No C 355/10 Official Journal of the European Communities 31. 12. 87 
Proposal for a Council Regulation on a Community action in the field of information 
technology and telecommunications applied to health care — Advanced informatics in 
medicine in Europe (AIM) — Pilot phase 
COM(87) 352 final 
(Submitted by the Commission to the Council on 13 August 1987) 
(87/C 355/02) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
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, 
Having regard to the opinion of the Economic and 
Social Committee, 
In cooperation with the European Parliament, 
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 emphasi­
zed 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(1); 
Whereas the Economic and Social Committee supports 
initiatives in this domain; 
Whereas, with the emergence of advanced and mobile 
communication services and the progressive introduc­
tion of computing in health care and services, the con­
ditions for major improvements for health care and 
possibilities for reduction of cost increases are 
emerging; 
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 con­
tribute to the creation of the internal market and pre­
vent 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 the health care infrastruc­
ture 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-com-
petitive research and development towards the develop­
ment 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 develop­
ment (1987 to 1991) (2) envisages the utilization 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 com­
munication'; whereas the framework programme con­
tains special provision for a Community action in the 
field of medical and bio-informatics; 
Whereas the constitution or consolidation of a specifi­
cally European industrial potential in the technologies 
concerned is an urgent necessity; whereas its benefici­
aries must be industry, health care service providers, 
research establishments, undertakings, including small 
and medium-sized enterprises and other bodies estab­
lished in the Community which are best suited to attain 
these objectives; 
(!) OJ No C 76, 23. 3. 1987, p. 25. (2) COM(86) 430 final. 
31. 12. 87 Official Journal of the European Communities No C 355/11 
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 pro­
grammes involving cooperation in medical bio-infor­
matics; 
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 biotech­
nology (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 pilot phase that the Commission be assisted by a 
Committee; 
Whereas the implementation of concerted actions in the 
COST framework is an essential element to comp­
lement industrially-oriented research and development 
projects; 
Whereas the Scientific and Technical Research Com­
mittee (Crest) has expressed its opinion, 
HAS ADOPTED THIS REGULATION: 
Article 1 
1. A pilot phase of a Community action in the field 
of medical and bio-informatics, hereinafter referred to 
as '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 inter­
national 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 
The action shall consist of the development of a com­
mon conceptual framework for cooperation, pre-nor-
mative work and technology exploration and the inves­tigation of the non-technological factors as required for 
the objective of concerting European efforts in improv­
ing health care by means of MBI. 
The scope of the AIM pilot phase is described in the 
Annex and in the draft workplan. 
Article 3 
1. The detailed objectives of the action to be under­
taken are defined in a work plan to be adopted under 
the procedures 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 a research and development 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 
organizations established in the Community. Contrac­
tors 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 Com­
munities and involve the participation of at least two 
independent partners, not all established in the same 
Member State. One of the partners shall be a commer­
cial undertaking. 
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 pro­
cedure set out in Article 7, to derogate from the prin­
ciples set out in paragraphs 3 and 4. 
Article 4 
Where Framework Agreements for scientific and techni­
cal cooperation between non-Community European 
countries and the European Community have been con­
cluded, organizations and enterprises established in 
these countries may become partners to a project under­
taken within this action. 
Article 5 
1. The funds estimated as necessary for the Com­
munity contribution to the execution of the pilot phase 
No C 355/12 Official Journal of the European Communities 31. 12. 87 
amount to 20 million ECU over 18 months, including 
expenditure on staff (nine A, two B and four C tempor­
ary officials). 
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 necess­
ary to this end, without prejudice to the procedures 
provided for in Article 3. 
2. The Commission shall be assisted in the execution 
of its tasks by a Committee, composed of two represen­
tatives from each Member State, chaired by a represen­
tative of the Commission and hereinafter referred to as 
'the Committee'. 
The members of the Committee can call on the assist­
ance 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 this Regu­
lation. 
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 Mem­
ber States are weighted as indicated in that Article. The 
chairman does not vote. The Commission shall adopt the measures under con­
sideration when they are in accordance with the opinion 
of the Committee. When the measures under consider­
ation are not in accordance with the opinion of the 
Committee, or in the absence of an opinion, the Com­
mission shall submit to the Council without delay a 
proposal relating to the measures to be taken. The 
Council shall decide by a qualified majority. 
