Download R41 Irish Cancer Society

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,
[email protected]
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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.
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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
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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.
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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
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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.
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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,”
and further that the Canadian Data Commissioner has expressed concerns that the use of
the PPS number as a UHI,
“could become a National Identification number by stealth…”
Therefore the Society would recommend that public information and campaigns would be
essential in delivering on UHIs as a strategy to gain acceptance by the public.
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Key Issue 4:
What legal issues need to be considered in establishing a National Electronic Health
Records system: especially as regards an individual’s choice to participate or not and
his or her control over the extent of any participation? (See Appendix 1)
Electronic Health Records
The Society supports the development of Electronic Health Records as an effective and an
efficient method of securing health care information about an individual patient and the
continuous health care to that patient.
However, the Society is of the view that evidence based health care requires access to a
wider range of information to create data sets.
The use of and access to ICT requires an accompanying technology literate workforce. The
issue of the rights of individuals to choose to participate in the NEHR system again relates
to issues of having confidence in the integrity of such a system. It is important that the
NEHR system enables patient health information to be accessed and exchanged between
the various health facilities (e.g. GPs, hospitals).
The Society would advocate that other social and health care settings (e.g. health centres,
community based health facilities, community based nursing services) should be included.
The issue of ‘ownership’ and ‘control of information’ needs to be more clearly defined in
the legislation. The question of ownership is complex. While patients may have rights to
access their personnel medical records, such information is, in practice held by various
medical professionals and is shared and passed on through the health care system as the
needs of the patient arises.
The Society suggests that the following questions need to be addressed in the legislation:
At each point of contact with medical services:

who has access to this information?

who controls this information?

who makes decisions on the sharing of this information and with whom?
Following on from this the legislation should determine:

does the patient have the right to refuse access to their personnel information at
any stage in the information flow?
Consent
The Society notes the Discussion Document descriptors on the issue of consent, i.e. whether
it is implicit / implied or explicit / expressed and agrees with the position that “consent
must always be informed to be valid”.
Since there is no single definition of consent in Irish Law, other than the EU Data Protection
Directive (95/45/EC), the Society notes the definition on implied consent from the Privacy
Commissioner for Canada, that:
“… [the] office recognises …the principle of implied consent for information to flow
freely within the ‘circle of care’. The definitions around the ‘circle of care’ relate to
the care and treatment of the patient and healthcare services for the therapeutic
benefit of the patient. This would include laboratory work and professional case
consultation with other healthcare providers.”
Therefore the process of access to and the sharing of patient information with this circle of
care via electronic health records must be explicit in the legislation.
Here we refer the legislators to 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
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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.
Taken together with the UHIs and Population Registers, EHRs would provide opportunities
to generate quality integrated health care information which is “retrospective, concurrent
and prospective” ISO TS 215 (2005).
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Key Issue 5:
What principles should guide the development and regulation of National Health
Population Registers, such as the National Cancer Registry, and the instances in
which reporting to such registers should be mandatory? (See Appendix 3)
The Irish Cancer Society supports the development of National Health Population Registers
in Ireland (NHPR).
Population Registers will provide a national repository of information for health care
planning and research in different disease areas.
The Society would also advocate that registries used in current screening programmes (e.g.
Breast Check, the national breast screening programme and Cervical Check – the newly
created cervical screening programme) would also be included in a manner consistent with
Data Protection Law in any NHPR.
The Society is of the view that access to reliable and comprehensive health information is
vital in the planning of how services are designed and delivered.
This involves the collation of information screening, treatment, follow up, survivorship and
mortality.
Since cancer can affect people at any stage of their life, the need to be able to follow
people over long periods of time is also essential. In addition, the information that is
required for collection today may be needed for future uses that are currently unknown.
The collection of information, not only in relation to cancer patients for current use, but
also future uses, might also include information relating to:

Preventative health care

Geographical cancer information data

Specialist collection of data, e.g. lifestyle behaviours, smoking status, BMI

Familial genetics

Cancer mortality
Population Registries contribute to the mapping of the health of the population and the
planning, monitoring and evaluation of health services and to the education of health care
professionals.
The Society would also recommend that if such NHPR registries are established, that the
value of them would be further enhanced by allowing access to information for research
purposes, underpinned with the appropriate ethical standards and legal assurances.
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Key Issue 6:
What needs to be done to provide consistency and clarity in and between legislation,
other legal rules and professional ethical codes in the treatment of personal health
information having regards to considerations of privacy, confidentiality, consent and
security? (See Parts 2 and 3)
Cancer patients’ rights to privacy, confidentiality and security of health information are of
prime importance to the Society, to embed good relationships between patients and health
professionals.
These rights are specifically articulated in the ECL: 2002: Joint Declaration on the
Promotion and the Enforcement of Cancer Patients’ Rights, Article VI: Right to
confidentiality and privacy: (Appendix 1)
6.1 All information about a cancer patient’s health status, medical condition,
diagnosis, prognosis and treatment and all other information of personal kind must
be kept confidential.
This position is further endorsed in the ECL: 2004: European Guidelines Cancer Patients
Rights: 3. Relationships between patients and health professionals
…..the relationships must be developed in mutual respect and confidence.
…..these relationships should be defined in terms of rights connected to duties and
responsibilities.
The ECL in particular identifies the “right to privacy” as a relevant component in this issue
of privacy, therefore in order to inform patients as to how their privacy is protected,
patients need to be advised of the following:

Who has access to patient information?

How is that access operated? (e.g. gateways of access, security codes / Pin
numbers)

What is the radius of disclosure of patient information?

Disclosure of patient information is made by whom and then to whom?
Professional Ethical Codes
There are existing professional ethical codes for doctors, nurses, midwives, occupational
therapists, however there are areas within the health profession that are not covered by
professional ethical codes.
It will be important that all health care professionals, designated by this legislation, be
required to have professional ethical codes of practice endorsed by the Health Information
Quality Authority (HIQA) and the Department of Health and Children.
Such measures would help to gain public support and confidence in a Public Health
Information System dictated by this new legislation, by offering another layer of security.
Health Care Professionals
Any new legislation needs to clearly define what is meant by a ‘health care professional’
and the range of health care roles included in the ambit of the legislation.
Typically cancer patients encounter a wide range of healthcare professionals at all stages
of the cancer journey (diagnosis, treatment and follow-up care)
The multidisciplinary team managing the cancer patient can comprise a GP, surgeon,
medical oncologist, radiation oncologist, social worker, dietician, specialist cancer care
nurse and in some instances, members of a palliative care team.
The establishment of protocols and standards for managing access to patient health
information by the vast array of health care professionals and health providers is essential
in this legislation.
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Key Issue 7:
Is there a need for a comprehensive definition of personal health information and, if
so, what should it encompass? (See Parts 2 and 3)
The Irish Cancer Society supports the need for a comprehensive definition of ‘Personal
Health Information’.
It is important that the legislation should clearly delineate between information on:

the health status of people who have not yet accessed the healthcare system

information on patients who have accessed or are currently accessing the
healthcare system
Such definitions would be key to ensuring the support of the public.
Furthermore should Population Health Registries be introduced under the legislation, these
should not be used solely as mechanisms to record disease but should encompass a wider
data set on the health of the population to inform the design and delivery of better
healthcare services.
The Society has taken cognisance of practices in other jurisdictions, e.g. in England and
Wales. The National Health Service (NHS) has a well developed EHR system. It is designed
to be ‘‘...a cradle-to-grave system with a Care Record for each patient,”.
However, experiences in the UK have identified areas of controversy in terms of costs,
consultation process, lack of direction, delays, privacy and security.
The Electronic Health Record in the UK includes:

personal health information - e.g. drug allergies; details of operations and/or
conditions; medication history; pathology, radiology and other results and a
summary of contacts with care providers

demographic data - e.g. address details, held nationally and accessible through
local systems

a unique identifying NHS number, which will also form the common link between
personal health information and demographic data

define “personal health information” in a way that is relevant to the modern Irish
health system and address particular issues relating to genetic information
In this regard the Society believes that legislation should be drafted with the benefit from
the positive and negative impacts experienced in other jurisdictions when drafting the Bill.
The Department of Health and Children introduced – Making Knowledge Work for Health: A
Strategy for Health Research in 2001. Under the Act, the National Health Research Strategy
set out the view that “knowledge-based innovation and new ways of thinking are required
for the future development of the health services”.
The Society is concerned that the definitions of implicit and explicit consent, in order to
access personal health information data sets for the purposes of research, should be clearly
explained in the Bill, with the attendant regulations on ethical codes and practices.
While there are conflicting positions on the question of “what is consent” and the
circumstances in which it may or may not be attained, the Society feels that the legislators
should carefully adjudicate on international perspectives in the issue of patient consent
and research.
When Health Information is kept for statistical or research purposes it is within the scope of
the Data Protection Acts. However exemptions from provisions in the Acts relating to
research, do not cover the situation where information is intended to be released to a third
party for research purposes, for example by a doctor to a university.
12
This position is further endorsed under the ECL: 2002: Joint Declaration on the Promotion
and the Enforcement of Cancer Patients’ Rights: (Appendix 1)
Article IV: Right to Information
4.1.
The right to informed consent ….as a prerequisite for any medical act,
participation in research and/or in teaching of medicine.
The right to be informed is also valid for any participation in scientific
research and teaching of medicine.
The Society recognises that consent is a much contested area, however it is our view that
when such data is collected and collated via a patient consultation process, due regard
should be given to protect the privacy of patients, whilst allowing for the research
community to be proactive in discovery for the public good.
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Key Issue 8:
To what extent do certain categories of personal health information -for example,
mental health information and information on children and deceased individuals require special rules on collecting, keeping, using, disclosing and accessing? (See
Parts 2 and 3)
Special Rules on Sensitive Personal Data
The Society’s view is that all personal health information which is collected and its further
uses, should be explicitly covered under the ambit of the legislation.
The Society supports the goals of the proposed Health Information Bill to:

provide special rules to deal with particular categories of personal health
information, e.g. Mental Health Records, STD and HIV.

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;
However the legislation should specifically consider how sensitive personal data should be
protected – this is in line with the Society’s view that all access is controlled in a multi
layered system with appropriate secure access codes on a ‘need - to – know’ basis.
Genetic Data
New privacy concerns in relation to the significance and impact of genetic tests and the
processing of genetic data are of significant concern to the general public at present. While
Article 21 of the Charter of Fundamental Rights of the EU, prohibits “any discrimination
based (…) on genetic features” and the issues have been partly addressed under the
Disability Act 2005 and other Data Protection legislation, nonetheless the new Health
Information Bill should specify these areas in detail.
In the case of the collection and design of cancer data sets, in relation to familial genetic
data, the Society would recommend the Health Information Bill should explicitly set out
such protections to enable this work to be undertaken and to assure the confidence of the
general public.
Survivor Privacy
The Society also would regard that personnel information of a deceased individual would
enjoy the same protection as applied to information relating to a living individual.
Notwithstanding this position, the Society is cognisant of the current position of the right of
access of a family member to a deceased person's records under Freedom of Information
and Data Protection legislation.
The work of the Society in compiling information data sets in relation to cancer mortality,
highlights the issue of survivor privacy.
We note from the Consultation Document that in the USA, the concept of "survivor privacy"
has been upheld by the Supreme Court and further that “survivor privacy" is an aspect of
the protection of private and family life under article 8 of the European Convention on
Human Rights.
Therefore the Society recommends that the issue of survivor privacy is dealt with
specifically in the Health Information Bill.
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Key Issue 9:
Should the Health Information Bill be a comprehensive piece of legislation dealing
with all the relevant issues or should it build on the legislative framework (data
protection and freedom of information) that is already there and working well? (See
Part 1)
The Society believes that the Health Information Bill should be built upon the existing
legislative framework - Data Protection, Freedom of Information, the Constitution and
other legal and binding EU legislation.
The Health Information Bill therefore needs to be clear, unequivocal and seamless, i.e.
there should be ‘joined up legislation’.
Existing legislation has provided certain protections in public health information, however
it is somewhat fragmented, for example,

the Health Information Strategy acknowledges that health research requires “a
robust legislative basis to support appropriate research activities, together with
inbuilt safeguards to protect privacy and confidentiality”

further the Health (Provision of Information) Act 1997, provided exemptions for the
National Cancer Registry of Ireland from certain provisions under the Data
Protection Acts, however it does not deal with the duty of confidentiality

similarly, the Disability Act 2005, provided substantial safeguards for the use of
personal information for those with disabilities as contained in the Data Protection
Acts.

in addition the Health Act 2007, confers certain information related obligations as
set out in the National Health Information Strategy (2004).
However it is clear to the Society that the issue of public health information is currently
legislated for in a disjointed manner.
The EU funded EuroSOCAP Project (European Standards on Confidentiality and Privacy in
Healthcare) stated that “ethical standards of healthcare professional confidentiality are not
reducible to data protection standards, although they operate in conjunction with them.”
The Society believes that the Health Information Bill should provide an enabling legislative
framework, which accommodates all existing legislative rights within a national, european
and international arena.
Notwithstanding the citizens’ rights, patient and health information needs to be framed in
such terms to recognise a balance between a rights based legislative model and a wider
public / societal benefits based model.
Therefore the Society would recommend that the legislation should include the
establishment of a role for a Public Health Commissioner to oversee the implementation of
the Health Information Bill.
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Irish Cancer Society (ICS) submission to the
Public Consultation process on the Proposed Health Information Bill
CONCLUSIONS
1
The Irish Cancer Society believes that the Health Information Bill should build upon
the existing legislative framework - Data Protection, Freedom of Information, the
Constitution and other legal and binding EU legislation.
2
The Health Information Bill therefore needs to be clear, unequivocal and seamless there needs to be joined up legislation.
3
The Health Information Bill should provide an enabling legislative framework, whilst
protecting individual’s rights. There must be a balance between a rights based
legislative model and a wider public / societal benefits based model.
4
The Society strongly supports and welcomes the proposal to introduce a national
programme to provide a Unique Health Identifier for Patients in Ireland.
5
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. 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.
6
The Society advocates for the development of National Population Registers in
Ireland. Population Registers will provide a national repository of information for
health care planning and research.
7
Therefore the Society would recommend that new legislation should provide for the
mandatory reporting of diseases and of gathering health information of public
importance to the National Population Registers in Ireland.
8
The Society, in pursuit of its research remit for information for the benefit of the
population, recommends that access to such patient and health information should
be subject to a wider framework of interpretation of evidence based research
methodologies. We would hope that this position would be made clearer in the new
Bill.
9
The Society sees that the issue of consent should be viewed as a multi-layered
process. Patient consent may be required at various levels e.g. from general health
and life style information to clinical information and the consent required to use
such information in research. The Bill should make provisions for the regulations of
such a system.
10 Definitions in the legislation need to be clear and unambiguous. There should be
definitions of and explaining what is meant by:

Patient information

Health information

Health services information

Health care professionals, i.e. clinical, social, supportive, management
11 The Health Information Bill needs to include explicit detail on the ethics and
ethical codes of practice required of all stakeholders. The Society is content that
existing Ethical / Research Committees are effective.
12 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.
16
13 Access to specialist patient information, i.e. information concerning disability,
mental health, substance abuse, and other special medical conditions, should be
protected on behalf of the patient but accessible on a need-to-know and secure
basis.
14 Setting up and developing an e-Health system, dependant on ICT, requires specific
specialist training for the personnel concerned. Access to e-Health information by
whomsoever, should be via secured Pin Numbers and clearly defined in the Health
Information Bill.
15 Legislative consent: while the Society supports the option of building the Health
Information Bill to encompass existing legislative, it is nonetheless important that
the new Bill identifies such rights of the citizen within the context of the patient
and the private- public health systems.
16 Therefore levels of patient consent should be stratified and accompanied by ethical
codes of practice and guidance to health professionals at all levels of access.
17 The Society also would regard that personnel information of a deceased individual
would enjoy the same protection as applied to information relating to a living
individual.
18 Therefore the Society recommends that the issue of survivor privacy is dealt with
specifically in the Health Information Bill.
19 In the case of collection and design of cancer data sets in relation to familial
genetic data, the Society would recommend the Health Information Bill should
explicitly set out such protections to enable this work to be undertaken and to
assure the confidence of the general public
20 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.
21 The Society would also advocate that registries used in current screening
programmes (e.g. Breast Check, the national breast screening programme and
Cervical Check – the newly created cervical screening programme) would also be
included in a manner consistent with Data Protection Law in any National Health
Population Registers in Ireland.
22 The Society would also recommend that if such National Health Population
Registers in Ireland registries are established, that the value of them would be
further enhanced by allowing access to information for research purposes,
underpinned with the appropriate ethical standards and legal assurances.
23 The Society has extensive experience in the design and implementation of cancer
related public information and awareness campaigns. Such campaigns help to gain
public support and confidence, therefore the Society would recommend that the
legislation should include the establishment of a role for a Public Health
Commissioner to oversee the implementation of the Health Information Bill.
Appendix 1
ECL: 2004: European Guidelines Cancer Patients Rights
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3.
Relationships between patients and health professionals
The relationships must be developed in mutual respect and confidence.
These relationships should be defined in terms of rights connected to
duties and responsibilities.
Relevant components are:
-protected time for consultation and communication
-right to the best quality of care
-right of free choice
-right to have full information about diagnosis, treatment, care and
prognosis, and the right to choose not to be informed
-right to get information in appropriate media
-right to give or withhold consent
-right to have access to personal medical file
-right to privacy
-right to have complaints listened to and responded to
-right to involve family members if desire, to such information for
legitimate purposes
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.
ECL: 2002: Joint Declaration on the Promotion and the Enforcement of Cancer Patients’
Rights also substantiate our position.
6.1. All information about a cancer patient’s health status, medical condition,
diagnosis, prognosis and treatment and all other information of personal kind must
be kept confidential.
6.2. Cancer patients have the right of access to their medical files and technical
records and to any other files and records pertaining to their diagnosis, prognosis,
treatment and care and to receive a copy of their own files, records or parts
thereof.
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.
6.4. All identifiable patient data must be protected in an appropriate way.
6.5. Cancer patients have the right to require the correction, completion,
deletion, clarification and /or updating of personal and medical data concerning
them which are inaccurate, incomplete, ambiguous or outdated, or which are not
relevant to the purposes of diagnosis, prognosis and treatment and care.
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