assessment element tables - terveyden ja …meka.thl.fi/htacore/model/ae-tables_intervention.pdf ·...

The EUnetHTA J oint A ction i ssupported by a gr ant from theEuropean Commission

®

Assessment element tables

1 Health Problem and Current Use of the Technology2 Description and technical characteristics of technology3 Safety4 Clinical Effectiveness5 Costs and economic evaluation6 Ethical analysis7 Organisational aspects8 Social aspects9 Legal aspects

HTA Core Model® Online | Assessment element tables http://localhost/htacore/ViewTables.aspx?id=4

1 of 27 8.2.2011 16:27

HTA Core Model® Online | Assessment element tables 1/27HTA Core Model® Online | Assessment element tables 1/27

ilonen_terhi

Typewritten Text

ilonen_terhi

Typewritten Text

2

ilonen_terhi

Typewritten Text

ilonen_terhi

Typewritten Text

ilonen_terhi

Typewritten Text

ilonen_terhi

Typewritten Text

7

ilonen_terhi

Typewritten Text

9

ilonen_terhi

Typewritten Text

11

ilonen_terhi

Typewritten Text

14

ilonen_terhi

Typewritten Text

16

ilonen_terhi

Typewritten Text

ilonen_terhi

Typewritten Text

21

ilonen_terhi

Typewritten Text

ilonen_terhi

Typewritten Text

23

ilonen_terhi

Typewritten Text

25

1 Health Problem and Current Use of the Technology

ID Topic Issue Clarification Im. Tr. Information sources Reference Relations Core

A0001 TargetCondition

Which disease/healthproblem/potential health problem willthe technology be used for?

Definition (naming) of thecondition, health problem,disease for which thetechnology is intended.

3 3 Medical literature, at the bestsystematic reviews onmechanism of disease, riskfactors, course and prognosis.Developers/ manufacturers viewon the potential targets andwhat they expect/claim from thetechnology.

Burls et al. 2001,Busse et al.2002, Liberati etal. 1973Imaz-Iglesia etal. 1998,Kristensen et al.2009

Yes


What, if any, is the precise definition/characterization of the target disease?Which diagnosis is given to thecondition and according to whichclassification system (e.g. ICD-10)?

Characteristics of thecondition which allow aprecise diagnostic anddifferentiation of theindication for the use of thetechnology

3 3 Medical literature, at the bestsystematic reviews onmechanism of disease, riskfactors, course and prognosis.


Choice of ”Patient” component of thePICO for effectiveness assessmentSubgroups or indications are alsoconsidered under Clinical Effectiveness

Yes


Which are the known risk factors foracquiring the condition?



Identification of alternative (i. e.preventive) approaches

Yes


What is the natural course of thecondition?

For example stages of thedisease which can be objectof different interventions.



Choice of outcome parameter foreffectiveness assessment (PICO).Disease path can be used to constructeconomic models

Yes


What are the symptoms of thedisease?


Burls et al. 2001,Busse et al.2002, Liberati etal. 1973Imaz-Iglesia etal. 1998,

Choice of outcome component of thePICO for effectiveness assessment.

Yes


2 of 27 8.2.2011 16:27


ID Topic Issue Clarification Im. Tr. Information sources Reference Relations CoreKristensen et al.2009


What are the consequences of thecondition?

Qualitative description of theburden of disease for theindividual (e.g. disability, pain)



Choice of outcome parameter foreffectiveness assessment (PICO).Disease path can be used to constructeconomic models

Yes


How many people belong at themoment (will belong) to the specifictarget group (describe according tosex, age)?

Incidence and/or prevalenceof the target condition or theindication for use of thetechnology

3 1 Systematic reviews ofepidemiological studies such ascross-sectional Studies(prevalence), cohort studies(incidence), routine statistics.Own analysis of: Diseaseregister, administrativedatabases (dischargedatabases, reimbursementclaims databases)


Data can be used when constructingmodels, however only if they are reallygeneralisable/transferable

Yes


What is the burden of disease(mortality, disability, life years lost)?

Disease-specific mortality.Prevalence of disability ordisabling symptoms causedby the condition.Prevalence/Incidence of earlyretirement due to thecondition

3 2 Systematic reviews ofepidemiological studies such ascross-sectional Studies(prevalence), cohort studies(incidence), routine statistics.Own analysis of: Diseaseregister, administrativedatabases (dischargedatabases, reimbursementclaims databases)


Data can be used when constructingmodels, however only if they are reallygeneralisable/transferable

Yes


What aspects of the burden ofdisease are targeted by thetechnology, i.e. are expected to bereduced by the technology?

The application of thetechnology may target onlyone aspect of the burden ofdisease, eg. disability but notmortality. Or mortality but notsymptomatligy

3 3 Yes

A0011 Utilisation How much is the technology beingused?

2 1 Utilisation reviews,audits,studies on praxis-variation. Own primary analysisof: Disease register, procedure

Burls et al. 2001,Busse et al.2002, Liberati etal. 1973

No


3 of 27 8.2.2011 16:27


ID Topic Issue Clarification Im. Tr. Information sources Reference Relations Coreregister, device register,administrative data (DRG,dicharge databases,reimbursement claimsdatabase).

Imaz-Iglesia et al.1998, Kristensenet al. 2009

A0012 Utilisation Describe the variations in use acrosscountries/regions/settings, if any?

2 2 Utilisation reviews,audits,studies on praxis-variation. Own primary analysisof: Disease register, procedureregister, device register,administrative data (DRG,dicharge databases,reimbursement claimsdatabase).


Yes

A0013 CurrentManagementof theCondition

How is the disease/health conditioncurrently being diagnosed?

Self-explaining. 3 1 Surveys, utilisation reviews. Ifsuch information is lacking:Expert surveys / expertinterviews

Findings can be used to assess whethertechnology could add anything in themanagament of the disease. Findings canbe used when constructing CE-Modelscomparing to alternatives. Differentdiagnostic techniques are applied bydifferent professional groups, thus this itemis also relevant for organisational domain.

Yes


According to publishedalgorithms/guidelines (if any), howshould the condition be diagnosed?

Asssessment of this allowsto draw conclusions on howfar the current managementis optimal.

3 2 Clinical guidelines,recommendations, appraisingtheir quality with for exampleAGREE Instrument. If suchinformation is lacking: expertsurveys / expert interviews,textbooks.

Findings can be used to assess whetherthe technology could add anything in themanagament of the disease.

Yes


How is the disease/health conditioncurrently being managed?

3 1 Surveys, utilisation reviews. Ifsuch information is lacking:Expert surveys / expertinterviews


Findings can be used to assess whethertechnology could add anything in themanagament of the disease. Findings canbe used when constructing CE-Modelscomparing to alternatives

Yes

A0016 CurrentManagementof the

According to publishedalgorithms/guidelines (if any), howshould the condition be managed?

