FAQ - InCareHeart

00-IPR-2

Could you please further explain what it is understood as “not marketing a commercial application”? Is it understood as making the actions towards the commercialization of the application? Or there is a need of being successful in such marketing actions and get to sell the application?

Large scale promotion, and, if applicable, producing goods and/or service in quantity. So yes, it is understood as making the actions towards the commercialisation of the application, including large scale promotion and, if applicable, the application for certification as medical devices and making contributions to the relevant standards bodies if extension or modification of existing standards, or new standards, if those are required for or would promote exploitation.

00-IPR-1

In which situation is it foreseen that the ownership is transferred to the Buyers Group?

In the FWA, Article 8, 2.7, states that: “the Buyers Group has the right to require the contractors to transfer ownership of the IPRs if the contractors fail to comply with their obligation to commercially exploit the results or use the results to the detriment of the public interest (including security interests).”

This failure is specified as failing “not marketing a commercial application of the results (directly or indirectly, through a subcontractor or licensee).”

00-29

We believe that by developing the user interface and leveraging the already tested algorithm, we would be able to meet the requirements under use case number 9 (MDT decision support). Nevertheless, further validation of the algorithm would be necessary and our main question is, if that could be done within INCAREHEART as part of the proposal?

The solutions will be pilot tested under real conditions in Phase III of the project, however it will not be a clinical trial and most possibly not useful for validating an algorithm. As we do not have any further information on your algorithms, we signpost you to Phase III in both TD1 and TD2.

00-29

On page 25 of the Challenge Brief, when talking about FR10.1 – “Incorporation of patient held devices”, you say: “In relation to devices for monitoring, suppliers will be required to consider innovations from the HSMonitor PCP.”. Could you please specify which innovations you refer to? To our knowledge the results of HSMonitor are not in the public domain, are they?

For the time being, information obtained from the website and the websites of the suppliers of Phase III should be sufficient. Updates on Phase III of HSMonitor are expected to be available online in the first half of March 2022.

00-36

Please clarify further in detail what you mean by: “The financial compensation for IPRs must reflect the market value of the benefits received (i.e., the opportunity that the IPRs offer for commercial exploitation) and the risks assumed by the contractor (e.g. the cost of maintaining IPRs and bringing the products onto the market)” page 40, section 4.4 TD1. Does this concern the financial compensation that shall be given after the project 2024 to the regions involved in the project?

Yes, it concerns a price reduction for retaining the IP.

00-35

Since both of the two solutions will be piloted in all five procurers’ regions in Phase 3 of the project (FAQ 13), and possibly multiple sites at each region (FAQ 32) this also requires adopting the solution for all sites. Roughly this can be broken up into the following tasks 1. Technical integration with the specific systems (e.g. EHR) at each site. 2. Developing, deciding, and describing the process and workflow at each site, including the content (text and other media) that should be served by the solution. 3. Technically setting up the solution to fit process and content from 2. For each of these tasks, which party (procurer or supplier) will be a) responsible for performing it, b) financing it (i.e. should it be included in the price offered)?

1. Performance and financing: Supplier
2. Performance: Procurer and supplier together – Financing: Supplier
3. Performance: Procurer and supplier together – Financing: Supplier

00-34

On multiple questions we are asked to describe how “the proposed solution meets the requirements”. Since this is a procurement of R&D services, the degree to which the requirements are met will vary for our proposed solution considerably throughout the project time. So, to which point in time, or phase, should the description in the reply to the PCP apply in phase 1-3?

Describe the way the requirement is met during the PCP phases.

00-33

To what extent should the written report (abstract) in Phase 1 cover the objectives mentioned, i.e. technical, medical, financial and commercial?

The written report should be a comprehensive summary of your work done in Phase I, and cover all the aspects mentioned. It should lay the ground to assess the work to be done in Phase II.

00-31

If you receive a grant from EIT Accelerator, are you then disqualified from this procurement?

If it would result in a double funding for the solution do be developed: Yes

0-11

Considering NFR13.4, what are the available options for an integration with WINCARE EHR platform? Is there a Web API available or Web Services that would allow an interaction with WinCare? What would be the available data? What would be the data format (e.g. JSON, XML)?

At the moment no API available, intermediator format like CSV or XML required.

Frequently asked questions

This section covers all the questions that we were asked during the OMC. It will be updated regularly with answers to your questions.

The INCAREHEART PCP

© 2021 empirica. All rights reserved. Incareheart has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No. 965134.