wiki:The Origins of openEHR

openEHRプロジェクトのはじまり

The Origins of openEHR

この文章はThe Origins of openEHRの日本語訳です。翻訳の正確さについては一切保証しませんので、適宜原文を参照してください。

David Ingram October 2002 Translated by Shinji KOBAYASHI 2008

GEHRプロジェクトが完結した1989年から10年ほどたった頃、プロジェクトのパートナー達が再び集まって、その間の年月でどのくらいの経験が積み重ねられたのか評価することになった。それは心強いものであり、来るべきISO標準が電子的健康記録(EHR)の標準的プロセスにおいて高いレベルの臨床的要件を公式に定義するために制定されるであろということを示唆していた。EHRとして表現される多くのシステムが存在するが、その間でそのエンティティがどのようなもので何のために存在するのかを共有するための共通概念がほとんどなかった。

Some ten years after the GEHR project was established in 1989, partners in that project have come together again to review experience gained over the intervening years. It is especially encouraging that a forthcoming ISO standard will elevate formally defined clinical requirements to the highest level in the standards process for electronic healthcare records. So many systems describe themselves as electronic healthcare records and yet share little common concept of what such an entity is and what it is for.

この分野での研究開発は必然的に商業的、政策的、そして学術的意図や競争、レガシーシステムを採用し続けようという強力な要求のためのとんでもない惰性によって必然的に混沌に導かれ、歪んだ発展を遂げてきた。間違って定義された臨床用語やプロセス、コミュニケーションに対する難解なモデルについて、議論は混乱させられてきたし、さらに混乱も生み出してきた。このレベルの抽象化のために車輪の再発明(より正確にはおそらく車輪のようなものの代わりになる定義や計画をでっちあげようとする!)が続けられることで、進歩が妨げられてきた。今でも高品質なEHRを提供するための多様なアプローチを比較検討し、実装について実証的な研究が求められている。したがって、満たされるべき要件について国際的なコンセンサスが知らされなければならない。

The research and development in this field has followed a chaotic and tortuous evolution, influenced inevitably by commercial, political and academic considerations and rivalries and also by severe inertia because of powerful needs to continue to accommodate legacy systems. Confused and confusing arguments have raged about esoteric models of ill-defined clinical terminology, processes and communications. Continuing reinvention of wheels at these levels of abstraction (more precisely concoction of alternative definitions and plans of possibly wheel-like objects!), has inhibited progress. There is still an urgent need for empirical study of the implementation and comparative evaluation of a diverse range of approaches to the provision of high quality electronic healthcare records. This must be informed by international consensus about the requirements to be met.

はじめに - ヨーロッパでのAIM Initiative

Introduction - the AIM Initiative in Europe

1988年にヨーロッパ連合(EU)は医療分野での先進的情報学イニシアチブ(AIM Initiative; Advanced Informatics in Medicine initiative)を発足し、ヨーロッパでの研究や技術開発のためのプログラムフレームワーク(Framework Programme)を幅広く網羅することとした。

In 1988, the European Union established the Advanced Informatics in Medicine (AIM) initiative, within the wide-ranging Framework Programme for Research and Technology Development in Europe.

プログラムフレームワーク(Framework Programme)ための論理的根拠は以下の事項である

  • コミュニティの経済的および社会的結束力を強化するため
  • いくつかの国家の共同作業を通じて、明確な利益を得るため
  • コミュニティ全体にむけて重要で補完的な結果が提供されるため
  • 共通の市場や科学技術的な共同体に貢献するため

The rationale for the Framework Programme was:

  • To strengthen the economic and social cohesion of the Community
  • To offer obvious benefits through the collaboration of several States
  • To apply significant and complementary results across the whole Community
  • To contribute to a common market and to scientific and technical unification

これによりヨーロッパ経済のすべての部門に対して新しい提携関係の波を作るような触媒作用が得られた。

It succeeded in catalysing a wave of new partnerships across all sectors of the European economy.

健康に関連したプログラムフレームワーク(Framework Programme)の目的は1988年に以下のように設定された。

  • 診療記録や知識が理解しやすく互換性を保つために効率よい伝達手段を提供することにより、ヨーロッパでのアクティビティを統一し、健康情報システムの統合することができるようにすること。
  • 製品やサービスの技術的基盤の新保と、すべての規模のヨーロッパの企業の創造を商用化していくことで競争力を高めていくため。
  • 診断と治療の進歩による生活の質(Quality of Life)の向上と、大衆のヘルスケアについての知識や自覚を増やし、向上したサービスをより広く提供するため

In relation to health, the Framework Programme objectives set out in 1988 were:

  • To unify European activities by providing the means for efficient communication of medical records and knowledge so that these may be understood and compatible, thereby permitting the integration of health information systems
  • To strengthen competitiveness by advancing the technical basis of products and services and commercialising European inventiveness in all scales of enterprise
  • To improve the quality of life through improving diagnosis and treatment, increasing public awareness and knowledge of health care and widening access to improved services

つまり、プログラム(Programme)の初期段階から電子的健康記録(EHR)のハーモナイゼーションがヨーロッパのヘルスケア開発のための戦略上の重要性において高い位置に存在した。Dr Niels Rosslingの卓越したリーダーシップの元で、AIMプログラムは以下の主要な段階を経て開発されていた。

  • 1988 - 90 予備的段階、2000万 ECU, 43プロジェクト
  • 1990 - 94 1億1000万 ECU、38プロジェクト、12の協調行動
  • 1994 - 98 1億3500万 ECU、~60プロジェクト

Thus, from the earliest stages of the Programme, the harmonisation of electronic health care records was seen as of the highest strategic importance for health care development in Europe. Under the outstanding leadership of Dr Niels Rossing, the AIM Programme was developed in key phases, as follows:

  • 1988 - 90 Exploratory phase, 20 million ECU, 43 projects
  • 1990 - 94 110 million ECU, 38 projects; 12 concerted actions (eg. Medirec)
  • 1994 - 98 135 million ECU, ~60 projects

AIM Workplanによる最初の大規模な提案募集は1989年に発表された。電子的健康記録(EHR)アーキテクチャの研究開発のためには重要な行動であった。この試みにおける作業に出資を求める競争相手の共同事業体のなかで熾烈な競争が繰り広げられた。臨床用語体系(Terminology)や診療プロトコールなどのこの分野で重要な事業についてそのほかの重要な取り組みがAIMプログラムプロジェクト(たとえば Galen, Games, Dilemma)により発展してきており,この時期に一緒に働いた仲間とは今日まで一緒に活動している。

The first major Call for Proposals under the AIM Workplan was issued in 1989. A Key Action was to be research and development for an electronic health care record architecture. There was intense competition among rival consortia seeking funding to work on this challenge. Other Key Actions addressed clinical terminology and clinical care protocols and important work in these areas evolved in the early AIM Programme Projects (e.g. Galen, Games, Dilemma), and colleagues from these days work alongside us to this day.

