Healthdata.be applications such as HD4DP v2 and healthstat.be process sensitive personal information. Therefore, strictly controlled processes are used to grant access to these applications.

The Entity Access Management (EAM) portal of healthdata.be facilitates these processes. In this article we describe how to use it. To navigate to the EAM application, enter the URL https://eam.healthdata.be in your internet browser.

Note: As the documentation of the EAM portal is being updated on a regular basis, please be advised to check the Release notes first.

Select one of the following capacities that suits your position in order to request access to an HD application:

• End-users
• Single IT points-of-contact, also 'IT SPOC'
• International users

Standard End-users

To request access to healthdata.be applications (such as HD4DP v2 and healthstat.be) as a standard end-user, you need to click on REQUEST ACCESS in the blue text box in the middle of the screen.

You will be directed to the next screen, where you select the button Log in with eID.

Clicking on this button leads you to the government's Federal Authentication Service (FAS), where you can log in with multiple digital keys with eID or digital identity.

If you choose to connect with ItsMe, you can enter your cell phone number.

Follow the instructions on your mobile device via the ItsMe application.

Once you have run through the ItsMe login procedure, you want to select the green confirmation button (available in FR and NL) in the screen below to access the Sciensano environment.

After selection of the confirmation button, you are logged in to the EAM portal page as indicated by the available My profile and Log out options to the top-left of your screen.

When selecting the REQUEST ACCESS link in the blue highlighted text box, in order to fill out the Request access form, the following message appears:

Click on the My profile link in the message, which redirects you to your profile page. Your user profile needs validation before being able to enter and complete the Request access form.

Select the Edit tab to complete your profile information.

Next to the profile information that is automatically prefilled based on your eID data, you need to complete the following fields:

NIHDI Number: Your NIHDI number if available.

Organization: Add the organization(s) you are affiliated with. This field includes the name and NIHDI number of the organization.

Email address: Mandatory field for which the content can't be retrieved from the eID. Your email address will be used for communication on the profile validation and access request.

State: Select one of the options (see image underneath):

• Draft: This status indicates that you have not finished completing the profile fields yet. Only you can see the filled in data at this stage. Modification of the profile information is restricted to the status "Draft". You can however Save profile information as Draft to finalize and send it for validation lateron.
• Validation Requested: The provided user profile information is complete and you want to send it for validation to the SPOC.

Click on the Save button to send your profile information to the SPOC. An Access Denied message appears on the screen, indicating you can't modify your filled in and sent profile information anymore.

When you return to My profile you will see that your user profile has the pending status. Also, the Edit tab has disappeared, preventing from further modifications:

Your user profile will soon be validated by the SPOC, which will look as follows:

After validation of your profile by the SPOC, you select Home to return to the EAM portal page.

Attention: Do not select the button "Request access" (soon: "Request SPOC rights"), since this guides you to the process of requesting access as a SPOC.

In the EAM portal page you want to select the REQUEST ACCESS link in the blue highlighted text box again.

Select the hospital you are affiliated with for the application(s) and project(s) you want to request access to.

You can now start completing the Request Access form.

Please fill in all required fields (indicated with a red asterisk *), make a selection in the mandatory drop-down lists and, optionally, tick the check boxes for additional help and/or information.

Type of login field:

If you select "Belgium resident" for the field “Type of Login”, entering the mobile phone number is optional.

If you are a "Non-Belgium resident", the Mobile phone number field becomes mandatory to allow for the two factor authentication:

'Role of requestor in project' field

Select your role in the project: Local Study Lead, Local Study Associate or Local Study Support.

Your role determines your access options in the HD application for this project and does not necessarily corresponds to the staff structure within your organization. Read more about the scope of the roles in User roles in HD4DP v2.

'Author group user belongs to' field

When selecting Local Study Lead or Local Study Associate the data entered in the previous fields First name of the requestor and Last name of the requestor are automatically used to create your Author Group.

When selecting Local Study Support an extra field appears: Author group user belongs to. This field contains a drop-down list with Author group names. Select the one that applies to your profile. The author group names list is automatically populated and specific to the organization you have selected above.

HD4DP2.0 field

Click in the field under HD4DP2.0 if you want to access the application to make registrations for the selected project:

Healthstat.be field

Click in the field under healthstat.be if you want to access the reporting of the selected project:

It can happen that a user inadvertently submits requests for access to the same applications and/or projects. The requests are screened for duplicates by checking on organization number, role, author group and project code. In case duplicates are detected, the end-user will receive the following message:

Once you have completed the Request Access form, click on the Submit button. When the submission was successful, you will receive a confirmation message.

Single IT points-of-contact (IT SPOC)

A single-point of contact or SPOC is a role that extends beyond the function of a VTE/RAE. More specific, it can be any employee within an organization whom this role has been assigned to.

To request access to healthdata.be applications such as like HD4DP v2 and healthstat.be as a single-point of contact (SPOC), you want to select GIVE ACCESS in the white text box to the right of the screen.

If you have not yet requested access to these forms, and therefore are not recognized as a user with the SPOC role, you will receive the following message:

In this case you want to select My Profile (top left in the menu) and click on the button Request access (soon: "Request SPOC rights").

The Request access [RAE] screen pops up.

Fill in all requested fields and click on the Submit button.

After submission of the RAE form healthdata.be support carries out a background check considering your SPOC authority within the organization mentioned, and will send you a confirmation e-mail with a special token. Once you have received this token, return to the My Profile page and select the button Enter access token.

The Access token screen appears:

Fill in the NIHDI code for your organization and the access token you received per e-mail. After clicking on Submit, you will be redirected to the EAM portal page, where you again select GIVE ACCESS.

The ACCESS REQUEST form appears. By filling out the requested fields, a SPOC is able to give access to users within their organization who want to access a healthdata.be application (HD4DP2.0 or Healthstat).

Once you have completed the Access Request form, click on the Submit button. When the submission was successful, you will receive a confirmation message.

If you now return to My profile, you will see that it has been extended with the information "Responsible Access Entry" under User role(s). Also the tabs Profiles, Requests, Batch create requests and Edit have been added.

The Profiles tab of the validated SPOC profile offers the possibility to Search, Select and Sort profiles. Selected user profiles in the list can be Validated or Rejected via the Action drop-down menu.

In the Requests tab the SPOC can manage the overview of requests. More information is to be found on SPOC actions upon a request.

