| 1 | = The Origins of openEHR = #dsy20-OE |
| 2 | |
| 3 | * [http://www.openehr.org/about/origins.html#dsy20-OE_intro Introduction] |
| 4 | * [http://www.openehr.org/about/origins.html#dsy20-OE_gehr The Good European Health Record (GEHR) Project Proposal] |
| 5 | * [http://www.openehr.org/about/origins.html#dsy20-OE_gehr-participants Participants in the GEHR Project] |
| 6 | * [http://www.openehr.org/about/origins.html#dsy20-OE_gehr-accomplishments The Accomplishments of the GEHR Project] |
| 7 | * [http://www.openehr.org/about/origins.html#dsy20-OE_centc251 The Interface between the GEHR Project and Technical |
| 8 | Committee TC/251-Medical Informatics of CEN] |
| 9 | * [http://www.openehr.org/about/origins.html#dsy20-OE_synapses From GEHR to Synapses in Europe] |
| 10 | * [http://www.openehr.org/about/origins.html#dsy20-OE_australia Australia awakens the world electronic health care |
| 11 | records community to the approach of GEHR] |
| 12 | * [http://www.openehr.org/about/origins.html#dsy20-OE_implementation Implementation, Implementation, implementation! - |
| 13 | from GEHR and Synapses to Synex, Medicate and 6-winit in CHIME and UCL] |
| 14 | * [http://www.openehr.org/about/origins.html#dsy20-OE_openehr openEHR] |
| 15 | * [http://www.openehr.org/about/origins.html#dsy20-OE_openehr-manifesto First Ideas for the openEHR Foundation] |
| 16 | * [http://www.openehr.org/about/origins.html#dsy20-OE_whehr Whehr now?] |
| 17 | |
| 18 | ''David Ingram October 2002'' |
| 19 | |
| 20 | Some ten years after the GEHR project was established in 1989, partners in |
| 21 | that project have come together again to review experience gained over the |
| 22 | intervening years. It is especially encouraging that a forthcoming ISO standard |
| 23 | will elevate formally defined clinical requirements to the highest level in the |
| 24 | standards process for electronic healthcare records. So many systems describe |
| 25 | themselves as electronic healthcare records and yet share little common concept |
| 26 | of what such an entity is and what it is for. |
| 27 | |
| 28 | The research and development in this field has followed a chaotic and |
| 29 | tortuous evolution, influenced inevitably by commercial, political and academic |
| 30 | considerations and rivalries and also by severe inertia because of powerful |
| 31 | needs to continue to accommodate legacy systems. Confused and confusing |
| 32 | arguments have raged about esoteric models of ill-defined clinical terminology, |
| 33 | processes and communications. Continuing reinvention of wheels at these levels |
| 34 | of abstraction (more precisely concoction of alternative definitions and plans |
| 35 | of possibly wheel-like objects!), has inhibited progress. There is still an |
| 36 | urgent need for empirical study of the implementation and comparative evaluation |
| 37 | of a diverse range of approaches to the provision of high quality electronic |
| 38 | healthcare records. This must be informed by international consensus about the |
| 39 | requirements to be met. |
| 40 | |
| 41 | |
| 42 | == Introduction - the AIM Initiative in Europe == #dsy20-OE_intro |
| 43 | In 1988, the European Union established the Advanced Informatics in Medicine |
| 44 | (AIM) initiative, within the wide-ranging Framework Programme for Research and |
| 45 | Technology Development in Europe. |
| 46 | |
| 47 | The rationale for the Framework Programme was: |
| 48 | |
| 49 | |
| 50 | * To strengthen the economic and social cohesion of the Community |
| 51 | * To offer obvious benefits through the collaboration of several States |
| 52 | * To apply significant and complementary results across the whole Community |
| 53 | * To contribute to a common market and to scientific and technical unification |
| 54 | |
| 55 | It succeeded in catalysing a wave of new partnerships across all sectors of |
| 56 | the European economy. |
| 57 | |
| 58 | In relation to health, the Framework Programme objectives set out in 1988 |
| 59 | were: |
| 60 | |
| 61 | |
| 62 | * To unify European activities by providing the means for efficient |
| 63 | communication of medical records and knowledge so that these may be understood |
| 64 | and compatible, thereby permitting the integration of health information systems |
| 65 | * To strengthen competitiveness by advancing the technical basis of products |
| 66 | and services and commercialising European inventiveness in all scales of |
| 67 | enterprise |
| 68 | * To improve the quality of life through improving diagnosis and treatment, |
| 69 | increasing public awareness and knowledge of health care and widening access to |
| 70 | improved services |
| 71 | |
| 72 | Thus, from the earliest stages of the Programme, the harmonisation of |
| 73 | electronic health care records was seen as of the highest strategic importance |
| 74 | for health care development in Europe. |
| 75 | |
| 76 | Under the outstanding leadership of Dr Niels Rossing, the AIM Programme was |
| 77 | developed in key phases, as follows: |
| 78 | |
| 79 | |
| 80 | * '''1988 - 90''' Exploratory phase, 20 million ECU, 43 projects |
| 81 | * '''1990 - 94''' 110 million ECU, 38 projects; 12 concerted |
| 82 | actions (eg. Medirec) |
| 83 | * '''1994 - 98''' 135 million ECU, ~60 projects |
| 84 | |
| 85 | The first major Call for Proposals under the AIM Workplan was issued in 1989. |
