret ordering processes of reflexive standardization. Theory of reflexive modernization, 1

in contrast has guided us discern of mechanisms of the standardization that create disorder: 2

how the uncertainties and difficulties with the standard implementation were not due to 3

external factors, but, in contrast, were internally and reflexively produced. By directing our 4

attention to the critical role of side-effects, and their production mechanisms we could thus 5

analyze how standardization situations were created that lapsed out of control. 6

7

We will examine these questions in the context of a case study that focused on the 8

development of a national standard EPR system and its initial implementation in the 9

Rikshospitalet in Oslo, Norway. This is a specialized University research hospital with 10

approximately 600 beds, 17 clinical departments, and approximately 3500 potential users of 11

clinical information systems. We studied both the intended and unintended consequences of 12

this standard implementation with a particular emphasis on the possible side-effects of on-13

going standardization actions.14

15

Research Design and Context16

The data for this paper were collected in the period 2001-2004. Other information is derived 17

from our previous collaborations between 1996-2001, where the EPR implementation was18

one topic for Master student projects and three master theses. Since 2001 the cooperation 19

has evolved into a structured research program with the purpose of studying the 20

implementation and use of clinical information systems in particular the EPR system. From 21

2001 up to the time of writing, the project has involved two professors, three post-doctoral 22

and doctoral researchers, and three Master students.23

24

14

The fieldwork has been structured as a longitudinal case study in order to follow the 1

implementation process in its various stages. To gain the valid knowledge for the case 2

analysis we grounded data analysis and collection in interpretive principles of case study 3

method (Klein and Myers, 1999; Walsham, 1993, 1995). In line with these principles the 4

focus of the research has evolved over time while the authors gathered and analyzed more 5

data which has influenced next round of data collections, and while the case progressed into 6

new stages. 7

8

As noted the case deals with developing an electronic patient ecord (EPR) that was 9

accompanied with the design and implementation of a specific product (called first DocuLive, 10

then IntEPR, then GlobEPR8) by Alpha Medical Solutions (the medical division of Alpha9), 11

as well as the adoption of this standard via the implementation at our study site. The EPR 12

was intended to be the electronic equivalent of the paper-based patient record. For decades, 13

EPR systems have been a major topic in the field of Medical Informatics internationally. 14

Their design, development, and implementation entail considerable complexity and 15

challenge (see e.g. Berg and Bowker 1997; Ellingsen 2002). In our study context, EPR 16

systems had for some years been widely used in general practitioners’ offices and in smaller 17

hospitals. Specialized and limited systems have also existed within single clinical 18

departments in larger hospitals. However, developing a hospital-wide centralized EPR 19

system, which involves standardizing the local systems and practices across clinical 20

8 The names of the product and the company have been disguised.

9 Alpha is a global multinational employing about 430,000 people generating revenue of over 75 billions Euros. Alpha is engaged in diverse industries such as healthcare, manufacturing, services, transportation and telecommunications.

15

departments, had proven to be a different task, not to mention efforts to develop generic 1

systems used in hospitals across multiple countries. 2

3

Research Methods and Data Analysis4

We gathered data from seven clinical departments (out of 17), and from the archive 5

department and the IT department by following theoretical replication. These clinical 6

departments were chosen using the implementation stage and department size as a 7

sampling criterion. Specifically, we sought to increase variance in these conditions and8

therefore gathered data from departments where the EPR system had been in use for a long 9

time, a short time, or where it was still under implementation. 10

11

We collected data with more than 35 formal interviews with 23 different employees of the 12

hospital including medical doctors, nurses, and secretaries in clinical departments, and 13

project leaders, heads of hospital units and senior managers in the IT department, including 14

the former CIO of the hospital. The interviews were semi-structured and lasted from one to 15

two hours each. Most interviews were audio recorded, while notes were taken as well. All 16

interviews were summarized and circulated within the research group, and key interviews 17

were fully transcribed. 18

19

Data were also collected in 18 in direct observations by participating in various discussions 20

and meetings, as well as from document analyses. The length of these observations varied 21

between two to eight hours. These observations covered, for example, tracing a patient 22

trajectory in or between clinical departments (and the production and use of information); 23

use of the paper-based and electronic patient record; observation of individual- and team-24

work in relation to information artifacts and IT support; observation of nursing activities and 25

16

use of information before and after implementation of the EPR (in the form of “shadowing”); 1

attendance at project meetings; attendance at EPR courses for user groups; and attendance 2

at preliminary meetings by the IT department and clinical departments before the actual 3

implementation.4

5

Regarding document analysis, we made use of primary and secondary sources. Primary 6

sources of documents included EPR project documents and other material produced mainly 7

by the managers of the IT department. We also analyzed policy documents and contracts 8

from the Norwegian consortium project. We had full access to the intranet of the IT 9

department which contained relevant documentation on the department’s budget and 10

strategic plans. The main secondary source of documental information comprised the 11

fieldwork reports and theses written by Master students during the period 1996-2001, and 12

reports, articles and theses written by members of the EPR research group since 2001. 13

Finally, relevant data were gathered during numerous meetings between members of the IT 14

department of Rikshospitalet and the research team. A weekly meeting of the EPR research 15

group was organized to discuss fieldwork, preliminary findings and further research 16

activities. The head of research of the hospital IT department joined these meetings at least 17

once a month, providing continuous updates on the ongoing activities in the project and 18

proposing new themes of research.19

20

Finally, we note limitations of our fieldwork. We recognize that the fieldwork could have been 21

extended to both the software company and to other hospitals implementing the same 22

system. We approached the software company but could not reach an agreement regarding 23

participation in the research. We intentionally decided to focus the fieldwork on the one 24

