Frequently asked questions
Find below Frequently Asked Questions collected during the eCARE Open Market Consultation (OMC). The answers provided represent the joint position of the four eCare procurers to their best knowledge at this point in time. This page will be continuously updated to include new questions and their answers.
Q1. Does the eCare project assume an age limit for patients from which screening should be performed?
The eCare procurers do not foresee to set a limit regarding the age of patients who must be screened.
Q2. Will eCare tool services also support formal or informal carers or both?
eCare solutions must account for both informal (updaid) and formal (paid) carers. More information on this matter is available via the use cases published in the Challenge Brief.
Q3. Who is the main recipient of eCare services apart from patients?
Apart from the frail adults, the stakeholders to be addressed by the eCare solutions are:
- Informal caregiver: a relative without formal training who helps with the activities of daily living
- Formal carers: a caregiver who is paid to provide professional care to an individual or group of individuals
- Healthcare Professional: one who provides health care treatment and advice based on formal training and experience.
- Social Worker: one who aims to improve people’s lives by helping with social and interpersonal difficulties, based on formal training and experience
- Emergency Services: organization that responds to and deals with emergencies when they occur
Q4. Should the recruitment of patients enable their self-registration in eCare or should the recruitment of patients be coordinated by formal caregivers?
The self-registration in eCare may be possible but an activation/validation of the process by the healthcare or social professional will be needed. In the description of the use case 0 is stated: Each Procurer will have an overall administrator who can create new healthcare professional and/or social worker profiles. Healthcare professionals and/or social workers register new older adults and their caregiver into eCare. More information on this matter is available via the tender documents.
Q5. Is it possible to demonstrate reference implementations of projects in the field of senior telecare, e.g. patients with multiple diseases, as part of the offer to participate in the eCare project?
Yes, demonstrating reference implementations in the field is always a strength in a proposal and the eCare procurers encourage participants to do so. As part of the OMC, we invited potential suppliers to tell us more about their previous experience or existing solutions using the supply-side OMC questionnaire https://ecare-pcp.eu/omc
Q6. Are there any requirements as to the form of design development? i.e. what design methodology (UML, BPMN) and what design artifacts are to be created.
There is not a design methodology pre-established. The suppliers are encouraged to propose innovative approaches to tackle this challenge. When doing so, suppliers must take into account the need for interoperability, flexibility, and scalability; as well as the cost-effectiveness, sustainability, and affordability of the solution in terms of both purchasing prices and maintenance costs.
Q7. Whether there are or will be criteria for the evaluation of the eCare project?
The evaluation and eligibility criteria will be published in the Call for Tenders. The Consortium is in the process of designing such criteria.
Q8. In addition to psychosomatic factors, such as depression or the weakness syndrome, is the system supposed to also cover the management of the patient’s condition in the field of coexisting chronic diseases, such as diabetes, cardiological diseases or oncological diseases?
Frailty management, prevention and detection should be the goal of the proposed system. The solutions could cover the management of the patient’s condition in the field of coexisting chronic diseases, but it isn’t the project focus.
Q9. Are there any algorithms – what data are to be based on – for the early detection of weakness syndromes or will the development of these methods also be the subject of a study?
One of the challenges of the project is to create holistic, and responsive technology solutions for frailty detection. Including or not algorithms as part of a better methodology for the screening and identification or pre-frail status in older adults should be decided and offered by the suppliers to the extent that they consider it valuable within the solution. There are already some instruments that address frailty detection and which suppliers can build upon such as FACET system, FraylSurvey, FRAIL or Perssilaa.
Q10. Does the project take into account the role of informal caregivers (family, volunteer work) in patient health management when self-management of the health by the patient is not possible? If so, to what extent?
The main focus is in self-management/empowerment/capacity building, although the caregiver role must be considered to obtain better overall results in terms of independent living. See question ID:Q2.
Q11. Do I understand correctly that the supplier will be independent in carrying out the analysis and product discovery process and in developing the optimal product concept for the target group?