| 86 | A Key Action was to be research and development for an electronic health care |
| 87 | record architecture. There was intense competition among rival consortia seeking |
| 88 | funding to work on this challenge. Other Key Actions addressed clinical |
| 89 | terminology and clinical care protocols and important work in these areas |
| 90 | evolved in the early AIM Programme Projects (e.g. Galen, Games, Dilemma), and |
| 91 | colleagues from these days work alongside us to this day. |
| 92 | |
| 93 | |
| 94 | == The Good European Health Record (GEHR) Project Proposal == #dsy20-OE_gehr |
| 95 | A Consortium was drawn together by Dr Alain Maskens and Dr Sam Heard to bid |
| 96 | to work within AIM on electronic health record architecture. Alain, a Belgian |
| 97 | oncologist, was running HDMP, a small software company specialising in |
| 98 | electronic healthcare records for GPs. Sam, an Australian General Practitioner, |
| 99 | was lecturer at the Medical College of St Bartholomew’s Hospital in London and |
| 100 | ran a practice in East London and had developed a general practice system |
| 101 | supported by a cooperative of general practices. The two had met through |
| 102 | Professor Mal Salkind, head of General Practice at St Bartholomew’s, during the |
| 103 | AIM exploratory phase and had begun to collaborate on the development of a |
| 104 | generic EHR system. |
| 105 | |
| 106 | The Consortium comprised seven professional, industrial and academic |
| 107 | partners: St Bartholomew’s Medical College (co-ordinating partner); HDMP; The |
| 108 | French Red Cross Hospitals; The Association of Doctors and Dentists of |
| 109 | Luxembourg; The General Practice Institute of Oporto, Portugal; France Telecom; |
| 110 | Smithkline Beecham. |
| 111 | |
| 112 | Professor David Ingram, Professor of Medical Informatics at St Bartholomew’s |
| 113 | Medical College, was invited to lead the Consortium, to prepare the proposal |
| 114 | and, subsequently, as Project Director, to run the project. In this, he worked |
| 115 | closely with Lesley Southgate, who had succeeded Mal Salkind as Head of Primary |
| 116 | Care at St. Bartholomew’s. |
| 117 | |
| 118 | The project proposal was put together in three months in early 1991 and was |
| 119 | given the title ''The Good European Health Record'' (GEHR); the name was |
| 120 | proposed by Alain Maskens. After a final 72 hour, round the clock, weekend |
| 121 | flurry of preparation, it was submitted just in time. It emerged as an |
| 122 | unexpected but warmly endorsed winning proposal, in the adjudication that |
| 123 | followed. Some rival consortia had worked for several years to position |
| 124 | themselves for the work, so the result was controversial. Negotiations, led for |
| 125 | GEHR by David Ingram, were completed with the Commission who were represented by |
| 126 | the Project Officer, Jacques Lacombe, and Michael Wilson. The project commenced |
| 127 | in January 1992. |
| 128 | |
| 129 | |
| 130 | == Participants in the GEHR Project == #dsy20-OE_gehr-participants |
| 131 | In addition, to David and Sam, of those still closely involved in the |
| 132 | continuing story of GEHR, Dr Dipak Kalra, who led the GEHR Clinical Task Group, |
| 133 | and David Lloyd, a key contributor to the technical Task Group, joined the St. |
| 134 | Bartholomew's team at the outset. Dr Jo Milan, Director of Information at the |
| 135 | Royal Marsden Hospital, London, and Dr Stanley Sheppard, Chief Executive of |
| 136 | Update, a UK general practice software company, joined as sub-contractors to St. |
| 137 | Bartholomew's. Update had to withdraw from the Consortium in the early days of |
| 138 | the project, but Stan maintained contact on a personal basis. Tom Beale was |
| 139 | employed as a consultant to the Royal Marsden in 1993 and subsequently joined |
| 140 | the St Bartholomew's GEHR team, as a consultant, to assist in the key modelling |
| 141 | phase, leading to the first GEHR object model for the health care record. David |
| 142 | Ingram was appointed Professor of Health informatics at UCL in London in 1995 |
| 143 | and the team, moved there to establish the Centre for Health Informatics |
| 144 | (CHIME). Marcia Jacks was the GEHR Project Administrator and is now co-ordinator |
| 145 | of CHIME at UCL, where the St. Bartholomew's team moved. |
| 146 | |
| 147 | Notable contributions in GEHR were also made by: |
| 148 | |
| 149 | Jeff Geboers, HDMP; Christian Aligne, French Red Cross; Olivier Baille, |
| 150 | France Telecom; Daniel Mart, Association of Doctors and Dentists of Luxembourg; |
| 151 | Jose Calado and Helder Machado, Institute of General Practice, Oporto; Mario |
| 152 | Cortelezzi, Luxembourg; Penny Grub, Richard Dixon, University of Hull; Lesley |
| 153 | Southgate, Jeanette Murphy and Sian Griffiths, St Bartholomew's Medical College; |
| 154 | Ian Grey and John Shorter, !SmithKline Beecham; Benoit Hap, C2V Paris;Gerhard |
| 155 | Brenner, Carlos Salvador. |
| 156 | |
| 157 | Lesley Southgate, is now President of the Royal College of General |
| 158 | Practitioners of the UK and Daniel Mart is General Secretary of the Association |
| 159 | of Doctors and Dentists of Luxembourg. |
| 160 | |
| 161 | |
| 162 | == The Accomplishments of the GEHR Project == #dsy20-OE_gehr-accomplishments |
| 163 | The work of the GEHR project is well documented in its many widely |
