 |
Summary of the Health Surveillance and Research Discussion Group, Nov 21, 2003 |
Participants:
Susanne Burkhardt, OPHA Environmental Health Workgroup
Section F - Health Surveillance and Research
Q. 102 Do you agree with what is being proposed?
We agree in principle. It is important that this section continues to address issues broader than communicable diseases.
Concerns
Throughout this section there is little reference to the Local level. Although this is to govern the surveillance and research of Health Canada, in many surveillance situations the data are collected at the local level and then fed up through the Province / Territory to the federal level (e.g. communicable disease.). There must be linkages and integration between the three levels of government to ensure seamless surveillance reporting. Specifically, reference to this needs to be made in F1 Background, F4 "national framework for co-ordinated public health-related surveillance and research activities"; F5 bullet points 1, 2, 3; etc.
Specific Recommendations
F2.1 Add to the end of this statement the concept of policy " ?and guide public health policy and action." F4 Could the "National Health Surveillance Network" referred to in the italics be housed in a "National Health Promotion and protection Agency" as identified in the Kirby report? F6.1 Research should include that into issues that affect the data used for surveillance such as the impact of the change from ICD-9 to ICD-10. Emerging issues are important and so are the issues that impact the data and thus our ability to interpret what is happening.
Questions Raised
F6.6 - F6.12 How will "?health laboratory centres" link with existing provincial public health labs? F6.13.4 This would be a very useful and important area in which to improve data collection and reporting. Will there be a commitment to be able to provide these data at smaller geographic levels than the province or planning areas especially in urban areas? In large urban areas it is also important to break the city down in order to identify potential areas of the city where specific health issues may be located.
back to top
Section G - Information:
G1 - Authority to Collect, Use or Disseminate Information
Q. 104 Do you agree with what is being proposed?
Q. 105 If not, what would you suggest instead?
Q. 106 Do you agree with the circumstances in which a person or an organization could be compelled to provide information to Health Canada?
We agree with the intent of this section, however have some concerns and recommendations (see below). It is important to ensure that the appropriate government officials have access to the information they need to effectively protect the health of Canadians, (whether this is through surveillance, research, epidemiological study, etc.) while protecting the individual and their information. There needs to be balance.
Information collected or accessed by Health Canada needs to be flowed to the appropriate other levels of government or agencies who need it to protect the health of Canadians. The proposed Act and accompanying Regulations need to ensure a workable balance.
Concerns
"... particularly sensitive personal and commercial information" is a very broad statement and since the proposed legislation does not define "health" this section seems even less clear. Different people view the same information about themselves in different ways. The same issue would be perceived to have different levels of sensitivity by different people. There needs to be a way to clearly assess what is "sensitive personal information" and what is "sensitive commercial information". For example: In cervical screening, many women concerned about their name being on a list for recall post screening. Concern was expressed about the who, how, etc. of data collection, use and disclosure. The regulations need to be carefully crafted so that the proposed Act is implemented well.
Specific Recommendations
Issue: How can we control that what is being reported reflects the truth? The same data can be analyzed in different ways and end up reporting different results. Usually this occurs when data quality is poor.
Quality of the data is critical to minimize this issue. The better the data quality (e.g. the higher the response rate, the more complete the data, collecting the right data from the right person(s) in the right way, etc.) the more likely there will be consistency of analysis and thus findings. This would help to reduce controversy and disagreement over a specific issue. Transparency is important. What data is being used and how - this will allow others to flag potential problems / issues / alternatives while being clear about what is being used in the process and what is not. Quality Assurance procedures need to be place to ensure data quality from start to finish (reporting).
The principles outlined earlier in the proposed Legislation are important to apply in the "collection, use and disclosure" of data.
Questions Raised
What Acts guide Statistics Canada's collection, use, data linkage and disclosure of health data? Statistics Canada has a solid reputation regarding the collection and use of personal information, therefore the proposed Act can benefit from the legislation and regulations governing their work as well as from the processes employed. What is the legislative framework for CIHI in the various registries they administer? Could these inform this section of the proposed Act?
G1.2.1 Pg 140: Should the Minister have the authority to require that a person provide Health Canada with information needed for health surveillance and research purposes, by way of a formal notice published in the Canada Gazette or in some other manner, an easier process than having to adopt regulations? This would be similar to section 46 of the Canadian Environmental Protection Act.
