- Latest Updates:
- 26/02/2021: Update on Easing of measures (transition measures): Monitoring and surveillance by Antonio Giulio de Belvis, Giovanni Fattore, Alisha Morsella, Gabriele Pastorino, Andrea Poscia, Walter Ricciardi, Andrea Silenzi
- 26/02/2021: Update on Monitoring and Surveillance by Antonio Giulio de Belvis, Giovanni Fattore, Alisha Morsella, Gabriele Pastorino, Andrea Poscia, Walter Ricciardi, Andrea Silenzi
1.4 Monitoring and surveillance
Risk-assessment is based on a pool of 21 indicators, adopted through Ministerial decree of 30th April 2020, that aid Italian policy makers in understanding epidemic trends and risk status of regions and autonomous provinces (APs). Regions are required to record specific data for this pool of indicators, mostly relative to Covid-19 cases, via a dedicated platform developed by the National Health Institute (ISS) which processes the received information on a weekly basis and validates it through its Control Room, before gathering it in reports to be shared with the Regions/PAs. Measuring 16 out of the 21 indicators is compulsory whereas the rest remain optional. From the first week of May (4th-10th May 2020) the data have been used by the government to gauge and make decisions (on a weekly basis) on three major risk -determinants (probability of the spread of infection, impact of the disease, and a composite metric defined as ‘territorial resilience’). The government categorizes geographical areas according their risk status (from very low to very high) which also takes into account regional health services’ resilience.
The 21 indicators are classified as follows:
1. Process indicators on data quality, which describe the level of data reliability by allowing to assess completeness, availability and timeliness of data;
2. Process indicators on diagnostic assessment, investigation and contact management capacities, which focus on evaluation of both diagnostic capacity and contact tracing efficacy;
3. Outcome indicators relating to transmission rates and healthcare services’ resilience, which serve to assess appropriateness of the local health systems’ responses with regard to the evolution of the epidemic. In fact, they provide data on new cases, on the Rt (defined as the infectiousness rate after the application of a set of measures aimed at containing the spread of the virus), number of outbreaks and bed capacity saturation.
For some indicators, thresholds are specifically identified (eg. the Rt ought to be less than 1, or ICU bed capacity saturation for Covid-19 patients is required to be below or equal to 30%). For others, policy makers conduct comparative evaluations taking into account data from previous days and build an epidemiological reference value in time (this is, for example, the case for incidence rates).
Once the data is received, it is firstly validated by assessing its compliance with the quality standards compatible with the adopted Informative Systems. Once quality has been ascertained the risk-assessment phase begins. In cases where the data are of low quality, the Region’s evaluations are suspended and the situation is considered to be potentially uncontrolled, ie. unmanageable. (This has occurred for three consecutive weeks in the region of Valle d'Aosta).
Each Region is then assigned its own level of risk and classified into one of 4 hypothetical pre-designed scenarios, distinguished according to the intensity of the required restrictions, for which a specific set of measures have been elaborated.
Despite national and regional institutions showing solid collaboration capacity, this system has raised some concerns with regard to the timeliness of publishing data (sometimes up to 2 weeks) due to the number of bureaucratic stages (both technical and institutional in nature) that are required. Furthermore, some difficulties in monitoring the time it takes to undertake testing processes has emerged (eg., the time taken from administering tests to delivering samples to the laboratory; to undertake procedures; and to release results). Such delays inevitably impact on the predictive models used for decision making. The president of GIMBE, a large independent organization dedicated to the promotion of research for evidence based practices/policy, suggested at a Senate hearing on 10th November 2020 that the system could consider relying on automatized ‘adjustment’ measures able to compensate for the delays in order to make predictions with ‘worst-case scenarios’ as opposed to ‘best-case scenarios’ (For example lowering acceptable Rt thresholds or using upper bounds of confidence intervals (Fondazione GIMBE)).
Guidelines released nationally by the ISS on 25th May (“Territorial surveillance and protection of public health: some ethical-juridical aspects”) recognize that while the use of digital apps for contact tracing are effective tools to ease monitoring and surveillance processes, they cannot be considered substitutes to the traditional ‘non digital’ contact tracing methods that Local Health Units are obliged to conduct once a new positive case is identified. Despite the struggle in performing comprehensive and rigorous contact tracing given the number of cases, at 10th November 2020, tracing activities have been showing that transmission seems to occur more severely within domestic contexts.
