#  Executive Summary

The document provides an initial data management plan concerning the data
processed, generated and preserved during and after KONFIDO Action, as well as
relative concerns generated from their usage. The deliverable aims to define a
framework outlining KONFIDO’s policy for data management. In particular, this
deliverable covers topics like information about the data, metadata content
and format, policies for access, sharing and re-use and longterm storage and
data management. During the KONFIDO Action, health data will be processed and
the processing of this personal data is submitted to strict data protection
legal rules. In addition, the data management plan will be affected by future
results of the work performed in WP2-WP7. Therefore, the initial framework
presented in this deliverable will further evolve during the Action.

#  Introduction

The document provides an initial data management plan concerning the data
processed, generated and preserved during and after KONFIDO Action, as well as
relative concerns generated from their usage. The deliverable aims to define a
framework outlining KONFIDO’s policy for data management. In particular, this
deliverable covers topics like information about the data, metadata content
and format, policies for access, sharing and re-use and longterm storage and
data management. This deliverable is “living” and strongly linked with the
work taking place in the Action’s Work Packages. We note here that throughout
the duration of the Action, KONFIDO consortium will closely follow the
activities in the eHealth Network (eHN), the Joint Action to Support the
eHealth Network (JAseHN) and the eHealth Digital Service Infrastructure
(eHDSI).

##  Action goal

KONFIDO Action will advance the state of the art of eHealth technology with
respect to security aspects by providing a holistic approach – i.e. targeting
all architectural layers of an IT infrastructure, namely: _storage_ ,
_dissemination_ , _processing_ , and _presentation_ – to address challenges of
secure storage and exchange of eHealth data, protection and control over
personal data, and security of health related data gathered by mobile devices.
KONFIDO will build on and extend the results of a best of breed selection of
successful projects (namely: epSOS, STORK, DECIPHER, EXPAND and ANTILOPE).

The KONFIDO approach will be implemented in a technological framework that
will rely on six technology pillars, namely:

i. The new security extensions provided by some of the main CPU vendors; ii.
Physical Unclonable Function (PUF)-based security solutions based on photonic
technologies; iii. Homomorphic encryption mechanisms; iv. Customised
extensions of selected Security Information and Event Management (SIEM)
solutions;

  5. A set of disruptive logging and auditing mechanisms developed in other technology sectors - such as blockchain - and transferred to the healthcare domain and 

  

  6. A customised STORK-compliant eID implementation. Given the recent advances in the field, KONFIDO will consider a customized eIDAS-compliant cross-border eID implementation. 

  

  

The usability of the proposed solutions will be tested in a realistic setup,
deployed on top of a federated cloudbased infrastructure where data will be
exchanged and services interoperate cross-border. Building on results that are
already widely accepted and relying on a handful of complementary technologies
(some of which are already at a high level of maturity), KONFIDO has a
dramatic potential in terms of cross-sector transfer of innovation in the
field of coordinated care towards improved acceptance of healthcare solutions.

##  Work Package goal

The deliverable is written in the context of WP1 – Project Management. The
main goal of this WP is to guarantee the successful realisation and conclusion
of the Action including the project administration and control, risk
management, problem handling and quality assurance on management levels. This
WP makes sure, that the Action runs to budget, is on time and the expected
results are achieved. This goal will be reached by ensuring the correct and
efficient collaboration between partners.

##  Deliverable goal

The deliverable aims to define a framework outlining KONFIDO’s policy for data
management. The deliverable is based on the guidelines provided in “
_Guidelines on Data Management in Horizon 2020_ ” published by the European
Commission and aims to answer the following issues:

  * What types of data will the Action generate/collect? 

  

  * What standards will be used? 

  

  * How will this data be exploited and/or shared/made accessible for verification and re-use? 

  

  * How will this data be curated and preserved? 

  

As mentioned above, the document is dynamic and will be periodically updated
in parallel with the development work taking place in other WPs. Overall, a
common policy will be defined indicating the procedures for the data
management during and after the Action, as well as at internal and external
level.

