Privacy notice for reporting an issue related to human organs 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.

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 collects the contact details of the reporter submitting an adverse reaction and event report for human organs intended for transplantation. These details are only used to follow up with the reporter regarding the report.

Legal basis for processing

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 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.

How is your information processed and shared?

The HPRA uses third party service providers and suppliers (also known as data processors) to carry out both our regulatory functions and other related matters. These third parties process personal data on behalf of the HPRA and appropriate arrangements are in place with them to protect personal data.

The personal data processed is not transmitted to third countries by the HPRA. 

The personal data is retained permanently. 

The HPRA fully respects your right to privacy and treats all personal information with the appropriate standards of security and confidentiality, strictly in accordance with data protection legislation.  

What are your rights under data protection law?

Data protection law provides you with the following rights regarding the processing of your personal data:

  • The right to request access to your data
  • The right to request your data be rectified or erased if it is inaccurate
  • The right to request processing of your data be restricted
  • The right to lodge a complaint to the Data Protection Commission

How to contact us

For more information or to make a request regarding your personal data under data protection law, please submit your request in writing or via email to:

Data Protection Officer
Health Products Regulatory Authority
Kevin O'Malley House,
Earlsfort Centre,
Earlsfort Terrace,
Dublin 2

Tel: +353 (1) 676 4971
Fax: +353 (1) 676 7836
Email: dataprotectionofficer@hpra.ie

Please provide sufficient information in your request to enable us to deal with your query. 

Further information regarding data protection at the HPRA can be found in our main privacy notice.