Based on the requirements and conditions stated in the request for tender documents (results expected, progress monitoring,milestones…), suppliers are encouraged to propose innovative approaches to tackle this challenge.
Q12. Regarding the question about informal Caregivers, does the system is also required to support Caregivers, e.g. in terms of the CSS Burnout Factor (Caregiver Stress Syndrome)?
Caregivers are not the main target users of the solution, although any improvement to the system that will have an impact on the delivery of care to older adults is welcome (nice-to-have as opposed to must-have).
Q13. What interface is expected on the patient side? Weak and frail people or the so-called may have communication problems through ICT e.g. a keyboard or is there a voice interface expected to be incorporated in the final solution?
This is an important issue. The solution has to keep in mind the barriers of technology for all the actors involved. The solution must ensure user engagement and ICT acceptance to promote independent living, taking in account the existing multidimensional barriers (e.g sight, hearing, cognition, motricity, etc)
Q14. Should the contractor provide a complete solution as part of the project, including tele-technical infrastructure, or maybe one of the Partners will provide the contractor with access to the systems and infrastructure?
The contractor should be able to provide a complete solution. Suppliers must indicate the design for the final solution, defining the technical infrastructure needed. During the pilot phase procurers are in charge of any infrastructure needed.
Q15. Did I understand correctly that the budget planned for, for example, the 1st stage can be divided into e.g. 8 partners, but equally well for 6, if only 6 proposals are worthy of attention? At the same time, does this mean that some complex proposals may not be funded for a specific stage?
For phases I and II contracts will be financed until the remaining budget is insufficient to fund the next best tender. The exact number of contracts finally awarded will thus depend on the prices offered and the number of tenders passing the evaluation. The lower the average price of tenders, the more contracts can be awarded. As the leftover budget from the previous phase will be transferred to the next phase, the total budget available for phases 2 and 3 may eventually be higher than stated here (but the maximum budget per contractor for phases 2 and 3 will remain the same).
However, the total value of the contracts awarded can also be lower than initially expected if there are fewer tenders than expected that meet the minimum evaluation criteria.
Maximum phase total budget: €392,000
8 suppliers expected to be funded [minimum of 3]
49.000 € maximum allowed price for each supplier and phase
Maximum phase total budget: €1,960,000
4 suppliers expected to be funded [minimum of 3]
490.000 € maximum allowed price for each supplier and phase
Maximum phase total budget: €1,568,000
2 suppliers expected to be funded [minimum of 2]
784.000 € maximum allowed price for each supplier and phase
Q16. Will information be shared – what companies are participating in the dialogue to be able to find out about solutions and possible technological partnerships?
A matchmaking tool is available on the website (https://ecare-pcp.eu/matchmaking/). The companies featured there are currently interested in finding partners to create consortia to participate. Have a look if they complement your profile and get in touch with them using the given contact details. If you want to be on the list, please register by filling in the OMC supply-side questionnaire.
Q17. I am in the UK (Brexit). Will I still be able to participate?
Participation in the tendering procedure is open on equal terms to all types of operators from any country, regardless of their geographic location, size or governance structure. However, there is a requirement relating to the place of performance of the R&D services. At least 50% of the total value of activities covered by the framework agreement must be performed in the EU Member States or H2020 associated countries. The principal R&D staff working on the PCP must be located in the EU Member States or H2020 associated countries.
In terms of the UK, scientists, researchers and businesses can continue to participate in Horizon 2020 as if the UK remained a member state for all H2020 projects (here).
Q18. Does the solutions have to meet all the requirements/use cases or only some of them?
Unless explicitly stated otherwise, all requirements are mandatory and must be fully complied with.
Q19. The test in the 4 procurers, does it have to be in parallel or will it be sequential?
As long as they comply with the established deadlines there are no restrictions of any kind. However, it will be necessary to carry out planning in accordance with the procurers.
Q20. For the tests, are cloud solutions accepted? Or should it be implemented/spread onsite in the 4 sites?
There are no restrictions about how the solution is implemented. On premises deployment should be checked for each procurer separately according to their preferences.