##  Deliverable structure

The deliverable is divided into following sections:

  * Section 2 describes the Action’s approach regarding open access to scientific publications; 

  

  * Section 3 refers to the Action’s approach regarding open access to research data; 

  

  * Section 4 describes the datasets that will be used in the Action, provided by SUNDHED and PAUSIL; 

  

  * Section 5 details any standards and metadata that will be utilised in the framework of KONFIDO; 

  

  * Section 6 includes a description of the data sharing policies regarding access, sharing, re-use and distribution; 

  

  * Section 7 refers to archiving and presentation in the context of KONFIDO and - Section 8 concludes the document. 

  

#  Open access to scientific publications

Open access to scientific publications refers to free of charge online access
for users. Open access will be achieved through the following steps:

  1. Any paper presenting the Action results will acknowledge the Action: “ _The research leading to these results has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 727528-KONFIDO_ ” and display the EU emblem. 

  

  2. Any paper presenting the Action results will be deposited at least by the time of publication to a formal repository for scientific papers. If the organisation does not support a formal repository  ( _https://www.openaire.eu/participate/deposit/idrepos_ )  , the paper can be uploaded in the European sponsored repository for scientific papers:  _http://zenodo.org/_ . 

  

  3. Authors can choose to pay “author processing charges” to ensure open access publishing, but still they have to deposit the paper in a formal repository for scientific papers (step 2). 

  

  4. Authors will ensure open access via the repository to the bibliographic metadata identifying the deposited publication. More specifically, the following will be included: 

     * The terms “ _European Union (EU)_ ” and “ _Horizon 2020_ ”; 

  

     * “ _KONFIDO - Secure and Trusted Paradigm for Interoperable eHealth Services_ ”, Grant agreement number 727528; 

  

     * Publication data, length of embargo period if applicable; and 

  

     * A persistent identifier. 

  

  

  5. Each case will be examined separately in order to decide on self-archiving or paying for open access publishing. 

  

  

#  Open access to research data

Open access to research data refers to the right to access and re-use digital
research data generated by Actions. EU expects funded researchers to manage
and share research data in a manner that maximises opportunities for future
research and complies with best practices in the relevant subject domain. That
is:

  * The dataset has clear scope for wider research use; 

  

  * The dataset is likely to have long-term value for research or other purposes;  The dataset has broad utility for reference and use by research communities; 

  

  * The dataset represents a significant output of the research project. 

  

Openly accessible research data generated during KONFIDO Action will be
accessed, mined, exploited, reproduced and disseminated free of charge for the
user. Specifically, the " _Guidelines on Data Management in Horizon 2020_ "
clarifies that the beneficiaries must:

_“Deposit in a research data repository and take measures to make it possible
for third parties to access, mine, exploit, reproduce and disseminate — free
of charge for any user — the following:_

_i. The data, including associated metadata, needed to validate the results
presented in scientific publications as soon as possible; ii. Other data,
including associated metadata.”_

The following section describes some sample datasets that we are planning to
use in the framework of KONFIDO. The provided datasets are, at this early
stage of the Action, possible examples which are probably subject to change
with the evolution of the Action.

For each dataset that we are going to share in the project lifetime, policies
for access and sharing as well as policies for re-use and distribution will be
defined and applied. A generic guideline is provided in Section 6 " _Data
sharing_ " and Section 7 " _Archiving and preservation_ ".

#  Datasets description

KONFIDO pilots involve the cross-border exchange of patient data. The end-user
partners of the consortium have access to such types of data; however, it is
not clear yet if the Action will require the use of real patient data for the
pilots. In case this is needed, KONFIDO partners will follow best practices
during pilot definition, including data anonymisation or pseudoanonymisation,
ethical approvals for working with these data, informed consents of patients
etc. All patient data will be handled according to national law and
guidelines. This deliverable is a “live” document; therefore, it will be
updated as the progress progresses and all relevant issues will be addressed.

Below, we provide a brief overview of the datasets that can be provided to the
KONFIDO pilots by SUNDHED and PAUSIL partners, if needed.

##  SUNDHED dataset

The 1  st  KONFIDO end-user workshop gave valuable input in regards to the
potential dataset. The typical scenario will involve a consultation or
treatment situation where the general practitioner or hospital doctor will
have a limited time to get an overview of the patient. Therefore, the dataset
needs to be short and to the point.

