Joe Flaherty (Longford-Westmeath, Fianna Fail) | Oireachtas source

In the time I came from my office to the Chamber, there was a changing of the guard. In that context, I was going to mention to the Minister, Deputy Donnelly, the Topical Issue I raised last night. However, I will leave it and follow up with him later.

I welcome much of the spirit and intention of this Bill. It places priority focus on the establishment of digital health records and access to health data for care and treatment. Its provisions underpin the Government's roadmap, Digital for Care: A Digital Health Framework for Ireland 2024-2030, and align with the EU's digital decade target of all patients having access to their digital health records by 2030. Crucially, however, there is no provision for an opt-out for patients, unlike in the UK and many EU countries. The Bill would be enhanced by the inclusion of such an opt-out provision.

The Bill will mandate GPs and other healthcare workers to pass every patient's medical records to the State. They will form part of a centralised system that will then be used beyond direct care and without patients' consent. There is more to this than mere privacy and data protection law. The doctrine of confidentiality allows patients to have their medical records confined to those involved in their care. Everybody in this House is steadfast in their agreement that research is important. It must be nurtured and encouraged. However, studies show that patients want to be asked about how their very sensitive data may be used, and for what purpose, beyond their direct care. The Bill, as it stands, would force patients to become involved in research they do not even know about. This could lead to objectionable uses, commercial exploitation and an undermining of trust. Nowadays, research often includes academics and pharmaceutical companies working together. Many of them are working for the common good. However, if a patient chooses to become part of a centralised system, as many will agree to do, studies show that such patients want visibility of their full medical record and not just a summary. They also want to see who has accessed those medical records, including anybody not connected with their direct care. This is also not provided for within the Bill. If GP records are centralised without consent, it may have a chilling effect on patients. Trust in the medical profession will evaporate.

The Netherlands, to give an example, has an opt-out option in its system. The opt-out numbers there are quite high. More than half the population have opted for sharing GP data and more than 60% have opted to share pharmacy or medication data. Given that not everyone receives care, this includes most people who have a need to get their data shared. For people who do not opt into the Dutch system, it is still possible to exchange data directly between health professionals involved in their treatment and when sending referral letters. In the case of our near neighbour, the UK data guardian has provided the UK public with two opt-out choices. Type 1 is for patients who want their GP records to be confined to their GP practice and used only for their direct care. Type 2 offers a similar arrangements for hospitals. The European health data space legislation provides for every EU member country to decide for itself whether it wants to offer an opt-out to patients for secondary use outside of the state.

This Bill does not offer patients in Ireland such flexibility. Will the Minister of State comment on the provision for the information of patients who have died to be uploaded to a centralised electronic health record? I understand this is for research purposes but their family may never know that these records are to be used. There will be a series of amendments to the Bill. I expect one of them will be to provide for comparative effectiveness research, which is a well thought-out and valuable learning healthcare system. However, this is a slippery slope. It will allow for research clinicians to randomise patients to one drug or another if the medical community is unsure which works best. It might be a case of assigning one drug versus a placebo. Patients entering a hospital will think it is the doctor in the ICU making a decision based on their best interests. Often, people are alone when they present at a hospital. Sometimes, if someone is with them, that person may not even be asked for consent.

I agree with the core tenets of the Bill but I have reservations in the absence of an opt-out provision for patients. Nor am I convinced that patients are assured of certainty as to who will access their records. Both are critical oversights. They need to be addressed as the Bill progresses.

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