Yes.
Questions Raised
How does this relate to duplication with other jurisdictions and provincial / territorial Privacy Acts and other acts regarding the collection of personal or product data?
It is important to ensure that acts do not contradict each other between different levels of government and different parts of federal government.
G1.3 Pg 141: Should the proposed Act specify that information provided to Health Canada on a purely voluntary basis and on the condition that the information remains confidential, could not be disclosed by Health Canada (not even to the person to whom the information relates), without the consent of the provider of the information?
Questions Raised
Why is this? Who owns the information about an individual - the individual or the group who collected it? Is this to protect the group that collected it in case it is inaccurate?
G1.3 Pg 141: Should the proposed Act specify that information provided to Health Canada on a purely voluntary basis and on the condition that the information remains confidential, could not be disclosed by Health Canada (not even to the person to whom the information relates), without the consent of the provider of the information?
back to top
G2.1 General
Q. 107 Do you agree with what is being proposed?
Q. 108 If not, what would you suggest instead?
Agree with the spirit or intent of this section, however it needs more clarity.
Q. 109 Do you agree with the definition of "identifying personal information"?
General Comments
The definition proposed does not clearly define "identifying personal information". What is considered to be 'identifying personal information'? Does it include combinations of 2 or more elements (e.g. name & health condition, postal code + sex, etc.? Combinations of information could identify a specific person in certain situations / locations.
As it stands the definition does not help to understand the intent of this section.
Specific Recommendations
The definition could use examples, especially of combo's of data that may lead to identification and could start the examples with the phrase "such as and not limited to ?."
G2.1.3 Pg 145: The definition of "identifying personal information" is broad enough to include genetic information. Should genetic information be treated differently due to its special characteristics? For example, such information reveals the hereditary characteristics of the individual and the pattern of inheritance of such characteristics within a related group of individuals (children, parents, brothers, sisters). Should this framework cover this type of information or should we develop a specific framework with certain special features such as: use genetic information only with the express consent of the individual; prohibit discrimination based on genetic characteristics; provide that the public interest in collecting, using or disclosing such information must clearly outweigh not only the interest of the individual but also the interest of the group concerned (e.g. other members of the family); recognize an individual's right not to be informed of the results of genetic examination (e.g. the right not to know that I am suffering from a degenerative disease); and allow biological relatives certain access rights where there is a high probability of a serious harm, and where disclosure would prevent harm to the relative?
General Comments
Yes, the inclusion of genetic information is probably important, however it is beyond the scope of this group to fully comment. It needs to be reviewed carefully by people who are more aware of the key issues.
back to top
G2.2 Collection and Use
Q. 110 Do you agree with what is being proposed?
Q. 111 If not, what would you suggest instead?
General Comments
We agree in principle to this content of this section.
Specific Recommendations
Move the Informed Consent section to be close to this section so that the definition and concept is understood where it is first being used.
"Informed choice" and "informed consent" are similar and related concepts that should be at work in the collection of personal data. "Informed choice" refers to individual understanding of the various options / choices (the issues and consequences, etc) and "informed consent" refers to the individual agreeing to participate based on the clear understanding of the option chosen.
With informed consent, the data collector is responsible to ensure that the individual understands what they are consenting to. Informed consent needs to include providing info re risks and benefits not just use and disclosure. The concept of informed consent needs to be consistently used throughout the proposed legislation
Health Canada is not seen as handling data in a more secure manner. There is a lack of confidence about how it handles information. On the other hand Statistics Canada is perceived as a secure and responsible holder of data. This perception may partially relate to the fact that Health Canada does not give data back to the public, other levels of government and agencies in a consistent manner. Statistics Canada does this well.
Q. 112 Do you agree with the circumstances in which Health Canada could collect and use identifying personal information?
Q. 113 Are there any additional circumstances in which Health Canada could collect and use identifying personal information?
Specific Recommendations
Each situation / circumstance needs to be addressed on an individual basis since cannot cover all possible combinations in one Act. Therefore it is important to make clear that there are safeguards around information. Disclosure needs to be addressed clearly and the consequences made clear.
