CELEX: 51988PC0315
Language: en
Date: 1988-05-31
Title: Amended Proposal for a COUNCIL DECISION on a Community action in the field of Information Technology and Telecommunications applied to Health Care AIM (Advanced Informatics in Medicine) - Exploratory Action - (presented by the Commission, pursuant to Article 149(3) of the EEC Treaty)

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 ---pagebreak---   COMMISSION OF THE EUROPEAN COMMUNITIES
                                               COM(88 ) 315 final  -  SYN 95
                                               Brussels , 31 May 1988
                                                                      t>     ,< \ - A
                               Amended Proposal for a        y ^
                                                                      ^/'-v .,v>
                                  COUNCIL DECISION                V     "
                                                                           W' '■&
    on a Community action in the field of Information Technology and Telecom¬
                        munications applied to Health Care
                                          AIM
                        ( Advanced Informatics in Medicine )
                               - Exploratory Action -
                   ( presented by the Commission , pursuant to
                         Article 149(3 ) of the EEC Treaty )
/
 ---pagebreak---                                                           2
                                                                                   Co ft - ? i S'
                                            Amended Proposal for a
                                                  COUNCIL- DECISION
     on a Community action in the field of Information Technology and Telecommunications
                                          applied to Health Care
                             Advanced Informatics in Medicine (AIM)
                                          - Exploratory Action -
THE COUNCIL OF THE EUROPEAN COMMUNITIES
Having regard to the Treaty establishing the European Economic Community, and in
particular Article 130Q (2) thereof,
Having regard to the proposal from the Commission,^
In co-operation with the European Parliament (2),
Having regard to the opinion of the Economic ar d Social Committee (3),
Whereas the Community has as its task, by esta' ishing a common market and progressively
approximating the economic policies of Member States, inter alia 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^;
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 improved cost-effectiveness may be
emerging;
Whereas it is important for increasing the quality, flexibility and accessibility of health
care in the Community that there should be adequate consultation of organisations working
in this field;
(»)   OJ .
(2 )  Opinion :OJ....(Approval: OJ. ;Amendment : OJ ....)
(3)   OJ ...
(4)   Resolution OJ C76/ 25-29 , X987
 ---pagebreak---                                                              3
      Whereas particular attention must be paid to questions of privacy , confidentiality and data
      protection and this can build on related work carried out in the framework of ESPRIT and
      RACE;
      Whereas developments in health care will benefit the general public and the building of a
      competitive European industry for developing and sustaining advances in health services;
      Whereas advances in health care will contribute to resolving pressing social needs associated
      with changing age structures in the Community, and to the earliest possible recognition of
      new diseases and health-care problems;
      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 common functional specifications for equipment and services
      will enable the better targeting of effort and use of scarce resources ;
      Whereas the development of a European health care infrastructure technology will
      encourage and draw upon the best work in the Community and will ensure the passage of
      such work into the processes of health care.
