Kiri

EpiPulse Event-Based Surveillance

Substances of human origin (SoHO)

Agoritsa Baka, Flavia Cunha, Stefania De Angelis, Francois-Xavier Lamy, Jenny Mohseni Skoglund, ECDC

17 May 2024

European Centre for Disease Prevention and Control

Before we start

Please mute your microphone when not speaking.

Please use the chat function or raise your hand to ask questions during the meeting.

Any unanswered questions will be followed up on after the meeting.

The meeting will be recorded for back-up purposes.

2

Meeting objectives

To introduce the SoHO network to EpiPulse

• Gain understanding of the EpiPulse platform, including its purpose and functionalities.

• Gain an overview of how to navigate in EpiPulse.

• Highlight the benefits of EpiPulse for the SoHO network.

• Describe roles and responsibilities.

• Outline the plan for implementation of EpiPulse for the SoHO network.

3

Agenda

1. Introduction

• Webinar objectives • EpiPulse for the SoHO-Net • EpiPulse implementation plan for the SoHO-Net

2. Overview of the EpiPulse platform

• The EpiPulse platform • What information can be shared • Access to the SoHO domain • EpiPulse item types • Role of ECDC Round Table

3. EpiPulse for the SoHO network

• Practical examples relevant to SoHO

4. Demonstration of EpiPulse

5. Summary and next steps

4

EpiPulse

▪ The European surveillance portal for infectious diseases for EU/EEA public health stakeholders and international partners

▪ Collect, analyse, share, and discuss data for threat detection, monitoring, risk assessment and outbreak response

▪ Up-to-date-overview on potential cross-border threats to health

▪ Provides forum for information exchange and collaboration between countries

5

EpiPulse for the SoHO-Net

Information to be shared by the SoHO-Net in EpiPulse

▪ Events related to donor-derived communicable disease transmission through SoHO

▪ Events related to communicable disease relevant to SoHO safety

▪ Sharing of experience and good practice related to SoHO donor selection.

(To be discussed further with each SoHO-Net group)

6

Receive information reported by ECDC and by other ECDC networks

▪ Up-to-date-overview on potential cross-border threats to health relevant for SoHO

▪ Surveillance data on infectious diseases relevant to SoHO

Introduction and Implementation of EpiPulse for the SoHO Network

7

Actions Timeline Excepted outcome for the NFPs

EpiPulse access for the SoHO-Net May 2024 Access to EpiPulse

Webinar: Introduction to EpiPulse

May 2024 Introduced to the platform

EpiPulse training (Virtual)

September 2024 Know how to navigate and utilise EpiPulse

Workshop: Information to be shared in EpiPulse

June 2024 (Organs ) September 2024 (Blood, Tissues and Cells and MAR)

Agreed on what information specific for SoHO-type that should be shared in EpiPulse.

SoHO-Net use of EpiPulse Autumn 2024 Fully introduced to the platform

Expected contribution from the SoHO-Net NFPs

Log in and explore the platform • Log in and explore the EpiPulse platform May 2024

• Receive and respond to events created from May 2024, after introduction webinar ECDC and other ECDC users

• Create items and communicate in EpiPulse Autumn 2024, after the EpiPulse hands-on with ECDC and the SoHO network. training

8

The EpiPulse platform

What is EpiPulse? The European surveillance portal for infectious diseases

• Online portal for EU/EEA public health authorities, public health stakeholders and international partners.

• Collect, analyse, share, and discuss data for threat detection, monitoring, risk assessment and outbreak response.

• Platform integrates indicator-based and event-based surveillance, including molecular typing.

9

The regulation

Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-

border threats to health (SCBTH) and repealing Decision No 1082/2013/EU

Complies with the General Data Protection Regulation (GDPR)

10

Events, Forum and News sections launched in 2021

Epidemiologic surveillance is the systematic collection, analysis and interpretation of data on communicable diseases to inform action EU Dec 2018/945 ~60 diseases

Event-based surveillance in EpiPulse

11

The value of timely positive or negative findings in country replies

• When an Event is posted by Country A, e.g. observing an atypical outbreak or trend in detections

- Country B may post a response, confirming that they have made similar observations

• It is extremely helpful during ECDC’s assessment to receive timely

- positive findings from other countries

- negative findings from other countries

- updates about ongoing investigations

• This facilitates more effective and informed risk assessment of this event

What information can be shared further

✓ Only personal account to access EpiPulse – no generic email

✓ Info cannot be shared further, unless ECDC agrees on doing so upon request

Terms of Service - Purpose and legal basis of EpiPulse

The purpose of EpiPulse is to support infectious disease surveillance, early threat detection and risk assessment in the European Union/European Economic Area (EU/EEA). The web-based platform is designed for collecting, retrieving, exploring, exchanging and discussing data and information on cases of infectious diseases, pathogens and signals and events posing potential threats to public health in Europe and beyond. EpiPulse brings together nominated national experts from EU/EEA and non-EU/EEA countries, ECDC staff and representatives of other European authorities and international organisations.

