#  Deliverable Description

This document is a deliverable of the STARR project, which is funded by the
European Union’s Horizon 2020 Program under Grant Agreement #689947. It is a
follow-up to Deliverables 1.6 and 1.7, which described what data the project
would generate, how they would be produced and analyzed. The following
deliverable also aims to detail how the data related to the STARR project will
be disseminated and afterwards shared and preserved.

#  1\. Scope of the document

The STARR project Data Management Plan (DMP) primarily lists the different
datasets were produced by the project, the main exploitation perspectives for
each of those datasets, and the major management principles the project were
implemented to handle those datasets.

The purpose of the DMP is to provide an analysis of the main elements of the
data management policy that were used by the consortium with regard to all the
datasets that were generated by the project.

As mentioned in the previous versions of this deliverable, the data management
plan covers the whole data life cycle.

_Figure 1: Steps in the data life cycle. Source: From University of Virginia
Library, Research Data Services_

#  3\. Responsability for the data  
  
<table>  
<tr>  
<th>

**Person in charge of the data management during the oroject**

</th>  
<th>

Margarita Anastassova (personal and non-personal data)
_margarita.anastassova@cea.fr_

Franziska Boehm (specific focus on EU regulations about personal data
management) _franziska.boehm@kit.edu_

</th> </tr>  
<tr>  
<td>

**Partners’ reponsability**

</td>  
<td>

Every partner is responsible for the data they are collecting. This is valid
for both personal and non-personal data. The data has been collected,
combined, stored and transmitted according to the relevant national, European
and institutional regulations. As far as the management of personal data is
concerned, the partners were supported by FIZ Karlsruhe, providing guidance on
personal data management in an EU perspective.

</td> </tr>  
<tr>  
<td>

**Data management policy**

</td>  
<td>

All personal data collection in STARR was done within the remit of formal
ethics clearances obtained at our testing sites and granted by the relevant
university and/or local health officials. Thus, any patient-related data, such
as data from pre-exiting health record data and behavioural data depicted, for
example, by keyboard presses, video, audio, motion tracking falls under the
ethics clearance. Some nonpatient data, such as requirements from stakeholders
in WP3, in the form of anonymous questionnaire responses & focus group
opinions, can be gathered more informally.

The legal basis for the personal data processing is the participant’s consent,
obtained in accordance with the rules to which the collecting partner is
subject.

The most relevant standards regarding data handling, in this experimental
context with patients, concern the area of ethics, data protection and
privacy. They are listed below:

\- Directive 95/46/EC: Protection of individuals with regard to the processing
of personal data and on the free movement of such data.

</td> </tr> </table>  
<table>  
<tr>  
<th>

</th>  
<th>

-Directive 99/5/EC: Radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity. 

  * Directive 98/44/EC: Legal protection of biotechnological inventions. 

  

  * Art. 7, 8 Charter of Fundamental Rights 

  

  * Art. 8 European Convention on Human Rights 

  

  * Case Law by the European Court of Human Rights 

  

  * Documents of the Aricle 20 Working Party 

  

  * Ilves report on E-health 

  

  * GDPR regulation (2016/679). 

  

  * Draft data protection regulation. 

  

All of our patient data is reported as anonymized group summaries in the
project deliverables and in peer reviewed publications. Anonymous individual
quotes describing requirements are also be used in these reports. During
system evaluation, user performance data (e.g. task execution time and number
of errors) is transient and context sensitive (to the particular task, sensors
and user). There is no public value in the data and hence no foreseen need for
public access beyond that of the therapist. Nonetheless we have no objection
in principle to releasing this data in the spirit of Open Access if requested.

