Project Overview

Questions and Answers

This section provides Questions and Answers to relevant THALEA-topics and will be updated regularly. If your company or your company representative are not able to attend one of the meetings or information days with Consortia partners regarding THALEA call for tender, you are invited to send an email to our THALEA mailbox, in order to raise questions, comments, or give feedback.

Global project information

 

What does THALEA stand for?

THALEA (Telemonitoring and Telemedicine for Hospitals Assisted by ICT for Life saving co-morbid patients in Europe As part of a Patient personalised care program of the EU) .

Aim of THALEA is to create a Telemedical control-centre software for tele-ICUs capable of capturing workflow-data including physiologic parameters, laboratory results, and current medication - but not limited to those - in order to set up a robust real-time analysis tool enabling telemedical ICU-staff to monitor and oversee an entire ICU patient population. Our goal is to support identification of patients at risk of prolonged ICU stay, organ dysfunction, or death. Thalea is funded by the European Union as part of the Seventh framework programme

What are main objectives of THALEA?

The proposed THALEA project has two main objectives. The first is to solve an important identified need of Intensive Care Unit (ICU) within telemedicine of the eHealth sector through innovative ICT solutions. The second main objective is Pre-Commercial procurement (PCP) process and experiencing the advantages and results of such a process.

What is the main challenge of THALEA?

It is the challenge to develop a prototypical application which enables innovative telemedical control centers to automatic data integration in order to screen larger numbers of ICU- patients.

Which organizations are part of the core consortium?

University Hospital Aachen (UKA) takes part in the project as procurer and project coordinator and leads work packages WP 1, 2, and 7.
The Ministry of Innovation, Science, Research and Technology of the state of North Rhine-Westphalia (MIWF NRW) participates as member of the steering committee.
University Hospital Maastricht (AZM) is involved as procurer in the consortium and focuses on WP 6, together with Netherlands Enterprise Agency (Ministry of Economic Affairs).
Spanish institutions concentrate on WP 4, namely Parc Tauli Sabadell University Hospital (FPT) and the Catalan Agency for Health Information, Assessment and Quality (AIAQS) are part of the consortium, FPT will be procurer.
Hospital East Limburg (ZOL), which fulfils a role as academic partner and as procurer, is responsible for WP 5.
Finally, the Finish Northern Ostrobothnia Hospital District (NOHD) as procurer with Oulu University Hospital (OUH), leads WP 3.

What is a pre-commercial procurement (PCP) process?

According to the EU definition: "Pre-commercial procurement involves direct public R&D investment in the first three phases (pre-commercial part) of a typical R&D project life cycle (Figure below). Innovative Procurement, corresponding to phase 4 in the typical R&D project life cycle, is a very important complement to Pre-commercial procurement to ensure wide take up of newly developed pre-commercial R&D pre-products/services. It is clear that pre-commercial procurement involves a higher degree of risk than Innovative Procurement; both in terms of technological risks (require earlier stage R&D, prototyping, testing, etc) and/or in terms of non-technological risks (more uncertain return on investment period, higher risk of uncertainty in cost estimations, etc). The way to get pre-commercial procurement going is to share, not only the risks, but also the benefits of the R&D between procurers and suppliers."

What are aligned projects of THALEA?

THALEA refers on their website to SILVER and DECIPHER, as they both are European PCP-projects as well.

What is the greatest benefit of THALEA?

THALEA will contribute to personalized health care by means of an ICU telemedicine application. Through PCP, telemedicine on ICU care programs will be more effective and personalized solutions will be feasible. Therefore, it become possible to treat co-morbid patients in a patient oriented way.

How will THALEA change things?

Today no tool exists offering the scope of technical requirements to run a European telemedical data centre. For telemedicine services - especially in the context of ICU care - there is a significant lack of interoperability and standardization between different patient data management systems (PDMS). Therefore, particular systems function in a closed or isolated way which means that all ICUs in Europe act like being on an isolated island. Relevant data is not easily accessible for professionals, which could lead to delay in treatment. In turn, regional or national ICU-telemedicine centers would open a horizon for better care of acutely live-threatened patients all over Europe. THALEA will provide deliverables to solve such problems and by means of that will add societal value.

Which are the intended users of the THALEA technology development?

THALEA technology is intended to be used by European intensive care specialists. 

