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Platform for European Medical Support during major emergencies

Final Report Summary - PULSE (Platform for European Medical Support during major emergencies)

Executive Summary:
PULSE, “the Platform for European Medical Support during major emergencies” is driven by the 7th Framework Programme THEME SEC-2013.4.1-4: Development of decision support tools for improving preparedness and response of Health Services involved in emergency situations.
European Health Services (EHS) is one of the core emergency response services to deadly threats such as pandemic disease and terrorism attacks in Europe. The EHS comprises key stakeholders that include hospitals, community health services, pre-hospital emergency care services, medical suppliers, rescue services, health related voluntary services and others. It is crucial to the EHS that it remains in an excellent state of preparedness supported by first-class planning and decision support tools. Moreover in the response phase, EHS need consistent, co- ordinated and standardized advanced support methods and tools providing support in critical tasks like e.g. early threat detection, common operational picture, creation of surge capacity etc. Finally, at a pan European level, EHS also requires an interoperable framework with the ability to provide a co- ordinated European response to any major medical incident. The strategic goal of PULSE has been to define, develop and validate a methodology, an architecture and set of technologies and tools to improve- by design the preparedness and response of Health Services involved in emergency situations. This strategic goal can be mapped into a set of specific objectives:
1. To develop a standardised approach to improving preparedness, response and decision making across Europe for specific major medical emergencies.
2. To provide an EU wide operational and technical framework to enable risk managers to undertake a threat analysis situation assessment and forecast and to react accordingly with effective decision making, resources and logistics planning, assignment and control.
3. To develop innovative technology and tools to support preparedness, response and decision making and present a common operational picture to emergency personnel
4. To identify how improved legislation, directives and guidelines across Europe could improve decision making, preparedness and co-operation across , taking into consideration the protection of human rights and social norms. A pan European roadmap has been developed.
5. To develop an open operational and technical platform which will define, develop and validate procedures and processes, develop architecture and a set of technologies and tools to improve –by design– the preparedness, reliability and preparedness of European states to manage a medical crisis.
6. To develop a draft suite of European standard for large scale medical emergency including ‘common vocabulary and definitions’ – suitable for Europe and an integral part of our dissemination strategy.
7. To promote PULSE and the project results – timely and efficiently disseminate the project results; implement feasibility study and environmental analysis for effective exploitation of the project results.

Project Context and Objectives:
The overall objective of PULSE is to improve the preparedness and response of Health Services involved in emergency situations to mitigate the loss of life and improve survival rates among mass casualties. The expected impacts of the PULSE project are:
• Improved preparedness of Health Services
• Improved response of Health Services
• Improved cross-border co-operation
• A comprehensive set of operating procedures & processes
• A comprehensive set of tools
• A comprehensive training tools
• Improved logistics
• Improved understanding of legal, ethical and social issues in major emergency management
• Improved understanding of public acceptance in major emergency management
In addition to delivering key technological outputs to improve major crisis preparedness and responses, further aims are that the project can and will deliver improvements on existing technologies and methodologies which are most important and appropriate to partners and end users in general. Furthermore, the active participation of end users presents the project with a number of essential paths for user adoption across Europe. The PULSE project also allowed participants to share knowledge, expertise, foster relationships, and potential future research for future collaborations. In addition, the interoperability and cross border EU-wide aspects of the project, ensures an ability to prepare and react in a consistent manner during a major medical emergency. Finally, the sharing, comparing and assessing of different countries approaches to emergency management also strengthens the understanding of what is required within Europe to ensure an effective, speedy response by Europe as a whole to a crisis.


Project Results:
Expected benefits of the PULSE type system

The PULSE system is not a substitute for existing procedures, planning and decision support system. It was designed to fill obvious or assumed gaps in the existing regional, National and EU-level health systems (EHS). It is aimed at contributing to harmonizing response procedures, improving decision making, harmonizing information management and controlling information distribution, improving training and feedback from lessons learned and enhancing the information exchange between authorities and people. PULSE provides a framework and interoperable platform for a coordinated European response.

Requirements of a Pulse-like Platform

The vision of this PULSE support system is of an integrated approach of innovative PULSE Models of patients and treatment effects, improved situational awareness (Common Operational Picture) and sophisticated event evolution assessment and forecast, use of social media, logistics and surge capacity improvement, and powerful training and exercising.

The vision for the PULSE system includes the following;
• Better monitoring of indicators
• Early on-site contingency planning
• Fast setup of disaster control (staffing, authorization, infrastructure)
• Fast and flexible on-site treatment and availability of first-aid material
• Cross border resource sharing and coordination
• Flexible and targeted use of hospital capacities, surge requirements
• Better use of volunteers and NGOs
• Flexible state-of-the-art and collaborative training and exercising

1. Innovation in Technology and Software
Principal System Architecture of PULSE

In the first year of the project, the PULSE consortium agreed on a functional architecture approach that serves as basis to implement - and enhance existing - preventive and reactive tools and services in ICT systems supporting Major Medical Emergencies. The architecture of the PULSE platform is composed of several software modules/components distributed on a service-based architecture. A component based view of the architecture is shown in the attached graphic to the final report ‘PULSE_Architecture_Component_Diagram.PNG’

The core of the architecture is represented by the Decision Support and Validation tool (DSVT) that acts as the front-end interface as well as the communication backbone of the platform. All the other PULSE tools can (1) exploit the interfaces provided by the DSVT or (2) provide functionalities to the DSVT itself. The PULSE platform is specifically composed of the following tools:
• Decision Support and Validation Tool (DSVT): it is front-end interface as well as the communication backbone of the platform.
• Intelligence Analysis Tool (IAT): it focuses on weak signal detection to alert decision makers to the occurrence of an unusual biological event.
• Logistic Tool (LT): it is used to assess the required stockpiles of any necessary equipment, medications and vaccinations.
• Surge Capacity Generation Tool (SCGT): it provides support for the creation of surge capacity in the event of a major health crisis.
• Training Tools (TT): these tools include a MPORG training platform for personnel involved in crisis management and a training learning management system (LMS) tailored for the emergency and health services.
• Post Crisis Evaluation Tool (PCET): this tool is responsible for storing and classifying all the resources (including geospatial and time references), events and decisions that have been taken during the crisis. It allows then the creation of an historical crisis report and the definition of lessons learnt.
• Event evolution model for Biological Events (ENSIR): this tool is the implementation of a mathematical model of epidemics evolution.
• Smartphone application (SA): the Android application can be used to access the PULSE platform.