Q21. In terms of the Intellectual Property rights, as it is an innovative public purchase and part of an European program, to whom does the rights of the developments belong?
The PCP is an action from procurers to improve the solutions of the market and they have no intention to hold the IPR. However, preferential conditions should be offered to procurers. See details in section 2.7 of ‘TD1 – Call for tenders’ document.
Q22. How many subprojects do you have in mind to release in the tender?
We do not use the term subprojects and we are not sure we have to elaborate a proper answer. The proposal must be complete for each phase. We will not split each tender phase into several. There will be only 3 phases, one single call for tenders for each phase. If the word ‘subprojects’ can be understood as ‘offers’, each phase has a number of contracts to be awarded, see Q15.
Q23. Would we have the chance to do focus group sessions with end-users in the procurer’s countries?
If the contractors deem those focus groups necessary for testing the solution, they must include them in their proposal explaining reasons and objectives and how they will contribute to improve the solution. Besides, focus groups with end-users have already been conducted by the procurers and the results will be made available for your convenience.
Q24. I would like to know if the wanted technological solution has to be (or should be) linked to professional services or is it a solution that addresses itself all the objectives? I ask because it includes psychological and emotional support topics.
A global solution is sought. The internal way in which the solution is structured, providing a comprehensive service or relying on other external services is part of its design. Logically, the viability of the proposed solution will be evaluated and, if the proposal reaches the pilot development phase, the proposed approach will be validated. If one of the proposals has services associated, we will evaluate the technology and the service as a whole.
Q25. Do the developments have to offer support in the four languages?
The languages required are those of the procurers (Italian, German, Spanish, Catalan) and English.
Q26. Do we have to present it in paper in Italy?
No, an electronic submission platform will be made available.
Q27. Do you foresee the implication of the clinical part, such as primary care or geriatrics units in hospitals within the management of frailty?
For the solution the consortium envisaged a shared care planning, in this sense it follows an integrated and person centred care approach where both social and healthcare professionals may play a role in the management of frailty. However, among the procurers there are partners with a clinical profile and partners with a social health responsibility profile. Procurers cannot guarantee the involvement and implication of any external entity. The exact actors to be involved at each site are described in the tender documents.
Q28. Do we have to pilot the solutions with the 4 procurers? Or some of them only? In our case, will it be in Santander and Catalonia or only one of them?
The pilot should be implemented and carried out in 4 procurers sites.
Q29. Would it be appropriate to offer connectable gadgets (hardware) to evaluate the frailty or to improve the autonomy of the users or only software solutions are expected?
As far as the tender requirements are fulfilled there are no restrictions from the side of the procurers on how the solution is designed. A combination of both seems to be a good approach. Suppliers have to propose the solution that better fits with the needs and challenges described in the request for tender.
Q30. I understand that several services are based on data already collected in the regional health services, for example, the evaluation of the frailty and the characteristics of each person in UC1 and UC2. Can we count on the availability of the health services to access real or fictitious data on their EHRs from the very beginning, in order to develop and evaluate predictive models?
Each procurer has a series of data available according to their profile (social or health organisation). These data can be made available to the proposers in compliance with the established data protection rules and any other requirements that the procurer may establish. Specific agreements may need to be made with each procurer based on their own specific procedures and regulations. The data and profile of each procurer will be detailed in the tender documents.
Q31. How is the evaluation process between the phases? I mean: will it be the people who give feedback at the end of the phase, the same people evaluating the proposal for the next phase? If not, how will you avoid the incoherence that may occur between the difference of criteria among those who give feedback during execution and external consultants who haven’t been during the execution process of the project?
The intention is to maintain the same evaluation committee during the whole process. The 4 procurers will be directly involved and lead the process. The committee will apply the evaluation criteria stated in the request for tender document. It will be able to review specific issues with external experts but final decisions will be made by the committee.
Q32. Are you planning to define financial guarantee criteria for eligibility keeping in mind the total amount of the call? Do you have an estimate of the amount if you were like this?