Where can I find more information or contact details if I have any further questions?

 For more information you can visit our website: http://www.thalea-pcp.eu or write an email to thalea@ukaachen.de.

 

PCP-process/procedure issues

 

How does the THALEA PCP-process look like?

According to official EU publications: "Pre-commercial procurement is an R&D procurement of the type 'public service contract' because it refers to acquisition of knowledge – collected by the supplier by carrying out intellectual investigation services (R&D services) consisting of critical solution analysis, prototyping, field testing and small scale pre-product/service development – with the objective to prove the feasibility or unfeasibility to transform a technologically innovative idea into a first working batch of pre-commercial volume and quality pre-products/services according to the requirements in the tender specifications. As the definition of R&D services in the Directives ranges from 'research (laboratory) services' through 'experimental development services' up to 'design and execution of research and development', the R&D public service contract can cover all three pre-commercial phases of the typical R&D project life cycle." THALEA will run a single PCP call which will be disseminated by contacting regional and national networks, authorities, and by using European "Tender electronic daily (TED)". An open, transparent, and fair competition is ensured in this joint PCP. Successful bidders will receive a contract which clarifies all relevant issues during THALEA PCP-process. It allows companies to participate in the first phase of THALEA and provides the opportunity to reach the following phases as well. For a more detailed description of phases see  below.

What kind of organizations or companies are allowed to participate in the PCP?

All European companies and organizations developing technologies in the e-health and telemedicine sector are invited to participate within THALEA. Non-European companies are invited as well, if they perform at least 51% of their research and development activities for development of a THALEA solution in Europe. Furthermore, all companies and organizations which present a satisfying proposal and which have also the ability to develop such technologies are invited to join. No matter of their size. It is also possible for companies to form consortia in order to deliver a proposal which fulfills the previously defined functional specifications of THALEA Consortium.

How many phases are there and what do they require?

THALEA´s PCP-process will include three phases of solution development. In the first phase five selected suppliers (which got selected based on their submitted proposals, which were written and submitted before start of phase one: so to say phase zero) have to present their feasibility studies. Three of those will be selected to attain the second phase, in which prototypes will be developed and presented. The two most promising prototypes will reach phase three, which deals with development of a pre-production model. 

What is the basis for selection of the five contracted companies?

In the current phase (phase zero) companies will receive relevant information about requirements and functional specifications of THALEA solutions. This information should be used to develop a proposal which presents a convincing solution design to the THALEA Consortium. This proposal will be used to select five companies which will be the contractual partners during phase one of THALEA´s PCP-process.  

What is the duration of each phase?

The first phase of THALEA PCP-process will last for six months and is expected to start around end of April 2014. Phase 2 will have a duration of 12 months, which leads to November 2015 as presumed end point. The last phase or third PCP-process phase will last for six project months, according to THALEA´s preliminary project plan.

Is it possible for bidders to step directly into phase two or three?

No, this is not possible. Selected suppliers are obliged to start in phase one and follow through the process of stages. The second phase will be reached if the proposal get selected by the consortium as one of the three most suitable proposals. Only two suppliers will get selected for the third and last phase of THALEA PCP-process. 

Is it possible to reduce the amount of selected suppliers within one phase of PCP-process?

No, it is not possible to reduce the number of selected suppliers within or during one phase. If for instance in phase one, five companies are selected, five companies will end phase one. 

How much money is available for each stage of the development?

The stages are described in detail on yhis website. However, according to the preliminary planning each of the selected supplier will receive a certain amount of money per PCP-process phase:

  • 40.000 € for the first stage
  • 200.000 € for the second stage
  • 375.000 € for the third stage

Will the money be paid before or after product development?

All contracted companies will be paid according to a milestone payment in which a certain amount of money will be paid per milestone in accordance with the project plans of the companies.

Will the medical data interpretation be available during the project from consortium partners?

Yes, this kind of information will be available from consortium.

Will the proposals be public?

No, proposals submitted by companies will not be public. They will be dealt with as confidential and will only be discussed inside THALEA consortium.

When will the THALEA product book be available?

The product book will be available during spring 2014. 

When will the evaluation criteria be available? What will be the emphasis of criteria?

During the next months, evaluation criteria will be published together with the THALEA product book on this website

Is there an obligation for companies to provide information on their earlier experience of ICU system development?