GEHR(Good European Health Record)プロジェクトの提案

The Good European Health Record (GEHR) Project Proposal

Dr Alain MaskensとDr Sam Heardがコンソーシアムを共同で率いて,EHRアーキテクチャに関する作業を行った。ベルギーの腫瘍内科医であるAlainはGPのために特化したEHR作成するHDMPというソフトウェア会社を経営していた。オーストラリアの家庭医(GP; General Practitioner)のSamはロンドンのSt Barthlomew's Hospital医科大学の講師であり,AIMの予備段階から一般的なEHRシステムを共同開発していた。

A Consortium was drawn together by Dr Alain Maskens and Dr Sam Heard to bid to work within AIM on electronic health record architecture. Alain, a Belgian oncologist, was running HDMP, a small software company specialising in electronic healthcare records for GPs. Sam, an Australian General Practitioner, was lecturer at the Medical College of St Bartholomew’s Hospital in London and ran a practice in East London and had developed a general practice system supported by a cooperative of general practices. The two had met through Professor Mal Salkind, head of General Practice at St Bartholomew’s, during the AIM exploratory phase and had begun to collaborate on the development of a generic EHR system.

コンソーシアムは専門集団,産業,学術団体からなる7つのグループで構成されていた。St Bartholomew's 医科大学(主幹),HDMP,フランス赤十字病院,ルクセンブルグ医師および歯科医師会,ポルトガルのオポルト総合医療学会,フランステレコム,スミスクラインビーチャムであった。

The Consortium comprised seven professional, industrial and academic partners: St Bartholomew’s Medical College (co-ordinating partner); HDMP; The French Red Cross Hospitals; The Association of Doctors and Dentists of Luxembourg; The General Practice Institute of Oporto, Portugal; France Telecom; Smithkline Beecham.

David Ingram教授はBarthromyew医科大学の医療情報学教授であり,コンソーシアムを率いるために招かれた。そこで提案を準備し,プロジェクトのディレクターとしてプロジェクトを遂行することとなった。これについて,彼はMal Salkindの後任としてSt. Bartholomewのプライマリケア部長であったLesley Southgateと密接に連携した。

Professor David Ingram, Professor of Medical Informatics at St Bartholomew’s Medical College, was invited to lead the Consortium, to prepare the proposal and, subsequently, as Project Director, to run the project. In this, he worked closely with Lesley Southgate, who had succeeded Mal Salkind as Head of Primary Care at St. Bartholomew’s.

3ヶ月後の1991年初めにThe Good European Health Record (GEHR)と名付けられたプロジェクトの提案が共同で出された。この名前はAlain Maskensによって提案された。週末に突貫工事で72時間ぶっ通しで準備作業が続けられ,提案は期限内に提出された。判断が下される間,提案が認められることについて思いがけずしかし暖かい支持が寄せられた。競合するコンソーシアムはその業務について数年間の経験を持っているため,その結果については様々な議論の余地があった。Jacqes LacombeとMachael Wilsonをプロジェクトの役員として代表される委員会に対して,David Ingram主導でGEHRのために行われた交渉は完璧であった。プロジェクトは1992年1月に開始された。

The project proposal was put together in three months in early 1991 and was given the title The Good European Health Record (GEHR); the name was proposed by Alain Maskens. After a final 72 hour, round the clock, weekend flurry of preparation, it was submitted just in time. It emerged as an unexpected but warmly endorsed winning proposal, in the adjudication that followed. Some rival consortia had worked for several years to position themselves for the work, so the result was controversial. Negotiations, led for GEHR by David Ingram, were completed with the Commission who were represented by the Project Officer, Jacques Lacombe, and Michael Wilson. The project commenced in January 1992.

GEHRプロジェクトの参加者たち

Participants in the GEHR Project

DavidとSamに加えて,GEHRの話を続けていく上で密接にかかわっていく人々がいる。Dr. Dipak KalraはGEHR臨床タスクグループを指揮し,David Lloydは技術的タスクグループの主要な貢献者である。二人は最初からBartholomewのチームに加わっていた。Dr Jo Milanはロンドン王立Marsden病院の情報部長であり,Dr Stanley Sheppardはイギリスの一般内科向けソフトウェア会社であるUpdate社の社長であった。二人はSt. Bartholomewのチームに下請け開発として加わっていた。Update社はプロジェクトの初期にコンソーシアムから手を引かなければならなかったが,Stan(ley Sheppard)は個人的に関係を維持していた。Tom Bealeは王立Marsdenに1993年にコンサルタントとして雇用された,引き続きSt BartholomewのGEHRチームにコンサルタントとして加わり,重要なモデリングを行う時期を手伝ってヘルスケア記録(health care record)のために最初のGEHRオブジェクトモデルへと作っていった。David Ingramは1995年にロンドンUCLの医療情報学の教授に任命され,チームもそこに移り,医療情報センター(CHIME; Centre for Health Informatics)を設立した。Marcia JacksはGEHRプロジェクトの管理者であり,現在はSt. Bartholomewのチームが移籍したUCLのCHIMEの調整役となっている。

In addition, to David and Sam, of those still closely involved in the continuing story of GEHR, Dr Dipak Kalra, who led the GEHR Clinical Task Group, and David Lloyd, a key contributor to the technical Task Group, joined the St. Bartholomew's team at the outset. Dr Jo Milan, Director of Information at the Royal Marsden Hospital, London, and Dr Stanley Sheppard, Chief Executive of Update, a UK general practice software company, joined as sub-contractors to St. Bartholomew's. Update had to withdraw from the Consortium in the early days of the project, but Stan maintained contact on a personal basis. Tom Beale was employed as a consultant to the Royal Marsden in 1993 and subsequently joined the St Bartholomew's GEHR team, as a consultant, to assist in the key modelling phase, leading to the first GEHR object model for the health care record. David Ingram was appointed Professor of Health informatics at UCL in London in 1995 and the team, moved there to establish the Centre for Health Informatics (CHIME). Marcia Jacks was the GEHR Project Administrator and is now co-ordinator of CHIME at UCL, where the St. Bartholomew's team moved.