| 164 | communicated project reports, publications and software, and described on the |
| 165 | CHIME.ucl.ac.uk web site. The final AIM Conference Paper concluded the first |
| 166 | stage of the story of GEHR. All public deliverables of the Project may be |
| 167 | downloaded from the UCL, CHIME web site. |
| 168 | |
| 169 | Working on the GEHR Project was an absorbing and unforgettable experience. It |
| 170 | tackled an intrinsically difficult and contentious domain. Its results, which |
| 171 | have continued to evolve in many projects and standards developments, have |
| 172 | proved to be enduring accomplishments, from clinical, technical and |
| 173 | organisational perspectives. |
| 174 | |
| 175 | Key attributes of the project approach and accomplishment were: |
| 176 | |
| 177 | |
| 178 | 1. Experienced, competent, committed and passionate multi-professional |
| 179 | teamwork. The team worked very hard, disagreed and fought at times, but also |
| 180 | evolved a culture of friendship, mutual support and loyalty, through some |
| 181 | difficult challenges. |
| 182 | 1. Development of an original, formal approach to electronic health record |
| 183 | architecture, based on object modelling methods and founded on a comprehensive |
| 184 | and systematic review of patient and clinical professional roles and |
| 185 | requirements, across Europe, in relation to records. |
| 186 | 1. An empirical and iterative prototyping approach to the evolution of the |
| 187 | architecture, emphasising implementation and testing of concepts, practically, |
| 188 | at each stage. |
| 189 | 1. The decision of the partners, in the interests of effective dissemination of |
| 190 | the work, to publish the project results openly, within the public domain. The |
| 191 | EU Contract in principle vested IPR for the work with the Consortium. |
| 192 | |
| 193 | Warmly supported as it was by Niels Rossing and the Commission and by its |
| 194 | Project Officer, Jacques Lacombe, the Project proved from its very earliest |
| 195 | stages and over time not to be short of powerful opponents, as well. Its results |
| 196 | were provided, step by step as they were available and often before official |
| 197 | publication, into all the stages of the formulation of EU pre-standards of CEN |
| 198 | and further afield. |
| 199 | |
| 200 | |
| 201 | == The Interface between the GEHR Project and Technical Committee |
| 202 | TC/251-Medical Informatics of CEN == #dsy20-OE_centc251 |
| 203 | At about the same time that the AIM Programme was initiated, CEN established |
| 204 | a standards initiative for medical informatics through its Technical Committee |
| 205 | TC/251, led by Prof. Georges de Moor. The strategic co-ordination achieved |
| 206 | between the AIM and CEN activities was sometimes disappointing and their goals |
| 207 | and methods were very different. AIM was tackling the domain through extensive |
| 208 | and well funded applied research and development in wide-ranging consortia such |
| 209 | as GEHR. CEN, with much less resource, was tackling its role as a consensus |
| 210 | building process, using task forces of experts to propose standards which were |
| 211 | then voted on by national delegates. Of course, both empirical research and |
| 212 | standards setting activities are needed to advance the field. |
| 213 | |
| 214 | During the course of the GEHR Project, a Project Team was established under |
| 215 | TC/251 of CEN, to propose a pre-standard health record architecture. Some early |
| 216 | deliverables of GEHR, in formulating clinical requirements and proposing early |
| 217 | formal models for the EHCR, were requested by and provided to the CEN project |
| 218 | team, led by Petter Hurlen. This team, in which some members of GEHR |
| 219 | participated, published the first CEN pre standard, ENV 12265. The extensive use |
| 220 | and influence of GEHR project results and concepts available at that time are |
| 221 | clear in the CEN publication. The GEHR project continued to develop and refine |
| 222 | its approach after the pre-standard was published. |
| 223 | |
| 224 | GEHR sought to work in a spirit of co-operation. Recognising its deficiencies |
| 225 | and successively refining its results, in the public domain, was a key feature |
| 226 | of its working method. Opposition and contrary perspectives provide an important |
| 227 | and useful crucible for innovation. GEHR was quite radical in its approach and |
| 228 | no doubt uncomfortable to have as a partner, as a result. |
| 229 | |
| 230 | |
| 231 | == From GEHR to Synapses in Europe == #dsy20-OE_synapses |
| 232 | The GEHR Project came to an end at the end of 1994 and two proposals to |
| 233 | extend its work plan were not immediately successful. One of these was for a |
| 234 | Support Action to maintain co-ordination in health record architecture work and |
| 235 | the other for more extensive field trials of the architecture. GEHR had |
| 236 | delivered a significant, but by no means completed, advance in the application |
| 237 | of object modelling approaches to the electronic health care record (EHCR) and |
| 238 | its evaluation against comprehensive clinical and ethical requirements as well |
| 239 | as implementation experience. It was clear to the team that this first stage |
| 240 | GEHR architecture, the first GEHR Object Model, would require continuing |
