FAQs

A1: That is perfectly OK, as long as you are compliant to the framework of the patient safety and regulatory issues in each procurer country as well as applicable EU laws related to the user testing as well as clinical evaluation procedures required both for MD-ISO 14385 and proper consent with regards to the GDPR accordingly. Please bear in the mind the goals of data sharing in the CRANE vision. We will eventually clarify this further in the tender documents

A2: During the CRANE tender execution it is not planned to happen any specific integration with the IT systems of the procuring organizations.
The way that the data from the citizens participating in the Phase 3 validation will be incorporated into the CRANE Open Platform will be discussed with the bidder organizations during the co-design process in Phase 1.

A3: The focus is self-management support for chronic patients.

A4: Complex patients are not part of CRANE desired solution, considering complex to patients with more than one pathology.

A5: Yes, we believe it is needed a consortium in order to cover all range of expertise and capabilities demanded in CRANE. However note that this is not a requirement.
About the needed technologies: Core technologies from the very beginning: Virtual lake and myHealthEnabler related technologies. Then in addition we expect some services to be included related to the Use Cases, including motivation and behavioural change; self-management for the three pathologies. And then the local support for the community care/engagement. The rest is up to the bidding consortium to propose how it will manage that and show a viable plan for it:
For example we believe it will be needed companies answering on building trust and creating a viable business. Third party advanced solutions for self-management we expect them to be integrated during the validation phase, but not need to be part of the core consortium/to be develop in CRANE.
Also note that it will be possible to subcontract non-core activities during the course of the project as needed in phase 2 or 3.
Note also that all bidders, but specially those designing and implementing the data sharing architecture and virtual data lake concept are expected to have deep knowledge, compliance to and understanding of gpdr, the data governance act and all related regulations to data privacy.
The key profiles are already incorporated in our matchmaking tool.

A6: We welcome Open Source but we cannot put it as compulsory requirement in order not to stifle innovation. What is compulsory is to expose Open APIs/Interfaces, so that your solution can be interoperable with any other in the market and we avoid any vendor lock-in.

A7: The only limitation is that at least 50% of the research has to be done in European countries.

A8: There is not trademark associated to CRANE.

A1: The main IP belongs to the suppliers. There can be some specific cases of shared IP with the promoters but the main scenario is that the IP will be property of the suppliers.

A10: We do not have a specific stance related this topic. The best solution to our needs and requirements is what we look for.

A11: There is no defined stance about this. We are open to the best solution. Of course you need to comply with whatever applicable regulations to your solution.

A12: We have no a specific stance related to this topic. We are just selecting the best solution for the needs and requirements of CRANE.

A13: A local partner will be needed for the validation phase. But we do not need to know it until the end of Phase 2 when you present the plan for the full development of the validation. So, local partners will not be needed from the very beginning of the project and they can be added later.

A14: For each of the Phases there will be milestones and deliverables agreed on a contract calendar. The payments will be linked to achieving the related milestones and the deliverable of results being approved.

A15: Secondary use of data is part of the overall concept behind CRANE and CRANE permission wallet (MyHealth Enabler) will be one of the key pieces for it to happen. Note that at this moment (more information will be available on the tender documents) we are not requesting any specific demonstration about the secondary use of data in CRANE during the project timeline execution.

A16: For the Validation Phase (Phase 3) the Garden of care concept is involving local stakeholders and it should be able to be demonstrated that they can be a provider of activities that improve health. But this needs then to be proposed/taken into account during the prototyping phase as well (Phase 2). And it needs to be included in the detailed plan (outcome from Phase 1).

A17: For Region Västerbotten: This solution for sharing data between stakeholders is something that we need very badly and that we have been working in it for many years. We are now in the process of moving healthcare services closer to the patient and in their homes. In this context we see that CRANE is solving the need of being able to share data among different patient care services. So if a solution is developed in CRANE that can be roll out in large scale for broader use that would be very interesting for Region Västerbotten to use (no commitment for purchase being made here at this moment). We expect to be able to move into a PPI with the data collected from CRANE for a more wider roll-out and scaling up.
For Agder Region: In Agder we expect to benefit from CRANE project being able to combine health data from various sources in order to better serve the citizens, specially with regard to the increasing elderly population. Also we hope to be able to further integrate our already existing solutions for the management of chronic patients into a future CRANE solution. This is the perfect timing for CRANE in Norway due to the government backup of the CRANE concept of moving care closer to the patients and their homes. CRANE is also aligned to the high digital skills of the patients in Norway.
For Extremadura Region: It will depend on the outcome of the project. Note that in Extremadura we have right now a strategic plan for the management of chronic diseases with is very much aligned to the objective and scope of CRANE. Moreover the Use Cases in CRANE are the more prevalent and most costly chronic conditions in Extremadura region, so the results of CRANE project are very much expected to improve the value base delivery of services to the patients in the region and have a high chance of being acquired (no commitment being made here) after the project ends.

