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 - (submitted by the Commission)

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 ---pagebreak--- COMMISSION          OF    THE      EUROPEAN           COMMUNITIES
                                                              COM(87) 352 final
                                                              Brussels, 24 July 1987
     Proposai for a Council Régulation 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 -
                       ( submitted by the Commission )
COM(87) 352 final
 ---pagebreak---                                                    1
                                             Contents
SUMMARY                                                                                  l
 1 . INTRODUCTION "THE CHALLENGE IN MEDICAL CARE"                                       4
        1.1 Growing opportunities in medical care and the implicit rôle of informatics  4
        1.2 Medical care is a major socio-economic sector with great potential
            for the future                                                              8
        1.3 Characteristics of future developments                                      8
        1.4 Medical care by the year 2000                                               9
2 . OPPORTUNITIES AND ISSUES IN MEDICAL - AND BIO-INFORMATICS                          11
       2.1 Socio-political dimension                                                   11
       2.2 Convergence of health care and information services                         11
       2.3 Convergence of Biotechnology and Information technology
            (Mastering the complexity)                                                 12
       2.4 Speed of évolution                                                          12
       2.5 Mastering économies and shortages in technological resources                12
       2.6 Conclusions                                                                 13
3 . OUTLINE OF AN        ACTION PLAN                                                   15
       3.1 Action Line   I                                                             15
       3.2 Action Line   II                                                            15
       3.3 Action Line   III                                                           16
4 . PHASING OF THE IMPLEMENTATION                                                      17
       4.1 Pilot Phase                                                                 17
       4.2 Main Phase                                                                  17
5 . ORGANIZATION AND MANAGEMENT OF THE COOPERATION                                     17
       5.1 Evaluation                                                                  18
       5.2 Relationship with International Projects and National Efforts               18
       5.3 Participation of public and private organizations established in
            Non-Community European countries                                           18
       5.4 Secondment Scheme                                                           19
       5.5 Participation of SMEs, Research Organizations and Universities              19
       5.6 OverView of actions in MBI                                                  19
6 . GLOSSARY                                                                           25
Enclosures:
            Draft Regulation
            Draft Workplan
            Financial Record
 ---pagebreak---                                                    1
SUMMARY
European Heads of State and Government have agreed that medical care and work in
related technological areas represents a priority area for European cooperation. This
includes, as one specific line of action the exploitation of the advances in information
technologies , telecommunications and broadcasting to improve medical care and support
the underlying technological efforts in medicine and biotechnology.
Health is next to food and shelter one of the basic human needs. Conscious of the high
priority of health care and of the growing possibilities , but also of the cost constraints,
the Community needs to optimize its efforts towards this common objective. Leading
experts have joined the Commission in identifying actions which are suited to exploit the
technological advances in Medical and Bio-informatics so as to bring the maximum care
to the patient while staying within reasonable limits of individual and collective
expenditure.
The Community initiative in Medical and Bio-informatics (MBI ) is to be seen as part of
a concerted effort in related domaii^ both medical and technological, on which it builds
and of which it forms a specific action to re-inforce progress and draw systematically on
the benefits of collaboration on a European scale in the form of greater cost-
effectiveness and a faster propagation of the best practices.                   The conception and
development of new health care technology and services calls for an optimal use of
human resources, facilities as well as financial means and the participation of all the
main sector actors . Broad consensus and participation is a key requirement for success
and progress in this domain where social and human considerations are of outstanding
importance.
Based on exploratory work in 1985/86 involving 150 leading experts                   a programme of
cooperation in MBI has been developed of which this proposal represents the Pilot Phase.
The global objective is to serve the concertation of European efforts towards
       sustained improvement in health care in the Community for the 1990’s within
      economically acceptable limits by exploiting the potential of Medical and Bio-
                                                informatics .
AIM is designed in such a way that it will contribute to the strengthening of the internai
market and free compétition for health care related equipment and services which
dépend on compatibility and interoperation of information Processing and
communication. It will do this by
            fostering work which will lead to the identification of common functional
           spécifications , minimum standardization and conventions for Medical
           Bioinformatics for health care related telematics which is the pre-requisite for
           an open compétition and the strengthening of the market for information and
           télécommunication assisted health care services;
           stimulating the standardization work in related areas and contributing to the
           spécifie work required for MBI equipment and services;
    1)     In particular the Medical Research Programme, ESPRIT, RACE and the work on standardisation and
           certification
    2)     BICEPS Planning Exercise and Exploratory Investigations in 1985 /6
 ---pagebreak---                                              2
           fostering Community-wide open competition of ideas and approaches to
           developing specific MBI-based health care concepts and services at the pre-
           normative and pre-competitive level;
           initiating reflection on the adaptation of the regulatory framework facilitating
           Community-wide collaboration in developing and using advanced medical and
           bio-informatics to improve the quality and cost-performance of health care.
The proposal consists both of ’precompetitive systems R&D’ and of pre-normative
measures concerning the establishment of synergy in developments in related applications
(personal computing, consumer electronics, telecommunications and broadcasting) which
will be beneficial for an open competition on a European market place.
AIM at the technological level situates itself at the ’pre-competitive’ and ’pre-normative’
stage , while being quite specific as to the objectives to be achieved . The present
situation being one of extreme fragmentation and , for advanced work , subcritical effort,
the suggested worksharing and cooperation can be expected to reduce duplication but not
so extensively as to constrain competition. The allocation of contracts will be based on
an open competition and in some cases it may be desirable to explore several competing
concepts as a means to a stated objective.
AIM will help to establish the basis for a European market for Health Care Services.
However, AIM designedly does not include development or production as such , but only
the common tools and facilities this will require .
In its contribution to standardization and certification AIM will help to stimulate
compétition by early on defining principles and initial development conventions.
Within these general objectives AIM is expected
          to make major contributions towards improving quality, flexibility and
          accessibility of health care in the Community;
          to increase the effectiveness of patient care in order to bring about a réduction
          in the cost of health care;
          to make a major contribution towards increasing that part of the sector
          resources which directly benefits the patient and assists the medical profession
          in their mission;
          to   contribute   to  the  establishment  of  minimum    standards  and  common
          functional spécifications prerequisite for the emergence of a strong and
          compétitive European industry providing medical informatics equipment and
          services;
          to contribute to the development of agreed codes of good practice, protection
          of privacy, and reliability for medical informatics as a prerequisite of
          appropriate regulation and protection of the patients privacy;
          to stimulate collaboration and concertation in the analysis of the requirements
          and opportunités in MBI and its application;
 ---pagebreak---                                             3
            to contribute to the common adaptation of the regulatory framework to
            advances in the nature of health care .
 AIM will pursue these objectives through the more effective deployment in the
 Community of new MBI-techniques
            to support all branches of health care , including prevention , diagnosis,
            treatment , the medical record and its analysis; and
            to support the advance of research in related scientific and technological areas
            by using MBI to increase R&D-productivity.
 AIM directly concerns
            the national authorities administering health care ,
           staff providing health care ,
           patients receiving health care ,
            the medical equipment industry ,
           the communications industry,
           medical and biotechnology researchers ,
and strongly concerns the interests of :
           health insurance
           the pharmaceutical industry
           medical education and training institutions .
AIM is to be implemented in a phased approach starting with a Pilot Phase which is the
subject of this proposal . Subject to a successful implementation of the Pilot Phase a
Main Programme extending initially over 5 years may be proposed .
The nature of the work proposed includes
           analytical work towards the identification of common requirements and their
           functional characteristics;
           pre-normative work on MBI towards common functional spécifications and the
           development of minimum standardization proposais;
           pre-competitive work as required to establish the techno-economic feasibility
           of common functional spécifications and standardization proposais;
           vérification of standards and their testing with respect to the functions and
           operations they are to support in medical care and biotechnological research;
           contributing to thè rapid exploitation of thè results by systematically
           familiarizing thè health care professionals with thè potential of MBI
           applications .
In order to carry out the Pilot Phase of the action described in this communication , it
has been estimated that 300 Man Years of work will be required . Industry is expected to
contribute at least 50% to this action . For non-profit making participants not receiving
any related support from other sources the requests for support of up to 100% may be
considered . Assuming that 2/3 of the projects can be supported at a level of 50% and
1 / 3 can only be carried out by higher funding levels , the amount of Community funding
is estimated at 20 MECU over a period of 18 months .
 ---pagebreak---                                             4
1 . INTRODUCTION "THE CHALLENGE IN MEDICAL CARE"
After a mainly evolutionary advance in health care, recent decades have seen a
considerable acceleration driven by scientific and technological progress as well as a
strong and lasting commitment of large resources to this objective. Some of the new
means already available and the potential of the coming decades may well revolutionize
health care. This is of obvious social consequence but it is also of considerable political
and economic importance. Europe can pride itself on a leading role in some areas of
health care and the related scientific domains. However, as the need increases for
concentration of efforts , skills, facilities and financial resources for R&D in related
domains such as biotechnology and medical informatics, so Europe is rapidly falling
behind. Cooperation between scientists, research centres and increasingly with industries
is becoming a necessity to engage and stay in this high-technology domain .
For a more cost-effective approach to the challenge in health care and related
technological R&D, flexible and effective frameworks for concertation and cooperation
are required which permit the sector actors to make their respective contributions within
a consistent perception of objectives , thereby avoiding redundancy where it is wasteful
and focussing resources on central objectives.
1.1 Growing opportunities in medical care and the implicit rôle of informatics
The last decade has seen
          the introduction of powerful diagnostic tools based on technological progress in
          the medical field as well as the systematic application of MBI, e.g. magnetic
          resonance ( MR ), computer tomography (CT), nuclear medicine ( NM),
          ultrasound , digital subtraction angiography (DSA ), etc.;
          the intégration of these tools into department-wide Systems;
          the introduction of more précisé and less invasive therapy methods , such as
          laser angioplasty, endoscopie surgery, extracorporeal shock wave lithotripsy
          ( ESWL ), and précision radiotheraphy;
          the emergence of biotechnology, intimately linked with the progress in
          bioinformatics, as a new driving force of techno-economic change , with the
          bulk of expenditure in biotechnology effort being focused on health care in the
          areas of therapeutics, diagnostics , selective delivery systems, and immunology,
          bringing greater understanding, information intensity, screening possibilities ,
          greater precision of diagnosis and therapy, rational drug design , genetic
          intervention;
          the penetration to the bio-molecular level of analyses , diagnostics , treatment
          and bio-engineering assisted by some of the most advanced products of
          information technology, eg gene-mapping , computer-assisted engineering of
          substances , computer simulation of biomolecular processes , etc;
 ---pagebreak---                                                                                          ΛΙ412
        Schema of the Health Care System
Main Economie Forces
Mounting Costs of Health Care                                     Main Acbors                   T1
Growing Demand and Offer                                          Public Health Authorities
                                                                                                ha *
                                                                                               00
Economy of Integrat i on                                          Insurances                    C
Economy of Scale                                                                                ■n
                                                                                               fi
Demographic change                                                Hospi ta la
                                                                  Medi col Profession
                                                                                                     V/t
Technol ogi cal Change                                         Impact of MBI
Progress m Biomedicine        Common Requirements              Increased cost-performance
Progress in IT & Telecom.     Interoperation                   Closer matching of patient 8
Convergence of ITSBT          Common functional specifications medical  needs
                              Minimum standardisation
                              Bevel , of MBI capability
                              Expertise and more funaina
 ---pagebreak---                                                       6
  Table 1 :                                                  . reliability
                                                            . speed
  SCOPE OF APPLICATIONS OF MBI IN                           . non-invasivenes*
  BIOMEDICAL R&D                                            . miniaturisation and portability
                                                            , autonomy
  Medical        Bio-Informatics           is  strongly     . interoperation
  embedded in all sectors of health care and                . remote control and monitoring.
  the scientific/technological activities it is
 based on . The following listing gives
 examples where MBI is playing a                         THERAPY
 particularly strong role .
                                                         High précision radiotherapy
 PREVENTION                                              - Brachytherapy
                                                         - Précisé dynamic beam control
 Efforts are increasing in preventing health problems
 from arising or from reaching a level where therapy     Fibroscopy
 becomes necessary . Examples where MBI is important     - Classical fibroscopes
 include :                                                 . plastic and silica fibres
 - screening of tissue samples for cancerous cells         . bundles
 - epidemiological screening of the population           - Video-endoscopy
 - search and identification of new diseases and health    . CCD transducers miniaturisation
     problems                                            - Infrared thermography
 - information and education of the population (eg         . Infrared photodetection
     using the media in the case of AIDS )
                                                         New surgical techniques
DIAGNOSTICS                                              - Electrotome
                                                         - Cryosurgery & coagulation by electromagnetic wave
Computer assisted diagnostics                            - Therapeutic laser
                                                         - Lithotripsy ti ultrasonic lancet
- Expert Systems                                         - Operating microscopy
- Data Bases                                             - Life support Systems
Imagine                                                 Sensors for in vivo diagnostics
- Digital radiology and digital angiography
 - Computer Tomography                                  MEDICAL COMMUNICATIONS
- Nuclear Medicine
       . single photon émission computer tomography     In Prevention /Early Detection / Self Care
     ( SPECT)                                                   Use      of telecommunications     networks  for
   . positron émission tomography (PET)                      epidemiology purposes and medical counselling
- Magnetic Résonance                                           Computer assisted systems providing health
- Echography                                                 information ,    health   education ,  training  in
- computer assisted diagnosis .                             elementary health care .
Laboratory equipment                                    In Primarv Care
- Molecular absorption spectrophotometer                - Professional medical information System
- Liquid chromatography                                 - Management of referral
- Electrophoresis                                       - Medical record data collection and analysis
- Blood cells counter                                   - administration of health check-ups
- Electronic microscopes
- Cytofluorimeters                                      In Secondarv Care
- Microscope image analysera                            - Hospital communications
- Doctor's office tests                                 - Resource scheduling
- Microbiology analysera                                - Patient record data bases
- Spécifie uses of MBI to achieve                       - Clinical research
 ---pagebreak---                                                         7
 - Data proceaaing for ancillary services
 - Integrated hospital information Systems
 * In Administration of health care Systems
 - Medical records management
- Decision support for medical resource management
- Health statistics
- Epidemiology
* Surveillance functions
- Medical information management
   . laser cards and disks
  . large data base management techniques
  . advanced decision support
  . advanced présentation aids
BIOMEDICAL RESEARCH
- Supercomputing in bio-molecular research
- X-ray cryatallography and analysis of structures in
    solution
-   Dynamic modelling of biological Systems
-   Gene mapping and sequencing
-   Protein engineering
-  Artificial intelligence as a research support tool .
MEDICAL TRAINING
- Computer-based simulation in diagnosis
- Expert Systems as diagnostic check and in tutoring
- Computer assisted spécial skill training
etc.
 ---pagebreak---                                            8
           an unprecedented growth in medical and related scientific knowledge, e.g.
           the number of researchers in life sciences represents about 25% of the total
           number of scientists;
           the number of distinct diseases recorded in medical literature has increased
           more than tenfold since 1900;
           the number of pharmaceutical products, which presently exceeds 10 000
           increases by about 250 each year;
           in recent years biotechnology has resulted in dramatic progress in the quality
           and production économies of pharmaceutical products;
Throughout MBI has been instrumental and an essential ingredient of progress .
Figure 1 and Table 1 illustrate the rôle of medical and bioinformatics in Health Care.
