No C 214/2 Official Journal of the European Communities 16. 8. 88 
Article 2 
After consulting the Commission, the Member States shall 
bring into force the laws, regulations and administrative 
provisions necessary to comply with this Directive before 
1 July 1989. 
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 cooperation with the European Parliament, 
Having regard to the opinion of the Economic and Social 
Committee, 
Whereas the Community has as its task, by establishing 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, 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 (2); The Member States shall communicate to the Commission 
the texts of the main provisions of national law which they 
adopt in the field covered by this Directive. 
Article 3 
This Directive is addressed to the Member States. 
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 organizations 
working in this field; 
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; 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 
COM(88) 315 final — SYN 95 
(Submitted by the Commission pursuant to Article 149(3) of the EEC Treaty on 9 June 1988) 
(88/C 214/02) 
(!) OJ No C 355, 31. 12. 1987, p. 10. 
(2) OJ No C 76, 23. 3. 1987, p. 25. Whereas the concerted efforts in this domain will 
contribute to the creation of the internal market and 
16. 8. 88 Official Journal of the European Communities No C 214/3 
prevent the formation of new internal frontiers to health 
care; 
Whereas the development of common functional speci­
fications 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 speci­
fications 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 opportu­
nities 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-competi-
tive 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 (]), the 
Council adopted a framework programme of Community 
activities in the field of research and technological 
development (1987 to 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 (2); 
Whereas the terms of Article 130K 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; 
Whereas the Council Decision of 28 September 1987 
concerning the framework programme for Community 
activities in the field 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; 
Whereas the same decision further provides that Com­
munity action is justified where research contributes inter 
alia to the strengthening of the economic and social 
cohesion of the Community and the promotion of its 
0) OJ No L 302, 24. 10. 1987, p. 1. 
(2) Action Line 2.3, new services of common interest. 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 of 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 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 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 to 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, 
HAS ADOPTED THIS DECISION: 
Article 1 
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 
of 18 months commencing on 1 June 1988. 
2. The Community action is designed to make available 
to citizens and health services, at minimum cost and 
No C 214/4 Official Journal of the European Communities 16. 8. 88 
minimum delay, improvements in health care, thereby 
contributing to social and economic objectives. 
3. The Community action is designed to promote 
development of a European infrastructure and framework 
within which existing developments and new advances can 
be brought to health care by cooperation between public 
and private activities at national 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 loss, 
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 health 
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 II. 
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 normally be at least 50 % of the total 
expenditure. 
Alternatively, in respect of universities and research 
institutes carrying out projects or actions, the Community 
may bear up to 100 % of the additional expenditure 
involved. 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, par­
ticularly 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 million ECU, 
it may be decided, in accordance with the procedures laid 
down in Article 8, to depart from the general provisions set 
out in paragraphs 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 million ECU over 18 months, including 
expenditure on staff (nine A, two B and four C temporary 
officials). 
2. The indicative allocation of these funds is set out in 
Annex 1. 
16. 8. 88 Official Journal of the European Communities No C 214/5 
Article 6 
1. The Commission shall ensure that the action is 
properly performed and establish the appropriate im­
plementation 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. 
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 (2), 
— the evaluation of work undertaken in respect of each 
part of the exploratory action by appropriate organi­
zations, groups and other bodies, 
— the assessment of the proposed projects for the 
implementation and the Community financial contri­
bution for a project when this contribution is in excess 
of 0,4 million ECU, 
— the participation in any project by European organiza­
tions 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 re­
presentatives 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 Ar­
ticle 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. 
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 forth­
with. In that event: 
— the Commission may defer application of the measures 
which it had decided for a period of not more than one 
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 abovementioned 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(2) of the framework programme. 
Article 10 
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. 
Information shall be exchanged according to a procedure 
to be definied 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. 
No C 214/6 Official Journal of the European Communities 16. 8. 88 
ANNEX / 
AIM EXPLORATORY ACTION 
Action line I 
IMPROVEMENT OF THE EFFECTIVENESS OF PUBLIC AND PRIVATE ACTIONS 
1. Development of a common conceptual framework for cooperation 
Action line II 
STRENGTHENING EUROPE'S POSITION IN MBI AND HEALTH CARE 
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 INTRO­
DUCTION AND APPROPRIATE APPLICATION OF MBI IN HEALTH CARE 
7. Non-technological factors 
Personnel costs 
Administrative costs 
Total 
(*) Estimated Community contribution in million ECU. 
ANNEX 11 
PROGRAMME SUMMARY 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: 4,80 (!) 
10,70 (!) 
2,25 (!) 
1,69 (i) 
0,56(]) 
20,00 f1) 
16. 8. 88 Official Journal of the European Communities No C 214/7 
— 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 standardization matches the growth of computerized information in health care 
which is now leading to a proliferation of independent systems in Europe. International, or at least European 
standardization 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 minimization of investment risks. 
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 harmonizing 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. 
No C 214/8 Official Journal of the European Communities 16. 8. 88 
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). 
Given this general objective, AIM will be concerned with realization 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 of 
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 organizations 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. 
— 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, authorized 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. 
16. 8. 88 Official Journal of the European Communities No C 214/9 
These deliverables, as detailed in the Draft Workplan, will represent useful results in their own right. 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. 
Amendment to the proposal for a Council Directive amending for the third time Directive 75/726/ 
EEC on the approximation of the laws of the Member States concerning fruit juices and certain 
similar products 
COM(88) 319 final 
(Submitted by the Commission pursuant to Article 149(3) of the EEC Treaty on 9 June 1988) 
(88/C 214/03) 
Having regard to the opinion delivered by the European Parliament on 13 April 1988 with regard to 
the proposal submitted by the Commission to the Council for a Directive on the approximation of 
the laws of the Member States concerning fruit juices and certain similar products (*) and pursuant 
to Article 149(3) of the Treaty establishing the European Economic Community, the Commission 
has decided to amend the abovementioned proposal as follows: 
The fifth recital is hereby deleted. 
(!) OJ No C 24, 31. 1. 1987, p. 12. 
Amended proposal for a Council Directive amending for the fourth time Directive 76/768/EEC on 
the approximation of the laws of the Member States relating to cosmetic products (*) 
COM(88) 323 final — SYN 84 
(Submitted by the Commission pursuant to Article 149(3) of the EEC Treaty 
on 15 June V. 
(88/C 214/04) 
(!) OJ No C 86, 1. 4. 1987, p. 3. 
INITIAL TEXT MODIFIED TEXT 
Proposal for a Council Directive amending for the fourth Amended proposal for a Council Directive amending for 
time Directive 76/768/EEC on the approximation of the the fourth time Directive 76/768/EEC 
laws of the Member States relating to cosmetic products 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100 Economic Community, and in particular Article 100A 
thereof, thereof, 
Having regard to the proposal from the Commission, 
In cooperation with the European Parliament, 
Having regard to the opinion of the Economic and Social 
Committee,