See documentation under Give access to multiple users in batch for more information on the Batch create requests tab.

Saved user profile information can't be modified, unless upon action of the SPOC. The Edit tab offers the option to enter the NIHDI number, add organizations, modify the email address and toggle the state between Validated or Rejected. Select the Save button to install the new profile information.

International users

For international users a link to a special form will be provided:

https://eam.healthdata.be/forms/hd_eam_access_request_user_int

Selecting this link redirects you to a more extensive Request Access form. Fill in all required fields (indicated with a red asterisk *), make a selection in the mandatory drop-down lists and, optionally, tick the check boxes for additional help and/or information:

After submitting the form, an e-mail is sent to the Service Desk staff for an identification and authorization process. If the request is approved, the international user receives an e-mail with account information. International users, however, are not able to log in, nor can they consult overviews of requests at this moment.

Deze documentatie wordt regelmatig bijgewerkt. We proberen de informatie zo correct, volledig en zo duidelijk mogelijk weer te geven. Als u desondanks iets in de documentatie ziet dat niet correct is, niet overeenkomt met uw ervaring, of verdere verduidelijking vereist, maak dan een verzoek aan (type: verzoek om informatie) via ons portaal (https://sciensano.service-now.com/sp) of stuur ons een e-mail via support.healthdata@sciensano.be om dit documentatieprobleem te melden. Vergeet niet de URL of het webadres van de pagina met het documentatieprobleem te vermelden. Wij zullen de documentatie dan aanpassen. Bedankt!

When logged in, you will see the Welcome page. In the left dark blue menu you can see all the study programs and projects you have access to.

When you select the study program QERMID Orthopedics, you can see the study projects Orthopride Hip, Orthopride Knee and Orthopride total femur.

Select the study project Orthopride total femur.

You will see that the study project Orthopride total femur consists of three parts: Primo-implantation, Revision and Resection.

This documentation is being updated regularly. We try to provide as correct, complete and clear as possible information on these pages. Nevertheless, if you see anything in the documentation that is not correct, does not match your experience or requires further clarification, please create a request (type : request for information) via our portal (https://sciensano.service-now.com/sp) or send us an e-mail via support.healthdata@sciensano.be to report this documentation issue. Please, do not forget to mention the URL or web address of the page with the documentation issue. We will then adjust the documentation as soon as possible. Thank you!

The study project Orthopride total femur consists of three parts: Primo-implantation, Revision and Resection.

On the following pages we explain how you can register for each part.

This documentation is being updated regularly. We try to provide as correct, complete and clear as possible information on these pages. Nevertheless, if you see anything in the documentation that is not correct, does not match your experience or requires further clarification, please create a request (type : request for information) via our portal (https://sciensano.service-now.com/sp) or send us an e-mail via support.healthdata@sciensano.be to report this documentation issue. Please, do not forget to mention the URL or web address of the page with the documentation issue. We will then adjust the documentation as soon as possible. Thank you!

The study project Orthopride total femur consists of three parts: Primo-implantation, Revision and Resection.

On the following pages we explain how you can find a registration for each section.

Cette page a été traduite à l'aide d'une machine de traduction automatique dans le but de fournir le contenu plus rapidement dans votre langue. Un traducteur humain n'a pas encore révisé cette page. Par conséquent, cette page peut encore contenir des erreurs grammaticales et autres erreurs linguistiques. Si vous voyez quelque chose dans la documentation qui n'a pas été traduit correctement, veuillez nous contacter à support.healthdata@sciensano.be (n'oubliez pas d'inclure l'adresse Web de la page). Nous ajusterons ensuite la traduction. Merci!

Cette documentation est encore en construction. Nous essayons de présenter les informations aussi correctes, complètes et aussi claires que possible. Cependant, si vous voyez quelque chose dans la documentation qui est incorrect, ne correspond pas à votre expérience ou nécessite des éclaircissements supplémentaires, veuillez créer une demande (type : demande d'information) via notre portail (https://sciensano.service-now.com/sp) ou nous envoyer un e-mail à support.healthdata@sciensano.be pour signaler ce problème de documentation. N'oubliez pas d'inclure l'URL ou l'adresse Web de la page avec le problème de documentation. Nous ajusterons ensuite la documentation. Merci!

The study project Orthopride total femur consists of three parts: Primo-implantation, Revision and Resection.

On the following pages we explain how you can update a registration for each section.

This documentation is being updated regularly. We try to provide as correct, complete and clear as possible information on these pages. Nevertheless, if you see anything in the documentation that is not correct, does not match your experience or requires further clarification, please create a request (type : request for information) via our portal (https://sciensano.service-now.com/sp) or send us an e-mail via support.healthdata@sciensano.be to report this documentation issue. Please, do not forget to mention the URL or web address of the page with the documentation issue. We will then adjust the documentation as soon as possible. Thank you!

The study project Orthopride total femur consists of three parts: Primo-implantation, Revision and Resection.

On the following pages we explain how you can delete a registration for each section.

This documentation is being updated regularly. We try to provide as correct, complete and clear as possible information on these pages. Nevertheless, if you see anything in the documentation that is not correct, does not match your experience or requires further clarification, please create a request (type : request for information) via our portal (https://sciensano.service-now.com/sp) or send us an e-mail via support.healthdata@sciensano.be to report this documentation issue. Please, do not forget to mention the URL or web address of the page with the documentation issue. We will then adjust the documentation as soon as possible. Thank you!

The study project Orthopride total femur consists of three parts: Primo-implantation, Revision and Resection.

On the following pages we explain how you can submit a registration for each section.

This documentation is being updated regularly. We try to provide as correct, complete and clear as possible information on these pages. Nevertheless, if you see anything in the documentation that is not correct, does not match your experience or requires further clarification, please create a request (type : request for information) via our portal (https://sciensano.service-now.com/sp) or send us an e-mail via support.healthdata@sciensano.be to report this documentation issue. Please, do not forget to mention the URL or web address of the page with the documentation issue. We will then adjust the documentation as soon as possible. Thank you!

Suppose we want to send a correction registration of "Primo-implantation" registration. In that case, we need to navigate to the study program QERMID Pneumology and then to the study project Endobronchial valve. There we need to select "Primo-implantation" in the dark blue left menu.

Important: a correction registration can be added only if the status of the registration is submitted.

A correction registration can be added in two ways. The first way is via the overview table and second way in the preview page of a registration.

