James Reilly (Dublin North, Fine Gael)
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I move amendment No. 3:

In page 10, to delete lines 19 and 20 and substitute the following:“(d) the carrying out of health research that is the subject of a research ethics approval (or any cognate expression) under an enactment or European act prescribed for the purposes of this paragraph,”.

The Bill provides that the IHI and its related identifying particulars - called relevant information, individual, in the Bill - can be used for relevant purposes, that is, primary and secondary purposes. Amendments Nos. 3 and 4 relate to a better focusing of the secondary purposes in the Bill. Consequently, I propose to take them together.
Currently, in the Bill, one of the permitted secondary purposes as per paragraph (d) of the definition of secondary purposes is the carrying out of health research that is governed by an enactment or a European Act prescribed for the purposes of that paragraph. Consistent with the objective of focusing the use of the IHI and its dataset, the intention had been that the provision should cover research that had been the subject of research ethics approval under national or EU law, for example, clinical trials or clinical investigations into medical products and medical devices. In addition, in the future, paragraph (d) was also intended to encompass other health research that would come through the voluntary but governed research ethics approval arrangements to be provided for in the proposed Health Information Bill.
However, the legal view was that the wording was too broad to achieve the intended objective. Hence, amendment No. 3makes explicit reference to the carrying out of healthresearch that is the subject of a research ethics approval, or any cognate expression, under an enactment or European Act where the Minister has prescribed that enactment or European Act for the purposes of paragraph (d). Amendment No. 4 relates to paragraph (g) of the definition of secondary purposes which currently refers to "any processing of personal data that is in accordance with the Data Protection Acts 1988 and 2003". Paragraph (g) is potentially very broad and could allow the use of the IHI and the disclosure of identifying particulars beyond what is intended.
Again, consistent with our desire to control and limit the use of the IHI and its dataset, it is proposed to replace the existing paragraph (g) with a more specific provision allowing the processing of the IHI and its dataset under the Bill where required to protect or prevent injury or other damage to the health or safety of an individual; where required under the law or by order of a court; where the processing is in accordance with the Data Protection Acts; and where required for the purposes of obtaining legal advice, the purposes of legal proceeding or the purposes of, or in the course of, alternative dispute resolution procedures.
In recognition that some flexibility may be desirable, the Minister will be able to prescribe other health related processing of the IHI and its identifying particulars not already covered under secondary purposes should experience show that to be necessary. This would only be done where, as per amendment No. 7, the Minister is satisfied that it is in the public interest to do so and he or she has also consulted the Data Protection Commissioner. Both amendments Nos. 3 and 4 have been positively discussed with the Office of the Data Protection Commissioner.