CELEX: 51987PC0352
Language: en
Date: 1987-07-24
Title: PROPOSAL FOR A COUNCIL REGULATION ON A COMMUNITY ACTION IN THE FIELD OF INFORMATION TECHNOLOGY AND TELECOMMUNICATIONS APPLIED TO HEALTH CARE AIM ( ADVANCED INFORMATICS IN MEDICINE IN EUROPE ) - PILOT PHASE -

No C 355/10                           Official Journal of the European Communities                                31. 12. 87
              Proposal for a Council Regulation on a Community action in the field of information
              technology and telecommunications applied to health care — Advanced informatics in
                                           medicine in Europe (AIM) — Pilot phase
                                                      COM(87) 352 final
                             (Submitted  by the Commission    to the Council on 13 August 1987)
                                                        (87/C 355/02)
 THE COUNCIL OF THE EUROPEAN COMMUNITIES,                          Whereas advances in health care will contribute to
                                                                   resolving pressing social needs associated with changing
                                                                   age structures;
 Having regard to the Treaty establishing the European
 Economic Community, and in particular Article
 130Q (2) thereof,                                                 Whereas the concerted efforts in this domain will con-
                                                                   tribute to the creation of the internal market and pre-
                                                                   vent the formation of new internal frontiers to health
 Having regard to the proposal from the Commission,
                                                                   care;
 Having regard to the opinion of the Economic and
 Social Committee,                                                 Whereas the development of common functional speci-
                                                                   fications for equipment and services will permit the
                                                                   less-developed regions to benefit fully from the efforts
 In cooperation with the European Parliament,                      of Member States piloting the improvements of health
                                                                   care, management and infrastructure developments in
                                                                   the Community;
Whereas the Community has as its task, by establishing
 a common market and progressively approximating
the economic policies of Member States, to promote                 Whereas the development of the health care infrastruc-
throughout the Community a harmonious development                  ture technology and services offers a wide range of
of economic activity and closer relations between the              opportunities for small and medium-sized companies
States belonging to it;                                            in the manufacture of equipment and in the provision
                                                                   of specialized services within the Community;
Whereas the Heads of State and Government emphasi-
zed the importance of health care as a major factor for            Whereas cooperation in pre-normative and pre-com-
economic growth and social development;                            petitive research and development towards the develop-
                                                                   ment of standards can make a major contribution,
Whereas the European Parliament, in its assessment of              notably by facilitating the evolution towards future
the situation and development, stressed the role of                more effective health care also at regional and local
cooperation in health care and related areas for the               levels;
future political, social and economic development of
the Community;
                                                                  Whereas the framework programme for Community
                                                                   actions in respect of research and technological develop-
Whereas the European Parliament, in its assessment of              ment (1987 to 1991) (2) envisages the utilization of the
biotechnology in Europe, has stressed the importance              technologies of information, telecommunications and
of medical biotechnology and bioinformatics( 1 );                  broadcasting in the interests of new services of common
                                                                   interest under its second heading 'Towards a large
                                                                   market and a society based on information and com-
Whereas the Economic and Social Committee supports                munication'; whereas the framework programme con-
initiatives in this domain;                                       tains special provision for a Community action in the
                                                                  field of medical and bio-informatics;
Whereas, with the emergence of advanced and mobile
communication services and the progressive introduc-
                                                                  Whereas the constitution or consolidation of a specifi-
tion of computing in health care and services, the con-
                                                                  cally European industrial potential in the technologies
ditions for major improvements for health care and
                                                                  concerned is an urgent necessity; whereas its benefici-
possibilities for reduction of cost increases are
                                                                  aries must be industry, health care service providers,
emerging;
                                                                  research establishments, undertakings, including small
                                                                  and medium-sized enterprises and other bodies estab-
Whereas developments in health care will benefit the              lished in the Community which are best suited to attain
general public and the international competitiveness of           these objectives;
the European industry and health services in particular;
(!) OJ No C 76, 23. 3. 1987, p. 25.                               (2) COM(86) 430 final.
 ---pagebreak--- 31. 12. 87                          Official Journal of the European Communities                          N o C 355/11
Whereas exploratory investigations have confirmed the         tigation of the non-technological factors as required for
need and the advantages of Community cooperation in           the objective of concerting European efforts in improv-
this field;                                                   ing health care by means of MBI.
                                                              The scope of the AIM pilot phase is described in the
Whereas it is in the Community's interest to consolidate
                                                              Annex and in the draft workplan.
the scientific and financial basis of European research
by means of the involvement to a greater extent of
participants from European third countries in certain
Community programmes and particularly in pro-                                          Article 3
grammes involving cooperation in medical bio-infor-
matics;                                                       1.    The detailed objectives of the action to be under-
                                                              taken are defined in a work plan to be adopted under
Whereas the AIM pilot phase will benefit from the             the procedures set out in Article 7.
results of ESPRIT and RACE as well as the on-going
efforts in standardization;                                   2.    The evaluation of projects is carried out by the
                                                              Commission having regard to the objectives defined in
                                                              the Annex and in the work plan. The eligibility of
Whereas the Community's programme in biotech-
                                                              projects involving a research and development effort
nology (1985 to 1989) will include the application of
                                                              exceeding 50 man-years is to be decided under the
medical bio-informatics and draw on the results of the
                                                              procedure set out in Article 7. For other projects the
work to be undertaken under AIM;
                                                              results of the evaluation will be brought to the notice
                                                              of the Committee referred to in Article 6.
Whereas there exists a need for close coordination
with actions on the national level and periodic reviews;      3.    Projects relating to the action shall be executed
whereas it is therefore necessary for the execution of        by means of shared cost contracts to be concluded
the pilot phase that the Commission be assisted by a          by the Commission with industrial enterprises, service
Committee;                                                    providers, universities, research institutes and other
                                                              organizations established in the Community. Contrac-
Whereas the implementation of concerted actions in the        tors shall be expected to bear a substantial proportion
COST framework is an essential element to comp-               of the costs, which should normally be at least 50 % of
lement industrially-oriented research and development         the total expenditure.
projects;
                                                              4.    The proposals for projects shall, as a general
Whereas the Scientific and Technical Research Com-            rule, be submitted in reply to an invitation to tender
mittee (Crest) has expressed its opinion,                     published in the Official Journal of the European Com-
                                                              munities and involve the participation of at least two
                                                              independent partners, not all established in the same
                                                              Member State. One of the partners shall be a commer-
                                                              cial undertaking.
HAS ADOPTED THIS REGULATION:
                                                              5.     In exceptional cases, where the call for tenders
                         Article 1                            has not resulted in a satisfactory response, in case of
                                                              urgency or in cases where the call for tenders is not
1.    A pilot phase of a Community action in the field        the right procedure in point of cost-effectiveness, the
of medical and bio-informatics, hereinafter referred to       decision may be taken, in accordance with the pro-
as 'AIM', is adopted for an initial period of 18 months       cedure set out in Article 7, to derogate from the prin-
commencing 1 January 1988.                                    ciples set out in paragraphs 3 and 4.
2.    The action is designed, in concertation with public
and private actions in the field of medical and bio-                                   Article 4
informatics (MBI) undertaken at national and inter-
national level, to promote the competitiveness of the          Where Framework Agreements for scientific and techni-
Community's industries, health service providers in            cal cooperation between non-Community European
order to make available to the citizens and health             countries and the European Community have been con-
services, at minimum cost and with minimum delay,              cluded, organizations and enterprises established in
the improvements in health care, thereby contributing          these countries may become partners to a project under-
to social as well as economic objectives.                      taken within this action.
                         Article 2
                                                                                       Article 5
The action shall consist of the development of a com-
mon conceptual framework for cooperation, pre-nor-             1.    The funds estimated as necessary for the Com-
mative work and technology exploration and the inves-          munity contribution to the execution of the pilot phase
 ---pagebreak--- No C 355/12                          Official Journal of the European Communities                            31. 12. 87
amount to 20 million ECU over 18 months, including             The Commission shall adopt the measures under con-
expenditure on staff (nine A, two B and four C tempor-         sideration when they are in accordance with the opinion
ary officials).                                                of the Committee. When the measures under consider-
                                                               ation are not in accordance with the opinion of the
2.     The indicative allocation of these funds is set out     Committee, or in the absence of an opinion, the Com-
in the Annex.                                                  mission shall submit to the Council without delay a
                                                               proposal relating to the measures to be taken. The
                                                               Council shall decide by a qualified majority.
