ARA.MED.160 Exchange of information on medical certificates through a central repository.

DATA CATEGORIES For the purpose of the EAMR, the information processed is divided into two categories as follows: Category 1: Basic applicant data as described in ARA.MED.160(b)(1) Category 2: Medical certificate data as described in ARA.MED.160(b)(2) Typically, the following information should not be recorded: Reasons for which a medical certificate has not been issued Only the fact that no certificate has been issued should be indicated. Any need for further clarification on whether the certificate has not been issued because of medical reasons, administrative matters or interruption of the medical assessment process before reaching the conclusion should be addressed, outside the scope of the EAMR, by the medical assessor of the licensing authority associated with the applicant’s class 1 medical certificate. Details of the limitations associated with a given medical certificate Only a ‘Yes/No’ status on the existence of such a limitation should be recorded. Any need for further clarification on the limitation(s) should be addressed, outside the scope of the EAMR, by the medical assessor of the licensing authority associated with the applicant’s class 1 medical certificate.

ROLE OF THE COMPETENT AUTHORITIES Each competent authority should:

(a)designate its EAMR administrator;

(b)ensure control and oversight of all personnel managing or using the EAMR.

RESTRICTED ACCESS TO INFORMATION Each competent authority should restrict access to personal data in the EAMR on need-to-know basis as follows:

USE OF THE EAMR The competent authority should ensure that:

(a)all personnel accessing the EAMR are trained and proficient in using the system and having the necessary knowledge for implementing the applicable data protection legislation;

(b)the oversight of persons and organisations, subject to Regulation (EU) No 2018/1139 and its implementing rules, includes the assessment of compliance with the provisions applicable to the use and functioning of the EAMR.

APPLICANT’S RECORD Each competent authority should ensure that:

(a)for each applicant for a class 1 medical certificate, a unique personal record is created in the EAMR, containing the category 1 personal data listed in ARA.MED.160(b)(1). This record is referred to as the ‘applicant’s record’;

(b)the applicant’s record is managed in accordance with the applicable regulation (typically for inserting, updating, viewing, validating data, etc.).

(c)an applicant is granted the right to obtain, without undue delay, the rectification of inaccurate personal data concerning them and, taking into account the purposes of the EAMR, the applicant is granted the right to have incomplete personal data completed. Such corrections should also be mirrored in the associated records kept in accordance with ARA.MED.150.

(d)the data recorded in the EAMR is complete as relevant for the purpose of the EAMR as described in AMC1 ARA.MED.160(b).

RECOVERY FROM UNSERVICEABILITY The competent authority should ensure that class 1 medical certificates issued or amended without being properly recorded in the EAMR, due to unserviceability of the system, are entered in the EAMR without undue delay when the system recovers.

INFORMATION OF APPLICANTS The competent authority should ensure at least the following:

(a)At the time of the creation of the applicant’s record at the latest, the applicants should be informed:

(1)that their personal data as listed in ARA.MED.160(b)(1) will be lawfully processed in a European central repository, in accordance with Article 72 of Regulation (EU) 2018/1139 and ARA.GEN.200(c) and ARA.MED.160 of Commission Regulation (EU) No 1178/2011.

(2)that the purpose of the processing is to verify that the information, as regards their previous medical certificates, provided in their declaration submitted in accordance with MED.A.035(b)(2), is consistent with the records available to all competent authorities in accordance with ARA.MED.150;

(3)of the contact details of the data protection officer as applicable;

(4)that the period for which the personal data will be stored is determined in accordance with ARA.MED.160(g);

(5)of the existence of their right to request access to, and rectification of personal data;

(6)of the contact details of the data controller;

(7)of their right to lodge a complaint with the competent data protection authority in accordance with the applicable data protection legislation;

(8)that it is ensured that access to personal data contained in the EAMR is restricted to authorised personnel in accordance with Commission Regulation (EU) No 1178/2011.

(b)When applying for a class 1 medical certificate, the applicants should be informed that the category 2 data of their medical certificate, as listed in ARA.MED.160(b)(2), will be processed to verify that the information provided in their declaration, as regards their previous medical certificates, is consistent with the information available in the EAMR.