The legal basis for this activity is Regulation (EC) No 851/2004 (ECDC’s Founding Regulation), in particular articles 3, 4, 8, 10 and 11, and Decision 1082/2013/EU on serious cross-border threats to health.

Confidentiality As a User, I hereby declare that: 1. I will use EpiPulse only for the purposes and within the legal framework described in art. 1 above.

12

Please treat the data in the platform as sensitive non-classified unless specifically indicated as public

Access to EpiPulse

• Public health stakeholders

o EU/EEA countries

o EU candidate and potential candidate countries

o European Neighbourhood Policy countries

o selected countries outside the EU/EEA that have agreed cooperation frameworks with ECDC

• European Commission (DG-SANTE, DG-ECHO, DG HERA)

• Early warning and response system (EWRS) users

• EU Agencies (EFSA, EMA, EEA, ECHA, EU-OSHA)

• WHO-EURO

13

ECDC infectious disease networks

Each ECDC network has a domain in EpiPulse

• You as ECDC National Focal Points for SoHO have access to the SoHO domain

• Different sectors in the SoHO domain:

o Blood o Tissues and cells o Human organs o Medically assisted reproduction

Other users can be invited to specific events (when applicable):

WHO Euro DG SANTE

You will receive only notifications related to events relevant to SoHO and your sector. o On creation of an event o Only if you want, for new comments and other

updates

14

EpiPulse functionality

EpiPulse Item types

There are different Item types to facilitate different activities within the platform:

• Signals

• Events

• Threats

• Long-term monitoring

• Forum

• News

15

Event-based surveillance

Event

• case(s)/cluster(s)/outbreak(s)/epidemiological situation(s)/incident(s)/public health risk situation(s)

• detected in/reported by one or several countries

• that according to your assessment pose (or may pose) a public health risk for the EU/EEA

Examples:

• a case of yellow fever imported from a country where the virus is not known to circulate

• an autochthonous case of a disease in the EU/EEA, where it has not been detected previously

• detection of a novel virus/disease

• first human case for the season of locally acquired West Nile Virus in the EU/EEA

• a human case of avian influenza

• an increase in the number of imported malaria cases in one EU/EEA country

• an increase of hepatitis E cases in one EU/EEA country

Event-based surveillance in EpiPulse

17

According to their permissions, users can create an Event, a Forum or a News item

• ECDC assesses all Events, summarising in the Situation Awareness Summary.

• Should the Event be of concern within the mandate of ECDC and assessed as posing a public health risk for the EU/EEA, ECDC will re- classify the event as a Threat.

• In such cases, DG SANTE (Health Threats Unit - B2) are granted access to the Situation Awareness Summary but cannot see the initial post nor any comments from stakeholders.

ECDC users

ECDC

Epidemic Intelligence monitoring

Algorithms running on indicator-based surveillance data (cases and isolates)

EU/EEA Member States or “partner” countries and institutions

SIGNALS EVENTS THREATS

Event-based surveillance in EpiPulse

* Access to daily/weekly restricted CDTR is limited to nominated Epidemic Intelligence and Preparedness domains 18

Role of ECDC Round Table

New EpiPulse Event

ECDC assessment

ECDC Round Table review

Follow-up actions

• Review Event and classification

e.g. Event → Threat

SCBTH criteria

• Open to relevant stakeholders

e.g. WHO EURO, EFSA

• Review Event post and responses from other countries

• Follow-up with countries

• Situation Awareness Summary

- restricted version

- public version

• Follow-up with countries

• Situation Awareness Summary included in CDTR

- Daily restricted - Weekly restricted

- Weekly public

EpiPulse *

ECDC website

Event-based surveillance in EpiPulse

19

Homepage, instructional videos, help and support docs

Event-based surveillance in EpiPulse

20

When and how to post

Event-based surveillance in EpiPulse

21 Public info that can be shared

Event-based surveillance in EpiPulse

22

ECDC → SoHO-Net - examples:

Increase in Parvovirus B19 infection in several EU/EEA countries, 2024

• Event opened by Preparedness domain.