                         Article 6                             If, after the expiry of a period of one month following
                                                               the Council's consideration of the matter, the Council
1.     The Commission shall ensure that the action is          has not taken a decision, the proposed measures shall
properly performed and shall take the measures necess-         be adopted by the Commission.
ary to this end, without prejudice to the procedures
provided for in Article 3.
2.     The Commission shall be assisted in the execution                                Article 8
of its tasks by a Committee, composed of two represen-
tatives from each Member State, chaired by a represen-         The result of the action shall be reviewed by the Com-
tative of the Commission and hereinafter referred to as        mission after 12 months. The Commission shall report
'the Committee'.                                               to the Council and the European Parliament on the
The members of the Committee can call on the assist-           results of this review, together with any proposals for
ance of experts or advisors according to the nature of         modification or prolongation of the action which the
the problems under study.                                      Commission deems appropriate.
The proceedings of the Committee shall be confidential.
The Committee shall adopt its own internal procedures.
The Commission shall provide the secretariat of the                                     Article 9
Committee.
                                                                1.    With regard to the coordination activities pro-
3.     The Commission may consult the Committee on             vided for in Article 1 (2), the Member States and the
any matter within the field of application of this Regu-       Commission shall exchange all appropriate information
lation.                                                        to which they have access and which they are free to
                                                               disclose concerning activities in the areas covered by
                                                               this Regulation, whether or not planned or carried out
                         Article 7                             under their authority.
                                                               2.     Information shall be exchanged according to a
Where the procedure laid down in this Article is to be
                                                               procedure to be defined by the Commission after con-
followed, the chairman shall refer to the Committee a
                                                               sulting the Committee, and shall be treated as confiden-
draft of the measures to be adopted. The Committee
                                                               tial at the supplier's request.
shall deliver its opinion on this draft within a time limit
set by the chairman in relation to the urgency of the
matter. This shall normally be one month and in no
case shall be longer than two months. The opinion is                                    Article 10
delivered by the majority specified in Article 148 (2) of
the Treaty for decisions which the Council is required         This Regulation shall enter into force on 1 January
to adopt on a proposal from the Commission. In the
                                                                1988.
Committee the votes of the representatives of the Mem-
ber States are weighted as indicated in that Article. The      This Regulation shall be binding in its entirety and
chairman does not vote.                                        directly applicable in all Member States.
 ---pagebreak--- 31. 12. 87                                Official Journal of the European Communities                                       No C 355/13
                                                                 ANNEX
                                                            INTRODUCTION
             The rationale developed in the main document illustrates the opportunities for cooperation but also the
             difficulties and complexities their inter-sectoral nature will pose to a concerted effort on a European scale.
             Besides the need to refine objectives one will need to analyze alternative approaches as well as test the ability
             to manage successfully the numerous inter-dependencies. Success of this action will ultimately depend on the
             ability to complement and reinforce efforts undertaken by the sector actors on a national level. Developing
              and reinforcing the mechanisms of concertation between the sector actors on a European scale is as much a
             challenge as the technical content of this initiative. Success in this respect will be decisive for realizing the
              advantages of concertation and cooperation and thereby a better use of the scarce human, institutional,
              technical and financial assets of the Community in this domain.
              For this reason a pilot phase has been conceived with the sector actors which has the following aims:
             — analyze and assess future requirements in health care and biotechnology for medical and bio-informatics
                  (MBI),
              — explore and assess technological developments and options with respect to their contribution to progress
                  in MBI,
              — define precise objectives and the optimal approach for concertation and collaboration in the field of MBI
                  at European level complementing and re-enforcing efforts of private and public organizations working in
                  this and closely related areas,
              — test and validate the organization and management support for concerted efforts in MBI,
              — develop an action plan for MBI based on analyses of future requirements and opportunities,
              — identify legal, regulatory, economic and other non-technological factors which may play a key role in
                  using MBI for the stated objectives.
              The following section describes the scope of the work proposed for the pilot phase. The areas of investigation
              and exploration have been chosen in accordance with the above objectives of the pilot phase so as to provide
              significant results without prejudice to the follow-up
1. DEVELOPMENT OF A COMMON                         CONCEPTUAL            — automatic collection of experimental data from different
    FRAMEWORK FOR COOPERATION                                                sources,
                                                                         — comparison of experimental data with those stored in data
Health care is in a process of continuous evolution and so is the
                                                                             banks and data bases,
technology supporting it. Central to the assessment of the role
and contribution of MBI is the accurate understanding of the
present and future role of information and the way it is used.           — tertiary structure prediction from sequence data,
                                                                         — molecular modelling,
The types of data a doctor generally needs to handle, review,
merge in a report, are:
                                                                         — quantum mechanical calculations for structure refinement.
— text (e.g. reports from colleagues in the referral system),
                                                                         This suggests three directions for the development of medical
— numeric laboratory results,                                            informatics:
— graphical presentations (of both numeric data and body sites),         a) medical records;
— signals (e.g. electro-cardiograms),                                    b) communications; and
— images (e.g. X-ray, sonograms, etc.).                                  c) information retrieval/decision-support systems.
 These data have three main origins: data they generate themselves
                                                                         Formulating a strategy about information technology for health
 about patients, data others generate about their patients, and
                                                                         care requires to identify the information needs and how they
 general medical knowledge.
                                                                         can best be met. This implies the analysis, understanding and
                                                                         agreement between the main actors concerned as to the approach
 The data handling requirements of researchers working on the            best suited to meet user needs in a way which is consistent with
 molecular basis of biological systems are:                              economic and technological constraints.
 ---pagebreak---  No C 355/14                                 Official Journal of the European Communities                                     31. 12. 87
 1.1. Development of a reference model for MBI                         1.1.3. Integration and interoperation    concepts
                                                                       This work would concentrate on analyzing and extending the
Objective                                                              OSI concepts for open interconnection for the field of MBI. As
                                                                       far as equipment is concerned, it will build on OSI work but
                                                                       extend the concept 'open interconnection' to the sector specific
The developments in MBI will build wherever possible on the
                                                                       upper layers of the OSI model. Main issues include access control
developments in information technology, telecommunications,            and user identity; electronic signature and time stamping; con-
broadcasting and value-added services. In addition, and relating       fidentiality; data integrity.
to the application specific aspects MBI will develop specific
features and capabilities. For example, remote patient monitoring
may feed into cellular radio, but will require the development of
data capture and broadcasting techniques specific to health care.
Similarly protein and nucleic acid data bases will use standard
                                                                       1.2. Data requirements analyses for MBI
data base management systems, but will need special tools, e.g.
expert systems, to assist in the efficient use of the data.
                                                                       Objective
To permit MBI to build on synergy with other domains and to
                                                                       In order to develop information systems which are open and
help identify the requirements in common functional specifi-
                                                                       flexible in meeting the needs of health care by building on
cations and minimum standardization, it is proposed to start, as
                                                                       the evolution of the underlying sciences and technologies, it is
part of the pilot phase, with the conception and development of
                                                                       necessary systematically to analyse information requirements.
a reference model for MBI. As far as the telecommunications and
                                                                       The understanding of information requirements is the pre-requi-
broadcasting is concerned, this work can build on the reference
                                                                       site for the conception and definition of common information
model developed as part of the RACE programme.
                                                                       processing functions and the development of information
                                                                       exchange and portability. This in turn is a pre-requisite for
The specific objectives of this work are:                              common functional specifications and minimum standardization.
— to create and maintain transparency for the requirements and
     their functional characteristics,
                                                                       Scope
— to come to a common understanding of the evolution in MBI,
                                                                       The scope of the work needs to include the analyses of health
                                                                       care related information requirements and the specification of the
— between the main sector actors to come to a common defi-             associated specific features relating to data capture, processing,
     nition and understanding of the functional and minimum            verification, protection, authentication, storage, transmission,
     standardization requirements,                                     recall, and presentation for the following relationships:
— to support the work of common functional specifications and          — patient-health care services,
     of standardization by the appropriate bodies to facilitate
     progress in MBI for health care and research in related           — doctor-patient (correspondence, information, advice, etc.),
     domains.
                                                                       — doctor-reference information (case history, diagnosis of
                                                                           symptoms, prognosis, treatments options, prescriptions,
                                                                           recent experiences in treatments, etc.),
Scope                                                                  — doctor-diagnostic services (laboratories),
                                                                       — doctor-therapy (surgery, dispensaries, special therapies of
The work will comprise three major elements, namely those                  various kinds),
relating to the informatics environment of the doctor, the
scientist/technologist working in related domains, and the general     — doctor-administrations (hospital, insurance, public adminis-
requirements for the development of the reference model.                   trations, accounting, etc.).