Digital contact tracing
After the launch of a call for proposals on 24th March, the Emergency Commissioner issued an ordinance announcing a free concession agreement to the use of a contact tracing software, designed by Bending Spoons S.p.A. The software, which will function through an App called “Immuni”, was selected among a total of 300 tenders by the experts of the Task Force set up by the Minister of Technological Innovation and Digitalization, in agreement with the Ministry of Health.
Instituted through Decree n°28 of 30th April 2020, Immuni became the Italian Government’s official contact tracing app, generated in collaboration with the Presidency of the Council of Ministers, the Minister of Health, the Minister for Technological Innovation and Digitization, the Regions, the extraordinary Commissioner for the Covid-19 emergency and the companies Sogei and PagoPa. It can be downloaded from the App Store or Google Play on a voluntary basis. It is made up of one centralized digital platform connected to an App that detects users that have potentially had close contact with positive cases. The Ministry of Health is qualified as the data controller, for the purposes of the regulations on the protection of personal data. Once Immuni is installed on a smartphone, it emits a Bluetooth signal that includes a random code. When two smartphones with Immuni find themselves in proximity, they exchange these codes via Bluetooth Low Energy technology and record them in their memory, thus keeping track of that contact. They also record how long the contact lasted and the strength of the signal, as an indicator of the distance between the two smartphones.
Once a user finds out that s/he is positive with the virus, s/he must authorize Immuni to send out alert messages that warn those who had close contact. The app returns a numeric code (OTP) that the user communicates to the healthcare provider of their Local Health Authority. The code is entered within a dedicated management interface, accessible via the “Tessera Sanitaria” [the National Health Card System], and the upload has to be confirmed by the user. The App notifies users with whom the case has been in contact, the risk to which they have been exposed and the indications to follow. By being informed promptly (potentially even before developing Covid-19 symptoms), these people can contact their GP who will make an initial assessment of the subject's risk exposure, analyse their clinical situation and advise him/her to avoid infecting others. If the potential risk is confirmed, the GP will address the user to the Local Health Authority for a deep evaluation aimed to classify the users as “close” (to be quarantined, surveyed and tested) or “casual” (for active surveillance and PCR test without quarantine) contact. Considering that the app does not allow knowing in any way the identity of the indexed case, mandatory quarantine should not be applicable without a clear link to a known Covid case. Nevertheless, GPs and local health authorities could inform users about appropriate behaviors, enable active surveillance for the early identification of COVID related symptoms and plan molecular swabs even for people who remain asymptomatic in the days following the Immuni notification.
User codes are randomly generated multiple times an hour and do not include information about the device or its user, to respect privacy. In fact, it is in no way possible to trace the identity of the user from his or her random codes. Therefore, Immuni determines when risky interactions have occurred without knowing who the two users are or where they met. The app does not collect data that allows the identity of the user to be traced. It does not ask, nor is it able to obtain, names, surnames, dates of birth, addresses, telephone numbers or e-mail addresses, the identity of the encountered people, localization or movements. It does not use geolocation data of any kind, including GPS data. This system is compliant with the model outlined by the Pan-European Privacy-Preserving Proximity Tracing (PEPPT-PT) Consortium to guarantee respect for privacy. All information saved on the device or server is collected by the Ministry of Health and will be used only to contain the Covid-19 epidemic or for scientific research purposes and will be deleted once no longer useful - in any case before 31st December 2020.
The app works in background when smartphones are turned on and Bluetooth is active but does not require an Internet connection. However, to check whether one has been exposed to positive contacts, it is necessary to log on to internet at least once a day. Immuni is also accessible to people with disabilities. In particular, it supports VoiceOver (on iOS devices) and TalkBack (on Android devices) that read writing out loud however it does not currently support voice commands.
First, a test phase was launched on June 8th 2020 in four regions, and from June 15th, the application was extended to the entire country. By 23rd July, Immuni had been downloaded by 4.3 million Italians, which is equivalent to 12% of the country’s population aged between 14 and 75 with a smartphone. By August 25th 2020, it had been downloaded by 5 million people (13% of the population). However, in order for it to be effective in containing the spread of the virus, it has been estimated that at least 60% of the population must download it. More specifically, since 1st of June 2020, a total of 105 users who tested positive were able to alert contacts via Immuni notifications.
Data on the Immuni website on 19th February 2021 shows that the digital contact tracing App has performed below expectations, with just 10.3 million users downloading the app (about 17% of the population) - of which only 11,500 positives truly uploaded their data - and around 90,000 contacts notified by the app notifications. These numbers are very low considering the aforementioned 60% threshold for effectiveness and given that, in recent months, the number of positive cases detected in Italy has been tens of thousands per day, testifying the low utilization of Immuni during the second wave.