Send a correction via Overview table

When the registration was submitted, the correction registration can be added via the overview table:

When you select a version of this study section, you will see the summary table in the main part of your screen. This table contains, among other things: Registration ID, Progress, Author, Co-author, Unique ID, Business Key, Registration Code, National Registry ID of the patient…

Use the filters in the table header to find the registration that need a correction. For example, you can use the "Status" (set to "Submitted") filter to get only submitted registrations.

Then, you must press the "Actions" button at the top right of the summary table.

Three options are displayed : "Submit" and "Delete" and "Add correction" but only option "Add correction" is available for submitted registrations. Now press "Add correction".

After you press "Add correction", a pop-up window will appear asking you to confirm the action of adding a correction registration for selected registration. If you are sure of this action, press "Confirm". If not, press "Cancel".

If you confirm, you will be redirected to correction registration form.

The correction DCD has no more than:

• Business key of original registration,
• The name of Data Collection,
• The field or variable which is wrong,
• The correction value,
• Comment field.

Some fields are automatically filled with values of original registration, like :"Data collection " and "Business_KEY" .

The number of fields to correct in the same correction registration is limited to three. You can add another field to correct by clicking on "Add another " button.

When you finish filling the correction registration, you can add a comment and send the correction by clicking on "submit" button.

Send a correction via Preview page

We can also add a correction form in the preview page of a registration.

Click on the registration to correct in overview table, you will be redirected to the preview page.

Click on "Add correction" button to add a correction for current registration.

Follow same steps described in previous section( See "1.Send a correction via Overview table")

Preview a correction registration

Correction form is a generic form available for all projects and DCDs.

If you want to preview "correction registrations" already submitted, you have to navigate to the study program Correction form and then to the study project Correction form. There you need to select the last version of "correction form" in the dark blue left menu.

All corrections registrations will be displayed(of different projects). You can use the filters in the table header to find a specific registration.

If you want to preview a correction registration, you need to click on, then you will be redirected to preview page.

Documentation for System 2 System API on Architecture 2.0

Description of the service

API is the acronym for Application Programming Interface, which is a software intermediary that allows two applications to talk to each other.

In this case, the API is used to have the system of the Data Providers communicate with the system of HealthData.

The S2S API is a unified API that will allow clients (Data Providers) to submit DCDs data to HD4DP2.0 in fully automated way.

End point information (per DCD) + examples

HOW TO: Upload data using System 2 System

Steps To Upload data

1. IT services of data providers must setup their systems to be able to communicate with HD4DP v2 System 2 System API

A prerequisite to be able to use the Health Data's System 2 System API, is that the IT services of the hospitals must have the following in place before the systems can communicate:

• The endpoint/URL is protected by credentials for which the support services need to be contacted.
• End-to-end API process to submit DCD registrations in a fully automated manner.
• Support for searching submitted DCD registrations.

2. Prepare the JSON file (example file in this section)

To send DCD registrations to Health Data, the file must be in a .json file format.

• At the Data Provider's side, we must foresee a way to extract the JSON file from the electronic patient files and/or other local databases.

• Author group, Author and Coauthor:
  • When the Author group, Author and Coauthor has been left out in the json file, the default Author group, Author and Coauthor will be used automatically.
  • When the desired Author group, Author and Coauthor are specified in the json file, the following fields TX_AUTHOR_GR, TX_AUTHOR and TX_COAUTHOR must be added to the json file with their values respectively.
    Example:

"TX_AUTHOR_GR": "Author Group",
"TX_AUTHOR": "author@example.com",
"TX_COAUTHOR": "coauthor@example.com",

Note:
The Author group, Author and Coauthor must exist and are well configured at the back-end of the system. TX_AUTHOR_GR can be a string that identifies the Author group to which this Author belongs. Commonly, the first name and last name are used to identify the TX_AUTHOR_GROUP. Be sure to avoid leading and trailing spaces when entering the Author group value.

• Make sure the name of the JSON file has the correct format:
  HD_DCD_submjson_HDBPnumber_HDBPabbreviation_versionnumber_versionreleasedate

So for Orthopride total femur - Primo-implantation the format would be:
HD_DCD_submjson_HDBP0048_Orthopride_TotalFemur-Primo_Implantation_01_20230504.json

Please note that this JSON example includes the latest changes. An overview of these changes can be found in the Release notes section.

Please find below an example file for Orthopride total femur Primo-implantation:

• HD_DCD_submjson_HDBP0048_Orthopride_Femur_Primo_Full_Haptic_totalHipProstetic_kneeRegion_v1_20230504.json
• HD_DCD_submjson_HDBP0048_Orthopride_Femur_Primo_Full_Other_dubbelMobiliteit_heupRegion_v1_20230504.json

Disclaimer: The example files above are only provided as a guideline and do not contain real life data.

3. Uploading the JSON File

• The IT department of the Data Provider must provide a manner in their system to send the API requests containing DCD registrations in a JSON file format, the correct end-points must be addressed.

• In this case the end-point to upload the json file will be:

4. Validate the JSON Upload

4.1 Validation of the S2S API Upload via the response:

Verify in the same way the request was sent, that the returned response is containing a valid Business key.

If a valid Business key has been provided, the registration upload via System 2 System API was succesful.

4.2 Validation of the System 2 System API via HD4DP 2.0:

Step 1: Open the web application HD4DP 2.0.

Step 2: Select the concerned organization in the dropdown list and click on Volgende (Next)

Step 3: Fill in the username and password, that has been provided by your IT Department or Healthdata team, and click on Log in to access the HD4DP 2.0 application.

Step 4: Navigate in the menu on the left-hand side panel to the desired study program:

Step 5: Check that the uploaded registration(s) is/are displayed in the overview table:

This documentation is being updated regularly. We try to provide as correct, complete and clear as possible information on these pages. Nevertheless, if you see anything in the documentation that is not correct, does not match your experience or requires further clarification, please create a request (type : request for information) via our portal (https://sciensano.service-now.com/sp) or send us an e-mail via support.healthdata@sciensano.be to report this documentation issue. Please, do not forget to mention the URL or web address of the page with the documentation issue. We will then adjust the documentation as soon as possible. Thank you!

Documentation for System 2 System API on Architecture 2.0

Description of the service

API is the acronym for Application Programming Interface, which is a software intermediary that allows two applications to talk to each other.