                                                                       With respect to the laboratories and research infrastructure for
1.1.1. Reference model for the doctor information         environment  health care, the corresponding analyses will need to be carried
                                                                       out including the following relationships:
This will include all the functional descriptions relating to the
                                                                       — scientist/technologist-reference information (e.g. DNA and
information processes involving the doctor in his relationship to
                                                                           protein sequence and structure data bases, literature, etc.),
the patient and the supporting infrastructures (e.g. hospitals, etc.)
and services (e.g. laboratories, etc.). In identifying and describing  — scientist/technologist-experimental data (e.g. X-ray and neu-
the functional requirements both technical as well as cost con-            tron diffraction); two-dimensional high-resolution nuclear
siderations will be taken into account.                                    magnetic resonance, electron microscopy),
                                                                       — scientist/technologist-experimental equipment (e.g. molecular
1.1.2. Reference model for the scientist/technologist      information     dynamics simulation, X-ray crystallography, advanced 3-D
         environment                                                       graphic system, etc.),
                                                                       — scientist/technologist-administrations (hospitals or other ser-
This covers the functional description relating to the work of             vice demander, insurance, public administrations, accounting,
scientists and technologists working in health care related                etc.).
domains, e.g. laboratories engaged in diagnostics, but more gener-
ally those engaged in biotechnology. Though the scope of biotech-      The result should identify the options and the approach for the
nology goes beyond health care, the bio-informatics requirements       development of application-specific coding structures, allowing
are to a large extent common to all domains of biotechnology.          for technology expansion and refinement for data transmission
 ---pagebreak--- 31. 12. 87                               Official Journal of the European Communities                                    No C 355/15
in processable form. Within the scope of the pilot phase this       unattended sensing. This can be used to greatly improve monitor-
could already be expected to make a significant contribution to     ing, accuracy and overcome time and distance constraints.
the urgently needed harmonization of future developments as
well as prepare the ground for further detailed work.
                                                                    Population            screening
                                                                    Information technology can improve population screening for a
                                                                    curable but otherwise fatal disease, by enabling much of the
1.3. Assessment of the cost-performance potential of MBI            preliminary detailed screening to be automatic.
Objective
                                                                    Cancer         therapy
Informatics can be used in health care and biomedical research
both to increase performance and to achieve better economies.       The quality of life of a cancer patient can be significantly
The objective of this work in the context of the reference model    improved by the use of computer models aid decision-making
is to investigate the cost-performance potential of MBI.            allowing for better treatment, e.g. optimizing the use of surgery,
                                                                    chemotherapy and radiotherapy. The challenge is to link the
                                                                    information base with the developing models to optimize therapy
Scope                                                               for each patient.
The work in this domain will consist of the identification of
the various levels of the health care system where information
                                                                    Primary care
technology provides opportunities to develop methods for con-
taining costs yet improving care. Specifically the following areas
                                                                    A combination of new measurement technology and information
will be scrupulously investigated:
                                                                    processing enables better primary care to be provided, showing
— prescribing,                                                      how technology convergence operates to the advantage of health
                                                                    care. In particular, development of 'alternate-site' medicine
— radiology-image processing,                                       requires convergence of film technology, chemistry, molecular
                                                                    biology and information processing.
— laboratory equipment,
— benefit of sensor techniques,
— population screening,                                             B i o - m o l e c u la r research
— cancer therapy,                                                   Bio-molecular research has the potential of revolutionizing the
                                                                    economics of pharmaceutical production and the related research
— primary care,                                                     and development. There are already examples where bio-molecu-
— biomolecular research.                                            lar engineering techniques have been able to produce directly
                                                                    highly pure substances at greatly better economics than tra-
                                                                    ditional techniques permitted.
Prescribing
With the development of expert system- and communications-
based approaches to primary care prescribing the administrative
overheads can be reduced and the accuracy of matching patient       2. MEDICAL INFORMATICS ENVIRONMENT
needs improved.
                                                                    Description
Radiology                                                           In context of the rapid development of technology and automated
                                                                    information systems, standards are required to enable compari-
The use of digital techniques and optical disk storage, by generat- sons and exchange of health information at international level.
ing a much more advantageous data acquisition, storage and          Medical data availability and comparability in Europe should
retrieval system, can significantly reduce the annual cost of radi- allow better understanding of the patterns of evolution of chronic
ology today in comparison with X-ray film, chemicals, current       diseases, optimize resources with the result that the quality of
equipment maintenance and film storage( 1 ).                        care and the quality of life will improve and contribute to
                                                                    management and research to the benefit of patients.
Laboratory        equipment
                                                                    The growth of information technology in medicine is now leading
While the cost of maintenance of laboratory equipment, com-         to a proliferation of independent systems in Europe. Thus, there
puters excluded, is considerable, adoption of a policy of having    is a danger of an increasing lack of comparability between medical
expert system diagnostics in even the most simple laboratory        information systems that will limit the possibility of large-scale,
equipment would permit economies and improvement in service.        national or international studies, as well as the possibility of
                                                                    evaluating the efficiency and quality of care at the European
                                                                    level.
Sensor      techniques
Advanced sensorics offer considerable potential for remote and      The first priority is therefore to produce the required commonalty
                                                                    of medical languages as the fundamental basis for transferable
                                                                    systems through design and development of a European medical
                                                                    lexicon of syntax and semantics. This lexicon will form a focus
                                                                    for most of the medical functions, thus allowing for the develop-
(') Purchase of X-ray films accounts for 2% of the overall budget   ment of the concepts of integration and convergence in health
     of a hospital and 60% of its radiology department.             care.
 ---pagebreak--- No C 355/16                                         Official Journal of the European Communities                                    '                 31. 12. 87
Objective                                                                         exchange and comparisons in Europe, and between Europe and
                                                                                  the United States.
The main objective of the work under this heading is to achieve
the development of improved classification systems for the coding
of medical terminology as a prerequisite for the solution of trans-
boborder health care problems.                                                    Differences                in     classification         of     procedures
                                                                                  among European                     hospitals
At a scientific level, the adoption of comparable classification                  Unlike diagnoses, which tend to be uniformly classified according
systems is particularly important to obtain a better understanding                to the international classification of diseases, operations and
of the differences in the spread of diseases as well as of differences            other procedures are coded by national classifications or
in health care delivery systems and their cost in Europe.                         nomenclatures which have been elaborated following different
                                                                                  requirements of clinicians, health care managers, financing bodies
At a political level, accurate and reliable data bases are vital for              and social insurance funds, for various purposes, mainly adminis-
the monitoring of the efficiency and the quality of care, as                      trative in nature. The task is to upgrade any classification systems
well as for the development of strategies and of international                    of medical data in order to cope with evolution of medical
standards.                                                                        techniques, new diagnoses and management changes, taking into
                                                                                  account that the original classification schemes of procedures in
                                                                                  each country might include some better organizations than the
                                                                                  ICD-9-CM code. The study of a combination of a minimum set
Scope
                                                                                  of medical data from each European classification scheme will
                                                                                  eventually be developed internationally.
To meet this objective, four major areas of activity are required:
— international comparison of diagnostic criteria and pro-
     cedures related to costs (hospital in-patients),
                                                                                  D i f f e r e n c e s in c a s e - m i x a m o n g E u r o p e a n     hospi-
— definition of a minimum basic data set (MBDS) for ambulat-                      tals
     ory care in Europe,
                                                                                  As a first step it is recommended to carry out a comparison of
— semi-automatic encoding of standardized medical data classi-
                                                                                  the international classification systems measuring the costs for
      fication systems in Europe,
                                                                                  specific case-mixes for European hospitals, e.g. ICD-9, ICD-9-
— development of European criteria to define severity of cases.                   CM and DRG's, and to develop an approach to harmonizing
                                                                                  their use.
 2.1. International comparison of diagnoses and procedures
         related to costs                                                          I n f l u e n c e of c a s e - m i x o n l e n g t h of s t a y a n d c o s t
                                                                                   f a c t o r s in E u r o p e a n h o s p i t a l s
 Objectives
                                                                                   As resources tend to be allocated according to past requirements,
                                                                                   new indicators are needed to measure the productivity of health
 — Harmonization of medical data classification systems through
                                                                                   care delivery systems. The most widely available source of medi-
      comparisons and common results, using the European MBDS
                                                                                   cal indicators of productivity indicating why certain care has
      defined for hospitals.