Asssessment of this allowsto draw conclusions on howfar the current management

3 2 Clinical Guidelines,recommendations. If suchinformation is lacking: Expert

Burls et al. 2001,Busse et al.2002, Liberati et

Findings can be used to assess whetherthe technology could add anything in themanagament of the disease.

Yes


4 of 27 8.2.2011 16:27


ID Topic Issue Clarification Im. Tr. Information sources Reference Relations CoreCondition is optimal. surveys / expert interviews,

textbooks.al. 1973Imaz-Iglesia et al.1998, Kristensenet al. 2009


What are the differences in themanagement for different stages ofdisease, if any?

Identification of practicevariations which point outdifferences in the quality ofhealth care

2 2 Surveys, utilisation reviews,clinical guidelines,recommendations. If suchinformation is lacking: Expertsurveys / expert interviews


Yes


What are the other evidence-basedalternatives to the current technology,if any?

3 2 Clinical guidelines,recommendations, systematicreviews


Choice of comparator for effectivenessassessment (PICO) Choice of comparatorfor cost-effectiveness assessment

Yes

A0019 Life-Cycle In which phase is the development ofthe technology (experimental,emerging, routine use, obsolete)?

This is related to the questionwhether there is enoughevidence or experiences onthe use of the technology onthe condition.

3 2 Horizon scanning databases,ongoing research databases.Information from manufacturers.


Status determines the kind of informationwhich can be expected on other domains(specially in long-term safety,effectiveness). Uncertainity grade

Yes

A0020 RegulatoryStatus

Which approval status has thetechnology in other countries, orinternational authorities?

3 3 Drugs: EMEA, FDA, NationalAuthorities. Devices:CE-Approval, NationalAuthorities. Manufacturersshould be contacted in order toidentify which steps have theytaken/ are they planning to takeconcerning Market-Approval


Legal Domain Yes

A0021 RegulatoryStatus

Has the technology been included in /excluded from the benefit basket ofany country? How is the coverage ofthe technology across countries? (e.g.

Are there co-payments, towhat extent?

2 3 Lists of benefits / services of theNational Health Services /Sickness Funds, inquiry oftechnical officers from MoH.

Burls et al. 2001,Busse et al.2002, Liberati etal. 1973

Legal Domain Yes


5 of 27 8.2.2011 16:27


ID Topic Issue Clarification Im. Tr. Information sources Reference Relations Corefull-coverage, co-payments, coverageunder specialcircumstances/conditional coverage?)

Manufacturers. Literature onBenefit Basket (Comparativepolicy studies)

Imaz-Iglesia et al.1998, Kristensenet al. 2009

A0022 Other Who manufactures the technology? 2 2 Burls et al. 2001,Busse et al.2002, Liberati etal. 1973Imaz-Iglesia etal. 1998,Kristensen et al.2009

Related to Organisational or Social domain Yes


6 of 27 8.2.2011 16:27


2 Description and technical characteristics of technology


B0001 Features of thetechnology

What is this technology? Provide a short technical description: Type of device, operation,imaging, etc. Biological rationale and mechanism of action of thetechnology.

3 3 Manufacturer, effectivenessstudies, clinical experts, studies inbasic science, textbooks

Current use Yes


Why is this technologyused?

Describe the aim of using the technology: How is it expected to bean improvement as compared to previous technologies used for thesame health problem?

3 2 Manufacturer, effectivenessstudies, clinical experts

Current use Yes


Phase of the technology:When was it developed orintroduced in health care?

Is it a truly novel one, or has it been used earlier for this or someother purpose? Is the technology fully developed or in its earlystages? Most technologies will be introduced at approximately thesame time in several countries. If an HTA has been done more thana few months before using it, the technology might have beenstudied in more detail and moved into another phase (with morepublished trials, for example).

3 2 Manufacturer, effectivenessstudies

Current use.Effectiveness

Yes


Who will apply thistechnology?

What types of professionals (nurses, doctors, other professionals) orpatients (all with a certain disease, narrowly defined groups) will beusing this technology?

3 2 Manufacturer, effectivenessstudies, clinical experts,legislation. National or localjudgement

Current use,Organisational

Yes


What is the place andcontext for utilising thetechnology

At which level(s) of health care (self-care, primary, secondary,tertiary) will the technology be used?

3 1 Manufacturer, effectivenessstudies, clinical experts,legislation. National or localjudgement


Yes


Are there any specialfeatures relevant to thistechnology?

Any points where this technology is different from its predecessors(other technologies used for similar purposes); new aspects thatneed to be considered when applying it.

3 2 Manufacturer, effectivenessstudies, clinical experts

Effectiveness,Safety

Yes

B0007 Investments andtools required touse thetechnology

What materialinvestments are neededto use the technology?

Devices, machinery, computer programs, etc. Those parts of thetechnology that need to be purchased (and often installed) by anorganization in order to use the technology. Includes need forback-up investment to cover for breakdowns in use.

3 2 Manufacturer, applicabilitystudies, clinical experts, userinformation. National or localjudgement


Yes


What kind of specialpremises are needed touse the technology?

Many technologies require purpose-built premises withinorganizations, such as radiation-secured areas, Faraday cages, etc.Typical premises in primary or secondary care may differ markedlyfrom country to country. A clear description of necessary facilities,training etc. is needed instead of lump statement (e.g. to be used inhospitals only)

3 2 Manufacturer, applicabilitystudies, clinical experts, userinformation. National or localjudgement

Current useOrganisational,Legal

Yes

B0009 Investments andtools required touse the

What equipment andsupplies are needed touse the technology?

Syringes, needles, medicines, fluids, bandages etc. All disposableitems necessary for using the technology

3 3 Manufacturer, applicabilitystudies, clinical experts, userinformation. National or local

Current use Yes


7 of 27 8.2.2011 16:27


ID Topic Issue Clarification Im. Tr. Information sources Reference Relations Coretechnology judgement


What kind of data andrecords are needed tomonitor the use thetechnology?

What kind of data needs to be collected about the use of thistechnology regarding care processes, professionals involved,patients and their health outcomes?

3 1 Clinical experts, administrativeexperts, legislation. National orlocal judgement

Current use, Legal Yes


What kind of registers isneeded to monitor theuse the technology?

Are there existing registries that should be used, or should a registrybe established, to collect the necessary data?

3 1 Clinical experts, administrativeexperts, legislation. National orlocal judgement

Current use, Legal Yes

B0012 Training andinformationneeded for utilizingthe technology

What kind of qualification,training and qualityassurance are needed forthe use or maintenance ofthe technology?