17

hospital discussed herein. Through our contacts to other researchers throughout Norway, we 1

were updated on the progress of concurrent implementations in the other hospitals involved. 2

3

DETAILED CASE DESCRIPTION 4

In Norway, work on the definition of a national standard for EPR’s started in the late 1980s. 5

A new organization called the Competence Center for IT in Health Care (with the Norwegian 6

acronym KITH) was established with standardization (definition as well as adoption) as its 7

main responsibility. It aimed at defining EDI (Electronic Data Interchange)-based8

communication standards for routine message exchange (e.g., lab orders and results, 9

prescriptions, admission, and discharge letters), closely linked with the work of CEN TC2511010

to which the EU commission had delegated the responsibility for development of European 11

IT standards for health care.12

13

In the early 1990s, two of the five Norwegian regional university hospitals and a small 14

Norwegian software company initiated a project aimed at developing an EPR system called 15

MEDINA. A project manager from KITH was hired. At this time KITH also started work on the 16

specifications of the Norwegian standard for EPR systems (KITH 2004), conforming to the 17

Norwegian standard for the paper record (Statens Helsetilsyn 1993) and the CEN EPR 18

standards as closely as possible. In 1996, the project enrolled the Rikshospitalet and the 19

other two regional university hospitals not already involved, whihc produced a consortium of 20

the five largest hospitals in Norway (see figure 1 to follow the timeline). This led KITH to see 21

10 CEN is the European branch of the International Standardization Organization (ISO).

18

this project as an important opportunity to develop a standardized Norwegian EPR system–1

not only a specification of some of its elements. To do so, they wanted to merge MEDINA 2

with another system DocuLive, which had been developed for about a decade, and had 3

been hosted by several software companies. Recently it had been acquired by Alpha-4

Norway. After the project organizations were merged, Alpha, as the largest and financially 5

strongest company, eventually bought MEDINA from the other vendors and took over the 6

entire product development project. 7

8

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Figure 1 The Timeline of products, projects, and events for our case11

12

19

In the new project, Alpha keept the DocuLive name and the deadline for the delivery of the 1

finalized system was set for the end of 1999.11 The DocuLive project started with the best 2

intentions of involving users, acknowledging current work practices, and favoring a bottom-3

up development strategy. Yet, as the number of involved users grew, large-scale 4

participatory development became unmanageable. After a few years, only a small number of 5

user-representatives from each hospital continued to actively participate in the development. 6

Moreover, the need to continuously find common agreements between the hospitals turned 7

the intended bottom-up approach into a top-down one.8

9

Overall, the strategy of the DocuLive project can be summarized as follows:10

The EPR should be developed to satisfy the needs of the five regional university 11

hospitals (with the implicit plan that with the successful completion of the project, the 12

EPR would also satisfy the needs of all other hospitals in Norway and accordingly 13

would be adopted by them). 14

The EPR should be “complete,” i.e., include all information about a patient.15

The EPR should be realized as one shared, integrated IS for all departments.16

17

This joint project between the five hospitals and Alpha was terminated early in 2004 without 18

the realization of the initial goal: the implementation of a complete EPR system. The version 19

of DocuLive currently in use has limited functionality in comparison to the project’s aims. 20

11 Ellingsen and Monteiro (2003a) have outlined the overall history of DocuLive from the early 1980s. They analyze other aspects of complexity in the Norwegian EPR project than those on which we focus in this article (Ellingsen and Monteiro 2003b).

20

Eventual further development of the system, at the time of writing, is regulated by separate1

contracts between the vendor and the individual hospitals. At the regional level, four of the 2

five regions in Norway (including the one which contains Rikshospitalet) have decided to 3

standardize on other EPR systems than DocuLive.4

5

The focus of our study is to analyze the role of one important factor behind the failure: 6

complexity. We have organized the empirical material into four stories. Each of them will be 7

on one or more of the “modes of ordering” exemplified by the strategy elements mentioned 8

above. The purpose of each is to illustrate how efforts aimed at making order interfered with 9

conflicting orders or order-making, ultimately producing more dis-order.1210

11

Alpha and the Stabilizing of the Scope of the Standard12

The first story focuses on the role of Alpha in relation to the shaping of the project trajectory. 13

Alpha is a large company and its international orientation challenged the stabilization of the 14

Norwegian standard and the creation of the EPR system. 15

16

When the project started in 1996, it was strongly expected to have the economic, political, 17

technical and medical capacity, both in terms of support and competence, to establish a 18

national standard EPR system in Norway. In the end, this did not happen because the 19

project evolved in unexpected directions. Shortly after the DocuLive project began, the IT 20

managers of Rikshospitalet became aware that Alpha UK was also engaged in EPR 21

12 The reader should refer to the timeline figure above to better follow the unfolding of the four stories.

21

development. Asking Alpha Norway for more clarification, they found out that within Alpha, 1

several EPR development projects co-existed: at least five EPR projects were underway in 2