A18: We expect that the technologies part of CRANE solution are starting at a TRL 5-6 and ending at TRL 8. We do not expect these technologies to be developed during CRANE but to be integrated/taken advantage.

A19: Spanish goverment, national and regional, is highly digitalised. Citizens have a regional health digital ID. Altough we have 17 regional healthcare systems in Spain, with diffrente healcare information systems, the NHS in Spain has a single EHR: https://www.sanidad.gob.es/en/profesionales/hcdsns/Accesos_HCD_SNS.htm that can be accessed by the citizen with its personal id.

A20: BankId concept is not used to access other external to bank services in Spain. Some banks integrate in their apps and platforms other banks accounts (and there are other apps integrating all). You can only visualize, but not operate in the case of a bank. Only operation through the bank account. For the healthcare information systems in Spain, you can see the information (https://www.sanidad.gob.es/en/profesionales/hcdsns/Accesos_HCD_SNS.htm) in all regions but operation is only allowed directly through the regional healthcare system.

A21: Prevalence and availability of self-management solutions as well as availability at regional level of target groups of patients and professionals willing to engage in CRANE project.

A22: The choice of the patient groups is final and there will not be an opening at a later stage to include other targets. The patient groups are: COPD, CVD (hypertension and ischemic heart disease) and Diabetes (type 1 and 2).

A23: It is not foreseen to look for other patient target groups in the course of CRANE project (although there are part of the overall concept). IBD is not a selected Use Case for CRANE tender.

A24: No, there is no requirement set on what should be the Use Case to be validated in the prototype phase (Phase 2).

A25: We want the bidders to describe/propose their potential business models behind CRANE concept and payment models for a health data-sharing platform. From the perspective of the Public Administration we expect to be able to implement these services in the future through a scale-up process (potentially a PPI, no commitment being made here about this happening). Also we will obtain as project result a set of value-based output indicators, that will be needed in order to apply for a subsequent CRANE scaling up phase and some percentage of the payments will be linked to these indicators. In addition there are many other potential actors and stakeholders that could become part of CRANE ecosystem and related business models, but it is up to the bidders consortium to propose how they want it to be tackled.

A26: They are currently being elaborated and will be shared in advance/as part of the tender documents. Value-based indicators are expected to be part of the selection criteria for the different phases. Part of the selection criteria will be the innovation, credibility, capacity, etc of the proposed bid and the consortium behind as well as its capacity for the long term sustainability and market uptake after the project end. Some selection criteria will be mandatory to comply and other will be open on how to address them.

A2: R&D programmes/public funds cannot fund twice the same work or/and work that is already done. Same development cannot be funded twice.

A28: The same general answer of A26 applies. The same consortium can apply to several PCPs, developments and results from other projects can be used in CRANE, the same bidder can be in more than one consortia, as long as the same work is not funded twice.

A29: From the 18th of May until the 15th of June 2022, it was possible to have a 1-on-1 meetings for bilaterally discussing with CRANE consortium any doubt or question about the upcoming CRANE tender, to be requested through the CRANE website.

A30: The core idea of CRANE PCP is to have the same solution that can be validated for the three procurers with the local adaptations and customized local services as needed. This will be possible during the tender since no integration with the health/social IT systems of the procuring organizations is expected to happen. During the co-design process in Phase 1 it will be discussed with the bidder organizations how the health data from the participant patients in phase 3 will be made available and integrated in the CRANE platform.

A31: After the PCP the CRANE procurers will have lots of data and results in order to define the final and real specifications of the CRANE product to be scaled up. The natural step will be then (no commitment being made here at this moment) to move into a PPI (Public Procurement of Innovative Solutions), that is an instrument though to be applied after a PCP, where the technology is there but is not fully industrialized/developed at scale.

A32: The procurers will provide patients for each of the selected pathologies and their data and the test sites (how exactly this will happen will be discussed during the co-creation process in Phase 1) as well as clinical assessment by professionals of the Insights data provided by the CRANE solution. Note that during the CRANE Tender it is not expected that the IT systems from the procurer regions will be integrated.

A33: In the tender documents it will be clear the mandatory parts and the extra/additional parts what will score higher in the evaluation. Some flexibility will be allowed in order to open for innovation/ideas and adapt to the local needs.
The core parts will be of course mandatory to deliver (this includes the concept of the data lake and the personal health permission wallet).