1.2 Medical care is a maior socio-economic sector with ereat potential for the future
          with roughly 8% of the GDP of Member States going into medical care, this
          sector is comparable to spending on Defence and bigger than
          Telecommunications;
          within the European Community there are roughly 800 thousand doctors and
           15 thousand hospitals with more than 3 million hospital beds for a population
          of about 320 million. This makes it the biggest service sector;
          with a growth rate of 8% per annum , health care services are one of the most
          rapidly expanding markets in Europe . Within this the growth-rate of MBI is
          about 15% per annum and is expected to increase its importance over the next
          decade until it represents 5% of the equipment and service expenditure. Due to
          the continued rise in expectations of improving the quality of life medical care
          can be expected to remain a crucial sector in future societal developments;
          non-pharmaceutical medical products represent today a market of about ECU
          25 billion market worldwide , growing at a compound rate of 10% per annum.
          Europe's part of this market is only 20% , despite the size of its population
          and the growing demand .
1.3 Characteristics of future developments
Future trends will be shaped by growing demand for health services (world wide and in
developed countries reinforced by demographic factors ) and rapid advances in science
and technology constrained primarily by the cost of providing health care .
Technology will be instrumental in
          offering more cost-effective means of diagnosis and therapy
          contributing to the further improvement of existing techniques of health care
          offering better adaptation to the needs of patients , doctors and health care
          services,
but will at the same time , in order to improve the delivery, organization and
management of health care
          permit improvements in providing health care in hospitals as well as in
          ambulant services (eg home health care)
          offer new and enhanced possibilities in supporting training and specialization
          of medical staff, and
 ---pagebreak---                                               9
            facilitate the administration of medical data and accounting.
 This can be expected to occur as a rapid evolution . However , some of the changes are
 likely to affect strongly the organizations involved in health care and the division of
 labour between different branches of health care . Implicit in this evolution are major
 structural changes involving all parts of health services including the supporting services
 and extending to the regulatory and legal environment as well as training and
 qualification of health care staff.
 The exact evolutionary paths are difficult to assess at this stage, but some of the main
 features can be identified and attention be focused on them . The following section
outlines a scenario of the kind of health service which might emerge in the late 1990’s.
 1.4 Medical care by the vear 2000
The technological developments of the coming decades will extend the possibilities of
health care and at the same time remove traditional constraints to providing care . Health
care will have been much more adapted to the needs of the patients , ie offered when ,
where and in the way the patient wishes, rather than according to the location and
organization of health care infrastructures and services .
Some examples can serve as illustration of the kind of changes one may see:
     1)      "Telemedicine" : Certain health care services, in particular of a diagnostic
           kind , couid be offered by the use of advanced telecommunication services,
           combined with new techniques of diagnostic packs, which permit the patient to
           provide the doctor with the essential information. The benefit would be to
           reduce the necessity of moving patients and improving the access to the doctor;
     2)    "Open Hospital Care": With the advance in medical equipment technology,
           their interworking with telemetry and remote control , it becomes possible to
           provide hospital-type care outside the constraints of hospital complexes;
     3)    " Integrated Hospital Care": An Integrated Hospital approach would bring the
           therapy and diagnostics to the patient instead of moving the patient to the
           facilities as is today largely the practice . This becomes possible only as a result
           of a systematic development of health care technology and their interoperation;
     4)    "Customized pharmaceuticals": As part of an integrated approach to health care
           and supporting services it will become possible to interpret the diagnostic data
           and treatment strategy in terms of designing patient-specific prescriptions . This
           will include drugs themselves, the mode of administration and the rate of
           administration . The drugs can be expected to include conventional
           pharmaceutics as well bioengineered products. The advantages of tailoring
           drugs and their delivery to the specific needs of the patient are considerable.
           The side effects could be reduced and thereby the speed of recovery could be
           expected to improve and the need for further treatment minimized .
Many other features and changes in the way health care is offered can be expected to
emerge. When and how they will be seen depends on several factors, BUT one of them
is common to all scenarios, the dependence on functional integration and interoperation
of equipment and services as offered by MBI .
 ---pagebreak---                                             10
 2 . OPPORTUNITES AND ISSUES IN MEDICAL - AND BIP - INFOR MATirs
 2.1 Socio-political dimension
 Health care and the use of technology to support it must, more than other domains take
 into account the social dimension. The use of technology, the organization of health care
 the way it is offered need to be governed by and centred on human relations. This
 implies that the consideration of all use of technology in medical care directly relating to
 the patient or the patient’s relationship with medical staff needs to be conceived and
 developed in accordance with the medical and psychological needs of patients and
 medical staff. Human Factor Engineering needs therefore, to play a central role in
 developing MBI where it relates to the patient and the patient relationship with medical
 staff.
 The proper understanding of the human element and its relationship to technology is a
 crucial element for acceptance and therefore utility. Furthermore the economic success
 of the related equipment, products and services is largely affected by the success in
 addressing this issue.
 In the MBI domains not relating directly to the patient-doctor relationship but to the
 utilisation of MBI within the professional medical services , good adaptation to meet
 user needs is also very important and needs to be addressed , but is not of the same
 paramount importance as in the patient-doctor context, where it is crucial.
The reason for stressing this point in the context of pre-competitive and pre-normative
 work is that more and more of the features of the ultimate application are conceived at
the early research stages , ie the social dimension needs to be included as a research
objective and design criterion already at this stage.
2.2 Convergence of health care and information services
Health care is the result of the systematic use and integration of many approaches and
techniques. But all of them depend to a very large degree on communications between
the patient and medical staff on the one hand and between medical specialists and
associated services on the other hand. It is , therefore, to be expected that health care
will increasingly exploit the enhanced possibilities of telecommunications. Now already
medical advice is being offered via the telephone . With the emergence of broad band
services one can expect that this kind of medical service will expand progressively.
Videoconferences between specialists in different parts of the world on a particularly
difficult case , may become standard practice in the 1990’s , to mention just one example
relating to the work of doctors. Biochemists supporting health care already rely on
protein data bases developed and maintained by experts world-wide . This kind of
development can be expected to expand rapidly offering progressively more powerful
research tools .
In technical terms this means that health care is a leading-edge user of information
services ranging from broad-band services to very sophisticated data base management
systems making use of the latest in artificial intelligence . While the basic techniques will
be in common between biomedical information services and many others , there are
additional specific requirements which need to be taken into account, eg relating to the
development of common functional specifications and minimum standards so that the
uninhibited use of these services becomes possible.
 ---pagebreak---                                              11
 2,3 Convergence of Biotechnoloev and Information technoloev ( Mastering the
         complexitv )
 Biological systems are the most complex known and investigated by man. Progress in
understanding has, therefore, at all times to be closely related with the ability to gather
information , analyze and interpret it. The scientific basis of future health care is to be
found largly in the understanding of the molecular basis of biological processes. This
may include the analysis and interpretation of millions of atoms making up the
biomolecular functions. One refers, therefore, in this context to ’Megacomplexity’ which
needs to be dealt with . It is for this reason that progress in biotechnology is intrinsically
linked with progress in information technology. Inversely, the biological processes are
increasingly serving as model for advanced work in information technology. For this
reason it is expected that in the long term information and bio-technology will converge
to a significant extent.
2.4 Soeed of évolution
The scientific basis of medical care is evolving so rapidly that some refer to mankind
facing a revolution. The reason for this lies in the fact that biotechnology has reached a
level of maturity where its application has come within reach . The application potential
and the associated economic potential have resulted in a major change in approach and
scale of efforts . Increasingly large resources in terms of money, equipment and human
resources are focused on specific objectives . Those countries who wish to maintain
strength in this domain will need to reflect not only on the financial resources but in
particular on the organization and orientation of their efforts . Providing a highly
dispersed scientific and technological community with a common framework for
collaboration is one of the necessities implicit in this trend to more concentration and
requirement for scale.
2.5 Mastering économies and shortaees in technological resources
Health care and all associated disciplines are major sectors of activity to which very
considerable financial and human resources are dedicated as well as extensive facilities .
Already this domain is highly capital intensive in the research stage , development, trial
and application. This trend can be expected to continue and with the emerging
biotechnology the requirements for scale of R&D efforts needed to participate in
advanced work may reach the dimensions known to govern other high-technology fields
such as aerospace and information technology. Cooperation is then not only an advantage
but becomes a necessity in term of financial as well as expert human resources . The
interdisciplinary nature of health care re-enforces the need to cooperate between
different domains .
Success in meeting this challenge in economics (financial as well as in human resources)
depends on setting up effective frameworks supporting the various sector actors in
making their respective contribution. The action under consideration is to assist the
sector actors in domains where the European dimension offers the most advantageous
framework of action .
 ---pagebreak---                                            12
2.6 Conclusions
          Health Care is of central socio-political as well as economic importance for the
         Community. The demand for further improvements are increasingly being met
         by advances in science and technology.
         All European countries (and most others in the world) face serious problems in
         the growth of their health delivery systems. For some the percentage of GNP
         spent on health care has reached at least 6 %, depending on what is seen as
         part of the health budget; it easily can be also seen as already surpassing the 10
         % limit in some EC-member nations. Though most experts consider this level
         of expenditure the maximum economically acceptable one, still most countries
         are conscious of deficiencies in their health system which they try to overcome
         by setting up new institutions and programmes.
         in spite of the differences in the socio-economic structure of the health care
         systems in the EC-member nations, these developmental areas provide a high
         degree of commonalty, ie a chance , if not the need , for joint efforts at
         Community level specifically in the area of advanced informatics.
         The field of medical informatics itself provides several excellent test beds and
         leading edge development areas for informatics in general.
         Medical information technology is a world market, as can be seen by the
         strong and still growing role that non- EC- based companies play in Europe and
         EC-based companies play outside Europe in areas like Hospital Information
         Systems, Medical Laboratory technique , and dedicated Systems in Image and
         Signal Processing.
         The future rôle of medical informatics will include:
         the support of well understood routine tasks in broad application areas,
         efficient, cheap and robust enough to serve throughout the Member countries;
         the provision of knowledge and expertise in situations and localities where
         these will not be routinely present, thus enhancing the quality of local problem
         handling;
         the provision of local and regional communication facilities to provide
         pertinent patient data wherever and whenever needed , while observing privacy
         and security, thus reducing unnecessary replications of check-ups and delay of
         action;
         the provision of aggregated data for more efficient health care resources
         planning. These and other effects which can be expected from a strategic
         implementation of medical informatics can be generalized to play a role in
         quality assurance , cost containment and equality of social service as well .
         The initiative is timely since:
         several Member States of the EC are now at the point of starting or developing
         pilot projects and R&D programs to promote their information technology in
         medicine on the national level, e.g. in areas such as informatics for primary
         health care, regional health information services, hospital information services;
 ---pagebreak---                                             13
           with the advent of personal computing and powerful mini computers,
          computing now becomes affordable on a broad scale to hospitals , general
           practitioners and other health care providers;
           advances in telecommunications and radio open up new possibilities for health
          care , eg mobile integrated services.
          The functional integration of health care equipment and services made possible
           by the advances in MB1 permits the realization of major advances in the
          quality and economics of health care (economies of integration and economies
          of flexibility).
          The realization of advances building on the new possibilities offered by MBI
          to improve quality and cost-performance depends on the collaboration of
          several sectors (Medical Profession, Molecular Biotechnology, Laboratory
          Instrumentation, Research Equipment, Telecommunications, Information
          Technology as well as of the standardization bodies working on the related
          domains).
          Progress in MBI opens up new possibilities with the potential for making
          health care more flexible and adapting it better to individual patient and needs
          of medical staff.
          Progress depends on the cooperation of independent actors making their
          respective contribution in a coherent framework of action.
          Shortage of human resources is in addition to lack of appropriate facilities and
          finance the most important argument in favour of cooperation on a European
          scale .
          The exploratory work which has preceded this proposal has confirmed the
          readiness of the sector actors to work together in this domain and identified
          areas of opportunities for cooperation.
          USA and Japan are investing large amounts of money in advanced informatics
          in medicine (e.g. in expert systems, communication , image processing) whereas
          at the same time dedicated US software companies are getting a growing share
          of the existing medical computing market in Europe .
          The existing R&D resources in Europe in certain areas like hospital
          information systems , image processing , expert systems and others are
          sufficiently strong to be able to capture relevant market shares in Europe and
          worldwide, provided that sufficient scale is achieved by joint efforts and
          harmonization .
          AIM can build on the cooperative efforts , in particular, ESPRIT and RACE as
          well as other advanced work realized         in other frameworks and thereby
          contribute to the exploitation of generic work done in these programmes .
AIM will combine tangible progress in the mid-term with work requiring longer term
efforts towards more ambitious objectives .
 ---pagebreak---                                              14
 3 . OUTLINE OF AN ACTION PLAN
 The central function of AIM is to improve the use of limited resources for the advance
 of health care and its constituent sectors. This includes human resources , facilities, and
 finance but also the time element, so as to achieve accelerated progress in quality as well
 as cost-performance .
 This implies the purposeful cooperation of the sector actors within a consistent
 framework of action. To this end , in order to make cooperation in such a complex
 domain manageable and effective, the action should be structured by reference to the
 main contribution each group of actors can make. The following Action Lines represent
 an approximate structure of the envisaged efforts. During the Pilot Phase these will be
 explored further and precise objectives as well as the optimal approach defined.
 3.1 Action Line I
 Improvement of the effectiveness of public and private actions
 by means of
 the development of a common conceptual framework for cooperation at the planning
 and management level in Europe.
This would be undertaken by the construction of a reference model (Annex, page 4 ).
This model would embody the consensus of the main actors as to the common patterns
 which underlie the activities of the sector, including the economic aspects . The model
 would be composed of several sub- models, each representing one of the environments
which can be recognised within the sector.
In health care very considerable private and public efforts are being undertaken in
Europe. Their impact could be considerably strengthened by an enhanced concertation in
the stage of the definition of objectives, the derivation of requirements, the participation
in the evaluation as well as in the translation into applications
This Action Line would enable regular reports to be rendered, identifying objectives,
achievements , recommendations, approaches to economic evaluation , requirements and
indicating the orientation for future efforts in the domain of MBI. These reports would
provide an integral view of the European situation and prospects in the world context.
3.2 Action Line II
Strengthening Europe’s position in MBI and health care
by means of
cooperation in pre-normative and precompetitive technology exploration concentrating
selectively on re-inforcing and complementing the technology base of MBI and its
services .
This is to provide the reinforcement and minimum organizational framework necessary
for multidisciplinary coopération drawing on Europe's assets in this domain.
This part of the action will need to involve medical practioners , researchers, the related
equipment and services industries as well as the related standardization bodies.
 ---pagebreak---                                            15
Scope
The ground to be covered under this Action Line would be the following headings of
 the Workplan
            Medicai Informatics Environment
            Data Structures and Medicai Records
            Communication and Functional Integration
            Biomedicai Expert Support Systems
            Biomedicai Instrumentation and Research Tools
Information technology and telecommunications brings flexibility and helps to overcome
distance and access constraints to information. For this to benefit health care ,
application-specific functional specifications and minimum standardization need to be
agreed upon by the health care sector. This is a pre-requisite for the improvement in
speed and accuracy of all information related processes in health care. Furthermore, it is
a prerequisite for the sharing of medical resources and equipment.