Sweden, UK, Germany, India, and Norway respectively. The IT department at Rikshospitalet 3

realized that the Norwegian project was not at the top of Alpha’s priorities since Norway 4

represented the smallest market. Within Alpha, the DocuLive project ran the risk of being 5

overrun by other internal projects for more profitable markets. As a consequence, the project 6

consortium, together with Alpha Norway, decided to make the first move to internationalize 7

the project, first to a Scandinavian level, and later to a European one. 8

9

A senior IT manager commented:10

Alpha decided and the hospital agreed to internationalize the product. At that time 11

there were different competing systems within the Alpha company. We saw potential 12

danger to our system and our development and requirements. We supported Alpha13

in bringing this up on the corporate level and getting DocuLive and the Norwegian 14

product to become a main product for Alpha internationally. Because that would 15

secure further development on our system. It was a strategic decision.16

17

The strategy of the consortium was to push the project to a larger dimension in order to 18

secure its continuity. On the other hand, this decision weakened the hospital consortium’s19

position with respect to Alpha, since now it was not the only client with system requirements. 20

Requirements from all other EPR projects in Alpha had to be merged and a new architecture 21

had to be designed. Furthermore, since the original deadline for the final delivery (1999) was 22

approaching, the project consortium agreed with Alpha to extend the time frame to include 23

the development of the new internationalized EPR solution (called IntEPR).24

25

22

At the time the IntEPR project started in 1999 (see timeline in Figure 1), Alpha decided to 1

acquire AMS (American Medical Systems13), a large US software development company. As 2

a consequence, the scope, resources, and balance of the Alpha medical division changed: 3

the division’s headquarters was moved from Europe to the US, and the project’s scope 4

became global. In this scenario, the project consortium supported Alpha to internationalize 5

IntEPR. However, as the project became global, the IntEPR architecture was dropped in 6

favor of a new system called GlobEPR. The basic requirements previously defined for the 7

Norwegian customers of DocuLive, were partly supported by the new architecture. 8

9

From this story we can see the meeting of two different “worlds,” each with their own mode 10

of ordering: the one of the Norwegian project for the Norwegian hospitals, and the one of 11

Alpha and its international scope. To Alpha, achieving economies of scale by targeting12

international markets is a key concern. In addition, the medical division within Alpha is large, 13

with a traditional base within medical imaging technologies. As the imaging instruments have 14

become digital, supplementary software systems have been built. As the EPR development 15

activities were increasing within Alpha, it became more and more important to align and 16

integrate the EPR strategy and product(s) with other Alpha products and strategies.17

18

Within this world, Norway becomes marginal, as the appetite for larger markets escalates in 19

a self-feeding process. From the Norwegian point of view, the original interest in creating a 20

Norwegian standard had to be reinterpreted in a Scandinavian, then European, and finally 21

13 The name of the company has been disguised.

23

global context. A side-effect of the expansion of ambitions and scope was increased 1

complexity: the larger the market Alpha was aiming at, the more diverse the user 2

requirements, and accordingly, the more complex the system had to be in order to satisfy 3

them. This implied that the development costs were growing, which again implied that a 4

larger market was required to make the whole project profitable.5

6

The Complete EPR7

In our second and third stories we look more closely into the implementation process inside 8

the hospital. The efforts aimed at replacing the fragmented paper-based record with a 9

complete and smoothly integrated electronic one turned out to be more challenging than 10

foreseen. In the end, the volume of paper records increased (second story) and the patient 11

record became more fragmented (third story). This in turn increased the overall complexity 12

and consequently slowed down the standardization and implementation processes.13

14

Before 1995, the main problem at Rikshospitalet (as well as most other hospitals) was the 15

fragmentation of the medical record system: each department had its own record archive. If 16

a patient was admitted to several departments, several records would be created, each one 17

containing its specific information. In addition, various smaller local information systems, 18

partially overlapping with the paper records, were in use. In this picture, a long time might be 19

needed to retrieve critical information on patients. This could lead to situations where critical 20

decisions were made without possessing vital information contained in all the relevant 21

medical records.22

23

In 1996, the same year as the DocuLive project started, Rikshospitalet standardized and 24

centralized its paper-based patient records according to the principle: one patient, one 25

24

record. The new centralized paper standard followed the recently published Norwegian 1

guidelines for paper-based patient records. This centralization process was not without 2

problems. In particular, a major complaint was familiar: the long time needed to retrieve a 3

patient record from the central archive. Doctors also complained that, due to the 4

centralization, the merged patient records had become less easy to browse quickly, as a lot 5

of the information was not relevant to their specific interests. In this situation it was widely 6

assumed among doctors, as well as IT people at the hospital, that a standardized, complete7

EPR system would make information instantly available anywhere at anytime, as well as 8

avoid duplication of information and inconsistency of data. 9

Basically, the aim of the DocuLive project was to replicate and replace the recently 10

standardized and centralized paper-based patient record. 11

12

However, at the time of writing (autumn 2004), a full transition from the paper to the 13

electronic record has not yet been accomplished. The DocuLive system mainly contains 14

textual information, while much other information is still on paper forms (lab results, radiology 15

reports, images and other printouts from various equipment). 16

17

A manager from Rikshospitalet’s IT department helped to quantify the situation: “Currently 18

DocuLive covers about 30-40% of information contained in an average paper-based record. 19

Basically most of the information is text.”20

21

From an October 2002 internal report, we found an even more pessimistic estimate of 22