| 241 | refinement in the light of implementation experience. |
| 242 | |
| 243 | The project had, throughout, grappled with the issues of relational versus |
| 244 | object database representations of clinical data. At the stage of evolution of |
| 245 | database technology then pertaining, these concepts were in a state of |
| 246 | considerable flux. Aspects of functionality were highly desirable, but they were |
| 247 | hard to combine. Both camps argued their case, responding to the emerging needs |
| 248 | of complex applications domains, of which the medical record was an obviously |
| 249 | challenging example. |
| 250 | |
| 251 | At the close of the project, the GEHR partners could see the potential |
| 252 | requirement for a public domain foundation to take forward their work. It was |
| 253 | resolved to leave this issue open until some future stage, when the rationale |
| 254 | for how this might operate had become more apparent. |
| 255 | |
| 256 | In summer 1995, the St Bartholomew's team moved with David Ingram, across |
| 257 | London to UCL, when he was recruited to establish the new UCL Centre for Health |
| 258 | Informatics and Multi-Professional Education (CHIME). Sam Heard and Tom Beale, |
| 259 | now both based in Australia, have remained in close touch with the UCL team have |
| 260 | continued regular visits to and fro. David Ingram has made academic visits to |
| 261 | Australian Universities and as participant and keynote lecturer at two national |
| 262 | Health Informatics Conferences, in Melbourne and Hobart. |
| 263 | |
| 264 | The GEHR approach remained alive in CHIME and its collaborating centres. |
| 265 | Successive research results and implementations of record servers based on this |
| 266 | are now making key contributions within the newly launched UK ''Information |
| 267 | for Health'' Strategy. The GEHR approach was taken forward on a broader |
| 268 | front, beyond the UK and Europe, especially by Sam Heard, Tom Beale and Peter |
| 269 | Schloeffel and their colleagues in Australia. |
| 270 | |
| 271 | Reactions against GEHR: When the GEHR project came to an end, a reaction set |
| 272 | in against it. The first GEHR Object Model became a focus of concerted |
| 273 | opposition within some groups working in the domain in the UK and within CEN |
| 274 | standards bodies. The questioning of the assumptions and approaches of existing |
| 275 | products and approaches had been inevitable, but did not make GEHR popular, |
| 276 | although its approach always sought to be constructive. It was unfortunate that |
| 277 | the work of GEHR came, apparently, to be perceived as a threat to other |
| 278 | interests and ambitions, evidenced by the manner in which it was opposed, early, |
| 279 | tentative and incomplete as its results were. |
| 280 | |
| 281 | One important area of controversy arose in the confrontation between the |
| 282 | record architecture paradigm and the paradigm of healthcare messages between |
| 283 | systems, as typified by the EDIFACT initiatives and the HL7 consortium of |
| 284 | suppliers, for interoperability between their products. The advocacy by GEHR and |
| 285 | its successors of a record architecture to anchor information standards and |
| 286 | services and their contexts within records was controversial and was, and still |
| 287 | is, opposed. It did not help that most available clinical systems claiming to be |
| 288 | clinical records systems did not meet the commonly agreed clinical understanding |
| 289 | of what a clinical record is and the requirements it must meet. |
| 290 | |
| 291 | It is interesting that, in facing the technical and clinical challenges of |
| 292 | implementing real clinical record systems within real health care contexts, |
| 293 | health care and international standards bodies have only recently begun to |
| 294 | explore rigorously what the requirements for such systems are and how their |
| 295 | performance may be assessed against these. This is inexorably drawing the issues |
| 296 | raised by the GEHR project, over ten years ago, back into play. The need to |
| 297 | focus efforts in this way, as we enter the post Human Genome Project era, is, if |
| 298 | anything, more crucial today. |
| 299 | |
| 300 | The objective of reverse engineering a health record information model from |
| 301 | the legacy of an evolving messaging semantics, as typified by successive HL7 |
| 302 | versions, is difficult! In GEHR, such messages were seen as being derivable |
| 303 | straightforwardly from the GEHR object model underlying the record formalism, in |
| 304 | a clinically comprehensive and ethically acceptable manner. However, without an |
| 305 | accessible public domain implementation of such a record architecture, it is |
| 306 | quite understandable that existing suppliers of systems, struggling to evolve |
| 307 | their products to meet the requirements of patient centred and clinically more |
| 308 | accountable care, view such an initiative with some concern. |
| 309 | |
| 310 | Synapses: In 1995, David Ingram and the UCL team joined forces with Professor |
| 311 | Jane Grimson of Trinity College Dublin in a new consortium aiming to propose a |
| 312 | project to explore the legacy systems integration issues in progressing towards |
| 313 | a federated electronic healthcare record. From the other GEHR participants, |