The PULSE architecture can be viewed from a multi-layered perspective. The three layered approach to the PULSE architecture is shown in the attached graphic to the final report titled ‘PULSE_MultiLayered_Architecture.PNG’. The tools have been grouped in three different layers:
• The Presentation Layer: composed of the User Interface module (part of the DSVT), the Smartphone Application and the MPORG’s GUI, represents the graphical user interface of the PULSE platform. It gives the opportunity, to the different consumers to exploit the features provided by the platform.
• The PULSE Smart Layer: it is the core of the PULSE platform. It is composed of all those tools that are able to analyse, store and elaborate the pieces of information coming from the Sources Layer and to provide enriched crisis management functionalities to the upper Presentation level.
• The Sources Layer: it is the bottom layer of the platform. It includes all the external services, data sources providing the medical and environmental information.

DSVT
The Decision support and Validation tool provides a complete set of functionalities that allow the decision makers to efficiently handle the crisis.
In particular the DSVT is able to:
• provide an enhanced operational overview to categorize and visualize the information obtained during the crisis.
• automatically create personalized suggestions to the decision makers in charge of the crisis management.
• manage (insert, update, delete) the set of crisis resources available in the platform.
Part of the functionalities are provided by DSVT thanks to the integration of the tool with the other PULSE components as explained in the following paragraphs.

DSVT – Logistic tool
The main objective of the PULSE platform is to develop an operational framework that allows the platform’s stakeholders to have access to timely key data, planning and decisions that efficiently help them to manage a major healthcare crisis. To achieve this the DSVT provides the front-end interface of the platform, invokes the Logistic tool which is in charge of managing all the data regarding events, such as the Ambulances, First Responders, Wounded, Hospitals in an incident-like scenario and the probable and confirmed cases and weak signals in a SARS-like scenario. The Logistic tool handles a diverse number of resources such as:
• Ambulance, Ambulance Category, Rescuer, Hospital, Person, Status, Resource, Resource Category, Triage, Triage Category, Task, Task Category, Contact, Clinical Record, Symptom, Symptom Category, Record, Location, Multimedia.
The Logistic tool provides a set of methods that allow to create, read, delete and update each one of above-mentioned resources and that are directly invoked by the DSVT to obtain or update the current status of the crisis

DSVT – IAT
The Intelligent Analysis Tool (IAT) is an architectural component that is able to systematically gather and analyse incoming disease-related data and, according to them, it notifies the presence of possible epidemic weak signals.
The IAT interfaces with the DSVT for different reasons:
1. it receives from the DSVT electronic clinical records related to symptoms caused by SARS infection;
2. DSVT is in charge to set up the keywords needed to configure the IAT for filtering incoming tweets by selecting only those related to SARS symptoms;
3. DSVT is also in charge to set up the rules that specify how the IAT internal CEP Engine has to derive weak signals from the input data;
4. IAT is in charge to send a week signal to the DSVT whenever it is generated; at this point, the DSVT can show on the Graphical User Interface (GUI) the message related to that week signal.

The first three functionalities are made available by the IAT through a Web Service RESTful interface. The forth one is instead offered by the DSVT again through a Web Service Restful interface. The messages exchanged through these interfaces are HTTP-based requests and responses.

DSVT – PCET
The Post Crisis Evaluation Tool (PCET) is another relevant component that interfaces with the DSVT. From the logical point of view, PCET implements two categories of functionalities: (i) those used to store information into its internal repository and (ii) those which allow to retrieve that information through the elaboration of ad hoc correlations, analytics and statistics. The first category is used by the DSVT to store historical information about an emergency (when it occurs), the second allows the DSVT to recover and analyse that information in order to show graphics, analytics and data that help understanding the evolution of the event for a post crisis evaluation. All the mentioned functionalities are made available by PCET through a specific RESTful interface. The offered HTTP methods are POST requests that include a message body whose information content is represented in JSON. On the other hand, the DSVT is equipped with an integrated RESTful client which is used to invoke the desired operations. Additional details on implemented POST requests and structure of possible message bodies are already reported in D4.6 [2].
The activity carried out to integrate DSVT and PCET mainly consisted in adapting the DSVT RESTful client to correctly invoke the PCET operations in order to obtain useful data for the post crisis evaluation. The DSVT was also treated to correctly interpret the content of each response message body, both in case of information storage and in case of query for information retrieval. This content, if present, is returned in JSON format and afterwards it is properly reported to the user with a user-friendly GUI.

DSVT – ENSIR
The objective of the ENSIR Tool is to provide the expected evolution of the spatial distribution of an epidemic, taking into account different factors that depend on the social and logistic characteristics of the interested area. In the SARS-like scenario, a decision maker (that accessed the PULSE platform through the DSVT) could be interested in knowing the possible spread of the disease within the following days/months/years. This information can help him/her to suggest an intervention (e.g. major procurement of resources) in the hospitals located in the zones that according to the simulated scenario will probably suffer from the epidemic evolution.
The ENSIR functionalities are made available through a Web Service interface based on the SOAP protocol. The DSVT integrates then a SOAP client able to specifically invoke the methods provided by the ENSIR tool. Additional details on implemented requests and structure of possible message bodies are already reported in D4.7.
The activity carried out to integrate the DSVT and the ENSIR mainly consisted in adapting the DSVT SOAP client to correctly invoke the ENSIR Web service operations. The DSVT, once obtained the data from the ENSIR, performs an internal evaluation of the responses and directly visualizes on a map the possible spread of the disease, as described in D6.1.