In this case, the API is used to have the system of the Data Providers communicate with the system of HealthData.

The S2S API is a unified API that will allow clients (Data Providers) to submit DCDs data to HD4DP2.0 in fully automated way.

End point information (per DCD) + examples

HOW TO: Upload data using System 2 System

Steps To Upload data

1. IT services of data providers must setup their systems to be able to communicate with HD4DP v2 System 2 System API

A prerequisite to be able to use the Health Data's System 2 System API, is that the IT services of the hospitals must have the following in place before the systems can communicate:

• The endpoint/URL is protected by credentials for which the support services need to be contacted.
• End-to-end API process to submit DCD registrations in a fully automated manner.
• Support for searching submitted DCD registrations.

2. Prepare the JSON file (example file in this section)

To send DCD registrations to Health Data, the file must be in a .json file format.

• At the Data Provider's side, we must foresee a way to extract the JSON file from the electronic patient files and/or other local databases.

• Author group, Author and Coauthor:
  • When the Author group, Author and Coauthor has been left out in the json file, the default Author group, Author and Coauthor will be used automatically.
  • When the desired Author group, Author and Coauthor are specified in the json file, the following fields TX_AUTHOR_GR, TX_AUTHOR and TX_COAUTHOR must be added to the json file with their values respectively.
    Example:

"TX_AUTHOR_GR": "Author Group",
"TX_AUTHOR": "author@example.com",
"TX_COAUTHOR": "coauthor@example.com",

Note:
The Author group, Author and Coauthor must exist and are well configured at the back-end of the system. TX_AUTHOR_GR can be a string that identifies the Author group to which this Author belongs. Commonly, the first name and last name are used to identify the TX_AUTHOR_GROUP. Be sure to avoid leading and trailing spaces when entering the Author group value.

• Make sure the name of the JSON file has the correct format:
  HD_DCD_submjson_HDBPnumber_HDBPabbreviation_versionnumber_versionreleasedate

So for Orthopride total femur - Revision the format would be:
HD_DCD_submjson_HDBP0048_Orthopride_TotalFemur-Revision_01_27022023
Please note that this version includes editorial changes.

Please find below example files for Orthopride total femur - Revision:

• HD_DCD_submjson_HDBP0048_Orthopride_Femur_Revision_Full_Haptic_kneeRegion_v1_20230504.json
• HD_DCD_submjson_HDBP0048_Orthopride_Femur_Revision_Full_Other_hipRegion_v1_20230504.json

Disclaimer: The example files above are only provided as a guideline and do not contain real life data.

3. Uploading the JSON File

• The IT department of the Data Provider must provide a manner in their system to send the API requests containing DCD registrations in a JSON file format, the correct end-points must be addressed.

• In this case the end-point to upload the json file will be:

4. Validate the JSON Upload

4.1 Validation of the S2S API Upload via the response:

Verify in the same way the request was sent, that the returned response is containing a valid Business key.

If a valid Business key has been provided, the registration upload via System 2 System API was succesful.

4.2 Validation of the System 2 System API via HD4DP 2.0:

Step 1: Open the web application HD4DP 2.0.

Step 2: Select the concerned organization in the dropdown list and click on Volgende (Next)

Step 3: Fill in the username and password, that has been provided by your IT Department or Healthdata team, and click on Log in to access the HD4DP 2.0 application.

Step 4: Navigate in the menu on the left-hand side panel to the desired study program:

Step 5: Check that the uploaded registration(s) is/are displayed in the overview table:

This documentation is being updated regularly. We try to provide as correct, complete and clear as possible information on these pages. Nevertheless, if you see anything in the documentation that is not correct, does not match your experience or requires further clarification, please create a request (type : request for information) via our portal (https://sciensano.service-now.com/sp) or send us an e-mail via support.healthdata@sciensano.be to report this documentation issue. Please, do not forget to mention the URL or web address of the page with the documentation issue. We will then adjust the documentation as soon as possible. Thank you!

Documentation for System 2 System API on Architecture 2.0

Description of the service

API is the acronym for Application Programming Interface, which is a software intermediary that allows two applications to talk to each other.

In this case, the API is used to have the system of the Data Providers communicate with the system of HealthData.

The S2S API is a unified API that will allow clients (Data Providers) to submit DCDs data to HD4DP2.0 in fully automated way.

End point information (per DCD) + examples

HOW TO: Upload data using System 2 System

Steps To Upload data

1. IT services of data providers must setup their systems to be able to communicate with HD4DP v2 System 2 System API

A prerequisite to be able to use the Health Data's System 2 System API, is that the IT services of the hospitals must have the following in place before the systems can communicate:

• The endpoint/URL is protected by credentials for which the support services need to be contacted.
• End-to-end API process to submit DCD registrations in a fully automated manner.
• Support for searching submitted DCD registrations.

2. Prepare the JSON file (example file in this section)

To send DCD registrations to Health Data, the file must be in a .json file format.

• At the Data Provider's side, we must foresee a way to extract the JSON file from the electronic patient files and/or other local databases.

• Author group, Author and Coauthor:
  • When the Author group, Author and Coauthor has been left out in the json file, the default Author group, Author and Coauthor will be used automatically.
  • When the desired Author group, Author and Coauthor are specified in the json file, the following fields TX_AUTHOR_GR, TX_AUTHOR and TX_COAUTHOR must be added to the json file with their values respectively.
    Example:

"TX_AUTHOR_GR": "Author Group",
"TX_AUTHOR": "author@example.com",
"TX_COAUTHOR": "coauthor@example.com",

Note:
The Author group, Author and Coauthor must exist and are well configured at the back-end of the system. TX_AUTHOR_GR can be a string that identifies the Author group to which this Author belongs. Commonly, the first name and last name are used to identify the TX_AUTHOR_GROUP. Be sure to avoid leading and trailing spaces when entering the Author group value.

• Make sure the name of the JSON file has the correct format:
  HD_DCD_submjson_HDBPnumber_HDBPabbreviation_versionnumber_versionreleasedate

So for Orthopride total femur - Resection the format would be:
HD_DCD_submjson_HDBP0048_Orthopride_TotalFemur-Resection_01_20230504.json
Please note that this version includes editorial changes.

Please find below an example file for Orthopride total femur - Resection:

• HD_DCD_submjson_HDBP0048_Orthopride_Femur_Resection_Full_v1_20230504.json

Disclaimer: The example files above are only provided as a guideline and do not contain real life data.