Training materials: writing and/or translation, other adaptation?Personal training: individual and/or group sessions, number andlength of sessions, number and qualifications of trainers

3 2 Manufacturer, effectivenessstudies, observational studies,applicability studies, clinicalexperts, user information.National or local judgement

Current use,Organisational,Legal

Yes


What kind of training isneeded for the personneltreating or investigatingpatients using thistechnology?

Training materials: writing and/or translation, other adaptation?Personal training: individual and/or group sessions, number andlength of sessions, number and qualifications of trainers. If thetechnology requires a specific skill that is developed over a period oftime using the technology (learning curve) it should be estimatedhow many cases a professional needs to treat (as a basis or peryear) in order to reach acceptable quality

2 1 Manufacturer, effectivenessstudies, observational studies,applicability studies, clinicalexperts, user information.National or local judgement

Current use,Organisational,Legal

No


What kind of training andinformation are neededfor the patients receivingor using this technology &their families?

Training materials: writing and/or translation, other adaptation?Personal training: individual and/or group sessions, number andlength of sessions, number and qualifications of trainers

3 1 Manufacturer, effectivenessstudies, observational studies,applicability studies, clinicalexperts, user information, patientorganisations. National or localjudgement

Current use,Organisational,Ethical, Legal

Yes


What information dopatients outside the targetgroup and the generalpublic need on thetechnology?

Training materials: writing and/or translation, other adaptation? 3 1 Manufacturer, effectivenessstudies, observational studies,applicability studies, clinicalexperts, user information, patientorganisations. National or localjudgement

Current use,Organisational,Ethical, Legal

Yes


8 of 27 8.2.2011 16:27


3 Safety


C0001 Patient safety What kind of harms can use of the technologycause to the patient and what is the incidence,severity and duration of harms?

Are the harms intrinsic to the technology(primary effect) or application dependant(secondary effects) or an unrelated eventconsequent on its use?

3 2 Ref 1, 2, 4 Yes

C0002 Patient safety What is the dose relatedness of the harms topatients?

Here one should consider also the accumulatedharm due to repeated testing

3 3 Research articles,manufacturers' product datasheets, safety monitoringdatabases

Yes

C0003 Patient safety What is the timing of onset of harms topatients: immediate, early or late?

The onset of the harm will be differentdependant on the mechanism of action andtype of technology. Some harms may not bedetected because the duration of follow up isnot sufficiently long.

3 3 Manufacturers/ medicalliterature/ grey literature/registries/ national orinternational safety monitoringsystems

Yes

C0004 Patient safety Is the incidence of the harms to patients likelyto change over time?

For some technologies the occurrence of harmsmay change over time and be dependant onthe experience or training of the operator?

3 2 Medical literature/ greyliterature/ professionalsocieties/ registries

Ref 1 Current use/ Clinicaleffectiveness/Economic evaluation

Yes

C0005 Patient safety Are there susceptible patient groups that aremore likely to be harmed through use of thetechnology?


4 Yes

C0006 Patient safety What are the consequences of false positive,false negative and incidental findings broughtabout using the technology to the patientsfrom the viewpoint of patient safety?

3 2 Research articles Accuracy Yes

C0007 Patient safety What are the special features in using(applying/interpreting/maintaining) thetechnology that may increase the risk ofpatient safety?

Is there evidence for operator dependentharms? Is there a learning curve and what is itsconsequence? Is there is a big intra- or inter-observer variation in the reading of test results,what is its consequence?


Description Yes

C0008 Patient safety What is the safety of the technology incomparison to alternative technologies usedfor the same purpose?

Relative impact of harms comparative toalternative treatment(s) for individual patients,populations, service delivery & costeffectiveness

1 2 Other HTA reports orsystematic reviews of maincomparators. Manufacturer orregulators information

Current use/organisational aspects/costs, economicevaluation

No

C0020 Occupationalsafety

What kind of occupational harms may existthrough using the technology?


Yes


9 of 27 8.2.2011 16:27


ID Topic Issue Clarification Im. Tr. Information sources Reference Relations CoreC0040 Environmental

safetyWhat kind of environmental risks may use ofthe technology cause?


No

C0060 Safety riskmanagement

How does the safety profile of the technologyvary between different generations, versionsor products?


Description andTechnicalCharacteristics

Yes


Is there evidence that harms increase ordecrease in different organizational settings?

3 3 Accuracy and effectivenessresearch, epidemiological riskresearch

Current use, Accuracy Yes


How can one reduce safety risks for patients(including technology-, user-, and patient-dependent aspects)?

Is there a requirement for specific training, useof a protocol or guideline or restricting use tospecialist centres, providing patient information,etc. may all reduce the occurrence or severityof harm.

2 2 Organisational aspects Yes


How can one reduce safety risks forprofessionals (including technology-, user-, andpatient-dependent aspects)?

2 2 Research in occupationalhealth and safety

Yes


How can one reduce safety risks forenvironment (including technology-, user-, andpatient-dependent aspects)?

2 2 Research articles,manufacturers' product datasheets

Yes


10 of 27 8.2.2011 16:27


4 Clinical Effectiveness


D0001 Mortality What is the effect of theintervention on overallmortality?

Use of technology may have animpact on patients' lifeexpectancy.

3 2 Systematic reviews of RCTs (Randomised controlledtrials) or CTs (controlled trials), if not available RCTs orCTs itself. If these not available, non-controlled studiesand respective systematic reviews. Health care registerdata.

Several sources,see theReference list.

Yes

D0002 Mortality What is the effect of theintervention on the mortalitycaused by the target disease?

Use of technology may have animpact on mortality caused bythe target disease.



Yes

D0003 Mortality What is the effect of theintervention on the mortalitydue to other causes than thetarget disease?

Use of technology may have animpact on the mortality due toother causes than the targetdiseas.



Yes

D0004 Mortality What is the mortality related tothe technology studied?

Use of technology may have animpact on mortality related tothe intervention studied.



Safety domain Yes

D0005 Morbidity How does the interventionmodify the severity andfrequency of symptoms andfindings?

Use of technology may have animpact on patients' symptoms.

3 2 Systematic reviews of RCTs (Randomised controlledtrials) or CTs (controlled trials), if not available RCTs orCTs itself. If these not available, non-controlled studiesand respective systematic reviews.


Yes

D0006 Morbidity How does the interventionmodify the progression ofdisease?

Use of technology may have animpact on course of the illness.



Yes

D0007 Morbidity How does the interventionmodify the recurrence ofsymptoms and findings?

Use of technology may have animpact on course of the illness.



Yes

D0008 Morbidity What is the morbidity related tothe intervention?

Use of technology may have animpact on morbidity related tothe intervention.



Safety domain Yes


11 of 27 8.2.2011 16:27


ID Topic Issue Clarification Im. Tr. Information sources Reference Relations CoreD0010 Change-in

managementHow does the technologymodify the need forhospitalization?

Use of technology may have animpact on morbidity related tothe need for hospitalizations.



