Proceedings of the 3rd International Conference on E-Health and Bioengineering - EHB 2011,
24th-26th November, 2011, Iaşi, Romania
___________________________________________________________________________________________________________________
Health Technology Assessment
and Medical Devices
Vladimír Rogalewicz, Alena Ujhelyiová, Lubomír Poušek, Veronika Šinkorová, Peter Kneppo
Faculty of Biomedical Engineering, Czech Technical University in Prague, Czech Republic
rogalewicz@fbmi.cvut.cz
Abstract-Health technology is everything that can be utilized in
medical processes, i.e. drugs, biologics, devices, equipment and
supplies, medical and surgical procedures, support systems, and
organizational and managerial systems. Health Technology
Assessment (HTA) comprises a number of various methods
utilized to assess health technologies. Medical devices constitute
a large area of interest for HTA. As an example of a
comprehensive HTA methodology, clinical and economic
effectiveness of targeted preventive of breast cancer (for women
with the BRCA1/2 gene mutation) is studied on a sample of 105
women included in the program against a control group of 91
patients (with the same gene mutation). Generally, there is not
much interest in HTA results in the Czech Republic. Basic
reasons and prospects are discussed. At present, the question of
assessing a particular medical device purchased or to be
purchased is topical in the Czech Republic. The situation is quite
cloudy, as each installation differs both in its technical
specification, and in sale and guarantee terms and conditions.
Moreover, there is an ambiguous role of consolidating dealers in
a market, where no price list exist. As an example, MRI 1.5T
purchases in the Czech Republic in 2008-9 are analyzed.
Keywords: Health Technology Assessment, clinical and
economic effectiveness, breast cancer preventive, BRCA1/BRCA2,
assessing medical devices, MRI 1.5T purchases.
I. INTRODUCTION
In the 1960s, environmental impact assessment (EIA)
began to be used as a rational decision making method
evaluating impact of a proposed (development) project on the
environment. EIA was made mandatory in the US when it
was incorporated in the National Environmental Policy Act
(NEPA) in 1969. Today it is used quite routinely even in such
countries as China, India or Sri Lanka [16].
Health Technology Assessment (HTA) plays the same role
in decision making concerning medical technologies
(technology meant in a wide sense, interventions). It was
developed according to the same pattern. HTA takes into
consideration clinical effectiveness, cost effectiveness, but
also such ambiguous criteria as quality of life or number of
days of the treatment (loss in GDP?). Intricate methods allow
multi-criteria comparison of technologies [6].
At first glance, HTA seems to be nothing new; statisticians
or economists have used similar methods for many years. The
novelty is in a comprehensive scope and strictly prescribed
and observed methodological rules. Thus, although some
studies that could be labeled as pre-HTA date nearly two
hundred years ago [21], and especially the pharmaco-
econimics has used methods measuring clinical and cost
effectiveness for a long time, first serious studies giving the
origin to a new branch appeared in the beginning of 1970s
[3].
Despite EIA, HTA did not become a part of any legislation
in the early 1970s. One reason is probably that its methods
were not so profoundly studied and described. A more
important reason could be that highly sophisticated costly
medical interventions were not as widely employed in
hospitals in that time as they are today (Christiaan Barnard
transplanted heart in 1967 [1], first MRI image was published
in 1973 [12], robotic surgery dates back to late 1980s [11]).
A more intense development of Health Technology
Assessment appeared, together with establishing specialized
HTA agencies, in early 1990s, led by the Unites States and
Great Britain [12]. The International Network of Agencies for
Health Technology Assessment (INAHTA), a non-profit
umbrella organization, was established in 1993 [10]. Today, it
has 46 members in 24 countries. Next to it, Health
Technology Assessment International (HTAi), an inter-
national society for HTA promotion, was founded in 2004 [8]
covering both individuals and organizations that are involved
in HTA (from researchers to politicians and decision makers).
It organizes the principal annual world conference; this year
its 8th run was held in Rio de Janeiro, and stayed the main
platform for HTA methodology and research. In line with this
development, also IFMBE established its division for Health
Services Technology Assessment [9].
In individual states, HTA reports are coordinated,
methodically supervised and acknowledged by so called HTA
agencies. Such bodies can have 3 basic forms:
1. They are independent bodies that are usually established
by legislation and whose responsibilities may be but need
not be stated by an act.
2. They are special departments of national authorities
(usually ministries), and their responsibilities are given by
the organizational chart.