      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 for the provision of health care 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, by its Decision of 87/516/Euratom/EEC^5^, the Council adopted a framework
      programme of Community activities in the field of research and technological development
      ( 1987-1991 ) providing for research to be undertaken in the field of the application of
      information technology and telecommunications to meet common social needs; whereas the
      Framework Programme contains special provision for a Community action in the field of
      Medical and Bio-informatics ^ ;
      Whereas the terms of Article 130 K of the Treaty provide that implementation of the
      Framework Programme be carried out by means of specific programmes developed within
      each of its action lines;
-  JT
                                                               ;v
                                                                                                  I
                                                                                          f
 *
      (6)  OJ No . L 302 , 24.10.1987, p. 1
      (5)  Action Line 2.3 , new services of common interest
                                                                                             • , *
 ---pagebreak---                                                    4
Whereas the Council Decision of 28 September 19-87 concerting the Framework Programme
for Community activities in the ficid of R&T&D^ provides that a particular aim of
Community research shall be to strengthen the scientific and technological basis of European
industry especially in strategic areas of high, technology and to encourage it to become more
competitive at international level and whereas the same decision further provides that
Community action is justified where research contributes inter alia to the strengthening of
the ect-nomic and social cohesion of the Community and the promotion of its overall
harmonious development , while being consistent with the pursuit of scientific and technical
quality; whereas it is intended that the AIM action should contribute to the achievement of
these objectives;
Whereas the need Is recognised to construct a specific European infrastructure in which
existing and advanced technologies can be developed and focused to solving problems off
health care; whereas the end beneficiary must be the individual patient;
Whereas the building of this infrastructure and achieving the human objectives is an urgent
necessity; whereas the attainment of these objectives is best brought about by unifying the
efforts of health care providers , research establishment, undertakings including small and
medium sized enterprises and other bodies in the Community;
Whereas exploratory investigations have confirmed the need and the advantages of building
a programme of Community cooperation in this field;
Whereas it is in the Community’s interest to cc f olidate the scientific and financial basis of
European research by means of the involveme . to a greater extent of participants from
European third countries in certain Community rogrammes and particularly in programmes
involving cooperation in medical bio-informatics
Whereas the AIM Exploratory Action 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;
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 Exploratory
Action that the Commission be assisted by a Committee;
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---                                                        5
HAS ADOPTED THIS DECISION :
                                                Article Î
1.    An exploratory Community action in the field of Information Technology and
      Telecommunications applied to health care , called AIM , is adopted for an initial period
        f Î3 months commencing on 1 . June 19i;8 .
2.    The Community action is designed to make available to citizens &</ d health services , at
      minimum cost and minimum delay , Improvements in health care , thereby contributirg to
      social and economic objectives .
3.    The Community action is designed so promote development of a European iL’^t-str-ieCsre
      and framework within which existing developments and new advances can be brought to
      health care by cooperation between public acd private activities at natios'jl and
      international levels .
                                                Article 2
1.    The action shall consist of the development of a common conceptual framework for
      cooperation , 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 medical and bio-informatics .
2.    The action is intended to provide cost effective advances in the care of the individual
      citizen and in the development, planning and management of health care services . In
      work relating to patient information the action will place priority on the development
      of safe and reliable methods for the protection of medical records against Mss ,
      corruption or unauthorised disclosure .
   3.   The field of application of the action includes
                  1 . Development of a common conceptual framework for cooperation
                 2.   Medical informatics environment
                 3.   Data structures and medical records
                 4.   Communication and functional integration
                 5.   Integration of knowledge-based systems into heal tit care
                 6.   Advanced instrumentation , equipment and services for health care and
                      medical research environment
                 7.   Non-technological factors .
      The summary and objectives of the AIM are set out in more detail in Annex 11 .
                                                Article 3
1.    Projects relating to the action shall be executed by means of shared cost contracts .
      Contractors shall be expected to bear a substantial proportion of the costs , which should
      r. , rma!ly be at least 50% of the total expenditure .
        dleroatively , io respect of universities and research institutes carrying cut projects or
      actions , the Community may bear up to ! 00% of the additions ! expenditure Ht.jjv’d .
 ---pagebreak---                                                     6
2. The proposals for projects shall , as a rule , be submitted in reply to an open invitation to
   tender and involve the participation of at least two independent partners not all
   established in the same Member State. At least one of the partners shall be an industrial
   undertaking. Within each project at least one partner should represent health care
   interests. The invitation to tender shall be published in the Official Journal of the
   European Communities .
3. In   exceptional      cases  concerning   projects    indispensable for   implementing    key
   requirements of the workplan:
        where a proposal would involve
        (i)    unreasonable burden on the participants , particularly small and medium sized
               enterprises and research establishments ,
        ( ii) only one independent partner,
        (iii )  only independent partners established in the same Member State, or
        where an open tendering procedure would be unjustified on grounds of cost or
        efficiency, or
        where the amount of Community’s contribution to the cost does not exceed
        0.25 MECU,
   it may be decided , in accordance with the \ mcedures laid down in Article 8 , to depart
   from the general provisions set out in parage sphs 1 and 2 of this article.