• Original Event reported an increase in human parvovirus B19 infections in pregnant women in Denmark in the 1st quarter of 2024, with information on current epidemiological features.

• Additional countries stated an increasing trend of parvovirus B19 infection in children and pregnant women, but also of B19V detections in blood and plasma donors.

• Continuous updates to the Event with additional information.

Actions by ECDC SoHO team:

• Performed: Exchange of information on detection trends of B19V by email between ECDC and NFPs for the blood sector within SoHO-Net.

• Expected: ECDC sharing the event through EpiPulse with the blood sector of SoHO-Net for the provision of information by NFPs.

Actions for SoHO-Net:

• Provide information to ECDC. NFP can consider if relevant donor assessment procedures need to be implemented locally.

23

ECDC → SoHO-Net - examples:

Increase in hepatitis E in Finland, 2024

• Item opened by the Food and waterborne domain.

• Original Event described an unusual increase in hepatitis E cases in Finland.

• Several country replies indicating similarly an unusual increase.

• Some countries did not observe this increase.

• Through further studies and genotyping, the source of infection was identified.

Actions for SoHO-Net

• For information only. NFP can consider if relevant donor assessment procedures need to be implemented locally.

24

Next steps

After this webinar:

• Please log in to the EpiPulse platform and watch the tutorials

• You will be able to receive notifications on events reported by ECDC and other ECDC networks and respond to these events if applicable/requested by creating a comment. You can log in to the platform upon an e-mail-notification with the link to the event.

• Please do not share restricted information with others. You may share information that is in the public part of the situation summary or please ask ECDC about sharing restricted information further.

September

• EpiPulse hands on training and workshop, more information will follow.

• You will be able to communicate and report events in EpiPulse after the hands-on training.

25

• The presentation will be shared after the meeting.

• Any unanswered questions will be followed up, after the meeting.

Additional questions?

• General EpiPulse feedback and technical issues - [email protected]

• Access support or login questions - [email protected]

• For SoHO specific content in EpiPulse - [email protected]

26

Thank you!

27

EpiPulse Event-Based Surveillance

Substances of human origin (SoHO)

Agoritsa Baka, Flavia Cunha, Stefania De Angelis, Francois-Xavier Lamy, Jenny Mohseni Skoglund, ECDC

17 May 2024

European Centre for Disease Prevention and Control

Before we start

Please mute your microphone when not speaking.

Please use the chat function or raise your hand to ask questions during the meeting.

Any unanswered questions will be followed up on after the meeting.

The meeting will be recorded for back-up purposes.

2

Meeting objectives

To introduce the SoHO network to EpiPulse

• Gain understanding of the EpiPulse platform, including its purpose and functionalities.

• Gain an overview of how to navigate in EpiPulse.

• Highlight the benefits of EpiPulse for the SoHO network.

• Describe roles and responsibilities.

• Outline the plan for implementation of EpiPulse for the SoHO network.

3

Agenda

1. Introduction

• Webinar objectives • EpiPulse for the SoHO-Net • EpiPulse implementation plan for the SoHO-Net

2. Overview of the EpiPulse platform

• The EpiPulse platform • What information can be shared • Access to the SoHO domain • EpiPulse item types • Role of ECDC Round Table

3. EpiPulse for the SoHO network

• Practical examples relevant to SoHO

4. Demonstration of EpiPulse

5. Summary and next steps

4

EpiPulse

▪ The European surveillance portal for infectious diseases for EU/EEA public health stakeholders and international partners

▪ Collect, analyse, share, and discuss data for threat detection, monitoring, risk assessment and outbreak response

▪ Up-to-date-overview on potential cross-border threats to health

▪ Provides forum for information exchange and collaboration between countries

5

EpiPulse for the SoHO-Net

Information to be shared by the SoHO-Net in EpiPulse

▪ Events related to donor-derived communicable disease transmission through SoHO

▪ Events related to communicable disease relevant to SoHO safety

▪ Sharing of experience and good practice related to SoHO donor selection.