DocuLive’s coverage:23

[It] covers 18 of a total of 66 document groups defined in the Norwegian standard for 24

the paper patient record. In terms of volume – with a high degree of uncertainty – that 25

25

accounts on average for about 10% of the total volume of a paper-based record.1

(Translated from Norwegian by the authors)2

3

Although the implementation of the EPR aimed at reducing paper and eventually replacing 4

the paper system, the paper-based record still remained an important tool. Paradoxically, the 5

production of paper documents increased markedly after the implementation of DocuLive. 6

First, new laws on medical documentation required detailed records from professional 7

groups not previously obliged to maintain a record, such as nurses, physiotherapists and 8

social workers. Second, for legal reasons the hospital kept the paper version of the record 9

updated. Thus, each time a clinical note was written in the EPR, a paper copy was also 10

printed and added to the paper record. Printout efficiency was not a design principle for the 11

current EPR, causing non-adjustable print layouts that could result in two printed pages for 12

one electronic page form. Third, multiple printouts of preliminary documents (e.g. lab test 13

results) were often stored in addition to final versions. The result was that the volume of 14

paper documents increased. This growth created a crisis at the paper record archive 15

department. The hospital had moved into new facilities designed with a reduced space for 16

the archive as it was supposed to handle electronic records only. In 2003 the archive was full 17

and more than 300 shelf meters of records were lying on the floors. This situation also 18

affected the time needed to find records, and often requests failed to be satisfied.19

20

From an internal report:21

In .. 2002 a daily average of 790 requests for paper records were received. … About 22

half of the requests did not turn out as an actual delivery. There are several reasons 23

for this. The most common are that the record has already been delivered in another 24

department or has already been collected; that it is not possible to locate the record25

26

(due to wrong archiving); or that the archive never had the record for that patient 1

(usually because it is a new patient). (Translated from Norwegian by the authors)2

3

To alleviate this situation, a scanning project was started in 2003, with the aim of reducing 4

the amount of paper documents sent to the archive. However, even after the documents 5

were scanned they had to be kept. One reason was that DocuLive’s storage solution was not 6

yet accredited; for that one had to wait for release and implementation of a new version of 7

the software. Another reason was that the existing communication and coordination of work 8

practices were based on a flow of paper documents, and DocuLive did not (yet) contain 9

functionality that would allow the paper to be removed from the daily work practices. The 10

result is that the benefits from the scanning activities were slow to be realized.11

12

This story may be seen as a confrontation between what we might call “the order of 13

computers” and “the order of paper.” Computers, we can argue, are best exploited if they are 14

allowed to work the way that fits them best: where all information is stored in a shared, 15

consistent and non-redundant database. However, the paper record is ordered according to 16

different principles in order to also be an efficient tool for local work practices, and the 17

assumption that all patient related information could be ordered according to the “computer 18

order” has not yet been proven. At best, the transition period from paper-based to digital 19

information will be long. During this period the electronic and the paper-based record have to 20

coexist and “cooperate.”21

22

One Record (per Patient) - One (Integrated Information) System23

The third story focuses on the relation between the new EPR system and the other clinical24

information systems in the hospital. When the implementation of DocuLive started, a few 25

27

local systems containing clinical patient information already existed. Those systems were 1

often overlapping with DocuLive’s (planned) functionality. The original plan as revealed by 2

project documentation was to replace these with DocuLive so as to have the EPR as one 3

integrated information system:4

5

[DocuLive should] create a common platform for a multitude of customized EPR 6

modules,7

[be] powerful enough to support all health-related information and legal aspects8

[be] general enough to serve as a basis for a wide variety of hospital information 9

systems …10

(Technical Overview Document, 1998, translated by the authors)11

12

In this story, again the project’s ambitious plan ended up producing the opposite outcome, 13

which contributed to intensifying the degree of fragmentation of the medical record. The 14

main ordering principles for achieving the integrated record were that there should be one 15

record for each patient, containing all patient related information, that this record should be 16

shared among all units within the hospital, and that all patient records should be maintained 17

by and stored in one single integrated information system. In order to achieve this, DocuLive 18

was planned to be integrated with a few other systems: the central Patient Administrative 19

System (PAS), and certain “information supply” systems, notably laboratory systems that 20

store and deliver laboratory test results, and image archives for radiological images. The 21

idea of entirely substituting the other local EPR-like systems was slowly abandoned. Firstly, 22

to include the functions of all these systems into the EPR would have made its development 23

unmanageable. Secondly, users generally perceived local systems to better support their 24

28

work routines and refused to give them up. For instance a doctor in pediatric cardiology 1

stated referring to a local system:2

3

If you have congenital heart defects it is very likely that you have also other 4

congenital defects. So it is a very complex logistics of patients. These two reasons, 5

the very detailed diagnostics, and the need of keeping track of the patient are the 6

bases for the design of our system.7

8

Rather than replacement, various solutions for technical integration of DocuLive with some 9

of the local systems were considered. These intentions were realized only for a few systems, 10

leading to a situation where users had to either perform double entries or cut and paste 11

information between the systems. Simultaneously the number of specialized information 12

systems were growing, based on well justified needs of the different medical specialties and 13

departments. For example, the in-vitro fertilization clinic needed a system that allowed them14

to consider a couple as a unit, as well as allow tracking of information from both semen and 15

egg quality tests through all procedures involved, up to the birth of the child. The intensive 16

care unit acquired a system that allowed them to harvest digital data from a vast array of 17

medical equipment and thus eliminate the specialized paper forms previously used to 18

document events and actions. Moreover, new digital instruments in use in many different 19

departments include software components with medical record functionality.20

21

Hence, the envisioned role of DocuLive has changed from being the only system to being 22

one among a large (and increasing) number of systems (see figure 2: from “Original Vision” 23

to “Later Vision”). As the problems and the challenges with the original integration strategy 24

emerged, the popularity of the Internet and its technology triggered the IT department at the 25