Yes

D0023 Change-inmanagement

How does the technologymodify the need for othertechnologies and use ofresources?

2 2 Economic &Organisationdomains

Yes

D0011 Function / HRQL(Health-relatedquality of life)

What is the effect of theintervention on globalimprovement of function?

Use of technology may have animpact on functional ability



Yes


What is the effect of thetechnology on health-relatedquality of life?

Use of technology may have animpact on quality of life



Yes


What is the effect of theintervention on disease specificquality of life?

Use of technology may have animpact on quality of life



Yes


What is the effect of theintervention on return to work?

Use of technology may have animpact on working ability.



Yes


What is the effect of theintervention on return toprevious living conditions?

Use of technology may have animpact on ability to return toprevious living conditions.



Social domain Yes


How does the use oftechnology affect activities ofdaily living?

Use of technology may have animpact on ability to perform dailyactivities.



Social domain Yes

D0017 Patient satisfaction Was the use of technologyworth it?

Patients overall assessment ofthe worthiness of theintervention.



Yes

D0018 Patient satisfaction Would the patient be willing touse the technology again?

Patients overall assessment ofthe worthiness of theintervention.

3 2 Systematic reviews of RCTs (Randomised controlledtrials) or CTs (controlled trials), if not available RCTs orCTs itself. If these not available, non-controlled studies


Yes


12 of 27 8.2.2011 16:27


ID Topic Issue Clarification Im. Tr. Information sources Reference Relations Coreand respective systematic reviews.


13 of 27 8.2.2011 16:27


5 Costs and economic evaluation


E0001 Resourceutilization

What types ofresources are usedwhen delivering theassessed technologyand its comparators(resource useidentification)?

In order to do an economic evaluation all types ofresource utilization must be identified. The studyperspective determines what kinds of resourceutilization must be identified. A societal perspectiveimplies identifying all kinds of resource utilizationirrespective of who pays for the resources. If a healthcare provider perspective is applied, then resourceutilization paid for by the patient is not relevant

3 2 Health care registers, RCT’swith resource utilization data,reimbursement databases,micro-level costingstudies/ABC-costing studies

Guidelines for economicevaluation of HealthTechnologies: Canada,3rd edition, 2006,Guidelines forPharmacoeconomic.Evaluations in Belgium,2008

Yes

E0002 Resourceutilization

What amounts ofresources are usedwhen delivering theassessed technologyand its comparators(resource usemeasurement)?

For all types of resource utilization the amounts ofresources used when delivering the assessedtechnology as well as when delivering the comparatortechnologies must be measured

3 2 Health care registers, RCT’swith resource utilization data,reimbursement databases,micro-level costingstudies/ABC-costing studies

Guidelines for economicevaluation of HealthTechnologies: Canada,3rd edition, 2006,Guidelines forPharmacoeconomic.Evaluations in Belgium,2008

Yes

E0003 Unit costs What are the unitcosts of the resourcesused when deliveringthe assessedtechnology and itscomparators?

Ideally unit cost estimates should be (proxies for)opportunity costs. By the opportunity cost is understoodthe (lost) health gains that could have been achievedfrom an alternative technology, which, however, cannotbe introduced or retained, because the resources e.g.manpower, are used on the new technology. Marketprices are often used as proxies for opportunity costs.

3 1 Market prices, companies,hospital accounting systems,reimbursement databases,micro level costingstudies/ABC-costing studies

Guidelines for economicevaluation of HealthTechnologies: Canada,3rd edition, 2006,Guidelines forPharmacoeconomic.Evaluations in Belgium,2008.

Yes

E0004 Indirect Costs What is the impact ofthe technology onindirect costs?

Indirect costs include costs to society of lost production.This can be due to patient’s temporary absence fromwork due to illness, reduced working capacity due toillness and disablement, or lost production due to anearly death

2 2 Different registers e.g. registeron sick leave, sicknessallowance, patientadministration systems/clinical databases, earlierstudies, cost diaries.

Kristensen 2007 Overlap with socialdomain.

Yes

E0005 Outcomes What are theincremental effects ofthe technology relativeto its comparator(s)?

The calculation of an incremental cost-effectivenessratio requires the estimation of the incrementaleffectiveness/utility/benefit of a technology relative toits comparator(s).

3 2 Estimation of the incrementaleffects can be based oninformation provided in theeffectiveness domain (e.g.mortality data). Additionalinformation collection may beneeded (e.g. on health-relatedquality of life indices). The

Overlap witheffectiveness domain

Yes


14 of 27 8.2.2011 16:27


ID Topic Issue Clarification Im. Tr. Information sources Reference Relations Coreincremental effectivenessmay result from an economicmodel, where inputs from theeffectiveness domain areused (amongst others)

E0006 Cost-effectiveness What is theincrementalcost-effectivenessratio?

The result of the economic analysis will most often bean incremental cost-effectiveness ratio eg. costs/QALYif quality-adjusted life years is used as the mainoutcome indicator. The incremental cost-effectivenessratio does not in itself determine that a technology isdesirable. Decision makers need – implicitly or explicitly– to weigh the benefits of a technology against thecosts. The concept of a cost-effectiveness threshold isone way of expressing decision-makers willingness-to-pay for health benefits. If other types of economicevaluation is chosen, eg. cost benefit analysis, othertypes of measures are used to express results of theanalysis, but most current economic analysis withinHTA’s are done within the cost-effectiveness/cost-utilityframework

3 1 Sources of data used arespecified under relevantissues under domains safety,effectiveness and costs. TheICER estimate might resultfrom the economic model,using inputs from the safetyand effectiveness domain.

In addition to theresource utilizationand unit costsspecified below theeconomic evaluationuses information fromall types of outcomesspecified under thedomains safety andeffectiveness(mortality, morbidity,HRQoL etc.)

Yes


15 of 27 8.2.2011 16:27


6 Ethical analysis

ID Topic Issue Clarification Im. Tr. Informationsources

Reference Relations Core

F0001 Principal questions about theethical aspects of technology

Is the technology a new,innovative mode of care,an add-on to ormodification of a standardmode of care or areplacement of astandard?

The consequences of totally new models of care are likely to bemore difficult to predict than the consequences of replacing an oldtechnology (for individual values, attitudes and expectations aswell as for health care systems). Novel, innovative treatmentmodes may require extra emphasis on ethical analysis, althoughthe literature and research base on the topic may be narrow.

3 2 Literaturesearch. Expertopinion

Mitcham 2004 technologydescription,organizational

Yes


Can the technologychallenge religious,cultural or moralconvictions or beliefs ofsome groups or changecurrent socialarrangements?