Therefore, one of the horizontal aspects of these activities to be explored early in the
action would be towards reinforcing the efforts in standardisation of medical
classifications as related to MBI , including diagnosis and data structures relating to
records, taking full account of data protection requirements.
Full advantage can be taken of the advances realized in information technology and
télécommunications generally only if a complementary effort is undertaken addressing
the aspects which are health care spécifie or spécifie to the needs of the related
biomédical and biotechnological research.
Therefore, other more technology- intensive collaborative , research activities would relate
to specialist fields such as expert systems for use in knowledge-base construction and
access as well as in more ‘intelligent’ human-machine interfaces , and to the exploitation
of MBI in medical laboratories and in research . This work would lead the way, via the
development of common functional specifications and minimum requirements of
standardisation referred to above , towards the exploration and development of advanced
MBI techniques by means of cooperation in pre-normative and pre-competitive R&D in
specific domains of MBI particularly relevant to progress in health care or related
research domains and suited for a transnational approach .
3.3 Action Line III
The creation of an environment favourable to rapid progress in the introduction and
appropriate application of MBI in health care
by means of
the development of specific proposals addressing the policy , regulatory , legal ,
organizational framework of MBI applications including the training and manpower
related factors .
Scope
The work relating to this Action Line is identified in the Workplan under the heading:
           Non-technological factors .
 ---pagebreak---                                               16
 4 . PHASING OF THE IMPLEMENTATION
 Progress in this domain requires the purposeful cooperation of several actors within their
respective responsibilities. The challenge is as much in the motivation of the
collaboration as it is in the subject itself. However, motivation and a cooperative attitude
cannot be planned or decided but must grow and prove itself. A phased approach is
therefore suggested, permitting the progressive reinforcement of the effort as the
definition of the objectives improves, the cooperation proves its value and the
commitment of the actors increases the credibility of the approach.
4.1 Pilot Phase
Following the completion of the exploratory work which has led to the formulation of
the proposal the full-scale implementation is to be preceded by a Pilot Phase . The Pilot
Phase will serve to explore the scope and options to be included in the Main Phase, as
well as to develop and test the framework of cooperation. The work during the Pilot
Phase is to be exploratory in nature and self-contained , though representing the basis for
later work under the Main Phase .
The initial Workplan for the AIM Pilot Phase is annexed to this document. It will be
subject to revision by the Management Committee to be set up under the Decision
adopting the action.
4.2 Main Phase
The Main Phase will be proposed based on the success of the launching and
implémentation of the Pilot Phase. Its objective will be to carry out the pre-normative
and where necessary pre-competitive R&D required to achieve measurable progress with
respect to the objectives identified for this programme and will be complemented by the
spécifie technical objectives in the Workplan which is to accompany the proposai for the
Main Phase .
5 . ORGANIZATION AND MANAGEMENT OF THE COOPERATION
Cooperation in MBI, even at the level of exploratory work and advanced work, is very
demanding in terms of management and organization. There are several important factors
which already need to be taken into account in the Pilot Phase
           there should be for each component of the work a clearly defined objective in
          terms of functional characteristics and cost-performance together with the
          fixing of milestones marking progress towards the objective. The verification
          of progress by this means is the ultimate            measure of the technology
          investment and the standard by which the results can be evaluated . It is not the
          technical feasibility as such which matters but the techno-economic feasibility
          and the benefit for health care;
          the health care system and its merger with research, information services
          including mobile communications creates a high degree of complexity and
          interdependence of future investments and applications;
 ---pagebreak---                                              17
            there are numerous actors with their own respective responsibilities who need
            to work together in a purposeful manner ( the medical profession , service
            providers , hospital and medical service operators , industry and on regulatory
            issues also the respective administrative and political authorities ).
 This ihakes organization and management of cooperation in this domain a challenge in
 itself. Developing a sound approach to these questions will be decisive for reaching the
 objectives and minimizing the overheads inevitably associated with cooperation .
 5,1 Evaluation
The evaluation is an ongoing process designed into the workplan including verifiable
objectives and assured in the execution by progress monitoring and milestone reviews .
The evaluation of the project proposals and of the results will be carried out with the
assistance of independent experts. The overall evaluation of the Pilot Phase will be
carried out by the Management Committee itself.
5.2 Relationship with International Proiects and National Efforts
An estimated overall investment of the order of 100 billion ECU in R&D for health care
will be made in developed countries over the next ten years. The work envisaged for
AIM serves to minimize risks and uncertainties as well as the optimal use of limited
human resources and finance. AIM relates to the initial R&D stage of very much larger
efforts required later on for product development. AIM is focused towards infrastructure
technologies where these are specific to health care and supporting scientific services and
relate to predominantly common requirements requiring large scale cooperation or the
establishment of a critical size of effort by cooperation . Where international or national
projects are engaged with related objectives close coordination and collaboration between
the efforts is proposed and will be essential.
5.3 Participation of public and private organizations established in Non-Communitv
         European countries
During the AIM Pilot Phase it is proposed to work closely together with existing bodies
and administrations working in this domain . This should where possible extend to
include public or private organizations established in non-Community European
countries .
The Community has a strategic as well as an operational and economic interest to come
to a European solution for health care questions which also includes non-Member States .
Therefore , the Commission , intends to allow for the interest expressed by industry,
hospital operators, health care service providers , and health administrations in the COST
countries by extending the criteria for participation in AIM .
It is suggested that private or public organizations established in COST countries be
permitted to submit proposals and to be signatories to AIM projects where a Framework
Agreement on R&D Cooperation has been concluded with the corresponding country .
The select organizations would , however, have to cover their own costs ( plus , as
appropriate , a participation in the operational expenses).
Projects with participants from these countries would hâve to comply with the same
sélection criteria , contract conditions and management procedures.
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 5.4 Secondment Scheme
 In order to mobilize the human resources and make optimal use of research facilities it
 would be of great advantage if experts from one organization could be associated with a
 AIM project carried out by another organization where this is wished by both parties.
 This mechanism would aid the organizations responsible for the respective AIM project
 by providing additional skilled manpower and it would assist the seconding organization
 in participating in the form of one of its experts in leading-edge work.
 5,5 Participation of SMEs . Research Oreanizations and Universities
The importance of SMEs, Research Organizations and Universities as a strong inventive
and innovative element is well recognized and therefore their appropriate participation
 will be an important consideration in the implementation of AIM.
 High technology SME’s, Research Organizations and Universities will in general stand to
gain from AIM in that it creates a framework in which the specific strength of SME’s
can express themselves and create market opportunities by fostering a symbiotic
relationship with large companies and service providers.
50% or more of the employees in the Community telecommunications industry are in
firms with 20-99 employees. This is an index for the variety of activities comprised
within this industry, the different effects of scale between activities, and the extend of
sub-contracting. There is little doubt that this high degree of involvement of SME’s ,
Research Organizations and Universities will also characterize the future work in MBI
and AIM .
5.6 OverView of actions in MBI
In order to situate the objectives of AIM in the context of existing national and
international actions this section contains a strongly condensed overview of some of the
major activities which have been taken into account in the definition and orientation of
the proposal for the AIM Pilot Phase.
Belgium
Good level of R&D in medical informatics. Some research teams are outstanding in the
following fields : medical terminology, medical record administration , integrated hospital
systems , intensive care monitoring , data banks in cardiology, etc.
No national programme in bio-informatics, but some funding has been allocated to this
area through various channels (public bodies , BAP framework , etc. ).
Denmark
Denmark cooperates with Finland , Norway and Sweden in two major medical
informatics R&D programmes : CART (Computer-Aided Radiotherapy) and KUSIN -
MED (Knowledge-Based Systems in Medicine ).
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 Public funding for basic research in the general area of biotechnology comes from
 general purpose appropriations channelled through the Research Council in Science ,
 Medicine , Agriculture and Technology. There are presently two specialized programmes
 relevant in the context of bio-informatics : the Biomolecular Technology Programme
 (Dkr 33 million over 5 years starting 1984 ), and a 5 year programme of basic research
 underlying industrially related developments in biotechnology (start 1985 with a total
 budget of Dkr 60 million). The Danish government is considering a major effort in
 biotechnology.
 France
 Medicai informatics has received in thè past significant support from government, public
 institutions (Agence de ITnformatique, Centre Mondial Informatique et Resources
 Humaines) and national institutions ( INSERM, CNRS). In addition , a number of
 scientific associations are engaged in developing medicai informatics , in particular
 MEDIA , which groups 5 pilot teams selected by thè Ministry of Health . In 1985 , Agence
 de ITnformatique helped establish a new association called Ophis , intended for
 participating in thè organization of thè medicai informatics market.
 In biotechnology and bio-informatics, public funding of research operates at two levels.
 First, there are a number of research bodies , including CNRS, Institut Pasteur, INRA
 and INSERM, each with its own funding , laboratories , staff, etc. Secondly, France has a
specific programme, the "Programme Mobilisateun Essor des Biotechnologies", originally
set up in 1982 and administered by the Ministry of Industry. This programme has a
subprogramme in bio-informatics whose objective is to encourage and support the
utilization of computational tools in the development of biotechnological research and
 industry.
CGR, a subsidiary of Thomson , is internationally active in the MBI sector.
Germany
 In biotechnology, a major effort was launched in 1984 , in the form of a programme
administered by the Bundesministerium fur Forschung und Technologie (BMFT). This
programme , which has a total budget of DM 1140 million , should be seen in the context
of local initiatives in the individual Lander. Although the programme does not
specifically identify bio-informatics as a research priority , research in this area is
supported under this scheme. Between the Lander the percentage of computerisation in
hospitals varies from about 80-100%. The in-hospital usage of computers consists mainly
of mini-computers with the exception of large hospital sites (eg in Munchen , Hannover,
Gottingen, Aachen and Kiel ) which have hospital computer centres . The main usage is
in administration and financial applications based on the use of software harmonised
with the support of governement.
Hessen has recently given a contract for a demonstration project for a state - wide
Hospital Information System .
In biomedical instrumentation , the FRG is the principal European manufacturer. Siemens
is the world leader in Imaging and , on its domestic market , stands well ahead of C.H.F.
Muller (a subsidiary of Philips ), Hellige (a subsidiary of PPG Industries ) and CGR Koch
& Sterzel (a subsidiary of Thomson ).
Many developments in medical informatics , especially expert Systems .
 ---pagebreak---                                             20
 Greece
 Funding of research in biotechnology and bio-informatics is the responsibility of the
 Ministries of Industry, Agriculture , and Health and Welfare. There is work on basic
 research in biology at universities and research centres . There is at present no national
 research programme relating specifically to bio-informatics.
 Two companies, Vioryl and Bio-Hellas, are known for their work in biotechnology.
 Ireland
Basic and applied research in Ireland is supported by the National Board for Science and
Technology (NBST), the Industrial Development Authority, the Irish Medical Research
Council, a number of private foundations, and directly by the government Departments .
The NBST, which has the responsibility for advising government on general matters of
science policy, has identified biotechnology as one of three areas in which research is to
be funded under a Strategic Research Programme. Bio-informatics has been identified
by the NBST as an important element in biotechnology and advanced molecular biology.
Italy
A National Research Programme, to be completed in 1989, has been launched in the
biomedical field. For its execution a service company called Tecnobiomedica S.p.A. was
founded in December 1980 to identify, set up and develop applied research projects in
the biomedical field. At present it is managing 16 research projects for an approximate
total amount of ITL 85 billion. In this framework 16 manufacturers are working together
with more than 20 research centres (Universities , Hospitals , Units of the National
Research Council).
Specifically relating to the field of Medical Informatics , there are several major activities
working on the use of artificial intelligence in medicine : Roma, Pisa, Pavia, Torino ,
Milano, Padova, Genova, etc. However, the level of government support (National
Council of Research, Department of Public Education ) for this work is comparatively
low.
The Netherlands
Medicai informatics is developed at Universities (Free University of Amsterdam ,
University of Leiden , State University of Maastricht , State University of Groningen...)
and by industry (Philips and locai subsidiaries of US companies such as Unisys ,
Datapoint, SMS, Honeywell , Hewlett-Packard ...).
Philips, which has in 1987 formed a joint venture with GEC, has a strong position on
the world market in spécifie sectors , eg imaging .
Portugal
Research is funded by the Research Council of the Ministry of Planning , which has
declared biotechnology and bio-informatics priority areas .
 ---pagebreak---                                             21
 Spain
 Some projects are currently being developed in application of the National Informatics
 and Electronic Plan .
 Spain participates jointly with Denmark and France in a Eureka development programme
 for non - invasive medical measuring methods ("Galeno/2000").
 United Kingdom
 There have been two major initiatives in advanced computing : the Alvey Initiative - the
 British 5th Generation programme - and the three-phase programme initiated by the
 Forty Report on Future Facilities for Advanced Research Computing. Within the Alvey
 programme there were some projects directly related to medical informatics .
The IT 86 Report, which addresses the follow-up to be given to the Alvey Programme ,
 recommends a three-pronged programme: applications (ECU 700 million ), research (ECU
 770 million) and end-user education . Health has been considered as one of eight priority
application projects, with emphasis put on clinical data and process models .
Several UK centres are involved in advanced software developments for protein and
 nucleic acid studies . The Cambridge Structure Databank (CSD) is one of Europe’s most
 important data bases for biological research .
The UK has strong activities in medical expert systems in research institutions (ICRF,
Imperial College , Manchester University, Sheffield U. , St-Thomas’ Hospital , Sussex U. ,
...) and industry ( ICL, Logica, Oxford University Press, Hewlett-Packard ...).
Funding for research in biotechnology and bio-informatics is provided by the
Department of Education and Science (DES) and the Department of Trade and Industry.
DES funding is mostly done via Research Councils: the Agricultura! and Food Research
Council (AFRC), the Medical Research Council (MRC), the Natural Environment
Research Council (NERC), and the Science and Engineering Research Council (SERC).
British biomedical industry is relatively strong with a number of companies which are
competitive on strategic segments ( imaging , monitoring , superconductive magnets for
MRI...). General Electric Company (GEC) is a major company in the imaging through its
subsidiary Picker International .
United States
The US was among the first countries seriously to address the application of computers
to the health care area, starting in the early 1960s. Most recently in 1983 , the
implementation of Medicare’s Prospective Payment System ( PPS) for hospital inpatient
services has had a major effect on health care administration , resulting in a significant
boost for the computer industry as hospitals found their old systems unable to cope with
the new scheme . Presently 90% of all hospitals with more than 100 beds have some
degree of automation in the patient admission/handling areas.
 ---pagebreak---                                             22
 Federal funding is directed mainly to universities and colleges , and federally funded
 R&D centres, through agencies such as the National Science Foundation (NSF) which is
 the primary agency responsible for funding basic research at universities. The NSFs
 budget will be ECU 3.2 billion by 1992, three times that in 1980. The Department of
 Energy (DOE) plans to spend ECU 20 million to ECU 40 million a year on the "Genome
 Initiative" for the next four to seven years after 1988 . The objective of this project is to
 map and sequence the entire human genome, thus accomplishing the tremendous task of
 reading the exact sequence of the more than 3.5 billion chemical units.
Biomedical research instrumentation is mainly supported by the NIH (National Institute
of Health). In the fiscal year 1985 the Division of Research Resources (DRR) of the
NIH awarded 1103 research grants. The appropriations for the DDR amounted to 300
Million ECU .