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 Com­
mission 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 
1. With regard to the coordination activities pro­
vided 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. 
2. Information shall be exchanged according to a 
procedure to be defined by the Commission after con­
sulting the Committee, and shall be treated as confiden­
tial at the supplier's request. 
Article 10 
This Regulation shall enter into force on 1 January 
1988. 
This Regulation shall be binding in its entirety and 
directly applicable in all Member States. 
31. 12. 87 Official Journal of the European Communities No C 355/13 
ANNEX 
INTRODUCTION 
The rationale developed in the main document illustrates the opportunities for cooperation but also the 
difficulties and complexities their inter-sectoral nature will pose to a concerted effort on a European scale. 
Besides the need to refine objectives one will need to analyze alternative approaches as well as test the ability 
to manage successfully the numerous inter-dependencies. Success of this action will ultimately depend on the 
ability to complement and reinforce efforts undertaken by the sector actors on a national level. Developing 
and reinforcing the mechanisms of concertation between the sector actors on a European scale is as much a 
challenge as the technical content of this initiative. Success in this respect will be decisive for realizing the 
advantages of concertation and cooperation and thereby a better use of the scarce human, institutional, 
technical and financial assets of the Community in this domain. 
For this reason a pilot phase has been conceived with the sector actors which has the following aims: 
— analyze and assess future requirements in health care and biotechnology for medical and bio-informatics 
(MBI), 
— explore and assess technological developments and options with respect to their contribution to progress 
in MBI, 
— define precise objectives and the optimal approach for concertation and collaboration in the field of MBI 
at European level complementing and re-enforcing efforts of private and public organizations working in 
this and closely related areas, 
— test and validate the organization and management support for concerted efforts in MBI, 
— develop an action plan for MBI based on analyses of future requirements and opportunities, 
— identify legal, regulatory, economic and other non-technological factors which may play a key role in 
using MBI for the stated objectives. 
The following section describes the scope of the work proposed for the pilot phase. The areas of investigation 
and exploration have been chosen in accordance with the above objectives of the pilot phase so as to provide 
significant results without prejudice to the follow-up 
1. DEVELOPMENT OF A COMMON CONCEPTUAL 
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 presentations (of both numeric data and body sites), 
— signals (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 data 
banks and data bases, 
— 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; and 
c) 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. 
No C 355/14 Official Journal of the European Communities 31. 12. 87 
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, e.g. 
expert systems, to assist in the efficient use of the data. 
To permit MBI to build on synergy with other domains and to 
help identify the requirements in common functional specifi­
cations 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 specific 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 defi­
nition 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 (e.g. hospitals, etc.) 
and services (e.g. laboratories, etc.). In identifying and describing 
the functional requirements both technical as well as cost con­
siderations will be taken into account. 
1.1.2. Reference model for the scientist/technologist information 
environment 
This covers the functional description relating to the work of 
scientists and technologists working in health care related 
domains, e.g. laboratories engaged in diagnostics, but more gener­
ally those engaged in biotechnology. Though the scope of biotech­
nology goes beyond health care, the bio-informatics requirements 
are to a large extent common to all domains of biotechnology. 1.1.3. Integration 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 '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; con­
fidentiality; data integrity. 
1.2. Data requirements analyses for MBI 
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 analyse information requirements. 
The understanding of information requirements is the pre-requi-
site 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, treatments 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 adminis­
trations, 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 (e.g. DNA and 
protein sequence and structure data bases, literature, etc.), 
— scientist/technologist-experimental data (e.g. X-ray and neu­
tron diffraction); two-dimensional high-resolution nuclear 
magnetic resonance, electron microscopy), 
— scientist/technologist-experimental equipment (e.g. molecular 
dynamics simulation, X-ray crystallography, advanced 3-D 
graphic system, etc.), 
— scientist/technologist-administrations (hospitals or other ser­
vice 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 
31. 12. 87 Official Journal of the European Communities No C 355/15 
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. 