There is no financial guarantee criteria established for adminisibitily. The aim is to facilitate any entity, mainly SMEs, to access the call for tender.
Q33. Is it mandatory to submit the supply-side questionnaire to participate in the tender?
No, participating in the OMC is not mandatory for participating in the tender. However, submitting the supply-side questionnaire helps the procurers to fine-tune the final requirements according to the market. So, it is much appreciated and highly advisable for the suppliers.
Q34. Regarding the approach to the solution (hardware level): one of the key points to take in consideration would be the use and knowledge of certain technologies by the target (old people, who normally use little technology or not use any). Have you considered any preference regarding the gadgets to whose it may be the solution oriented (e.g. smartphone, tablet, PC…). At hardware level, are you foreseeing the provision of the gadget to the end-users inside the amounts of the call?
Design preferences are not established, however, the acceptance and engagement of the solution by older people is one of the challenges that the solution must face (see Q13). If the solution proposed includes gadgets/devices, they have to be provided by the contractor. Besides, if the solution involves the integration and use of devices which correspond to the definition of Medical Device provided for by Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, they must be certified.
Q35. Can you please specify more the kind of patients? As an example: oncological, chronic… etc.
Patients who are pre-fail and frail, having or not chronic diseases. Here you are the definition of frailty agreed by the consortium to be used throughout the project: “Frailty is an age-related state of decreased physiological reserves characterized by a weakened response to stressors and an increased risk of poor clinical outcome. Frailty predisposes falls and fractures, disability, dependency, hospitalization, and institutional placement, and ultimately leads to death. It can be preceded by, but also occurs in the absence of, chronic disease. According to some authors, this clinical condition results from decrease in reserves across multiple physiological systems that are normally responsible for healthy adaptation to stress. Alternatively, it is considered that frailty is due to critical accumulation of dysregulation in important signalling pathways and subsequent depletion of homeostatic reserve and resilience. Other authors describe this state of increased vulnerability as being associated with the reduced capacity to compensate ageing-related molecular and cellular damage. Independently of pathophysiological conceptualization, it is assumed that frailty is a dynamic process that leads to a spiral of decline in various functional domains and that exacerbates risk of geriatric syndromes”
Q36. Although we have the drafts of the use cases, I would appreciate it if you could briefly describe in your words how you see the solution, from the perspective of potential users: elderly people (pre-fragile and different degrees of fragility), carers (formal / informal)
A disruptive solution that allows to prevent and manage frailty, by encouraging elderly people to live independently, detecting and preventing loneliness and isolation, promoting healthy habits and exercise. The solution must progress on the development of the state of the art on ageing, frailty, and integration of care. Issues such as user-centered care interventions, holistic approach, psychosocial factors, stakeholder’s engagement and empowerment, continuum care across a range of health and care services are the “must” of the solutions to be developed.
Q37. Just to confirm, the 8 suppliers selected will be at european level? Including the 4 sites?
See Q15. Also note that:
- Eligibility criteria for the proposers will be explicitly stated in the tender documents.
- The number of proposals to be funded is an indication, not mandatory, and will depend on the number of proposals received and their quality and price according to the specific budget allocated for each phase. The proposal selected will be for the whole project, it means, including the 4 sites.
Q38. For the frails, even “non-technological”, we have solved the communication problems for Home Assistance through the home TV. See video at the link https://youtu.be/GLlkWAIiXb4 Can this new technology be useful to you too, adaptable to every chronic condition?
The technology to be used is up to the supplier as long as it meets the challenges, requirements, and uses cases stated in the request for tender documents.
Q39. Is there a single supply of integrated solution, or several different supplies, to be integrated later? Are there any reference times and budgets for the various supplies?
The call for procurement is for a single integrated solution. You can check the expected time per PCP phase and budget in the tender documents.
Q40. Would the solution be considered as a Medical Device?
As eCare is a pre-commercial procurement for the research and development of an integrated “non-commercial” solution, the certification of the components as Medical Devices (MD) is not required at this stage. Certification as a medical device is necessary for large scale or commercial use, which is out of the scope of eCare PCP. Obviously, if the solution involves the integration and use of devices, already on the market, which correspond to the definition of MD provided for by Regulation 2017/745, they must be certified.
