Health Identifiers Bill 2013: [Seanad Bill amended by the Dáil] Report and Final Stages

This is a Seanad Bill which has been amended by the Dáil. In accordance with Standing Order 118, it is deemed to have passed its First, Second and Third Stages in the Seanad and is placed on the Order Paper for Report Stage. On the question, "That the Bill be received for final consideration," the Minister may explain the purpose of the amendments made by the Dáil. This is looked upon as the report of the Dáil amendments to the Seanad. For Senators' convenience, I have arranged for the printing and circulation of the amendments. The Minister will deal separately with the subject matter of each related group of amendments. I have also circulated the proposed groupings. Senators may speak only once on each grouping. The only matters, therefore, which may be discussed are the amendments made by the Dáil.

Question proposed: "That the Bill be received for final consideration."

I call on the Minister to speak on the subject matter of the amendments in group 1, amendments Nos. 1, 2 and 5 to 7, inclusive, together.

Amendments Nos. 1, 2 and 5 were necessary owing to the renumbering caused by the substantive amendment No. 7, while amendment No. 6 was a drafting amendment to bring it into line with amendment No. 7. The objective of amendments Nos. 6 and 7 was to introduce an explicit public interest consideration where the Minister was making regulations on the following matters.

Those are adding to the list of authorised disclosees; adding to the list of specified persons; adding to the health-related purposes in secondary purposes for which the individual health identifier and the related identifying particulars can be processed; restricting access to the information in the individual health identifier register; and restricting the disclosure by specified persons of information in the register.

In determining the public interest, the Minister is required to have due regard to protecting the privacy of individuals and securing the effective achievement of one or more relevant purposes. Relevant purposes are the primary and secondary uses of the identifiers, as set out in the Bill. It should be further noted that, in all of the above cases, any such regulations made by the Minister will also be subject to consultation with the Data Protection Commissioner.

I call on the Minister to speak on the subject matter of the amendments in group 2.

This group comprises amendments Nos. 3 and 4. The Bill provides that the individual health identifier and its related identifying particulars, called relevant information, can be used for relevant purposes, namely, primary and secondary purposes. The amendments relate to a better focusing of the secondary purposes in the Bill. Consequently, I will report on them together.

In the Bill as passed by the Seanad in February, 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 identifier and its data set, the intention had been that the provision would cover health research that had been the subject of research ethics approval under national or EU law, for example, clinical trials of medicinal products for human use. In addition, 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 forthcoming health information Bill. However, the legal view was that the wording was too broad to achieve the intended objective. Hence, amendment No. 3 provides an explicit reference to 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 where the Minister has prescribed that enactment or European Act for the purposes of paragraph (d).

This issue was the subject of some discussion in the Dáil, where concerns were raised that the inclusion of the reference to research in the definition of secondary purposes might somehow suggest that private bodies that carried out research, such as research institutes and pharmaceutical companies, would have access to a person's personal health data that they did not have previously. I want to make it clear that the Bill does not change the current law on the collection, use and disclosure of personal data for any purpose including health research. If, for example, a person wants to participate in an ethically approved clinical trial, it will still be for him or her to allow the researcher access to his or her medical records. In that situation, a researcher might wish to associate the person's individual health identifier with such a record to ensure that each person voluntarily participating in the trial is uniquely identified. Accordingly, it is most important to note that allowing the use of the identifier for research purposes is tightly controlled in the Bill. Even in the limited circumstances where it is allowed, the Bill in and of itself does not confer a right of access to anyone's medical records. Any disclosure of personal health data, those being, patient identifiable information, by a health care provider, for example, the HSE, a hospital or a general practitioner, GP, to a third party for any purpose not connected with patient care is governed by data protection legislation, the common law duty of confidentiality that a health care provider owes to a patient and professional ethical rules.

Amendment No. 4 relates to paragraph (g) of the definition of secondary purposes, which initially referred to "any processing of personal data that is in accordance with the Data Protection Acts 1988 and 2003." Paragraph (g) was potentially broad and could have allowed the use of the identifier and the disclosure of identifying particulars beyond what was intended. Consistent with our desire to control and limit the use of the identifier and its data set, the original paragraph (g) was replaced with a more specific provision allowing the processing of the identifier and its data set 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 or where the processing was in accordance with the Data Protection Acts and necessary for obtaining legal advice or for the purposes of legal proceedings or alternative dispute resolution procedures. As some flexibility may be desirable, the Minister will be able to prescribe other health-related processing of the identifier and its identifying particulars not already covered under secondary purposes, should it be necessary. This will only be done where 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.

For completeness, I should add that amendments Nos. 3 and 4 have been positively discussed with the Office of the Data Protection Commissioner. In fact, this is an appropriate point to acknowledge the constructive engagement with the commissioner and his officials on this Bill generally. That engagement has ensured that the commissioner plays an important role under the Bill, as is expressly evident in numerous provisions. It also reflects my desire that privacy protection considerations should underpin the Bill.