| 314 | Daniel Mart of The Association of Doctors and Dentists of Luxembourg and Jo |
| 315 | Milan of the Royal Marsden also joined this larger consortium of EU teams and |
| 316 | industries, which included Siemens and Hiscom as major suppliers. |
| 317 | |
| 318 | Reflecting on the results of the GEHR Project, and looking at the new |
| 319 | challenges of implementation of a federated approach, Jo Milan and David Ingram |
| 320 | developed and wrote the methodological section of the Synapses Project Proposal |
| 321 | that proposed a new paradigm for implementation of the record, which divided the |
| 322 | formal description of the architecture into a high level structural model |
| 323 | (Synom) and a model of clinical content (Synod), implemented through a clinical |
| 324 | object dictionary. |
| 325 | |
| 326 | The Synapses project from 1995-98 succeeded in implementing several pilot |
| 327 | record servers, built according to the Synom/Synod principle, across Europe (see |
| 328 | CHIME and TCD web sites). The user requirements and information modelling |
| 329 | workpackage was led by Dipak Kalra, and the implementation workpackage by David |
| 330 | Ingram. |
| 331 | |
| 332 | Controversy still dogged the formal methods to be adopted and the principles |
| 333 | and detail of the Synom and Synod were difficult and contentious matters within |
| 334 | the Synapses consortium. Legacy environments in the demonstrator sites inhibited |
| 335 | freedom to design ''de novo'' and reconciling those who wished to restrict |
| 336 | implementation to the concepts of the earlier CEN pre-standard model and those |
| 337 | who favoured further evolution, utilising the later results of GEHR and moving |
| 338 | forward from there was also difficult. Synapses proved another burning crucible |
| 339 | of endeavour, where staying power was challenged to the full! |
| 340 | |
| 341 | Synapses reached a compromise to extend the fundamental concepts of Env |
| 342 | 12265, with new aggregation structures to accommodate the requirements analysed |
| 343 | and provided for within the GEHR Object Model (GOM) in the later stages of the |
| 344 | GEHR project. The low-level Synom/Synod approach, as further developed by the |
| 345 | UCL team, proved a robust foundation of implementation, avoiding some of the |
| 346 | implementation difficulties associated with the fine granularity of the single |
| 347 | level architecture of the original GOM. Progress at UCL with the concept of the |
| 348 | object dictionary and tools to support it was encouraging. |
| 349 | |
| 350 | |
| 351 | == Australia awakens the world electronic health care records |
| 352 | community to the approach of GEHR == #dsy20-OE_australia |
| 353 | Aware of the anti-GEHR sentiments in the UK and in CEN in Europe, Sam Heard |
| 354 | and Tom Beale joined forces again in Australia, in 1996, to work together to |
| 355 | refine the GEHR Object Model through implementation. This also led to a two |
| 356 | level modelling approach - the health record architecture itself and the |
| 357 | clinical models or standards required for automatic processing of information. |
| 358 | The latter has become known as the GEHR archetype system. |
| 359 | |
| 360 | The SynOD and Archetype approachesweresubsequently discovered to be largely |
| 361 | the same and have been progressively haremonised within a common ''open''EHR architecture. Peter Schloeffel had met David Ingram with |
| 362 | Michael Britton, at UCL, in 1996 Michael and David Newble obtained British |
| 363 | Council support to invite him to contribute key lectures at a symposium in |
| 364 | Adelaide in August 1998, with Sam Heard, and there he met Peter again, as a |
| 365 | local systems supplier. |
| 366 | |
| 367 | Following this event, Peter subsequently met Stan Sheppard and started to |
| 368 | develop a business partnership. In these partnerships began the renewed |
| 369 | Australian focus on developing the results of the original GEHR project which |
| 370 | has had a considerable influence, internationally in the ISO, HL7, CEN and, more |
| 371 | importantly in many Net discussion groups and in meetings about the EHCR in the |
| 372 | USA. In Australia, the team achieved considerable success in moving to the |
| 373 | centre of the national development programme for the EHCR. They worked with |
| 374 | systems R&D teams at DSTC on implementation of a GEHR server or kernel, |
| 375 | based on the archetype model for content within a higher level information model |
| 376 | close to the higher levels of the original GEHR object model. |
| 377 | |
| 378 | |
| 379 | == Implementation, Implementation, implementation! == #dsy20-OE_implementation |
| 380 | '''- from GEHR and Synapses to Synex, Medicate and 6-winit in CHIME and |
| 381 | UCL ''' |
| 382 | |
| 383 | The behaviour of standards communities in these times, spending much time, |
| 384 | money and energy disputing and seemingly seeking above all else to dominate one |
| 385 | another’s agendas, was scientifically extremely questionable, yet seemed to |
| 386 | brook no questioning. It is not sufficient justification that standards for |
| 387 | health information management are deemed crucially needed, that a crude |
| 388 | consensus and legislative process be adopted for their definition, when the |
| 389 | underpinning empirical foundations for organising and modelling information in |