29

hospital to start thinking about other potential strategies. It started tinkering with portal 1

technology, and this led to the idea of an integrated EPR system achieved by means of a 2

more loosely coupled infrastructure where the many clinical and laboratory systems (and 3

DocuLive itself) were brought together under the common umbrella of a portal (see figure 2: 4

“Current Vision”). The portal was part of a larger change in strategy which went under the 5

acronym CSAM: Clinical Systems All Merged. Thus, while visualization and access to the 6

systems were integrated, the systems themselves did not need to be integrated with each 7

other.8

9

Original vision Later vision Current vision

PAS

LabSystem

LabSystem

...

LocalEPR

LocalSystem

LocalEPR

LocalSystem

DocuLive ”Umbrella” PAS

LabSystem

LabSystem

...

LocalEPR

LocalEPR

LocalSystem

LocalSystem

DocuLive ”Umbrella”

All systems integrated within DocuLive Some Systems integrated(loosely or tightly)

PAS

LabSystem

LabSystem

...

LocalEPR

LocalSystem

LocalEPR

New Portal ”Umbrella”

DocuLive

Variable levels of integrationunder the New Portal

10

Figure 2 Three stages of the envisioned role of DocuLive11

This story shows, again, how the world of DocuLive and its order was confronted with other 12

worlds with different orders and ongoing ordering processes. Different medical specialties 13

30

focus on different types of information (this being even truer in the case of specialized or 1

tertiary hospitals like the one in this case). The ordering principle of “one patient – one 2

record” is non-problematic for many, but may interfere with and create dis-orders for others. 3

As a result, the attempt to achieve a tightly coupled integration of systems (in the view of the 4

logic of ordering of DocuLive) clashes against different logics which reflect the actual 5

complexity and diversity of the work practices to be standardized. From this clash–this 6

interference of orders–comes the generation of a new logic, implicit in the portal strategy 7

CSAM.8

9

To a certain degree, the novel portal strategy appears promising. It is a less strict and 10

accordingly a more flexible way of standardizing and ordering. It seems more likely that this 11

IS strategy can deliver a “complete” system for accessing information. To implement such 12

strategy is far from trivial or without risk. It entails further development work, as adapters13

need to be developed between the portal software and the different applications. Moreover, 14

the laws and regulations concerning documentation of patient information are clearly based 15

on the envisioned all-encompassing EPR. One complete patient record is recognized to be 16

the legal document, while the idea of keeping information in different sources as the CSAM17

strategy proposes is legally problematic: not all of the underlying systems are designed with 18

adequate security of patient data in mind; therefore they do not conform to the standards of 19

the privacy laws, neither when it comes to access control solutions nor long-term storage of 20

confidential data.21

22

The Role of the Regional University Hospitals Revisited23

The fourth story describes how a health sector reform in Norway interfered with the ongoing 24

EPR standardization process. When the DocuLive project started, new procedures and 25

31

technologies were usually developed or first adopted by the five university hospitals, and 1

subsequently by the other hospitals. The standardization of the EPR was expected to follow 2

this pattern, but a major reform in the health sector, initiated in 2001, affected the 3

standardization process significantly.4

5

Before the reform, the hospitals in Norway were owned by the country’s 19 counties. There 6

was a widely held view that the health system was too fragmented, did not encourage 7

smooth collaboration and did not maintain a rational division of labor. The reform implied that 8

the government was taking over the ownership of all hospitals by means of five regional 9

health enterprises, which again owned the individual hospitals. The reform significantly 10

altered the dynamics in the sector. As a health enterprise, each region had to define cost-11

efficient and effective strategies to realize benefits of scale. A key concern was then to 12

standardize on IT, and specifically to select one standard EPR system among the three 13

systems in use. Inevitably, this created competition among the hospitals for each to have its 14

own EPR system prevail over the others.15

16

At this point the DocuLive system progressed slowly due to continuously emerging new17

elements and demands originating from Alpha’s activities and shifting strategies. In this 18

situation, the IT department at Rikshospitalet attempted to market DocuLive as the standard 19

system to be adopted by other hospitals, even though its development was far from 20

complete. Moreover, Rikshospitalet sought to become the reference center for delineating 21

and implementing regional IT strategies. However, this strategy of promoting DocuLive was 22

soon changed, as the IT department at Rikshospitalet acknowledged its rather weak position 23

in the regional “battle of systems” (Hughes 1983). Accordingly, they made a strategic move, 24

promoting the portal concept rather than DocuLive. This turned out to be a more flexible and 25

32

robust strategy in order to enroll the other hospitals in the region into a collaborative rather 1

than competitive standardization effort. The strategic move to promote the portal strategy 2

also implied that DocuLive was “buried” as “the standard” EPR (although not as product).3