The actual nature of the required data will vary a lot from patient to
patient, so it will be very hard to pinpoint a one-size-fits-all. For example,
a patient with a broken leg will primarily need x-rays, while a COPD patient
might need data on current medication and lung function. In all the
situations, the doctors at the end-user workshop agreed on Electronic Health
Record (EHR) notes not being important for the vast majority of the patients.

A minimum dataset that would cover most of the basic needs would include:

  * Diagnose data based on ICPC-2 and/or ICD-10 codes; 

  

  * Access to laboratory test results based on IUPAC codes; 

  

  * Current medication based on ATC codes; 

  

  * Open prescriptions for the patient – preferred useable to local pharmacies; 

  

  * X-rays pictures or descriptions if the bandwidth is limited or the pictures are very large or scans; 

  

  * EHR notes should be made available but, in a situation with limited time on hand, some kind of filter would need to be used to help the doctor get an overview. Often the notes are generated by dictation and data are not structured; 

  

  * Specific data for chronic patients like INR values, lung function, HbA1c or similar. It is very important that all members of the health data ecosystem agree on the measurement values and standards, so that there is no doubt on how a doctor will interpret the numbers. 

  

##  PAUSIL dataset

The PAUSIL Information System (IS) can be decomposed into three main areas:
_Management and Accounting IS_ , _Clinical IS_ and _Communication and web
services_ . For the purpose of KONFIDO Action, the Clinical IS is described in
the Figure 1. The Clinical IS (CIS) is a computer-based infrastructure
designed to collect, store and manipulate data related to the healthcare
delivery process. CIS data consists of structured/unstructured text
represented in a proprietary format. CIS can be, in turn, divided into
Diagnostic IS and Emergency Department IS (EDIS). The Diagnostic IS includes
the Laboratory IS (Lab IS) and the Radiology Information Service (RIS). The
Lab IS integrates and manages the results of patients’ tests with the
Electronic Health Record (EHR) and Transfusion Medicine. Data managed by RIS
system are digital radiological images (DICOM format) that represent large
volumes of data. The picture archiving and communications system (PACS) is
designed for paper and film archiving. It provides archiving, viewing, and
distribution of medical images to radiologists, physicians of other
specialties, and doctors in other hospitals and it is integrated with EHRs
too. All the system integrations are realised using the standard HL7 that
refers to a set of international standards for transfer of clinical and
administrative data between software applications used by various healthcare
providers.

**Figure 1. PAUSIL Information System**

EDIS is based on a dedicated application that collects patient information
from the triage to the discharge or admission, following the work flow
described in Figure 2. Each dataset comes in specific formats, as specified in
Table 2.

**Figure 2. ED workflow**  
  
<table>  
<tr>  
<th>

**Data**

</th>  
<th>

**Description**

</th>  
<th>

**Size**

</th>  
<th>

**Type**

</th>  
<th>

**Structure**

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

CIS

</td>  
<td>

Clinical information system

</td>  
<td>

~15 GB/500 GB

</td>  
<td>

Text

</td>  
<td>

Structured/unstructured

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

EDIS

</td>  
<td>

Emergency department information system

</td>  
<td>

~5 GB

</td>  
<td>

Text

</td>  
<td>

Structured/unstructured

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

RIS

</td>  
<td>

Radiology information system

</td>  
<td>

~6.5 TB/130 GB

</td>  
<td>

Text

</td>  
<td>

Structured/unstructured

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

PACS

</td>  
<td>

Picture archiving and communications system

</td>  
<td>

~19.5 TB/8 TB

</td>  
<td>

Image

</td>  
<td>

Unstructured

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

Lab IS

</td>  
<td>

Laboratory information system

</td>  
<td>

~2 GB

</td>  
<td>

Text

</td>  
<td>

Structured/unstructured

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

EHR

</td>  
<td>

Electronic health record

</td>  
<td>

~9 TB

</td>  
<td>

Text

</td>  
<td>

Structured/unstructured

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

**Table 1. Emergency Department Dataset**

#  Standards and metadata

Metadata is needed on the datasets. This will provide transparency and
traceability to make security and audit possible. The law and regulations
demand a large degree of control when handling this type of data. Also, unique
identifies need to be in place for patients and doctors to make sure that data
is going to the right people at the right time.