DSVT – SCGT
The objective of SCGT is to predict the possible evolution of some critical medical resources during a major health crisis. This functionality is exploited by the DSVT during the simulation phase, the description of the possible behaviour of all the actors involved in the scenario (e.g. casualties, first responders, ambulances, hospitals) according to the available information and the integrated evolution models.
The SCGT functionalities are made available through a Web Service interface based on the SOAP protocol. Similarly to the DSVT – ENSIR integrates a SOAP client able to specifically invoke the methods provided by the SCGT tool. Additional details on implemented requests and structure of possible message bodies are already reported in D4.4.
The activity carried out to integrate the DSVT and the SCGT mainly consisted in adapting the DSVT SOAP client to correctly invoke the SCGT Web service operations. Therefore, the DSVT elaborates the data coming from the SCGT during the simulation to efficiently predict the possible evolution of the emergency situation.

MPORG – Logistic tool
Similar to the DSVT, the MPORG provides a front end to the other Pulse services, in this case for the purposes of game-based training. After authentication, the MPORG interfaces with the other Pulse components in a read-only manner. To calculate the players score, the MPORG compares each decision made with the optimal decision at that time by sending the current hospital & patient state details to the Logistic tool and comparing that result with the state of the game after that decision has been made.

MPORG – SCGT
For generation of casualty details, the SCGT service is used.
During the game, as the player applies treatment to a patient subsequent requests are made to the SCGT service to update the status of the patient.
Smartphone app – Logistic tool
The Smartphone App is another front-end to the system, in a mobile/tablet form factor for the specific task of allowing responders in the field to read tasks & respond by submitting data records.
The App authenticates the users as normal, then requests the latest list of tasks from the Logistic tool
Communication layer
The previous paragraphs summarize all the logical connections occurring between the PULSE tools. But from an operational point of view, all the connections are actually handled by the DSVT that acts as the backbone communication layer and can be considered the “Service Bus” used by the PULSE tools to communicate. The DSVT Manager is able to:
- Group the tool functionality under a single software interface
- Group several and heterogeneous data sources and provide such sources as a single repository
- Hide the internal modularity of the platform
- Make transparent to the user the internal mapping of the tool
Because of this, the DSVT Manager provides an API that makes available the internal functionalities of the tool.

Integration with external systems
Considering the necessity to offer always updated information and to provide a complete and efficient support, the PULSE platform has been integrated with already existing services that are currently used by actors involved in emergency coordination activities.
Three different systems have been selected for this purpose:
• Open Data for real-time access in the emergency department of Lazio:
o This dataset allows to acquire the status of the emergency department of all the hospitals located in the Lazio Region (in Italy).
For each hospital it is possible to see the number of patients under observation, under treatment or that are waiting to be examined by a doctor. The number of patients is in turn divided among four different categories (red, yellow, green, white) depending on the priority code assigned to each individual patient.
o The system is currently used by the Emergency coordinator operating in the Lazio Region and it is publicly accessible through the Lazio Region web site: http://www.regione.lazio.it/accessiprontosoccorso/
o The PULSE platform integrates the functionalities provided by this dataset by invoking the API accessible at this link: http://dati.lazio.it/catalog/en/dataset/pronto-soccorso-accessi-in-tempo-reale
o The functionality has been integrated into the DSVT GUI and allows any emergency coordinator using the PULSE platform to have a real-time access to the Lazio Hospital emergency department information.
• ProMED - the Program for Monitoring Emerging Diseases:
o ProMED is dedicated to the rapid dissemination of information on outbreaks of infectious diseases and acute exposures to toxins that affect human health. It is also able to provide up-to-date and reliable news about threats to human, animal, and food plant health around the world.
o The system is accessible at the website http://promedmail.org/
o The PULSE platform allows to access the information handled by the ProMED website directly from the DSVT GUI.
o The PULSE platform provides also an alerting system that periodically checks the ProMED website and sends an alert whenever a new ProMED communication has been added to the system. This allows the decision makers to have an always updated status of epidemics all around the world.

• HealthMap:
o HealthMap brings together disparate data sources, including online news aggregators, eyewitness reports, expert-curated discussions and validated official reports, to achieve a unified and comprehensive view of the current global state of infectious diseases and their effect on human and animal health. The system monitors, organizes, integrates, filters, visualizes and disseminates online information about emerging diseases.
o The system is accessible at the website http://www.healthmap.org/en/
o The PULSE platform integrates the search widget and the results generated by HealthMap directly into the DSVT general overview map. In this way, a decision maker can easily access to the HealthMap-related alerts by simply selecting the HealthMap layer on the DSVT GUI.

As well as integrating data from external emergency response system, PULSE also provides an external interface to facility the integration of PULSE generated information into third party applications. These methods, as seen above, are actually invoked by other PULSE tools (e.g. DSVT, Smartphone app and MPORG), but the same integration can be performed by other authorized external systems that can exploit the Logistic tool functionalities and then retrieve and possibly update the crisis resources handled by the PULSE platform.

Integration with existing standards
All the PULSE tools are based on well-known and up-to-dated standards for the web communication such as:
• HTTP with the RESTful approach used by most of the PULSE tools
• SOAP used by 2 tools (SCGT and ENSIR).
As a result of this and considering the increasing acceptance of these two standards as the standards de-facto for the systems communication, the PULSE platform can be easily adaptable and integrated with a plethora of already existing systems. This approach can be considered valid for most of the domains but in the case specific of the Health domain, some effort has been spent towards the integration with already existing standards that can facilitate the communication with a usually strict and pretty closed environment.

2. Innovation in Operational Processes

The Pulse Project has designed and implemented above technological solutions with the clear purpose to introduce improvement and innovation, in the existing emergency management operational processes.
The key activities of major emergency management known as the “Process Architecture”, shown in the attachment graphic to the final report titled ‘PULSE_Process_Architecture.PNG’, mirror the proven general assessment and decision support cycle. Adapted to the PULSE project, the five key operational elements continuously revolve around a basic Knowledge Management (KM) concept. Each existing national or international system already now uses its own knowledge base for knowledge management. What is new in PULSE, however, is the consistent and integrative concept PULSE proposes to structure, to standardize and harmonize the KM process nationally and across national concepts.

The purpose of WP5 was to identify and describe, for both scenarios, the processes in place in Germany, Ireland, Italy and Romania. The analysis included also the international regimes: bi- and multilateral agreements, the EU framework, and the UN framework.