The research division of the National Library of Medicine (MIH) was created to address
specifically the application of information technology and telecommunications to
problems in health care and to improve the system for collecting , processing and
disseminating biomedical information. In 1987 its activities included electronic image
processing , electronic document storage and retrieval , video imaging systems, knowledge
based information systems to name just some of the more ambitious projects.
Federal funding has also begun to flow into the private sector. Two kinds of federal
support concern MBI : SBIR (small business innovation research programme) and SBICs
(small business investment companies). Small high technology companies also receive
state and local support through various mechanisms (Corporations for Innovative
Development, State Pension Funds, venture capital) aimed at spurring innovation and
growth. As concerns local support, there are some very interesting examples, such as the
NBS-University of Maryland partnership on biotechnology (GARB ), or the Chicago
Technology Park which, together with nearby University of Illinois and medical centres,
is reportedly the largest medical training centre in the world . US suppliers have become
world leaders in the provision of health care-related software products. Major suppliers
include IBM, Shared Medical Systems (SMS), McDonnell Douglas , DEC, Unysis,
Technicon Data Systems , which represent just a few of the 160 leading suppliers active
today in this market.
This results in a very strong position in the world medical equipment market and an
outstanding position in medical and bio-informatics.
 ---pagebreak---                                             23
 Japan
 Public funding of research in MBI lies under the auspices of the Agency of Industrial
 Science and Technology (A1ST), the Ministry of International Trade and Industry
 ( MITI), the Ministry of Education , Science and Culture , and the Ministry of Health .
 Exchange between public research and private research are very dense . On the basis of
 the fundamental technology about system control and filing information obtained
 through past trial tests , and on the basis of adopting the newest picture processing and
 storage technologies, NTT has developed a new interactive video information system
 called Video Response System (VRS). An experimental service for "Medical VRS" was
 started on April 23 , 1986. In 1976 the Technology Research Association of Medical and
 Welfare Apparatus was established to meet the need for products which are difficult and
 financially risky to develop and have low selling price . In 1974 , the Ministry of Health
and MITI set up the Medical Information System Development Centre ( MEDIS DC). A
significant feature of the growth of hospital information systems has been the increased
 market share held by the native companies from 20% in 1960 to 80% today, mainly
through the strategically directed production of small and medium-sized computers.
Key players in medical informatics include Fujitsu , NEC, IBM Japan, Hitachi , and DEC
Japan . Biotechnology-related market may reach Yen 6 trillion by the year 2000 ( Yen 25
million in 1986), with the market growth being mainly attributable to the accelerating
commercialization of pharmaceuticals . Medical equipment is in Japan a fast-growing
industry which comprises close to 20 important makers . Three leading companies :
Toshiba, Hitachi and Shimadzu . Medical informatics develops rapidly, especially local
area networks for hospitals and medical IC card systems.
On the research side, Japan’s Science and Technology Agency will begin in 1988 a study
to carry out exploratory work to fund a project to develop advanced equipment for
decoding DNA . Sequencing the whole genome with a totally automated , rapid DNA
sequencing system , would take 30 years instead of 250 years and ECU 1.1 billion if done
by hand . MITI has proposed in 1986 the Human Frontier Programme with the intention
to promote basic research on a world scale which includes medical and bio-informatics.
EUREKA Projects
           Galeno 2000: Development of non-invasive medical measuring methods
           Expert System for incorporation in medical instruments
           Biomédical Image Processing
           Ultrasonic Signal Capture Systems
           Oncology Therapy Advisor
           Protein Design
           Operating room 2000
           Medical disposable sensors
           Automated diagnosis of blood
 ---pagebreak---                                              24
 COST Actions
 Cost 13 : Artificial Intelligence and Pattern Recognition.
 Among the collaborative research projects is "Artificial Intelligence in Medical Science".
 The objective is to study and critically evaluate:
           communication between the clinical staff and a decision support system;
           knowledge acquisition by apprenticeship, literature and learning from example;
           knowledge representation techniques for medical data;
           handling of uncertain medical data;
           decision support systems with clinically acceptable response times.
Community
Research and development co-ordination programme of the EEC in the field of medical
and health research:
Three coordination programmes of medical and health research have been adopted by
the Council between 1978 and 1986 . A fourth coordination programme encompassing
more than 70 concerted actions is expected to become operational until 1989. Ref.: COM
(86) 549 final
"Europe against cancer" programme: proposai for a plan of action 1987-1989. Ref.: COM
(86) 717 final
The Community has specific programmes both on information technology and
biotechnology. The ESPRIT and RACE programmes address the information and
telecommunication technologies respectively. The Biotechnology Action Programme
(BAP) does include some aspects of the applications of information technology. AIM is
conceived as a well focused specific effort to complement these programmes with respect
to developing specific advanced and new capabilities.
 ---pagebreak---                                                  25
6 . GLOSSARY
AIM                             Advanced Informatie « in Medicine
Ambulatory care                 Care rendered without hospitalisation - ie primary care, outpatient« hospital
                                care , emergency visit· and one - day care surgery
Angiography                     Techniques for depicting blood vessels
Angioplasty                     Ways of dealing with obstacles to the flow of blood - eg by laser
APACHE                          Acute Physiology and Chronic Health Evaluation , a classification system
                                developed at the George Washington University Intensive Care Research
                                Unit
Architecture                    The selection , design , and interconnection of the physical components of a
                                large scale computer system
Artificial Intelligence ( AI )  The concept that computers can be programmed to assume some capabilities
                                normally thought to be like human intelligence , such as learning , adaptation ,
                                and self-correction . Applications also known as Intelligent Knowledge Based
                                Systems (IKBS )
Automatic encoding              Transformation of each medical term in natural language into a code inside
                                the computer, without human intervention
AVG 5s                         Ambulatory Visit Groups . Methodology used in the United States to define
                                the product of health care in ambulatory setting
Bio-Informatics                The various topics at the interface between information technology and
                               biotechnology . One important attribute is that bio-informatics covers not
                               only     the  present   use  of   computers    for  information  processing   in
                               biotechnology , but also the potentials for computerisation within this area
Biomolecular modelling         A scientific field at the interface between advanced computing and
                               biotechnology . Main areas include databases of nucleic acid structures ,
                               protein sequences , macromolecular crystal structures and organic crystal
                               structures , sequence modelling for laboratory sequence and cloning studies
                               and for detection of sequence homologies between different molecules ,
                               prediction of protein structure from amino acid sequence to model both
                               secondary and tertiary structure , macromolecular energy calculations , and
                               molecular graphics to display and manipulate representations on calligraphic
                               and raster screens
Biosensor                      A device which recognises an analyte in an appropriate sample and converts
                               its concentration into an electrical signal via a suitable combination of a
                               biological recognition system and an electrochemical transducer
Biotechnology                  Application of scientific and engineering principles to the processing of
                               materials by biological agents to provide goods and services
 ---pagebreak---                                      26
 Bus                An interconnected system path over which information U transferred , from
                    any one of many source· to any one of many destinations , the devices
                    involved being connected in parallel
 CART               The Nordic Radiographic planning project involving industry, R&D
                    institutes and users for the development of new radiographic systems and
                    communications
CCD                 Charge-Coupled Device , a new and compact image sensor technology
CIM                 Computer Integrated Manufacturing
Classification     A distribution by classes or categories , following preexisting criteria. The
                    Internationa] Classification of Diseases ( ICD ) has been designed for
                    statistical purposes and for the indexing of hospital records by diseases and
                   operations , for data storage and retrieval
Coding             The coding of diseases or medical terms is the process of attributing a code
                   to each notion which is to be separately identified . This notion can then be
                   found in a classification or a nomenclature
COM(86 ) 549       Propiosal for a research and development co-ordination programme in the
                   field of medical and health research ( 1987-1989)
COM(86 ) 717       Proposal for a plan of action against cancer ( 1987-1989)
COMAC-BME          Concerted Action Committee-Biomedical Engineering
Computer graphics The use of computers to process graphics . Unlike image processing, the
                   images are not from life but are man - or machine-made . Graphics are easier
                  to manipulate than images because they are defined to a computer's " mind"
                   as geometric figures - a set of p>oints and a few other bits of information
                  regarding shading or coloring
Compatibility     Refers generally to the ability of two ( hardware /software ) devices to work in
                  conjunction
Computer language A set of characters , conventions , and rules that is used for conveying
                  information
COST              Committee of European Cooperation in the field of Science and Technology
CREST             The Scientific and Technical Research Committee . Set up in 1974 , it is
                  composed of senior officials of the member states and gives advice to both
                  the Commission and the Council
Data Integrity    Data must be received as sent and not be changeable by a false author or by
                  " noise" in the system , at any p>oint en route or at either sender or receiver's
                  station without being detectable by the sender or receiver
Data modelling    Procedure according which the data are seen within a model that defines
                  their relationships and meaning in order to meet information requirements .
                  Data models extracted from information needs form the baseline from which
                  to approach the question of information technology systems
 ---pagebreak---                                               27
DNA                          Deoxyribonucleicacid
DRG's                        Diagnosis Related Groupe . DRG's are a subclassiftcation of the ICD - O - CM
                             code that groups patients by diagnostic categories with homogeneous costs
                             based on length of stay and medical activity analysis
DSA                          Digital Subtraction Angiography (see also angiography )
ECG                         Electrocardiography
Economies of integration    Economic advantages arising from multiple use and therefore higher utility
                            of facilities
Economies of scale          Advantages arising out of scale of production or service
Economies of scope          Advantages arising out of commonality and synergy between different
                            products or services
Electronic Image Processing The use of electronic imaging technology in the capture, itorige, Processing,
                            online retrieval , transmission and display of biomédical documents and
                            medical imagery
Electrophoresis             Separation of macromolecules according to their sise and electrical charge by
                            passing through a gel under the influence of an electric field
Endoscopy                   The use of flexible tubes for in vivo examination , diagnosis and treatment
ESPRIT                      European Strategic Programme           for   Research    and   Development  in
                            Information Technology
ESWL                        Extracorporeal Shock Wave Lithotripsy , an apparatus which permits the
                            fragmentation of lithiases (stones) in urology , by transferring sucrosa the
                            tissues towards the lithiases shock waves produced outside the body
Eureka                      Industrial cooperation scheme in high technology commercial development
Expert System               A computer program that simulates or mimics the judgement and reasoning
                            of human experts , allowing it to address problems normally thought to
                            require human specialists for their solution
Fibroscope                  A long , flexible endoscope using optical fibres to transmit the image
Functional specification    Definition of what a device/system is designed to do but not how it is done
Genome                      All human genes taken together. More than 3.5 billion chemical units make
                            up the human genome , and only 1% to 2% of the genome has been sequenced
Harmonisation               An increase in consistency of approaches rather than a strict conformity of
                            measurement systems . Harmonisation can also be obtained through a
                            learning process by a transparency of results and more systematic
                            international exchange of comparable informations
Laser Card                  A data recording technique similar to an optical disk but in a card form
 ---pagebreak---                                            28
 Lithotriptor            Apparatus which allows the fragmentation of lithiases in urology.
                          Extracorporeal shock wave lithotripsy (ESWL) allows fragmentation of a
                         " stone" by transfer across the tissues towards the lithiasis of a mechanical
                         wave produced outside the body
Man-Machine Interface    Interaction of the user with a computer or communication system
MBDS                     The Minimum Basic Data Set , recommended by the EEC in 1082
MBI                      Medical - and Bio-Informatics
MEDIA                    A French association grouping five pilot teams in medical informatics
Medical Record           Information acquired in the process of medical consultation , examination ,
                         investigation , and treatment
Medicare                A US . government programme of medical care especially for the aged
MIB                     The medical information bus , a standard communications protocol for
                         instrumentation used in hospitals , and particularly for intensive care
MITI                    The Japanese Ministry of Industry and Foreign Trade
Molecular Biotechnology A research field which plays a key role for health care, eg in the form of
                        diagnostic tests , drugs , hormones , proteins , vaccines and so on
MRI                     Magnetic Resonance Imaging
NHS                     the UK National Health Service
NM                      Nuclear Medicine
OSI                     Open systems integration standards
PACS                    Picture Archiving and Communication Systems
PET                     Positron Emission Tomography
Portability             The ability of an application to be physically moved with ease or used on a
                        variety of different types of computer
PPS                     The Prospective Payment System of the U.S. Medicare programme
Pre-competitive R&D     Mid - to long-term RAD proceeding commercial product development
Pre-normative R&D       RAD required to prepare the definition of standardisation proposals
Primary Health Care     Essential health care made universally accessible to individuals and families
                        in the community by means acceptable to them, through their full
                        participation and at a cost that the community and country can afford
 ---pagebreak---                                               29
Procedures in health care Medical treatment and in particular surgical interventions follow specific
                          rules of conduct involving the patient , highly trained specialists and special
                          facilities in a hospital setting (e g . cardiac catheterisation , laparoscopy , liver
                          biopsy , endoscopy with biopsy)
RACE                      R&D in Advanced Communications Technologies in Europe
R&D                       Research and Development
Secondary Care            Care provided ( a) in a clinic or office located at a hospital , by a consultant
                          specialist , ( b) in acute or general hospitals
Smart card                One portable storage and processing device used for authentication , payment
                          and storage of personal data. Small microprocessor or memory chips are
                          encapsulated in a plastic card meeting ISO standards . With existing
                          technologies up to 64 Kbits can be at present be stored .
SMEs                      Small - and Medium-sized enterprises
SPECT                     Single Photon Emission Computer Tomography
Standardisation           Standardisation of medical data is international harmonisation of medical
                          terminologies with classifications and nomenclatures allowing to encode
                          medical terms
Telemedicine              The use of telematics to offer medical services
Tertiary care             Long-term care provided through long-stay in special hospitals , nursing
                          homes , and similar residential facilities
Voice processing          Voice processing technology gives a computer the ability to hear and speak .
                          These capabilities su-e provided by two distinct aspects of the technology :
                          voice recognition, which allows a computer to understand spoken words and
                          execute the appropriate commands or actions ; and voice output , which
                          endows the computer with speech
 ---pagebreak---                                       PROPOSAL FOR A COUNCIL REGULATION
                                                       of .
Community action in the field of Information Technology and Telecommunications applied to Health
                               Advanced Informatics in Medicine (AIM)
                                                  - Pilot Phase-
 THE COUNCIL OF THE EUROPEAN COMMUNITIES
 Having regard to the Treaty setting up the European Economic Community, and in particular
 Article 130Q paragraph 2,
 Having regard to the proposal from the Commission/1)
 Having regard to the opinion of the Economic and Social Committee ^2),
 In coopération with the European Parliament (s),
 Whereas the Community has as its task, by establishing a common market and progressively
 approximating the economic policies of Member States, to promote throughout the
 Community a harmonious development of economic activity and closer relations between the
 States belonging to it;
 Whereas the Heads of State and Government emphasized the importance of health care as a
 major factor for economic growth and social development;
 Whereas the European Parliament, in its assessment of the situation and development stressed
 the role of cooperation in health care and related areas for the future political, social and
 economic development of the Community;
 Whereas the European Parliament, in its assessment of biotechnology in Europe, has stressed
 the importance of medical biotechnology and bioinformatics^4);
 Whereas the Economic and Social Committee supports initiatives in this domain;
 Whereas with the emergence of advanced and mobile communication services and the
 progressive introduction of computing in health care and services, the conditions for major
 improvements for health care and possibilities for reduction of cost increases are emerging;
     ( 1)  OJ.
     (2)   OJ ...