4

ANALYSIS AND DISCUSSION5

In this section we discuss the complexities that this case exhibits, and identify three research 6

contributions. First, we show the socio-technical complexity of IS standardization by 7

highlighting how the standardization was shaped by the different orders, multiple actors at 8

play and the interferences between orders. which created dis-orders. Second, by analyzing9

how dis-orders may undermine the creation of a possible stable ordering logic or solution 10

and of a closure of the standard, we show how this complexity generates reflexive 11

mechanisms. We call this phenomenon reflexive standardization. Third, we discuss how the 12

reflexive mechanism is an instance of the complexity inherent in IS standardization, and we 13

contrast our findings with traditional approaches to IS development and standardization.14

15

Interference and Propagation of Side-effects16

The four stories presented above provide an account of the multiplicity of perspectives, 17

intentions, constraints, challenges, and agendas at work in the socio-technical network of the 18

standardization process. As Law points out, orders are not “simply told, performed and 19

embodied in agents, but rather they speak through, act and recursively organize the full 20

range of social materials” (Law 1994, p. 109). This perspective helps us to go beyond the 21

intentionality of single actions and to see how ordering logics are embedded in 22

heterogeneous social networks. Thus, their character is contingent and, in part, a matter to 23

be determined empirically (Law 1994). 24

25

33

Different orders interact with and re-organize one another: they may create dis-orders, or 1

reinforce existing orders. While it is true that standardization processes may eventually 2

stabilize- we have a large number of standards embedded in our practices- this case 3

suggests that, under certain circumstances, interferences between orders will reflexively 4

produce additional interferences with greater complexity that will ultimately destabilize the 5

initial order. 6

7

In the first story we see how the two main actors, Alpha and the Norwegian EPR project, 8

mutually and iteratively redefined their aims, strategy, and design of the standard as the 9

project gradually escalated to a global level. The overall result of this dance of orders and 10

redefinition of interests was that the Norwegian standardization project, as initially 11

conceived, did not succeed. The second story highlights conflicts between (the order of) the 12

electronic patient record and (the order of) the paper-based record. As a result, the strategy 13

for creating an integrated record created, as an unintended consequence, a more 14

fragmented one. The third story illustrates how the ordering principle of “one record (for each 15

patient) – one integrated Information System” created dis-orders in terms of making it more 16

difficult for workers to have easy access to the specific information they needed. The final 17

story illustrates how a new order enforced by the government interfered with the ordering 18

principles of the project. 19

20

The failure of DocuLive, at least as a standardization story, can be seen as a failure in 21

attempting to control complexity. Arguably, the main mistake was to follow a “traditional” 22

standardization approach–typical for (first) modernity that is, overemphasizing criteria of 23

universality, uniformity, and centralization of control to achieve alignment, stabilization and 24

closure. In line with our theoretical framework, our case data suggest that the complexity 25

34

defines standardization as the emergence of multiplicities, inconsistencies, ambivalence, 1

and ambiguities (Law 2003b, Law and Mol 2002). Ironically, what happened became the 2

opposite of the initial aims. When actors tried to stabilize the standard by enrolling more 3

actors, this made it less stable. Attempts to improve fragmented records by means of one4

integrated EPR made the records more fragmented. The complexity of DocuLive turned out 5

to be one where the ordering efforts created dis-orders. The side-effects triggered new ones, 6

which again were reflected back on the origin–the standardization process turned out to be 7

reflexive and self-destructive. The dynamics of reflexive processes at work are summarized 8

in figure 3.9

More varied and complex work practices to be supported

More complex and fragmented IS portfolio constituting the EPR

More complex EPR product

More fragmented medical record

Larger market to get economies of scale

10

Figure 3 The reflexive standardization process11

The concept of reflexivity offers thus an interpretation of the dynamics of the case. The 12

theory of “high” modernity helps to observe how the logics of the “first” industrial modernity 13

find their limits (Beck et al. 1994). The intensified interconnectedness of social practices with 14

technical artifacts on the one hand, and the need to align geographically dispersed actors on 15

the other hand, effectively undermines the reductionist approach to control complexity. The 16

35

weakness of such approach become visible when the control itself reflexively reproduced the1

complexity- thus creating the immanent paradox of modernity Reflexive standardization 2

seeks to highlight the need to develop alternative standardization approaches that better 3

overcome the paradoxes to deal with complexity as pointed out below.4

5

On the Validity of the Case Analysis6

We have so far attributed the failure of the standardization effort to the inherent complexity of7

the standardization process and the ways in which how such complexity was addressed. But 8

this may not be the only possible explanation. It may be argued that the effort failed because 9

of poor project management, insufficient user participation, incomplete requirements 10

specifications, bad decisions, historical circumstances like stupid people, following wrong 11

standardization approach, and so on. In our view, a standardization effort like the one 12

described here almost never fails for one reason only. We do believe that the EPR project 13

management followed strategies and made decisions that were well in line with “best 14

practices” in software engineering, based on traditional standardization models. Without 15

doubt, questionable decisions were made. Yet, we think that improved user participation or 16

requirements specifications would not have saved the effort. In the similar vein sophisticated 17

risk management methods would not have been of much help, rather they, most likely, would18

have added to the overall complexity and triggered new reflexive dynamics. In fact, when 19

dealing with complex phenomena we will always be confronted with unpredictable events 20

and problems (Perrow 1999). We think that a different approach to complexity could have 21