There is no obligation to provide this kind of information. If companies have experience in this field, of course it can be communicated. However, the goal is to find the best solution for the THALEA consortium, independently of past experiences of companies. But the capability of companies and organizations to deliver adequate quality of solution designs and solve possible problems should be considerable. In addition, the THALEA consortium follows strict non-discrimination politics. 

Which regulations do apply to the THALEA PCP-process?

Of utmost importance is compliance with regional, national, European standards of patient rights, ethical principles and European civil rights as privacy, security of personal data, and ownership of data. This becomes possible due to a close adherence to current EC directives. The Public Procurement Directives, 2004/18/EC and 2004/17/EC provide the legal bases under which PCP is covered. PCP is an R&D procurement that is considered as exception to the Public procurement Directives and WTO’s definition of Public Procurement and State Aid.

 

Medical issues

 

What is the definition of “intensive care” in various countries within the EU?

Intensive Care is defined as care for patients with one or more acutely threatened or disturbed vital functions. These patients are in need of continous monitoring. Intensive care is given in a dedicated Intensive care unit, by trained medical specialists and specialized nurses.

 

Technical issues

What are the main challenges with current systems?

Currently systems providing an overview over more than one ICU are lacking. As Tele-ICU is a new field lacking interoperability of different PDMS systems in terms of e.g. interoperability, comparability of data, almost proprietary data base models, and seamless data procession are perceived as major obstacles. Systems work as isolated systems, are not connected, and difficulties in providing consultation occur.

What are the required measurements from patients?

These shall be finally defined in the first phase of PCP together with suppliers. The THALEA-product book will contain most of the planned measurement definitions. For the different phases a defined set of measurements will be published in order to ensure a fair and transparent competition. Applicants shall demonstrate their way of how to deal with integration of future measurements. Maintenance and license costs will be part of the evaluation matrix.

What is the size of the planned pilot run?

System shall be piloted in five university hospitals. Countries are Belgium, Finland, Germany, the Netherlands and Spain. Demonstrator products have to be capable to demonstrate provision of functionality in different countries in a rotating test scenario.

Who will take care of system administration?

System administration shall be handled independently within hospitals. There has to be an administrator role available. During the competition, the participants will be responsible for the installation of the THALEA solution/ software. However, industry has to provide demonstration hospitals with hardware, e.g. rented by themselves. Otherwise hospitals would be forced to invest in hardware for the evaluation process which is not foreseen in budget scheme.

What kind of interfaces do current ICU PDMS systems provide?

Knowledge about current interfaces of ICU PDMS systems should be an integral part of interested companies, due to the fact that it is an important prerequisite to participate as potential supplier. However, examples for interfaces from a semantic point of view are HL7 or ADT and from a technical perspective Ethernet or RS 232.

How many interfaces are there for different Hospital Information Systems?

Focus is on medical relevant data, and a limited administrative set of data. Medical data and laboratory data will include vital signs, microbiology test results like culture results, antibiotic susceptibility testing results, results from blood count, clinical chemistry, radiology. As some of finding are expected to be plain language rather than defined code, text analysis or a search for keywords in findings could be useful. For instance, in Oulu, ICU PDMS has approximately 15 interfaces (invoicing, medication, laboratory results, microbiological findings, etc.)

What is the aimed (software) platform of THALEA System?

The aim of THALEA is to develop such a software (platform). However, if a company already developed a comparable software this one could be used as a basis on which THALEA specific features are build and developed. But it has to be stated that an already existing software solution has to fulfill functional specifications of THALEA as well. Companies are invited to present a convincing solution design in their proposal including or excluding already existing software. 

What is the minimum amount of information that needs to be available in ICU cockpit/regional level Cockpit?

This information is described in functional specifications.  Furthermore, the regional level cockpit is thought as a natural consequence of developed THALEA software on a local level. It could function as a sort of dashboard for regional or national level. Stimulation of such development might be interesting for industry and European PCP-approach itself.

What are the required response times for THALEA system?

Technical issues will be left to industry. However, a minimum frequency of 15 minutes for input and a maximum of about 15 minutes response time are intended.  

How fast has the data got to be available from the server and how long can it take to load new information?

It is expected to have the data in real time.

Will there be different user profiles to the system? e.g. doctors, nurses, senior intensivists?