     (3)   Opinion :OJ....(Approval : OJ . ;Amendment : OJ ....)
     (4)   Re»oIution OJ C76/25-29, 1987
 ---pagebreak---                                                              2
 Whereas developments in health care will benefit the general public and the international
 competitiveness of the European industry and health services in particular;
 Whereas advances in health care will contribute to resolving pressing social needs associated
 with changing age structures;
 Whereas the concerted efforts in this domain will contribute to the creation of the internal
 market and prevent the formation of new internal frontiers to health care;
 Whereas the development of common functional specifications for equipment and services
 will permit the less developed regions to benefit fully from the efforts of Member States
 piloting the improvements of health care, management and infrastructure developments in
 the Community;
Whereas the development of the health care infrastructure technology and services offers a
wide range of opportunities for small and medium sized companies in the manufacture of
equipment and in the provision of specialized services within the Community;
Whereas cooperation in pre-normative and pre-competitive R&D towards the development of
standards can make a major contribution, notably by facilitating the evolution towards future
more effective health care also at regional and local levels;
Whereas the Framework Programme for Community actions in respect of research and
technological development ( 1 987-9 1 )^               envisages the utilisation of the technologies of
information , telecommunications and 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 communication"; whereas the Framework Programme contains special
provision for a Community action in the field of Medical and Bio-informatics                ;
Whereas the constitution or consolidation of a specifically European industrial potential in
the technologies concerned is an urgent necessity; whereas its beneficiaries must be industry,
health care service providers, research establishments, undertakings, including small and
medium-sized enterprises and other bodies established in the Community which are best
suited to attain these objectives;
Whereas exploratory investigations have confirmed the need and the advantages of
Community cooperation in this field;
Whereas it is in the Community’s interest to consolidate 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 programmes
involving cooperation in medical bio-informatics;
Whereas the AIM Pilot Phase will benefit from the results of ESPRIT and RACE as well as
the on-going efforts in standardization;
Whereas the Community’s programme in biotechnology ( 1985-1989) will include the
application of medical bio-informatics and draw on the results of the work to be undertaken
under AIM;
     (5)   OJ COM(86)4SO fin *!, Bruuelf OS .08 . 1886
     (6)   Action Line II /3 , new Mrvice* of common interot
 ---pagebreak---                                                 3
Whereas there exists a need for close coordination with actions on the national level and
periodic reviews; whereas it is therefore necessary for the execution of the pilot phase that
the Commission be assisted by a Commitee;
Whereas the implementation of concerted actions in the COST framework is an essential
element to complement industrially-oriented R&D projects;
Whereas the Scientific and Technical Research Committee (CREST) has expressed its
opinion.
 ---pagebreak---                                                   4
HAS ADOPTED THIS REGULATION :
                                           Article 1
     1.  A Pilot Phase of a Community Action in thè field of Medicai and Bio-informatics ,
         called AIM, is adopted for an initial period of 18 months commencing 1 January
         1988 .
    2.   The action is designed , in concertation with public and private actions in the field
         of Medical and Bio-informatics ( MBI) undertaken at national and international
         level, to promote the competitiveness of the Community’s industries , health service
         providers in order to make available to the citizens and health services, at
         minimum cost and with minimum delay , the improvements in health care , thereby
         contributing to social as well as economic objectives .
                                           Article 2
     1.  The action shall consist of the development of a common conceptual framework for
         coopération , pre-normative work and technology exploration and the investigation
         of the non-technological factors as required for the objective of concerting
         European efforts in improving health care by means of MBI .
         The scope of the AIM Pilot Phase is described in Annex and the Draft Workplan .
                                           Article 3
  1.    The detailed objectives of the action to be undertaken are defined in a work plan
        to be adopted under the procedure set out in Article 7 .
  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 projects
        involving an R&D effort exceeding 50 man-years is to be decided under the
        procedure set out in Article 7 . For other projects the results of the evaluation will
        be brought to the notice of the Committee referred to in Article 6 .
  3.    Projects relating to the action shall be executed by means of shared cost contracts
        to be concluded by the Commission with industrial enterprises , service providers ,
        universities , research institutes and other organisations established in the
        Community . Contractors shall be expected to bear a substantial proportion of the
        costs , which should normally be at least 50% of the total expenditure .
  4.    The proposals for projects shall , as a general rule , be submitted in reply to an
        invitation to tender published in the Official Journal of the European Communities
        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 commercial
        undertaking .
  5.    In exceptional cases where the call for tenders has not resulted in a satisfactory
        response; in case of urgency or in cases where the call for tenders is not the right
        procedure in point of cost-effectiveness , the decision may be taken , in accordance
        with the procedure set out in Article 7 , to derogate from the principles set out in
        paragraphs 3 and 4 .
 ---pagebreak---                                             5
                                     Article 4
    Where Framework Agreements for scientific and technical cooperation between
    non-Community European countries and the European Community have been
    concluded, organizations and enterprises established in these countries may become
    partners to a project undertaken within this action.
              i
                                     Article 5
1. The funds estimated as necessary for the Community contribution to the execution
   of the Pilot Phase amount to 20 MECU over 18 months, including expenditure on
   staff (9A,2B,4C temporary officiais).
2. The indicative allocation of these funds is set out in the Annex .
                                     Article 6
1. The Commission shall ensure that the action is properly performed and shall take
   the measures necessary to this end , without préjudice to the procedures provided
   for in Article 3 .
2. The Committee shall be assisted in the execution of its tasks by a Committee,
   composed of two representatives from each member State and chaired by a
   representative of the Commission, hereinafter referred to as "the Committee".
   The members of the Committee can call on the assistance of experts or advisors
   according to the nature of the problems under study.
   The proceedings of the Committee shall be confidential . The Committee shall
   adopt its own internal procedures. The Commission shall provide the secretariat of
   the Committee .
3. The Commission may consult the Committee on any matter within the field of
   application of the présent Régulation.
                                     Article 7
   Where the procedure laid down in this Article is to be followed , the chairman shall
   refer to the Committee a draft of the measures to be adopted .        The Committee
   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 delivered by the majority
   specified in Article 148(2) of the Treaty for decisions which the Council is
   required to adopt on a proposal from the Commission . In the Committee the votes
   of the representatives of the Member States are weighted as indicated in that
   Article . The chairman does not vote .
   The Commission shall adopt the measures under considération when they are in
   accordancea with the opinion of the Committee.            When the measures under
   considération are not in accordance with the opinion of the Committee or in the
   absence of an opinion , the Commission shall submit to the Council without delay a
   proposai relating to the measures to be taken.        The Council shall décidé by a
   qualified majority.
 ---pagebreak--- If, after the expiry of a period of one month following the Council’s consideration
of the matter, the Council has not taken a decision, the proposed measures shall be
adopted by the Commission.
                                  Article 8
The result of the action shall be reviewed by the Commission after 12 months. The
Commission shall report to the Council and the European Parliament on the results
of this review, together with any proposals for modification or prolongation of the
action which the Commission deems appropriate.
                                  Article 9
With regard to the coordination activities provided for in Article 1(2 ), the Member
States and the Commission shall exchange all appropriate information 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 under their
authority.
Information shall be exchanged according to a procedure to be defined by the
Commission after consulting the Committee, and shall be treated as confidential at
the supplier’s request.
                                 Article 10
This Regulation shall be binding in its entirety and directly applicable in all
Member States .
This Régulation shall enter into force on 1 January 1988 .
Done at Brussels , . 1987
                                                           For the Council
                                                           The President
 ---pagebreak---                                                                    7
 ANNEX 1 : Summary of Areas (7)
                                                     AIM Pilot Phase
 Action Line I
 1 . Development of a Common Conceptual Framework for Coopération
           1.1 Development of a Reference Model for MBI
           1.2 Data Requirements Analyses for MBI
           1.3 Assessment of the cost-performance potential of MBI
Action Line II
2 . Medical Informatics Environment
          2.1 International comparison of diagnoses and procedures related to costs
          2.2 Définition of a minimum basic data set for ambulatory care in Europe
          2.3 Semi-automatic encoding of standardized medical data classification Systems in
                        Europe
          2.4 Development of European criteria to define severity of cases
3 . Data Structures and Medical Records
          3.1 Clinical data and process modelling
          3.2 General distributed medical record
          3.3 Medical record System / data cards
4 . Communication and Functional Intégration
          4.1 Hospital Information Services
          4.2 Wide Area Biomédical Information Services
          4.3 Data Protection/Authentication/Fail safe
3 . Biomédical Expert Support Systems
          5.1 Biomédical Expert and Knowledge Based Systems
          5.2 Dedicated Computer Language Tools
          5.3 Spécial Information Processing Requirements
          5.4 Human-computer interface
          5.5 Flexible open-architecture inference Systems
6.   Biomédical Instrumentation and Research Tools
          6.1  Integrated Biomédical Laboratory
          6.2  Biomédical Knowledge Bases
          6.3  Automated DNA Sequencing
          6.4  Automated Protein Analyzer/Synthesizer
Action Line III
7 . Non-Technological Factors
         7.1 Investigation of the opportunities of doser collaboration between national actions
         7.2 Review of the functional spécification, standardization and certification practices
         7.3 Review of the legal and regulatory framework applying to MBI
         7.4 Economie assessment of the MBI potential for health care and biomédical research
         7.5 Assessment of spécial skill training requirements and options to meet them
     ( 7)     For the apecification of the objectives and task aee AIM Workplan
 ---pagebreak--- Proposai for a CounciI Regulalion on a Community Action in thè field of
             Information Technology and Telecommunications
                           applied to health care
                                  A I M
              ( Advanced Informatics in Medicine in Europe)
                              - Pilot Phase -
                            Draft Workplan
                submitted by the Commission
 ---pagebreak---                                                      1
                                               Contents
 INTRODUCTION                                                                          1
                                            Action Line I
 I. DEVELOPMENT OF A COMMON CONCEPTUAL FRAMEWORK FOR
      COOPERATION                                                                      2
        1.1 Development of a Reference Model for MBI                                  2
               1.1.1 Reference Model for the Doctor Information Environment           3
               1.1.2 Reference Model for the Scientist/Technologist Information
                     Environment                                                      3
               1.1.3 Intégration and interoperation concepts                          3
        1.2 Data Requirements Analyses for MBI                                        4
       1.3 Assessment of the cost-performance potential of MBI                        4
                                            Action Line II
2.   MEDICAL INFORMATES ENVIRONMENT                                                   7
       2.1 International comparison of diagnoses and procedures related to costs      8
       2.2 Définition of a minimum basic data set for ambulatory care in Europe       9
       2.3 Semi-automatic encoding of standardized medical data classification
            systems in Europe                                                        10
       2.4 Development of European criteria to define severity of cases              11
3.   DATA STRUCTURES AND MEDICAL RECORDS                                             12
       3.1 Clinical data and process modeling                                        12
       3.2 General distributed medical record                                        13
       3.3 Medical record System / data cards                                        14
4.   COMMUNICATION AND FUNCTIONAL INTEGRATION                                        16
       4.1  Hospital Information Services                                            16
       4.2  Wide Area Biomédical Information Services                                18
       4.3 Data Protection/Authentication/Fail safe                                  19
              4.3.1 Assessment of the data protection , authentication and fail-safe
                    requirements in MBI                                              19
              4.3.2 Development of international medical data protection protocols   20
5 . BIOMEDICAL EXPERT SUPPORT SYSTEMS                                                21
       5.1  Biomédical Expert and Knowledge Based Systems                            21
       5.2  Dedicated Computer Language Tools                                        22
       5.3  Spécial Information Processing Requirements                              23
       5.4  Human-computer interface                                                 24
       5.5  Flexible open-architecture inference Systems                             24
6 . BIOMEDICAL INSTRUMENTATION AND RESEARCH TOOLS                                    26
       6.1  Integrated Biomédical Laboratory                                         26
       6.2  Biomédical Knowledge Bases                                               27
       6.3  Automated DNA Sequencing                                                 27
       6.4  Automated Protein Analyzer/Synthesizer                                   28
 ---pagebreak---                                                   11
                                         Action Line III
7 . NON-TECHNOLOGICAL FACTORS                                                        29
      7.1 Investigation of the opportunities of doser collaboration between
           national actions                                                          29
      7.2 Review of the functional spécification , standardization and certification
           practices                                                                 29
      7.3 Review of the legal and regulatory framework applying to MBI               29
      7.4 Economie assessment of the MBI potential for health care and
           biomédical research                                                       30
      7.5 Assessment of spécial skill training requirements and options to meet them 30
 ---pagebreak---                                              1
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
          analvze and assess future reouirements in health care and biotechnoloev 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 . économie 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.
 ---pagebreak---                                                2
 1.  DEVELOPMENT OF A COMMON CONCEPTUAL FRAMEWORK FOR
           COOPERATION
 Health care is in a process of continuous evolution and so is the 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 .
The types of data a doctor generally needs to handle , review, merge in a report, are:
     - text (e.g. reports from colleagues in the referral System )
     - numeric laboratory results
     - graphical présentations (of both numeric data and body sites)
     - signais (e.g. electro-cardiograms)
     - images (e.g. x-ray, sonograms etc. ).
These data have three main origins: data they generate themselves about patients ,
data others generate about their patients , and general medical knowledge.
The data handling requirements of researchers working on the molecular basis of
biological systems are:
             automatic collection of experimental data from different sources;
             comparison of experimental data with those stored in databanks and
            databases;
             tertiary structure prediction from sequence data;
             molecular modelling;
             quantum mechanical calculations for structure refinement.
This suggests three directions for the development of medical informatics:
(a )       medical records ,
(b)       communications ,
(c )      and information retrieval/decision-support Systems.
Formulating a strategy about information technology for health care requires to
identify the information needs and how they can best be met. This implies the
analysis , understanding and agreement between the main actors concerned as to the
approach best suited to meet user needs in a way which is consistent with economic
and technological constraints .
1.1   Development of a Reference Model for MBI
Objective
The developments in MBI will build wherever possible on the developments in
information technology , telecommunications , broadcasting and value-added services .
In addition , and relating 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 data base management systems , but will need special tools , eg expert
systems , to assist in the efficient use of the data .
 ---pagebreak---                                              3
 To permit MBI to build on synergy with other domains and to help identify the
 requirements in common functional specifications and minimum standardization, it is
 proposed to start, as part of the Pilot Phase, with the conception and development of
 a Reference Model for MBI. As far as the telecommunications and broadcasting is
 concerned , this work can build on the Reference Model developed as part of the
 RACE Programme.
 The spécifie objectives of this work are
           to create and maintain transparency for the requirements and their
           functional characteristics,
           to come to a common understanding of the evolution in MBI,
           between the main sector actors to come to a common definition and
           understanding of the functional and minimum standardization requirements
           to support the work of common functional specifications and of
           standardization by the appropriate bodies to facilitate progress in MBI for
           health care and research in related domains .
 Scope
The work will comprise three major elements, namely those relating to the
Informatics Environment of the Doctor, the Scientist/Technologist working in related
domains, and the general requirements for the development of the Reference Model.
 1.1.1 Reference Model for the Doctor Information Environment
This will include all the functional descriptions relating to the information processes
involving the doctor in his relationship to the patient and the supporting
infrastructures (eg hospitals,...) and services (eg laboratories...). In identifying and
describing the functional requirements both technical as well as cost considerations
will be taken into account.