| 390 | the domain are still in process of evolution through empirical research. |
| 391 | Monolithic modelling of healthcare information domains is clearly a fascinating |
| 392 | exercise but, if devoid of empirical and practical context, clear domain |
| 393 | definitions and verifiable objectives, has little if any meaning. Such models |
| 394 | are in any case inevitably non-identifiable or non-unique formulations, |
| 395 | incapable of purposive application within implementable and clinically viable |
| 396 | systems. |
| 397 | |
| 398 | This may all sound rather obvious but a review of much work from many bodies, |
| 399 | especially governmental and inter-governmental bodies over recent decades, will |
| 400 | show that information standardisation has frequently proceeded devoid of |
| 401 | empirical testing and validation and that many costly failures have resulted |
| 402 | therefrom. This matters to patients and has been disastrous in the quest to use |
| 403 | information technology to support cost-effective health care services! |
| 404 | |
| 405 | Given this flow of events, the UCL team concluded that three immediate things |
| 406 | now mattered more than any other. These were implementation, implementation and |
| 407 | implementation! |
| 408 | |
| 409 | The team thus put its head down to get on with developing its new research, |
| 410 | alongside new graduate and educational programmes. In developing its ideas, post |
| 411 | GEHR, it started a prolonged period of intensive software implementation and |
| 412 | evaluation of the record architecture and object dictionary, led by Dipak Kalra |
| 413 | with Tony Austin, David Lloyd and Alexis O’Connor, and Vivienne Griffith. This |
| 414 | work was conducted throughout the EU Synapses project, then in the EU Synex, |
| 415 | Medicate and now the 6-WINIT and CLEF projects, and with David Patterson as an |
| 416 | invaluable clinical sponsor as head of the Whittington Hospial Cardiology |
| 417 | services. In these projects, the underlying concepts evolved beyond GEHR were |
| 418 | widely tested for implementation in cardiology, cancer and respiratory medicine |
| 419 | domains, in hospital, telecare and now in mobile systems contexts. In the Synex |
| 420 | Project a wider grouping of record architecture, terminology (GALEN) and |
| 421 | protocols (Proforma) formalisms were drawn into the Consortium. This six-year |
| 422 | trial by implementation rather than trial by standardisation committee has borne |
| 423 | much fruit in implemented practical clinical exemplars of the record |
| 424 | architecture and object dictionary at work. |
| 425 | |
| 426 | David Lloyd, co-ordinating the EHCR-SupA project, put a great deal of effort |
| 427 | into continuing inputs to the next CEN team established to take record |
| 428 | architecture forward and also into a concerted action within the Framework |
| 429 | Programme, to look at synthesis among the different modelling approaches to the |
| 430 | EHCR. |
| 431 | |
| 432 | |
| 433 | == ''open''EHR == #dsy20-OE_openehr |
| 434 | In 1998, at the conclusion of the Synapses Project, David Ingram circulated a |
| 435 | paper about the need for a clinically focused Foundation to own the content |
| 436 | domain around standards for clinical information management. It attracted |
| 437 | interested comment and it was left with UCL to take it forward. In late 1999, a |
| 438 | joint meeting of the Australian and UCL teams, in London, considered the forward |
| 439 | pathway for the work of their two teams, in this context. They feared that some |
| 440 | divergencies in their respective implementation pathway, architecture and |
| 441 | content models were emerging and wished to work towards convergence again, if |
| 442 | possible. The meeting decided to work to establish an open source foundation to |
| 443 | take forward harmonisation in the field, from patient and clinical perspectives. |
| 444 | The name ''open''EHR, proposed by David Ingram, was adopted. Membership, it |
| 445 | was felt, should be open to all signing up to a set of principles guiding the |
| 446 | Foundation’s activities, which emphasised constructive, inclusive and |
| 447 | empirically based evolution of rigorously defined software and systems, |
| 448 | organised around the two level strategy of the UCL object dictionary and the |
| 449 | Australian archetype methodology. It was agreed to allow implementation to |
| 450 | proceed in parallel over a further period of about a year before meeting to seek |
| 451 | to reconcile a common achievable way forward. |
| 452 | |
| 453 | David Lloyd undertook the task of drawing together the threads from the |
| 454 | meeting and developing an ''open''EHR web site. David Ingram was given a |
| 455 | brief as chairman of the initiative to seek early funding of an umbrella to hold |
| 456 | together the concept of a three-time zone foundation with component groups in |
| 457 | Europe, Australia and the USA. Peter Schloeffel was asked to pursue a role as |
| 458 | ambassador for ''open''EHR, to press ahead with Sam and Tom to establish |
| 459 | the Australian chapter as the first step and to seek to find a USA partner. |
| 460 | |
| 461 | |
| 462 | == First Ideas for the ''open''EHR Foundation == #dsy20-OE_openehr-manifesto |
| 463 | A draft "manifesto" was prepared for discussion with interested parties, as |