The new Decree of the President of the Council of Ministers (DPCM) n. 258 of 18th October 2020, instructed health employees of the Local Health Authority Prevention Departments to identify Immuni user key codes of positive cases to make the use of the App more effective. However some regions had difficulties in uploading the data correctly. To boost Italy’s Immuni-system, a National Call Center was set-up in mid-January 2021, after receiving the approval the Italian GPDP (The Data Protection Authority) where people who have tested positive communicate the following three details:
- National Health Card number;
- The Unique National Code, derived from the molecular swab’s medical report
- The Immuni numeric code
This Call Center simplifies the procedure for public users and lightens the workload of Local Public Health Departments by taking care of sending the Immuni alerts to the person’s past contacts. However, by mid-February 2020, relevant changes are still to be seen.
In a partnership with Here Technologies, Enel X had made available for free, until September 30th 2020, City Analytics - Mobility Map, a mobility analysis service that functions at national level to help citizens and public administrations find the best measures to combat the spread of Covid-19. The interactive web map shows time trends of 6 key indicators:
● Variations in volume of movements
● Variations in Kilometres travelled;
● Distribution of inflows;
● Distribution of outflows;
● Variation of inflows;
● Variation of outflows.
Movements, inflows and outflows are calculated for selected geographical areas such as regions, provinces or municipalities. Information, updated daily by 12.00 pm, is processed on the basis of location data obtained from mobile apps and Public Administration open data, gathered in aggregate and anonymous form and useable for informative purposes only. No personal data used in such reports (e.g. location, contacts or movements) are made available or can be associated with identifiable individuals and tracing is not possible.
Italian Regions are autonomously finding and developing several different digital solutions for the control and containment of infected citizens which, in most cases, are based on analyses of movements and gatherings on the basis of anonymous data. For example, Lazio has activated a portal for reporting gatherings called “Unique Alert System” (https://www.comune.roma.it/web/it/di-la-tua-segnala.page) while Liguria, Lombardy, Sardinia and Umbria have started analyzing phone records and interactions. Citizens’ health status is monitored in regions like Lombardy, which has created the “LOM Alert” app.
Piedmont has designed "COVID-19 Piedmont Region Platform" for the Regional Crisis Management Unit to track and monitor all the activities concerning patients with COVID-19. Puglia and Tuscany also have regional web platforms that support assistance, care and monitoring of patients from a distance.
Lombardy has launched a Remote Training course in order to train interns and healthcare professionals specifically in contact tracing, to monitor the infected, keep contacts under surveillance and solicit testing in case of risk exposure. Such initiative has been jointly agreed and set-up by the National Health Institute (ISS) and the Directors of five specialization schools located within the region and for approximately 100 trained hygienist interns.
- ALTEMS Covid-19 working group - Instant REPORT#6: 8 Maggio 2020 - Analisi dei modelli organizzativi di risposta al Covid-19, available at https://altems.unicatt.it/altems-6REPORT%20ALTEMS.pdf
- Ministero della Salute. CIRCOLARE 18584 del 29/05/2020 “Ricerca e gestione dei contatti di casi COVID-19 (Contact tracing) ed App Immuni” [Available at: https://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2020&codLeg=74178&parte=1%20&serie=null]
- Gruppo di Lavoro Bioetica COVID-19. Sorveglianza territoriale e tutela della salute pubblica: alcuni aspetti etico-giuridici. Versione del 25 maggio 2020.
Roma: Istituto Superiore di Sanità; 2020. (Rapporto ISS COVID-19 n. 34/2020) [Available at: https://www.iss.it/documents/20126/0/Rapporto+ISS+COVID-19+34_2020.pdf/8685bd38-3ee6-f0cc-213d-2cfbe7a556cf?t=1591004947842]
- Decreto del presidente del consiglio dei ministri 18 ottobre 2020, “Ulteriori disposizioni attuative del decreto-legge 25 marzo 2020, n. 19, convertito, con modificazioni, dalla legge 25 maggio 2020, n. 35, recante «Misure urgenti per fronteggiare l'emergenza epidemiologica da COVID-19», e del decreto-legge 16 maggio 2020, n. 33, convertito, con modificazioni, dalla legge 14 luglio 2020, n. 74, recante «Ulteriori misure urgenti per fronteggiare l'emergenza epidemiologica da COVID-19». (20A05727)”, G.U. Serie Generale , n. 258 del 18 ottobre 2020 [Available at: https://www.trovanorme.salute.gov.it/norme/dettaglioAtto?id=76753]
- Ministry of Health Decree 30th April 2020 [Available at: https://www.gazzettaufficiale.it/eli/id/2020/05/02/20A02444/sg]
- Ministero della Salute - Istituto Superiore di Sanità. Prevenzione e risposta a COVID-19: evoluzione della strategia e pianificazione nella fase di transizione per il periodo autunno-invernale. vii, 115 p. 12th October 2020.