Scope 
The work in this domain will consist of the identification of 
the various levels of the health care system where information 
technology provides opportunities to develop methods for con­
taining 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 generat­
ing a much more advantageous data acquisition, storage and 
retrieval system, can significantly reduce the annual cost of radi­
ology today in comparison with X-ray film, chemicals, current 
equipment maintenance and film storage(1). 
Laboratory equipment 
While the cost of maintenance of laboratory equipment, com­
puters excluded, is considerable, adoption of a policy of having 
expert system diagnostics in even the most simple laboratory 
equipment would permit economies and improvement in service. 
Sensor techniques 
Advanced sensorics offer considerable potential for remote and 
(') Purchase of X-ray films accounts for 2% of the overall budget 
of a hospital and 60% of its radiology department. unattended sensing. This can be used to greatly improve monitor­
ing, 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. 
Primary 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-molecu la r research 
Bio-molecular research has the potential of revolutionizing the 
economics of pharmaceutical production and the related research 
and development. There are already examples where bio-molecu­
lar engineering techniques have been able to produce directly 
highly pure substances at greatly better economics than tra­
ditional techniques permitted. 
2. MEDICAL INFORMATICS ENVIRONMENT 
Description 
In context of the rapid development of technology and automated 
information systems, standards are required to enable compari­
sons 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 develop­
ment of the concepts of integration and convergence in health 
care. 
No C 355/16 Official Journal of the European Communities ' 31. 12. 87 
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 differences in the spread of diseases as well as of differences 
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 pro­
cedures related to costs (hospital in-patients), 
— definition of a minimum basic data set (MBDS) for ambulat­
ory care in Europe, 
— semi-automatic encoding of standardized medical data classi­
fication systems in Europe, 
— development of European criteria to define severity of cases. 
2.1. International comparison of diagnoses and procedures 
related to costs 
Objectives 
— Harmonization of medical data classification systems through 
comparisons and common results, using the European MBDS 
defined for hospitals. 
— Evaluation of the diagnosis related group (DRG) method­
ology 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 adminis­
trative 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 hospi­
tals 
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, e.g. ICD-9, ICD-9-
CM and DRG's, and to develop an approach to harmonizing 
their use. 
Influence of case-mix on length of stay and cost 
factors in European 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 medi­
cal 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 in-patient. The work will be 
aimed at obtaining a better description of the health care delivery 
systems in Europe by linking MBDS levels, abstracted from 
medical record summaries with financial data as well as know­
ledge data bases. 
Definition of proposals to harmonize medical 
data classification systems in European hospi­
tals 
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 under­
developed countries — and flexible in order to allow for changes 
in the future. The approach will be multi-disciplinary, to enable 
dialogue between health professionals and managers. 
Definition of research and development require­
ments in software and hardware to allow compe­
titiveness with the US industry 
Harmonization of medical data is a prerequisite for a large-scale 
European market in medical informatics. In order to have the 
capacity to compete against strong American companies, the 
European industry will be supported to design and further provide 
well adapted packages that include MBDS and DRG's. 
31. 12. 87 Official Journal of the European Communities No C 355/17 
2.2. Definition of a minimum basic data set for ambulatory care 
in Europe 
Objectives 
— Harmonization of medical data classification systems by 
defining a MBDS for ambulatory care, e.g. the core of knowl­
edge 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) method­
ology in Europe to explore its feasibility, advantages and 
disadvantages. 
Scope 
The scope includes the following tasks: 
Definition of an MBDS for ambulatory care 
So far in Europe only a small number of general practitioners 
(between 1 and 5% in different countries) use computers to 
process medical information. Standardization of classifications is 
therefore a prime concern. The task is aimed at the validation of 
standardization concepts and pre-normative work for the coding 
in ambulatory care and the definition of a MBDS for family and 
out-patient care. 
Use of the MBDS defined and of the AVG method­
ology 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 method­
ology which has been developed in the USA in 1986, in order to 
compare medical data linked with financial data in ambulatory 
care. 
Definition of proposals to harmonize medical 
data and patient classification systems for 
ambulatory care in Europe 
The definition of a MBDS in ambulatory care which is of para­
mount importance in the frame of health care delivery systems 
will allow the requisite preparations for the harmonization of 
medical data classification systems. 
