Irish Cancer Society
Submission to the Department of Health and Children
on the
Public Consultation Process
for the
Proposed Health Information Bill
September 2008
Preamble
· This Paper is the response from the Irish Cancer Society on the consultation process on the Health Information Bill as proposed by the Department of Health and Children.
· This is a Discussion Paper and sets out our responses to the nine key issues as set out on Page 4 of the Discussion Document.
· Furthermore we have referred to segments of the Discussion Paper and the Audit of Key International Instruments where appropriate to illustrate our position.
· For further information please contact Joan Kelly, Nursing Services Manager, Irish Cancer Society, 43-45 Northumberland Road, Dublin 4, 01 2310519,
1. Introduction
The mission of the Irish Cancer Society, the national cancer care charity, is to play a vital role in achieving world-class cancer services in Ireland, to ensure fewer people get cancer and those that do, have better outcomes. Our goals are focused around prevention, early detection and fighting cancer with three programme areas to achieve them; advocacy, cancer services and research.
Over the next five years (2008 - 2012) our goals will centre around implementing a zero tolerance approach to smoking in young people, reducing the incidence of advanced colorectal cancer and mortality from that cancer and ensuring every member of the Irish public has access to the information and support they need. Thus our remit concerns health information which is critical to patients with cancer.
New legislation on the collection, use, sharing, storage, disclosure and transfer of personal health information as well as ensuring that the privacy of such information is appropriately respected, is a key objective of the Irish Cancer Society and will be promoted through the central tenets of our strategic plan over the next five years.
As a very significant step towards a comprehensive and integrated health information policy in Ireland, the Irish Cancer Society welcomes and supports Government proposals to introduce legislation in the form of a Health Information Bill.
DISCUSSION PAPER: 9 KEY ISSUES FOR CONSIDERATION
Key Issue 1:
What are the benefits to patient care and safety which should be the objectives of any legislation? (See Part 1)
Public health information and the collection of such data is of enormous benefit to patients and society, therefore the Irish Cancer Society (to be called ‘the Society’ hereafter in this document):
· supports the underlying principle of the legislation and the expansion of the collection of data in relation to disease
· welcomes the proposal to extend the process of disease registration
· supports the principle of evidence based health care as a means to delivering on its mission in the care of cancer patients and in preventative measures.
However the management of Information Communications Technology (ICT) systems and the stakeholders likely to be involved in this process, need to be more clearly identified.
The Society believes that the public has the right to information to all aspects of their health care, not only in access to their medical records but access to information to make informed choices about their health and treatment.
Such rights are already supported by the Society through the European Cancer League (ECL): 2002: Joint Declaration on the Promotion and the Enforcement of Cancer Patients’ Rights, Article IV: Right to Information
4.1. Cancer patients have the right to be fully informed about their health status including the medical facts about their condition; about the proposed medical procedures, together with potential risks and benefits of each procedure; about alternatives to the proposed procedures including the effect of non-treatment and about the diagnosis, prognosis and progress of treatment.
However there is some confusion regarding terminologies being used in the Discussion Document, between health information and personal health information. There needs to be clearer definitions set down in any proposed legislation - health information has a wide interpretation – it should include lifestyles and behaviours e.g. smoking status, Body Mass Index (BMI).
However the development of an e-Health information system also carries potential risks. Public perceptions of ICT, as a means of access to their personal and sensitive information, has the potential to create anxiety and concerns, therefore these need to be addressed.
The Society recognises and endorses the Document’s view that e-Health solutions has the potential to make a major contributions to:
· Improved patient safety
· More evidenced based care and seamless integrated care across all health care sectors and environments
· Empowerment of patients
· Better research and disease management outcomes
· Establishing new data collections and data sets
· Mitigating public health and other population
· More accessible continuing education for healthcare professionals
· Enhancing the privacy, confidentiality, integrity and security of patient information
The Society supports and endorses the proposed framework set out in the Consultation Documents on the potential benefits of e-Health which includes the following elements:
· extending the collection of information
· promoting an awareness throughout the health system and sees information as a valuable asset
We agree that this requires a cultural change throughout the health system to enable the establishment of the new institutional framework for the Irish health system.
However the Society is also aware of the potential deficiencies in the information strategy under existing legislation, notwithstanding the establishment of the Health Information and Quality Authority.
Since the Society has a remit of a very public engagement with disseminating health information in cancer, it is of particular importance and significance to us that proper information governance arrangements should exist on a system wide basis, throughout the Irish health system, which is clear to the general public and builds confidence in them to support such a system.
Key Issue 2:
What is the balance to be struck between the right of individuals to control their healthcare information and the needs of those managing healthcare systems, providing healthcare services and undertaking medical research (including the role of Research Ethics Committees) to have limited and controlled access, without individual consent. (See Parts 2 and 3 and Appendices)
The Society recognises the need to balance the rights of patients in relation to control of their personal health information, while at the same time facilitating appropriate access to such information by medical and health care professionals.
However there needs to be a more precise definition of persons and agencies, under the umbrella of health care systems and providers of health care services, who should have access to this information.
What is not clear is ‘who’ manages information relating to the health of the individual and information relating to individuals who participate in research.
Patients’ rights to information and to privacy of their personal data are covered to a greater or lesser degree in existing legislation and policy.
It is covered specifically in the European Cancer League (ECL): 2002: Joint Declaration on the Promotion and the Enforcement of Cancer Patients’ Rights, Article VI: Right to confidentiality and privacy. (Appendix 1)
However a ‘rights based approach’ to health information is not always conducive to informing medical and social advances in healthcare.