4. The contracts for all parts of the action shall be concluded with undertakings, including
   small and medium sized enterprises, service providers , universities , research
   establishments and other bodies established in the Community.
                                             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, in accordance with the
   procedures laid down in Articles 3 and 8 , become partners to a project undertaken
   within this action .
                                                                               *
                                             Article 5
1. The funds estimated as necessary for the Community contribution to the execution of
   the Exploratory Action amount to 20 MECU over 18 months , including expenditure on
   staff (9A,2B,4C temporary officials ).
2. The indicative allocation of these funds is set out in the Annex I.
                                             Artide 6
1. The Commission shall ensure that the action is properly performed and establish the
   appropriate implementation measures .
2. The Commission shall establish a draft workplan defining the detailed objectives , the
   type of projects and actions to be undertaken and the corresponding financial plan .
 ---pagebreak---                                                   7
3. The procedure laid down in Article 8 shall apply to:
         the establishment of the workplan referred to in Paragraph 2 of this Article;
         any departure from the general conditions laid down in Article 3(1 ) and 3(2);
         the evaluation of work undertaken in respect of each part of the Exploratory Action
         by appropriate organisations, groups and other bodies;
         the assessment of the proposed projects for the implementation and the Community
         financial contribution for a project when this contribution is in excess of 0.4
         MECU;
         the participation in any project by European organisations and enterprises not
         established in the Community.
4. The Commission may consult the Committee referred to in Article 7 on any matter
   falling within the scope of this decision .
                                           Article 7
   The Commission shall be assisted in the performance of its tasks by a committee ,
   hereinafter referred to as "the Committee". The Committee , consisting of two
   representatives of each Member State, shall be set up by the Commission on the basis of
   nominations by the Member States .
   Members of the Committee may be assisted by experts or advisors depending on the
   nature of the issues under consideration .
   The Committee shall be chaired by a Commission representative.
   The proceedings of the Committee shall be confidential. The Committee shall adopt its
   own rules of procedure. The secretarial services shall be provided by the Commission .
                                           Article 8
1. Where the procedure laid down in this Article is to be followed , the Chairman shall
   refer the matter to the Committee , either on his own initiative or at, the request of one
   of its members .
2. Under this procedure , the representative of the Commission , who acts as Chairman ,
   refers the draft of the measures to be adopted to the Committee . The Committee
   delivers an opinion within a time limit which shall normally be one month and shall in
   no case exceed two months . The opinion is delivered by the majority specified in Article
   1 48(2 ) of the Treaty for decisions which the Council is required to adopt on a proposal
   from the Commission , the votes of the representatives of the Member States being
   weighted as indicated in that Article . The chairman does not vote .
 ---pagebreak---                                                    8
3.  The Commission shall adopt measures which shall apply immediately. However, if these
    measures are not in accordance with the opinion of the Committee they shall be
    communicated by the Commission to the Council forthwith. In that event
              The Commission may defer application of the measures which it had decided
              for a period of not more than 1 month from the date of such communication;
              The Council acting by a qualified majority may take a different decision within
              the time limit referred to in the previous paragraph.
                                            Article 9
1.  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 .
2.  After completion of the action, the Commission shall send to the Council and the
    European Parliament a report on the performance and results of the action.
3.  The above mentioned report will be carried out in relation to the precise objectives set
    out in Annex II to this Decision and in conformity with the provisions of Article 2
    Paragraph 2 of the Framework Programme.
                                            Article 10
1.  With regard to the concertation 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 Decision, whether or not planned or carried out under their authority.
2.  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 11
    This Decision shall apply from 1 . June 1988 .