- Istituto Superiore di Sanità – Come funziona l’analisi del rischio epidemico https://www.iss.it/primo-piano/-/asset_publisher/o4oGR9qmvUz9/content/id/5513288
- Cartabellotta N, Chamber of Deputees’ auditions , 10th November 2020 [Full video available at: https://www.camera.it/leg18/1132?shadow_primapagina=11417]
- Brusaferro S, Chamber of Deputees’ audition, 10th November 2020, Social Affairs’ Commission regarding ‘Prevention and response to Covid-19' [Full video available at: https://webtv.camera.it/evento/17060 ]
On the Ministry of Health’s official website, COVID-19 is defined as the disease caused by SARS-CoV-2, as stated by WHO, which can be transmitted between humans through close contact with a probable or confirmed positive case. For surveillance purposes, Italy adopts the European Centre for Disease Prevention and Control (ECDC) definition, which describes a case as a person who is confirmed as having the virus that causes COVID-19 through lab testing, regardless of signs or clinical symptoms.
The MOH’s definition of close contact is also taken from the ECDC and includes:
● Living in the same house as a COVID-19 positive case
● Having direct physical contact (such as a handshake) with a COVID-19 positive case
● Having unprotected contact with secretions from a COVID-19 case
● Face-to-face interactions, meaning those that occur with less than 2-meter distance for more than 15 minutes
● Being in a closed environment with a COVID-19 positive case (waiting rooms, meetings) for at least 15 minutes and at a distance less than 2 meters
● Being in contact with a) a healthcare professional b) someone assisting a COVID-19 positive patient and c) laboratory staff handling samples of a COVID-19 positive, without using the recommended or appropriate Individual Protection Devices (IPD)
● Travelling by plane and sitting at a distance of less than two seats from a COVID-19 positive case. The probability of infection is extended to travel companions and crew members
For the purpose of surveillance, once a person manifests symptoms, the close contact may have occurred in the previous 14 days. However, at present, it appears that the likelihood increases most in the 48 hours prior to the manifestation of symptoms – thus, contact tracing has been focused on this timeframe. After a period of careful consideration, on 16th April the government approved digital contact-tracing software to track proximity among individuals through smartphones, to allow the detection of infected people’s proximity to others, preventing secondary transmission. More detailed information is available in Section 6. 1 “Transition measures: Measures in other sectors”.
A National Surveillance System, coordinated by the ISS, was activated on 27th February 2020 and oversees the daily gathering of data from regions and from ISS’s National Laboratory for SARS-CoV-2 through a dedicated web portal reporting infographics (graphs, maps and tables), describing the diffusion in space and time of the spread of the disease across the country and providing a brief description of infected cases. A bulletin that elaborates on this information is published daily and every Tuesday and Friday is commented by a member of the National Scientific Committee.
One year later, on February 16th 2021, the ISS also published a technical report of the first investigation on the VOC-202012/01 of the SARS-CoV-2 virus (Lineage B.1.1.7, commonly known as the UK variant or Kent variant). The result of this flash survey conducted by the ISS, the Ministry of Health and regional laboratories revealed that in Italy there is a sustained circulation of the variant - as well as in the rest of Europe - which is likely to become the prevalent one in the coming weeks. Within Italy, the prevalence of the so-called "UK variant" at the beginning of February 2021 was 17.8%, slightly lower than in France, where the prevalence was 20-25% and in Germany, where it was above 20% in the same period. For the investigation, the laboratories in the Regions were asked to select subsamples of positive cases and to sequence the genome of the virus. A total of 852 samples (from 82 laboratories in 16 Regions) were analyzed. The Ministry of Health has emphasized the need to carefully monitor the prevalence of the English variant due its greater transmissibility compared to the original virus and must be supported by strengthened mitigation measures, to stem the effects of the new variant while continuing with vaccinations, which remain effective even against the mutated virus. A second flash survey is being carried out on samples taken on 18 and 19 February (2000 sequencing planned) with a view to establishing the prevalence of not only the UK variant (B.1.1.7), but also two others (P.1 variant (Brazilian) and the B.1.351 variant).
Ministry of Health, 27th February 2020. Circular N° 0006360.
Ministry of Health, 20th March 2020. Circular N° 9774 - http://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2020&codLeg=73714&parte=1%20&serie=null