(To be discussed further with each SoHO-Net group)

6

Receive information reported by ECDC and by other ECDC networks

▪ Up-to-date-overview on potential cross-border threats to health relevant for SoHO

▪ Surveillance data on infectious diseases relevant to SoHO

Introduction and Implementation of EpiPulse for the SoHO Network

7

Actions Timeline Excepted outcome for the NFPs

EpiPulse access for the SoHO-Net May 2024 Access to EpiPulse

Webinar: Introduction to EpiPulse

May 2024 Introduced to the platform

EpiPulse training (Virtual)

September 2024 Know how to navigate and utilise EpiPulse

Workshop: Information to be shared in EpiPulse

June 2024 (Organs ) September 2024 (Blood, Tissues and Cells and MAR)

Agreed on what information specific for SoHO-type that should be shared in EpiPulse.

SoHO-Net use of EpiPulse Autumn 2024 Fully introduced to the platform

Expected contribution from the SoHO-Net NFPs

Log in and explore the platform • Log in and explore the EpiPulse platform May 2024

• Receive and respond to events created from May 2024, after introduction webinar ECDC and other ECDC users

• Create items and communicate in EpiPulse Autumn 2024, after the EpiPulse hands-on with ECDC and the SoHO network. training

8

The EpiPulse platform

What is EpiPulse? The European surveillance portal for infectious diseases

• Online portal for EU/EEA public health authorities, public health stakeholders and international partners.

• Collect, analyse, share, and discuss data for threat detection, monitoring, risk assessment and outbreak response.

• Platform integrates indicator-based and event-based surveillance, including molecular typing.

9

The regulation

Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-

border threats to health (SCBTH) and repealing Decision No 1082/2013/EU

Complies with the General Data Protection Regulation (GDPR)

10

Events, Forum and News sections launched in 2021

Epidemiologic surveillance is the systematic collection, analysis and interpretation of data on communicable diseases to inform action EU Dec 2018/945 ~60 diseases

Event-based surveillance in EpiPulse

11

The value of timely positive or negative findings in country replies

• When an Event is posted by Country A, e.g. observing an atypical outbreak or trend in detections

- Country B may post a response, confirming that they have made similar observations

• It is extremely helpful during ECDC’s assessment to receive timely

- positive findings from other countries

- negative findings from other countries

- updates about ongoing investigations

• This facilitates more effective and informed risk assessment of this event

What information can be shared further

✓ Only personal account to access EpiPulse – no generic email

✓ Info cannot be shared further, unless ECDC agrees on doing so upon request

Terms of Service - Purpose and legal basis of EpiPulse

The purpose of EpiPulse is to support infectious disease surveillance, early threat detection and risk assessment in the European Union/European Economic Area (EU/EEA). The web-based platform is designed for collecting, retrieving, exploring, exchanging and discussing data and information on cases of infectious diseases, pathogens and signals and events posing potential threats to public health in Europe and beyond. EpiPulse brings together nominated national experts from EU/EEA and non-EU/EEA countries, ECDC staff and representatives of other European authorities and international organisations.

The legal basis for this activity is Regulation (EC) No 851/2004 (ECDC’s Founding Regulation), in particular articles 3, 4, 8, 10 and 11, and Decision 1082/2013/EU on serious cross-border threats to health.

Confidentiality As a User, I hereby declare that: 1. I will use EpiPulse only for the purposes and within the legal framework described in art. 1 above.

12

Please treat the data in the platform as sensitive non-classified unless specifically indicated as public

Access to EpiPulse

• Public health stakeholders

o EU/EEA countries

o EU candidate and potential candidate countries

o European Neighbourhood Policy countries

o selected countries outside the EU/EEA that have agreed cooperation frameworks with ECDC

• European Commission (DG-SANTE, DG-ECHO, DG HERA)

• Early warning and response system (EWRS) users

• EU Agencies (EFSA, EMA, EEA, ECHA, EU-OSHA)

• WHO-EURO

13

ECDC infectious disease networks

Each ECDC network has a domain in EpiPulse

• You as ECDC National Focal Points for SoHO have access to the SoHO domain

• Different sectors in the SoHO domain:

o Blood o Tissues and cells o Human organs o Medically assisted reproduction

Other users can be invited to specific events (when applicable):

WHO Euro DG SANTE

You will receive only notifications related to events relevant to SoHO and your sector. o On creation of an event o Only if you want, for new comments and other

updates

14

EpiPulse functionality

EpiPulse Item types

There are different Item types to facilitate different activities within the platform:

• Signals

• Events

• Threats

• Long-term monitoring

• Forum

• News

15

Event-based surveillance

Event

• case(s)/cluster(s)/outbreak(s)/epidemiological situation(s)/incident(s)/public health risk situation(s)