 1.1.2 Reference Model for the Scientist /Technoloeist Information Environment
This covers the functional description relating to the work of scientists and
technologists working in health care related domains , eg laboratories engaged in
diagnostics, but more generally those engaged in biotechnology. Though the scope of
biotechnology goes beyond health care , the bio-informatics requirements are to a
large extent common to all domains of biotechnology.
1.1.3 Intégration and interoperation concepts
This work would concentrate on analyzing and extending the 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 of "Open Interconnection" to the sector specific
upper layers of the OSI model. Main issues include access control and user identity;
electronic signature and time stamping; confidentiality; data integrity.
 ---pagebreak---                                                4
 1.2  Data Reauirements Analyses for MB I
Objective
 In order to develop information systems which are open and flexible in meeting the
needs' of health care by building on the evolution of the underlying sciences and
technologies , it is necessary systematically to analyze information requirements . The
understanding of information requirements is the pre-requisite for the conception
and definition of common information processing functions and the development of
information exchange and portability. This in turn is a pre-requisite for common
functional specifications and minimum standardization.
Scope
The scope of the work needs to include the analyses of health care related
information requirements and the specification of the associated specific features
relating to data capture , processing, verification , protection , authentication , storage,
transmission , recall , and presentation for the following relationships:
           patient - health care services
           doctor-patient (correspondence, information, advice, etc)
           doctor-reference information (case history, diagnosis of symptoms ,
           prognosis , treatment options, prescriptions, recent experiences in
           treatments , etc)
           doctor-diagnostic services (laboratories)
           doctor-therapy (surgery , dispensaries , special therapies of various kinds)
           doctor-administrations      (hospital ,  insurance ,   public   administrations ,
          accounting , etc ).
With respect to the laboratories and research infrastructure for health care , the
corresponding analyses will need to be carried out including the following
relationships
          scientist /technologist-reference information (eg DNA and protein sequence
          and structure data bases , literature , etc.)
          scientist /technologist-experimental data (eg . x-ray and neutron diffraction;
          two-dimensional high-resolution nuclear magnetic resonance , electron
          microscopy)
          scientist /technologist-experimental eauipment (eg molecular dynamics
          simulation , X-ray crystallography , advanced 3-D graphie Systems ...)
          scientist /technologist-administrations ( hospitals or other service demander,
          insurance , public administrations , accounting , etc )
The result should identify the options and the approach for the development of
application-specific coding structures , allowing for technology expansion and
refinement for data transmission in processable form . Within the scope of the Pilot
Phase this could already be expected to make a significant contribution to the
urgently needed harmonization of future developments as well as prepare the ground
for further detailed work .
1.3  Assessment of the cost-performance potential of MBI
Objective
Informatics can be used in health care and biomedical research both to increase
performance and to achieve better economies . The objective of this work in the
context of the reference model is to investigate the cost-performance potential of
MBI .
 ---pagebreak---                                                     5
 SüQES.
 The work in this domain will consist ofthe identification of the various levels of the
 health care system where information technology provides opportunities to develop
 methods for containing costs yet improving care. Specifically the following Areas will
 be scrupulously investigated:
 - Prescribing
 - Radiology - Image Processing
 - Laboratory equipment
 - Benefit of sensor techniques
 - Population screening
- Cancer therapy
- Primary care
- Biomolecular research
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 needs improved.
Radiology
The use of digital techniques and optical disk storage , by generating a much more
advantageous data acquisition, storage and retrieval system, can significantly reduce
the annual cost of radiology today in comparison with X-ray film , chemicals , current
equipment maintenance and film storage 1^.
Laboratorv eauipment
While the cost of maintenance of laboratory equipment, computers excluded, is
considérable, adoption of a policy of having expert System diagnostics in even the
most simple laboratory equipment would permit économies and improvement in
service .
Sensor techniques
Advanced sensorics offer considerable potential for remote and un-attended sensing .
This can be used to greatly improve monitoring , accuracy and overcome time and
distance constraints .
Population screening
Information technology can improve population screening for a curable but otherwise
fatal disease , by enabling much of the preliminary detailed screening to be automatic.
Cancer therapy
The quality of life of a cancer patient can be significantly improved by the use of
computer models aid decision-making 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 for each patient.
    π Purchase of X-ray film* account! for 2% of the overall budget of a hospital and 60% of its radiology
           départment .
 ---pagebreak---                                             6
Primarv care
A combination of new measurement technology and information processing enables
better primary care to be provided , showing how technology convergence operates to
the advantage of health care . In particular, development of "alternate-site" medicine
requires convergence of film technology, chemistry, molecular biology and
information processing .
Bio-Molecular research
Bio-molecular research has the potential of revolutionizing the economics of
pharmaceutical production and the related R&D. There are already examples where
bio-molecular engineering techniques have been able to produce directly highly puré
substances at greatly better economics than traditional techniques permitted .
 ---pagebreak---                                               7
 2.  MEDICAL INFORMATICS ENVIRONMENT
 Description
 In context of the rapid development of technology and automated information
 systems, standards are required to enable comparisons and exchange of health
 information at international level. Medical data availability and comparability in
 Europe should allow better understanding of the patterns of evolution of chronic
 diseases, optimize resources with the result that the quality of care and the quality of
 life will improve and contribute to management and research to the benefit of
 patients .
The growth of information technology in medicine is now leading to a proliferation
of independent systems in Europe. Thus, there is a danger of an increasing lack of
comparability between medical information systems that will limit the possibility of
large-scale , national or international studies, as well as the possibility of evaluating
the efficiency and quality of care at the European level.
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
development of the concepts of integration and convergence in health care.
Objective
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.
At a scientific level , the adoption of comparable classification Systems is particularly
important to obtain a better understanding of the différences in the spread of
diseases as well as of différences in health care delivery Systems and their cost in
Europe.
At a political level , accurate and reliable data bases are vital for the monitoring of
the efficiency and the quality of care, as well as for the development of strategies
and of international standards .
Scope
To meet this objective , four major Areas of activity are required:
            International comparison of diagnostic criteria and procedures related to
            costs ( hospital in-patients ).
            Definition of a minimum basic data set (MBDS) for ambulatory care in
            Europe.
            Semi-automatic encoding of standardized medical data classification systems
            in Europe .
            Development of European criteria to define severity of cases .
 ---pagebreak---                                              8
 2.1  International comparison of diagnoses and procedures related to costs
            Harmonization of medical data classification systems through comparisons
       •    and common results , using the European Minimum Basic Data Set ( MBDS)
            defined for hospitals.
            Evaluation of the Diagnosis Related Group (DRG) methodology in Europe ,
            to understand differences and explore ways of comparisons.
This work has an exceptional importance in order to coordinate 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.
Scope
The work in this part will consist of seven strongly interrelated Areas:
Development of standards for data input
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 being replaced by computerized data entry and
processing.
Differences in diagnostic classification systems among European hospitals
Whenever MBDS are available and comparable within and between countries , pilot
studies will be designed to obtain data exchange and comparisons in Europe , and
between Europe and the United States .
Differences in classification of procedures among European hospitals
Unlike diagnoses , which tend to be uniformly classified according to the
international classification of diseases, operations and other procedures are coded by
national classifications or nomenclatures which have been elaborated following
different requirements of clinicians, health care managers, financing bodies and
social insurance funds , for various purposes, mainly administrative in nature . The
task is to upgrade any classification systems of medical data in order to cope with
evolution of medical 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 of medical data from each European classification
scheme will eventually be developed internationally.
Differences in case-mix among European hospitals
As a first step it is recommended to carry out a comparison of the international
classification systems measuring the costs for specific case-mixes for European
hospitals, eg ICD-9 , ICD- 9 - CM and DRG’s , and to develop an approach to
harmonizing their use.
 ---pagebreak---                                                9
 Influence of case-mix on length of stav and cost factors in Eurooean hospitals
 As resources tend to be allocated according to past requirements , new indicators are
 needed to measure the productivity of health care delivery systems. The most widely
 available source of medical indicators of productivity indicating why certain care has
 been delivered to patients appears to be the medical record summary that includes
 the hospital MBDS with all diagnoses and procedures performed for each inpatient.
The work will be aimed at obtaining a better description fo the health care delivery
systems in Europe by linking MBDS levels, abstracted from medical record
summaries with financial data as well as knowledge data bases.
Definition of proposals to harmonize medical data classification systems in European
hospitals
Programs will be developed in Europe to harmonize medical data classification
systems. They must be as universal as possible - taking into account needs of all
countries, including underdeveloped countries - and flexible in order to allow for
changes in the future. The approach will be multidisciplinary, to enable dialogue
between health professionals and managers.
Definition of R&D requirements in software and hardware to allow competitiveness
with the U.S. industry
Harmonization of medicai data is a prerequisite for a large scale European market in
medicai informatics. In order to have thè capacity to compete against strong
American companies , thè European industry will be supported to design and further
provide well adapted packages that include MBDS and DRG’s .
2.2 Définition of a minimum basic data set for ambulatorv care in Europe
Objectives
            Harmonization of medical data classification systems by defining an MBDS
           for ambulatory care, e.g. the core of knowledge that should be available
           everywhere in a comparable way for the maximum number of usages in
           ambulatory care .
           Evaluation of the Ambulatory Visit Groups ( AVG ) methodology in Europe
           to explore its feasibility, advantages and disadvantages.
Scone
The scope includes the following tasks:
Definition of an MBDS for ambulatory care
So far in Europe only a small number of generai practitioners (between 1 and 5% in
different countries ) use computers to process medicai information. Standardization of
classifications is therefore a prime concern . The task is aimed at thè validation of
standardization concepts and pre-normative work for thè coding in ambulatory care
and thè definition of a MBDS for family and outpatient care .
Use of the MBPS defined and of the AVG methodology in pilot centers in Europe
Once a MBDS has been defined at European level , there is a strong need for
assessing the Ambulatory Visit Groups methodology which has been developed in the
USA in 1986 , in order to compare medical data linked with financial data in
ambulatory care.
 ---pagebreak---                                                 10
 Definition of proposals to harmonize medical data and patient classification systems
 for ambulatorv care in Europe
The definition of a MBDS in ambulatory care which is of paramount importance in
the frame of health care delivery systems will allow the requisite preparations for the
 harmonization of medical data classification systems .
 Definition of R&D requirements in software and hardware to allow competitiveness
with the U.S. and Japan
Building on the advanced professional know-how in ambulatory care in Europe and
the considerable experience in the field of financial data onambulatory care, the
work will define software and hardware specifications for medical data classification
systems in ambulatory care.
2.3 Semi-automatic encoding of standardized medical data classification svstems in
         Europe
Ob jectives
            Encoding and decoding from natural medical language to international
            classification systems.
            Automatic grouping of these classifications into sub-classifications related
            to costs (DRG’s for in-patients and AVG’s for outpatients).
            Harmonization of rules for medical data classification systems in Europe .
This work has a strategic importance for the development of coherent health
indicators and thereby health services standards , as well as the development of
harmonized medical information systems that could generate a large industrial market
for medicine in Europe.
Scope
Specifically the work is to concentrate on two major Areas of activity:
Development of standards for diagnoses in European languages
This work aims at meeting the need for standards in extensions of the ICD-9 coding
scheme for diagnoses in Europe. Semi-automatic programs for encoding medical
diagnoses will be designed and then made available on a European scale . Coding
could be part of an expert System front-end which , apart from coding transparently
from free-text input will incorporate context-specific coding and automatic error
détection and corrections .
Development of standards for procedures in each European language
Comparisons will be made between national procedures for coding schemes and
between     extensions    of  international classifications and nomenclatures   that   are
currently being generated in several European countries . The appropriateness of those
classification schemes will be examined in relation to their use 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 ,
allowing for terminology expansion and refinement for data transmission in
processable form.
 ---pagebreak---                                               11
These procedures must be compatible with DRG’s and AVG’s, which requires the
development of editing programs and grouping programs.
2.4 Development of European criteria to define severitv of cases
Objective
The objective of this part is to obtain a simple set of criteria to determine the
severity of cases in hospital and in ambulatory care , allowing the better assessment of
the productivity of health services in all European countries. Work in this domain
will 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 .
The strategie importance of this work is summarized hereunden
           Variations in costs hâve been shown in the USA as well as in some
          European studies to be largeîy dépendent on the severity of cases , but
          criteria to define "severity" are not yet standardized , even in the USA .
          Criteria of severity should be easily available coutry-wide . They can be
          based either on an analysis of the content of the MBDS or on physiological
          signs (like the APACHE system in intensive care).
Scope
Physiological indicators
The task is to select physiological indicators in relation to intensity of care and
severity of cases , with linkage to financial data.
Complications and procedures in DRG's
The work in this domain is aimed at refining the definition of DRG’s in relation to
intensity of care and severity of cases, with linkage to financial data.
 ---pagebreak---                                                 12
 3.   DATA STRUCTURES AND MEDICAL RECORDS
 Description
 As information requirements are identified, the data to meet those requirements must
 be carefully defined if they are to be 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 be seen within a
 model which defines their structure . This is a prerequisite for the computerization of
 medical records. Regarding the broad medical market with abundant varieties of
 initiatives in hard- 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 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 standardization and harmonization work to be achieved
at European level.
Objective
The objective of this part is to stimulate work at a European level in the
development of medical data and process models as a key to progress with
information technology in health care , and to foster concertation on the common
functional specifications and minimum standardization required for the
computerization of medical records and progress in portable storage techniques .
Scope
To meet these objectives, this part would comprise three major Areas of activity:
            Clinical data and process modelling , thè development of which is essential
            not only for information transfer across boundaries , but also as dynamic
            reference models for voice input , image processing and so on .
            Spécification of the functional requirements for a general distributed
            medical record .
            Common functional specifications and harmonization proposals for patient
            data cards to be used for storage of a single patient’s relevant data .
3.1   Clinical data and process modeline
Description
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 , pharmacy , therapeutics , and biotechnology , where there is a data ¬
set which needs to be understood by a non-specialist in that particular data . Clinical
data modeling needs to be developed for ensuring transferability of data and
processes . In principle , the clinical process (a patient’s entry to , passage through , and
exit from clinical care ) can be expressed as a series of related data and process
statements. These can be formally encoded to provide a scheme describing the care
of the patient . Since the scheme is based on the patient and the disease , there is
minimal dependence on style of practice .
 ---pagebreak---                                              13
 Objective
 The objective is to design standard clinical data models acceptable across Europe.
 This will enable the reference model to operate in any required direction at any
 required level of care.
 Scope
 Specifically the work is to concentrate on:
 Development of a common coding set
 The task is to develop a common coding set integrating the requirements of medicine
 and data protection. Medical codes are 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 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 national obligations , yet the embedded code is still transportable
 between different systems and different users .
 Development of common data formats
Common formats are required to represent diseases and therapeutic processes . They
optimize transfer of data and process information which thereby become independent
of communications and of host systems. Transferred data can immediately be
reconstructed, whether it is read from an input communications line, a magnetic tape
or a smart card .
Correctness , validation and verification
At present there are no formal rules of medical correctness for validating medical
expert systems. One of the great applications for expert systems in medicine is their
role in defining "normality", thereby saving staff appreciable time and effort which
can be more efficiently directed to solving the problems of abnormality. Correctness
of medical expert systems is therefore central to the development of biomedical
informatics, especially as practitioners thereby know that a particular system for
clinical use has been formally validated as correct.