                                                                                   been delivered to patients appears to be the medical record
 — Evaluation of the diagnosis related group (DRG) method-                         summary that includes the hospital MBDS with all diagnoses and
      ology in Europe, to understand differences and explore ways                  procedures performed for each in-patient. The work will be
      of comparisons.                                                              aimed at obtaining a better description of the health care delivery
                                                                                   systems in Europe by linking MBDS levels, abstracted from
                                                                                   medical record summaries with financial data as well as know-
 This work has an exceptional importance in order to coordinate                    ledge data bases.
 actions generated independently in each European country in the
 field of MBDS and diagnosis related groups, and to understand
 better differences in health services activities, productivity and
 quality of hospital care in Europe.                                               D e f i n i t i o n of p r o p o s a l s t o h a r m o n i z e m e d i c a l
                                                                                   d a t a c l a s s i f i c a t i o n s y s t e m s in E u r o p e a n h o s p i -
                                                                                   tals
 Scope
                                                                                   Programs will be developed in Europe to harmonize medical data
 The work in this part will consist of seven strongly interrelated                 classification systems. They must be as universal as possible
 areas:                                                                            — taking into account needs of all countries, including under-
                                                                                   developed countries — and flexible in order to allow for changes
                                                                                   in the future. The approach will be multi-disciplinary, to enable
 D e v e l o p m e n t of s t a n d a r d s f o r d a t a          input           dialogue between health professionals and managers.
 The two major aspects of this work concern the definition of
 standards for the collection and interpretation of medical data,
 taking into account that manual procedures are more and more                      D e f i n i t i o n of r e s e a r c h a n d d e v e l o p m e n t r e q u i r e -
 being replaced by computerized data entry and processing.                         m e n t s in s o f t w a r e a n d h a r d w a r e t o a l l o w c o m p e -
                                                                                   t i t i v e n e s s w i t h t h e US i n d u s t r y
 D i f f e r e n c e s in d i a g n o s t i c c l a s s i f i c a t i o n systems  Harmonization of medical data is a prerequisite for a large-scale
 among European hospitals                                                          European market in medical informatics. In order to have the
                                                                                   capacity to compete against strong American companies, the
 Whenever MBDS are available and comparable within and                             European industry will be supported to design and further provide
 between countries, pilot studies will be designed to obtain data                  well adapted packages that include MBDS and DRG's.
 ---pagebreak--- 31. 12. 87                                        Official Journal of the European Communities                                                   No C 355/17
2.2. Definition of a minimum basic data set for ambulatory care                    — Harmonization of rules for medical data classification sys-
         in Europe                                                                     tems in Europe.
Objectives                                                                         This work has a strategic importance for the development of
                                                                                   coherent health indicators and thereby health services standards,
— Harmonization of medical data classification systems by                          as well as the development of harmonized medical information
      defining a MBDS for ambulatory care, e.g. the core of knowl-                 systems that could generate a large industrial market for medicine
      edge that should be available everywhere in a comparable                     in Europe.
      way for the maximum number of usages in ambulatory care.
— Evaluation of the ambulatory visit groups (AVG) method-                          Scope
      ology in Europe to explore its feasibility, advantages and
      disadvantages.
                                                                                   Specifically the work is to concentrate on two major areas of
                                                                                   activity:
Scope                                                                              D e v e l o p m e n t of s t a n d a r d s f o r d i a g n o s e s in E u r o -
                                                                                   pean languages
The scope includes the following tasks:
                                                                                   This work aims at meeting the need for standards in extensions
D e f i n i t i o n of a n M B D S f o r a m b u l a t o r y c a r e
                                                                                   of the ICD-9 coding scheme for diagnoses in Europe. Semi-
So far in Europe only a small number of general practitioners                      automatic programs for encoding medical diagnoses will be
(between 1 and 5 % in different countries) use computers to                        designed and then made available on a European scale. Coding
process medical information. Standardization of classifications is                 could be part of an expert system front-end which, apart from
therefore a prime concern. The task is aimed at the validation of                  coding transparently from free-text input will incorporate con-
standardization concepts and pre-normative work for the coding                     text-specific coding and automatic error detection and correc-
in ambulatory care and the definition of a MBDS for family and                     tions.
out-patient care.
                                                                                   D e v e l o p m e n t of s t a n d a r d s      for     procedures          in
                                                                                   each E u r o p e a n language
U s e of t h e M B D S d e f i n e d a n d of t h e A V G m e t h o d -
o l o g y in p i l o t c e n t e r s in E u r o p e
                                                                                   Comparisons will be made between national procedures for cod-
Once a MBDS has been defined at European level, there is a                         ing schemes and between extensions of international classifi-
strong need for assessing the ambulatory visit groups method-                      cations and nomenclatures that are currently being generated
ology which has been developed in the USA in 1986, in order to                     in several European countries. The appropriateness of those
compare medical data linked with financial data in ambulatory                      classification schemes will be examined in relation to their use
care.                                                                              for different purposes: epidemiology, cost control, severity of
                                                                                   cases, quality of care, clinical research and management at all
                                                                                   levels. Application specific coding structures will be investigated,
D e f i n i t i o n of p r o p o s a l s t o h a r m o n i z e m e d i c a l       allowing for terminology expansion and refinement for data
data and patient classification                             systems          for   transmission in processable form.
a m b u l a t o r y c a r e in E u r o p e
                                                                                   These procedures must be compatible with DRG's and AVG's,
The definition of a MBDS in ambulatory care which is of para-                      which requires the development of editing programs and grouping
mount importance in the frame of health care delivery systems                      programs.
will allow the requisite preparations for the harmonization of
medical data classification systems.
                                                                                   2.4. Development of European criteria to define severity of cases
D e f i n i t i o n of r e s e a r c h a n d d e v e l o p m e n t r e q u i r e -
m e n t s in s o f t w a r e a n d h a r d w a r e t o a l l o w c o m p e -
t i t i v e n e s s w i t h t h e US a n d J a p a n                               Objective
Building on the advanced professional know-how in ambulatory                       The objective of this part is to obtain a simple set of criteria to
care in Europe and the considerable experience in the field of                     determine the severity of cases in hospital and in ambulatory
financial data on ambulatory care, the work will define software                   care, allowing the better assessment of the productivity of health
and hardware specifications for medical data classification sys-                   services in all European countries. Work in this domain will
tems in ambulatory care.                                                           provide a better understanding of the cause of health care costs,
                                                                                   a better control of costs adjusted to the need of the population,
                                                                                   and a large potential for the market of hospital information
                                                                                   services and ambulatory care systems.
2.3. Semi-automatic encoding of standardized medical data
         classification systems in Europe
                                                                                   The strategic importance of this work is summarized hereunder:
Objectives
                                                                                   — variations in costs have been shown in the USA as well as in
                                                                                   some European studies to be largely dependent on the severity
— Encoding and decoding from natural medical language to
                                                                                   of cases, but criteria to define 'severity' are not yet standardized,
       international classification systems.
                                                                                   even in the USA,
— Automatic grouping of these classifications into sub-classifi-
       cations related to costs (DRG's for in-patients and AVG's for               — criteria of severity should be easily available countrywide.
       out-patients).                                                              They can be based either on an analysis of the content of the
 ---pagebreak--- No C 355/18                                        Official Journal of the European Communities                                        31. 12. 87
MBDS or on physiological signs (like the Apache system in                    3.1. Clinical data and process modelling
intensive care).
                                                                             Description
Scope
Physiological             indicators                                         The lack of transferable understanding of a set of facts is often
                                                                             a serious impediment to the solution of day-to-day problems and
                                                                             to long-term progress. This is particularly true in medicine,
The task is to select physiological indicators in relation to inten-         pharmacy, therapeutics, and biotechnology, where there is a data
sity of care and severity of cases, with linkage to financial data.          set which needs to be understood by a non-specialist in that
                                                                             particular data. Clinical data modelling needs to be developed
                                                                             for ensuring transferability of data and processes. In principle,
C o m p l i c a t i o n s a n d p r o c e d u r e s in D R G ' s
                                                                             the clinical process (a patient's entry to, passage through, and
                                                                             exit from clinical care) can be expressed as a series of related
The work in this domain is aimed at refining the definition of               data and process statements. These can be formally encoded to
DRG's in relation to intensity of care and severity of cases, with           provide a scheme describing the care of the patient. Since the
linkage to financial data.                                                   scheme is based on the patient and the disease, there is minimal
                                                                             dependence on style of practice.