Due to differing access and user rights of named medical professions there is a need to have different user profiles.

Is the PDMS data adequate for treatment? Do patient history, laboratory results, medication etc. have to be known?

A linkage to different hospital information systems is needed.

Which patient information is displayed in THALEA System?

Basic patient information is required and will be listed in the THALEA product book. Permission of displaying information in THALEA is needed. If permission is given, information can be accessed externally. Although, only anonymous patient information is displayed in THALEA software for external partners. Internally regular patient information is accessible.

How will patient data information security be ensured?

Applicants have to demonstrate their approach to ensure data information security.

How is consent management taken care of?

Consent management is managed locally, an lies in the liability of local hospitals. 

How are different treatment processes evaluated?

Treatment processes are related to data export services and then evaluated regarding realized actions, given medication, or comparable information. One example of a collection tool is 'Intensium', which collects data of ICU patients which can be evaluated afterwards. 

What treatment processes are considered important per country?

This information is stated in the functional specifications

Is it possible to utilize open source components in the THALEA solution proposal?

Yes, this is possible. Also, the commission has shown a strong interest in prototyping open source software.

Is it possible to include commercial solutions in THALEA solution proposal?

Yes, this is possible.

Is THALEA a “medical device”?

Due to the fact that THALEA software will support medical decision making by consultation of experts it can be seen as a medical device. 

How are you going to ensure that required data outputs are available from current PDMS systems? (For example, there should be a data pipe open from Clinisoft)

Main technical objective is that applicants demonstrate their ability to get data out of PDMS systems irrespective of manufacturer, brand of local configuration. Start dialogue with manufacturers

How relevant are reference cases/solutions from previous medical device development?

Reference cases would be useful because they demonstrate knowledge and skills of participants. However, the Thalea consortium acts according to a strict policy of non-discrimination and the very idea of a PCP as a search for the optimal solution.

Shall the THALEA System write data into Hospital Information System?

At the moment, the THALEA system is planned to collect and display data from various systems. It shall not be possible to make e.g. drug prescriptions in the THALEA system. However, a definition of very limited writing into source systems (PDMS) is in work. This limited input could be for instance progress notes of Tele-ICU center specialist or the writing of hand-over notes for other shifts in the center. 

 

THALEA PCP-workshop 31-3-2014

What is your vision of communication from cockpit to ward?

Several options are possible. One option could be via teleconference or via a screen. The communication needs to be twofold; aiming at ICU registry on an EU level and supporting colleagues to enhance quality of care for individual patients.

Who “sits” in the centre?

An intensive care or ICU specialist sits in the centre, but the ward is responsible.

And why is the specialist not responsible for care?

The specialist is not responsible for care because of legal reasons. It is not our scope to replace or change responsibilities and basically it is not possible from legal, medical, and ethical perspective. The specialist functions as a second opinion for 24/7, which is highly effective and will provide a lower rate of mortality (see study of Lilly, 2014 now published in CHEST). 

There is a database for drugs but not for ICU data?

There is no EU database, but there is a huge potential.

What is the content of phases?

The First phase contains the solution design. The second phase is the transfer from design into a prototype, and the third phase leads to a pre-series model of the product.

Do you have to work with hospitals or with Patient Data Management System manufactureres?

There is no obligation to work together with one of those or both. However, in the end you need convincing solutions, which can be developed alone or in teamwork with potential partners. You are free to have conversations with hospitals and contact with patient data management system manufacturers. It is crucial that you show show how you will get data out of PDMS.

Do we get a list of patient management data system manufacturers?

No, that is part of your own research. The system should be generic in order to adapt to changes in PDMSs. You should cover 75% of PDMS.

Is the result of phase one just a white paper?

Yes, a convincing white paper is crucial as well as a convincing and solid presentation. This will be basis of the decision making process in phase one.

How to get in phase two? What are the steps to be done?

An evaluation of proposals will be done by expert reviewers.

What are the dates and times?

We will prolong the time since it is very short.

Is it allowed to form a consortium with a university?

Yes, whatever you think is possible or target oriented. It is not possible to cooperate with the participating hospitals and agencies from THALEA.

Is there support in forming consortia?

Yes, we will publish contact information on our THALEA website, for companies who would like this service.

Are consortia of only research organizations possible?

No, there has to be a producer in the consortia.