Q41. The solution is aimed at the kind of frailty you have clearly described. Does it not therefore extend to other types of problems linked for example to the concept of fragility understood as non self-sufficiency? I mean blind or disabled people for example
Non self-sufficiency is one of the possible factors of frailty but cannot be understood as equivalent to frailty. The scope of the tender is clearly linked to the definition of frailty stated in the project (see Q35). Additional problems, diseases or conditions could be faced, as long as it does not interfere with the frailty challenges and unmet needs defined in the tender. Therefore, the solution must be clearly focused on frailty and its main consequences for older people.
Q42. I understand that there will be specific calls to respond to?
There will be a single call for procurement for phase I. Those awarded in phase I will be the only eligible for the next phase. To sum up, the PCP process has three phases: I (solution design), II (prototype) and III (field-testing). To participate in phase II it is mandatory to be awarded in phase I. To participate in phase III it is mandatory to be awarded in phase II.
Q43. Would it be an added value to involve other vulnerable groups, for example?
The target group are the pre-frail/frail old adults with emphasis on those that feel lonely and/or isolated. See Q35 to understand the frailty definition adopted by the procurers.
Q44. In order to be able to aggregate more interested parties, is it possible to have the list of interested parties (participants in this meeting)?
Due to personal data protection restrictions we cannot provide that information. However, companies interested in finding partners to create consortia and jointly participate in the eCare PCP tender can register in our matchmaking page: https://ecare-pcp.eu/matchmaking/
Q45. A list of Italian companies interested in creating partnerships/consortia for the eCare PCP project will be published? These projects are strong if presented with more companies
Companies interested in finding partners to create consortia and jointly participate in the eCare PCP tender can register in our matchmaking page: https://ecare-pcp.eu/matchmaking/
Q46. Can health professionals and universities be present in the consortium? Is there a limit to the number of consortium partners? What is the submission deadline?
There will be no restriction regarding the profile of consortium partners. In fact, multidisciplinary teams are valuable.
There are no restriction regarding the profile of consortium partners. In fact, multidisciplinary teams are valuable.
There is no limit to the number of consortium partners as long as there will be a single contact one and the feasibility is assured by sensible coordination by the partners forming the consortium.
In terms of planning, the submission deadline is the 15th september 2021 at midday.
Q47. As for interoperability and integration with the application infrastructures of the 4 procurers, any documentation will be available?
Detailed information of procurers existing systems is provided in ‘TD2 – Challenge brief’ document. As a general approach, it is expected that the solutions meet international interoperability standards.
Q48. How many languages does the solution need to be developed in? Should interoperability with the procurers be effective with the EHR / PHR?
For this project the scope in terms of languages must be English and the procurers official language (Italian, German, Spanish, Catalan). See Q25.
The proposed solutions must be interoperable with the procurers’ EHR / PHR (see draft use case UC6.1). The detailed requirements and information of procurers existing systems will be described in the tender documents. Of course, it is expected that the solutions meet international interoperability standards.
Q49, Is it required/preferable that companies from more than one of the 3 European countries directly involved in eCARE be part of any proposing groupings?
There is not any requirement regarding the composition of the consortium of suppliers (if they decide to apply in group). However, regardless of their country of origin, suppliers must be able to provide the solution in the languages of the procurers (Italian, German, Spanish, Catalan) and English (see Q25). Besides, if selected, suppliers will have to conduct the pilots in the procurers’ organisations, where end-users are not able to speak English.
Q50. Did the list of companies interested in creating partnerships / consortia derive from joining this webinar or is it necessary to register in another way?
Q51. In fact, I meant precisely for the final phase of Real World Evidence for the Research and Demonstration of the results of the project. So in the third phase will it be possible to work together also in third-party structures or in any case in shared laboratories?
Proposers must include, consider and budget in their proposal all the needs and facilities they need. Procurers cannot guarantee that any third party laboratory or facilities will be made available.