3. DATA STRUCTURES AND MEDICAL RECORDS
                                                                             Objective
Description
                                                                             The objective is to design standard clinical data models acceptable
As information requirements are identified, the data to meet                 across Europe. This will enable the reference model to operate
those requirements must be carefully defined if they are to be               in any required direction at any required level of care.
consistent, aggregated, manipulated for a variety of purposes,
exchanged and shared. As the data will be processed and stored
in computers of different types at different locations, they must            Scope
be seen within a model which defines their structure. This is a
prerequisite for the computerization of medical records. Regard-
ing the broad medical market with abundant varieties of initiat-             Specifically the work is to concentrate on:
ives in hardware and software developments mostly without
conceptual links to each other, only major breakthroughs in the
conceptualization and development of the medical record can
dramatically enhance the quality of medical care and at the same             Development          of  a common         coding      set
time really open the market as the doctor is the major actor in
the field and provides the main market target. The potential
growth of the demand is therefore very strong, but first requires            The task is to develop a common coding set integrating the
standardization and harmonization work to be achieved at Euro-               requirements of medicine and data protection. Medical codes are
pean level.                                                                  necessary as they provide a satisfactory compressed base for truly
                                                                             transportable systems, independent of the user language and the
                                                                             host system; they satisfy an increasing need to produce statistical
Objective                                                                    analyses of reliable demographic data on an international scale;
                                                                             they are required to provide common links for medical expert
                                                                             systems; data protection can be built into codes in fulfillment of
The objective of this part is to stimulate work at a European                national obligations, yet the embedded code is still transportable
level in the development of medical data and process models as               between different systems and different users.
a key to progress with information technology in health care,
and to foster concertation on the common functional specifi-
cations and minimum standardization required for the computer-
ization of medical records and progress in portable storage tech-            Development          of c o m m o n   data      formats
niques.
                                                                             Common formats are required to represent diseases and thera-
Scope                                                                        peutic processes. They optimize transfer of data and process
                                                                             information which thereby become independent of communi-
                                                                             cations and of host systems. Transferred data can immediately
To meet these objectives, this part would comprise three major               be reconstructed, whether it is read from an input communi-
areas of activity:                                                           cations line, a magnetic tape or a smart card.
— clinical data and process modelling, the development of which
     is essential not only for information transfer across bound-            Correctness,        validation      and      verification
     aries, but also as dynamic reference models for voice input,
     image processing and so on,
                                                                             At present there are no formal rules of medical correctness for
— specification of the functional requirements for a general                 validating medical expert systems. One of the great applications
    distributed medical record,                                              for expert systems in medicine is their role in defining 'normality',
                                                                             thereby saving staff appreciable time and effort which can be
— common functional specifications and harmonization pro-                    more efficiently directed to solving the problems of abnormality.
    posals for patient data cards to be used for storage of a single         Correctness of medical expert systems is therefore central to the
    patient's relevant data.                                                 development of biomedical informatics, especially as prac-
 ---pagebreak--- 31. 12. 87                                 Official Journal of the European Communities                                  No C 355/19
titioners thereby know that a particular system for clinical use     data cards to be used for storage of a single patient's relevant
has been formally validated as correct.                              data. The conceptualization and harmonization of this developing
                                                                     technology has to be thoroughly prepared in order to develop
                                                                     standards efficiently.
3.2. General distributed medical record                              Scope
                                                                     Specifically the work in the following areas is envisaged:
Objective
The objective is to design a record system that should provide       Card       technologies
easy, flexible structuring and summarizing of complex patient
records and be integrated with the decision support functions.       The task is to stimulate collaboration and concertation in the
The record system must both aid in the care of individual patients   analysis of the requirements and opportunities in card technol-
and support studies of populations for research and 'anticipatory    ogies, e.g. improved storage capacity for smart cards, mixed
care'. Above all, doctors must find that its usefulness repays the   smart-optical cards, readers, writer-readers.
effort of entering data and the maintaining system.
                                                                     Pointers
Scope                                                                Adequate addressing is required for use of pointers which, stored
                                                                     on the card, would allow retrieval of certain information, such
Conceptual studies will be undertaken to clarify the potential       as X-ray pictures, if necessary.
of a harmonized approach to a medical distributed data base/
transaction model. Major interest will be focussed on the
                                                                     Archival        storage
approach of distributed transaction processing.
                                                                     New techniques for adequate archival storage have to be investi-
                                                                     gated.
Identification        of  common         functional      require-
ments
                                                                     Picture       storage
Main activities will be directed to clarifying the requirements
                                                                     Compression techniques for picture storage require further devel-
for developing model hospital information systems and model
                                                                     opments.
regional systems using the new techniques of distributed trans-
action processing based on medical standards of data exchange.
                                                                     Medical       records     storage
Development         of   standardization          proposals          The task is to define methods for storing medical records in a
                                                                     hierarchical fashion, from a brief description of episodes, infor-
Standardization developed in this context may finally lead to        mation used to reach a diagnosis, and related data.
data exchange protocols on the medical application layer conform
to the OSI concepts.
                                                                     4. COMMUNICATION               AND      FUNCTIONAL          INTE-
                                                                          GRATION
3.3. Medical record system/data cards
                                                                     Description
Description                                                          Medical informatics still relies to a large degree on isolated
                                                                     solutions implying costly and wasteful procedures of transferring
                                                                     information between the different processes occurring in the
As the central source of information for all forms of clinical       health care system. Establishing communications between the
practice, the medical record is a key issue in the computerization   range of equipment and systems in use and under development
of medicine. The choices made in the design of computerized          offers considerable saving in terms of cost, but even more import-
medical record systems, which determine not only how medicine        antly in terms of time and flexibility. Beyond establishing the
can be practiced, but also how changes can be made in practice       ability to transfer and access information there is the potential
or in computerized activities, are vast and affect many aspects of   of removing some of the inherent redundancy in stand-alone
medical communications. There are several issues relevant to an      equipment and facilities. This is referred to as 'economies of
efficient medical record system. The ability to develop systems      integration' and means simply that as a result of functional
on a European basis requires answers to the following questions:     integration resources can be shared between equipment and fa-
what should be stored in a record? How should information be         cilities giving a considerable improvement in cost-performance
stored? Where should data be stored? What medium should it be        and flexibility.
stored on?
                                                                     However, the benefits of 'economies of integration' require the
                                                                     realization of functional integration and inter-operability going
Objective                                                            beyond the simple exchange of information.
There are several issues relevant to an efficient medical record     Objective
system. Any strategy in information technology for health care
will depend on projects incorporating studies on the design and      The work in this part is to investigate requirements and tech-
use of medical records. In this section reference is made to patient nology options in the domain of medical communications by
 ---pagebreak--- No C 355/20                                Official Journal of the European Communities                                        31. 12. 87
concentrating on some specific aspects of particular importance      would lie in the further foundation of a European-wide standard
for future developments.                                             in medical local area networks which could be used in connection
                                                                     with other efforts in harmonization to develop an attractive
                                                                     market and to contain health care costs.
Scope
                                                                     Scope
The scope includes the consideration of the information flow and
communication functions specific to the health care system. The
proposed work is structured in distinct work areas described         Further developments in technology, notably in the areas of
below.                                                               communications, local area networks, distributed processing and
                                                                     data-base systems/techniques as well as in the progress made on
                                                                     the agreement to international technical communication stan-
                                                                     dards, mean that the present emphasis in the area of hospital
4.1. Hospital information services                                   information services is on the integration of the different func-
                                                                     tional systems within a hospital into one unified information
                                                                     planning and management system.
Description
                                                                     The scope consists therefore in bringing together the relevant
The functioning of a hospital is highly information-intensive and
                                                                     European companies, the health care specialists and health econ-
has very stringent requirements. The information needs to be
                                                                     omists to develop the basic design and prerequisites for a common
available when and where needed often with no advance notice
                                                                     standard in hospital information networks.
or even real-time; the system needs to function in a reliable
manner; the services it offers must be well adapted to both
the medical personnel and, in parts, to the patients, placing        Specifically, this work will have to include the consistent investi-
considerable demands on the human factor engineering of such         gation of all the main aspects of integral information processing,
systems in order to make them user-friendly.                         i.e. medical standards for data exchange, medical bus, intercon-
                                                                     nection to medical instrumentation, and so on.
