The National Registry of Vaccines is starting in Italy

kids and vaccines

With the month of April, the regions and autonomous provinces start sending the first data to feed the National Vaccine Register. Let’s see how it is made and how it works.

The specifications for the establishment of the National Vaccine Register (AVN System) were defined by the technical specification attached B to the Decree of the Minister of Health of 17.09.2018. This decree foresees in Article 1, paragraph 4 that the National Register of Vaccines established at the Ministry of Health records the data relating to:

  1. the vaccinated subjects;
  2. the subjects to be vaccinated;
  3. the immunized subjects referred to in Article 1, paragraph 2, of Decree Law No 73 of 7 June 2017;
  4. subjects for whom vaccinations may be omitted or deferred only in the event of ascertained danger to health, pursuant to Article 1, paragraph 3, of Decree Law No 73 of 7 June 2017;
  5. the doses and times of administration of carried out vaccinations;
  6. any undesirable effects.

The national registry of vaccines, pursuant to paragraph 2 of Article 4 bis of Law No 119/2017, collects:

  • data relating to notifications made by the treating physician, pursuant to Article 1 of the Decree of the Minister of Health of 15 December 1990, published in the Official Gazette no. 6 of 8 January 1991;
  • data concerning any undesirable effects of vaccinations that are included in the national pharmacovigilance network as per the decree of the Minister of Health of 30 April 2015.

The national register of vaccines is fed, as specified in Article 2 paragraph 2 of DM 17.09.2018, through the card of the vaccination status. This is the set of information on vaccinations administered and not administered to the patient during his/her lifetime. The form is updated in the event of a change in residence or vaccination status (i.e. if the patient receives a new dose of vaccine or if the existence of an exemption condition, omission or deferral is attested, or finally if the death of the patient occurs).

As required by Article 2, paragraph 3 of DM 17.09.2018, the sending of the updated vaccination status of each patient will take place on a quarterly basis. The cards, which are sent even if there was no change in the quarter, will always replace those sent in the previous quarter.

In case of patient transfer for change of residence, the regions and autonomous provinces from which the patient has moved, must transmit to the AVN System the patient card of vaccination status within twenty days from transfer. The same data will be made available within ten days from acquisition to the regions and autonomous provinces of the patient’s new residence.

In the case of vaccinations administered to non-resident patients, the transmission of vaccination data to the AVN System must take place within ten days of the administration date.

Three data streams are foreseen for the transmission:

  • RE – Resident Subjects;
  • TR -Subjects transferred to another region;
  • MV – Vaccination events outside the region of residence

To support the verification and monitoring of the transmitted data, the Ministry of Health provides the following systems:

  • Monitoring of Sending Flows from the Flow Management and Reception System (GAF),
  • Monitoring of loads from the NSIS dashboard system – AVN area.

Autonomous regions and provinces can choose between three alternative modes of data transmission:

  1. using the technical rules for applicative cooperation of the Public Connectivity System (SPC);
  2. using the application services that the System provides through the secure https protocol and according to the authentication rules;
  3. using bilateral authentication between systems based on digital certificates issued by an official certification authority.

The data flows, in XML format, will have an encrypted identification code of the assisted person. The files will in turn be encrypted and transmitted as described above.

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