GEHRで注目すべき貢献をした人物は他にもいる。HDMLのJeff Geboers, フランス赤十字のChristian Aligne,フランステレコムのOlivier Baille,ルクセンブルグ医師および歯科医師会のDaniel Mart,オポルト総合医療学会のJose CaladoとHelder Machado,ルクセンブルグのMario Cortelezzi,Hull大学のPenny Grub,Richard Dixon,St Bartohomew医科大学のLesley Southgate, Jaenette MurphyそしてSian Griffiths,スミスクラインビーチャムのIan GreyとJohn Shorter,C2VパリのBenoit Hap,そしてGehard Brenner,Carlos Salvadorである。

Notable contributions in GEHR were also made by: Jeff Geboers, HDMP; Christian Aligne, French Red Cross; Olivier Baille, France Telecom; Daniel Mart, Association of Doctors and Dentists of Luxembourg; Jose Calado and Helder Machado, Institute of General Practice, Oporto; Mario Cortelezzi, Luxembourg; Penny Grub, Richard Dixon, University of Hull; Lesley Southgate, Jeanette Murphy and Sian Griffiths, St Bartholomew's Medical College; Ian Grey and John Shorter, SmithKline Beecham; Benoit Hap, C2V Paris;Gerhard Brenner, Carlos Salvador.

Lesley Southgateは英国の王立総合医療医科大学の学長であり,Daniel Martはルクセンブルグ医師および歯科医師会の書記長となっている。

Lesley Southgate, is now President of the Royal College of General Practitioners of the UK and Daniel Mart is General Secretary of the Association of Doctors and Dentists of Luxembourg.

GEHRプロジェクトが達成したこと

The Accomplishments of the GEHR Project

GEHRプロジェクトの業績はプロジェクト報告や出版物,ソフトウェアやCHIP.ucl.ac.ukのウェブサイトとして広く伝えられており,多くの文書が残されている。最後のAIMカンファランス報告では,GEHRの第一段階のストーリーがまとめられている。プロジェクトに関するすべての公式配布物はUCLのCHIMEのウェブサイトからダウンロードできる。

The work of the GEHR project is well documented in its many widely communicated project reports, publications and software, and described on the CHIME.ucl.ac.uk web site. The final AIM Conference Paper concluded the first stage of the story of GEHR. All public deliverables of the Project may be downloaded from the UCL, CHIME web site.

GEHRプロジェクトでの作業は非常に興味深く忘れられない経験であった。GEHRプロジェクトでは本質的に難解で異論の多い領域に取り組んだ。その結果,多くのプロジェクトや標準の開発において進歩が続けられることとなり,臨床的,技術的,そして組織的観点からゆるぎない成果として実証されてきた。

Working on the GEHR Project was an absorbing and unforgettable experience. It tackled an intrinsically difficult and contentious domain. Its results, which have continued to evolve in many projects and standards developments, have proved to be enduring accomplishments, from clinical, technical and organisational perspectives.

プロジェクトの主要な取り組みと成果の特性を以下に示す。

  1. 経験を有し,能力もあり,情熱を持って傾倒した多くの専門家によるチームワーク。チームは非常に熱心に働き,時には意見が食い違い,論争もあったが,困難への挑戦を通じて友情と相互に支援し尊敬しあうという文化が育まれた。
  2. 独創的なEHR(Electronic Health Record)アーキテクチャの形式についてオブジェクト指向モデリングの手法を基礎とし,その要件に関連してわかりやすく系統的な調査を患者や臨床のプロの役割についてヨーロッパ全体に対して調査して開発した。
  3. 経験に基づいたプロトタイピング手法を繰り返すことで,アーキテクチャを進歩させ,すべての段階で実装を強調し実践的に概念のテストを行った
  4. 業務を効率よく分担することに対する利益があり,プロジェクトの結果をパブリックドメインとして公開するパートナーを決めることができた。EUの基本的規約で,コンソーシアムと行った業務に関して知的所有権が得られた。

Key attributes of the project approach and accomplishment were:

  1. Experienced, competent, committed and passionate multi-professional teamwork. The team worked very hard, disagreed and fought at times, but also evolved a culture of friendship, mutual support and loyalty, through some difficult challenges.
  2. Development of an original, formal approach to electronic health record architecture, based on object modelling methods and founded on a comprehensive and systematic review of patient and clinical professional roles and requirements, across Europe, in relation to records.
  3. An empirical and iterative prototyping approach to the evolution of the architecture, emphasising implementation and testing of concepts, practically, at each stage.
  4. The decision of the partners, in the interests of effective dissemination of the work, to publish the project results openly, within the public domain. The EU Contract in principle vested IPR for the work with the Consortium.

Niels Rosslingと委員会,そしてプロジェクト役員のJacques Lacombeの温かい支援を受けて,プロジェクトはごく初期の段階からずっと強力な競争相手もまた絶えることがないことが示されていた。その結果が提供されることで,徐々にそれが利用可能なものとなっており,しばしばそれが公式に発表される前に利用できた。それはEUのプレ標準化についての形式を作るCENやそれとは全く関係ないことについてもすべての段階で利用された。

Warmly supported as it was by Niels Rossing and the Commission and by its Project Officer, Jacques Lacombe, the Project proved from its very earliest stages and over time not to be short of powerful opponents, as well. Its results were provided, step by step as they were available and often before official publication, into all the stages of the formulation of EU pre-standards of CEN and further afield.