I call on the Minister to speak on the subject matter of the amendments in group 3.

I will now report on amendments Nos. 8 and 9. Section 10 provides for access to the national individual health identifier register by the Minister and specified persons, including health professionals, their employees and agents, health organisations, their employees and agents, and other bodies. The potential number of specified persons is, therefore, large. As the section stood after the Bill was passed by the Seanad, access was to all of the information on the register, that is, the identifier and identifying particulars, with no provision to allow the Minister to control or restrict access by specified persons to a lesser amount of information. It was appropriate to include such a provision, as not every specified person would need access to all of an individual's information on the register. While the PPS number, for example, should be a searchable element in establishing an individual's identifier, it should not be something that is universally available to any specified person accessing the register. Accordingly, the purpose of amendment No. 8 was to allow for the making of regulations to limit access to the information on the register. Such regulations will require consultation with the Data Protection Commissioner and a public interest dimension.

Amendment No. 9 to section 11 is similar in principle to the amendment to section 10. Among other matters, section 11 deals with the processing by the Minister and specified persons of the identifier and the related identifying particulars in the register and the disclosure by them of such information to another specified person for relevant purposes or to an authorised disclosee for secondary purposes. Amendment No. 9 has allowed for the possibility, through regulations, of restricting the processing or further processing by specified persons of certain information on the register and the disclosure by them of such information to other specified persons for a relevant purpose. The notion of restricted disclosure is additionally strengthened by amendment No. 9 as regards disclosure by specified persons to authorised disclosees by providing for the possibility that it may also extend to restricting the use of such information in terms of certain secondary purposes. Regulations made pursuant to amendment No. 9 will involve consultation with the Data Protection Commissioner and have regard to the public interest.

I call on the Minister to speak on the subject matter of the amendment in group 4.

Amendment No. 10 is a drafting amendment to align subsections (1) and (2) of section 20 in terms of references to "relevant communication". Section 20 deals with the use of the health services provider identifier and the related national register.

Question put and agreed to.
Question proposed: "That the Bill do now pass."

I welcome the Minister to the Chamber and am glad that we have got our work done in such a short time. I am also glad that we have accepted these amendments from the Lower House. The Minister might recall that, following our debate on the Bill, I spoke to him about the question of specified persons under the Data Protection Act. That matter is now covered under section 4 where it relates to paragraph (g) in section 2. I am glad that the Minister accepted my suggestion, as it adds clarity in terms of the Data Protection Act where the provision was previously a little loose.

The Bill is highly technical and we have given it a good bit of consideration here and in the other House. It is long overdue and I am very glad that we have passed it today in this House. I congratulate the Minister.

I appreciate the Minister being here again in person and I am happy to support the legislation. I do not know whether he will be able to stay with us for the rest of the day and evening. I hope he can because we are debating health matters all day.

I thank the Minister for bringing forward the legislation. I also thank all of the people who were involved in his Department and the people on the legal side. This is a very technical Bill. It is important that it is brought through but it must also provide the necessary protections and the Bill covers all of them.

Once the Bill is fully operational, perhaps in three or four years' time, and I know none of us may be around in that capacity, the Department could check to see if it needs to be reviewed in any way. In other words, the Department must ensure that all of the adequate protections exist but at the same time ensure that the Bill is doing what it set out to do. The legislation is very technical in nature but down the line someone may decide that it goes too far or not far enough. I would be inclined to have the legislation reviewed in four or five years' time and I do not want it left unsupervised or unchecked in the future. This is important legislation and I agree with my colleague that it is long overdue. I thank the Minister for the work done on this matter.

I thank the Senators for their co-operation and support for the Bill. I also thank the Department and all of those who worked on the Bill.

An issue relating to the Bill was reported in The Sunday Business Post which indicated that patients' records were somehow made available to pharmaceutical companies and insurers. I want to put on the record of the House the fact that the HSE has confirmed that the healthcare pricing office does not - and I repeat does not - make hospital patients' personal records available to pharmaceutical companies, insurers or any other companies or entities. However, it does provide statistics on hospital activity. All data made available by the HPO is aggregate in nature which means patients cannot be identified. The type of data requested by agencies, external to the HSE, typically relates to aggregated statistical data at a national level, not at patient or hospital level. For instance, a query could relate to the number of hip replacements carried out in a given year. The release of this type of statistical data does not represent a breach of confidentiality. There is a lot more to be said. The Bill, in no way, will enable a further disclosure of people's information and in fact it protects further against same.

I seek clarification on the matter. I read the report and listened to a radio interview about the matter. The information is statistical, anonymised and is covered, I presume, by the same guidelines that govern the release of information by the CSO and other Government bodies. Is that correct?

Question put and agreed to.

I propose the suspension of the House until 3 p.m.

Sitting suspended at 2.35 p.m. and resumed at 3 p.m.