While the Discussion Document sets out systems and approaches which support a more managerial approach, the balance needs to be focused between the rights of the patient and the needs of the healthcare system.
While Ireland does not have an overall framework within which existing ethics committees operate, in relation to research, the Society would support the view that the proposed legislation should take account of this but enable a more strategic and streamlined management of these committees. (We also note the setting up of the Irish Council of Bioethics and the transposition of the EU Directive on Clinical Trials on Medicinal Products for Human Use Regulations 2004).
Ultimately the Society would advocate for a single unit (i.e. a new National Ethics Authority) with a remit to ensure the effective implementation of the Health Information Bill. The Society would also advocate that this new National Ethics Authority would have an Appeals Board.
Consent
The Society understands that the Data Commissioner might only make minor changes with regard to the issue of consent and that these changes might be insufficient.
The Society is also aware that data collection agencies, such as the National Cancer Registry in Ireland, do not have access to information collected by all healthcare institutions currently (e.g. information collected in private hospitals).
Health information when collected is used in a variety of instances, so the Society would view that asking for consent, while important and is representative of best practice in most instances, can result in the collection of unreliable information if it is not collected in a consistent fashion.
The Society endorses the position of consent under the ECL: 2002: Joint Declaration on the Promotion and the Enforcement of Cancer Patients’ Rights, Article VI: Right to confidentiality and privacy. (Appendix 1)
6.3. Confidential information can only be disclosed if the cancer patients give explicit consent or if expressly provided for in the law among others in case of research projects. Consent may be presumed where disclosure is to other health care professionals involved in the cancer patient’s treatment or follow-up but must happen on a strictly “ need to know” basis.
The Society recognises the validity of the policy objectives of the Health Information Bill. In particular the central policy objective of the Health Information Bill, “to support the creation of an effective system-wide health information governance framework that is focussed on patient care and safety”.
We agree that the associated major challenge is to build public confidence in this process through legislative principles that are workable, transparent and widely supported.
In this regard the Society supports the goals of the proposed Health Information Bill, as set out in the Consultation Document to:
· ensure that health information can flow between the public and private health sectors
· to ensuring that individuals can access their health information (subject access rights) without compromising public policy on matters such as adoption related records or third party provision of information (in confidence and in good faith);
· facilitate, in a transparent and accountable manner, the development of modern information systems and technologies
· allow for the introduction of a Unique Health Identifier
· facilitate the establishment of national population registries (similar to the National Cancer Registry)
· define “personal health information”
· protect the traditional trust relationship between healthcare professionals and patients
· establish a framework that provides clarity to all involved on the obtaining, use, retention and disclosure of identifiable personal health information
The Society would draw the attention of the legislators to the ECL: 2004: European Guidelines Cancer Patients Rights: 3. Relationships between patients and health professionals. (Appendix 1)
These relationships are defined in terms of developing, in particular, two key components of these relationships:
-right to have full information about diagnosis, treatment, care and prognosis, and the right to choose not to be informed
-right to involve family members if desire, to such information for legitimate purposes
These are significant in that they directly relate to the issue of ‘Consent’ and access to ‘Sensitive Personal Data’ in the proposed Bill.
The Society’s position is to endorse these rights as set out in the ECL 2004 document.
Key Issue 3:
What rules should accompany the introduction of a Unique Health Identifier for both patients and healthcare providers? In particular, what factors should influence the regulation of the collection, use, disclosure and linkage of such an identifier? (See Appendix 2)
Unique Health Identifier
The Society strongly supports and welcomes the proposal to introduce a national programme to provide a Unique Health Identifier for all people living in Ireland.
The Society supports the utilisation of the Personal Public Service Number (PPS number) and its supportive infrastructure as the most suitable and efficient option – as set out in ‘Option 2’ of the Discussion Document.
The PPS number already exists and is known to the public and allows for flexibility. Therefore the programme to provide a Unique Health Identifier could be built on the PPS number system but might not necessarily use the PPS numbers available.
This would mean the institution of new Pin Numbers with ICT generated assess security codes which would promote patient privacy, confidentiality and security.
Overall the issue of access of patient information, whilst already in place within some medical and clinical areas, needs to be explicitly addressed to enable appropriate levels and degrees of access by other health care professionals within a multi layered system.
The Society endorses the central policy objective of the Health Information Bill: “to support the creation of an effective system-wide health information governance framework that is focussed on patient care and safety”.
However we recognise the associated major challenge that this brings to building public confidence in this process through legislative principles that are workable, transparent and widely supported.
We concur that the proposed goals of the proposed Health Information Bill should be to:
· allow for the introduction of a Unique Health Identifier
· protect the privacy, confidentiality, security and integrity of personal health information and ensure that these principles apply explicitly to all persons who have a legitimate reason to be involved with or access such information
· protect the traditional trust relationship between healthcare professionals and patients
· safeguard the rights of children in relation to their personal health information and, at the same time, vindicate the right of parents to have access to such information as is required to act in their children’s best interest
· enhance consistency, where necessary, between the Data Protection and Freedom of Information regimes
However legislators need to be highly perceptive of public concerns about other future uses of a UHI.
The position in Canada (as referred to in the Discussion Document) is noteworthy, where they identified the challenges presented:
“…to ensure that such a highly reliable identifier is not usurped for purposes beyond the health system and the clinical care of individuals,”