Definition of research and development require­
ments in software and hardware to allow compe­
titiveness with the US and Japan 
Building on the advanced professional know-how in ambulatory 
care in Europe and the considerable experience in the field of 
financial data on ambulatory care, the work will define software 
and hardware specifications for medical data classification sys­
tems in ambulatory care. 
2.3. Semi-automatic encoding of standardized medical data 
classification systems in Europe 
Objectives 
— Encoding and decoding from natural medical language to 
international classification systems. 
— Automatic grouping of these classifications into sub-classifi­
cations related to costs (DRG's for in-patients and AVG's for 
out-patients). — Harmonization of rules for medical data classification sys­
tems 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 Euro­
pean 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 con­
text-specific coding and automatic error detection and correc­
tions. 
Development of standards for procedures in 
each European language 
Comparisons will be made between national procedures for cod­
ing schemes and between extensions of international classifi­
cations 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. 
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 severity 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 strategic importance of this work is summarized hereunder: 
— variations in costs have been shown in the USA as well as in 
some European studies to be largely dependent 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 countrywide. 
They can be based either on an analysis of the content of the 
No C 355/18 Official Journal of the European Communities 31. 12. 87 
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 inten­
sity 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. 
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. Regard­
ing the broad medical market with abundant varieties of initiat­
ives in hardware and software developments mostly without 
conceptual links to each other, only major breakthroughs in the 
conceptualization and development of the medical record can 
dramatically enhance the quality of medical care and at the same 
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 Euro­
pean 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 specifi­
cations and minimum standardization required for the computer­
ization of medical records and progress in portable storage tech­
niques. 
Scope 
To meet these objectives, this part would comprise three major 
areas of activity: 
— clinical data and process modelling, the development of which 
is essential not only for information transfer across bound­
aries, but also as dynamic reference models for voice input, 
image processing and so on, 
— specification of the functional requirements for a general 
distributed medical record, 
— common functional specifications and harmonization pro­
posals for patient data cards to be used for storage of a single 
patient's relevant data. 3.1. Clinical data and process modelling 
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 modelling 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. 
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 thera­
peutic processes. They optimize transfer of data and process 
information which thereby become independent of communi­
cations and of host systems. Transferred data can immediately 
be reconstructed, whether it is read from an input communi­
cations 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 prac-
31. 12. 87 Official Journal of the European Communities No C 355/19 
titioners 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. 
Identification of common functional require­
ments 
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 trans­
action 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 conform 
to the OSI concepts. 
3.3. Medical record system/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 technol­
ogies, e.g. improved storage capacity for smart cards, mixed 
smart-optical cards, readers, writer-readers. 
Pointers 
Adequate 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. 
Archival storage 
New techniques for adequate archival storage have to be investi­
gated. 
Picture storage 
Compression techniques for picture storage require further devel­
opments. 
Medical records storage 
The task is to define methods for storing medical records in a 
hierarchical fashion, from a brief description of episodes, infor­
mation used to reach a diagnosis, and related data. 
4. COMMUNICATION AND FUNCTIONAL INTE­
GRATION 
Description 
Medical informatics still relies to a large degree on isolated 
solutions implying costly and wasteful procedures of transferring 
information between the different processes occurring in the 
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 import­
antly 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 fa­
cilities giving a considerable improvement in cost-performance 
and flexibility. 
However, the benefits of 'economies of integration' require the 
realization of functional integration and inter-operability going 
beyond the simple exchange of information. 
Objective 
The work in this part is to investigate requirements and tech­
nology options in the domain of medical communications by 
No C 355/20 Official Journal of the European Communities 31. 12. 87 
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. 
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 1990s 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 com­
munication system. The collection of data will be done from 
peripheral units or personal computers at admission and dis­
charge 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 internal frontiers to health 
care it is of great importance to start the reflection on the 
requirements and functional specifications of hospital infor­
mation services early enough to permit a coherent development 
in this sector facilitating the collaboration between hospitals, of 
hospitals with insurance and administrations, and also to make 
the hospital administrative procedures easier and more trans­
parent 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 
data-base systems/techniques as well as in the progress made on 
the agreement to international technical communication stan­
dards, mean that the present emphasis in the area of hospital 
information services is on the integration of the different func­
tional 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 econ­
omists to develop the basic design and prerequisites for a common 
standard in hospital information networks. 