The analysis (see D5.1 for details) has shown the need to put in evidence a sixth cross-cutting process cluster: Knowledge Management (KM), in addition to the five operational procedural areas in the circle of above picture. Knowledge is meant to be the whole body of information, cognitions and skills which individuals and organizations use to solve problems. The KM process includes all activities that ensure the capture, retention and sharing of knowledge from/among the people and organizations that need and/or generate that Knowledge.
This structuring of the KM process at national and European level is a key innovation introduced by the project.
If the most part of the European Countries, with the endorsement of European actors (e.g. ECDC), adopt PULSE as common decision support system and set up the related KM roles and procedures, then a powerful knowledge sharing mechanism will leverage the experiences gained every year across Europe.
In addition to KM, Pulse enables the improvement of all five operational process clusters; improvements are detailed at two levels:
• At cluster level (paragraphs 4.1 in D5.1 and 4. In D5.2): for each cluster, guiding principles are provided and the role of PULSE is specified, including the recommended best practices and related implications and guidelines for PULSE
• At use-case level; a total of 17 use-cases were identified (see 3.3 in D5.2: 9 for the SARS-type scenario, 8 for the Stadium crush scenario) covering all the process clusters; for each one, a detailed description was given, clearly showing where and why Pulse tools facilitate improvements (see 5. in D5.2).
With its software tools and its process architecture, Pulse contributes to a common European framework that will ease harmonization of systems, cross-border coordination and knowledge sharing while leaving to each country the freedom to take care of its specific organization and processes.
Use cases represent some typical recurrent operational situations within a scenario. Their processes are described in terms of flow diagrams using a formalized existing scheme known as a Swim Lane Diagram. An example of a PULSE UC represented as a swim lane diagram is shown in the attachment graphic to the final report titled ‘PULSE_Swim_Lane_Diagram_UC2.PNG’. It sets the basis for harmonization across Europe and makes clear in which procedural steps Pulse introduces the improvements. It could set a European standard for process description, covering all essential process element:
• The responsible organization/ process owner,
• The key action elements,
• Points of decision,
• Applied PULSE decision and planning support tools and
• The logical flow of the course of actions.

The potential for actual improvement has been evaluated in both trials, using an innovative evaluation methodology.

3. Innovative Evaluation Methodology

Evaluation Methodology
The PULSE system has been evaluated in two different scenarios (see next chapter) that were broken down into a number of individual use cases (sometimes also named "Scenes"). A complex system such as the PULSE platform needs to be evaluated from very different aspects and user perspectives as it would have impact on healthcare effectiveness in diverging future scenarios, on healthcare organizations and personnel, on political decision makers and on the consequences for society as a whole and individuals affected in cases of disastrous incidents. Consequently, the evaluation process was broken down into four different "Views" on the PULSE system, its modules and on the project as a whole. The basic evaluation methodology was designed in WP5 and has already been described in D5.2.
The individual evaluation criteria and the associated questionnaires were developed on the basic PULSE SOP areas taken from the requirements analysis of WP2.
Concerning SOPs the following has to be born in mind:

- In conformity with the a definition found on ‘merriam-webster.com’, a Standing or Standard Operating Procedure can be defined as:
‘Method documented and to be followed step by step in accordance with agreed upon specifications for the routine performance of designated operations or in designated situations to help ensure a consistent and quality output’.

- It is generally understood that SOPs not only depend on processes but also on individuals and skills, infrastructure, equipment, IT and software, training and education, and other influencing factors. In a European context, this is very much so different from country to country.

In consequence, not to end in an impasse a common denominator for the project in terms of SOP development had to be identified. It was found in six SOP areas (see also 3. above). They include
• Intelligence-information gathering
• Threat and risk analysis; Warning/ alerting
• Operational picture generation and situational assessment
• Task planning and execution (like movements, triage, ...) including prioritization; Resources and capacities planning and control; Logistics/ stockpiling
• Training and exercising capability
• Knowledge management

The innovation of this approach was permissive to the determination, coordination and exercising of operational procedures no matter which specific national or international confines were underlying.
This approach allowed to combine and integrate diverse national and international operational procedures facilitating the development and utilization of nation- or region-specific use cases and health care environments, applied to the evaluation trials (see chpt.5.).
More details on tailoring and application of evaluation criteria to the specific use cases are described in D7.3.
All use cases in each selected scenario and their processes are depicted in in detailed workflow diagrams using the "Swim Lane Diagram" (SLD) methodology (see 2. above). Each diagram is further detailed by a table describing the functions to be performed in the use case and describing the application of the PULSE tools in the respective use case. A further column was created by the tool developers which contains the expected benefits the tools will or should facilitate when applied to the use case. From these expected benefits, the main measures of effectiveness (MoEs) have been derived by which the power of the tools is finally proven and validated.
The four different evaluation "Views" have covered
1. Effectiveness of the system based on criteria that address the technical and operational effects of the system in the different scenes. Measures of effectiveness (MoE) include reaction times to events, speed or timeliness of information generation, logging and access to data, quality and completeness of information and of planning and decision support, reduction of error rates, visualization of information, real-time access to information, trend analysis and re-planning information.
2. Performance of the system evaluates the inherent characteristics and the innovative features of the PULSE system. So-called measures of performance (MoP) were used to evaluate e.g. flexibility of the PULSE system to adapt to different or changing situations and to other security domains, system maturity, readiness and ease of learning and applying the system.
3. Ethical, economic, legal, political and societal implications (EELPS) were assessed with criteria covering the expected effects of PULSE on societal and ethical values, openness and transparence of information, compliance with existing regulations and rule of law, fitting into national and international operational and political health concepts, risks of and provisions for privacy and data protection. Beside the related questionnaire, also a tool has been created and demonstrated. It has a much larger and more differentiarted set of EELPS criteria and is suggested to be applied by decision makers when it comes to operational implementation of the PULSE system. To support future decision makers in evaluating the system's EELPS relevance and impacts, the PULSE consortium developed the EELPS methodology and tested a sample of its criteria using questionnaires in the two PULSE trial exercises. The methodology offered is a typical multi criteria decision analysis (MCDA) tailored to the numerous specific non-quantifiable qualitative criteria relevant for security-related planning and decision making processes. The evaluation logic and criteria were developed in close cooperation with WP8. Including such EELPS-oriented formal evaluation is supposed to be new in the security domain.
4. The General Evaluation delivered results on the general quality of the PULSE project, on the assessment of the quality and adequacy of the trial experiments and its underlying scenarios, and on the expected future acceptance of the PULSE system.
All results of these 5 categories include statistical evaluations of scoring by external stakeholders involved and integrated in the trial experiments. A total of over 80 criteria in two scenarios each have been presented and analyzed in D7.3 and documented in graphical and numerical form in a separate working document. The evaluations also included detailed analyses of the verbal contributions given in the discussions and in writing.
Generally, the evaluation results were very positive. But also questions and suggestions for further improvement were appreciated and evaluated. Evaluation results show the improvements of PULSE generated relative to the existing system.
Two typical evaluation results are depicted in the two attachment graphics i.e. ‘PULSE_Evaluation_Report_1.PNG’ and ‘PULSE_Evaluation_Report_2.PNG’, the scale ranging from 1=poor/failed to 5=excellent. Evaluation returns numbers from external stakeholders were in the order of 30.
A typical EELPS evaluation result is given in the attachment graphic ‘PULSE_Evaluation_Report_3.PNG’, showing the potential to create and evaluate positive as well as negative societal impacts .
Finally, an internal technical evaluation was performed by those team members who were involved in the development and testing of the system and its modules. The comparison with the performance evaluation done by external stakeholders revealed that the internal evaluation has no typical bias (as may have been expected): There are no statistically significant differences between the external and the internal evaluation.
Evaluation support tools included the commercial TYPEFORM system, the EELPS tool and a dedicated statistical evaluation tool developed for PULSE.

