Carrera, Alessandro
Zoccarato, Francesca
Mazzeo, Margherita
Lettieri, Emanuele
Toletti, Giovanni
Bertoli, Simona
Castelnuovo, Gianluca
Fresa, Emanuele
Article History
Received: 24 August 2022
Accepted: 23 January 2023
First Online: 10 February 2023
Declarations
:
: This study has been fully performed in accordance with guidelines and regulations. The study did not require to pass through approval from an ethics committee because this study did not change in any way patients’ therapy plans, as stated by the Decree of the Minister of Health dated February 1, 2022, and by the Regulations of the “National Ethics Committee for trials of public research institutions (EPRs) and other public institutions of national character,” at the Istituto Superiore di Sanità (ISS). Such laws state that ethic committee approval is required in the following circumstances: evaluation of clinical trials under EU Regulation 536/2014 carried out by ISS, EPRs and other public bodies of national character; evaluation of protocols of other studies (including clinical, observational, diagnostic, public health, with medical devices, with the use of human biological material, with environmental ethics implications) carried out by ISS and, possibly, by other EPRs and public bodies of national character; Advice and expression of opinions on ethical aspects of activities and interventions of ISS, in relation to its functions and duties as defined by the Statute of ISS, the Rules of Organization and Operation of ISS, and in compliance with applicable regulations.In the current paper, instead, patients were involved in this study just to express their anonymous opinions about digital therapeutics. Patients were recruited by their doctors who informed them of the purpose of this study and the policy for data collection, processing, and communication (aggregated and anonymously) coherently to the GDPR indications.Participants expressed their acceptance through an informed consent form, and they cannot be reached by researchers. Attached, is possible to see the screenshot of the first page of the survey where participants were informed about the treatment of the data according to the European General Data Protection Regulation. Participants were also explicitly asked to accept the conditions regarding the data used for this study.
: Not applicable.
: The authors declare that they have no competing interests.