James Reilly (Dublin North, Fine Gael) | Oireachtas source

I welcome this opportunity to bring the Health Identifiers Bill 2013 before the House. It represents another step in the Government's reform programme, which will provide a modern integrated health service that places patient care and safety at its centre. The Bill will allow us to introduce a system of unique identifiers for both individuals and providers of health services right across the health system, including both public and private providers. The Bill sets out what these identifiers are and who will use them, as well as governance arrangements, including the registers that will be put in place to hold the identifiers.

In developing a system of health identifiers, my Department has been keen to ensure that the governance arrangements fully address any privacy concerns that individuals or health care providers may have. To that end, this Bill has been discussed with the Office of the Data Protection Commissioner during its development, and I thank the office for its input, which I believe has strengthened the governance arrangements set out in the Bill. I am sure Senators will agree that a strong governance framework is important to ensuring there is public confidence in the identifier system and right across the health system.

The case for health identifiers as key enablers of better patient safety and care is well established internationally. Individual health identifiers are fundamentally about patient safety and ensuring that the right information is associated with the right individual at the right time - at the point of care.

The 2008 report of the commission on patient safety and quality assurance, entitled Building a Culture of Patient Safety, recommended the development and implementation of a unique identifier system for the health service. The national health information strategy also recommended the introduction of health identifiers, and HIQA has advocated that identifiers should be provided for health care providers as well as individuals accessing health services. Health identifiers are not only an important tool in delivering safe and quality care; they will also play a critical role in managing the health service more efficiently and effectively. They are centrally important to the delivery of many reform initiatives - for example, the money follows the patient model - and this Government's ultimate goal for the health service, which is the introduction of universal health insurance to provide a single-tier health service in which everyone can receive safe high-quality treatment based on need rather than ability to pay.

Health identifiers also form an integral part of the e-health agenda. As Senators will remember, e-health strategy for Ireland was published on the same day as this Bill. The strategy sets out a strategic roadmap for improving health and well-being - for example, through the introduction of e-prescribing. The introduction of health identifiers will allow the health system to work much more efficiently. It will mean that the same information does not need to be collected on numerous occasions, something that can be a frustrating experience for both patients and health care providers. Unique health identifiers will also reduce the need for repeated diagnostic tests, because previous test results - even where they have been carried out by a different health provider - can be reliably associated with a patient's records.

Members will be aware that it had originally been intended to legislate for health identifiers in the Health Information Bill, and the consultation process on that showed widespread support for the introduction of unique health identifiers. However, given their critically important role in supporting the effective delivery of the wider health reform agenda, a decision was made to develop a separate and focused Health Identifiers Bill, which takes account of the view of HIQA and other relevant stakeholders. In meeting publication timeframes, it was not possible to bring this Bill for pre-legislative hearing. Work is continuing on the other elements of the Health Information Bill.

The purpose of the Bill is to provide the legal framework for a system of unique health care identifiers for both individuals and health care providers. It is principally about patient safety, ensuring that people are properly matched with their records, treatments and results.

The Bill sets out what health identifiers are, who can use them, and the governance arrangements, including the establishment of registers to house the health identifiers. As I have mentioned, my Department has worked with the Office of the Data Protection Commissioner to ensure that privacy considerations are fully addressed. In addition, the Bill provides for certain governance-related offences, which should also help to strengthen public confidence in the health identifier system. In relation to vaccination programmes and screening programmes, it is very difficult to have a true assessment of their effectiveness if doctors do not know what populations they are responsible for and if we cannot accurately determine who has been vaccinated and who has been screened. A unique health identifier will help in a major way.

I would now like to take members through the main provisions of the Bill. The first part of the Bill sets out a number of standard provisions, including commencement, interpretation, regulatory powers and provision for expenses incurred by the Minister for Health or any other government Minister.