GEHRプロジェクトとCEN医療情報技術委員会TC/251とのインターフェース

The Interface between the GEHR Project and Technical Committee TC/251-Medical Informatics of CEN

AIMプログラムが発足したのとほぼ同時期に、CENはGeorges de Moor教授をリーダーとする技術委員会TC/251により医療情報学の標準イニシアチブを発足させた。AIMとCENの間の戦略的協調についての活動は、しばしばその目的と手法がかなり異なるものであり失望することとなっていた。AIMはGEHRのような幅広いコンソーシアムによる豊富な資源を投じた研究開発によりドメインの問題に取り組んでいた。CENはそれに比べて非常に乏しい資源で専門家による特別委員会を通じて提案すべき標準を構築する手順に合意を得ることに取り組んでいた。提案された標準は国家の代表によって、投票がなされた。もちろん、実証的研究も標準を設定することも標準を設定する活動もこの分野を進歩させるためにはどちらも必要なものである。

At about the same time that the AIM Programme was initiated, CEN established a standards initiative for medical informatics through its Technical Committee TC/251, led by Prof. Georges de Moor. The strategic co-ordination achieved between the AIM and CEN activities was sometimes disappointing and their goals and methods were very different. AIM was tackling the domain through extensive and well funded applied research and development in wide-ranging consortia such as GEHR. CEN, with much less resource, was tackling its role as a consensus building process, using task forces of experts to propose standards which were then voted on by national delegates. Of course, both empirical research and standards setting activities are needed to advance the field.

GEHRプロジェクトが進められる間,CENのTC/251のもとで健康記録アーキテクチャのプレ標準を提案するプロジェクトチームが結成された。臨床からの要件やEHCRに関する初期の形式モデルについてのGEHRプロジェクトの初期の成果のいくつかが,EHCRの初期の形式モデルとしてPetter Hurlenが率いるCENプロジェクトチームに要求され提供された。このチームにはGEHRプロジェクトのメンバーの何名かが参加しており,CENの最初のプレ標準,ENV 12265として公開された。CENが発行したものをみると,その時点で利用可能であったGEHRプロジェクトの成果や概念がが幅広く利用されており,影響を受けていることが明らかである。GEHRプロジェクトはプレ標準が公開された後も開発を続けその手法を改良していた。

During the course of the GEHR Project, a Project Team was established under TC/251 of CEN, to propose a pre-standard health record architecture. Some early deliverables of GEHR, in formulating clinical requirements and proposing early formal models for the EHCR, were requested by and provided to the CEN project team, led by Petter Hurlen. This team, in which some members of GEHR participated, published the first CEN pre standard, ENV 12265. The extensive use and influence of GEHR project results and concepts available at that time are clear in the CEN publication. The GEHR project continued to develop and refine its approach after the pre-standard was published.

GEHRでは協調の精神で働くことが求められていた。パブリックドメインにあるもので,その欠点とその後に改良された結果を見てみると,その作業方法が重要な特徴である。反対意見や正反対の視点から発展のために重要で有用な議論が生み出される。GEHRはその手法においてきわめて急進的ではあったが,結果として協力者にとってはあまり快適なものではなかった。

GEHR sought to work in a spirit of co-operation. Recognising its deficiencies and successively refining its results, in the public domain, was a key feature of its working method. Opposition and contrary perspectives provide an important and useful crucible for innovation. GEHR was quite radical in its approach and no doubt uncomfortable to have as a partner, as a result.

ヨーロッパではGEHRからSynapsesへ

From GEHR to Synapses in Europe

GEHRプロジェクトは1994年に終了し,その活動を延長するための二つの提案はすぐには始まらなかった。そのうちの1つは健康記録アーキテクチャについての調整作業を維持するための支援活動であり,もう一つはアーキテクチャを試す範囲をより広げていこうとする作業だった。GEHRは,電子化された診療記録(EHCR; Electronic Health Care Record)に対するオブジェクト指向モデリングを適応することを進歩させ,わかりやすい臨床的倫理的要件と同様に実装経験を評価するという点で重要な成果をもたらしたが,決して完成されたものではなかった。GEHRアーキテクチャの第一段階においてGEHRの最初のオブジェクトモデルは実装経験を行うことで改良し続ける必要があるだろうということはチームにとっては明らかなものであった。

The GEHR Project came to an end at the end of 1994 and two proposals to extend its work plan were not immediately successful. One of these was for a Support Action to maintain co-ordination in health record architecture work and the other for more extensive field trials of the architecture. GEHR had delivered a significant, but by no means completed, advance in the application of object modelling approaches to the electronic health care record (EHCR) and its evaluation against comprehensive clinical and ethical requirements as well as implementation experience. It was clear to the team that this first stage GEHR architecture, the first GEHR Object Model, would require continuing refinement in the light of implementation experience.

プロジェクトの間中,臨床データを表現するためにはリレーショナルデータベースがいいかオブジェクト指向データベースがいいかという問題に取り組んでいた。データベースに関連する技術の進化の段階で,これらの概念は大きな変化が起きている状態だった。機能性の面については非常に求められていたが,その二つを一体化するのは困難であった。両方の陣営が,複雑なアプリケーションドメインへの新しい要求や,医学記録が明らかに先進的な例であったそれぞれの事例について議論していた。

The project had, throughout, grappled with the issues of relational versus object database representations of clinical data. At the stage of evolution of database technology then pertaining, these concepts were in a state of considerable flux. Aspects of functionality were highly desirable, but they were hard to combine. Both camps argued their case, responding to the emerging needs of complex applications domains, of which the medical record was an obviously challenging example.

プロジェクトが終了するときに,GEHRの協力者達は彼らの業績を進めていく公的な財団の潜在的な要求があると考えていた。この問題を将来の段階においてどのように扱うべきかについての論理的根拠がより明らかになるまで,公開しておくということで決着した。

At the close of the project, the GEHR partners could see the potential requirement for a public domain foundation to take forward their work. It was resolved to leave this issue open until some future stage, when the rationale for how this might operate had become more apparent.

1995年夏にSt BartholomewチームはDavid Ingramと一緒にLondonの向こう側にあるUCLに移籍した。その時彼は新しいUCLのCHIME(Center for Health Informatics and Multi-Professional Education)を設立するために雇用された。Sam HeardとTom Bealeは,二人とも現在ではオーストラリアを拠点としているが,UCLチームとは密接な関係を保っており定期的に訪問し合っている。David Ingramはオーストラリアの大学に学術的に訪問し,メルボルンやホバートで2回開催されたオーストラリア国内の医療情報学会に参加し,キーノート講演を行った。

In summer 1995, the St Bartholomew's team moved with David Ingram, across London to UCL, when he was recruited to establish the new UCL Centre for Health Informatics and Multi-Professional Education (CHIME). Sam Heard and Tom Beale, now both based in Australia, have remained in close touch with the UCL team have continued regular visits to and fro. David Ingram has made academic visits to Australian Universities and as participant and keynote lecturer at two national Health Informatics Conferences, in Melbourne and Hobart.

