Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

Bill recommitted in respect of amendments Nos. 1 and 2.

Ruairí Ó Murchú (Louth, Sinn Fein)
Link to this: Individually | In context

Amendments Nos. 1, 2 and 6 are related and may be discussed together.

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

I move amendment No. 1:

In page 5, line 31, after “Act;” to insert “to amend the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023;”.

I am pleased to bring forward the Health Information Bill for consideration on Report Stage. Its purpose is to bring forward a number of statutory measures around the consistent sharing and use of health information while ensuring it best serves the individual patient, healthcare practitioners and society as a whole.

However, amendments Nos. 1, 2 and 6, which I understand are related and can be taken together, concern technical amendments to section 68 of the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023, which I have agreed to carry as part of the Health Information Bill. The Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023 is significant legislation signed into law on 2 May 2023, but section 68 has not yet been commenced due to the need for a technical amendment to an existing provision.

Alongside a number of other provisions, the 2023 Act amends the Health Act 2007 to extend the powers of HIQA. Section 68 provides that a new section be inserted into the 2007 Act to provide the chief inspector with a discretionary power to carry out an independent review of a defined type of serious patient safety incident where some or all of the care of the patient was carried out in a nursing home. Prior to commencement, a query was raised as to whether the provisions of section 68, as it stood at the time, included public nursing homes. It is essential that public nursing homes are included. This was considered by the Department's legal department and the Office of the Parliamentary Counsel. As the current definition of a relevant designated centre does not include public nursing homes, these amendments are necessary to ensure that public as well as private nursing homes are covered by the provision and therefore to bring the section in question in line with the intent of the Act, which it currently is not.

It is important to note that it is not a new provision but the amendment we are bringing forward today would allow us to then commence the rest at the earliest possible date. I also apologise to the House for the non-textual amendments but there is nothing I can do about that.

David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context

I will not hold the Minister up on this. I would say we will get through this very quickly. It is a technical amendment and the Minister is right. It is the only section of the Bill that has not been commenced, but obviously it is an important section. As the Minister said, it gives the chief inspector the discretionary powers to commission an investigation, and that is an important part of the Bill we had passed.

Will the Minister say, if this Bill is passed, does it have to go to the Seanad or are these the final Stages of it? When will this section of the Act actually be commissioned? What is the timeframe for it? It is an important part of the Bill that has already been passed and it is something I have raised in the past. I am anxious that it would be commenced as soon as possible.

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

This whole Bill has to go to the Seanad yet and, once that is done and this Bill is enacted, then that other provision can essentially be commenced.

David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context

We are into next year, I take it.

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

January.

Ruairí Ó Murchú (Louth, Sinn Fein)
Link to this: Individually | In context

Pursuant to Standing Order 194(3), it is reported to the Dáil that the Long Title has been amended.

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

I move amendment No. 2:

In page 6, line 5, after “Act” to insert “, other than section 25,”.

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

I move amendment No. 3:

In page 8, line 17, to delete “2004,” and substitute “2004, or”.

This is a minor technical amendment to add the word "or" between subsections (b) and (c) and the definition of "relevant person" under the Bill.

David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context

It is very controversial.

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

It is indeed, one of the more controversial things we will deal with today. The definition of "relevant person" primarily relates to Part 4. Part 4 concerns the secondary use of health information for specified public interest purposes, namely, a public interest purpose in the area of public and occupational health, policy and regulatory activities, including in respect of service planning and performance management, and statistics. Under this Part, the HSE will be empowered to request and receive from a relevant person health information for these specified public interest purposes. The provisions set out under Part 4 will, therefore, support greater and effective use of information and data, including in support of a number of activities. It is a critical step in ensuring we move beyond our current, often fragmented and even reluctant, approach to information sharing. These obstacles to information sharing remain in place. They do not serve the interests of the public. They frustrate our collective efforts to provide for health service improvement commensurate with the sustained and substantial public investment in health and social care. The Bill will provide a clarity in law that will allow us to surpass these obstacles and join other EU nations who have made more progress in digital health and social care.

A "relevant person" is defined under the Bill as a body established by or under an enactment to perform functions in relation to health services, including section 38 and 39 bodies under the Health Act 2004 or private providers who have entered into an arrangement with the HSE to provide health services. This amendment is, therefore, a technical amendment to clarify that a relevant person can fall under any one of those three categories. Deputies may wish to note that under Part 4, the HSE also has the power to specify, among other matters, the structured collection of health information to be provided as well as the digital format in which the information should be provided. Requests under Part 4 must be complied with and, in the event of non-compliance, the HSE can apply to the Circuit Court for an order directing compliance.

