- Latest Updates:
- 21/10/2020: Update on Transition measures: monitoring and surveillance by Antonio Giulio de Belvis, Giovanni Fattore, Alisha Morsella, Gabriele Pastorino, Andrea Poscia, Walter Ricciardi, Andrea Silenzi
- 21/10/2020: 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
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.
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 has now become 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 advice 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 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, it had been downloaded by 5 million people (13% of the population) yet, 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 a total of 105 users who tested positive were able to alert contacts via Immuni notifications.
Furthermore, in a partnership with Here Technologies, Enel X has made available for free, until September 30th, City Analytics - Mobility Map, a mobility analysis service that functions at national level to help citizens and public administrations find the best measures to contrast to 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]
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 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.
- 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