It is important to identify those groups within the society forwhom the use of the technology may pose serious challengesdue to their beliefs, convictions or current social arrangements(e.g. need of blood transfusion adjunct to the use of thetechnology, contraception). Identification of these conflicts andfinding other, acceptable possibilities to treat the condition inthese groups is important. Identifying the conceptions behind thebeliefs and values may help put them in perspective, whenconsidering the overall acceptability of the technology.Technology may also change generally accepted socialarrangements by challenging traditional conceptions (e.g. assistedreproductive technologies have separated the concept of genetic,biological and social motherhood).

3 2 Literaturesearch. Expertopinion.Stakeholderhearing

Ogletree 2004 Social Yes


What can be the hiddenor unintendedconsequences of thetechnology and itsapplications for differentstakeholders.

In addition to intended use, the technology may be used for otherpurposes and have side-effects in addition to those following fromthe intended use. Unintended consequences are obviouslydifficult to predict, but the intended purpose and uses of thetechnology should be evaluated against the likely uses andconsequences of the technology in the real world. Newtechnologies tend to lead to new areas of inventions and give riseto new ethical questions (e.g. IVF and development of genetictesting has led to questions of preimplantation genetic diagnostics(PGD). As presymptomatic and prenatal genetic tests havebecome available, the health care system has to be prepared tohandle moral issues raised by true positive and false negativefindings.) Many treatments have indirect effects also on relatives.

3 2 Literaturesearch. Expertopinion.Stakeholder

Ogletree 2004,Hofmann 2005b,Hofmann 2002b

Yes

F0004 Autonomy Does the implementationor use of the technologychallenge patientautonomy?

Patients have in most cases a right to autonomy, i.e. right to beself-governing agents. This requires the right to decide aboutthings of importance to oneself on one hand, but also relevantinformation and a capability to understand the information,

3 2 Literaturesearch. Expertopinion.Stakesholder

Miller 2004 Yes


16 of 27 8.2.2011 16:27




consider it in relation to personal values and decide accordingly.Thus, technologies and health systems may interfere withpatient’s right to autonomy directly or indirectly by influencing thedecisional capacity. For example, a technology that does notallow itself to be understandably explained to the patient (e.g.gene therapy for dementia) is potentially problematic, as aretreatments that require patients to behave in a certain way (e.g.liver transplants given conditional to not drinking).

hearing

F0005 Autonomy Is the technology used forpatients/people that areespecially vulnerable?

The right and justification to use the technology for persons whoare vulnerable (critically ill or have otherwise reduced decisionmaking capacity, like children, mentally retarded, patients thathave due to their illness/state limited decision making capacity,pregnant women etc) has to be clarified. Who has the right tobalance the benefit against possible harm in these situations? Onwhat grounds can these decisions be made? Is the technology sovaluable, as to justify its use on people who can not giveinformed consent to it?


Miller 2004 Yes

F0006 Autonomy Can the technology entailspecial challenges/riskthat the patient/personneeds to be informed of?

Is the common professional practice of discussing the treatmentswith patients enough, or is special care needed with thistechnology? The technology to be used in life-threateningsituations may have life-threatening side effects (e.g. invasivetechniques). Technology used to get exact information may haveunexpected severe side-effects (e.g. miscarriage due toamniocentesis).

3 3 Literaturesearch. Expertopinion.Registers

Miller 2004 Safety Yes

F0007 Autonomy Does the implementationchallenge or changeprofessional values, ethicsor traditional roles?

Technologies may change the relationship between physician andpatient, challenge professional autonomy or otherwise interferewith professional ethics and values. The patient-physicianrelationship is traditionally based on mutual trust, confidentialityand professional autonomy so that individual treatment decisionscan be made in the best interest of the patient. Technologies thatinterfere with core virtues and principles of medical andprofessional ethics challenge the professional integrity of thephysicians or other health care professionals. Technologies thatalign with professional ethics are more likely to be implementedsuccessfully.

3 2 Expert opinion Hofmann 2005b.MedicalProfessionalismProject 2002

Organisational.Technologydescription

Yes

F0008 Human Dignity Does the implementationor use of the technologyaffect human dignity?

Especially technologies that are applied for persons with reducedautonomy may violate a person's dignity (children, mentallyimpaired, severely ill), i.e. challenge the idea that all humanbeings have intrinsic moral value, and should thus not be seen as

3 2 Literaturesearch. Expertopinion.Stakeholder

Kilner 2004 Yes


17 of 27 8.2.2011 16:27




means to others ends. hearingF0009 Human integrity Does the implementation

or use of the technologyaffect human integrity?

"Technology can challenge human integrity by preventing (oreven tempting) people (patients or professionals) to live accordingtheir moral convictions, preferences or commitments. This isespecially important for vulnerable patient groups. Integrity canalso be seen as a coherent image or identity of oneself. Thus, forexample, prenatal diagnostics might challenge the integrity ofpeople who value new life as gift; cochlear implants areproblematic for those, who do not see deafness as a disability.Institutions that discourage honesty or ethical conduct moregenerally are detrimental to integrity (for example, systemswhere lying about ones health state might lead to bettertreatment than being honest). "


Kilner 2004 Yes

F0010 Beneficence/nonmaleficence What are the benefits andharms for patients, andwhat is the balancebetween the benefits andharms whenimplementing and whennot implementing thetechnology? Who willbalance the risks andbenefits in practice andhow?

The decision to implement new technology requires carefuldecision on the balance between benefit and harm,cost-effectiveness, reallocation of resources etc. When thisdecision has been made the decision on individual patient levelrests on both the professional who offers the technology and thepatient who autonomously accepts the use of technology inher/his situation. The individual decision has to be based onobjective information on possible benefit and risks. Risks are onlyjustified to the extent they are needed to create benefits. If notproven otherwise, the individual patient is generally to be seen asthe best judge of risks and benefits for her/himself.


Autti-Rämö 2007 Safety.Effectiveness

Yes

F0011 Beneficence/nonmaleficence Can the technology harmany other stakeholders?What are the potentialbenefits and harms forother stakeholders, whatis the balance betweenthem? Who will balancethe risks and benefits inpractice and how?

Some technologies have the potential to unfold unwanted orharmful effects not only on the patients that the technology isdirectly applied to but also indirectly on other stakeholders(relatives, other patients, organisations, commercial entities,society etc.) Benefits and harms to individuals must be balancedwith benefits and harms that can befall society as a whole (socialutility, maximizing public health). These harmful effects maymanifest in the physical, social, financial or even other domains oflife. For example results of genetic tests may negatively interferewith the family planning and social life of not only the individualbeing tested but also of his or her relatives. Table 2 in the processdescription can be used to describe benefits and harms.


Autti-Rämö 2007Beauchamp andChildress 2001

Organisational.Social

Yes

F0012 Justice and Equity What are theconsequences ofimplementing / not

A new intervention may require reallocation of human resources,funding and training. A large reallocation of resources mayseriously jeopardize other patient groups (e.g. new technology

3 2 Literaturesearch. Expertopinion.