                                                                              *
                                            Article 12
This Decision is addressed to the Member States
Done at Brussels, . 1988
                                                                    For the Council
                                                                    The President
 ---pagebreak---                                                   9
Annex I
                                    AIM Exoloratory Action
Summary of Areas                                                    Eatimated
                                                                    Community
                                                                   contribution in
                                                                       MECU
                                          Action line I
IMPROVEMENT OF THE EFFECTIVENESS OF PUBLIC
AND PRIVATE ACTIONS                                                       4.80
1 . Development of a common conceptual framework for cooperation
                                         Action Line II
STRENGTHENING EUROPE’S POSITION IN MBI AND HEALTH CARE                   10.70
2. Medical informatics environment
3 . Data structures and medical records
4 . Communication and functional integration
5 . Integration of knowledge based systems into health care
6 . Advanced instrumentation, equipment and services for
    health care and medical research environment
                                        Action Line III
CREATION OF AN ENVIRONMENT FAVOURABLE TO THE RAPID               '
INTRODUCTION AND APPROPRIATE APPLICATION OF MBI
IN HEALTH CARE                                                            2.25
7 . Non - technological factors
Personnel Costs                                                           1.69
Administrative Costs                                                       . 56
TOTAL                                                                   20.00
 ---pagebreak---                                                      10
Annex II
                                Programme Summarv and Objectives
1 . RATIONALE
The accurate understanding of the nature, role and use of Information in the medical domain
is fundamental to the success of any system designed to be an effective aid to satisfy
society’s health needs because health care is in a process of continuous evolution and so is
the technology supporting it. Information-related activities are growing rapidly and the cost
of such activities in many health care organisations has become very significant.
The impetus behind a progressive implementation of an Integrated Health Environment
(IHE) at the national and international level stems from various factors.
Firstly, there is the rising cost of medical care, the major element of which comes from
hospital services. In the context of a more efficient use of resources devoted to health care ,
there is a strong need :
          to obtain adequate indicators of performance and of quality of care ,
          to make these indicators available and comparable on computerized systems in order
          to better understand variations in costs as well as in practices and outcomes of care,
          to provide the Primary Care physician with the advanced IT tools needed to allow
          him to perform his "gate keeping function" by referring patients only when
          appropriate for hospital investigation or specialist opinion .
          to define the requirements for allowing a breakthrough in the provision of hospital
          information services which today are not optimized because clinical and
          administrative processes and procedures are generating numerous records for each
          patient, complicating storage , retrieval , and analysis of information required to
          support hospital functions .
          to shorten the delays related to the health care process by increasing the level of
          interaction between the health care providers through the facilitation of the flow
          and utilization of the existing skills and structures in the system (specialist
          availability , clinical data, health and pharmaceutical information , administrative
          mailing , professional documentation ...).
Secondly, the rapid development of Information Technology and Telecommunications
provides a great opportunity to improve quality, accessibility , efficiency and economy of
health care services . But this can be achieved only if a progressive standardisation matches
the growth of computerised information in health care which is now leading to a
proliferation of independent systems in Europe.            International , or at least European
standardisation does not mean a strict uniformity of measurement systems, but rather an
 increase in consistency of approaches through a better transparency of results and a more
systematic exchange of comparable information . Early agreement by sector actors on open
standards and requirements supporting IHE implementation will simultaneously provide
 transparency in practices, outcomes and costs of health care , a larger potential market in
 Europe, economies of scale to producers, a minimisation of investment risks.
 ---pagebreak---                                                     11
2 . GLOBAL OBJECTIVES AND DELIVERABLES
The development and application of Advanced Technologies in Health Care will allow a
breakthrough in the performance of health care systems, a major increase of the productivity
of medical and bio(techno)logical research and development, and a significant reduction in
the growth rate of health expenditures .
AIM will set a framework for possible government support to speed implementation of
potentially beneficial developments in both the provision and management of health care in
Europe .