• detected in/reported by one or several countries

• that according to your assessment pose (or may pose) a public health risk for the EU/EEA

Examples:

• a case of yellow fever imported from a country where the virus is not known to circulate

• an autochthonous case of a disease in the EU/EEA, where it has not been detected previously

• detection of a novel virus/disease

• first human case for the season of locally acquired West Nile Virus in the EU/EEA

• a human case of avian influenza

• an increase in the number of imported malaria cases in one EU/EEA country

• an increase of hepatitis E cases in one EU/EEA country

Event-based surveillance in EpiPulse

17

According to their permissions, users can create an Event, a Forum or a News item

• ECDC assesses all Events, summarising in the Situation Awareness Summary.

• Should the Event be of concern within the mandate of ECDC and assessed as posing a public health risk for the EU/EEA, ECDC will re- classify the event as a Threat.

• In such cases, DG SANTE (Health Threats Unit - B2) are granted access to the Situation Awareness Summary but cannot see the initial post nor any comments from stakeholders.

ECDC users

ECDC

Epidemic Intelligence monitoring

Algorithms running on indicator-based surveillance data (cases and isolates)

EU/EEA Member States or “partner” countries and institutions

SIGNALS EVENTS THREATS

Event-based surveillance in EpiPulse

* Access to daily/weekly restricted CDTR is limited to nominated Epidemic Intelligence and Preparedness domains 18

Role of ECDC Round Table

New EpiPulse Event

ECDC assessment

ECDC Round Table review

Follow-up actions

• Review Event and classification

e.g. Event → Threat

SCBTH criteria

• Open to relevant stakeholders

e.g. WHO EURO, EFSA

• Review Event post and responses from other countries

• Follow-up with countries

• Situation Awareness Summary

- restricted version

- public version

• Follow-up with countries

• Situation Awareness Summary included in CDTR

- Daily restricted - Weekly restricted

- Weekly public

EpiPulse *

ECDC website

Event-based surveillance in EpiPulse

19

Homepage, instructional videos, help and support docs

Event-based surveillance in EpiPulse

20

When and how to post

Event-based surveillance in EpiPulse

21 Public info that can be shared

Event-based surveillance in EpiPulse

22

ECDC → SoHO-Net - examples:

Increase in Parvovirus B19 infection in several EU/EEA countries, 2024

• Event opened by Preparedness domain.

• Original Event reported an increase in human parvovirus B19 infections in pregnant women in Denmark in the 1st quarter of 2024, with information on current epidemiological features.

• Additional countries stated an increasing trend of parvovirus B19 infection in children and pregnant women, but also of B19V detections in blood and plasma donors.

• Continuous updates to the Event with additional information.

Actions by ECDC SoHO team:

• Performed: Exchange of information on detection trends of B19V by email between ECDC and NFPs for the blood sector within SoHO-Net.

• Expected: ECDC sharing the event through EpiPulse with the blood sector of SoHO-Net for the provision of information by NFPs.

Actions for SoHO-Net:

• Provide information to ECDC. NFP can consider if relevant donor assessment procedures need to be implemented locally.

23

ECDC → SoHO-Net - examples:

Increase in hepatitis E in Finland, 2024

• Item opened by the Food and waterborne domain.

• Original Event described an unusual increase in hepatitis E cases in Finland.

• Several country replies indicating similarly an unusual increase.

• Some countries did not observe this increase.

• Through further studies and genotyping, the source of infection was identified.

Actions for SoHO-Net

• For information only. NFP can consider if relevant donor assessment procedures need to be implemented locally.

24

Next steps

After this webinar:

• Please log in to the EpiPulse platform and watch the tutorials

• You will be able to receive notifications on events reported by ECDC and other ECDC networks and respond to these events if applicable/requested by creating a comment. You can log in to the platform upon an e-mail-notification with the link to the event.

• Please do not share restricted information with others. You may share information that is in the public part of the situation summary or please ask ECDC about sharing restricted information further.

September

• EpiPulse hands on training and workshop, more information will follow.

• You will be able to communicate and report events in EpiPulse after the hands-on training.

25

• The presentation will be shared after the meeting.

• Any unanswered questions will be followed up, after the meeting.

Additional questions?

• General EpiPulse feedback and technical issues - [email protected]

• Access support or login questions - [email protected]

• For SoHO specific content in EpiPulse - [email protected]

26

Thank you!

27