3. They have been established within a university or research
institute, and comprise methodological issues with
research.
In any case, these agencies shall enjoy confidence of the
whole society. International experience shows that this works
in the first case, but does not fully work in the second and
third ones.
 Proceedings of the 3rd International Conference on E-Health and Bioengineering - EHB 2011,
24th-26th November, 2011, Iaşi, Romania
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The current situation of HTA in Europe and its transferability of the technology assessment, and concluded
development tendencies are described in [5]. The book by that individual countries should develop their own national
Michael Schlander [18] contains a critical discussion of many concepts and methods. Hence, foreign results cannot be
still unsolved problems. automatically accepted in another country.
There are several books available describing the general
II. FUNDAMENTAL METHODS methodology of HTA, the best of which is probably [6]. It
contains also an extensive bibliography.
Health (or medical) technology is everything that can be
utilized in medical processes, i.e. drugs, biologics, devices,
III. AN EXAMPLE: TARGETED PREVENTIVE
equipment and supplies, medical and surgical procedures, OF BREAST CANCER
support systems, and organizational and managerial systems.
HTA comprises a number of various methods utilized (in A. Material and Methods
different combinations) to assess health technologies. Health As an example, we can describe results of a study, the task
Technology Assessment considers the effectiveness, of which was to decide whether targeted (genetic based)
appropriateness and cost of technologies. It does this by preventive of breast cancer is clinically and economically
asking four fundamental questions: effective [20]. Data concerning targeted preventive program
1. Does the technology work? were collected from one of five Prague university hospitals.
2. For whom? In the time span 2002-2011, the program captured 10 cancer
3. At what cost? cases among 105 women included in the program. Tab. I
4. How does it compare with alternatives? ([6], p.12) shows recommended examinations for particular age groups;
Today, probably all HTA studies start with a thorough Tab. II shows cost of the preventive program per patient and
bibliographical research, using all available databases (above year.
all MedLink and Web of Science). Methods of data mining Tab. III shows the real distribution of 10 captured cases in
are employed. Found papers undergo a detailed critical the targeted program into 5 classes according to the disease
analysis (e.g. was it a randomized controlled trial?), and only stage (2nd line), as compared with the normal population (last
those papers are left, whose data sets both fulfill strict line). The difference is visible at first glance; however, a
scientific requirements and fit the general experiment design. statistical analysis is impossible due to a low number of cases
Typically, several hundreds or thousands papers are selected in each class.
from databases, but only tens or units are really included in
the study (see [7] for examples of such studies). TABLE II
PRICE OF THE TARGETED PROGRAM PER YEAR AND PATIENT
Alternatively, or if necessary, new primary data are collected. (RECOMMENDED EXAMINATIONS)
Three basic methods in this point are metaanalysis, modeling,
Frequ-
and/or consensus development. Cost analysis methods are Insur. ency Since
BRCA1
BRCA2
+other
usually used in the next step, mainly older and simpler cost- points (per (age) Remark
(CZK)
(CZK)
effectiveness analysis, or more modern cost-benefit analysis. year)
These analyses require a measure of quality of life. A unit of Examination
by oncologist 243 2 646.9 495.7
health care outcome that combines gains (or losses) in length
Until
of life with quality of life is the quality-adjusted life year meno-
(QALY). QALYs represent years of life subsequent to a MRI breast 5008 1 20 pause 5 660 5 508.8
health care intervention that are weighted or adjusted for the
US breast 159 2 20 425.4 349.8
quality of life experienced by the patient during those years
[22]. An integrate part of any HTA study is a decision how to MMG 521 1 30 648.7 573.1
use the study and its dissemination [6]. The OECD Report US belly 277 1 20 355.1 304.7
[15] drew the attention to the limitations related to Dermatology only
consultation 131 1 20 BRCA2 0 209.2
TABLE I Markers 4x 489 1 20 503.8 498.8
TARGETED PROGRAM (RECOMMENDED EXAMINATIONS)
Haemocult 55 1 45 61.1 56.1
Age Examinations for BRCA1 + other Examinations
group mutations for BRCA2
Examination by oncologist, MRI, Plus dermatology 20-29 years
20-29 US breast, US belly, markers consultation old 7 594 7 803
Examination by oncologist, MRI, Plus dermatology 30-44 years
30-44 US breast, MMG, US belly, markers consultation 8 240 8 023
old
Examination by oncologist, MRI,
US breast, MMG, US belly, markers,
Plus dermatology 45-50 years
45-50 Haemocult
consultation old 8 301 8 084
Examination by oncologist, US breast, Plus dermatology 51+ years old 2 641 2 924
51+ MMG, US belly, markers, Haemocult consultation
 Proceedings of the 3rd International Conference on E-Health and Bioengineering - EHB 2011,
24th-26th November, 2011, Iaşi, Romania
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Price of the therapy was calculated for each disease stage,

TABLE IV
based on a set of the clinic´s patients (see Table IV). In Table
PRICE OF THE THERAPY – REAL DATA OF 91 PATIENTS (IN CZK)
V, the cost of treatment of 10 captured cancer cases was
modeled with and without the targeted preventive. Costs per Stage N Mean Median M in Max
QALY were calculated using the utility values published in
[19] (see table VI). 0 2 62 516 62 516 52 005 73 028
Now, all necessary calculations for a cost-utility analysis
have been calculated. I 32 125 820 92 294 28 257 298 721
According to the results in Table VII, the preventive
II 38 246 156 214 200 50 140 1 081 956
program is less effective than the situation without any
preventive. However, this result is much influenced by a short
III 14 211 601 194 827 128 623 362 258
period of the preventive program (and observations).