| 464 | follows. |
| 465 | |
| 466 | The ''open''EHR Foundation is an international, on-line community whose |
| 467 | aim is to promote and facilitate progress towards electronic healthcare records |
| 468 | of high quality, to support the needs of patients and clinicians everywhere. It |
| 469 | will publish the theoretical foundations and evaluations of its work in the |
| 470 | public domain and make available relevant EHCR source programs and datasets |
| 471 | under an !OpenSource license. This continues the tradition of the GEHR project, |
| 472 | from which ''open''EHR has emerged, of placing results in the public |
| 473 | domain. We recognise that there is a certain initiative fatigue in the field and |
| 474 | we would not propose a new initiative were we not sure that something radically |
| 475 | different is now essential. So many systems describe themselves as electronic |
| 476 | healthcare records and yet share little common concept of what such an entity is |
| 477 | and what it is for. |
| 478 | |
| 479 | The research and development in this field has followed a chaotic and |
| 480 | tortuous evolution, influenced inevitably by commercial, political and academic |
| 481 | pressures and rivalries and also by severe inertia because of the need to |
| 482 | continue to accommodate legacy systems. Confused and confusing arguments have |
| 483 | persisted about esoteric models of ill-defined clinical terminology, processes |
| 484 | and communications. Continuing reinvention of wheels at these levels of |
| 485 | abstraction has inhibited progress. There is an urgent need for more empirical |
| 486 | study of the implementation and comparative evaluation of a diverse range of |
| 487 | approaches to the provision of high quality electronic healthcare records, |
| 488 | informed by and informing international consensus about the requirements to be |
| 489 | met. It is especially encouraging that the ISO has now adopted work which will |
| 490 | elevate formally defined clinical requirements to the highest level in the |
| 491 | standards process for electronic healthcare records. |
| 492 | |
| 493 | ''open''EHR directs its efforts towards: |
| 494 | |
| 495 | |
| 496 | * well-formulated clinical requirements, offered as a contribution towards |
| 497 | international consensus |
| 498 | * rigorous development, implemention and evaluation methodology for systems |
| 499 | * common information model for the record, where clinical requirements dictate |
| 500 | that this is necessary and where the relationship between model and requirements |
| 501 | is made explicit |
| 502 | * diversity of information models and implementations, where these will enrich |
| 503 | experience of a variety of approaches and systems and thereby promote the |
| 504 | evolution towards high quality and cost-effective EHR solutions offered |
| 505 | * empirical evaluation of systems performance against clinical requirements |
| 506 | |
| 507 | ''open''EHR recognises that achieving its aims is extremely complex on |
| 508 | many levels and certainly beyond the co-ordination powers of any one group. It |
| 509 | believes that progress can be enhanced by interested groups coming together to |
| 510 | promote and facilitate implementation and evaluation of systems using a |
| 511 | co-ordinated methodology, and working openly within the public domain. It has |
| 512 | not proved possible for the power of commercial and political organisations to |
| 513 | devise and mandate solutions which demonstrate that they provide good quality |
| 514 | EHCRs. An open developmental process is proposed in an effort to break this |
| 515 | damaging impasse. ''open''EHR has started a process of bringing together |
| 516 | like-minded conceptual thinkers and systems implementers, prepared to offer |
| 517 | their work to the EHR community in this way. |
| 518 | |
| 519 | In pursuing its aims, ''open''EHR will: |
| 520 | |
| 521 | |
| 522 | * be open to all who sign up to its objectives and methods of work |
| 523 | * have free individual membership |
| 524 | * charge membership fees for official bodies, on a not-for-profit basis |
| 525 | * help to define and support a common process of specification of clinical |
| 526 | requirements, specification and implementation of systems and evaluation of the |
| 527 | electronic healthcare records provided (Note: this will be termed the GEHR (Good |
| 528 | Electronic Healthcare Record) methodology, since it will rest initially very |
| 529 | heavily on the methods set out and followed for the first time in the GEHR |
| 530 | project from 1989. This 7-country R&D project developed concepts, object |
| 531 | model and early prototypes and tools for a common European Health Record |
| 532 | Architecture and has been drawn on in subsequent partnerships and projects |
| 533 | across the world. The work was placed by the partners in the public domain and |
| 534 | fed into and adopted by standards bodies) |
| 535 | * publish the work of projects and systems conducted within the ''open''EHR community and adopting the GEHR methodology. |
| 536 | * offer the sources of such GEHR-based systems, in which IPR will be assigned |
| 537 | to ''open''EHR, under an open-source license within the community. |
| 538 | Individuals or companies assigning IPR to the Foundation may where necessary and |