Section 2 sets out a number of key definitions. "Specified persons" aredefined as those who can use individual health identifiers and access the individual health identifier register. These health service providers and persons are listed in Schedule 2 of the Bill. "Authorised disclosee" is a person to whom an individual health identifier may be disclosed for a particular secondary purpose. Authorised disclosees are listed in Schedule 1. The Minister for Health can add to the list of specified persons and authorised disclosees by regulation, where doing so is in the public interest and following consultation with the Data Protection Commissioner. A "relevant purpose" defines the basis on which individual health identifiers can be collected, used and disclosed; this is divided into primary and secondary purposes. The "primary purpose"means the present, past or future provision of health services to an individual. A "secondary purpose" is defined as including the promotion of patient safety, including clinical audit and investigation and reporting of patient safety incidents; management of the health services, including planning, monitoring, delivering, improving, auditing and evaluating health services, investigating and resolving complaints about health services, and managing national health systems; certain health research; the provision of health or health-related insurance schemes; or the processing of personal data in accordance with the Data Protection Acts 1988 and 2003.

The second part of the Bill provides for individual health identifiers and the accompanying national register of individual health identifiers - the IHI Register. An individual health identifier will contain no personal data: it is simply a number.

Section 5 provides for the assignment of individual health identifiers. The Minister for Health can assign an individual health identifier to a living individual who is, has been, or may be provided with a health service, whether or not that individual is ordinarily resident in the State. An individual health identifier may also be assigned to a deceased individual where that person has died on or after the coming into operation of this section without having been assigned an individual health identifier when alive.

The section also makes clear that assigning an IHI does not indicate, in and of itself, entitlement to or eligibility for a particular health service. The intention is that members of the public will be advised of their IHI in making contact with the health service, allowing staff to confirm a person's identity in an efficient and cost-effective manner. The section also provides that the Minister for Health can put in place measures to help an individual to have his or her IHI made known to him or her or another person acting on his or her behalf, because of age, capacity or death, for example.

Section 6 provides for establishing and maintaining a national register of IHIs by the Minister for Health. The register will contain the IHI and any other known identifying information for each person who has been assigned an IHI. This identifying information, the basic details that allow a person to be uniquely identified, is defined in section 2. It includes, for example, a person's name, address, date of birth and PPSN. It also provides for a signature and photograph as further identifying information. The Minister for Health can make additions to this list but only following consultation with the Data Protection Commissioner. It must be stressed that the list of identifying information cannot include an individual's clinical information. The only items of information that can be contained in the IHI register are the IHI and the defined list of identifying particulars.

Sections 7 to 9, inclusive, enable the initial seeding of the national IHI register and provide for maintaining the accuracy of the information, which is vital if it is to operate efficiently and effectively. Section 7 allows the Minister for Health to make use of the identifying information with which he or the HSE must seed and populate the register in order to avoid having to ask people again for information they have already provided. It also allows a provider of health services to ask an individual who is, has been or will be provided with a health service for his or her identifying information. Health care providers must provide this information and relevant updates for the Minister for Health, as appropriate. Most of this exchange of information will be catered for by ICT systems that will be developed to underpin the register. It occurs to me that much of the confusion in the past over people's applications for medical cards where some information held locally was not transmitted centrally will be completely overcome by this provision. They will be able to obtain the information very quickly in an efficient fashion. Without getting into specifics, let me outline a recent case in which an individual's information was not known when a decision was made. This was understandable from the point of view of the GMS or PCRS section because there were approximately 133 people with the same name. What is proposed will overcome these difficulties.

Section 8 allows another Minister to provide the Minister for Health with a person’s identifying information but only where it is solely for the purpose of establishing and maintaining an accurate IHI register. Section 9 enables an ard-chláraitheoir to provide information for the Minister for Health relevant to the Minister's functions under the Bill.

Section 10 provides for access to the IHI register. The only persons allowed to gain access are the Minister for Health, a specified person as defined in section 2 and an equivalent person covered by an agreement under section 12. These persons can access the register only for relevant purposes. The Minister for Health may also access the register to perform a function conferred on him or her by the Bill or any other Act. The section requires the Minister for Health to put measures in place to allow the register to be accessed subject to these conditions and otherwise make it inaccessible in order to ensure the registry is secure and privacy is protected.