5. Pulse Trials

The Trials implemented the whole framework; in fact, it has been designed to improve the preparedness and response to major medical emergencies. The exercises carried out a concrete test of the PULSE methodologies, tools and services that will help to achieve the desired functionality described in the requirements and use cases identified in the PULSE project. Furthermore, the results of the demonstration exercise fed back directly to end users, technology providers and developers who will be able to enhance and improve the technologies going forward.
Use Case Assignment to the two Trials Sites
For each of the two Trials, and in order to perform the assessment exercise, we developed two very different scenarios

• Slow rising event Emerging Viral Disease (EVD):

• Fast pace, Mass Casualty Incident (MCI) immediate event Stadium crush:

The Emerging Viral Disease (EVD): Trial held in Rome was conducted as an Extended Table-Top Exercise. This means that it was similar to classical Table-Top where a realistic emergency is simulated in a meeting between expert members of organizations operating in the simulated scenario, but in addition it was extended, meaning that each member was called to interact with the PULSE platform to evaluate and appreciate the functionalities that it makes available. The EVD Trial was organised in seven scenes, each of which has a relationship with (1) a specific Pandemic Phase of the National Pandemic Plan and (2) a PULSE Use Case defined. All the scenes refer to a wider scenario where a new swine flu virus H1N1 (EAH1N1) originated from pigs, obtains the ability to infect humans and also causes the death of some infected persons.

The MCI trial: was held in Cork, Ireland and was designed to cover all actions associated with a fast, immediate Mass Casualty Incident (MCI)-in this instance a stadium crowd crush. Therefore, the stadium crush scenario (MCI) trial was based on following key concepts:
• Presenting a mass casualty incident during a rock concert in a stadium filled with a big crowd.
• Employment of local first responders accustomed to operating together in major emergencies, guided by established emergency roles and procedures.
• Involvement of actors and observer that have already managed similar situations in proven schemes.
• Participation of PULSE Consortium members for the evaluation of the system performance as an entity and on a technical system developer's scale.

Majority of the planned practical work within PULSE (delivering, deploying and applying tools and running test sets) was done by using the features presented by the Trials actual practical implementations. While working on the Trials, all partners and especially the PULSE consortium end user partners UCSC and IAEMO followed these basic considerations: Starting from the possible event structures, realistic scenarios and general risk, the actual trials infrastructure and its components were designed and implemented.

Upon that, the use case test steps have been derived by applying the methodology and all the experience of the partners in the project.
Beside the goal of building a realistic Trials scenario, which needed to resemble closely the likely decision making process of health service managers and current infrastructure of the end user partners, the practicability and the realness of event, scenarios and test steps were the basis which influenced all the work in the Trials.

In conducting the EVD- and MCI trials the main goal was to demonstrate and validate the effectiveness and performance of the PULSE tools and platform. PULSE technologies and scientific concepts developed aim at spanning the whole range of scenarios and requirements for medical support during major emergencies in a national and European context.
For the purpose of evaluation and validation, by design the two scenarios chosen were quite different by hazards involved, geographic distributions, target audiences affected, and inherent scenario dynamics, as described in detail in D2.2. Emphasising this approach the EVD trial applied an extended table-top scheme while the MCI trial has been executed in a semi-live format. Moreover, executing the trials in Italy and Ireland under realistic conditions has meant to encounter nationally shaped emergency routines and differently designed or interpreted international connections, all having had their own specific impact on the planning and execution of the trials.

The general characteristics of the PULSE platform were evaluated. The overall evaluations of both trials reflect a very good appreciation of the PULSE results. In both cases, the highest rates were awarded to the general concept of the PULSE project. Apart from the fact that PULSE is a research project (TRL 5) with segments that require further developments in order to become a mature and ready-to-market product, the participants indicated in both trials, similar expected obstacles for future PULSE implementation:
• need for integration with legacy systems
• heterogeneous operational frameworks
• investment for needed further developments
• general resistance to changes.
Particularly positive, convincing experiences and findings from the trials were
• PULSE was appreciated as a complex platform of tools, with an open architecture, offering support for sharing the information and achieving a real-time overview of an incident.
• The number and diversity of the external participants and the active discussions during the trials was very well appreciated.
• The PULSE’s support for actions/data logging and post incident analysis was very well regarded in both trials.