Are you interested in a brand new product?

No, but our specific function has to be addressed and it has to be a generic, open solution.

What is the duration of the phases?

phase 1:  4 months

phase 2: 12 months

phase 3:  6 months

What about the maintenance costs etc?

The maintainance costs are a part of the project.

Do we need different languages?

This is up to the suppliers, and part of your proposal.

To what extend are the participating hospitals involved in telemedicine?

The participating hospitals are experts in intensive care medicine and provide tele-medicical applications also in the field of intensive care medicine.

Can the consortium assist in the form of consultation from the participating hospitals?

No, this is not possible due to a potential conflict of interest.

Should Thalea be a self-learning system? Is self-learning obligatory or desirable? 

The system should support the physicians and the patients .

How do you take care of human factors and patient safety?

The Thalea consortium is responsible for the evaluation of the proposals. In the evaluation, there will be attention for human factors and patient safety by experts.

Is it possible to participate in more than one consortium?

No this is not possible, due to conflict of interest.

 

THALEA PCP-web conference 02-04-2014

Can you give an example of population based pattern recognition?

Concerning the epidemics of SARS, we looked at patterns in the EU-wide history. We looked e.g. at the patients travel and at the current failure of lung functions. Then, this information was tested by the pattern recognition analysis. Retrospective data analyses and pattern recognition could be more reliable for care of patients. Also clinical trials are very evident because of their pre-selection and inclusion criteria. Most importantly you can find patterns in real time data as well.
What we have in mind for future and upcoming events is detecting a common pattern in history, e.g. for organ failure, lung function etc. This could then deliver clues for diagnosis. If we can detect these patterns by software, this would be a great improvement for patients on the ICU .

Will the porposals be treated confidentially? 

Results of evaluation will be shared between consortium and EU-commission. The results are totally confidential. The details about confidentiality will be given in the legal framework contract. The process and evaluation will be a negotiated procedure. We will use knowledge to give feedback for the next phase in order to get optimal solutions.

When the solution is available, do we have the possibility to test it on real patients?

Yes! It will be done by rotating installation in the consortium hospitals. Every hospital has its own speciality and will test it in its own environment. By a rotating test scheme we want to demonstrate interoperability (which is more technical) of the solution. Also, we want to demonstrate usability and want to look whether there are positive effects in other countries because all environments are different.

 

THALEA PCP-web conference 04-04-2014

What is the Role of Aachen? And who is responsible for the management and coordination? 

The management and coordination is part of University Hospital Aachen acting as coordinator of THALEA. However, decisions will be taken in close cooperation with the consortium as a whole. The blue area in the picture below shows the CSA part of the THALEA project.

What is the main goal and what should be the result, a scientific data base or a learning system?  

The most important goal of THALEA is to save the life of more patients, by an enhanced guideline adherence and better pattern recognition.
Main objective is to provide a panoramic overview over physiologic parameters, derives scores, trend parameters and workflow in order to provide a second security network for remote ICU-patients. As one of the challenges seems to be semantic interoperability between systems it will be a small step to come from real time monitoring and decision support to an anonymized European ICU-outcomes registry.
Thalea is no learning system in the sense of an educational software.

Should the system be able to accommodate to new guidelines?

Implementation of new guidelines is necessary. Later on from the THALEA real life data additional evidence for development of guidelines can be derived. Furthermore, development of new guidelines could be a possible feature of your solution. However, you are the specialist and you should create your own idea in order to convince consortium of your proposal. Implementation of new guidelines or treatment paths should be manageable by an interested user by means of a graphical user interface by a modular set of functions, Boolean operators and rule sets.

Are hospitals without PDMS excluded? Can hospitals only participate with their PDMS?

The intention is to give the opportunity to include as many hospitals as possible. Suppliers are in charge of developing a system or present their ideas of how to include hospitals without PDMS systems.

What are the next steps for us to take? 

First, suppliers have the opportunity to get in contact with other companies to build a consortium. This is not mandatory, but could be a reasonable step. When suppliers decide not to form a consortium, they have to wait for the call for tender and could start brainstorming about possible solutions. There will be functional specifications given in the call. Thereafter, suppliers can start writing a convincing proposal. Before phase one, the Thalea consortium will evaluate all tenders and decides (on pre defined evaluation indicators) which tenders get to phase one.