IV 5 216 186 211 961 91 805 324 866
TABLE III
DISTRIBUTION OF CANCER CASES (NUMBERS OF CASES)
ACCORDING TO DISEASE STAGES TABLE VI
QUALITY OF LIFE
Disease stage 0 1 2 3 4 Chances of Cost
Costs Utility
Stage survival QALY per QALY
(CZK) [19] (%) (CZK)
Screening YES
2 6 2 0 0
(real data)
0 62 516 0,87 99,99 0,8699 71 866
Normal population
(manifested disease 350 2 573 2 229 877 512 I 125 820 0,79 98,6 0,7789 161 535
without screening)
II 246 156 0,72 87 0,6264 392 969
- in percent 5,35 39,34 34,08 13,41 7,83
III 211 601 0,64 64,6 0,4134 511 855
- distribution of
10 patients 0,54 3,94 3,41 1,34 0,78 IV 216 186 0,395 27,7 0,1094 780 455
(theoretical data)

TABLE V
MODEL OF COSTS FOR 10 CAPTURED CANCER CASES WITH AND WITHOUT PREVENTIVE (∆ = 394 667 CZK)

Incl. preventive w/o preventive

Price of Price of Price of
Time of Price of
Woman Price of therapy therapy therapy Difference
preventive stage stage therapy
No. preventive until now planned total (CZK)
(months) (CZK)
(CZK) (CZK) (CZK)
1 5 3 646 0 52 004 finished 55 690 I 125 820 70 130
2 54 36 738 I 95 263 5 168 137 169 I 125 820 -11 349
3 1 617 0 73 028 finished 73 645 I 125 820 52 175
4 19 11 155 I 77 176 finished 88 331 II 246 156 157 825
5 29 17 807 I 49 177 27 985 94 969 II 246 156 151 187
6 35 18 521 I 160 520 finished 179 041 II 246 156 67 115
7 42 27 086 I 142 291 finished 169 337 I 125 820 -43 517
8 14 10 420 II 367 120 5 168 382 708 III 211 601 -1 7 1 1 0 7
9 69 41 023 I 108 497 finished 149 520 II 246 156 96 636
10 13 8 986 II 148 475 33 153 190 614 IV 216 186 25 572
 Proceedings of the 3rd International Conference on E-Health and Bioengineering - EHB 2011,
24th-26th November, 2011, Iaşi, Romania
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TABLE VII attempt, it is not seen as a support, but as an open or hidden

COST-UTILITY ANALYSIS (CUA)
hostility, impeachment, breach of fellowship [24].