3. Uploading the JSON File

• The IT department of the Data Provider must provide a manner in their system to send the API requests containing DCD registrations in a JSON file format, the correct end-points must be addressed.

• In this case the end-point to upload the json file will be:

4. Validate the JSON Upload

4.1 Validation of the S2S API Upload via the response:

Verify in the same way the request was sent, that the returned response is containing a valid Business key.

If a valid Business key has been provided, the registration upload via System 2 System API was succesful.

4.2 Validation of the System 2 System API via HD4DP 2.0:

Step 1: Open the web application HD4DP 2.0.

Step 2: Select the concerned organization in the dropdown list and click on Volgende (Next)

Step 3: Fill in the username and password, that has been provided by your IT Department or Healthdata team, and click on Log in to access the HD4DP 2.0 application.

Step 4: Navigate in the menu on the left-hand side panel to the desired study program:

Step 5: Check that the uploaded registration(s) is/are displayed in the overview table:

This documentation is being updated regularly. We try to provide as correct, complete and clear as possible information on these pages. Nevertheless, if you see anything in the documentation that is not correct, does not match your experience or requires further clarification, please create a request (type : request for information) via our portal (https://sciensano.service-now.com/sp) or send us an e-mail via support.healthdata@sciensano.be to report this documentation issue. Please, do not forget to mention the URL or web address of the page with the documentation issue. We will then adjust the documentation as soon as possible. Thank you!

Documentation for CSV Upload on Architecture 2.0

Description of the service

The CSV Upload functionality gives the possibility to import multiple parameters from a set of patients in one time into HD4DP 2.0. The csv file is based on an extract of the electronic patient files and/or other local databases.

Currently there is no user interface in HD4DP 2.0 for uploading csv files. If a data provider wants to upload a csv file, the file has to be dropped at a specific location. These files will be picked up and processed periodically. The files should be “final”, meaning that no application is writing to them. The pick-up location will be identical for all registries.
Pre-registry handling will be based on a naming-convention of the csv file.

HOW TO: Upload data using CSV Upload

Steps To Upload data

1. Prepare the csv file (example file in this section)

• Extract the csv file from the electronic patient files and/or other local databases.
• Author group, Author and Coauthor:
  • When the Author Group, Author and Coauthor have been left out in the csv file, the default Author group, Author and Coauthor will be used automatically.
  • When the desired Author Group, Author and Coauthor are specified in the csv file, the following headers TX_AUTHOR_GR, TX_AUTHOR and TX_COAUTHOR must be added to the csv file with their values respectively.
    Example:

TX_AUTHOR_GR;TX_AUTHOR;TX_COAUTHOR Author Group;author@example.com;coauthor@example.com

Note:
The Author group, Author and Coauthor must exist and are well configured at the back-end of the system. TX_AUTHOR_GR can be a string that identifies the Author group to which this Author belongs. Commonly, the first name and last name are used to identify the TX_AUTHOR_GROUP. Be sure to avoid leading and trailing spaces when entering the Author group value.

• Similarly, add the filename 'STATUS' in an additional column. Add the value 'draft' in case a manual submission of the record is requested.
  If not, the record will be submitted without manual intervention.
• Make sure the name of the CSV file has the correct format:
  HD_DCD_submcsv_HDBPnumber_HDBPabbreviation_versionnumber_versionreleasedate

So for Orthopride total femur - Primo-implantation the format would be:
HD_DCD_submcsv_HDBP0048_Orthopride-TotalFemur-Primo_01_28022023

Please note that this CSV example includes the latest changes. An overview of these changes can be found in the Release notes section.

EXAMPLES:

• Please find below a HEADER file for Orthopride Total Femur - Primo-implantation:
  • HD_DCD_submcsv_HDBP0048_Orthopride_Femur_Primo_v1_20230504_HEADER.csv
• Please find below an example file for Orthopride Total Femur - Primo-implantation:
  • HD_DCD_submcsv_HDBP0048_Orthopride_Femur_Primo_Full_v1_20230504.csv
    

Disclaimer: The example files above are only provided as a guideline and do not contain real life data.

2. Uploading the csv file

Step 1: Open the sftp tool like WinSCP

Step 2: Get the credentials (Host name, Port number, User name and Password) from the IT department of the Data Provider, to log on to the sftp server located on the Data Provider side.

Step 3: Fill in the credentials into the Login screen and click on Login to be able to access the different upload folders:

Note: a warning might be given, just click on Update

Now the CSV Upload folder structure is displayed on the right-hand side panel:

Step 4: Select the project folder Orthopridetotalfemur-9 and open it by double-clicking on it:

Step 5: Double-click on the DCD folder to open it:

Step 6: Now go to the folder on the left-hand side panel where the CSV file to be uploaded is located:

Step 7: Drag the CSV file to be uploaded from the left-hand side panel into the folder on the right-hand side panel:

Step 8: Wait until the polling system of the CSV Uploader has picked up the CSV file and has processed it.
Once the CSV file has been processed it will disappear from the folder, when we refresh the page manually!

3. Validate csv upload

Once the csv file has been processed 3 folders will be created (if they haven't been created already) in the DCD folder:

• ARCHIVE (after a csv file has been processed, the original csv file will be saved in this folder)
• RESULT (when the csv file is placed in this folder, it means that the csv file has been processed, a file will be created or (or appended, if the file already existed) with the result of the upload of the csv file).
  All the errors that are described in this file are business related, which means that they are technically correct, but in violation with the business rules or contain wrong values for that field.
• ERROR (when the csv file is placed in this folder, it means that a technical error has occurred like the csv file contained erroneous formatting. The csv file won't get processed and an error file will be created with the errors and reason why the csv file couldn't be processed)

3.1 Validation of the csv upload via sftp tool:

Step 1: Double-click on the ERROR folder to open it, click on the refresh button and verify that there is no error file present.

Step 2: Return to the DCD folder. Now double-click on the RESULT folder to open it, click on the refresh button and verify that the result file is present.

Step 3: Double-click on the result file to open it.

Step 4: If there are multiple records in the result file, scroll to the entry of the current csv upload by looking at the upload date (Started at dd/mm/yyyy hh:mm).
Verify the result file that the upload was successful by searching for the word SUCCESS and having a look at the Status. This Status must contain: Success;Success Count:1;Error Count:0

3.2 Validation of the csv upload via HD4DP 2.0:

Step 1: Open the web application HD4DP 2.0.

