WHERE |
WHEN |
WHO |
HEALTHCARE PERSONNEL INVOLVED |
INFORMATION TOOLS |
REGULATORY-ETHICAL FRAMEWORK |
HEALTHCARE STRUCTURE |
In Emergency
|
Affected patient, unable to express consent or in an uncomfortable condition (i.e. in ICU) |
Health personnel not able to collect consensus in the emergency situation in which they operate
|
Oral communication to the patient of a short-term sample collection, simplified consent is postponed to stabilization and/or discharge.
The collection of biological materials with the postponement of the consent is reported in the patient record, creating an alert.
However, available
-simplified informed consent;
-glossary;
-in-depth information sheets. |
National level - for Italy:
Decreto Legge n. 14 del 9 marzo 2020, Disposizioni per il potenziamento del Servizio sanitario nazionale in relazione all’emergenza COVID-19
LINK
(EDPB) - Statement on the processing of personal data in the context of the COVID-19 outbreak. Adopted on 19 March 2020
LINK |
HEALTHCARE STRUCTURE |
In ward
|
Affected, stabilized patient |
Nurses and doctors |
-simplified informed consent;
-glossary;
-in-depth information sheets. |
GDPR, in particular ART. 5-7,13
LINK
National level - for Italy:
Provvedimento recante le prescrizioni relative al trattamento di categorie particolari di dati, ai sensi dell’art. 21, comma 1 del d.lgs. 10 agosto 2018, n. 101
LINK
REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials, in particular CHAP. V
LINK
Recommendation CM/Rec(2016)6 of the Committee of Ministers to member States on research on biological materials of human origin
LINK
WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks 2016
LINK |
HEALTHCARE STRUCTURE |
At hospital discharge
|
Recovered, SARS-Cov-2-negative patient, able to express his own will |
Nurses and hospital doctors
|
HEALTHCARE STRUCTURE |
At the communication of diagnosis - results of swab analysis
|
Patient with mild symptoms, sent back to territory
|
Hospital health personnel |
In the territory or at home |
Upon notification of the quarantine obligation
|
Subject in quarantine due to familiarity or direct interaction with affected patient
|
Professionals identified by the regional/territorial health organization |
In the territory or at home |
At the take charge in the territory or at home |
Patient with mild symptoms
|
Professionals identified by the regional/territorial health organization |
In the territory or at home |
Follow up |
Cured citizen |
Professionals identified by the regional/territorial health organization |
In the territory or at home |
On the basis of the provisions in place |
Asymptomatic citizen |
Professionals identified by the regional/territorial health organization |