These and other requirements specific to the hospital environment
make hospital information services an issue requiring special
attention.                                                           The    medical      information        bus
Local area network techniques as developed for office automation     The task is to define a standard communications protocol for
will provide the basis for the development of information services   instrumentation used in hospitals, particularly for intensive care.
in hospitals, but additional efforts will be required to meet the    A wide range of instruments used in hospitals lack a common
specific needs of health care.                                       means for data acquisition, and often lack computer-addressable
                                                                     interfaces. Furthermore the development of closed-loop control
Hospital information services require an interactive computer        for drug infusion or ventilation has accentuated the need for a
based system which will progressively integrate and automate the     simple means of computer control. The medical information bus
entire flow of information in a hospital. Although there are still   is explicitly designed to meet these deficiencies and needs.
discussions about the choice between hierarchical and relational
data bases for information systems in hospitals, the trend is
towards integration of patients' information at the data level.      Picture      archiving     and    communication             systems
Hospital information services in the 1990s will be provided from     (PACS)
a central data base where diagnoses and procedures will be part
of the long term patient abstract. The data base will be analyzed
through a query language and accessed through a central com-         The object in developing PACS is to assist the tasks of storage,
munication system. The collection of data will be done from          archiving and transmission of images in diagnostic radiology
peripheral units or personal computers at admission and dis-         departments. Ultimately techniques developed for this purpose
charge points. Encoding will be facilitated by a data dictionary,    may also be extended for other medical communication purposes
a knowledge base editor, a data interpreter and a knowledge          and even for other functions. The specific task here is to support
base.                                                                the work carried out by European actors in the identification of
                                                                     the common functional requirements of PACS.
Objective
                                                                     4.2. Wide area biomedical information services
As there should be no formation of internal frontiers to health
care it is of great importance to start the reflection on the
requirements and functional specifications of hospital infor-        Description
mation services early enough to permit a coherent development
in this sector facilitating the collaboration between hospitals, of
hospitals with insurance and administrations, and also to make       Within modern health systems there is a growing need for wide
the hospital administrative procedures easier and more trans-        area communication services. This is due to several reasons, the
parent to patients.                                                  major ones being the promotion of primary health care (including
                                                                     home care), the propagation of real-time information regarding
                                                                     transplants, drug security, nutrition, environment, etc. Other
Harmonizing present efforts and at the same time preparing
                                                                     aspects of health care also require wide area services, e.g. the
actions for the future require focussing on the definition of a
                                                                     linking of laboratories in quality assurance programmes, etc.
hospital information network. Within this initiative the objective
would be to obtain a close collaboration of European industry
and health care experts in the investigation, conception, designing  Typical user requirements of wide area biomedical information
and development. A major advantage of such a development             services include the provisions of general clinical data, the transfer
 ---pagebreak--- 31. 12. 87                                 Official Journal of the European Communities                                    No C 355/21
of laboratory analytical data. This implies the exchange of data      dently of system and network architectures. The issue is complex,
files of several megabytes concerning structural analyses or digiti-  for data protection has to be very high for the individual, yet the
zed images.                                                           mechanism of data protection has to be sufficiently transparent,
                                                                      so that it does not impede the legitimate and authorized use of
In the related research areas there is a need for unrestricted access the data.
to the large data-bases and collections which form the basis for
modern biotechnology. Among these are:
                                                                      Objective
— nucleic acid and protein sequences,                                 Positive identification of authorized users of data is an important
                                                                      issue which needs to follow the organization and management
— structural data on proteins and biopolymeres,                       of health care. Fail-safe considerations are also application
                                                                      specific. The standards developed, e.g. for office automation, are
— genetic maps,                                                       not necessarily adequate for health care. The objective of this
                                                                      work is therefore the identification of the functional and technical
                                                                      requirements as derived from the needs in health care.
— vectors for nucleic acid sequencing.
A start has been made under the BAP which provides for
improved access for researchers to nucleic acid and protein           Scope
sequence data-bases, to a monoclonal antibody data bank and to
strain collections. However, this access needs to be extended to      The scope of the work will include all generic information
encompass structural data, genetic mapping libraries, cloning         handling operations in health care and the supporting services.
vectors and bibliographic data-bases, etc. and to take in industry    It is to include the concerns of the individual, whether as patient,
as well as academia.                                                  doctor, researcher, economist or legal specialist.
AIM is in this context to develop new tools to address these
objectives.                                                           4.3.1. Assessment of the data protection, authentication and fail-
                                                                               safe requirements in MBl
 Objective
                                                                       Objective
The objective is to offer a universal solution to the need for a      With the participation of the main actors concerned with the
 common biomedical network which takes account of such aspects        development and use of MBI systems, the issues of data protec-
 as time zone differences and holiday periods in Member States,       tion, authentication and fail-safe requirements are to be investi-
 and also the need to deal with functional aspects such as unread     gated for the health care applications. This will be done based
 messages.                                                            on a critical assessment of the state-of-the-art with respect to the
                                                                       requirements. The result will be to identify measures and actions
                                                                      to provide adequate solutions.
 Scope
                                                                       Scope
 It can be expected that most wide-area communication needs for
 health care applications will be met by the general development       Data-protection aspects involve all areas of data acquisition,
 of telecommunication services, i.e. requiring no specific actions     transmission, filing, interpretation. The scope involves therefore
 to be taken. However, the use of these techniques for health care     several aspects such as, e.g., in-house systems, regional systems,
 may raise a number of operational, regulatory and political issues    data cards, etc. It also includes related aspects such as data
 which need to be identified in time and for which appropriate         interpreting.
 answers need to be found. These may well impact the technical
 and operational features to be developed. For these reasons this
 limited analytical work is included as part of the pilot phase.
                                                                       4.3.2. Development      of international   medical   data-protection
                                                                                protocols
 The scope will include preparative work on electronically- or
 optically-linked terminals, and on link by a portable medium
 such as a compact disk.                                               Objective
                                                                       The objective is to specify the requirements for protection-based
                                                                       information handling tools in order to ensure user confidence in
 4.3. Data protection/authentication/fail safe                         high-efficiency information handling systems.
 Description                                                           Scope
                                                                       The scope of the work is to:
 In the context of health care some of the most sensitive data-
 protection issues arise. Data protection is a fundamental aspect      — develop a coherent set of good practice rules from which
 of data handling which will gain in importance as health care              data-protection principles can easily be adopted as part of
 networks grow, as information networks grow, as the community              the national legislation for medical information handling,
 becomes more litigation conscious, and as information gains in        — meet the need to link data protection in computer networks
 commercial value in response to the world-wide competitive                 and individual host machines to systems of patient-portable
 position of Member States. As a consequence, consideration of              data such as data cards,
 data protection becomes enmeshed with details of international
 standards, network developments, computer architectures and           — devise data-protection rules for development of intelligent-
 the means by which data transferable systems will work indepen-            knowledge based systems, building on the satisfactory map-
 ---pagebreak--- No C 355/22                                 Official Journal of the European Communities                                          31. 12. 87
     ping of certain questions concerning the data and process        Expert systems can improve the quality of medical actions by
     aspects of disease into open systems interconnection proto-      increasing the accuracy of diagnoses and more specific and indivi-
     cols,                                                            dualized recommendations for medical treatment.
 — foster further research on design of large scale data-protected    Expert systems can also contribute to control cost of care:
     networks. These aspects include encryption, addressing, auth-
     entication of sender, authentication of recipient, notification  — mistakes are reduced thus allowing for a more efficient prob-
     of dispatch, notification of arrival, freedom from error, indel-     lem handling,
     ible audit of information trails,
                                                                      — the diagnostic process can be shortened or logistically simpli-
— define the most effective algorithms for solving the abovemen-          fied (in the sense that less referral from institutions to others
     tioned issues,                                                       is required),
— contribute to the further development of existing open sys-         — patient-oriented expert systems will enable more patients
     tems protocols in order to satisfy the medical data-protection       with chronic diseases to navigate their disease effectively.
     requirement.
                                                                      Objective
5. BIOMEDICAL EXPERT SUPPORT SYSTEMS
                                                                      The objective of the work here is to identify requirements and
                                                                      opportunities for expert and knowledge based tools in medical
                                                                      care and related research domains.