Section 11 sets out how the IHI and information on the register can be used. In providing a health service a health care provider must ask the individual for his or her IHI and the health care provider must associate the IHI with the patient's medical records and use it in relevant communications, with the provider's own identifier details, as per section 20 - for example, when a general practitioner writes a patient referral to a hospital consultant. Importantly, no one will be denied a health service solely because he or she either does not have an IHI or refuses to provide it. Obviously, however, by not providing one he or she would be making life very difficult for himself or herself and all those trying to help him or her. Given that the main reason for introducing IHIs is to enhance patient safety, it is reasonable to expect that very few people will refuse to co-operate positively with the new identifier system. However, it is important to recognise that certain occasions may arise, mainly in the area of very sensitive medical conditions, where someone may be reluctant to identify himself or herself fully. None of this changes the existing set of circumstances where a health care provider is entitled to satisfy himself or herself that it is right and safe to treat someone. The section also provides for disclosing an IHI and identifying particulars to an authorised disclosee for a particular secondary purpose.

Section 12 provides for the use of the IHI and access to the register in another member state in certain cases where an individual has travelled to that member state for a health service. This is subject to an agreement on which the Data Protection Commissioner has been consulted being in place between the Minister and the health service provider in that member state. The section is intended to provide for situations where, for example, the HSE has entered into an arrangement with a service provider outside the jurisdiction to provide services for a significant volume of patients. It is not intended for use in the case of individuals electing to seek services outside the jurisdiction or for small volumes of patient referrals.

Part 3 of the Bill provides for health service provider identifiers and the related national register of health service providers. The intention is that provider identifiers will be gradually rolled out to health service providers over time.

Section 13 sets out that health service provider identifiers can be assigned to a health practitioner such as a general practitioner or dentist; a relevant body such as a hospital; and a relevant employee or agent of a health practitioner or relevant body.

Section 14 provides for establishing and maintaining a national register of health service provider identifiers, the provider identifier register. Sections 15 to 18, inclusive, are designed to ensure the provider identifier register is seeded and accuracy is maintained on an ongoing basis. Sections 15 to 17, inclusive, make it clear that there is a proactive requirement on professional regulatory bodies, relevant bodies or health practitioners, as appropriate, to provide the specified information. The Minister for Health is not required to seek this information, either initially or for updating purposes. We intend to use existing professional registration numbers, in so far as it is possible to do so, in the new register - for example, by using Medical Council registration numbers for doctors. Section 18 allows the Minister to use relevant information he or she or the HSE already has to assign a health service provider identifier and establish and maintain the register.

Section 19 provides for access to the provider register, while section 20 provides for the use of the provider identifier and register. Senators should note that access to the provider register, under section 19, is different for the IHI register. Given its nature, the provider register will be publicly accessible and hold different information. As a register of health service providers, the only information that will be held on the provider register identifying individuals will relate solely to their role as health service providers. Consistent with section 10 and the use of the IHI, section 20 requires health service providers to associate their provider identifiers with patient records and relevant correspondence. However, this requirement does not apply where the provider is required by another Act to use the registration number given by his or her professional regulatory body when providing a health service.

Part 4 of the Bill provides for offences. Section 21 provides for offences relating to the assignment of IHIs, while sections 22 and 23 provide for offences relating to accessing the national register of IHIs and an offence relating to processing an IHI.

Section 24 provides for offences relating to the assignment of health service provider identifiers, while section 25 provides for offences by corporate bodies. These provisions are intended to secure the privacy and correct use of identifiers and registers.

Part 5 of the Bill provides for the delegation of certain functions of the Minister for Health. Section 26 provides that the Government may, by order, delegate to the HSE any or all of the Minister's functions under the Bill, except excluded functions. These excluded functions are the Minister's power to make regulations and enter into section 12 agreements. Any function delegated to the HSE continues to be vested concurrently in the Minister. The delegation does not remove or derogate from the responsibility of the Minister for Health to Dáil Éireann, or as a member of the Government, for the performance of any function that is delegated. When I mention the HSE, I mean it or any of its successor organisations. The section sets out that the Minister for Health is always responsible and, ultimately, accountable for the identifier system, which is as it should be. However, the section also recognises that responsibility for the actual day-to-day operation of the system may be delegated to the HSE as an organisation with the operational capacity to manage this national system.

Part 6 of the Bill addresses the application of the Data Protection Acts 1988 and 2003. The Data Protection Acts are concerned with the protection of the personal data of living identifiable persons.

Section 27 deals with the relationship between the Bill and those Acts. Subsections (1) and (2) deal with the individual health identifier of a living individual. Under subsection (1), a living individual's IHI will be considered personal data under the Data Protection Acts when held by the Minister, a specified person or the HSE when acting in a section 26 capacity under the Bill. However, this should not be construed as preventing a living individual's IHI held by any other person from being treated as personal data in accordance with the Data Protection Acts.