3.2   General distributed medical record
Objective
The objective is to design a record system that should provide easy, flexible
structuring and summarizing of complex patient records and be integrated with the
decision support functions. The record system must both aid in the care of individual
patients and support studies of populations for research and "anticipatory care".
Above all, doctors must find that its usefulness repays the effort of entering data and
the maintaining system .
Scope
Conceptual studies will be undertaken to clarify the potential of a harmonized
approach to a medical distributed data base /transaction model . Major interest will be
focussed on the approach of distributed transaction processing .
 ---pagebreak---                                              14
 Identification of commnn functional reauirements
 Main activities will be directed to clarifying the requirements for developing model
 hospital information systems and model regional systems using the new techniques of
 distributed transaction processing based on medical standards of data exchange.
 Development of standardization proposals
Standardization developed in this context may finally lead to data exchange protocols
on the medical application layer conforme to the OSI concepts..
3.3   Medical record svstem / data cards
Description
As the central source of information for all forms of clinical practice , the medical
record is a key issue in the computerization of medicine . The choices made in the
design of computerized medical record systems , which determine not only how
medicine can be practiced , but also how changes can be made in practice or in
computerized activities, are vast and affect many aspects of medical communications.
There are several issues relevant to an efficient medical record system. The ability
to develop systems on a European basis requires answers to the following questions :
what should be stored in a record ? how should information be stored ? Where should
data be stored ? What medium should it be stored on ?
Objective
There are several issues relevant to an efficient medical record system. Any strategy
in information technology for health care will depend on projects incorporating
studies on the design and use of medical records . In this section reference is made to
patient data cards to be used for storage of a single patient’s relevant data. The
conceptualization and harmonization of this developing technology has to be
thoroughly prepared in order to develop standards efficiently.
Scope
Specifically the work in the following Areas is envisaged:
Card Technologies
The task is to stimulate collaboration and concertation in the analysis of the
requirements and opportunities in card technologies, e.g. improved storage capacity
for smart cards, mixed smart-optical cards , readers, writer-readers.
Pointers
Adéquate addressing is required for use of pointers which, stored on the card , would
allow retrieval of certain information, such as X-ray pictures , if necessary.
Archivai storage
New techniques for adéquate archivai storage hâve to be investigated .
Picture storage
Compression techniques for picture storage require further developments.
 ---pagebreak---                                           15
Medical records storage
The task is to define methods for storing medical records in a hierarchical fashion,
from a brief description of episodes, information used to reach a diagnosis, and
related data.
 ---pagebreak---                                               16
 4.  COMMUNICATION AND FUNCTIONAL INTEGRATION
 Paçrjptim
 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 health care system. Establishing communications between the range
of equipment and systems in use and under development offers considerable saving
 in terms of cost, but even more importantly in terms of time and flexibility. Beyond
establishing the ability to transfer and access information there is the potential of
removing some of the inherent redundancy in stand-alone equipment and facilities .
This is referred to as "economies of integration" and means simply that as a result of
functional integration resources can be shared between equipment and facilities
giving a considerable improvement in cost-performance and flexibility.
However, the benefits of "economies of integration" require the realization of
functional integration and interoperability going beyond the simple exchange of
information .
Qbiçcüv?
The work in this part is to investigate requirements and technology options in the
domain of medical communications by concentrating on some specific aspects of
particular importance for future developments.
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 below .
4,1   Hospital Information Services
Description
The functioning of a hospital is highly information-intensive and has very stringent
requirements . The information needs to be available when and where needed often
with no advance notice 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 considerable demands on the human factor
engineering of such systems in order to make them user-friendly .
These and other requirements specific to the hospital environment make hospital
information services an issue requiring special attention .
Local area network techniques as developed for office automation will provide the
basis for the development of information services in hospitals , but additional efforts
will be required to meet the specific needs of health care.
 ---pagebreak---                                                 17
  Hospital information services require an interactive computer based system which
  will progressively integrate and automate the entire flow of information in a hospital.
 Although there are still 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. Hospital information services in
 the 1990’s will be provided from 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 communication system. The
 collection of data will     be done from peripheral units or personal computers at
 admission and discharge     points. Encoding will be facilitated by a data dictionary, a
 knowledge base editor, a    data interpreter and a knowledge base.
 Objective
 As there should be no formation of internai frontiers to health care it is of great
 importance to start the reflection on the requirements and functional specifications of
 hospital information Services early enough to permit a coherent development in this
 sector facilitating the collaboration between hospitais , of hospitais with insurance and
 administrations , and also to make the hospital administrative procedures easier and
 more transparent to patients.
 Harmonizing present efforts and at the same time preparing actions for the future
 require focussing on the definition of a 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 and development.
 A major advantage of such a development would lie in the further foundation of a
 European-wide standard 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
Further developments in technology, notably in the areas of communications, local
area networks, distributed processing and database systems/techniques as well as in
the progress made on the agreement to international technical communication
standards , mean that the present emphasis in the area of hospital information services
is on the integration of the different functional systems within a hospital into one
unified information planning and management system .
The scope consists therefore in bringing together the relevant European companies ,
the health care specialists and health economists to develop the basic design and
prerequisites for a common standard in hospital information networks .
Specifically, this work will have to include the consistent investigation of all the
main aspects of integral information processing , ie medical standards for data
exchange , medical bus , interconnection to medical instrumentation , and so on.
The medical information bus
The task is to define a standard communications protocol for instrumentation used in
hospitals, particularly for intensive care. A wide range of instruments used in
hospitals lack a common means for data acquisition, and often lack computer-
addressable interfaces . Furthermore the development of closed-loop control for drug
infusion or ventilation has accentuated the need for a simple means of computer
control . The medical information bus is explicitly designed to meet these deficiencies
and needs .
 ---pagebreak---                                                18
  Picture archiving and communication systems ( PACS )
 The object in developing PACS is to assist the tasks of storage , archiving and
  transmission of images in diagnostic radiology departments. Ultimately techniques
 developed for this purpose may also be extended for other medical communication
 purposes and even for other functions. The specific task here is to support the work
 carried out by European actors in the identification of the common functional
 requirements of PACS.
 4.2 Wide Area Biomédical Information Services
 Description
 Within modern health systems there is a growing need for wide area communication
 services . This is due to several reasons , the 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 aspects of
 health care also require wide area services , e.g. the linking of laboratories in quality
 assurance programmes etc .
 Typical user requirements of wide area biomedical information services include the
 provisions of general clinical data, the transfer of laboratory analytical data. This
 implies the exchange of data files of several megabytes concerning structural analyses
or digitized images.
 In the related research areas there is a need for unrestricted access to the large
databases and collections which form the basis for modern biotechnology. Among
these are
            nucleic acid and protein sequences;
            structural data on proteins and biopolymeres;
            genetic maps;
            verctors for nucleic acid sequencing .
A start has been made under the BAP which provides for improved access for
researchers to nucleic acid and protein sequence databases , to a monoclonal antibody
databank and to strain collections. However, this access needs to be extended to
encompass structural data, genetic mapping libraries , cloning vectors and
bibliographic databases , etc. and to take in industry as well as academia.
AIM is in this context to develop new tools to address thse objectives.
Objective
The objective is to offer a universal solution to the need for a common biomedical
network which takes account of such aspects as time zone differences and holiday
periods in Member States , and also the need to deal with functional aspects such as
unread messages .
Scope
It can be expected that most wide-area communication needs for health care
applications will be met by the general development of telecommunication services,
ie requiring no specific actions to be taken. However, the use of these techniques for
health care may raise a number of operational, regulatory and political issues which
need to be identified in time and for which appropriate 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.
 ---pagebreak---                                                   19
 The scope will include preparative work on electronically- or optically-linked
 terminals , and on link by a portable medium such as a compact disk.
 4.3  Data Protection / Authentication / Fail safe
 Description
 In the context of health care some of the most sensitive data protection issues arise.
 Data protection is a fundamental aspect of data handling which will gain in
 importance as health care networks grow, as information networks grow, as the
community becomes more litigation conscious, and as information gains in
commercial value in response to the worldwide competitive position of Member
States.   As a consequence, consideration of data protection becomes enmeshed with
details of international standards , network developments , computer architectures and
the means by which data transferable systems will work independently of system and
network architectures . The issue is complex , for data protection has to be very high
for the individual, yet the mechanism of data protection has to be sufficiently
transparent, so that it does not impede the legitimate and authorized use of the data.
Objective
Positive identification of authorized users of data is an important issue which needs
to follow thè organization and management of health care. Fail-safe considerations
are also application specific. The standards developed, e.g. for office automation, are
not necessarily adequate for health care . The objective of this work is therefore thè
identification of thè functional and technical requirements as derived from thè needs
in health care .
Scope
The scope of the work will include all generic information handling operations in
health care and the supporting services . It is to include the concerns of the
individual , whether as patient , doctor, researcher, economist or legal specialist.
4,3.1 Assessment of the data protection , authentication and fail-safe reauirements in
         MBI
Ob iective
With the participation of the main actors concerned with the development and use of
MBI systems, the issues of data protection , authentication and fail-safe requirements
are to be investigated for the health care applications . This will be done based 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
Data protection aspects involve all areas of data acquisition, transmission , filing ,
interpretation . The scope involves therefore several aspects such as, e.g. , in-house
systems , regional systems, data cards , etc . It also includes related aspects such as data
interpreting.
 ---pagebreak---                                              20
4.3.2 Development of international medical d ata protection protocpls
Objective
The objective is to specify the requirements for protection-based information
handling tools in order to ensure user confidence in high-efficiency information
handling systems.
S.CQPS.
The scope of the work is to:
          develop a coherent set of good practice rules from which data protection
          principies can easily be adopted as part of the national legislation for
          medical information handling .
          meet the need to link data protection in computer networks and individual
          host machines to systems of patient-portable data such as data cards .
          devise data protection rules for development of intelligent-knowledge based
          systems, building on the satisfactory mapping of certain questions
          concerning the data and process aspects of disease into Open Systems
          Interconnection Protocols .
          foster further research on design of large scale data protected networks.
          These aspects include encryption , addressing , authentication of sender,
          authentication of recipient, notification of dispatch , notification of arrival ,
          freedom from error , indelible audit of information trails.
          define the most effective algorithms for solving the above-mentioned
          issues .
          contribute to the further development of existing Open Systems Protocols in
          order to satisfy the medical data protection requirement.
 ---pagebreak---                                                21
 5.  BIOMEDICAL EXPERT SUPPORT SYSTEMS
 Description
 Expert support systems - the marriage between computers and 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.
 Decision support systems were developed within the data processing world because of
 the practical limitations of data processing for helping people solve complex problems
 in actual organizations such as hospitals or national health organizations. Expert
 system technology reflects a largely independent evolution that took place in
 computer science research laboratories in answer to the limits of traditional computer
 science techniques for solving the complex problems that people can solve . These two
separate progressions can now be united to help solve a broad range of important
 practical problems.
Objective
The objective of this part is to explore the opportunities of expert support systems in
the field of health care and to identify the common functional specifications
prerequisite for the emergence and development of a competitive European market
for this very promising area.
SÇQPi.
To meet the objective stated above, this part would comprise the following tasks:
5.1   Biomédical Expert and Knowledge Based Systems
Description
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 size hospital information systems are remarkable and could
even be more important in a broader sense of quality assurance in medical care . The
same holds for the impact on biomedical training.
Expert systems can improve the quality of medical actions by increasing the accuracy
of diagnoses and more specific and individualized recommendations for medical
treatment .
Expert Systems can also contribute to control cost of care:
            mistakes are reduced thus allowing for a more efficient problem handling;
            the diagnostic process can be shortened or logistically simplified ( in the
           sense that less referral from institutions to others is required );
           patient-oriented expert systems will enable more patients with chronic
           diseases to navigate their disease effectively.
Objective
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 .
 ---pagebreak---                                                22
 SCQPZ
 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 scope it is suggested that the task be restricted initially to a
 specific medical problem area, e.g. diabetes. On-going collaborations could form the
 basis for such an initiative. This experiment would help to develop the empirical
 background on which to judge future work towards sharing of diagnostic tools and
 other health care features . Specifically it would be expected to show the impact that
 these developments could have on quality and cost containment in health care . Main
 tasks would include:
            Definition of a framework for expert systems in medicine;
            Analysis of knowledge representation;
            Analysis of medical reasoning;
            Analysis of the interfaces
            Interaction between expert Systems and other types of Systems
The framework for expert Systems in medicine
The areas of medicine and health care in which it is possible to apply expert systems
are to be identified and the possible conditions for their effective use are to be
analyzed.
Knowledge representation
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 .
Medical reasoning
The various types of expert systems usable in health care (diagnosis , description of
possible scenarios , planning) with their respective architectures are to be analyzed ,
focussing attention on the procedural aspects and those that are supposed to be meta ¬
knowledge .
Interfaces
Starting from an analysis of the existing interfaces used in expert systems , the
characteristics that the interfaces for the next generation of expert systems should
have are to be studied , focussing attention on both natural language and graphics.
Interaction
The types of systems already existing in an information system (decision support
systems , mathematical models and statistical packages ) that will have to interact with
expert systems will be analyzed as well as the type of interaction . Data bases ,
especially those that have a universal relation interface , will be also considered .
5.2   Dedicated Computer Language Tools
Description
It is proposed to investigate the feasibility of a "macro language for health care", ie a
language building on general purpose languages but having special features
facilitating their use in health care and related research .
 ---pagebreak---                                                       23
  Obieçtive
  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 objective of the
 work is to explore the options for a computer language that could support the design
 and usage of application software in terms of medical and health organization meta¬
 data and their contextual (semantic) and syntactical relations (semantic data models).
 Scope
 This work could build on the work in ESPRIT and on progress made in other
 countries relating to this objective. The Pilot Phase could help clarify the chances of
 success and the timeliness of such an initiative. The work could also include some
 exploration of semantic data models for medical database developments.
 5.3 Spécial Information Processing Reouirements
 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
 development is needed before they can find an application to the problems in health
 care and the related research areas particularly biotechnology.
 Real-time high-speed processing of medical information is required in several areas
 including:
     - image Processing1^
     - voice Processing
     - real-time and greater - than - real- time modeling
     - development of neuromuscular prostheses
     - network management.
Among improvements which real-time high speed processing could bring to
biotechnological research are:
            a substantial increase in the quality of information displayes on the screen ,
            the spreading up of multiple itérative calculations for the validation of
            computer modelling of proteins .
Oh jective
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 that other application areas may not have similar special purpose
requirements ). Specifically this work would investigate concurrent high order
integration computers for biomedicine .
       Medical (canning accounts for 11% of the U.S. image-processing market . Fast-developing applications
           range from dynamic cardiac imaging to fracture analysis and use of biosensor-derived
           information .
 ---pagebreak---                                                  24
 Scope
 The scope would include the design and the requirements for its development, as
 well as the assessment of the potential field of application in MBI and other domains
 of similar needs.
This work can build on the work carried out in the framework of ESPRIT and
 national programmes in this domain as well as the experience in other countries
 working in this area.
 5.4 Human-computer interface
Description
As information processing systems require data input from medical and other staff,
great weight needs to be given to the development of the user interface . In
particular, there is a strong need for a clear demonstration that these systems will be
of benefit to the user who has to input the data.
Objective
The definition of European standards and their feasibility requires a specific effort
which is the objective of the work defined here .