6. PULSE legal, ethical, privacy and policy (LEPPI) issues

The PULSE ethical impact assessment process, which examined legal, ethical, privacy and policy issues, included the following steps: (1) develop the EIA plan, (2) identify stakeholders, (3) consult stakeholders, (4) identify and analyse ethical impacts, (5) check whether the project complies with legislation, (6) identify risks and possible solutions, (7) formulate recommendations, (8) prepare and publish the EIA report, (9) implement recommendations, (10) third-party review. The LEPPI team assumed the primary responsibility for the steps in the process, supported by the PULSE consortium partners. While most of the steps were largely sequential in nature, several were repeated at various stages in the project, e.g. review of the risks and possible solutions, and consultation with stakeholders (at project events, trial exercises, via interviews, public consultation on project deliverables etc.).

The PULSE LEPPI work resulted in a repository of ethical, legal and social principles relevant to PULSE and public health emergency management. This repository guided the consortium and will be highly useful for organizations carrying out work in public health emergency management. The repository maps the principles against potential threats, vulnerabilities and risks, and outlines potential mitigation measures, based on a literature and good practice review.

PULSE made several types of recommendations targeted at different stakeholders who are critical to public health emergency management and response.

It recommended policy-makers: foster respect for fundamental rights in the implementation of public health emergency measures; monitor public health emergency measures implemented by private companies and agencies to ensure compliance with legal and ethical obligations; pay attention to principles such as provision of care notwithstanding personal risks, accountability mitigation, privacy of personal and sensitive information, and over-triage or under triage; collaborate with industry in the development of effective, shared strategies and promote discussion on reducing potential legal complications in cross-border co-operation and collaboration in emergencies).

PULSE recommended that implementers and end users of the PULSE system: implement the system in a coordinated manner; share knowledge with users and the public, ensuring transparency of the system; respect the purpose limitation principle; support training for operators, and employees on how to manage ethical issues; be accountable for how they use or process personal data; have a good understanding of the differences in healthcare practices and priorities across jurisdictions; consult relevant authorities to develop this understanding; create better media and public awareness about the usefulness of the system and the way risks will be managed).

PULSE recommended that designers and developers of similar systems for public health emergency management should consult the PULSE EIA and EELPS assessment results as a reference point, and review the recommendations of other relevant projects that have considered ethical, legal and societal aspects. They should conduct a privacy impact assessment and/or ethical impact assessment (e.g. using the tools such as EELPS assessment proposed in PULSE) in consultation with relevant stakeholders. They should consider, address, review and improve (as technology progresses) the security and integrity of the system, and protect it against internal compromises and external attacks. They should use strong encryption and optimize access controls.



Potential Impact:
Dissemination
Dissemination activities were an essential and pervasive activity throughout the project’s life which was integrated within all its work packages. The PULSE dissemination plan described the project’s dissemination intents and measures throughout the project’s lifecycle. It defined the key objectives for dissemination. The plan also identified the main stakeholder types and categories and assessed their role/impact on the project development. It also identified and prioritizes dissemination tools.
The following key dissemination activities were undertaken throughout the duration of the project.
Making deliverables available to the public. This activity included technical documentation on the architecture and methodologies and interfacing standards and manuals for tools and utilities developed under the project. All documentation comes with a Creative Commons License. The project’s website contains the reports and tools resulting from the project.
Contributing to (inter) national conferences and Publishing RTD results to the wider scientific community through referred journal publications, (chapters in) books and conference proceedings. The academic consortium partners submitted publications to relevant scientific journals and conferences over the course of the project.
Transferring knowledge and establishing contacts and liaisons with existing initiatives. This activity includes research exchange, workshops for professionals on the integration, maintenance, deployment of the architecture, methodologies and tools for future users and training for stakeholders.
Building communities of actors and users through a continuous networking activity with influential end-users, key health and emergency management personnel and policy makers.
Organizing end user days. This activity refers to different forms of demonstration of the possibilities that the newly developed technologies will offer. Target audience has been relevant industry, institutional, public and research actors whose main focus is the protection of the public during major crises. Participating in activities related to significant events.Furthermore they will use these events as dissemination channels for the PULSE results.
Publishing press releases about completed milestones. The PULSE consortium published press releases about important milestones, public availability of new methodologies or software components. The dissemination channels has been: research and technology related news websites, press release channels, mailing lists and the Web 2.0 community.

Target Audience:
The key messages to spread are directly connected with the impact and results expected, such as: provide a solid basis for the description of the Demonstration project and achieve qualified Europe wide awareness. The messages – the underlying themes for the project’s materials and activities - are designed taking into account the different interest groups identified and the stage at which the project is. They contain several factors that might help to determine interest groups acceptance: clarity, consistency, main points, tone and appeal, credibility and audience needs.
An important element of the dissemination process has been to define the target audiences for the dissemination activities. Target audiences clearly have to be relevant for the project’s objectives, in order to provide and receive useful information for PULSE work and further developments. The following categories of target audience are certainly relevant for PULSE:
The PULSE tools, models and methodology were designed and developed considering the requirements from a large domain of end-users, from medical and emergency management domains. The main target customers for PULSE are:
• Emergency Management Agencies,
• Public Health Authorities,
• Public Sector Decision Makers,
• Medical Officials and Scientific Community,
• Software development companies,
• Organization ensuring humanitarian protection and assistance for victims in response to major emergencies.

PULSE offers support for the improvement of the health services in both preparedness and response stages of a major medical incident, leading to a more efficient emergency management. PULSE provides validated procedures, adequate to improve the operation and success of the healthcare system in challenging disaster situations where combined operations are required at local, regional, cross border and international levels.

Public Sector Decision Makers includes institutions and authorities working in crisis and emergency management at technical or solution level, as well as decision makers in the different government bodies and authorities (e.g. health care, crisis and emergency management, etc.). PULSE supports key decision makers, by integrating a suite of models/simulations and analysis tools able to provide insights into the collective behaviour of the Health Services. The software development companies can be partners in adapting the system to the specific local requirements, to commercial exploitation as well as to installation and system maintenance.