Specifically, this work will have to include the consistent investi­
gation of all the main aspects of integral information processing, 
i.e. medical standards for data exchange, medical bus, intercon­
nection 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. 
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 biomedical 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 
31. 12. 87 Official Journal of the European Communities No C 355/21 
of laboratory analytical data. This implies the exchange of data 
files of several megabytes concerning structural analyses or digiti­
zed images. 
In the related research areas there is a need for unrestricted access 
to the large data-bases 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, 
— vectors for nucleic acid sequencing. 
A start has been made under the BAP which provides for 
improved access for researchers to nucleic acid and protein 
sequence data-bases, to a monoclonal antibody data bank and to 
strain collections. However, this access needs to be extended to 
encompass structural data, genetic mapping libraries, cloning 
vectors and bibliographic data-bases, etc. and to take in industry 
as well as academia. 
AIM is in this context to develop new tools to address these 
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, i.e. 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. 
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 world-wide 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 the 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 the identification of the functional and technical 
requirements as derived from the 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 requirements in MBl 
Objective 
With the participation of the main actors concerned with the 
development and use of MBI systems, the issues of data protec­
tion, authentication and fail-safe requirements are to be investi­
gated 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. 
4.3.2. Development of international medical data-protection 
protocols 
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. 
Scope 
The scope of the work is to: 
— develop a coherent set of good practice rules from which 
data-protection principles 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 map-
No C 355/22 Official Journal of the European Communities 31. 12. 87 
ping of certain questions concerning the data and process 
aspects of disease into open systems interconnection proto­
cols, 
— foster further research on design of large scale data-protected 
networks. These aspects include encryption, addressing, auth­
entication of sender, authentication of recipient, notification 
of dispatch, notification of arrival, freedom from error, indel­
ible audit of information trails, 
— define the most effective algorithms for solving the abovemen-
tioned issues, 
— contribute to the further development of existing open sys­
tems protocols in order to satisfy the medical data-protection 
requirement. 
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-pro­
cessing world because of the practical limitations of data pro­
cessing 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. 
Scope 
To meet the objective stated above, this part would comprise the 
following tasks: 
5.1. Biomedical 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 sens 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 indivi­
dualized recommendations for medical treatment. 
Expert systems can also contribute to control cost of care: 
— mistakes are reduced thus allowing for a more efficient prob­
lem handling, 
— the diagnostic process can be shortened or logistically simpli­
fied (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. 
Scope 
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 collabor­
ations 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 sys­
tems. 
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 con­
ditions 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 (diag­
nosis, description of possible scenarios, planning) with their 
31. 12. 87 Official Journal of the European Communities No C 355/23 
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 gener­
ation 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 
package) 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 con­
sidered. 
5.2. Dedicated computer language tools 
Description 
It is proposed to investigate the feasibility of a 'macro language 
for health care', i.e. a language building on general purpose 
languages but having special features facilitating their use in 
health care and related research. 
Objective 
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 data-base developments. 
5.3. Special information processing requirements 
Description 
Health care and related research very often require the processing 
of images or other problems entailing extremely high computing 
power. Although there are a number of European ventures in 
novel processors or super-computers, further research and devel­
opment 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 processing (*), 
— voice processing, 
— real-time and greater-than-real-time modelling, 
— 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 displays 
on the screen, 
— the spreading up of multiple iterative calculations for the 
validation of computer modelling of proteins. 
Objective 
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 concur­
rent high order integration computers for biomedicine. 
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 medi­
cal and other staff, great weight needs to be given to the develop­
ment of the user interface. In particular, there is a strong need 
for a clear demonstration that these systems will be of benefit to 
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 appli­
cation. It has to be developed to serve under the special working 
conditions of doctors taking into account also the requirements 
for efficient data protection. 
(') Medical scanning accounts for 11% of the US image-pro­
cessing market. Fast-developing applications range from 
dynamic cardiac imaging to fracture analysis and use of 
biosensor-derived information. 
No C 355/24 Official Journal of the European Communities 31. 12. 87 
5.5. Flexible open-architecture inference systems 6.1. Integrated biomedical laboratory 
Description 
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 data-base, nor provide for 
interconnections or transferability. To realize its potential useful­
ness, artificial intelligence has to be part of an integrated concept, 
where it plays the role of the assistant in every day work. 