If you plan to subcontract third parties:
- there are restrictions on the allowed amount(s) that can be subcontracted;
- there are provisions of national law that apply to subcontracting;
- there are parts of the contract that can be subcontracted
In any case, the contractors remain fully liable to the procurers for the performance of the contract (and this is the reason why subcontracts must reflect the rules of the H2020 grant agreement, including as relates to the place of performance, the definition of R&D services, confidentiality, results and IPRs, the visibility of EU funding, conflicts of interest, language, obligation to provide information and keep records, audits and checks by the EU, the processing of personal data, liability for damages and ethics and security requirements). See ‘TD1 – Call for tenders’ and ‘TD4 – Framework agreement’ for more detailed information.
Q52. So when is the expected date for the publication of the call for tenders?
The publication of the call for tenders was planned for March 2021. However, the tender launch was delayed to the 1st of July 2021.
Q53. Can a consortium of suppliers change? Is it possible, for instance, to add a new member from phase 2 to phase 3?
The request for tender will specify this information in the section “3.1 Eligible tenderers, joint tenders and subcontracting” of TD1 – Request for tenders. While these conditions are maintained, there is no special restriction for changing members and/or suppliers along the phases.
Q54. Please kindly elaborate what are the financial and employment criteria required by the Supplier to be successful.
The request for tender will specify this information in the section ”Eligible tenderers, joint tenders and subcontracting”.
Q55. Could you all please further explain the role that Jaggaer will have in the project? In addition, will part of the budget need to be saved for their participation?
Jaggaer is the coordinator of the project, giving support to partners, monitoring the project progress and being the link with the PO and the European Commission. Besides, Jaggaer will be in charge of the e-tender platform. No budget has to be saved for its participation. Jaggaer is funded by the European Commision, as are the rest of partners in the eCare consortium.
Q56. Can you please specify the type of assistance/support that the technical supporting organizations will be providing?
Supporting organizations (Jaggaer, SCMA and TBM) are supporting the procurers in the different phases of the PCP process, revising the documents and templates. Besides, Jaggaer will be in charge of the e-tender platform and TBM is in charge of the OMC Phase, with support from all the partners.
Q57. Kindly define independent living. Does it include no further use of pharmaceuticals? Or you would prefer the client to remain dependent on medication?
“Independent living” means having every opportunity to be as self-sufficient as possible, and so living autonomously, having opportunities to make limited decisions and activities in the same way as non-frail people. This does not imply independence from drug or rehabilitation therapies.
Q58. Those fragile, could also be due to disease, accident etc. Fragility can also be extended to the younger patient, instead of restricting to specific ages. For example, those with asthma could be any age, who might be reliant on medication,
unable to live a normal life.
Frailty should not be confused with Impairment or disability. Please refer to the frailty definition adopted by the procurers (see Q35).
Q59. Whilst contemplating on marketing/recruiting patients/clients/actors to the e-Care project, I ask the question, who identifies and recruits patients? Could I for example in the UK, trial on patients here?
Procurers identify and recruit the patients in each site. Conducting a trial on patients from other countries is up to the supplier, but this is out of the scope of the PCP, and will have to be conducted with the supplier’s own means.
Q60. Due to now country lock down we/I will be unable to travel. Would this be a problem?
Exceptional circumstances in each moment will be treated following law and regulations. Besides, a potential lockdown should be seen as a risk to be taken in account by suppliers. In this sense, countermeasures should be defined to mitigate its impact, whilst complying with the contract.
Q61. Are there some templates for the proposal preparation and a summary for all the documents that we need to prepare?
Proposals templates will be made available to suppliers when the Call for Tenders is launched. The tender will be managed by an eTender platform. A manual is available.
Q62. Does the supplier have to be a company to be able to apply for the tender? Are non-for-profit associations eligible? Can applications be individual or do they oblige to a consortium of institutions?