</th> </tr>  
<tr>  
<td>

**Ownership and access to data**

</td>  
<td>

A consortium agreement was negotiated and signed by all the parties in order
to inter alia specify the terms and conditions pertaining to ownership, access
rights, exploitation of background and results and dissemination of results,
in compliance with the grant agreement and Regulation n°1290/2013 of December
11th, 2013. The consortium agreement was based on the DESCA Horizon 2020 Model
Consortium Agreement with the necessary adaptations considering the specific
context and the parties involved in the project. Its basic principles are as
follows:

\- The parties exhaustively identified the background intellectual property
they brought to the project, and assessed its availability for access rights
as regards to potential third parties’ rights over such background;

</td> </tr> </table>  
<table>  
<tr>  
<th>

</th>  
<th>

  * Ownership of results including joint results generated by two or more parties goes to the party(ies) having generated such results; 

  

  * The owning parties take all appropriate measures for the protection of the results capable of commercial or industrial exploitation, notably through intellectual property rights when relevant; 

  

  * The parties use their best efforts to exploit and disseminate the results, either directly or indirectly, for instance by out-licensing said results; 

  

  * Each party gives access rights (through licenses) to their background and results to the other parties for the implementation of the project and/or for the exploitation of those other parties’ own results (under fair and reasonable conditions). 

  

Knowledge management follows the strategy presented in the Figure below. The
IPR activities are organized according to the different project phases.

In principle, Foreground is managed according to the provisions of the
European Commission, and the access to the foreground created throughout the
project lifetime is specified by the Consortium Agreement. As a general rule,
the foreground is considered as a property of the Contractor generating it,
and in this sense the originator is entitled to use and to license such right
without any financial compensation to or the consent of the other
Contributors. In case of licensing to third parties, the Contributors shall be
informed in advance and appropriate financial compensation shall be given to
them. Starting from these

</th> </tr> </table>  
<table>  
<tr>  
<th>

</th>  
<th>

basic rules, other particular situations have been treated in WP9
(Dissemination & Exploitation):

  * If the features of a joint invention, design or work are such that it is not possible to separate them, the Contributors could agree that they may jointly apply to obtain and/or maintain the relevant rights and shall strive to set up a joint exploitation agreements in order to do so; 

  

  * An originator of the foreground could decide not to seek protection of its Foreground. In this case, another contractor interested in such protection might apply for it, advising the other Contractors. In case several Contractors are interested, an agreement is necessary between them. 

  

Concerning access rights, each Contractor shall take appropriate measures to
ensure that it can grant Access Rights and fulfill the obligations under the
EU Contract. The Contractors agree that Access Rights are granted on a
nonexclusive basis, and that, if not otherwise provided in the Consortium
Agreement or granted by the owner of the Foreground or Background, the Access
Rights does not include the right to grant sub-licenses. The Consortium
agreement has one section or one appendix to define which access rights to the
background may be granted. Access rights to foreground and background needed
for the execution of the project are be granted on a royalty-free basis to the
project partners.

Publication and dissemination of foreground are granted with the approval of
the Consortium, making sure that the period of secrecy needed for IP
protection is respected. Contractors have to inform the Consortium and the
Commission of its intention to publish on its foreground. Adequate references
to the Contract with the EC shall be given in the publication. Publication can
be impeded if another contractor can show that the secrecy of the foreground
is not guaranteed.

</th> </tr>  
<tr>  
<td>

**Publication of research data**

</td>  
<td>

Since in STARR certain research activities rely on the processing of personal
data of stroke survivors, the privacy and the protection of their personal
data should be ensured. However, this does not exclude the publication of
aggregated, properly anonymized data, e.g. in statistical form. In this way
both the privacy of the stroke survivors are respected and scientific results
can be disseminated

</td> </tr> </table>

#  4\. Data set description

The project partners have identified the dataset that was produced during
different phases of the project. The list is provided below, while the nature
and details for each dataset are given in the subsequent sections.  
  
<table>  
<tr>  
<th>

**Data set name**

</th>  
<th>

**Personal identifiable data**

</th> </tr>  
<tr>  
<td>

**Type of data**

</td>  
<td>

Name, gender, age, marital status, deprivation index, hand dominance,
educational level, type of job, hobbies, socio-familiar support

</td> </tr>  
<tr>  
<td>

**Format**

</td>  
<td>

Documents (paper and digital such as Word documents or Excel sheets),
pictures, audio or video recordings, inputs to the STARR application

</td> </tr>  
<tr>  
<td>

**Source**

</td>  
<td>

This data comes from:

  * Questionnaires (paper originals, responses captured in an Excel spreadsheet), analysis (e.g. charts) within the spreadsheet 

  

  * Interviews transcribed to Word documents 

  

(anonymized), analyzed data from the interviews

  * Focus groups: discussions transcribed to Word documents (anonymized), synthesis of themes captured in Word documents 

  

  * Consent forms: signed paper documents 

  

  * Inputs to the application 

  

  * Video or audio recordings of user testing and studies 

  

  * Pictures from user testing and studies 

  

</td> </tr>  
<tr>  
<td>

**Reuse and sharing**

</td>  
<td>

Only relevant anonymized and aggregated data are transmitted and reused by the
partners not collecting the data.