With W/o Although no comprehensive HTA study has been probably
preventive* preventive produced in the Czech Republic yet, some efforts to a larger
(CZK) (CZK) utilization of HTA methods can be seen, above all in
2 739 952 pharmacoeconomics [17]. What discourages their higher
Targeted program utilization in medical devices and/or clinical interventions is a
0
cost (105 women) (1 914 681) lack of interest in HTA studies results from the side of health
273 995 care providers, decision makers (the Ministry, regional
Cost of capturing administrations, health insurance companies), missing
0
1 breast carcinoma (191 468) methodology, absence of methodological guidance (non-
Mean cost of
existence of a national agency), pending funding, and (non)-
treatment per 137 226 191 569 participation in international networks. In the Czech
woman Republic, no HTA agency has been established yet. The
country is represented in EUnetHTA, a common action of EU
Total cost 411 221 countries, by its Ministry of Health Services (which is not
191 569
per woman (328 694) optimum), it is not represented in INEHTA, and only
individuals are members of HTAi. There is no legislation
QALY 0.77 0.61 concerning health technology assessment in general, only an
534 053 introduction of a new drug requires a HTA comprehensive
Cost per QALY 351 033 study according to a recent amendment of the Public Health
(426 875) Insurance Act (these studies are probably produced by
*
The cost of recommended examinations (without parentheses) and the cost pharmacological companies themselves, and they are not
of actual examinations (in parentheses). The difference is due to patients who public).
sometimes do not appear for a planned examination.

The predicted risk of breast cancer in women with
BRCA1/BRCA2 gene mutation is 78% to 83% by age of 70
years [2]. Hence, if we prolonged the preventive program,
several times more cancer cases would be captured, changing
the economy of the program dramatically. Hence, to get a
more realistic view, a model for the observed group of 105
women in the preventive program should be constructed
based on epidemiologic data.
IV. HTA IN THE CZECH REPUBLIC
There are three important factors that should be taken into
consideration if speaking about HTA in the Czech Republic
(and they seem to be analogous in the other East and Middle
Europe countries). The first is typical for any medical
environment. Clinical practice is used to work with particular
drugs, devices and pharmaceuticals in a specific way, and
patients are used as well. They know that if they visit a
physician, they can expect a given type of answers, ordering a
given type of treatment, and they think that if they do not
bring home some drugs and/or if the physician does not order
some kind of treatment, it is a bad doctor. However, he can be
good, only acting in another environment [4].
The second factor is a relatively difficult availability of
(historical) data. Many data were published incomplete (or
were not published at all), and some institutions consider their
data for confidential. Moreover (and this is the third factor),
comparison of results of individual clinics between
themselves (benchmarking) for the purpose of general health
care is practically unacceptable. If somebody would make an
V. RETROSPECTIVE PRICE ASSESSMENT FOR
INVESTMENTS IN MEDICAL DEVICES
In spite of the preceding theory, the main field of interest of
specialists interested in medical devices economics is just a
partial problem at present. Czech hospitals were historically
under-equipped with modern expensive technology (above all
medical imaging equipment). Huge amount of money
available to the Czech Republic from European Structural
Funds in the period 2007-13 has been a welcome possibility
to change this situation. Several operational programs are
focused at medical infrastructure, and hospitals have filed a
lot of projects.
It appeared, however, that the prices realized at the Czech
market are much higher than prices of the same equipment at
other comparable markets (e.g. Germany, Austria, Belgium).
Some installations seem to be overcharged even by 100 per
cent. There are several hypotheses of the reasons including
the size of the market, expectation of suppliers of a huge sum
predetermined to be spent in the industry, lower effort of
investors to obtain better prices when spending EU money (in
fact a gift), the role of consolidating dealers, and maybe even
bribery or criminal behavior.
At present, state authorities (Ministry of Health Services,
Ministry of Finance, Police, the Parliament and others) try to
analyze projects realized in 2008-2010 and utilize the
experience in new calls. They are interested mostly in the
realized prices, not in the factual aspects of the projects. This
task appeared to be quite difficult. Main problems that the
researcher has to face are:
• Different technical specification in individual supplies
 Proceedings of the 3rd International Conference on E-Health and Bioengineering - EHB 2011,
24th-26th November, 2011, Iaşi, Romania
___________________________________________________________________________________________________________________
• Different sale and guarantee conditions
• Selection of an appropriate model for the particular clinic
(not to pay for parameters that will not be utilized in the
clinic)
• Different offer prices, non-existence of dealers´ price-lists
• The role of consolidating dealers
In order to assess one business case, it is necessary to fix
the normal price in the place and time. Practically all realized
prices are considered confidential and are not disclosed, even
if they were paid by public institutions. Thus, there are just
two sources of information: (i) official lists of public tenders,
e.g. http://ted.europa.eu/TED/main/HomePage.do; or (ii)
unofficial information from producers, dealers, or clinics
(hospitals). Since the Czech market is relatively small (at the
end of 2010, there were 189 hospitals in the Czech Republic
[13]), it is necessary to take into account the whole area of the
Czech Republic and relatively large time span when fixing
the normal price. The price data collected have to be adjusted
considering particular specifications. Then, there are several
possibilities where to place the normal price (of a particular
device given its technical specification), e.g.:
• The price of the technically equal or very similar device
• The price of a very similar device plus/minus financial
assessment of differences in specifications
• The price span given by the nearest worse device and the
nearest better device
• The price span given by the mean of worse devices and
the mean of better devices
VI. AN EXAMPLE: MRI PURCHASES IN 2008-9
Ujhelyiová and Poušek recently analyzed the situation in
the MRI scanners market in the Czech Republic in last three
years [23]. The task was to assess the 2009 normal price of
Siemens MAGNETOM Avanto 1.5 in the specification as
delivered to Krajská zdravotní a.s. (Masaryk Hospital in Ústí
nad Labem).