The Bill is clear as to the powers provided to the HSE in recognition of its role as the custodian of public investment in health and social care services. The Bill is also clear as to the positive obligation it places on health service providers, including section 38 and 39 bodies, to provide this information when and as requested to do so. Of course, it should not be necessary to wait for legislation to be enacted to ensure there is a full alignment of reporting across our publicly funded health and social care services and to ensure an effective and efficient use of resources. This should be happening in any event under existing provisions and arrangements, including the service level arrangements that section 38 and 39 bodies are required to enter into with the HSE in return for the very significant levels of public funding received.

I will continue to reflect on my engagement with the sector. I know this is something that is of great importance and interest to the health committee and the Deputies across from me, who have already expressed their support for the full integration of, for example, the integrated financial management system throughout the voluntary hospitals as well as the HSE hospitals and more broadly. I will continue to reflect on our engagement with the sector, and should I or Deputies consider it necessary, we will bring further legislative provisions or other measures to ensure this obligation is complied with without exception.

David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context

On the issue of voluntary hospitals, as the Minister has raised it, I raised this issue with the CEO of the HSE, Bernard Gloster, when he appeared before the health committee last week, as well as with Derek Tierney, the assistant secretary in the Department of Health. I have seen media reports of attempts to make sure the voluntary hospitals play ball in relation to the integrated financial service management system.

This is something I raised with staff in the HSE when we were looking at the health regions. Muiris O'Connor and others were in briefings we got when the health regions were at that point - this was before they were established - on what they would do and what they would look like. The issue of voluntary hospitals came up and it came up again in the Oireachtas Committee on Health today. There is value in them, obviously. There is a value in those hospitals having boards. They value that themselves. They are very protective of and precious about it.

It is important for all of us, whether we are in government or in opposition, to make it very clear that there is a very high expectation from this House and from, I would imagine, the public who signs the cheques for those voluntary hospitals, that they provide all of the data asked for by the HSE. The HSE is the funder on behalf of the taxpayer. There have been incidents when it has not happened and if we want consistency across all hospitals we need every hospital, including voluntary ones, to play ball. From my perspective, it is important there is not any division between the Government and Opposition and that a very clear, unified message is sent to voluntary hospitals that there cannot be any excuse for not operating these systems in full.

I would expect voluntary hospitals to engage with all of those systems in the exact same way as any other HSE publicly-funded hospital.

Pádraig Rice (Cork South-Central, Social Democrats)
Link to this: Individually | In context

I support those calls in relation to the voluntary hospitals and the requirement the right information systems are put in place and that we have robust systems and the same systems across all of our hospitals and all of our health services. We are dealing with very large sums of public money. I believe €5 billion goes into voluntary hospitals. We need to ensure there are levels of accountability and transparency there. That is required so I support the calls from others around that and support the Minister's work in that area. If we require additional amendments to this Bill to require voluntary hospitals put these systems in place, does the Minister intend to bring forward more amendments in that regard?

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

I thank both Deputies for their very clear political direction and statement of intent on this issue, which align with mine and with the broader public interest in the supervision of public funds.

From the perspective of the patient, I honestly believe the patient does not know whether he or she is attending a voluntary hospital or HSE hospital. If you are attending hospital due to a trauma or in a vulnerable situation, you honestly do not care whether the structure of the hospital to which you are presenting in need is a voluntary one or otherwise. Patients particularly do not care when they know that, as taxpayers, they are funding all of the hospitals. Indeed we are essentially funding all of the hospitals between 95% and 100%. There is simply no question that they are publicly funded and the staff are public servants. The background to voluntary hospitals is that they come from the days before when health services were in large part provided by religious orders and that is as may be. Many of them are providing a simply exceptional service with extraordinary clinical outcomes and research but they are nevertheless entirely funded by the public system and must adopt those structures.