Description
Expert support systems — the marriage between computers and           Scope
management science — are a promising development as expert
systems and decision support systems are merging to create the
software support required for a new type of computer system.          The task is to investigate and demonstrate the feasibility of
                                                                      European cooperation in the development of artificial intelligence
                                                                      tools for health care and related research. In order to limit the
Decision support systems were developed within the data-pro-
                                                                      scope it is suggested that the task be restricted initially to a
cessing world because of the practical limitations of data pro-
                                                                      specific medical problem area, e.g. diabetes. On-going collabor-
cessing for helping people solve complex problems in actual
                                                                      ations could form the basis for such an initiative. This experiment
organizations such as hospitals or national health organizations.
                                                                      would help to develop the empirical background on which to
Expert system technology reflects a largely independent evolution
                                                                      judge future work towards sharing of diagnostic tools and other
that took place in computer science research laboratories in
                                                                      health care features. Specifically it would be expected to show
answer to the limits of traditional computer science techniques
                                                                      the impact that these developments could have on quality and
for solving the complex problems that people can solve. These
                                                                      cost containment in health care. Main tasks would include:
two separate progressions can now be united to help solve a
broad range of important practical problems.
                                                                      — definition of a framework for expert systems in medicine,
Objective                                                             — analysis of knowledge representation,
The objective of this part is to explore the opportunities of expert  — analysis of medical reasoning,
support systems in the field of health care and to identify the
common functional specifications prerequisite for the emergence       — analysis of the interfaces,
and development of a competitive European market for this very
promising area.                                                       — interaction between expert systems and other types of sys-
                                                                          tems.
Scope                                                                 The framework            f o r e x p e r t s y s t e m s in medicine
To meet the objective stated above, this part would comprise the      The areas of medicine and health care in which it is possible to
following tasks:                                                      apply expert systems are to be identified and the possible con-
                                                                      ditions for their effective use are to be analyzed.
5.1. Biomedical expert and knowledge-based systems
                                                                      Knowledge         representation
Description                                                           The types of knowledge used in health care are to be analyzed
                                                                      and the way in which the usual techniques of artificial intelligence
                                                                      can exhaustively capture that knowledge is to be studied.
Whatever the speed and success of expert systems developments
in medicine, the already observable impact in standard products
of medical informatics reaching from dedicated systems to full        Medical       reasoning
size hospital information systems are remarkable and could even
be more important in a broader sens of quality assurance in
medical care. The same holds for the impact on biomedical             The various types of expert systems usable in health care (diag-
training.                                                             nosis, description of possible scenarios, planning) with their
 ---pagebreak--- 31. 12. 87                                 Official Journal of the European Communities                                   No C 355/23
respective architectures are to be analyzed, focussing attention      Real-time high-speed processing of medical information            is
on the procedural aspects and those that are supposed to be           required in several areas including:
meta-knowledge.
                                                                      — image processing (*),
                                                                      — voice processing,
Interfaces
                                                                      — real-time and greater-than-real-time modelling,
Starting from an analysis of the existing interfaces used in expert   — development of neuromuscular prostheses,
systems, the characteristics that the interfaces for the next gener-
ation of expert systems should have are to be studied, focussing      — network management.
attention on both natural language and graphics.
                                                                      Among improvements which real-time high-speed processing
                                                                      could bring to biotechnological research are:
Interaction
                                                                      — a substantial increase in the quality of information displays
                                                                           on the screen,
The types of systems already existing in an information system
(decision support systems, mathematical models and statistical        — the spreading up of multiple iterative calculations for the
package) that will have to interact with expert systems will be            validation of computer modelling of proteins.
analyzed as well as the type of interaction. Data bases, especially
those that have a universal relation interface, will be also con-     Objective
sidered.
                                                                      It is proposed to examine the options and the comparative
                                                                      advantages of special purpose super-computers for the domain
                                                                      of health care and biotechnological research (this does not mean
5.2. Dedicated computer language tools
                                                                      that other application areas may not have similar special purpose
                                                                      requirements). Specifically this work would investigate concur-
Description                                                           rent high order integration computers for biomedicine.
                                                                      Scope
It is proposed to investigate the feasibility of a 'macro language
for health care', i.e. a language building on general purpose
                                                                      The scope would include the design and the requirements for its
languages but having special features facilitating their use in
                                                                      development, as well as the assessment of the potential field of
health care and related research.
                                                                      application in MBI and other domains of similar needs.
                                                                      This work can build on the work carried out in the framework
 Objective                                                            of ESPRIT and national programmes in this domain as well as
                                                                      the experience in other countries working in this area.
 Usefulness, developmental speed and acceptance of applications
on medical communication systems would be greatly increased
 if a computer language existed that would support applied
nomenclatures and classification schemes as well as their further
development: meta-information as a tool of integration. The            5.4. Human-computer interface
objective of the work is to explore the options for a computer
 language that could support the design and usage of application       Description
 software in terms of medical and health organization meta-
 data and their contextual (semantic) and syntactical relations        As information processing systems require data input from medi-
 (semantic data models).                                               cal and other staff, great weight needs to be given to the develop-
                                                                       ment of the user interface. In particular, there is a strong need
                                                                       for a clear demonstration that these systems will be of benefit to
 Scope                                                                 the user who has to input the data.
 This work could build on the work in ESPRIT and on progress           Objective
 made in other countries relating to this objective. The pilot phase
 could help clarify the chances of success and the timeliness of       The definition of European standards and their feasibility requires
 such an initiative. The work could also include some exploration      a specific effort which is the objective of the work defined here.
 of semantic data models for medical data-base developments.
                                                                       Scope
                                                                       The general usability requires as much harmonization as possible
                                                                       in the human interface, regardless of the special medical appli-
 5.3. Special information processing requirements                      cation. It has to be developed to serve under the special working
                                                                       conditions of doctors taking into account also the requirements
                                                                       for efficient data protection.
 Description
 Health care and related research very often require the processing
 of images or other problems entailing extremely high computing
 power. Although there are a number of European ventures in
 novel processors or super-computers, further research and devel-      (') Medical scanning accounts for 11% of the US image-pro-
 opment is needed before they can find an application to the               cessing market. Fast-developing applications range from
  problems in health care and the related research areas particularly      dynamic cardiac imaging to fracture analysis and use of
  biotechnology.                                                           biosensor-derived information.
 ---pagebreak--- No C 355/24                                 Official Journal of the European Communities                                        31. 12. 87
5.5. Flexible open-architecture inference systems                      6.1. Integrated biomedical laboratory
                                                                       Objective
Description
                                                                       The objective is to investigate the options for realizing major
Use of information technology by physicians will largely be            improvements in research and development productivity in health
affected by the future developments in artificial intelligence which   care and related technological work by a concerted effort in
will require the ability to offer high-speed graphics and inferential  biomedical instrumentation with particular reference to the role
processing in a form accessible to a large market of practitioners.    of MBI. The specific concept to be explored is that of an inte-
In practical terms though, present developments are of limited         grated biomedical laboratory.
usefulness as they neither provide integration with every day
system aspects, as e.g. the patient data-base, nor provide for         The systematic development of the MBI as applied to biomedical
interconnections or transferability. To realize its potential useful-  laboratory activities could lead to the realization of integrated
ness, artificial intelligence has to be part of an integrated concept, biomedical laboratories bringing a considerable improvement in
where it plays the role of the assistant in every day work.            the cost-performance, quality, flexibility, reliability and speed of
                                                                       biomedical research, i.e. have a major impact on the research
                                                                       and development productivity in this domain.
Objective
                                                                       Scope
The objective of the work in this domain is to design a 'flexible
open-architecture inference system' as well as investigate its         The scope of investigation of an integrated biomedical laboratory
potential with respect to the technical features needed for            should include:
efficiency and adaptation to user needs.
                                                                       — integrated measurement of biomedical variables in vitro and
                                                                            their interpretation,
                                                                       — in-vivo sensors for diagnostics and therapy,
Scope
                                                                       — image and data interpretation,
The scope is aimed at the definition of a high-level operating
                                                                       — computerized scanning,
system which, using in-built expertise, can speedily and unam-
biguously interface with quite different system functions from         — magnetic resonance imaging (MRI),
different positions within the system. Specifically the task is to
analyze and assess the requirements for the design of a net of         — endoscopy, particularly video-endoscopy,
interacting experts, in which every expert gets the same initial       — picture archiving and communication systems (PACS),
data and during the consultation process the output of the others.