Sterba 2004Daniels 2001

Cost-effectiveness.Organisational.Social

Yes


18 of 27 8.2.2011 16:27




implementing thetechnology on justice inthe health care system?Are principles of fairness,justness and solidarityrespected?

that requires human resources in acute care). How thisreallocation affects the existing health care system has to bestudied for all stakeholders? Can the technology be applied in away that there is equal access to those in equal need? How canthis be guaranteed? Could potential discrimination or otherinequalities (geographic, gender, ethnic, religious, employment,insurance) prevent access? Are specific safeguards needed? Howwill possible caregivers’ burden and well-being be influenced?Potential inequalities and discrimination should be justified.

Stakeholderhearing

F0013 Justice and Equity How are technologiespresenting with relevantlysimilar (ethical) problemstreated in health caresystem?

Clearly presenting how relevantly similar technologies are treatedin a health care system may help to adopt coherent and justhealth policies, either by applying past precedents to currentcases, or showing that past cases need reconsideration.Similarity is to be defined individually for each technology. Theidea is to concentrate only on the similarities relevant for solvingthe ethical problems found important for the current HTA project.The similarity may be, for example, of medical, technological,economical, ethical, social, organisational or legal nature.

3 2 Littraturesearch. Expertopinion

Hofmann 2005b Yes

F0014 Rights Does the implementationor use of the technologyaffect the realisation ofbasic human rights?

Human rights exist both in ethics and legislation, most notably inthe United Nations declarations and related statements, like theEuropean Council Biomedicine convention. Basic human rightsare universal and consider the most important goods, protectionsand freedoms. Classes of rights are civil and political rights, socialrights, minority and group rights and environmental rights. ForHTA, perhaps the most relevant are the rights to equality,non-discrimination, safety, adequate standard of living and healthcare. For example: -Right to life, liberty and security of person.-Right to a standard of living adequate for the health andwell-being of himself and of his family, including medical care andnecessary social services, and the right to security in the event ofsickness, disability or old age. -Right of the child to the enjoymentof the highest attainable standard of health and to facilities for thetreatment of illness and rehabilitation of health.

3 3 Literaturesearch. Law,rules andregulations.Expert opinion.Stakeholderhearing

Marks 2004 Social. Legal Yes

F0016 Legislation Is legislation andregulation to use thetechnology fair andadequate?

Technology may lead to ethical problems that make currentregulation inadequate (e.g. ethical reflection is needed whenconsidering what kind of regulation is needed. This considerationis done on the basis and in combination with the legal domain.Emphasis should be put on considering the ethically relevantaspects and consequences of current law, needs for legalregulation that have arisen from the ethical analysis, and a global

2 1 Law, rules andregulations.Stakeholderhearing. Expertopinion

Capron 2004 Legal No


19 of 27 8.2.2011 16:27




assesment of the adequacy of the legislation based on allavailable information.


20 of 27 8.2.2011 16:27


7 Organisational aspects


G0001 Process What kind of work flowand patient flowprocesses are needed?

A new technology could change current work tasks and processes (includingalso quality control). Work and patient processes should be described, and itshould be explained what kind of activities a new technology might replace orreduce in the target organisation. Patient flow and changes required in patientpath should be taken to account when implementing new technology. It isessential to know the change the use of the new technology generates tothe performance of care.

3 2 Systematic reviews (andother studies), annualreports and statistics ofthe hospital, otherqualitative researchmethods

Kristensen 2001,Kristensen 2007

(Currentuse)

Yes

G0002 Process What kind of patient andrelative involvement intreatment or care has tobe mobilized?

A new technology may require changes in the distribution of tasks amongthe people involved in the treatment and care. Patients and their importantothers may be more actively involved in own care and treatment – or tasksthey used to carry out may be taken over by health professionals.

2 1 Kristensen 2007 No

G0003 Process What kind of staff,training and otherhuman resources isrequired?

It has to be clarified what kind of staff is needed, and whether the existingstaff can be trained or extra staff must be brought in. A new technology canbring along the need for extra staff when extending the ongoing activities inthe organisation or when there is a demand for special expert knowledge. Itmust be considered if there will be a need to increase or decrease theamount of the staff. The implementation of a new innovation can meanchange in job satisfaction. It could make some tasks monotonous or bringalong new boring job descriptions. It is crucial that there is not just one personfamiliar with the new technology. If just one person has been trained for anew technology, there is a risk of loosing know-how when he/she leaves theorganisation (or moves to other tasks).

3 2 Systematic reviews (andother studies), reports ofthe hospital or hospitaldistricts and otherqualitative researchmethods

Busse 2002,Kristensen 2001,Kristensen 2007

Description Yes

G0004 Process What kind ofco-operation andcommunication ofactivities have to bemobilised?

The use of technology can presume new co-operation and communicationwith other parts of the structure (e.g. other units) or outside the structure(e.g. other hospitals, pharmacies). The type of technology 'determines' thefrequency of need for information exchange between different actors. Alsointeraction and communication with patients and their important others willchange.


Kristensen 2001,Kristensen 2007,Senter för Medisinskmetodevurdering(SMM) 2003

Yes

G0005 Structure What consequences theimplementation of thenew technology willhave in respect ofdecentralisation orcentralisation?

The location of use of the technology (primary - secondary - tertiary care)could vary between different countries depending on the system oforganisational systems. (De)centralisation could have some economical andqualitative benefits. Centralisation could make a new technology moredifficult to access. For example some expensive technologies are centralizedto tertiary care units.


Busse 2002,Kristensen 2001,Kristensen 2007,Senter för Medisinskmetodevurdering(SMM) 2003

Currentuse,Description

Yes

G0006 Structure What kinds ofinvestments are needed(material or premises)?

The new technology could require many changes in the organisation e.g.premises must be according to the directions of the manufacturer. This couldbe very costly for the organisation. High costs of the new technology can

3 2 Systematic reviews (andother studies), reports ofthe hospital or hospital

Kristensen 2007 Description Yes


21 of 27 8.2.2011 16:27


ID Topic Issue Clarification Im. Tr. Information sources Reference Relations Coreinfluence the decision of purchasing the new technology. It is important toknow which organisation(s) participate in the investments of a newtechnology and to what extent the other organisations take part in the runningcosts.

districts and otherqualitative researchmethods. Informationfrom manufacturers

G0007 Structure What is the likely budgetimpact of theimplementation of thetechnology for thepayers (e.g.government)?

When a new technology is introduced, the question about reimbursementquickly arises. Whenever a technology is reimbursed, there will be an impacton the health care budget. Budget impact analysis examines the likelyimpact of the reimbursement of a new technology on financial outlays fromthe perspective of the payers (e.g. government).


Yes

G0008 Management What managementproblems andopportunities areattached to the newtechnology?