Suppliers must have a legal entity, but they do not necessarily have to be for-profit. Therefore, non-for-profit associations are eligible. Besides, eCare is welcoming individual or joint tenders, as long as all the requirements published in the Call for Tenders are met.
Q63. Should we need to include a clinical partner (due to the crucial need to be provided with clinical knowledge namely about frailty syndrome assessment) or would that clinical knowledge be provided by eCARE partners?
Clinical knowledge of frailty and, in general, any other knowledge to design and develop the solution, must be provided by the supplier. The involvement of a clinical partner is not mandatory, but the supplier must demonstrate in the proposal that it has the necessary knowledge to meet the requirements (clinical, social or any other).
Q64. Has the buyers group changed?
Yes. Due to internal adjustments to answer the challenges posed by the COVID-19 pandemic, Falkiewicz Specialist Hospital has decided to leave the project. The tender requirements will of course exclude the need to make the solutions available in Polish and to test them in Wrocław. Falkiewicz will not participate in the evaluation of offers.
Q65. Could you please clarify the level of the procurers’ involvement when it comes to generating and validating clinical/socio-sanitary content?
Here we have doubts regarding the level of involvement the procurers would have when it comes to various use cases involving both clinical and socio-sanitary scenarios, specifically:
1. UC1 – Detecting frailty and pre-frailty in Older adults
2. UC2 – Matching older adults´needs, preferences and limits with existing care pathways
3. UC4.1 – Providing psychological and emotional support
4. UC4.2 – Managing functional decline
5. UC5 – Increasing the skills of Older adults, their caregivers and care professionals
Once we have a fully formed understanding of the procurers´ respective roles during the project we will be able to more effectively complement our current competencies as a consortium with a final partner.
The field-testing study protocol will be defined by the group of procurers. This protocol will describe the study aims as well as its primary and secondary objectives. Besides, the procurers will also establish the recruitment process. The field-testing validation will be implemented in a coordinated way between the social /healthcare procurers and the contractors. Further details, including how procurers will implement the field-testing, are provided in the Tender document.
At this point, we can describe generally the users expected to be involved at each site:
- ASL BN: old adults, caregivers, health care professionals, social care professionals, social care volunteers, project managers/facilitators, IT Managers.
- CSI: old adults, caregivers, health care professionals, social care professionals, project managers/facilitators, IT Managers.
- UKA: old adults, caregivers, health care professionals, project managers/facilitators, IT Managers.
- SDR: old adults, social care professionals, social care volunteers, pilot managers, old adults’ relatives, IT manager
Q66. Do you have any information about e-sign for the submission process? Is it applicable for non EU countries? (For example Turkish entities)
The e-signature process is not done through the platform. The platform will validate that the documents have been signed electronically, but the process of signing itself has to be done outside the platform. You should sign your documents electronically, with your usual e-signature application, and then upload them to the platform. A manual will be provided with this information and support will be available.
Q67. Phase 3 is for a total duration of 3 months for 4 procurers. Would this mean 3 month of piloting at each site? Or this would be an implementation in parallel at each pilot site? 4 sites accessing at the same time to the pilot, during 12 months?
The third phase will last 12 months and during that period the suppliers should provide the solution for the 12 months in each pilot site.
Q68. Where will the call for Tender templates be available?
Everything will be available on the eCare website. There will be a specific section in the website for the call for tenders where you will see all the documents, including the templates you will need to use. And this will link to the e-tendering platform where you should upload all the documents.
Q69. Is it necessary to include in a consortium from the beginning the possible partners in the local regions for the assistance during the final implementations, or can these be engaged during the other phases?
You will be able to modify the consortium composition in the subsequent phases. The door is open to include different organisations in the joint tenderer in each phase of the Call for Tenders
Q70. I think that the question about the participation of non-EU entities has not been addressed. Is it always true that some work can be done outside the EU provided this does not exceed a certain percentage?
Yes, there’s a requirement that at least 50% of the research and development services have to be performed in member states or in Horizon 2020 associated countries. If you’re not a member state or an associated country, you will be able to participate if you conduct at least 50% of the research and development services in Europe. You can participate in consortiums with other EU member states and associated countries.