A34: Extremadura: The procurer is the Regional Ministry of Health, social services that will be directly involved. Similar for the Health and care system it will be directly involved, providing all the needed resources. And then we will have also the municipalities participating. In CRANE two municipalities will engage (Jarandilla y Villanueva de la Vera) that will provide social services.
Region Västerbotten:Two different municipalities involved from Social Services side and in addition Home Care Services (from National Swedish scope). Municipal nurses (including with medical nurses) will be mainly involved along with the patients that are potential users of CRANE. It will be mainly primary care (doctors and nurses) the involved actors in the validation (this also included the chronic conditions patients). Being able to share patient data between health and social care services is one of the main reasons of our involvement in CRANE.
Agder Region: We have done in the past years many projects cooperating in telemedicine and telehealth and then the team around CRANE project, both health providers and patients is huge apart from our gained experience. Moreover the timing for CRANE is perfectly in line with the message from our government to bring the hospital out to the homes and to our need to share the patient data.

A35: This is one of the core value propositions of CRANE, to drive an interoperable infrastructure for self-management of chronic condition patients able to support the analysis of anonymised data by data driven algorithms.
All of it done in an ethical transparent, legally compliant right way.
The core idea of AI is the more well described amount of solid data surrounding the Use Case, the better the results will be.
From the CRANE project we provide the framework for this to happen. It is then the bidders to propose how this will be actually happening and implemented.
We do not really want new services applications to be developed but new functionalities to be added to the available service applications.

A36: We have a contract obligation with the European Commission and an ethical commitment for all the CRANE tender process to be transparent, clear and accountable in all phases.
All information being made available to any bidder or company will be available through our website, which is our main contact point.

A37: We require that all the bidders start from Phase 1. It is not possible to apply directly to Phase 2 or 3.
Moreover we do not expect at components of CRANE solution to be at the same TRL, but we expect all of them to have reached TRL8 by the end of the tender Phase 3.

A38: We welcome these results to be integrated/part of CRANE solution, but note that their development/costs cannot be charged to CRANE twice. CRANE is an R&D procurement project where with public funds it is paid the development of a customized R&D solution to public needs. So it is not a classic tender procedure where a gain margin can be included. Only the real costs borne in the project will be 100% paid.
We must guarantee fair competition and we will not make any alliance or commitment to any previous, ongoign or future R&D project.

A39: The CRANE TD2 tender document, chapter 2, contains a reference architecture, technical objectives, expected functionalities and key concepts from the CRANE model and vision that can be used in order to design the proposed solution. Chapter 4 contains the deriving technical applicable requirements.

A40: The role of the supporting organisations is to help the procurers to organise, define the CRANE scope and requirements and support them in the overall PCP organisation.
They cannot apply to the tender process.

A41: We aim to publish CRANE call for tender on the 31st of August and have it open for a minimum of 60 calendar days.

A42: We are open to receive the best solution and improvements to our current ideas. The requirements to comply will be functional and they will not impose any technical solution. The same applies to the CRANE technical architecture.

A43: We expect that you integrate in your consortium entities acting as service providers for self-management for the targeted pathologies and that they already provide the needed apps.
Although it is not excluded we do not expect that the needed apps for the self-management of the chronic conditions are part of the undertaken works in the CRANE PCP.

A44: Yes they are. During Phase 1 it will be designed the specific way that they will be tackled in each of the locations and what data will be available in the validation Phase 3 from the participating patients. During Phase 2 one of conditions is to be demonstrated under Lab conditions. In Phase 3 the three conditions are to be demonstrated in the procure regions real environment.

A45: The core focus of CRANE is the citizen self-management of its chronic condition. During the CRANE tender execution, no integration with the procurer IT systems is expected to happen. But relevant data on the patients should be provided to the health/social personnel who oversee the patients during the validation Phase 3, so that they are able to evaluate the solution for its future integration in their integrated care models.

A46: Yes. In addition we also expect apps/services that cover motivation/coaching of the patient.

A47: No. That part is out of the scope of CRANE. If needed for your service it should have been carried out in advance.

A48: During the tender execution integration with the IT health/social systems of the procurer regions is not required to happen (although it will be welcomed given the case). The way that data from the patients taking part in the validation will be incorporated to the CRANE platform during the Phase 3 validation will be specifically discussed in the co-design process in Phase 1 between the procurer and the bidder organizations.

A49: No. In the tender specifications we will be requesting functionalities to comply, but the actual technology to use is up to the bidders to decide.

A50: Yes. We are looking for a self-management solution, which includes self-monitoring as well as self-care. And in addition coaching/motivation to the patients will be a part of it.
Moreover remember that our focus is the patient. We are not looking for algorithms for diagnosis by professionals.

A51: It is expected that the bidders provide the data generated through the self-management services and also have access to/provide other health data sources. For the validation in Phase 3 the data from the participant patients will be provided. The way this data will be integrated will be clarified during the co-creation process in Phase 1.

A52: No. This is in fact one of the cornerstones of CRANE concept. Data rests where it is created. We are not building a data repository/copying data, but a system that allows accessing and to the patient data with privacy and security guarantees