I set out some measure of reserve, as it were, to bring Seanad amendments because I am very conscious that there has been sustained engagement for a number of years on this and it has not happened. There has been sustained political direction and engagement from me and from the Minister for public expenditure in this part of the year and the service level agreement going into 2026 will be exceptionally clear as to the need to do this. However, I reserve some position because what I would like to see from the voluntary hospitals is communication to me about their timeline for this. It is incumbent on me to provide to the health committee or the public accounts committee a list of the voluntary hospitals, the budget each of them received in 2024 and 2025 and the number of public servants that are working there. I believe it is appropriate for me to be able to provide the Deputies with a timeline as to the implementation, hospital by hospital, of IFMS. I am not in receipt of information that enables me to do that at present. Were I to receive that sort of enthusiastic engagement from the voluntary hospitals within the next number of weeks, it would ease my path to providing that sort of accountability both to the Comptroller and Auditor General and to your good selves as the lead members of the health committee.

David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context

I have a final point on this issue. I do not want to hold up the discussion on the Bill itself. I have read media reports between tensions between the Minister and some of voluntary hospitals. I do not want to get into that because I do not know the accuracy of it and I am not really that interested in it, in any event. The only interest I have is that the voluntary hospitals are fully compliant, play ball and implement in full the new financial management system that has been put in place, and any other system because I hope we will roll out electronic health records or summary care records at some point so we want the voluntary hospitals to be compliant with that as well.

The Minister is talking about amendments that may come to the Seanad as well in that area but has there been any pushback? Is there cause for concern about the voluntary hospitals? Notwithstanding what I said about reading in the media about tensions between the Minister and some of the voluntary hospitals, what has the engagement been like? Are there fears within the Department and the Minister that there is a reluctance from either all or some of the voluntary hospitals to comply with the new system that is being put in place?

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

There is no tension between me and any part of the health system. There is a report of an engagement in relation to one of the voluntary hospitals and the Chair and there is a difference of opinion that was aired in the media. My broad sense is that there is exceptionally good work being done in voluntary hospitals. Many of them, for example, have addressed their trolley situations in exceptionally good ways and are to be commended on that.

I think there is a difference of understanding in relation to the role of the board and the obligations of the board, who take their obligations under the Companies Act very seriously. Of course, the first obligation of any company director is to comply with the law of the land and to comply with the direction of the funders and shareholders, where that is appropriate within certain sectors. It is fair to say in the same way we have had the Health Information Bill, there has been a difficulty of engagement over different issues, whether it is sharing of patient data or the adoption of certain systems. There are already media reports of voluntary hospitals buying other systems that are not IFMS and it is the taxpayer who is paying for those as well so there simply has to be an alignment. It is fair to say I would not be doing this if there had not been a reluctance of some kind. That reluctance has been expressed directly to the CEO of the HSE, less so directly to me, but obviously the CEO and the chair of the HSE are working at my direction on Deputies' behalf and there has been a specified and written reluctance in relation to that. I have written directly to the CEOs or chairs. The Minister, Deputy Chambers, has supported that so there is very clear political direction on this and it really is up to those entities that are entirely publicly funded. They are staffed by public servants who will of course not just get public service salaries but public service pensions. They are entirely public servants. It is up to them to adopt the systems that in a small country help us to have visibility over how tax payers money is used, to have consistency and also better opportunities for realising savings and efficiencies through better procurement management.

Pádraig Rice (Cork South-Central, Social Democrats)
Link to this: Individually | In context

I move amendment No. 4:

In page 9, between lines 30 and 31, to insert the following:

“Review of data protection compliance

7. The Minister shall, within 18 months of the passing of this Act, prepare and lay a report before both Houses of the Oireachtas evaluating compliance with relevant data protection legislation and regulations in the collection, usage, and storage of patient health data.”.

This is long overdue and much needed legislation that will provide for a legal basis for electronic health records and patient information sharing. More generally, it represents a critical step towards digitising our health services and this is crucially important. Digitisation is an area the health committee is quite interested in and one we will engage with the Department on and engage on during a public session.

However, it is important to note the process of transforming our health service from paper files to digital files comes not just with benefits but also with risks. Privacy and security risks are unavoidable but the majority can be prevented by having the right safeguards in place. I accept that safeguards are being put in place via the Bill but ehealth represents a big change for our health service that will undoubtedly have teething problems. Significant and meaningful ongoing engagement with the Data Protection Commissioner will be crucial and more tangible action is needed given the sensitivity of the data concerned. This is why I believe it is essential a review is carried out early and that it is put on a statutory footing. We need to be sure the safeguards put in place are working effectively and that we identify areas for improvement early because the opportunities for breaches will increase as we digitise, particularly as new systems are implemented. As we all know, healthcare data is a prime target for a cyber attack. We should not discount the impact on AI on future healthcare provision either.