Step 2: Select the concerned organization in the dropdown list and click on Volgende (Next)

Step 3: Fill in the username and password, that has been provided by your IT Department or Healthdata team, and click on Log in to access the HD4DP 2.0 application.

Step 4: Navigate in the menu on the left-hand side panel to the desired study program:

Step 5: Check that the uploaded DCD(s) is/are displayed in the overview table.

Documentation for CSV Upload on Architecture 2.0

Description of the service

The CSV Upload functionality gives the possibility to import multiple parameters from a set of patients in one time into HD4DP 2.0. The csv file is based on an extract of the electronic patient files and/or other local databases.

Currently there is no user interface in HD4DP 2.0 for uploading csv files. If a data provider wants to upload a csv file, the file has to be dropped at a specific location. These files will be picked up and processed periodically. The files should be “final”, meaning that no application is writing to them. The pick-up location will be identical for all registries.
Pre-registry handling will be based on a naming-convention of the csv file.

HOW TO: Upload data using CSV Upload

Steps To Upload data

1. Prepare the csv file (example file in this section)

• Extract the csv file from the electronic patient files and/or other local databases.
• Author group, Author and Coauthor:
  • When the Author Group, Author and Coauthor have been left out in the csv file, the default Author group, Author and Coauthor will be used automatically.
  • When the desired Author Group, Author and Coauthor are specified in the csv file, the following headers TX_AUTHOR_GR, TX_AUTHOR and TX_COAUTHOR must be added to the csv file with their values respectively.
    Example:

TX_AUTHOR_GR;TX_AUTHOR;TX_COAUTHOR Author Group;author@example.com;coauthor@example.com

Note:
The Author group, Author and Coauthor must exist and are well configured at the back-end of the system. TX_AUTHOR_GR can be a string that identifies the Author group to which this Author belongs. Commonly, the first name and last name are used to identify the TX_AUTHOR_GROUP. Be sure to avoid leading and trailing spaces when entering the Author group value.

• Similarly, add the filename 'STATUS' in an additional column. Add the value 'draft' in case a manual submission of the record is requested.
  If not, the record will be submitted without manual intervention.
• Make sure the name of the CSV file has the correct format:
  HD_DCD_submcsv_HDBPnumber_HDBPabbreviation_versionnumber_versionreleasedate

So for Orthopride total femur - Revision the format would be:
HD_DCD_submcsv_HDBP0048_Orthopride-TotalFemur-Revision_01_28022023
Please note that this version includes editorial changes.

EXAMPLES:

• Please find below a HEADER file for Orthopride Total Femur - Revision:
  • HD_DCD_submcsv_HDBP0048_Orthopride_Femur_Revision_v1_20230504_HEADER.csv
• Please find below an example file for Orthopride Total Femur - Revision:
  • HD_DCD_submcsv_HDBP0048_Orthopride_Femur_Revision_Full_v1_20230504.csv

Disclaimer: The example files above are only provided as a guideline and do not contain real life data.

2. Uploading the csv file

Step 1: Open the sftp tool like WinSCP

Step 2: Get the credentials (Host name, Port number, User name and Password) from the IT department of the Data Provider, to log on to the sftp server located on the Data Provider side.

Step 3: Fill in the credentials into the Login screen and click on Login to be able to access the different upload folders:

Note: a warning might be given, just click on Update

Now the CSV Upload folder structure is displayed on the right-hand side panel:

Step 4: Select the project folder Orthopridetotalfemur-9 and open it by double-clicking on it:

Step 5: Double-click on the DCD folder to open it:

Step 6: Now go to the folder on the left-hand side panel where the CSV file to be uploaded is located:

Step 7: Drag the CSV file to be uploaded from the left-hand side panel into the folder on the right-hand side panel:

Step 8: Wait until the polling system of the CSV Uploader has picked up the CSV file and has processed it.
Once the CSV file has been processed it will disappear from the folder, when we refresh the page manually!

3. Validate csv upload

Once the csv file has been processed 3 folders will be created (if they haven't been created already) in the DCD folder:

• ARCHIVE (after a csv file has been processed, the original csv file will be saved in this folder)
• RESULT (when the csv file is placed in this folder, it means that the csv file has been processed, a file will be created or (or appended, if the file already existed) with the result of the upload of the csv file).
  All the errors that are described in this file are business related, which means that they are technically correct, but in violation with the business rules or contain wrong values for that field.
• ERROR (when the csv file is placed in this folder, it means that a technical error has occurred like the csv file contained erroneous formatting. The csv file won't get processed and an error file will be created with the errors and reason why the csv file couldn't be processed)

3.1 Validation of the csv upload via sftp tool:

Step 1: Double-click on the ERROR folder to open it, click on the refresh button and verify that there is no error file present.

Step 2: Return to the DCD folder. Now double-click on the RESULT folder to open it, click on the refresh button and verify that the result file is present.

Step 3: Double-click on the result file to open it.

Step 4: If there are multiple records in the result file, scroll to the entry of the current csv upload by looking at the upload date (Started at dd/mm/yyyy hh:mm).
Verify the result file that the upload was successful by searching for the word SUCCESS and having a look at the Status. This Status must contain: Success;Success Count:1;Error Count:0

3.2 Validation of the csv upload via HD4DP 2.0:

Step 1: Open the web application HD4DP 2.0.

Step 2: Select the concerned organization in the dropdown list and click on Volgende (Next)

Step 3: Fill in the username and password, that has been provided by your IT Department or Healthdata team, and click on Log in to access the HD4DP 2.0 application.

Step 4: Navigate in the menu on the left-hand side panel to the desired study program:

Step 5: Check that the uploaded DCD(s) is/are displayed in the overview table.

Documentation for CSV Upload on Architecture 2.0

Description of the service

The CSV Upload functionality gives the possibility to import multiple parameters from a set of patients in one time into HD4DP 2.0. The csv file is based on an extract of the electronic patient files and/or other local databases.

Currently there is no user interface in HD4DP 2.0 for uploading csv files. If a data provider wants to upload a csv file, the file has to be dropped at a specific location. These files will be picked up and processed periodically. The files should be “final”, meaning that no application is writing to them. The pick-up location will be identical for all registries.
Pre-registry handling will be based on a naming-convention of the csv file.