Scope
The general usability requires as much harmonization as possible in the human
interface , regardless of the special medical application. It has to be developed to
serve under the special working conditions of doctors taking into account also the
requirements for efficient data protection.
5.5   Flexible open-architecture inference svstems
DeSÇrjptiçn
Use of information technology by physicians will largely be affected by the future
developments in artificial intelligence which will require the ability to offer high
speed graphics and inferential processing in a form accessible to a large market of
practitioners. In practical terms though , present developments are of limited
usefulness as they neither provide integration with every-day system aspects , as e.g.
the patient database , nor provide for interconnections or transferability. To realize
its potential usefulness , artificial intelligence has to be part of an integrated concept,
where it plays the role of the assistant in every day work.
Objectifs
The objective of the work in this domain is to design a "flexible open-architecture
inference system" as well as investigate its potential with respect to the technical
features needed for efficiency and adaptation to user needs.
 ---pagebreak---                                              25
Scope
The scope is aimed at the definition of a high-level operating system which, using
in-built expertise , can speedily and unambiguously interface with quite different
system functions from different positions within the system. Specifically the task is
to analyze and assess the requirements for the design of a net of interacting experts,
in which every expert gets the same initial data and during the consultation process
the output of the others . Further realization may be in a system of local distributed
experts connected by a Local Area Network or one computer with parallel processing
facilities .
 ---pagebreak---                                              26
6 . BIOMEDICAL INSTRUMENTATION AND RESEARCH TOOLS
Description
Biomédical instrumentation is one of the key factors of progress in MBI and is
crucial for its future development. Information technology embedded in biomédical
instrumentation represents the single most important factor in the explosive advance
achieved in biomédical research. The crucial importance of integrating advances in
ail technological domains including, in particular advances in information technology ,
télécommunications and broadcasting is expected to persist for the coming décades.
While European scientists rank high in the international comparison , the productivity
of their work is lower, ie the time spent for a given research result, is very much
higher. In other words the productivity of European R&D, not the quality, is lacking
compared with other developed regions. This is to a large extent due to inadequate
progress realized in biomedical instrumentation and the integration of information
technology.
The performance of the Community in the timely adaptation of concepts and
objectives to the technological advances will be decisive for the cost-performance of
health care and also for the international competitiveness in offering health care
products, equipment and services.
6.1   Inteerated Biomédical Laboratorv
Objective
The objective is to investigate the options for realizing major improvements in R&D
productivity in health care and related technological work by a concerted effort in
biomedical instrumentation with particular reference to the role of MBI . The specific
concept to be explored is that of an Integrated Biomedical Laboratory .
The systematic development of the MBI as applied to biomedical laboratory activities
could lead to the realization of integrated biomedical laboratories bringing a
considerable improvement in the cost- performance, quality, flexibility, reliability and
speed of biomedical research, ie have a major impact on the R&D-productivity in
this domain .
Scope
The scope of investigation of an Integrated Biomédical Laboratory should include:
           integrated measurement of biomedical variables         in vitro and their
           interpretation
           In-vivo sensors for diagnostics and therapy
           Image and data interpretation
           Computerized scanning
           Magnetic Resonance Imaging (MRI)
           Endoscopy, particularly video-endoscopy
           Picture archiving and communication systems ( PACS)
           Biochemical analyses
           Gene mapping
           Protein characterisation
           Cell screening
 ---pagebreak---                                               27
 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 instrumentation . Furthermore this work is to result in the definition of
 implementation concepts and the specification of the related technological work and
 indicate the key factors which would need to be taken into account.
6.2   Biomédical Knowledge Bases
Description
The complexity and volume of medical and biotechnological information is
considérable and growing at a rapid rate. Tens of thousands of genes control spécifie
life processes, three billion units of DNA form the human genome. With current
techniques, sequencing these three billion units could consume 3000 man years.
However, automated DNA sequencing machines are under development which may
eut costs of sequencing a gene to a fraction of an ECU within the next decade.
Similar progress is being made in the analysis of other biological materials and in
work on the molecular basis of medicine and therapy. However, much of this
progress depends on the effective management of the information acquired. Here the
design and development of Biomedical Knowledge Bases is a central issue.
Objective
The objective is to identify and assess alternative approaches to manage biomedical
information systems and avoid overloading. This requires the rapid storing and
sharing of information from medical, pharmaceutical and genetic research.
Scope
The information system and therefore the related Knowledge Bases need to support
biotechnological and genetic research as 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 effective information
acquisition, organization, maintenance , retrieval, access, for biotechnological,
pharmaceutical and medical uses.
The resuit of the exploratory work would serve to identify and assess the options for
effective and économie management of genetic and biomolecular information .
6.3   Automated DNA Sequencing
Description
Progress in biotechnology has led to new techniques for diagnosis , treatment and
prévention of disease. Most of these - from new vaccines based on recombinant DNA
to the création of therapeutic proteins for the treatment of cancer or heart disease -
dépend on rapid and économie sequencing of DNA .
Over the last decade the rate at which DNA can be sequenced has increased to
several thousand nucleotides per day. U.S. and Japanese teams are developing
automated DNA sequencers which will increase this by several orders and also reduce
the cost .
 ---pagebreak---                                            28
Objective
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 the application of advanced CIM techniques to achieve
high - 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 techniques .
Scope
The work is to include the systematic assessment of requirements and technology
options for automated DNA sequencing .
6.4   Automated Protein Analvzer /Svnthesizer
Description
Besides DNA there is a whole range of biomolecules playing a key role in medicine
and biology. The problems of analyzing structures and synthesizing them in a
controlled manner is of paramount importance for therapy on the molecular level.
Objective
The objective is the development of an approach to automated protein analysis and
its linking to protein synthesis .
Scope
The scope of the exploratory work to be included here extends to medical,
pharmaceutical and biotechnological requirements for protein analysis and synthesis .
The work is to address primarily the potential of MBI and CIM .
 ---pagebreak---                                              29
7 . NON-TECHNOLOGICAL FACTORS
The orientation of technological efforts towards meeting socio-economic needs
implies taking into consideration the context in which the technology is to be used.
The optimal use of resources implies furthermore that the organization and
management issues are equally taken into account. The political nature of high-
technology requires that even at the stage of pre-competitive R&D 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 wider context of related activities.
7.1 Investigation of the opportunities of doser collaboration between national actions
There is already a large effort under way within Europe and excellent work is being
done. However, due to the predominantly national orientation of these activities,
there is a significant amount of redundancy in the work being undertaken and the
possibilities for synergy often remain unexploited.
The investigation proposed as part of the Pilot Phase is to develop measures to assist
existing actors in identifying related activities and establishing collaboration where
appropriate . The investigation and consultation will also include the formulation of
recommendations to facilitate the common exploitation of results and transfer of
technology.
7.2 Review of the functional spécification, standardization and certification practices
The problems of coming to agreed functional specifications and 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 organizations focussed on health care and of others oriented towards
information technology and telecommunications . In addressing the issues of MBI one
will wish to build on existing standardization bodies. In order to achieve an effective
approach and in view of the national differences and the multitude of organizations
already involved in one way or the other it is proposed to carry out a survey of
standardization, specification and certification practices in Europe and
internationally. This work is to result in a recommendation as to the optimal
approach to addressing future requirements in standardization , specification and
certification in Europe .
7.3 Review of the legal and regulatorv framework applving to MBI
The use of information technology and telecommunications for health care needs to
include appropriate regulatory and legal measures to assure the protection of patient
interests as well as the commercial interest of service providers and operators .
In order to avoid the formation of new internal frontiers in the Community there is a
need to engage in an effort aiming at the definition of common rules and conditions
for the introduction of MBI .
As a starting point for so doing it is proposed to analyze the présent régulations and
législation governing the use and introduction of MBI. The work is to resuit in the
identification of the options and measures which could be developed in order to
support a harmonious development of the regulatory environment for MBI
applications in Europe.
 ---pagebreak---                                             30
7.4 Economie assessment of the MBI potential for health çare and biomédical
        research
Besides the qualitative advances MBI offers for Health Care the potential of cost-
containment is the most important contribution to be looked for. However, the
relationship between the performance of a technology or a service and the impact on
improvements in cost-performance are not straightforward. They depend on
numerous other factors and conditions which need to be understood and taken into
account. It is , therefore , proposed to investigate the economic impact of MBI on
Health Care and on the supporting services, in particular biomedical research. The
result of this work is expected to provide an understanding of the economics of
information in health care and indicate the way MBI can make the best contribution
to improvements in cost-performance of the overall system.
7.5 Assessment of spécial skill training reauirements and options to meet them
For the exploitation of opportunities created by technological advance special training
plays a key role . Typically the professional staff in place have received their
education some 10 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 very rapidly, as in the case in MBI, special
efforts will be needed to overcome the difficulties of technology and knowledge
transfer .
The work proposed as part of the Pilot Phase is the assessment of requirements and
the development of a scheme for special skill training directed at familiarizing
researchers and practitioners with the potential of advanced MBI.
 ---pagebreak---                                                      I
                                    FINANCIAL STATEMENT
 1 . Budget Headine: 7345
                        Advanced Informatics in Medicine in Europe ( AIM)
                                           - Pilot Phase -
 2 . Legal Base: Article 130
 3 . Description of Project
The global objective is to serve the concertation of European efforts towards
  sustained improvement in health care in the Community for the 1990’s within economically
          acceptable limits by exploiting the potential of Medical and Bio-informatics.
 AIM is an action of which the présent proposai is a Pilot Phase, which seeks to concert the
development, on a European scale, of the Medical - and Bioinformatics (MBI ) services ,
equipment, Systems, tools, standards, functional spécifications and conventions for health
care , by building , incrementally, on equipment, Systems and services devised for other uses ,
and on complementary actions to realize in the shortest possible delay the advantages of
technological progress for improving the quality and cost-performance in medical care and
its supporting services. The Pilot Phase has 3 Lines of Action.
Action line I :
            Improvement of the effectiveness of public and private actions
by means of
            the development of a common conceptual framework for coopération at the
            planning and management level
Action Line II:
            Strengthening Europe’s posture in MBI and health care
by means of
            coopération in pre-normative and pre-competitive technology exploration
            concentrating selectively on re-inforcing and complementing teh technology base of
            MBI and its services
Action Line III:
            The création of an environment favourable to rapid progress in the introduction
            and appropriate application of MBI in health care
by means of
            the development of specific proposals addressing the policy, regulatory, legal ,
            organizational framework of MBI applications including the training and manpower
            related factors .
4 . Justification of the proiect
Health is next to food and shelter one of the basic human needs. Conscious of the high
priority of health care and of the growing possibilities, but also of the cost constraints, the
Community needs to optimize its efforts towards this common objective. Sector actors have
joined the Commission in identifying actions which are suited to make best use of limited
financial , human and technological resources to exploit the technological advances in Medical
and Bio-informatics so as to bring the maximum care to the patient while staying within
reasonable limits of expenditure.
 ---pagebreak---                                                                    2
AIM seeks, therefore, to take advantage of the progress made in information technology,
télécommunications and mobile communications to contribute to qualitative advances in
medical care and improvements in the cost-performance by means of actions suited to
accelerate progress and to establish synergy between different streams of development and
actors .
MBI equipment and services represent also a major future market opportunity for
Community industry, but it will require quick and determined steps to increase the efforts in
this direction and to make better use of existing human , industrial and financial resources , so
as to match the increasing commitment to this domain in other parts of the world .
5 . Financial implications for the intervention appropriations ^
5.0       Implications for exoenditure (Million ECU)
5.0.0    Total cost over the whole of the expected duration:
          From the Budget of the Communities:                                           20.00
          From other sectors at the national level                                      17.75
                                                                            TOTAL:      37.75
5.0.1    Multiannual schedule
Commitment Appropriations               1987     1988     1989       1990   1991        Total
                                                                            and later
Contracts                                          0.85    13.59-     3.31              17.75
Personnel Costs                                    0.10        1.10   0.49                1.69
Administrative Costs                     -·-       0.05        0.31  0.20    -·-          0.56
Total                                              1.0       15.0     4.0               20.00
Payment Appropriations                  1987     1988     1989       1990   1991        Total
                                                                            and later
Contracts                                          0.35     6.09       7.31 4.0         17.75
Personnel Costs                                    0.10      1.10      0.49               1.69
Administrative Costs                     -·-       0.05     0.31       0.2   " ··         0.56
Total                                             0.5          7.5   8.0    4.0          20.00
     1)     The Proposal for a Council Regulation concerning the Framework Programme of Community Activities in
            the Field of Research and Technological Development ( 1987-1991 ) COM(86) 430 final includes the
            provisions for this action under Action Line III .
 ---pagebreak---                                                       3
          5.0.2   Method of calculation
             a)   Expenditure bv contract
            This expenditure covers the Community's financial contribution to analytical work,
             pre-normative and pre-competitive R&D as required for identifying functional
            spécifications, standardization and technology requirements, carried out normally
             under shared-cost contracts (research and development for a total of about 300
            Man Years) to be concluded with health care equipment industry, service
            providers , research establishments , undertakings , including small and medium sized
            enterprises and other bodies established in the Community (average Community
            financial contribution - about 50% of total costs).
     b)     Qperational expenditure
            Administrative costs (management committee and working party meetings,
            consultation of experts , missions, document distribution or dissémination of
            techniques , use of data Processing, télécommunication and broadcasting equipment).
     c)     Management staff expenses
            The requirements of this project hâve been estimated on the basis of a staff of :
     [9]    temporary officiais - category A
     [2]    temporary officiais - category B
     [4 ]   temporary officiais - category C.
This staff is requested under the Budgets 87 to 89.
6 . Financial implications for staff and current administrative appropriations
(See sub-point 5 above - included in the general budget of the Commission)
7 . Financing of expenditure
The appropriations required to cover the Community’s contribution to this project are to be
entered in the Community’s future budgets.
8 . Implications for revenue
            Community tax on salaries of officiais
            Officiais* pension contributions .
9 . Type of Control
            administrative control by the Director General for Financial Control as regards
            budget implémentation;
            Scientific Control:
                  Management Committee
                 scientific control by officials of the Commission
                 audit by the Court of Auditors in accordance with provisions of the Treaty.
                                                  ***********
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                                      AIM and the SME’s
AIM is relevant for SMEs since
           it provides opportunities for start ups and other innovative companies to enter a
           high-technology application at a formative stage,
           it reduces the development and innovation risks by defining common functional
           spécifications , minimum standards and concepts , thereby reducing the entry -
           barriers for SMEs, and
           créâtes opportunities for the direct involvement in pre-normative and pre-
           competitive work on a European scale.
The object of AIM, as a complement to Medical and Biotechnological Research Programmes,
is to stimulate and support the development of Medical and Bioinformatics which is a crucial
infrastructure for progress both in health care as well as the development and application of
Biotechnology.. The supply side is at the moment largely in the hands of a few specialist IT
and telecom equipment manufacturers with the services relying largely on techniques
developed primarily for other uses. However, in order to exploit the potential of MBI the
practitioners, hospitals and innovative specialized service providers have a major contribution
to make. Within the consistent framework for action in MBI to be created by AIM these
innovative SMEs will be able to engage with a calculable risk and perspective.
Part of the development of MBI depends on the creation of a European market-place - ie a
means whereby buyers know where to seek information on what is available and suppliers
can let it be known what they have to offer. The market-place is thoroughly imperfect at
the moment, even nationally, and AIM will help to make it function, via communications
links and contacts, at the Community level.