GEHRの手法はCHIMEとその共同研究センターに引き継がれた。これを基にして続けられた研究結果や記録するサーバの実装は現在立ち上げられたイギリスの新しい「健康のための情報」(Information for Health)戦略に重要な貢献をもたらしている。GEHRの手法はイギリスやヨーロッパにとどまらずSam HeardやTom Beal,Peter Shloeffelとその窯たちによってオーストラリアでも広がっていた。

The GEHR approach remained alive in CHIME and its collaborating centres. Successive research results and implementations of record servers based on this are now making key contributions within the newly launched UK Information for Health Strategy. The GEHR approach was taken forward on a broader front, beyond the UK and Europe, especially by Sam Heard, Tom Beale and Peter Schloeffel and their colleagues in Australia.

GEHRに反対する反応:GEHRプロジェクトが終了した時にはそれに対して反発する動きがあった。最初のGEHRオブジェクトモデルには,UKやCEN標準化団体でこのドメインに関する作業をしているグループから一致して反対意見が寄せられた。既存の製品や手法についての前提条件や手法についての疑問は当然なものであったが,GEHRが建設的な手法であるということを願っていても広められることにはならなかった。不幸にもGEHRの業績が他のグループの利益やその野望にとって脅威であると認識された。その結果が初期の試験的なものであって不完全なものであると反対するというやりかたでそれは明らかであった。

Reactions against GEHR: When the GEHR project came to an end, a reaction set in against it. The first GEHR Object Model became a focus of concerted opposition within some groups working in the domain in the UK and within CEN standards bodies. The questioning of the assumptions and approaches of existing products and approaches had been inevitable, but did not make GEHR popular, although its approach always sought to be constructive. It was unfortunate that the work of GEHR came, apparently, to be perceived as a threat to other interests and ambitions, evidenced by the manner in which it was opposed, early, tentative and incomplete as its results were.

議論のもっとも重要な分野は,レコードアーキテクチャパラダイムとシステム間の医療情報メッセージについての対立に端を発していた。典型的なものとしては,EDIFACTイニシアチブとHL7コンソーシアムが提供するものとの間での各製品の相互可用性についての対立である。GEHRとその後継者による情報の標準やサービス,レコードについてのコンテキストを支援するためのレコードアーキテクチャについて擁護する意見については今でも反対意見がある。臨床記録システムと称する臨床システムのほとんどは,それが満たすべき要求や臨床記録が何であるかについての臨床的理解について一般に合意がなされたものではない。

One important area of controversy arose in the confrontation between the record architecture paradigm and the paradigm of healthcare messages between systems, as typified by the EDIFACT initiatives and the HL7 consortium of suppliers, for interoperability between their products. The advocacy by GEHR and its successors of a record architecture to anchor information standards and services and their contexts within records was controversial and was, and still is, opposed. It did not help that most available clinical systems claiming to be clinical records systems did not meet the commonly agreed clinical understanding of what a clinical record is and the requirements it must meet.

実際の診療記録システムを実際のヘルスケアコンテキストの範囲内で実装していくという技術的で臨床的試みに直面していると,ヘルスケアや国際標準団体はほんの最近までシステムに対する要件は何かとか,そのシステムのパフォーマンスがどのように評価されるのかについて熱心には検討していなかったというのは興味深い事実である。これはGEHRプロジェクトにより10年以上前に厳然と突きつけられた問題である。ヒトゲノムプロジェクトの時代の後に突入した今,このやり方に労力を集中させる必要性は重要となってきている。

It is interesting that, in facing the technical and clinical challenges of implementing real clinical record systems within real health care contexts, health care and international standards bodies have only recently begun to explore rigorously what the requirements for such systems are and how their performance may be assessed against these. This is inexorably drawing the issues raised by the GEHR project, over ten years ago, back into play. The need to focus efforts in this way, as we enter the post Human Genome Project era, is, if anything, more crucial today.

一連のHL7のバージョンに代表されるようなメッセージの意味論の進歩の遺産からなる健康レコードの情報モデルをリバースエンジニアリングの対象とすることは非常に困難である!GEHRでは,そのようなメッセージはレコード形式主義を基礎とるすGEHRオブジェクトモデルから直接導き出すことができるものであり,臨床的にわかりやすく倫理的に受容できる方法である。しかしながら,そのようなレコードアーキテクチャのパブリックドメイン実装が入手できなければ,その製品を患者中心でより診療上より責任のあるケアができ,何らかの懸案事項について決断できるような情報を提示するように改良しようと奮闘している既存のシステム提供者に対して理解させることはできない。

The objective of reverse engineering a health record information model from the legacy of an evolving messaging semantics, as typified by successive HL7 versions, is difficult! In GEHR, such messages were seen as being derivable straightforwardly from the GEHR object model underlying the record formalism, in a clinically comprehensive and ethically acceptable manner. However, without an accessible public domain implementation of such a record architecture, it is quite understandable that existing suppliers of systems, struggling to evolve their products to meet the requirements of patient centred and clinically more accountable care, view such an initiative with some concern.

Synapses: 1995年にDavid IngramとUCLチームはEHR(Electronic Healthcare Record)の統合を推進するためにレガシーシステムの統合に向けた調査を行うためのプロジェクトを提案することを目的とした新しいコンソーシアムのためにダブリンのTrinity大学のJane Grimson教授と力を合わせることになった。そのほかのGEHR参加者からルクセンブルグ医師および歯科医師会のDaniel Mart,Royal MarsdenのJo Milanも,この産業界からSiemensやHiscomといった大企業も加わったEUのチームによるさらに大規模なコンソーシアムに参加した。

Synapses: In 1995, David Ingram and the UCL team joined forces with Professor Jane Grimson of Trinity College Dublin in a new consortium aiming to propose a project to explore the legacy systems integration issues in progressing towards a federated electronic healthcare record. From the other GEHR participants, Daniel Mart of The Association of Doctors and Dentists of Luxembourg and Jo Milan of the Royal Marsden also joined this larger consortium of EU teams and industries, which included Siemens and Hiscom as major suppliers.