Further realization may be in a system of local distributed experts    — biochemical analyses,
connected by a local area network or one computer with parallel
 processing facilities.                                                — gene mapping,
                                                                       — protein characterization,
                                                                       — cell screening.
                                                                       The result is to give clear indications as to the comparative
                                                                       advantages of the concept of integrated biomedical laboratories
                                                                       compared with other options of advanced approaches to instru-
                                                                       mentation. Furthermore this work is to result in the definition
6. BIOMEDICAL INSTRUMENTATION AND RESEARCH                             of implementation concepts and the specification of the related
     TOOLS                                                             technological work and indicate the key factors which would
                                                                       need to be taken into account.
Description
Biomedical instrumentation is one of the key factors of progress
in MBI and is crucial for its future development. Information
technology embedded in biomedical instrumentation represents
the single most important factor in the explosive advance achiev-      6.2. Biomedical knowledge bases
ed in biomedical research. The crucial importance of integrating
advances in all technological domains including, in particular
                                                                        Description
advances in information technology, telecommunications and
broadcasting is expected to persist for the coming decades.
                                                                       The complexity and volume of medical and biotechnological
While European scientists rank high in the international compari-       information is considerable and growing at a rapid rate. Tens of
son, the productivity of their work is lower, i.e. the time spent      thousands of genes control specific life processes, three billion
for a given research result is very much higher. In other words        units of DNA form the human genome. With current techniques,
the productivity of European research and development, not the         sequencing these three billion units could consume 3 000 man-
quality, is lacking compared with other developed regions. This is     years. However, automated DNA sequencing machines are under
to a large extent due to inadequate progress realized in biomedical    development which may cut costs of sequencing a gene to a
instrumentation and the integration of information technology.         fraction of an ECU within the next decade.
The performance of the Community in the timely adaptation of           Similar progress is being made in the analysis of other biological
concepts and objectives to the technological advances will be          materials and in work on the molecular basis of medicine and
decisive for the cost-performance of health care and also for the      therapy. However, much of this progress depends on the effective
international competitiveness in offering health-care products,        management of the information acquired. Here the design and
 equipment and services.                                               development of biomedical knowledge bases is a central issue.
 ---pagebreak--- 31. 12. 87                                 Official Journal of the European Communities                                   No C 355/25
Objective                                                            Objective
The objective is to identify and assess alternative approaches to    The objective is the development of an approach to automated
manage biomedical information systems and avoid overloading.         protein analysis and its linking to protein synthesis.
This requires the rapid storing and sharing of information from
medical, pharmaceutical and genetic research.                        Scope
Scope                                                                The scope of the exploratory work to be included here extends
                                                                     to medical, pharmaceutical and biotechnological requirements
The information system and therefore the related knowledge           for protein analysis and synthesis. The work is to address primar-
bases need to support biotechnological and genetic research as       ily the potential of MBI and CIM.
well as the development of pharmaceutics, medical research and
medical care. The reason for this need derives from the increasing
use of diagnostics and therapy based on the understanding of
genetic and biomolecular processes.
The scope of the work would initially include the issues of          7. NON-TECHNOLOGICAL FACTORS
effective information acquisition, organization, maintenance,
retrieval, access, for biotechnological, pharmaceutical and medi-    The orientation of technological efforts towards meeting socio-
cal uses.                                                            economic needs implies taking into consideration the context in
                                                                     which the technology is to be used. The optimal use of resources
The result of the exploratory work would serve to identify and
                                                                     implies furthermore that the organization and management issues
assess the options for effective and economic management of
                                                                     are equally taken into account. The political nature of high
genetic and biomolecular information.
                                                                     technology requires that even at the stage of pre-competitive
                                                                     research and development these aspects are assessed and the
                                                                     implications brought to the forefront.
                                                                     This part of the pilot phase is dedicated to analyzing and assessing
                                                                     some of the non-technical factors embedding this initiative in the
6.3. Automated DNA sequencing                                        wider context of related activities.
Description
                                                                     7.1. Investigation of the opportunities of closer collaboration
                                                                            between national actions
Progress in biotechnology has led to new techniques for diagnosis,
treatment and prevention of disease. Most of these — from
new vaccines based on recombinant DNA to the creation of             There is already a large effort under way within Europe and
therapeutic proteins for the treatment of cancer or heart disease    excellent work is being done. However, due to the predominantly
— depend on rapid and economic sequencing of DNA.                    national orientation of these activities, there is a significant
                                                                     amount of redundancy in the work being undertaken and the
Over the past decade the rate at which DNA can be sequenced          possibilities for synergy often remain unexploited.
has increased to several thousand nucleotides per day. US and
Japanese teams are developing automated DNA sequencers which         The investigation proposed as part of the pilot phase is to develop
will increase this by several orders and also reduce the cost.       measures to assist existing actors in identifying related activities
                                                                     and establishing collaboration where appropriate. The investi-
                                                                     gation and consultation will also include the formulation of
 Objective
                                                                     recommendations to facilitate the common exploitation of results
                                                                     and transfer of technology.
The objective during the pilot phase would be the examination
of the options for European cooperation in the development of
 automated DNA sequencing. The special emphasis would be on
                                                                     7.2. Review of the functional specification, standardization and
 the application of advanced CIM techniques to achieve high
                                                                            certification practices
 productivity and reliability of the results. This would be pursued
 in close collaboration with biological researchers who are already
 involved in the BAP programme in improving sequencing tech-          The problem of coming to agreed functional specifications and
 niques.                                                              minimum standardization for the use of information technology
                                                                      and telecommunications in health care and related research is
                                                                      complicated by the need to combine the efforts of these organiz-
 Scope                                                                ations focussed on health care and of others oriented towards
                                                                      information technology and telecommunications. In addressing
 The work is to include the systematic assessment of requirements
                                                                      the issues of MBI one will wish to build on existing standardiz-
 and technology options for automated DNA sequencing.
                                                                      ation bodies. In order to achieve an effective approach and in
                                                                      view of the national differences and the multitude of organiz-
                                                                      ations already involved in one way or the other it is proposed to
                                                                      carry out a survey of standardization, specification and certifi-
                                                                      cation practices in Europe and internationally. This work is to
                                                                      result in a recommandation as to the optimal approach to
                                                                      addressing future requirements in standardization, specification
6.4. Automated protein analyzer/synthesizer                           and certification in Europe.
Description
                                                                     7.3. Review of the legal and regulatory framework applying to
Besides DNA there is a whole range of biomolecules playing a                MBI
key role in medicine and biology. The problems of analyzing
structures and synthesizing them in a controlled manner is of        The use of information technology and telecommunications for
paramount importance for therapy on the molecular level.              health care needs to include appropriate regulatory and legal
 ---pagebreak--- No C 355/26                               Official Journal of the European Communities                                          31. 12. 87
measures to assure the protection of patient interests as well as    gate the economic impact of MBI on health care and on the
the commercial interest of service providers and operators.          supporting services, in particular biomedical research. The result
                                                                     of this work is expected to provide an understanding of the
In order to avoid the formation of new internal frontiers in the     economics of information in health care and indicate the way
Community there is a need to engage in an effort aiming at the       MBI can make the best contribution to improvements in cost-
definition of common rules and conditions for the introduction       performance of the overall system.
of MBI.
As a starting point for so doing it is proposed to analyze the
present regulations and legislations governing the use and intro-
duction of MBI. The work is to result in the identification of the   7.5. Assessment of special skill training requirements and
options and measures which could be developed in order to                  options to meet them
support a harmonious development of the regulatory environ-
ment for MBI applications in Europe.
                                                                     For the exploitation of opportunities created by technological
                                                                     advance special training plays a key role. Typically the pro-
7.4. Economic assessment of the MBI potential for health care        fessional staff in place have received their education some 10
      and biomedical research                                        years back and even at that stage the education may not have
                                                                     been up to date. Of course there is a considerable investment in
                                                                     adult education and training, but in areas which are evolving
Besides the qualitative advances MBI offers for health care the      very rapidly, as in the case in MBI, special efforts will be needed to
potential of cost-containment is the most important contribution     overcome the difficulties of technology and knowledge transfer.
to be looked for. However, the relationship between the perform-
ance of a technology or a service and the impact on improvements     The work proposed as part of the pilot phase is the assessment
in cost-performance are not straightforward. They depend on          of requirements and the development of a scheme for special skill
numerous other factors and conditions which need to be under-        training directed at familiarizing researchers and practitioners
stood and taken into account. It is, therefore, proposed to investi- with the potential of advanced MBI.