Serious Adverse Reaction/Event Report Form – Human Tissues and Cells - Privacy Notice
As competent authority (CA) for the purpose of implementing EU and National legislation relating to Human Tissues and Cells, the HPRA is responsible for collecting reports about serious adverse reactions and events which may influence the quality and safety of human tissues and cells and serious adverse reactions which may be linked to the quality and safety of tissues and cells. The HPRA is legally obliged to receive reports of such serious adverse reactions and events from Tissue Establishments, Procurement Organisations or Organisations responsible for human application under the provisions of SI 158/2006 (as amended), SI 598/2007 and associated EU legislation.
What information do we process?
It is not expected that any identifiable personal data of donors or recipients of tissues and cells 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 tissue and cell adverse reaction or event report. This information comprises contact details of the reporter, and is collected to facilitate communication and follow up with the reporter and other organisations, if needed, in relation to a particular report.
How is your information shared?
In accordance with the legislative requirements, the HPRA submits an annual notification of summary data to the European Commission each year. This notification includes information relating to the above reports occurring in Ireland and which have been notified to the HPRA. This report contains only aggregated data with no individually identifiable information included.
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 serious tissues and cells adverse reactions and events incident reports. The personal data described above 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.