GEHRプロジェクトの成果を振り返り,連合された手法による新しい実装に展望して,Jo MilanとDavid Ingramは開発を行い,Synasesプロジェクトの提案書の方法論的なセクションを記述した。その提案書は臨床オブジェクト辞書を通じて実装された高レベルの構造モデル(Synom)と臨床内容モデル(Synod)にわけて,アーキテクチャに関する形式的記述を行ったものであり,実装に向けての新しいパラダイムを提案するものであった。

Reflecting on the results of the GEHR Project, and looking at the new challenges of implementation of a federated approach, Jo Milan and David Ingram developed and wrote the methodological section of the Synapses Project Proposal that proposed a new paradigm for implementation of the record, which divided the formal description of the architecture into a high level structural model (Synom) and a model of clinical content (Synod), implemented through a clinical object dictionary.

Synapsesプロジェクトは1995-98年から,Synom/Synod原則に基づいて,いくつかのレコードサーバのパイロット実装をヨーロッパの各地で行うことに成功した。ユーザー側の要件と情報モデリング作業パッケージについてはDipak Kalraが指揮をとり,作業パッケージの実装はDavid Ingramが指揮した。

The Synapses project from 1995-98 succeeded in implementing several pilot record servers, built according to the Synom/Synod? principle, across Europe (see CHIME and TCD web sites). The user requirements and information modelling workpackage was led by Dipak Kalra, and the implementation workpackage by David Ingram.

SynomとSynodの詳細について採用すべき形式的方法についての議論が尾を引いており,Synapseコンソーシアムだけで継続的に解決するには困難であった。実地でレガシーシステムを動作させているところでは,「新しい」設計についての自由がなく,初期のCENプレ標準モデルの概念を実装することを制限しようと考える人たちと,更なる進化を求め,GEHRのより新しい成果を活用して研究を進めていこうとする人たちの間を調整することもまた,困難であった。Synapsesにはまた,持久力が最大限に試されるような苦労と焼けるような試練が他にもあることがわかった。

Controversy still dogged the formal methods to be adopted and the principles and detail of the Synom and Synod were difficult and contentious matters within the Synapses consortium. Legacy environments in the demonstrator sites inhibited freedom to design de novo and reconciling those who wished to restrict implementation to the concepts of the earlier CEN pre-standard model and those who favoured further evolution, utilising the later results of GEHR and moving forward from there was also difficult. Synapses proved another burning crucible of endeavour, where staying power was challenged to the full!

SynapsesはEnv 12265という基本的な概念を超えるGEHRプロジェクトの後期のGEHRオブジェクトモデル(GOM)に適応した新しい集約した構造を持つ妥協点に到達した。UCLチームによりさらに開発された低水準のSynom/Synodアプローチは実装の強固な基礎であることを証明し,最初のGOMの2段階アーキテクチャの細粒度に関連した実装の難しさを回避することができた。オブジェクト辞書の概念とそれを支援するツールについてのUCLでの進歩はそれを可能にするものだった。

Synapses reached a compromise to extend the fundamental concepts of Env 12265, with new aggregation structures to accommodate the requirements analysed and provided for within the GEHR Object Model (GOM) in the later stages of the GEHR project. The low-level Synom/Synod? approach, as further developed by the UCL team, proved a robust foundation of implementation, avoiding some of the implementation difficulties associated with the fine granularity of the single level architecture of the original GOM. Progress at UCL with the concept of the object dictionary and tools to support it was encouraging.

オーストラリアが世界中のEHR(Electronic Health care Recods)コミュニティをGEHRの手法に目覚めさせた

Australia awakens the world electronic health care records community to the approach of GEHR

GEHRに対するイギリス、およびヨーロッパのCENの反感を覆したのは、Sam HeardとTom Bealeが再び一緒にオーストラリアで1996年にGEHRオブジェクトもデルを実装を通じて改良する作業が行われたことであった。これの、2段階モデリングアプローチとなり健康記録アーキテクチャ自身や臨床モデル、すなわち情報を自動で処理するために必要な標準となった。情報を自動で処理するための標準はGEHRのアーキタイプシステムとなった。

Aware of the anti-GEHR sentiments in the UK and in CEN in Europe, Sam Heard and Tom Beale joined forces again in Australia, in 1996, to work together to refine the GEHR Object Model through implementation. This also led to a two level modelling approach - the health record architecture itself and the clinical models or standards required for automatic processing of information. The latter has become known as the GEHR archetype system.

SynODとアーキタイプのアプローチはそのあとに大部分が同じものであることがわかり,共通のopenEHRアーキテクチャとしてハーモナイズがすすめらてきた。Peter ShloeffelはMichael Brittonと一緒にUCLでDavid Ingramと会った。1996年にMichaelとDavid Newlbleは英国文化振興会の支援を受けて,David Ingramを1998年8月に開催されたシンポジウムで基調講演をしてもらうことになった。Peterはそこで再びSam Heardとローカルシステムサプライヤーとして再会した。

The SynOD and Archetype approaches were subsequently discovered to be largely the same and have been progressively haremonised within a common openEHR architecture. Peter Schloeffel had met David Ingram with Michael Britton, at UCL, in 1996 Michael and David Newble obtained British Council support to invite him to contribute key lectures at a symposium in Adelaide in August 1998, with Sam Heard, and there he met Peter again, as a local systems supplier.

このイベントのあと,PeterはStan Shepperdにも会い,ビジネスパートナーシップを進めていくこととなった。このパートナーシップは世界的にISO,HL7,CENなどとともにUSAでのEHCRに関する会議やネット上の議論に影響を受けたと考えられるもともとのGEHRプロジェクトによってもたらされた結果を開発することで,オーストラリアについて改めて注目させるものとなった。オーストラリアでは,このチームがEHCRの国家的開発計画の中心に位置付けられるようになり,想定された成功をおさめた。彼らは,もともとのGEHRオブジェクトモデルよりも行為の水準にある行為の情報モデルによる内容についてのアーキタイプモデルを基盤としたGEHRサーバやカーネルの実装システム研究開発チームとともにDSTCで活躍した。

Following this event, Peter subsequently met Stan Sheppard and started to develop a business partnership. In these partnerships began the renewed Australian focus on developing the results of the original GEHR project which has had a considerable influence, internationally in the ISO, HL7, CEN and, more importantly in many Net discussion groups and in meetings about the EHCR in the USA. In Australia, the team achieved considerable success in moving to the centre of the national development programme for the EHCR. They worked with systems R&D teams at DSTC on implementation of a GEHR server or kernel, based on the archetype model for content within a higher level information model close to the higher levels of the original GEHR object model.