</td> </tr>  
<tr>  
<td>

**Diffusion principles**

</td>  
<td>

Within the consortium only respecting the limitations mentioned above.

</td> </tr>  
<tr>  
<td>

**Scientific publications**

</td>  
<td>

No personal identifiable data was used in scientific publications.

</td> </tr>  
<tr>  
<td>

**Relevant documentation**

</td>  
<td>

Personal identifiable data was not used in any documentation.

</td> </tr>  
<tr>  
<td>

**Archiving and preservation**

**(including storage and backup)**

</td>  
<td>

The data is stored by the partner collecting it (on their own computers and/or
institutional servers).

</td> </tr> </table>  
<table>  
<tr>  
<th>

**Data set name**

</th>  
<th>

**Sensitive data (except Health data)**

</th> </tr>  
<tr>  
<td>

**Type of data**

</td>  
<td>

Ethnic group, sex life or orientation, political opinions, religious beliefs
or other beliefs of a similar nature

</td> </tr>  
<tr>  
<td>

**Format**

</td>  
<td>

Documents (paper and digital such as Word documents or Excel sheets), audio
recordings or videos, inputs to the STARR application

</td> </tr>  
<tr>  
<td>

**Source**

</td>  
<td>

This data comes from:

  * Questionnaires (paper originals, responses captured in an Excel spreadsheet), analysis (e.g. charts) within the spreadsheet 

  

  * Interviews transcribed to Word documents 

  

(anonymized), analyzed data from the interviews

  * Focus groups: discussions transcribed to Word documents (anonymized), synthesis of themes captured in Word documents 

  

  * Inputs to the application 

  

  * Audios or videos recordings of user testing and studies 

  

</td> </tr>  
<tr>  
<td>

**Reuse and sharing**

</td>  
<td>

Only anonymized and aggregated relevant data are transmitted and reused by the
partners not collecting the data.

</td> </tr>  
<tr>  
<td>

**Diffusion principles**

</td>  
<td>

Within the consortium only respecting the limitations mentioned above.

</td> </tr>  
<tr>  
<td>

**Scientific publications**

</td>  
<td>

No sensitive data was used in scientific publications.

</td> </tr>  
<tr>  
<td>

**Relevant documentation**

</td>  
<td>

Sensitive data was not included in any documentation.

</td> </tr>  
<tr>  
<td>

**Archiving and preservation**

**(including storage and backup)**

</td>  
<td>

The data is stored by the partner collecting it (on their own computers and/or
institutional servers).

</td> </tr> </table>

Concerning sensitive data, it also includes health data. However, we chose to
separate it and create a specific category, as this is the major type of data
that was collected and analyzed during the project. It is further detailed in
the table below.  
  
<table>  
<tr>  
<th>

**Data set name**

</th>  
<th>

**Health data (physical + mental)**

</th> </tr>  
<tr>  
<td>

**Type of data**

</td>  
<td>

Medical history, blood pressure, lipidic profile, glycaemia, heart rate, diet,
toxic habits, disabilities, weight, depression, stress, pain, motor function,
physical activity, canes and wheel chair use, gait analysis, skeleton
movements in the game, emotions, behavior,

</td> </tr>  
<tr>  
<td>

</td>  
<td>

adherence to treatment, information needed and obtained from the psychological
model analysis

</td> </tr>  
<tr>  
<td>

**Format**

</td>  
<td>

Documents (paper and digital such as Word documents or Excel sheets), videos,
inputs to the STARR

application, visual sensing (Kinect or equivalent)

</td> </tr>  
<tr>  
<td>

**Source**

</td>  
<td>

This data comes from:

  * Questionnaires (paper originals, responses captured in an Excel spreadsheet), analysis (e.g. charts) within the spreadsheet 

  

  * Interviews / Focus groups transcribed to Word documents (anonymized), analyzed data from the interviews 

  

  * Inputs to the application via questions or sensing 

  

  * Video or audio recordings of user testing and studies 

  

  * Movement recordings by the games and training applications 

  

  * Movement recordings by the wearables 

  

</td> </tr>  
<tr>  
<td>

**Reuse and sharing**

</td>  
<td>

Only relevant anonymized and aggregated data are transmitted and reused by the
partners not collecting the data.