| 539 | appropriate be remunerated under contract or through license fees. |
| 540 | * offer all its work openly in a spirit of a public enterprise, believing that |
| 541 | this is the best and perhaps only way that appropriate high quality and |
| 542 | interoperable systems are likely to emerge, worldwide. |
| 543 | * seek constructive relationships with groups and communities focusing on |
| 544 | other aspects of clinical information management such as messages, terminology, |
| 545 | knowledge-management and decision-support. |
| 546 | |
| 547 | '''''open''EHR will not:''' |
| 548 | |
| 549 | |
| 550 | * campaign against or obstruct others working on electronic healthcare |
| 551 | records. On the contrary, it will welcome and endorse their success in meeting |
| 552 | the aims and objectives of ''open''EHR. |
| 553 | |
| 554 | |
| 555 | == Whehr now? == #dsy20-OE_whehr |
| 556 | Until implementations have been conclusively demonstrated and a pathway of |
| 557 | development of the Foundation is clear, no-one will listen very much or take |
| 558 | risks in what ''open''EHR is advocating - that is to start basing national |
| 559 | strategies on the approach we are advocating. Governments in every country are |
| 560 | receiving such contradictory advice from people who say either that HL7 already |
| 561 | solves everything or that EHCRs are easy/too difficult and don’t need/cannot |
| 562 | have a common approach to the record architecture! |
| 563 | |
| 564 | A presentation was made to The Provost of UCL and he enthusiastically gave |
| 565 | his support to UCL providing co-ordination of ''open''EHR, through its team |
| 566 | in CHIME. |
| 567 | |
| 568 | This presentation was also introduced to The Wellcome Trust, NHS Executive |
| 569 | and to the UK NHS Information Authority and Policy Unit. |
| 570 | |
| 571 | Following the UK CSR2000 public spending review, in which David Ingram |
| 572 | participated on the national research councils’ informatics committee, |
| 573 | substantial investment is planned in the UK and Europe into GRID demonstrator |
| 574 | projects. An opportunity arises to link bio-informatics and health informatics |
| 575 | research and development here. The UCL team linked with Alan Rector in |
| 576 | Manchester, with Don Detmar in Cambridge , and with other colleagues in |
| 577 | Sheffield and Brighton to bid successfully for the CLEF project. |
| 578 | |
| 579 | Through the NHS National Plan, the opportunity arises to take forward |
| 580 | demonstrators for the EHR in e-health incubator projects. Dipak Kalra has |
| 581 | established excellent links with Oracle and the NHS project delivering an EHR |
| 582 | for the national Cardiovascular disease service framework, building on the now |
| 583 | very strong collaborative work at the Whittington Hospital. |
| 584 | |
| 585 | A week long meeting of the embryonic ''open''EHR international |
| 586 | co-ordination group was held in London in February 2001, to review progress. It |
| 587 | was attended by Sam, Tom, Peter, Mary, Dipak, David L and chaired by David I. |
| 588 | |
| 589 | The clinical and technical motivations for the Australian work on GEHR since |
| 590 | 1997 and its focus on splitting the original GEHR approach into a two level |
| 591 | architecture, centred on user defined clinical archetypes, was closely studied, |
| 592 | alongside the implementations of the UCL ''open''EHR server incorporating |
| 593 | the two level object model and object dictionary concept, evolved by UCL through |
| 594 | its post GEHR projects. These systems are now seen, in the light of |
| 595 | implementation experience of both teams over the year, to have been largely |
| 596 | identical. UCL, now freed from the constraints of working within the compromises |
| 597 | of Synapses and Synex in Europe, has reverted to its earlier GEHR approaches, to |
| 598 | deliver clinical prototypes of its own EHCR record server, which is now termed |
| 599 | an ''open''EHR server. This has been adopted, with Oracle Corporation as |
| 600 | the basis of middleware for the South West Region of the NHS ERDIP project on |
| 601 | electronic records for cardiovascualr disease. |
| 602 | |
| 603 | Now that the outcomes of the two streams of work are drawing together again |
| 604 | in renewed collaboration, the differences appear small and the benefits of |
| 605 | aligning them completely are compelling. At the meeting, the Australian and UCL |
| 606 | teams worked intensively to define a convergence pathway for their work, within |
| 607 | the emerging ''open''EHR Foundation. |
| 608 | |
| 609 | In the mean time, the Australian team has succeeded wonderfully well in |
| 610 | creating the Australia and Far East ''open''EHR Foundation as a pilot |
| 611 | initiative towards the vision of three such Foundations in Australia, Europe and |
| 612 | the USA. |
| 613 | |
| 614 | We need to focus on these opportunities for cross-governmental funding for ''open''EHR, perhaps splitting the main open source and content |
| 615 | standardisation roles of the foundation from a trading arm, owned by the |
| 616 | Foundation, to develop revenue streams to support the goals of the Foundation. |
| 617 | |
| 618 | At the same time, we have to remain firmly focused on our continuing pathway |
| 619 | of keeping our teams together, expanding our partnerships and delivering the |
| 620 | results needed to win the day! |