実装,実装,実装!

Implementation, Implementation, implementation!

- GEHRとSynapsesからSynexへ,CHIMEとUCLのMedicate1と6-winit2

- from GEHR and Synapses to Synex, Medicate and 6-winit in CHIME and UCL

この時期に標準化コミュニティは他の団体が抱える問題に対して優位に立とうとしたいために多くの時間と費用とエネルギーを議論に消耗した。それは科学的には非常に疑わしいものであったが、いかなる疑問をも許さないようでもあった。医療情報管理のための標準は必要とされてきていたが、彼らの定義によるおおよその合意とそれを法制化するプロセスについては十分な正当性を持つものはなかった。この領域において情報をモデル化し、組織化していくための土台となる経験的基礎は経験的な研究を元に発展していく段階にすぎなかった。医療情報ドメインでのモノリシックなモデリングは明らかに魅力的な課題であったが、経験的で実践的な文脈において以外では、領域定義や検証可能な対象においてはほとんど意味のないものであった。

The behaviour of standards communities in these times, spending much time, money and energy disputing and seemingly seeking above all else to dominate one another’s agendas, was scientifically extremely questionable, yet seemed to brook no questioning. It is not sufficient justification that standards for health information management are deemed crucially needed, that a crude consensus and legislative process be adopted for their definition, when the underpinning empirical foundations for organising and modelling information in the domain are still in process of evolution through empirical research. Monolithic modelling of healthcare information domains is clearly a fascinating exercise but, if devoid of empirical and practical context, clear domain definitions and verifiable objectives, has little if any meaning. Such models are in any case inevitably non-identifiable or non-unique formulations, incapable of purposive application within implementable and clinically viable systems.

This may all sound rather obvious but a review of much work from many bodies, especially governmental and inter-governmental bodies over recent decades, will show that information standardisation has frequently proceeded devoid of empirical testing and validation and that many costly failures have resulted therefrom. This matters to patients and has been disastrous in the quest to use information technology to support cost-effective health care services!

Given this flow of events, the UCL team concluded that three immediate things now mattered more than any other. These were implementation, implementation and implementation!

The team thus put its head down to get on with developing its new research, alongside new graduate and educational programmes. In developing its ideas, post GEHR, it started a prolonged period of intensive software implementation and evaluation of the record architecture and object dictionary, led by Dipak Kalra with Tony Austin, David Lloyd and Alexis O’Connor, and Vivienne Griffith. This work was conducted throughout the EU Synapses project, then in the EU Synex, Medicate and now the 6-WINIT and CLEF projects, and with David Patterson as an invaluable clinical sponsor as head of the Whittington Hospial Cardiology services. In these projects, the underlying concepts evolved beyond GEHR were widely tested for implementation in cardiology, cancer and respiratory medicine domains, in hospital, telecare and now in mobile systems contexts. In the Synex Project a wider grouping of record architecture, terminology (GALEN) and protocols (Proforma) formalisms were drawn into the Consortium. This six-year trial by implementation rather than trial by standardisation committee has borne much fruit in implemented practical clinical exemplars of the record architecture and object dictionary at work.

David Lloyd, co-ordinating the EHCR-SupA project, put a great deal of effort into continuing inputs to the next CEN team established to take record architecture forward and also into a concerted action within the Framework Programme, to look at synthesis among the different modelling approaches to the EHCR.

openEHR

In 1998, at the conclusion of the Synapses Project, David Ingram circulated a paper about the need for a clinically focused Foundation to own the content domain around standards for clinical information management. It attracted interested comment and it was left with UCL to take it forward. In late 1999, a joint meeting of the Australian and UCL teams, in London, considered the forward pathway for the work of their two teams, in this context. They feared that some divergencies in their respective implementation pathway, architecture and content models were emerging and wished to work towards convergence again, if possible. The meeting decided to work to establish an open source foundation to take forward harmonisation in the field, from patient and clinical perspectives. The name openEHR, proposed by David Ingram, was adopted. Membership, it was felt, should be open to all signing up to a set of principles guiding the Foundation’s activities, which emphasised constructive, inclusive and empirically based evolution of rigorously defined software and systems, organised around the two level strategy of the UCL object dictionary and the Australian archetype methodology. It was agreed to allow implementation to proceed in parallel over a further period of about a year before meeting to seek to reconcile a common achievable way forward.

David Lloyd undertook the task of drawing together the threads from the meeting and developing an openEHR web site. David Ingram was given a brief as chairman of the initiative to seek early funding of an umbrella to hold together the concept of a three-time zone foundation with component groups in Europe, Australia and the USA. Peter Schloeffel was asked to pursue a role as ambassador for openEHR, to press ahead with Sam and Tom to establish the Australian chapter as the first step and to seek to find a USA partner.

First Ideas for the openEHR Foundation

A draft "manifesto" was prepared for discussion with interested parties, as follows.

The openEHR Foundation is an international, on-line community whose aim is to promote and facilitate progress towards electronic healthcare records of high quality, to support the needs of patients and clinicians everywhere. It will publish the theoretical foundations and evaluations of its work in the public domain and make available relevant EHCR source programs and datasets under an OpenSource license. This continues the tradition of the GEHR project, from which openEHR has emerged, of placing results in the public domain. We recognise that there is a certain initiative fatigue in the field and we would not propose a new initiative were we not sure that something radically different is now essential. So many systems describe themselves as electronic healthcare records and yet share little common concept of what such an entity is and what it is for.