</td> </tr>  
<tr>  
<td>

**Diffusion principles**

</td>  
<td>

Within the consortium only respecting the limitations mentioned above.

</td> </tr>  
<tr>  
<td>

**Scientific publications**

</td>  
<td>

Health data was used in scientific publications in the form of anonymized,
statistical data or anonymized, aggregated patient description.

</td> </tr>  
<tr>  
<td>

**Relevant documentation**

</td>  
<td>

Health data was only included in health-related files in OSA and HOP (the
medical partners).

</td> </tr>  
<tr>  
<td>

**Archiving and preservation**

**(including storage and backup)**

</td>  
<td>

The data is stored by the partner collecting it (on their own computers and/or
institutional servers).

</td> </tr> </table>  
<table>  
<tr>  
<th>

**Data set name**

</th>  
<th>

**Website traffic**

</th> </tr>  
<tr>  
<td>

**Type of data**

</td>  
<td>

Email addresses, Google Analytics data, HTTP cookies

</td> </tr>  
<tr>  
<td>

**Format**

</td>  
<td>

CSV files, HTTP cookies

</td> </tr>  
<tr>  
<td>

**Source**

</td>  
<td>

This data comes from user activity on the My Stroke Guide website.

</td> </tr>  
<tr>  
<td>

**Reuse and sharing**

</td>  
<td>

My Stroke Guide website collects email addresses, which are only used by the
Stroke Association, with consent of the users and are not shared with any
third parties.

My Stroke Association collects Google Analytics data from the website, which
is used anonymously to assess site use and is not shared with any third
parties.

</td> </tr>  
<tr>  
<td>

**Diffusion principles**

</td>  
<td>

This data is not diffused.

</td> </tr>  
<tr>  
<td>

**Scientific publications**

</td>  
<td>

This data is not included in any scientific publications.

</td> </tr>  
<tr>  
<td>

**Archiving and preservation**

**(including storage and backup)**

</td>  
<td>

The data is stored by the My Stroke Association (on their own computers and/or
institutional servers).

</td> </tr> </table>

#  5\. Data volume

The volume of data collected by the STARR platform is limited to the time
during which the pilot was run by each patient, as well as to the total number
of participating patients and the quantity of information that was be sent
from the client agents to the platform. The total amount of information
gathered from telemonitoring without including the smart-space was under
100Gbytes (N = 20, effective time pilot = 2 months, daily system usage = 12
hours, sensors data rate = 1Kbytes/s, which estimate a total of 52Gbytes).
This information is duly protected as described in section 7.

#  7\. Data security

The STARR project uses methods that emphasize good field access and extended
contact and trust building with participants. Due to the sensitive nature of
some of the topics that were discussed in interviews and focus groups, data
security is of vital importance. The following guidelines have been followed
throughout the project in order to ensure the security of the data:

  * Keep anonymized data and personal data of respondents separate; 

  

  * Encrypt data if it is deemed necessary by the local researchers; 

  

  * Store data in at least two separate locations to avoid loss of data; 

  

  * Do not store personal data on USB drives; 

  

  * Save digital files in one of the preferred formats (see table above), and 

  

  * Label files in a systematically structured way in order to ensure the coherence of the final dataset; 

  

  * Whenever possible and according to the ICT policies of each organization, on all devices (desktops, laptops, external hard disks, USB drives, etc.) that are for archiving, storing and data transferring is encrypted. 

  

Security of long-term preservation:

Long-term preservation of the data will be carried out by three partners:

  * CEA – preservation of the data for two years after the end of the project, for publishing purposes; 

  

  * Hopale and Osakidetza – the data on the health record is to be stored at OSA for 30 years which is a requirement under Spanish law. In HOP, this data will be stored for 20 years, as required by French law.