Subsection (3) is concerned with the information on the register on a deceased individual. As an additional protection, it provides that sections 2(1)(d) and section 2C of the Data Protection Acts - which deal with security arrangements for personal data - will apply to the information in the IHI register in relation to a deceased individual in the same way as those sections apply to a living individual.

Part 7, sections 28 to 39, inclusive, provides for a range of matters. Under section 28, the Minister for Health can arrange for investigations to be carried out on the operation of any provisions of the Bill, as he or she considers reasonable and necessary for the proper monitoring of the assignment and use of identifiers. Section 29 provides that the Minister for Health can enter into an agreement with another person to carry out certain activities, for example, specialist IT support services. Section 30 allows the Minister for Health to carry out measures to verify any information provided to him or her under the Bill, or to establish the efficient and effective operation of the registers.

Section 31 provides for data exchange agreements between the Minister for Health and other relevant persons. These will specify the procedures to be followed by each party when exchanging personal data between them. The Minister for Health must consult the Data Protection Commissioner in relation to data exchange agreements. As a further privacy protection safeguard, under section 32, any processing of personal data by the Minister for Health or the HSE will go no further than is reasonably necessary for the performance of those functions.

Section 33 provides for the Minister for Health's power to specify the form of documents required for the purposes of the Bill. To provide the flexibility that is needed, section 34 sets out that the Minister for Health can extend the time period for providing the information required under the Bill.

Sections 35 to 39, inclusive, allow for the legislation in relation to health professional regulatory bodies to be amended to enable the Minister for Health or, if delegated, the HSE to make complaints to regulatory bodies where a professional has not complied with a provision of the Bill, for example, where a health care provider has failed to associate an IHI and its own provider identifier to a patient record. While there is no reason to expect that to happen, the legislation must provide for a means of dealing with such exceptional circumstances.

Schedule 1 covers authorised disclosees and Schedule 2 lists specified persons. As the Child and Family Agency Act 2013 is now in force, I propose to bring a Committee Stage amendment to include the new Child and Family Agency as a specified person in Schedule 2.

The provision of health identifiers will require investment in ICT to develop and maintain the registers' infrastructure to hold the required information. There will also be costs associated with rolling out the new system of identifiers, including the change management processes. However, using the HSE to operate the identifier system will ensure that the technical and other expertise, as well as the operational infrastructure, of the Primary Care Reimbursement Service, PCRS, is maximised in implementing and operating the identifier systems on an ongoing basis. Likewise, appropriate leveraging of the public service card technology provides further possibilities for a cost-effective solution. The overall approach of building on the identity management infrastructure being developed by the Department of Social Protection will help to keep costs to a minimum, and I acknowledge the considerable assistance and co-operation of the staff in that Department in preparing this legislation.

The HSE is engaged in ongoing work on costs, and the publication of the Bill provides an opportunity to engage with the market to get accurate cost estimates to develop the most appropriate and cost effective model. Senators should note that individual project components will be subject to peer review, including costs review, prior to project approval being sought, in line with Government policy, from the Minster for Public Expenditure and Reform. All of this is designed to ensure that we have accurate and reliable costs at the time decisions need to be made, and approval sought, on particular elements of the implementation model.

We all are concerned with our own patient care and safety and that of family, friends and anyone who uses our health system. Individual health identifiers are principally about patient safety, ensuring that the right information is associated with the right individual at the right time - properly matching people with their records, treatments and results. The programme of health reform that I am implementing is designed to ensure that patient safety and quality care are the paramount concern of the broad health system, and the introduction of health identifiers is critically important in that regard, reducing the chance of duplication, confusion and unnecessarily repeating tests on patients who do not need to suffer twice for the same result.

We all want to build on health reform initiatives and the further development of a modern health system. Health identifiers will also support more efficient management and delivery of health services. They are, for example, an important component of fully implementing money-follows-the-patient, in advancing the e-health agenda, and ultimately, delivering universal health insurance where everybody will be treated on the basis of medical rather than on what they can afford.

Accordingly, I commend this Bill to the House. I look forward to Senators' contributions. I am always open to suggestions that will help improve the Bill and its operation.