HOW TO: Upload data using CSV Upload

Steps To Upload data

1. Prepare the csv file (example file in this section)

• Extract the csv file from the electronic patient files and/or other local databases.
• Author group, Author and Coauthor:
  • When the Author Group, Author and Coauthor have been left out in the csv file, the default Author group, Author and Coauthor will be used automatically.
  • When the desired Author Group, Author and Coauthor are specified in the csv file, the following headers TX_AUTHOR_GR, TX_AUTHOR and TX_COAUTHOR must be added to the csv file with their values respectively.
    Example:

TX_AUTHOR_GR;TX_AUTHOR;TX_COAUTHOR Author Group;author@example.com;coauthor@example.com

Note:
The Author group, Author and Coauthor must exist and are well configured at the back-end of the system. TX_AUTHOR_GR can be a string that identifies the Author group to which this Author belongs. Commonly, the first name and last name are used to identify the TX_AUTHOR_GROUP. Be sure to avoid leading and trailing spaces when entering the Author group value.

• Similarly, add the filename 'STATUS' in an additional column. Add the value 'draft' in case a manual submission of the record is requested.
  If not, the record will be submitted without manual intervention.
• Make sure the name of the CSV file has the correct format:
  HD_DCD_submcsv_HDBPnumber_HDBPabbreviation_versionnumber_versionreleasedate

• So for Orthopride total femur - Resection the format would be:
  HD_DCD_submcsv_HDBP0048_Orthopride-TotalFemur-Resection_01_28022023
  Please note that this version includes editorial changes.
  

EXAMPLES:

• Please find below a HEADER file for Orthopride Total Femur - Resection:
  • HD_DCD_submcsv_HDBP0048_Orthopride_Femur_Resection_v1_20230504_HEADER.csv
• Please find below an example file for Orthopride Total Femur - Resection:
  • HD_DCD_submcsv_HDBP0048_Orthopride_Femur_Resection_Full_v1_20230504.csv

Disclaimer: The example files above are only provided as a guideline and do not contain real life data.

2. Uploading the csv file

Step 1: Open the sftp tool like WinSCP

Step 2: Get the credentials (Host name, Port number, User name and Password) from the IT department of the Data Provider, to log on to the sftp server located on the Data Provider side.

Step 3: Fill in the credentials into the Login screen and click on Login to be able to access the different upload folders:

Note: a warning might be given, just click on Update

Now the CSV Upload folder structure is displayed on the right-hand side panel:

Step 4: Select the project folder Orthopridetotalfemur-9 and open it by double-clicking on it:

Step 5: Double-click on the DCD folder to open it:

Step 6: Now go to the folder on the left-hand side panel where the CSV file to be uploaded is located:

Step 7: Drag the CSV file to be uploaded from the left-hand side panel into the folder on the right-hand side panel:

Step 8: Wait until the polling system of the CSV Uploader has picked up the CSV file and has processed it.
Once the CSV file has been processed it will disappear from the folder, when we refresh the page manually!

3. Validate csv upload

Once the csv file has been processed 3 folders will be created (if they haven't been created already) in the DCD folder:

• ARCHIVE (after a csv file has been processed, the original csv file will be saved in this folder)
• RESULT (when the csv file is placed in this folder, it means that the csv file has been processed, a file will be created or (or appended, if the file already existed) with the result of the upload of the csv file).
  All the errors that are described in this file are business related, which means that they are technically correct, but in violation with the business rules or contain wrong values for that field.
• ERROR (when the csv file is placed in this folder, it means that a technical error has occurred like the csv file contained erroneous formatting. The csv file won't get processed and an error file will be created with the errors and reason why the csv file couldn't be processed)

3.1 Validation of the csv upload via sftp tool:

Step 1: Double-click on the ERROR folder to open it, click on the refresh button and verify that there is no error file present.

Step 2: Return to the DCD folder. Now double-click on the RESULT folder to open it, click on the refresh button and verify that the result file is present.

Step 3: Double-click on the result file to open it.

Step 4: If there are multiple records in the result file, scroll to the entry of the current csv upload by looking at the upload date (Started at dd/mm/yyyy hh:mm).
Verify the result file that the upload was successful by searching for the word SUCCESS and having a look at the Status. This Status must contain: Success;Success Count:1;Error Count:0

3.2 Validation of the csv upload via HD4DP 2.0:

Step 1: Open the web application HD4DP 2.0.

Step 2: Select the concerned organization in the dropdown list and click on Volgende (Next)

Step 3: Fill in the username and password, that has been provided by your IT Department or Healthdata team, and click on Log in to access the HD4DP 2.0 application.

Step 4: Navigate in the menu on the left-hand side panel to the desired study program:

Step 5: Check that the uploaded DCD(s) is/are displayed in the overview table

Four major actions are required in order to setup MyCareNet in HD4DP v.2:

1. Whitelisting URLs
2. Create certificate (ehealth_certificate.p12) with labels
3. Upload eHealth certificate in HD4DP v.2
4. Request credentials needed to upload the eHealth certificate

Whitelisting URL's

The following URLs must be whitelisted to communicate with MyCareNet and E-health. Without a direct connection from HD4DP v.2 server to these URLs, a registration to MyCareNet will not work.

https://prod.mycarenet.be:9443/*

https://services.ehealth.fgov.be/*

Create certificate (ehealth_certificate.p12) with labels

This part requires your organization's eHealth certificate. Create a certificate that has the name ehealth_certificate.p12 using the open source GUI KeyStore Explorer. Download and install the tool from https://keystore-explorer.org/

1. Open your organization's eHealth certificate

2. Export both certificates as a Key Pair

3. Open KeyStore Explorer, and create a new KeyStore

4. Select the type of the new KeyStore: PKCS#12

5. In the menu bar go to Tools -> Import Key Pair

6. Select the type of key pair import required:

7. Browse the authentication certificate and fill in the Decryption Password

8. Import the authentication PKCS #12 Key Pair and give it the NIHII number as alias, ex 71001129

9. Click OK and give it a password that needs to be same for all imported certs in the P12 KeyStore

10. The Key Pair is imported Successfully

11. Repeat steps 5 to 10 for importing the serial number PKCS #12 Key Pair and give it the same serial number as alias

12. Repeat step 3 to 8 to add more NIHII-HOSPITAL P12 certificates to this KeyStore

13. In the menu bar goto File-> Save All

14. Set the KeyStore Password and give it a password that needs to be same for all certificates

15. Click OK and save the KeyStore asehealth_certificate.p12

16. Click save and the P12 for HD4DP is created

Upload eHealth certificate in HD4DP v.2

The filename of your P12 certificate must be ehealth_certificate.p12

Request credentials needed to upload the eHealth certificate

The server name and the sftp credentials can be requested via our Service Portal. The password of your P12 certificate can be delivered to healthdata.be either via a secure password sharing tool of your choice or via Belnet Filesender to hd-architecture-2@sciensano.be. You can request a Belnet Filesender voucher via our Service Portal as well.