improved the chances of a successful standardization effort. Still, the people involved are not 22

to blame. Rather, we submit, the problem is the poor understanding of complexity and 23

standardization within the software engineering, information systems, and standardization24

fields.25

36

1

With regard to the external validity of our case, we can ask: is our case representative of a 2

new class of standardization problems? We believe so, especially in the health care domain 3

where plans for developing electronic health records grow continuously bigger and more 4

ambitious. For example, in his 2004 State of the Union address, George W. Bush Jr. 5

envisioned “an EHR for all Americans within the next decade” (The White House, 2004). In 6

addition, to building a national health information infrastructure, establishing data 7

interoperability and comparability for patient safety data is seen as crucial. This is expected8

to be facilitated through adopting standards that allow medical information to be stored and 9

shared electronically while assuring privacy and security. Similarly, the British “Connecting 10

for Health” initiative proposes to establish the NHS (National Health Service) Care Record 11

Service. For each individual patient the Patient Clinical Record will be used to deliver direct 12

patient care, and in addition a centralized database (“The Spine”) will contain a National 13

Summary Record in order to support urgent and emergency care (NHS, 2005). For both 14

initiatives, huge challenges can be recognized and critical voices emanating from our 15

analysis can predict significant obstacles. However, from official documents and 16

presentations of these projects, the general perception of standards is the value of increased 17

control: developing and adopting standards is definitely seen as part of the solution, rather 18

than part of the problem.19

20

We do not claim that standardization of medical information systems is impossible or 21

undesirable. Because our case study site is a specialized hospital, it represents a 22

paradigmatic example of the socio-technical complexity arising from the close intertwining of 23

technical standards with local and highly professional work practices (in terms of 24

professional disciplines and geography). To some extent our case represents a general25

37

class of problems associated with the interactions between the complexity of information 1

infrastructures, information processing, and local work practices. Thus, the common shared2

complexity in these classes is the immense heterogeneity and multiplicity of actors involved3

and the need to coordinate and standardize their behaviors. Not surprisingly, challenges 4

associated with complexity similar to those described here, have been recently identified in 5

multiple areas including Enterprise Resource Planning (ERP) systems, corporate IT 6

infrastructures in the oil and chemical industry (Hanseth et al. 2001; Ciborra et al. 2000), the 7

financial sector (Ciborra and Osei-Joehene 2003), ship classification (Rolland 2003), and e-8

government (Ciborra 2003). All these are responses to a “quest for integration” (Dechow 9

and Jan Mouritsen, in press) and will unavoidably lead to increases in IS complexity. 10

Accordingly, we believe that the reflexive processes as illustrated here will grow in number 11

and importance.12

13

Implications for Research and Practice14

What are the implications of our findings for practice? Significant research efforts into the 15

complexity of IS standards and their dynamics are called for before detailed concrete advice 16

can be given. We agree with the authors of the British Computer Society 2004 (BCS 2004) 17

report that complexity is the single most important issue for software engineering and 18

information systems design. Research on the “duality of standards” regarding complexity, 19

i.e., how standards may reduce as well as increase complexity, forms an important part of 20

this. We need also further research on specific reflexive effects of complexity in different 21

situations. Here, we will offer only tentative answers to this question. In doing so, after22

Perrow (1999) we assume that identified problems are inherent to complex systems and 23

better structured methodologies or management tools for control will not solve them. To 24

address such problems, we have to seek to avoid creating complex systems. 25

38

1

Avoiding the kind of socio-technical complexity we have pinpointed may be possible by, first 2

resisting the temptation to gain perfect order. The case study of the development of an EPR 3

standard illustrates that traditional engineering approaches are risk prone in complex areas 4

like designing technologies that span across multiple work practices. These approaches tend 5

to overestimate the universality of work practices, thus seeking order by simplification and 6

abstraction and thus laying strong emphasis on design criteria such as consistency, 7

completeness, and non-redundancy. These are all sound engineering principles and central 8

to modernity. These criteria have been explicitly emphasized within the development of IT 9

standards for health care (De Moor et al. 1993, McDonalds 1993),. They all work well if we 10

can start out by delimiting a part of the world that can be treated as closed and in isolation.11

But they can become a risk, if and when such assumptions do not hold as identified in12

failures of IS-related standards in various areas (Graham et al.1995; Graham et al. 1996; 13

Hanseth et al. 1996; Hanseth and Monteiro 1997; Hanseth and Braa 2001). In the case of IS 14

standards-making, the more the object of standardization is close to local work practices, 15

and the more knowledge-intensive the work practice is (e.g. a specialized hospital), the less16

likely the traditional approach is to succeed, possibly generating a reflexive self-destructive 17

process. AS Law (2003a, p. 14) notes: “[T]he search for system perfection is not only 18

impossible but, more strongly, it may be self defeating” (Law 2003a, p. 14). We need to 19

accept in our standard making that our complex worlds are populated with a multiplicity of 20

orders that are inconsistent. We need to be able to live with such multiplicities and 21

inconsistencies–we need to master the trade of what Charis Cussins (1998) calls 22

“ontological choreography.”23

24

39

Another key element of a strategy accepting a multiplicity of orders is to identify sub-worlds 1

which can be properly ordered and which are interfering with each other as little as possible, 2

i.e., making sub-worlds that are loosely coupled (Perrow 1999). Maintaining loose coupling 3

between the social and the technical is perhaps the most important strategic element. And 4

what should be avoided is the embedding of specific working practices into the standards. 5