A. Purchased MRIs and their prices
There are several possibilities, how to assess medical
devices (to determine their normal price). These methods
differ above all in source information available. Assessing the
normal price can be seen from two angles. The first is the
time aspect. Assessing can be ex-ante (for future), interim
(real time) and ex post (afterward). Ex-ante assessing is based
on technical specifications in the tender documentation. For
interim assessing, offers are available in addition to that.
Much more information should be available for ex post
assessing; next to that mentioned above, also contractual
documents, bills of delivery, completion certificates etc.
Another aspect is assessing the normal price according to
technical specifications and also to medical needs.
In this particular case, ex post assessing was carried out
based on technical specification requirements. For
comparison, all installations in the Czech Republic in 2008-9
were used (see Table VIII).
First, comparison tables were compiled as formalized and
structuralized source documents. These documents were
created in several steps:
1. A list of parameters for the particular device (in this case
for MRI 1.5T) was created; the criterion for a parameter
inclusion was that it characterizes the device and
significantly affects its final price.
2. If it is possible to divide the device into partial units (HW,
SW, common core part, auxiliary parts, special utilities
etc.), it was done.
3. Afterwards basic parameters for the whole installation
were determined in a similar way.
4. If seasoning is necessary, its characteristics were
identified.
5. Parameters concerning staff training were quantified.
6. Guarantee terms and conditions were identified.
7. Post-guarantee characteristics were identified.
These parameters were listed in a table, where the same
parameters were registered also for the nearest worse, and the
nearest better devices. Publicly available survey of technical
specifications of MRI scanners produced by that time [14]
was taken into account in the analysis of listed parameters.
The normal price of a device of the given technical
specification and at the given time moment was assessed,
based on all this information, to be CZK 24 000 000.
B. Consolidating dealers effect
Recently, the impact of a consolidating dealer to the final
price of equipment is a frequently discussed topic among
Czech health care managers. Fig. 1 shows situations that can
appear in determining the final price of a medical device. If
the customer purchases the device directly from the producer,
the (lowest) price 1 is paid. If he purchases the device from a
middleman, he pays the price 3, since the middleman buys
from the producer for the price 2 approaching the price 1,
and, of course the price 3 is then higher than price 2. In the
particular case investigated, two middlemen joined in a
consortium for the purpose of offering. One of them
purchased the scanner for the price 2. Within the consortium,
they created the price for the customer, i.e. the price 4, which
is the highest of all prices.
1 Purchaser
Producer 2 Middleman1 3 Purchaser
2 Middleman1 Middleman2 4 Purchaser
Fig. 1. Medical device final price depending on the number of middlemen
(consolidating dealers) in the chain.
 Proceedings of the 3rd International Conference on E-Health and Bioengineering - EHB 2011,
24th-26th November, 2011, Iaşi, Romania
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Prices from different suppliers were compared (all tenders ACKNOWLEDGMENT

placed in 2008-9, see Table VIII). Out of 10 supplies, 6 were
The authors acknowledge financial support for the
direct, and 4 included different consolidating dealers.
development of HTA methods for medical devices by the
Moreover, the price development in time was constructed
Ministry of Health Services of the Czech Republic under
from real contracts placed in the period 2006-10. The real
Grant No. NT11532-5/2010. A.U. acknowledges financial
time development of MRI 1.5T scanners is shown in Fig. 2.
support for the study of cost effectiveness of technological
The function is naturally decreasing, as the device becomes
processes in health services from CTU´s Student Grant
outdated and new better devices enter the market. Due to
Agency under Grant No. SGS11/143/OHK5/2T/17.
consolidating dealers, deviations from the main trend have
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