Although PULSE was designed to support the above organisations and institutions, the consortium have identified two other domains for the PULSE platform:
• NGO staff protection
• Non Medical First Responders for Emergency Response Scenarios

Identification of the Exploitable results
Summary of exploitable items, as identified for each of the project’s objectives. (see exploitation table)

1. Methodology
-Status quo analysis of the European health system, both national and at EU level
-A set of standard operational procedures (SOPs) for the PULSE system
2. Technology & Tools
-Development of a platform for decision making based on up-to-date web technologies for real-time monitoring of hazardous scenarios and visualization of incident updates.
-Development of enhanced screen sharing functionality able to facilitate the collaboration between the platform’s users
-Development an early warning system that is able to alert decision makers to the occurrence of an unusual biological event based on clinical record and Twitter messages NLP analysis
-SMARTPHONE APPS for triage and missing persons
-MPROG training tool and Learning management system
-Definition of an algorithm for the calculation of the optimized dispatch of casualties to hospitals.
-Development of innovative approach for post crisis evaluation based on structured storage and retrieval of the incident information.
-ENSIR model prototype

3. Ethical Impact assessment methodology: Legal, ethical, privacy, policy issues relating to public health emergency management and health systems


Exploitation: The way forward
The way forward-PULSE methodology
International co-operation framework
One prerequisite for future successful implementation of a system like PULSE will be clear regulations for cooperation among the different stakeholders involved in the use of such a system. That will require the establishment of an international cooperation framework between system providers, health-operators, and national governments, the EU, the UN. and /or the modification and application of existing frameworks.
In another project on CIP/ Security (ECOSSIAN, http://ecossian.eu ), CESS have analysed this and summarized under the term pubic private partnerships (PPP) . That project has developed and IT-system for the protection of critical infrastructure, which is of similar complexity as PULSE. Other than in PULSE, a dedicated analysis was requested in that project, on the conditions and possible models of a PPP. It will be documented in ECOSSIAN D7.10.
Subjects include:
• Lessons from other domains and other nations/ status quo
• Need and rational of a PPP
• Roles of the different partners involved: National healthcare organizations (public and private); EU; WHO; ...
• Sharing of resources for system implementation and operation
• Legal framework
• Harmonization, common standards
• The role of insurances
• Sharing models and incentives for future operation and cooperation on the basis of PULSE, including
o information sharing
o sharing of resources
o sharing of tasks and responsibilities
o sharing of risks (e.g. of failures)
o Incentives for implementation and cooperation
• Joint operations models, including
o joint "command and control", based on PULSE
o closed user groups
o rules on privacy and IPR
o joint decision making procedures
o lessons learned and best practices procedures and supporting tools
o joint training and exercising
PULSE Best practices and SOPs
Within WP5 considerable work was undertaken to clearly define and understand the operation and health services across four very diverse European countries, Germany, Romania, Ireland and Italy. Together, they form a small representative group of the diverse countries that form the EU. The outputs of the research highlighted considerable similarities and differences in the operation of major emergency management across Europe. The key role that ECDC and other International Health Organisations highlighted that a cohesive approach to major health emergency planning and management is possible across countries. Pulse highlighted that
• The Intelligent Analysis tool is the cutting edge of Epidemiological Surveillance. If it is integrated with existing systems and implemented by adequate models it will help in forecasting epidemiological risks worldwide.
• Logistic and Surge Capacity Generation tools are an upgrade of existing single agency Information Repositories. They must be tailored to the end users and implemented in National and Regional Emergency Medical Systems.
• The Post Crisis Evaluation Tool must be upgraded to the applicability in international Authorities. The possibility of having a lessons learned tool is fundamental in major emergencies to identify further gaps and needs towards major preparedness. Lessons Learned from emergencies are usually very generic in that it is sometimes impossible to identify exactly the moment a decision is taken and what data were available at that moment. The PULSE system reports exactly the moment the decision maker has taken the decision and the data available for him/her at that moment. Lessons learned with this methodology will surely enhance Preparedness and Response systems of every type of responder especially of high-level authorities such as WHO and ECDC.

The way forward-PULSE Tools and Technology
Pulse platform Reliance on Wi-Fi
The PULSE platform has initially been designed to operate within a web-based environment. During the trials, it emerged that Wi-Fi may not always be available and/or of a sufficient quality to support the PULSE platform. The consortium believes that the platform needs to be extended to support KA satellite communication and other communication options. This will ensure that PULSE will operate effectively in major emergencies. As outlined in the Pulse exploitation plan, Skytek’s proposed to address this limitation of the current system and seek to ensure that the PULSE platform has a robust communication system.
Improvements in the Triage process
Currently, during the triage process, the first responder documents on paper the casualty and the condition of a casualty, usually acting alone. During the trial, it emerged that two first responders working together allowed them to very quickly and effectively triage and record patient details via the platform. Feedback was extremely positive from the first responders, as it allowed one individual triage, while the other used the PULSE system. First responders believed that first responders’ working together was a more efficient process. A time and motion study would be an interesting activity to access the validity of the findings from the PULSE MCI trial

Inclusion of Management reporting
The PULSE platform was designed to support senior managers and key decision makers during major medical emergencies. During and post a major medical crisis preparing Government and Media updates and reports is a central and critical management task. Key end users who attended both trials suggested that the PULSE platform should have a management reporting function where decision makers can easily prepare and transfer information to third parties. The ability to log activities to allow post event analysis was also identified as potential valuable addition to the system.

Extension of the Casualty Bureau Functionality
End user feedback from the trial was very positive. This group suggested that the casualty bureau app could be integrated with the triage app to allow a more powerful ‘intelligent’ system that could effectively try match casualties with missing person reports filed for example by ethnic group, hair colour, distinctive body marks, tattoos etc. The casualty bureau and triage apps are stand-alone products that can operate independently of the PULSE platform. The involvement of a police service in a follow on research project would enable the development and integration of these two applications, with strong commercial potential. Skytek is currently exploring this possibility.

PULSE broader medical users
Each one of the PULSE tools may be further refined and better adapted to the end-user who is going to use it, through customization and tailoring of the user interfaces. The performance of the trials, in particular the EVD trial in Rome, consented to identify new possibilities in terms of end-users, such as for example the Airport Medical Authorities (targeted during the end user requirement gathering) and the National Veterinary systems (not targeted during the end user requirement gathering), the Epidemiological Surveillance Systems in case of Mass Gatherings (i.e. Jubilee in Rome 2016) (not targeted during the end user requirement gathering). The PULSE Platform for the slow rising medical events was exercised on the scenario of a new influenza epidemic, but it is also customizable to practically every infectious disease epidemic. In particular, the same tools will be adapted and upgraded for a new project REACHING OUT (started October 1st 2016) in which an Ebola Epidemic in Guinea Conakry is studied. The PULSE platform was considered interesting also by the OSDIFE (Osservatorio sulla Sicurezza e Difesa CBRNe), the Italian Center deputy to the reporting of CBRNe threats in Italy who identified in the DSVT a possible good platform for regular reporting of CBRNe threats.