To do so, one needs to be well aware of the local specificity of work practices, and the fact 6

that the practices are embedded into the technology. 7

8

Another way to reduce socio-technical complexity is to reduce the organizational complexity9

that results from the large number and heterogeneity of actors and their interdependencies. 10

This is caused by the reach and range (Keen 1991) of the standard, which we see as a key 11

source of its technical complexity. One strategy to reduce the scope is to split the standard12

into separate and independent packages, each of which has a more restricted reach and 13

range. Rather than one universal standard in which the elements are tightly coupled, we 14

should aim at a multiplicity of simpler standards that are loosely coupled. Such loose 15

coupling between standards and infrastructures based on them can be achieved by means 16

of gateways (Hanseth 2001). In the domain of EPR systems this means that one should 17

develop separate systems for different countries, and that these systems could be further 18

split up into individual systems for specific medical specialties or hospital departments or 19

functions. Different medical record systems in a hospital can then be integrated either by 20

sorts of gateways enabling the exchange of shared data between them, or by means of a 21

portal which provides a shared interface towards all of them.22

23

Complexity is a vague term. It is hard to measure. We have learned in both the natural and 24

social sciences that everything is indefinitely complex when we look at it carefully – if we 25

40

“open the black box” (Latour 1988). Black-boxing is a strategy for reducing complexity which 1

is closely related to modularization. It is indeed a potentially powerful strategy, but it works 2

well only under conditions of stability. A simple description of a complex system (in terms of 3

an interface or an abstract specification) may be sufficient for a specific purpose. However, if 4

the complex system is changing or the needs change, the simple description may not be 5

appropriate any more. From this we can derive another strategy to reduce complexity: look 6

carefully for elements in the world -medical practices, instruments, ICT solutions- that will not 7

change. These are the elements that may be black-boxed, ordered and turned into 8

standards.9

10

The points made above can be illustrated by contrasting DocuLive on the one hand and the 11

portal on the other. The portal strategy is certainly very promising in terms of its robustness 12

and flexibility. Its guiding principle is loose coupling between the different parts of the EPR 13

system in contrast to the tight coupling strategy of DocuLive where all information was stored 14

in one shared data base and all functions integrated into one single software system. The 15

portal strategy potentially makes it easy to include any kind of information and illustrations 16

produced by new IS into the electronic record. For the time being, this strategy also 17

embodies its risks. We do not know much about the long-term requirements of such portal 18

and how to structure and design it. Such a portal can also be complex as more applications 19

are integrated and its sophistication grows. It may become so complex that reflexive 20

processes are triggered.21

22

CONCLUSION23

In this article, we have argued that (1) socio-technical complexity is a major issue in 24

information system standardization. (2) Through a case study of EPR standardization critical25

41

dynamics related to this complexity relate to reflexivity. (3) Reflexivity (Beck 1994) explains 1

how under certain circumstances, efforts aiming at reducing complexity through 2

standardization may generate the opposite outcome. The circumstances described by the 3

case represent a paradigmatic example of increased intertwining of technical standards with 4

local, heterogeneous and dispersed work practices. Through our analysis we argue that 5

traditional standardization approaches can not deal with such complexity appropriately. Not 6

only will such approaches fail to not deliver the intended outcome- order-; they can also lead 7

to the opposite effects of greater dis-order, and instability. The need of future research on IS 8

standardization, is therefore critical in approaches that help mitigate the increasing 9

complexity IS standardization.10

11

Acknowledgements12

We would like to thank the IT department of Rikshospitalet, Oslo, Norway. We owe special 13thanks particularly to Ivar Berge and Arve Kaaresen for setting up the research project and 14for the long-lasting research relationship. We thank Eric Monteiro, Marc Berg, Geoff 15Walsham, Judith Gregory, Sundeep Sahay, Ola Henfridsson and the participants in the 16Workshop on Standard-Making organized by MISQ in Seattle for providing useful comments 17on earlier versions. Special thanks go to two anonymous reviewers, the editorial board, and 18the senior guest editors of the special issue for their insightful comments and 19encouragement.20

21

.22

23

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19

Author Biographies20

21Ole Hanseth, PhD, is Professor in the Department of Informatics, University of Oslo. His 22research focuses mainly on the interplay between social and technical issues in the 23development and use of large-scale networking applications. He is also Visiting Professor at 24London School of Economics, Department of Information Systems.25

26Edoardo Jacucci, MSc, is a PhD candidate at the University of Oslo, in the Department of 27Informatics at the Information Systems Group, Oslo, Norway. His research focuses on socio-28technical conceptualizations of standards and on processes of standard making in the health 29

49

care sector in Norway and in South Africa. He received his MSc degree in Information 1Systems Engineering at the Politecnico di Milano, Italy.2

3Miria Grisot, MA, is a PhD candidate at the University of Oslo, in the Department of 4Informatics at the Information Systems Group, Oslo, Norway. Her research interest is on 5issues of coordination related to the implementation of IT in hospitals. She holds a MA in 6Political Science from the University of Bologna, Italy.7

8Margunn Aanestad, PhD, holds a post Doctoral position in the Department of Informatics, 9University of Oslo. She worked within health care and telecommunications before her 10doctoral study of surgical telemedicine. Her research interests are broadly related to IT in 11health care.12

13