TEST2

The healthdata.be service (Sciensano) processes each incident report according to a standard operating procedure (SOP). A public version of this SOP "HD Incident Management Process" is also available on this portal docs.healthdata.be.

To submit an incident related to projects and applications in production and facilitated or managed by Sciensano's healthdata.be service, you must first log into the HD Service and Support portal: https://sciensano.service-now.com/sp

After the login step, you will arrive at the main page of the portal.

On the main page, you must select "Get Help".

A new page with the title "Create an incident" will appear.

You can now document your incident or problem by providing the following information:
Please indicate the urgency of resolving your issue based on its criticality to the business.

Please indicate the type of problem you are experiencing.

When the problem type "Application" is selected, two additional fields appear: "Project Name" and "Application".

Please select the appropriate information.

Please describe clearly and briefly (1 sentence) the subject of your problem.

Please describe the problem in detail. The following aspects are important for us to understand and solve the problem:

• a description of the actions you want to perform but fail to perform (e.g. provide us with a field name, a validation rule, a button, etc.)
• a description (if possible) of the sequential steps you follow to use the service or the application of healthdata.be for which you need support;
• a brief description of the technical problem you are experiencing (e.g. error messages)

We strongly recommend that you add a screenshot describing the problem (IMPORTANT: do not provide us with patient data!).

You can add the screenshot by clicking on "Add attachments".

On the right side of the form, the mandatory information items of the incident form are listed. When these fields are completed, their names disappear from the "required information" box.

The form can only be submitted if all required fields are filled in, by pressing the green "Submit" button.

If all required fields have not been completed, a warning message will appear at the top of the form.

In addition, missing mandatory fields will be highlighted in green.

When the incident form has been successfully submitted, a preview of your submission appears in a new screen.

On the right side of the screen you will find the details, including the incident number.

On the left side of the screen, you will find a chronology of your incident processing, starting with your creation.

A request for access to the online acceptance environment will be made available in the Entity Access Management tool available via eam.healthdata.be. See also https://docs.healthdata.be/EAM

This feature is foreseen to be added to the EAM portal during the summer of 2023. In the meantime or when the EAM portal should be unavailable, you can use the service portal to request access to the online acceptance environment by creating an incident and clearly mentioning you are an IT Department or IT partner of a data provider requesting access to the online acceptance environment.

More information on how to create an incident in the service portal is available on https://docs.healthdata.be/documentation/hd4dp-v2-health-data-data-providers/how-report-incident

You will receive 3 types of credentials:

• Credentials for the HD4DP2 web form application.
• Credentials for the API data transfer.
• Credentials for the SFTP server to upload CSV files.

The applications of healthdata.be (like HD4DP v2 and healthstat.be) process sensitive personal information. Therefore, strict controlled processes are used to grant access to these applications. The Entity Access Management (EAM) portal of healthdata.be facilitates these processes. In this article we describe how to use it.

The applications of healthdata.be (like HD4DP v2 and healthstat.be) process sensitive personal information. Therefore, strict controlled processes are used to grant access to these applications. The Entity Access Management (EAM) portal of healthdata.be facilitates these processes. In this article we describe how to use it.

First, navigate towards the EAM application via the following url: https://eam.healthdata.be

To request access to healthdata.be applications (such as HD4DP v2 and healthstat.be), you can click on REQUEST ACCESS in the blue box in the middle of the screen.

You will be transferred to the next page, where you select Connect with eID.

You will be directed to the government's Federal Authentication Service (FAS) where you can log in with multiple digital keys with eID or digital identity.

If you choose to connect with ItsMe, you can enter your cell phone number.

Follow the instructions on your mobile device via the ItsMe application.

You can now fill out the access request form.

Please fill in all fields with a red asterisk *

Note: You must indicate your role in the project (Local Study Lead, Local Study Associate or Local Study Support). Your role determines your access options in HD4DP2 for this project. Read more about User roles in HD4DP v2.

Check the boxes of the projects you wish to request access to.

Select HD4DP2.0 if you want to access the application to make recordings for the selected project.

Select Healthstat.be if you want to access the reporting of the selected project.

Click the Submit button when you have completed the form.

Once you have successfully completed the access request form, you will receive a confirmation message.

---

---

Your request will be forwarded to an employee of your organization who is authorized to grant you access. After he has approved your request, your account will be immediately created by healthdata.be. The whole procedure can take 2 working days. We will inform you once the account is active.

This documentation is being updated regularly. We try to provide as correct, complete and clear as possible information on these pages. Nevertheless, if you see anything in the documentation that is not correct, does not match your experience or requires further clarification, please create a request (type : request for information) via our portal (https://sciensano.service-now.com/sp) or send us an e-mail via support.healthdata@sciensano.be to report this documentation issue. Please, do not forget to mention the URL or web address of the page with the documentation issue. We will then adjust the documentation as soon as possible. Thank you!

The FAIR portal of healthdata.be is publicly accessible via a web browser. The web address https://fair.healthdata.be will take you to the portal's main page.

On the FAIR portal, a specific page is created for the Orthopride Total femur project. When you enter "orthopride femur" in the search bar, and push the "Go" button, you will find the project in the list of search results.

If you click on the project title, you will be directed to the project page on the FAIR portal of healthdata.be.

The current available resources are mainly so-called metadata files. Resources about the number of registrations, unique study subjects, ... are also planned to be made available on this page.

This documentation is being updated regularly. We try to provide as correct, complete and clear as possible information on these pages. Nevertheless, if you see anything in the documentation that is not correct, does not match your experience or requires further clarification, please create a request (type : request for information) via our portal (https://sciensano.service-now.com/sp) or send us an e-mail via support.healthdata@sciensano.be to report this documentation issue. Please, do not forget to mention the URL or web address of the page with the documentation issue. We will then adjust the documentation as soon as possible. Thank you!