Q71. When will the pre-commercial consultation be launched?
We conducted an Open Market Consultation from October to December. The call for tenders will be published in July.
Q72. Previously, we already discussed the importance of integration and interoperability with the local HISS and systems from the procurers, for the success of this type of solution. Would this be included in the scope? Would there be a definition of all the systems, standards or interfaces required in the scope of the Call for Tender?
During the call for tenders we will share general information about the system the procurers are using in the pilot sites, the state of the art in each hospital and the healthcare facilities. Besides, awarded suppliers during the different PCP phases, will have the chance to visit the sites of the procurers to gather as much information as possible. We’re looking for an integrated solution, so integration with the pilot site system is important, as well as interoperability and the availability of international standards.
Q73. Do you plan to launch a PPI after the PCP?
The procurers are open to launch a PPI if the results of the PCP are satisfactory. However, note that the launch of a PPI eventually does not mean that the providers selected are those that have participated in the PCP. The PPI is open to the whole market, not only for the PCP participants.
Q74. Can you please list again the countries and the languages where the solution will be tested?
The selected solutions will be tested in the procurers countries: Spain, Germany and Italy. In Spain we have Consorci Sanitari Integral which is based in Barcelona and therefore the solution should be available in Italian, German, Spanish and Catalan.
Q75. I am interested in this PCP and I already read at the FAQ. I also read the #40 and it is clear but I would like to know something more on how the new MDR will impact the PCP and in particular the PHASE 3. Should we foresee to arrange a pre-market clinical investigation? Who will be the sponsor of the pilot, according to the MDR definition? Should we also consider a budget for an insurance during the piloting phase?
As eCare is a pre-commercial procurement for the research and development of an integrated “non-commercial” solution, certification of components as a Medical Device (MD) is not required at this stage. Therefore, during phase 3 of the PCP there is no provision for a clinical investigation to be carried out in the pilot phase (i.e. first in human feasibility, early) pursuant to art. 62 of Regulation (EU) 2017/745. Nevertheless, the field testing of the prototypes could be conducted as a pilot clinical investigation, and so typically as an early-stage clinical investigation. Therefore these pilot clinical investigations must be designed in compliance with the ISO 14155: 20207 standard.
NOTE: In general, pilot stage clinical investigations are designed to enrol a limited number of subjects to assess a device early in its development phase with respect to the initial clinical safety andperformance (e.g. device functionality). The results of this kind of clinical investigation may guide further device design modifications or provide further information for the design of a subsequent clinical investigation. The outcomes of an early-stage clinical investigation can often support further development and iterative changes to the device. The data generated in pilot stage clinical investigations are in general insufficient to CE mark the device.
Q76. How can I contact the eCare team if I have a question regarding the eCare Call for Tenders?
The questions and clarifications related to the call for tender must be submitted in writing and in English through the messages section of the e-Tendering platform before 23rd of August 2021. Any question received after that deadline will not be answered. Questions must be submitted in English only. The summary of all questions and answers will be presented anonymously and will be regularly updated on the FAQs section of the eCare website. The last version will be available by the 1st of September 2021.
Q77. We downloaded the full eCare tender documentation and I wonder whether TD3, the tender forms, will be made available in EDITABLE formats. I would definitely appreciate the availability of an editable version as this would allow for accuracy and compliance of formats. And it would save a lot of time to all procurers, like us, who would spend hours in ‘simulating’ the formats of the tender documents.
The eCare PCP Call for Tenders is available through the eCARE eTendering PCP Portal (https://ecare.app.jaggaer.com/web/login.html), an online collaborative tool between buyer’s group and suppliers. You have to register and upload the data directly on this platform. Some questions are answered directly in the platform, others can be prepared freely offline and uploaded as separate pdf documents: no specific formats are needed for most of them, so you can create your response to each criteria freely. Those documents from the TD6 that do require a specific template have been made available in editable formatWe hope this clarifies your question. If you have any issue regarding the process, please send your questions through the platform before the 23rd of August.