PULSE as a training tool

The PULSE platform is also utilizable for many a Table Top exercise with adequate previous data input. Table Top exercises played out with the Platform may consent to identify needs and gaps not only of the system, but also of the systems that are being analyzed. Aside from the MPORG tool that may be tailored to different end users, the Platform itself pre-populated with specific data, taken from historical sources or hypothetical scenarios can be used as a Living Laboratory for Table Top Exercises.
Linking to external systems
From the outset, the consortium designed the system using open standard and COTS technology that would allow the platform be easily integrated into the diverse IT systems in operation across Europe. During the trial, several key systems were identified as priorities for the PULSE platform to link to and these were successfully interfaced with for the retrieval of information during the trials. These system were:

• Open Data for real-time access in the emergency department of Lazio
• ProMED - the Program for Monitoring Emerging Diseases.
• HealthMap

As well as integrating data from external emergency response system, PULSE also provides an external interface to facility the integration of PULSE generated information into third party applications. Third party applications can easily integrate with the PULSE platform. Leonardo is currently exploring the possibility of linking PULSE with key health service systems currently within their extensive portfolio of products.

The way forward- PULSE LEPPI
In both trial exercises, results showed that the clear majority of participants did not think PULSE changes societal ethical values in a negative way. In both cases, participants strongly believe that PULSE will help channel medical resources appropriately in a public health emergency. Similarly, there was a strong belief that PULSE would create market advantages for its suppliers, developers and operators. This is a positive sign for the future development and uptake of the PULSE system. A resounding majority of participants in both cases confirmed that PULSE would bring direct benefits to people and/or society; this confirms that PULSE could be highly beneficial to health crisis management and the enhancement of emergency preparedness and response by facilitating better decision-making and resource allocation.

Most participants in both trial exercises agreed that PULSE fits into related international and EU health strategies. This is a positive indication that the platform is suitable for use across the EU. The majority in both exercises also confirmed that PULSE fits with related national health strategies. However, industry, NGOs involved, policy-makers/ crisis management and possible other end-user groups should collaborate in the development of effective, shared strategies and promote discussion on reducing any potential legal complications in cross border co-operation and collaboration in emergencies. In both the exercises, participants agreed that PULSE is compatible with human rights principles and the core values of the Union such as human dignity, freedom, equality and solidarity. Policy-makers should continue to foster respect for fundamental rights in the implementation of public health emergency measures. The risks to privacy and personal data were highlighted; these can be eliminated or minimised by adopting technical measures and organisational practices to support privacy of personal and sensitive information, respecting the data protection principles, making health managers accountable for the use and processing of personal data (e.g. by conducting a data protection impact assessment). More importantly, as PULSE would form a part of critical infrastructure, the security and integrity of the system must be safeguarded at all levels, against internal compromises and external attacks. Further, in the future if the threat profile, technical specifications of the PULSE system and/or its utilization profiles change, we recommend a revised assessment of the performance in future scenarios and of the ethical and socio-political impacts of the system (see next chapter).

Exploitation activities
The successful exploitation required a well-structured and clear exploitation agreement. From the exploitation point of view, not all partners in the consortium have a specific role in the commercial exploitation of results. The consortium agreed the framework for the common exploitation of PULSE after the project end, defining the role that each partner will have and the exploitation activities that will be needed. From the IPR point of view, the consortium will follow the IPR guidelines gathered in the Consortium Agreement signed by all partners in the beginning of the project.

Further activities required for the exploitation of the PULSE platform after the end of the EU funded project for its introduction to the market were examined. Among the exploitable items identified were products that may become marketable products after several further activities, as described below.
• Further research under international (H2020), national or regional research programs.
• Identification of potential customers and gathering of stakeholders requirements (meetings and workshops with end users, operators, owners and other parties relevant for that area of application).
• Software development to derive products from research outcomes (aiming to the pre-industrialization phase, the outcome reaching TRL 8).
• Deployment in an operational environment (TRL 9).

The readiness level of the technology and tools is TRL 5 at present. The ENSIR model is at a TRL level 4.

Conclusions
The main exploitable results of PULSE are the decision support and training tools, which, together with the methodology, may improve the preparedness and response capabilities of the health services involved or emergency situations, mitigating the loss of life and raising the survival rates among mass casualties. The main elements that differentiate PULSE from existing solutions are its modularity, scalability as well as the ability to be rapidly customized for integration with existing systems and adoption of new procedures/standards.

The immediate promising commercial applications are:
• Smart Apps: the ability by Skytek to integrate the PULSE smart apps into its current systems.
• MPORG & LMS: are stand alone training support systems that can enhance the preparedness of decision makers. These systems will now be integrated into Skytek’s current systems.
• Leonardo’s commitment to explore the possibility of integration into Leonardo’s commercial operations in the area. Leonardo has the size and scale to effectively commercialise a public sector oriented system like Pulse.

The main drivers for PULSE further development and adoption as an operational system is:
• Support offered for the improvement of the health services in both preparedness and response stages of a major medical incident, enabling a more efficient emergency management.
• Potential for operational procedures harmonization across EU and an improved cross border cooperation of the medical services.
• Support for an enhanced management of hospital resources.
• Efficient training tools with real life simulations for better training and an enhanced preparedness of the personnel involved into the management of the major medical emergencies.
• Improved understanding of public acceptance, legal, ethical and social issues in major emergency management.
The different members of the consortium are interested in the exploitation of the project results from the perspective of their individual background and commercial interest. The strong involvement of end users ensured that the Pulse platform is a system that meets the needs and requirements of a modern European Health System.


List of Websites:
http://www.pulse-fp7.com

Dr Sarah Bourke
Project Co-ordinator
Skytek
69 Fitzwilliam Lane
Dublin 2
Ireland
Tel: +353 16787660
Fax: +353 1 6787636
Sarah.bourke@skytek.com