The research and development in this field has followed a chaotic and tortuous evolution, influenced inevitably by commercial, political and academic pressures and rivalries and also by severe inertia because of the need to continue to accommodate legacy systems. Confused and confusing arguments have persisted about esoteric models of ill-defined clinical terminology, processes and communications. Continuing reinvention of wheels at these levels of abstraction has inhibited progress. There is an urgent need for more empirical study of the implementation and comparative evaluation of a diverse range of approaches to the provision of high quality electronic healthcare records, informed by and informing international consensus about the requirements to be met. It is especially encouraging that the ISO has now adopted work which will elevate formally defined clinical requirements to the highest level in the standards process for electronic healthcare records.

openEHR directs its efforts towards:

  • well-formulated clinical requirements, offered as a contribution towards international consensus
  • rigorous development, implemention and evaluation methodology for systems
  • common information model for the record, where clinical requirements dictate that this is necessary and where the relationship between model and requirements is made explicit
  • diversity of information models and implementations, where these will enrich experience of a variety of approaches and systems and thereby promote the evolution towards high quality and cost-effective EHR solutions offered
  • empirical evaluation of systems performance against clinical requirements

openEHR recognises that achieving its aims is extremely complex on many levels and certainly beyond the co-ordination powers of any one group. It believes that progress can be enhanced by interested groups coming together to promote and facilitate implementation and evaluation of systems using a co-ordinated methodology, and working openly within the public domain. It has not proved possible for the power of commercial and political organisations to devise and mandate solutions which demonstrate that they provide good quality EHCRs. An open developmental process is proposed in an effort to break this damaging impasse. openEHR has started a process of bringing together like-minded conceptual thinkers and systems implementers, prepared to offer their work to the EHR community in this way.

In pursuing its aims, openEHR will:

  • be open to all who sign up to its objectives and methods of work
  • have free individual membership
  • charge membership fees for official bodies, on a not-for-profit basis
  • help to define and support a common process of specification of clinical requirements, specification and implementation of systems and evaluation of the electronic healthcare records provided (Note: this will be termed the GEHR (Good Electronic Healthcare Record) methodology, since it will rest initially very heavily on the methods set out and followed for the first time in the GEHR project from 1989. This 7-country R&D project developed concepts, object model and early prototypes and tools for a common European Health Record Architecture and has been drawn on in subsequent partnerships and projects across the world. The work was placed by the partners in the public domain and fed into and adopted by standards bodies)
  • publish the work of projects and systems conducted within the openEHR community and adopting the GEHR methodology.
  • offer the sources of such GEHR-based systems, in which IPR will be assigned to openEHR, under an open-source license within the community. Individuals or companies assigning IPR to the Foundation may where necessary and appropriate be remunerated under contract or through license fees.
  • offer all its work openly in a spirit of a public enterprise, believing that this is the best and perhaps only way that appropriate high quality and interoperable systems are likely to emerge, worldwide.
  • seek constructive relationships with groups and communities focusing on other aspects of clinical information management such as messages, terminology, knowledge-management and decision-support.

openEHRがやらないこと

  • EHR(Electronic Healthcare Records)について作業している人の邪魔をしたり反対するような運動。それどころか,openEHRの目的であり対象であることに巡り合えたということで彼らの成功を歓迎し支持する。

openEHR will not:

  • campaign against or obstruct others working on electronic healthcare records. On the contrary, it will welcome and endorse their success in meeting the aims and objectives of openEHR.

Whehr now?

Until implementations have been conclusively demonstrated and a pathway of development of the Foundation is clear, no-one will listen very much or take risks in what openEHR is advocating - that is to start basing national strategies on the approach we are advocating. Governments in every country are receiving such contradictory advice from people who say either that HL7 already solves everything or that EHCRs are easy/too difficult and don’t need/cannot have a common approach to the record architecture!

A presentation was made to The Provost of UCL and he enthusiastically gave his support to UCL providing co-ordination of openEHR, through its team in CHIM

This presentation was also introduced to The Wellcome Trust, NHS Executive and to the UK NHS Information Authority and Policy Unit.

Following the UK CSR2000 public spending review, in which David Ingram participated on the national research councils’ informatics committee, substantial investment is planned in the UK and Europe into GRID demonstrator projects. An opportunity arises to link bio-informatics and health informatics research and development here. The UCL team linked with Alan Rector in Manchester, with Don Detmar in Cambridge , and with other colleagues in Sheffield and Brighton to bid successfully for the CLEF project.

Through the NHS National Plan, the opportunity arises to take forward demonstrators for the EHR in e-health incubator projects. Dipak Kalra has established excellent links with Oracle and the NHS project delivering an EHR for the national Cardiovascular disease service framework, building on the now very strong collaborative work at the Whittington Hospital.

A week long meeting of the embryonic openEHR international co-ordination group was held in London in February 2001, to review progress. It was attended by Sam, Tom, Peter, Mary, Dipak, David L and chaired by David I.

The clinical and technical motivations for the Australian work on GEHR since 1997 and its focus on splitting the original GEHR approach into a two level architecture, centred on user defined clinical archetypes, was closely studied, alongside the implementations of the UCL openEHR server incorporating the two level object model and object dictionary concept, evolved by UCL through its post GEHR projects. These systems are now seen, in the light of implementation experience of both teams over the year, to have been largely identical. UCL, now freed from the constraints of working within the compromises of Synapses and Synex in Europe, has reverted to its earlier GEHR approaches, to deliver clinical prototypes of its own EHCR record server, which is now termed an openEHR server. This has been adopted, with Oracle Corporation as the basis of middleware for the South West Region of the NHS ERDIP project on electronic records for cardiovascualr disease.

Now that the outcomes of the two streams of work are drawing together again in renewed collaboration, the differences appear small and the benefits of aligning them completely are compelling. At the meeting, the Australian and UCL teams worked intensively to define a convergence pathway for their work, within the emerging openEHR Foundation.

In the mean time, the Australian team has succeeded wonderfully well in creating the Australia and Far East openEHR Foundation as a pilot initiative towards the vision of three such Foundations in Australia, Europe and the USA.

We need to focus on these opportunities for cross-governmental funding for openEHR, perhaps splitting the main open source and content standardisation roles of the foundation from a trading arm, owned by the Foundation, to develop revenue streams to support the goals of the Foundation.


  1. 1. The MEDICATE (Medical Diagnosis, Communication and Analysis Throughout Europe) project, http://www.chime.ucl.ac.uk/work-areas/ehrs/Medicate/index.htm
  2. 2. IPv6 Wireless Internet IniTiative, http://www.6winit.org/

At the same time, we have to remain firmly focused on our continuing pathway of keeping our teams together, expanding our partnerships and delivering the results needed to win the day!

Last modified 10 years ago Last modified on Jul 13, 2008, 5:53:55 PM