Privacy Notice - Serious Adverse Reaction/Event Report Form – Human Organs Intended for Transplantation
The HPRA, in conjunction with the HSE, is responsible for collecting reports about serious adverse events and reactions which may influence the quality and safety of human organs intended for transplantation. The HPRA is legally obliged to receive reports of such serious adverse reactions and events from procurement organisations and transplant centres under the provisions of SI 325/2012 (as amended) and associated legislation.
What information do we process?
It is not expected that any personally identifiable data of donors or recipients of human organs intended for transplantation will be collected by the HPRA. While information such as the sex, age and an identifier number of a donor or recipient may be collected, it is not anticipated that this information, alone or in combination with other information available to the HPRA, will identify any individual.
The HPRA does collect personal data of the reporter submitting a human organs intended for transplantation adverse reactions and events report. This information comprises contact details of the reporter, and is collected to facilitate communication and follow up with the reporter by the HPRA or the HSE in relation to a particular report.
The legal basis for processing personal data in incident reports is Article 6(1)(c) of the General Data Protection Regulation (GDPR), which states:
Processing is necessary for compliance with a legal obligation to which the controller is subject
The HPRA is a data controller in respect of the reporter personal data collected in human organs intended for transplantation serious adverse reactions and events incident reports. The personal data is retained indefinitely.
What are your rights under data protection law?
The right exists to request a copy of personal data held by the HPRA and to have any inaccuracies in such data corrected or deleted. Further details on data protection can be found here.
To make a request regarding your personal data under the GDPR, please submit your request in writing or via email:
Data Protection Officer
Health Products Regulatory Authority
Kevin O’Malley House,
Tel: +353 (1) 6764971
Fax:+353 (1) 6767836
Please ensure that you describe the records you seek in the greatest detail possible to enable us to identify the relevant records. The HPRA must confirm within one month if data is held and if so, the description of the data and the purposes for which they are kept. The Irish supervisory authority for data protection is the Data Protection Commission. They may be contacted here. Details of your entitlement to complain to the Data Protection Commissioner will be included in the decision letter or email.