The issue concerns the administrative / managerial questions of the newtechnology: management of resources (e.g. investments), co-ordination (inrelation to different levels), establishment of objectives, monitoring andcontrol, evaluation and sanctioning.

2 2 Kristensen 2007 Yes

G0009 Management Who decides whichpatients are to undergoa treatment and onwhat basis?

Procedurals about decisions about the patients who receive care could vary. 3 2 Systematic reviews (andother studies), reports ofthe hospital or hospitaldistricts and otherqualitative researchmethods

Kristensen 2007 Yes

G0010 Culture How is the newtechnology accepted?

Acceptance should bee looked at by different perspectives: by organisation,by personnel and by patients. A new technology could consist of elementswhich don't suit the image of the organisation. Also, the alternative ways tointroduce a new technology into the organisation could influence problemse.g. resistance among staff and dysfunction of processes. Patients areusually very technologically-oriented. However, patients can resist a newtechnology itself or its implementation. Objective and understandableinformation on a new technology is important.

2 2 Systematic reviews (andother studies), qualitativeresearch methods

Finohta's EUnetHTAworkshop 2006,Kristensen 2007

Ethical,Social

Yes

G0011 Culture How will the otherinterest groups of thenew technology betaken into account in theplanning /implementation of thenew technology?

It may be useful to know who are the possible stakeholders of the particulartechnology, as well as what kind of co-operation there has been and whatkind of interaction is needed. The stakeholders could be e.g. thepharmaceutical industry and companies offering new technologies,authorities (national / regional), administrative parties, municipalities, policymakers / decision makers, staff groups and patient organisation. One canalso ask: Has the patient organisation taken part into the process? Has itbeen involved from the beginning (in the planning) or in the later stages forexample as commentator? Furthermore, it is interesting to figure out whatkind of co-operation exists between hospitals and companies offering newtechnologies and what kind of co-operation is needed.

3 1 Systematic reviews (andother studies), qualitativeresearch methods

Kristensen 2001,Kristensen 2007,Senter för Medisinskmetodevurdering(SMM) 2003

Ethical Yes


22 of 27 8.2.2011 16:27


8 Social aspects


H0001 Major life areas Which social areas does theuse of the technologyinfluence?

Map the major life areas of the patient and the importantothers (family life, day care, school, work, leisure time,lifestyle, or other daily activities), where the technology isgoing to be used or where its use may have a direct orindirect influence.

3 2 Search for or conduct aliterature review or, if relevantdata is not available, conducta primary study; if there's notime for primary study, theopinion of health careprofessionals and contentexperts can be consulted.

Yes

H0002 Major life areas Who are the importantothers that the use of thetechnology may affect inaddition to the patient?

Describe who are the important other people that areinvolved in the use of technology in addition to thepatients (parents, children, friends, people at work placeetc)


Yes

H0003 Major life areas What kind of support andresources are needed ormight be released as thetechnology is put to use?

This issue is about any kind of support and resources(practical, physical, emotional, personal social, nurturing,financial etc.) that need to be mobilized, and organized -or might be released - in order for the patient to use thetechnology with satisfactory results. It covers allarrangements or adjustments that may be needed in themajor life areas (e.g. alteration of special tasks, workingtime, adjustments in the physical environment, emotionalsupport).


ICF(32) environmentalfactors: support andrelationships (chapter 3:e310-399); activities andparticipation, chapter 6:d698, structuralarrangements of patient’senvironment (10, 12, 13)

Organisational Yes

H0004 Major life areas What kinds of changesdoes the use of thetechnology generate in thepatient's role in the majorlife areas?

This issue is about the patient’s social roles and ability tomanage and maintain relations with other people in asocially appropriate manner in major life areas.


ICF(32) activities andparticipation, interpersonalinteractions and relationships(chapter 7, d710-779),community, social and civiclife (chapter 9:d910-d999),(5, 7, 33, 34)

Ethical.Effectiveness,safety

Yes

H0005 Major life areas What kind of changes doesthe implementation and useof the technology mean forthe patients physical andpsychological functioning in

This issue is about the physical and psychologicalconsequences the use of the technology may generatein the patient’s main life areas e.g. on person's bodyfunctions and structures, activities on daily living, orperformance at work, school, home or leisure time. This

3 2 Search for or conduct aliterature review or, if relevantdata is not available, conducta primary study; if there's notime for primary study, the

ICF(32),(15) Effectiveness.Safety

Yes


23 of 27 8.2.2011 16:27


ID Topic Issue Clarification Im. Tr. Information sources Reference Relations Corehis or her major life areas? issue covers whether, from a patient perspective, the

technology leads to improvements or harms (a crossreference to effectiveness, safety domain issues), orgenerates any other unexpected effects on functioning.

opinion of health careprofessionals and contentexperts can be consulted.

H0006 Individual How do patients andimportant others react andact upon the technology?

This issue is about the patients and her important others’attitudes, perceptions, preferences, satisfaction andrelations to the technology. This covers whether, from apatient perspective, any positive or negative issues ariseas a consequence of using the technology e.g. feelingsof unity or empowerment and existential experiences(e.g. insecurity, worries, hope, anxiety, stigmatisation,person's value as a human being or social status,courage to face life, satisfaction, changes inself-conception).


ICF(32) body functions:mental functions (chapter1:b110-b199) environmentalfactors: attitudes (chapter4:, e410-499) , (3)

Effectiveness Yes

H0007 Communication What is patients' andimportant others’knowledge andunderstanding of thetechnology?

This issue explores the patient’s and important others'understanding of the technology in order to describe anddecide what guidance and help (e.g. patient informationleaflets, counselling processes, need of follow upconsultation or help from other professionals) they needbefore, during and after the use of the technology.


Current use.Safety

Yes

H0008 Communication How is the informationregarding the use of thetechnology processed andexchanged?

This issue is about the exchange of information from apatient's perspective. What are patients' and significantothers' questions? How do they receive answers? How isinformation provided and received?


Organisational Yes

H0009 Communication What are the consequencesin decision making?

This issue clarifies the possible implications from thepatient's perspective to decision making e.g. limitations(dependent, passive user) and possibilities (empowered,active user) as a consequence of using the technology.


Organisational.Ethical

Yes


24 of 27 8.2.2011 16:27


9 Legal aspects



I0002 Autonomy of thepatient

Can patientsunderstand theimplications ofusing/not using thetechnology?

It is important to provide information on the (evermore complex)technologies in such a manner that the patient can trulyunderstand it.

3 2 Yes


Are there relevantoptional technologiesthat future patientsshould be allowed toconsider?

The concept of informed consent includes also the possibility toconsider other therapeutic options, if these are available.

3 2 Yes


Is it possible to givefuture patients enoughtime to consider theirdecisions?