AIM will be a very significant contribution to the creation of an Integrated Health
Environment ( IHE ). This means that it will be concerned with all forms of care , from
preventive medicine through primary care to secondary care .
This Community Programme will initially focus on common users requirements and
technological and functional options concerning the development and application of
Advanced Technology to Health Care . It will concentrate on complementing the cooperative
efforts in which research institutions , hospitals and industry are already engaged , taking into
account the requirements of public administrations , and on harmonising industrial and
medical priorities to advance the prenormative work needed for the introduction of an
Integrated Health Environment ( IHE ) throughout Europe .
Both Industry and Health Care Professionals need , and have asked for, the cooperation of
public authorities because the new systems which could be introduced require :
          common standards at the European level , and if possible at the international level
          design , development and management
          certification of those systems which are concerned with public health , data
          protection and ethical aspects in general
          public and political acceptance as reflected in regulatory provisions
The theme of AIM is the sustained improvement of health care in the Community within
economically acceptable limits by exploiting the potential of Medical and Bio Informatics
(MBI ).
 ---pagebreak---                                                       12
Given this general objective, AIM will be concerned with realisation of the following goals :
     1.   Improve the quality, accessibility, and flexibility of health care.
     2.   Increase the effectiveness of patient care, bringing about a reduction of unit costs.
     3.   Contribute to the establishment of minimum standards and common functional
          specifications.
     4.   Contribute to agreed codes of good practice, protection of privacy and reliability.
     5.   Stimulate collaboration and concertation in the analysis of the requirements and
          opportunities of Medical Bio Informatics and its application.
     6.   Contribute to the common adaptation of the regulatory framework to advances in
          the nature of health care .
These goals are best served by a phased approach of which the present action covers the
exploratory phase concentrating on the identification of user requirements, systems R&D
elucidating cost-benefits as well as the choice of technological options , and the development
of the appropriate evaluation tools.
The deliverables and precise objectives of the AIM Exploratory Action include :
          Development of a practical approach to interdisciplinary working on a European
          scale in this domain mobilizing the different actors involved in health care and
          setting up the required fora for the identification of common needs, definition of
          the best approaches and consensus building .
          Development of a conceptual model for health care information systems, by
          identifying its functions , components , requirements and interrelations. This model
          should cover the different levels of care (primary, secondary and tertiary care) and
          should be the basis for a common understanding of health care, leading to the
          further development of compatible procedures , services and systems .
          Definition of data requirements and information flows at the different levels of the
          health care system , taking into consideration the specific needs and constraints at
          the patient, clinical , scientific and administrative level. This should lead to the
          study of the medical record architecture and be followed by the evaluation of the
          different codification systems , their state of advance in the different countries and
          the agreement on common codification systems.
          Identification and definition of the minimum standards , recommendations and
          common agreed practices required to facilitate harmonious development of hospital
          information systems . This work should be done in close coordination with other
          international organisations in this field .
          Tailoring of existing or developing technologies for their introduction and
          acceptance in the health care environment.         The work will be focussed on the
          specific requirements as the human factor, the integration of systems and the
          acceptability and practical use in daily work .         The different applications of
          knowledge based systems and the advanced instrumentation will be considered .
 ---pagebreak---                                                    13
          The implementation of pilot projects aimed at testing the application and integration
          of developing technologies and methodologies in health care.
          Detailed    evaluation   of   the    potential  of   Information     Technology    and
          Telecommunications to address ethical , social and economic problems in the field of
          health care. This evaluation will pay special attention to the protection of privacy
          of information , authorised access to systems, data security , impact on doctor patient
          relationship, human factor in systems engineering in order to facilitate the
          acceptability of new systems, and legal aspects concerning responsability issues and
          the practical use of advanced systems in health care.
These deliverables, as detailed in the Draft Workplan , will represent useful results in their
own rieht . In addition the scope and orientation of the work has been chosen to prepare and
facilitate future European collaboration in this domain independent of the framework in
which this may be undertaken.
                                                                             4