I also have a concern regarding the level of preparedness in respect of the secondary use of data. Such use is vital for scientific research, policymaking and the development of treatments, but the State is poorly prepared to utilise it. In 2023, a pan-European steering committee stated that Ireland's infrastructure for secondary use of data will need to be built almost entirely from scratch and will be managed by people who are not yet on the payroll. I accept that the secondary use of data will be dealt with in future legislation, but all of these issues are interlinked. If we do not put these reviews on a statutory footing from day one, then I am not convinced they will happen. For those reasons, I am of the view that a review of data collection usage and storage needs to happen within 18 months.

David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context

I support the amendment, but I will pretty quickly make a point about the digital transformation of healthcare. This is something the Joint Committee on Health has spent a lot of time looking at over the past number of years. I will not rehearse all of the arguments, because we know we have a long road to travel. There is a direction of travel now with summary care records. It will take some time to get all the bells and whistles and electronic health records similar to those that exist in many other European countries. It strikes me that it is red tape that frustrates the system. I was in a hospital recently visiting a patient. We hear about patients on trolleys, but a trolley was rolled past me that was loaded with files. The nurse said that this is where we are in 2025. There were a huge number of patient files and records on that trolley. I do not know how any system could operate like that.

I have also dealt with many cases where the families request the records of patients who may have passed away in circumstances where there may be concerns about how they were treated. Again, in the context of medical records, I sometimes wonder how things are not missed and how doctors and nurses can keep on top of everything in a paper-based system. I have to reinforce that point. We need to do more.

The Oireachtas committee again stands ready to assist in respect of this matter and to do everything we can to support the Minister and the officials. Obviously, it will require funding. There is an amount of funding ring-fenced for this. The Minister cannot or will not say how much is involved because. obviously, contracts have to go out to tender. I accept that, but it is important for us, as spokespersons on health, to again point out the urgent need to invest in this area. There is or was a reluctance on the part of the Department of public expenditure and reform to invest in health, possibly and probably because of what happened with the personnel, payroll and related systems. Fingers were burnt in the past. We have to move away from that. We have to accept that the world has moved on and that everybody is using IT and digital systems now. The healthcare system has to keep pace with that.

While the Bill is important, it is only the starting point. It provides a legislative framework. The funding, the urgency and the delivery have to come from the political system. In the past, the health committee has played a very constructive role in working with officials. We will do so again if required.

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

It certainly will be required. I am very glad. I understand that there will be a technical briefing next week or the week after in relation to that, which is a step in the ongoing engagement that is appropriate of that nature. I agree with what Deputy Cullinane said in respect of taking forward electronic health records generally, but, if I may, I will deal with the amendment before us.

It is important to say to Deputy Rice that there has been a really sustained and positive engagement with the Data Protection Commission throughout the drafting process relating to this Bill. It is envisaged that this engagement will continue into the implementation phase. Consultation is specifically provided for in relation to data processing safeguards, ministerial regulations and HSE guidelines, among other things. This is going to be a constant frame of engagement. In addition, the Bill already provides for a full review no later than five years after the passing of the Act. That has to be done in consultation with the Commissioner for Data Protection.

The Health Information Bill complements and builds on the rights of natural persons provided under the GDPR in respect of their personal data. By way of example, it provides that a patient or their representative may restrict access by health service providers to all or part of their electronic health records, subject to being advised of the consequence of their decision. Importantly, if a health service provider accesses restricted information, the HSE has to keep a record of that and the reasons why it was accessed. Patients have the right, subject to some caveats, to obtain information on access to their records, the date and time of access, how it was accessed and the personal health data that was accessed. This is an important transparency measure to ensure patient confidence in the health record system.

We can imagine the circumstances in which this may be important. If I was in long-term care in, for example, a particular hospital in Dublin and then was involved in a car accident in Cork and is brought to Cork University Hospital, which is a major trauma centre, I would very much want my electronic health records to be immediately available to the staff there in order that they could treat me in the best way possible. That is the huge advantage of electronic health records generally and of the sharing of information that is enabled by this legislation. It is not something that I would opt out of, but the Bill provides for people to be able to do that and to have that respect afforded to them, as long as they are advised of the potential consequences of doing so. We are not trying to force anybody to do anything in particular, but there are major advantages to the sharing of information in their own interests.