It is usually advised that the patient is given some time to thinkover the treatment decision, especially if the decision involvesassimilating complex technical information or a tough weighingof risks and benefits of the procedure. It should be assessedbeforehand if a given technology allows such time forconsideration.

2 2 Yes


Is it possible to obtainan advance directive onthe use of thetechnology?

If it is expected that the technology may be used in anemergency situation in the future it is advised that the patient isconsulted beforehand and her opinion is recorded to the medicalfile as an advance directive on the use of a given technology.

2 1 No

I0009 Privacy of the patient Can the access to thepatient data securedproperly?

At the era of computer-based patient records it is crucial that thehealth care unit has taken appropriate measures to secure thepatient databases. Negligence may lead to liability.

2 1 Directive 95/46/EC Organisationalaspects

No

I0010 Privacy of the patient What levels of accessto which kind of patientinformation exist in thechain of care?

During the therapeutic process many people may either need toget access or semi-accidentally get access to the personalmedical data of patients. The delicacy of the informationdepends on the technology in question. Health care unit mustbe organised so that it minimises the number of people havingaccess to patient data. Also other measures to minimise the riskof information leakage from health care unit must be taken.

1 1 Organisationalaspects

No

I0011 Equality in health care Is the technologyequally accessible to allneeding members in agiven society?

This topic operates both at national and international level. Ingeneral, equality in health care is spoken out in the EU Charterof Fundamental Rights and it is also one of the central principlesof the Biomedicine Convention. In many Constitutions equalityof citizens covers also access to health care.

3 2 EU FR Charter Art 35,Biomedicine ConventionArticle 3, CMRecommendationR (2006)18

Social domain Yes


25 of 27 8.2.2011 16:27




I0012 Equality in health care Is the technologysubsidized by thesociety?

Governmental interventions or the lack of them may affect tothe expected number of patients.

2 1 Societal aspects,organisationalaspects,economicalaspects

No

I0013 Equality in health care Is there a widevariation in theacceptability of thetechnology acrossEurope?

Varying legal regimes may lead to health-care tourism acrossthe borders, especially if the technology in question iscontroversial.

3 3 Europe-wide legalcomparison

Social domain Yes

I0014 Equality in health care Is health-care tourismexpected from/to otherEuropean countries?

Varying legal regimes may lead to health-care tourism acrossthe borders.

2 3 C-158/96 (ECJ),C-372/04 (ECJ),Europe-wide legalcomparison

Social domain Yes

I0015 Authorisation & safety Has the technologynational/EU levelauthorisation?

Patient safety as expressed in product safety is one domain ofhealth care technology assessment which clearly falls under themandate of the European Union

3 3 Safety aspects Yes

I0016 Authorisation & safety Does the technologyneed to be listed in anational/EU register?

A European database of medical devices (EUDAMED) is underconstruction.

2 2 Safety aspects Yes

I0017 Authorisation & safety Does the technologyfulfil product safetyrequirements?

The implication of findings in the safety domain should bediscussed against the relevant European or national legalframeworks to ensure patient safety from using the technology:

3 3 Directive 93/42/EEC,Directive 95/2001/EC

Safety aspects Yes

I0018 Authorisation & safety Does the technologyfulfil tissue safetyrequirements?

Many novel health technologies may utilise human cells ortissue (so called advanced therapy medicinal products). Theseproducts must fulfil the safety requirements issued by ECDirective 2004/23/EC.

3 3 COM 567 (2005)final

Directive 2004/23/EC Safety aspects Yes

I0019 Ownership & liability Does the technologyinfringe someintellectual propertyright?

Issues in this topic are to be considered by the health care unitwhen considering the acquisition of a new technology. Thewording of acquisition contract may affect liability sharingbetween the manufacturer and health care unit.

2 3 Manufacturer,patent data bases

EPO Web site, Europeanpatent convention, nationalelgislation

Yes

I0020 Ownership & liability Does the introduction ofthe technologypresume someadditional licensing feesto be paid?

As novel technologies build up on existing knowledge, the useof the technology may involve the payment of some additionalfees to additional patent holders etc. In principle, themanufacturer should be able to clarify this to the health careunit/health care system in question.

2 2 Manufacturer,patent data bases

Yes

I0021 Ownership & liability What are the width,depth and length of the

The terms of the manufacturers guarantee are of importance tothe health care unit as well as to the society’s health care sector

3 3 Manufacturer Yes


26 of 27 8.2.2011 16:27




manufacturersguarantee?

when considering whether it is economically and/or liabilitywiseadvantageous to introduce the technology or not.

I0022 Ownership & liability Is the user guide of thetechnologycomprehensiveenough?

The wording and clarity of the user guide of the technology canhave legal effects on the liability issues in case the technology isnot working as expected.

3 3 Manufacturer Yes

I0023 Regulation of themarket

Is the technologysubject to price control?

As health care technology is essential to everyone at somepoint in their lives, its pricing may be regulated.

3 2 C-317/05 (ECJ),C-283/03 (ECJ)

Directive 1989/105/EEC Yes


Is the technologysubject to acquisitionregulation?

Expensive technology is subject to acquisition regulation. 3 2 Directive 2004/18/EC Yes


Is the marketing of thetechnology to thepatients restricted?

As health care technology is essential to everyone at somepoint in their lives, the way by which it can be marketed toconsumers may be regulated.

3 2 T-179/00 (ECJ) Directive 1989/105/EEC,directive 1992/27/EEC

Yes

I0026 Legal regulation ofnovel/experimentaltechniques

Is the technology sonovel existing legislationwas not designed tocover its regulation?

Modern biomedical sciences produce novel technologies whichmay not always be unambiguously covered by existingprovisions.

3 1 Yes


How the liability issuesare solved according toexisting legislation?

If the current law does not provide a straightforward answer tothe liability issues it may be advisible to consult a legal expert onthe interpretation of the existing provisions with regard to thetechnology in question. This way the health care unit canprepare itself for the possible future legal proceedings.

3 1 Yes


Are new legislativemeasures needed?

If the existing legislation is not satisfactory the introduction of anovel technology may require new legislative measures. At thelevel of a health care unit this may slow down the introduction,whereas at the level of the society it implies a need to useresources for preparing new laws.

2 1 No


Is the voluntaryparticipation of patientsguaranteed properly?

Use of experimental technologies may not compromise patientsafety. Patients must not be pressured into such treatments.

3 1 Biomedicine ConventionArticle 16

Yes


HTA Core Model® Online | Assessment element tables 7/27 HTA Core Model® Online | Assessment element tables 27/27

ilonen_terhi

Typewritten Text

Copyright 2010 THL/Finohta. All rights reserved. HTA Core Model is a registered trademark.

ilonen_terhi

Typewritten Text

assessment element tables - terveyden ja …meka.thl.fi/htacore/model/ae-tables_intervention.pdf ·...

Documents