Objective 
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. 
Scope 
The scope is aimed at the definition of a high-level operating 
system which, using in-built expertise, can speedily and unam­
biguously 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. 
6. BIOMEDICAL INSTRUMENTATION AND RESEARCH 
TOOLS 
Description 
Biomedical instrumentation is one of the key factors of progress 
in MBI and is crucial for its future development. Information 
technology embedded in biomedical instrumentation represents 
the single most important factor in the explosive advance achiev­
ed in biomedical research. The crucial importance of integrating 
advances in all technological domains including, in particular 
advances in information technology, telecommunications and 
broadcasting is expected to persist for the coming decades. 
While European scientists rank high in the international compari­
son, the productivity of their work is lower, i.e. the time spent 
for a given research result is very much higher. In other words 
the productivity of European research and development, 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. Objective 
The objective is to investigate the options for realizing major 
improvements in research and development 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 inte­
grated 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, i.e. have a major impact on the research 
and development productivity in this domain. 
Scope 
The scope of investigation of an integrated biomedical 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 characterization, 
— cell screening. 
The result is to give clear indications as to the comparative 
advantages of the concept of integrated biomedical laboratories 
compared with other options of advanced approaches to instru­
mentation. Furthermore this work is to result in the definition 
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. Biomedical knowledge bases 
Description 
The complexity and volume of medical and biotechnological 
information is considerable and growing at a rapid rate. Tens of 
thousands of genes control specific life processes, three billion 
units of DNA form the human genome. With current techniques, 
sequencing these three billion units could consume 3 000 man-
years. However, automated DNA sequencing machines are under 
development which may cut 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. 
31. 12. 87 Official Journal of the European Communities No C 355/25 
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 medi­
cal uses. 
The result of the exploratory work would serve to identify and 
assess the options for effective and economic management of 
genetic and biomolecular information. 
6.3. Automated DNA sequencing 
Description 
Progress in biotechnology has led to new techniques for diagnosis, 
treatment and prevention of disease. Most of these — from 
new vaccines based on recombinant DNA to the creation of 
therapeutic proteins for the treatment of cancer or heart disease 
— depend on rapid and economic sequencing of DNA. 
Over the past decade the rate at which DNA can be sequenced 
has increased to several thousand nucleotides per day. US and 
Japanese teams are developing automated DNA sequencers which 
will increase this by several orders and also reduce the cost. 
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 tech­
niques. 
Scope 
The work is to include the systematic assessment of requirements 
and technology options for automated DNA sequencing. 
6.4. Automated protein analyzer/synthesizer 
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 primar­
ily the potential of MBI and CIM. 
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 
research and development these aspects are assessed and the 
implications brought to the forefront. 
This part of the pilot phase is dedicated to analyzing and assessing 
some of the non-technical factors embedding this initiative in the 
wider context of related activities. 
7.1. Investigation of the opportunities of closer 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 investi­
gation 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 specification, standardization and 
certification practices 
The problem 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 organiz­
ations 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 standardiz­
ation bodies. In order to achieve an effective approach and in 
view of the national differences and the multitude of organiz­
ations already involved in one way or the other it is proposed to 
carry out a survey of standardization, specification and certifi­
cation practices in Europe and internationally. This work is to 
result in a recommandation as to the optimal approach to 
addressing future requirements in standardization, specification 
and certification in Europe. 
7.3. Review of the legal and regulatory framework applying to 
MBI 
The use of information technology and telecommunications for 
health care needs to include appropriate regulatory and legal 
No C 355/26 Official Journal of the European Communities 31. 12. 87 
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 
present regulations and legislations governing the use and intro­
duction of MBI. The work is to result in the identification of the 
options and measures which could be developed in order to 
support a harmonious development of the regulatory environ­
ment for MBI applications in Europe. 
7.4. Economic assessment of the MBI potential for health care 
and biomedical 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 perform­
ance 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 under­
stood 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 special skill training requirements and 
options to meet them 
For the exploitation of opportunities created by technological 
advance special training plays a key role. Typically the pro­
fessional 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.