It is also important for the Deputy to note that this Bill is the first of a suite of legislative measures to give full effect to the EU regulation on the European health data space under which member states are required to appoint a digital health authority to oversee governance of the primary use of electronic health data. Member states must formally appoint their digital health authorities by March 2027. As part of its role, the digital health authority must publish an activity report every two years. That report must contain the measures to implement the regulation and information on the percentage of the population with access to the various data categories in the electronic health records and on the handling of requests from individuals regarding the exercise of their personal rights under the regulation.

The digital health authority will also be expected co-operate with a range of health stakeholders. This will include the Data Protection Commission. The authority will be mandated to accept complaints in respect of infringements and patient rights, and to immediately refer those to the Data Protection Commission. I am not sure if Deputies received an update on this, but I can confirm that it is intended to appoint the HSE to the role of digital health authority. The Bill provides the HSE with the clarity in Irish law that it will need.

For all of these different reasons and the safeguards that are built in, I am not in a position to accept this amendment. I hope I have given the Deputy some comfort as to the level of detail of engagement the Data Protection Commission will have at all stages.

Pádraig Rice (Cork South-Central, Social Democrats)
Link to this: Individually | In context

I move amendment No. 5:

“Review of accessibility of health data

7. The Minister shall, within two years of the passing of this Act, prepare and lay a report before both Houses of the Oireachtas outlining - (a) the steps taken to assist persons with lower digital literacy or connectivity issues to access their health data and exercise their right to restrict access to information, in accordance with the legislation, and

(b) the specific supports made available to vulnerable populations to address barriers to understanding and utilising digital health.”.

This amendment relates to the review of the accessibility of the data. While the digitalisation of our health service is essential, it does risk deepening the digital divide. Digital literacy, access to technology and language barriers present challenges for some groups, such as, for example, older people, lower income households or migrant groups. The inability of certain groups to access their health data in line with legislation should be a real cause for concern. In 2021, the ESRI recommended the development of specific supports for vulnerable populations in order to address barriers to understanding ehealth, such as lower digital literacy and language competency. I accept that these supports may not be set down in legislation, but that does not minimise their importance. The Sláintecare 2025+ plan identifies health literacy as an issue and refers to developing a health literacy toolkit. That is very welcome, but I encourage the Minister to ensure there is a similar focus on digital health literacy.

Equally, it is important to ensure that patients can exercise their rights to restrict access to their healthcare data. This is provided for in the Bill, as mentioned, but some people will need additional support in exercising those rights. With this in mind, I am of the view that it is reasonable to assess these issues within two years of the enactment of this legislation. We cannot allow some people to be left behind as we digitalise our health services. We have to bring people with us to ensure that public trust in the entire system is not undermined.

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

Digital health literacy is critical to fostering trust and safety around the use of health data. For example, the HSE is working with a number of advocacy organisations to ensure that its app can be used by people with a wide range of needs.

It is also seeking to ensure that the app uses inclusive language and takes into account additional requirements that patient groups may need by conducting user research and testing groups to see where people might be experiencing challenges in using the app.

I am not in a position to accept the amendment for a number of reasons. Primarily, section 21 of the Bill empowers the HSE to prepare guidelines to enable patients to access their electronic health record as well as to set out the additional targeted measures to enable persons with a disability to access their electronic health record. These guidelines are to be prepared in consultation with stakeholders, including patient representative groups and the National Disability Authority.

In addition, the European health data space regulation we have discussed previously requires that health data be easily accessible for persons with disabilities, vulnerable groups and persons with low digital literacy. The regulation provides that member states should create targeted digital literacy programmes as well as providing patient-centred guidance in relation to the use of national guidelines, with specific attention paid to vulnerable groups. The digital health authority will be required to publish an activity report every two years and it must contain detail on how it does this. It is also required to facilitate persons with disabilities to exercise their rights under the regulation and to facilitate the submission of complaints, including providing easily accessible tools in this regard.

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

I move amendment No. 6:

In page 23, after line 22, to insert the following:

"PART 5

Amendment of Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023

Amendment of section 68 of Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023

25. (1) Section 68 of the Act of 2023 is amended, insofar as that section inserts section 41A(10) in the Health Act 2007, in the definition of "relevant designated centre", by the substitution of “paragraph (a)(iii) or (c)"for “paragraph (c) ".

(2) The amendment effected by subsection (1) shall come into operation on the date on which section 68 of the Act of 2023 comes into operation.

(3) In this section, "Act of 2023" means the Patient Safety (Notifiable Incidents and Open Disclosure) Act 2023.".