Most of the data will come from the local system with lots of metadata and
this will greatly vary from country to country, hospital to hospital and
system to system. Some of the base data needed will include:

  * Time stamp for when the data was generated; 

  

  * Time stamp for exchange of data; 

  

  * Health professional to contact regarding the data, organisation, email and phone number; 

  

  * Log with access and actions regarding the dataset; 

  

  * Unique identifiers on the doctors who access the data; 

  

  * Unique identifiers for the patient; 

  

  * Country code on data and access log; 

  

  * Data on who added or edited the data; 

  

  * Data on possible shielding of certain types of data. 

  

Standards can be selected to help the data exchange, but the variation in the
employed systems across Europe is very large and there will be hundreds of
standards and even big variations within the same standards and/or versions of
these. Datasets should be as standardized, if possible, but the exchange of
data will be very hard by using defined standards.

To use standards, you do not only need to invent new or develop current
standards, but implement them into the actual systems which is a very
difficult task. The reason for this is that you do not only need the
technological support, but you also really need to make it happen. It is a
rare thing that an organisation can adapt to a new standard with an existing
system since that system will likely be integrated with other systems. Also,
the systems/organisations asking others to adapt to a standard will not have
the budget or the governance in the other organisation. Experience shows that
you need to be able to handle a multitude of standards, if you want to
integrate a large number of systems and KONFIDO is aiming to potentially
integrate a very large number of systems.

A standard for integrating to KONFIDO should be defined, but it is a must that
it can co-exist with current standards and interfaces in the system. Even on a
European level it is hard to imagine all countries moving at the same pace.

#  Data sharing

The data sharing policy concerning KONFIDO Action is still under definition.
Most of the existing data are privately held by KONFIDO data owners. For the
time being, the consortium has not decided how the data/results generated
within the Action will be treated. This will be an on-going process and is
expected to be finalised later in the course of the Action as it closely
related to the definition and the requirements of the KONFIDO use cases. The
issues identified so far concern:

  * The definition of data owner(s); 

  

  * The definition of incentives concerning the data providers; 

  

  * The identification of user groups and the access policies concerning the data; 

  

  * The definition of access procedure and embargo periods; 

  

  * The compliance with corresponding legal and ethical issues. 

  

Open access to research data will be achieved in KONFIDO through the following
steps:

  1. Prepare the " _Data Management Plan_ " (current document) and update it as needed; 

  

  2. Select what data we will need to retain to support validation of the Action finding (the datasets described in Section 4); 

  

  3. Deposit the research data into an online research data repository. In deciding where to store Action data, the following choice will be performed, in order of priority: 

     * An institutional research data repository, if available; 

  

     * An external data archive or repository already established in the KONFIDO research domain (to preserve the data according to recognised standards); 

  

     * The European sponsored repository:  _http://zenodo.org/_ ; 

  

     * Other data repositories (searchable here:  _http://www.re3data.org_ )  , if the aforementioned ones are ineligible. 

  

  

  4. License the data for re-use (Horizon 2020 recommendation is to use CC0 or CC BY); 

  

  5. Provide information on the tools needed for validation, i.e. everything that could help a third party in validating the data (workflow, code, etc.). Independent of the selected repository, the authors will ensure that the repository: 

     * Gives the submitted dataset a persistent and unique identifier to make sure that research outputs in disparate repositories can be linked back to particular researchers and grants; 

  

     * Provides a landing page for each dataset, with metadata; 

  

     * Helps track if the data has been used by providing access and download statistics; 

  

     * Keeps the data available in the long term, if desired; 

  

     * Provides guidance on how to cite the data that has been deposited. 

  

  

  

Even following the previously described steps, each case will be examined
separately in order to select the most suitable online repository.

##  Policies for access and sharing

As suggested by the European Commission, the partners will deposit at the same
time the research data needed to validate the results presented in the
deposited scientific publications. This timescale applies for data
underpinning the publication and results presented _._ Research papers written
and published during the funding period will be made available with a subset
of the data necessary to verify the research findings. The consortium will
then make a newer, complete version of data, available within 6 months of
Action completion. This embargo period is requested to allow time for
additional analysis and further publication of research findings to be
performed.

Other data (not underpinning the publication) will be shared during the Action
life following a granular approach to data sharing and releasing subsets of
data at distinct periods rather than waiting until the end of the Action, in
order to obtain feedback from the user community and refine it as necessary.

An important aspect to take into account is who is allowed to access the data.
It could be the case that part of a dataset should not be publicly accessible
to everyone. In this case, control mechanisms will be established, including:

  * Authentication systems that limit read access to authorised users only; 

  

  * Procedures to monitor and evaluate access requests one by one. A user must complete a request form stating the purpose for which they intend to use the data; 

  

  * Adoption of a Data Transfer Agreement that outlines conditions for access and use of the data. 

  

Each time a new dataset will be deposited, the consortium will decide who is
allowed to access the data. Generally speaking, anonymised and aggregate data
will be made freely available to everyone, whereas sensitive and confidential
data will only be accessed by specific authorised users.

##  Policies for re-use and distribution

A key aspect of data management is to define policies in order for users to
learn the existence of data and the content it contains. People will not be
interested in a set of unlabeled files published on a website. To attract
interest, partners will describe accurately the content of published dataset
and, each time a new dataset is deposited, disseminate the information using
the appropriate means (i.e., mailing list, press release, Facebook, website
news) based on the type of data and the interested target audience.

Research data will be made available in a way that can be shared and easily
re-used by others. That means:

  1. Sharing data using open file format (whenever possible), so that they can be implemented by both proprietary and open source software; 

  

  2. Using format based on an underlying open standard; 

  

  3. Using format which is interoperable among diverse internal and external platforms and applications; 

  

  4. Using format which does not contain proprietary extensions (whenever possible). 

  

  

Documenting datasets, data sources and the methodology used for acquiring the
data establishes the basis for the interpretation and appropriate usage of the
data. Each generated/collected and deposited dataset will include
documentation to help users to re-use it.

As recommended, the license that will be applied to the data is CC0 or CC BY.
If limitations exist for the generated data, these restrictions will be
clearly described and justified.

Potential issues that could affect how data can be shared and used may include
the need to protect participant confidentiality, comply with informed consent
agreement, protect Intellectual Property Rights, submit patent applications
and protect commercial confidentiality. Possible measures that may be applied
to address these issues include encryption of data during storage and
transfer, anonymisation of personal information, development of Data Transfer
Agreements that specify how data may be used by an end user, specification of
embargo periods, and development of procedures and systems to limit access to
authorised users only.

#  Archiving and presentation

Datasets will be maintained for 5 years following Action completion. To ensure
high-quality long-term management and maintenance of the dataset, the
consortium will implement procedures to protect information over time. These
procedures will permit a broad range of users to easily obtain, share and
properly interpret both active and archived information and they will ensure
that information is:

  * Kept up-to-date in content and format so that they remain easily accessible and usable; 

  

  * Protected from catastrophic events (e.g., fire and flood), user error, hardware failure, software failure or corruption, security breaches, and vandalism. 

  

Regarding the second aspect, solutions dealing with disaster risk management
and recovery, as well as with regular backups of data and off-site storage of
backup sets, are always integrated when using the official data repositories
(i.e.,  _http://zenodo.org/_ )  ; the partners will ensure the adoption of
similar solutions when choosing an institutional research data repository.

Partners are encouraged to claim costs for resources necessary to manage and
share data; these will be clearly described and justified. Arrangements for
post-action data management and sharing must be made during the life of the
Action. Costs associated with long-term curation and preservation, such as
POSF (Pay Once, Store Forever) storage, will be purchased before the Action
ends.

#  Conclusions

The purpose of the Data Management Plan is to support the data management life
cycle for all data that will be collected, processed or generated by KONFIDO
Action. The Data Management Plan is not a fixed document, but evolves during
the lifespan of the Action. This document is expected to mature during the
Action; more developed versions of the plan could be included as additional
deliverables at later stages. The Data Management Plan will be updated at
least by the mid-term and final review to fine-tune it to the data generated
and the uses identified by the consortium since not all data or potential uses
are clear at this stage of the Action.