G 2.2.1.5 pg 148 Guidelines could provide guidance as to what factors should be considered to balance the public interest against the rights of the individual to whom the information relates. Should these factors be identified in the Act itself? Factors to consider could include: Would there be a significant public health benefit? Can it be identified specifically? How current and probable would it be? What would be the impact on the health of the people if the information is not available to Health Canada? Are there other reasonable means to achieve the same objective? How sensitive is the identifying personal information? What are the expectations of privacy in the circumstances? What are the probabilities that an individual's career, reputation, financial position, safety, health or well-being will be affected? How severe could the negative consequences be for the individual?
General Comments
We agree with intent. Yes, guidelines are important to balance the rights of the individual and the rights of public in general
Privacy and confidentiality are different and related concepts. It is important to focus on the appropriate one as it could hamper our ability to 'protect the health of the people'. Privacy relates to whether or not information is even made available (i.e. " leave me alone don't bother me"). Confidentiality refers to maintaining information secret.
back to top
G2.3 Disclosure
Q. 114 Do you agree with what is being proposed?
Q. 115 If not, what would you suggest instead?
General Comments
It is important that safeguards should be in place to protect people / companies relative to the disclosure of personal / commercial information
It will be important through the proposed legislation and related regulations to clarify who gets what information (anonymized, aggregate, identifying, ?), when & how.
Specific Recommendations
Use consistent terminology throughout the proposed legislation. Sometimes "promote & preserve" is used and then "promote and protect". Early in the proposed Act the concept of "promotion" was excluded from the Act, should it be used in the later parts? Should health promotion be defined at the same time as the definitions for protect and preserve in early parts of the Act?
Q. 116 Do you agree with the circumstances in which Health Canada could disclose identifying personal information?
Q. 117 Are there any other circumstances in which Health Canada could disclose identifying personal information?
General Comments
We agree in principle. Rather than try to be inclusive it will be important to define a mechanism to review a new circumstance that doesn't fit so that decisions are made in a consistent way regarding disclosure.
Questions Raised?
regarding G2.3.3: Should private institutions and private services be included under this re: reporting and disclosure?
back to top
G2.4 Operating Principles
Q. 118 Do you agree with what is being proposed?
Q. 119 If not, what would you suggest instead?
General Comments
We agree in principle. Re. G2.4.1.5. "? to protect confidentiality, in proportion to the degree of sensitivity of the information" - All personal information should be treated with equal confidentiality. If any information is accidentally released, trust will be lost. If that information is classified as "less sensitive" then the public will assume that "more sensitive" are also at risk. The only potential difference is the size of the court case and this act should be concerned about the protection of personal information not which type will be a greater court case.
Specific Recommendations
If this refers to aggregate versus non-aggregate then specify this. The precautions referenced in G2.4.1.6 & G2.4.1.7) are important. This section should be moved up to after authority so that is placed relative to importance. This is an overarching issue and priority. Current structure buries the importance Confidentiality and privacy should not be used to avoid transparency of process.
Questions Raised?
How define what is more sensitive?
Q. 120 Are there any other operating principles?
None that came to mind.
back to top
G2.5 Oversight
Q. 121 Do you agree with what is being proposed?
Q. 122 If not, what would you suggest instead?
Q. 123 Which oversight tools should be put in place to ensure that Health Canada does not collect, use or disclose information except in accordance with the proposed provisions?
Specific Recommendations
Include the following in an Oversight Package: Tools 1, 3, 5 with conditions, 6 Do not include Tool 4.
Issue If Tool 2 and Tool 3 were both used / available who would take precedence on any one situation? Therefore If use Tool 3 only:
If the Health Information Commissioner could not resolve a privacy issue then it would be bumped up to the Privacy Commissioner for comment and resolution. This needs to have connections with all of the tools when appropriate.
Questions Raised?
Does this mean that a researcher at a University or other institution needs to send their project to Health Canada Health Information Commissioner for review or just those proposed by Health Canada?
Comments about each of the tools are as follows:
Tool #1 - Transparency
Yes, public should be aware of the processes. All decision made should be transparent.
Tool #2 - Transparency
This could be a duplication from the provinces: Which level of government would have more power: Provincial or Federal? It is inappropriate that all research should go to Privacy Commissioner. The Privacy commissioner is familiar with privacy issues and not necessarily the range of issues related to health data or research. At a minimum there should be a dialogue to ensure that proposed research is within the confines of the legislation. There also could be the development of policy and process that allows / supports dialogue to guide researchers in whether there may be privacy problems with their research proposal.
Tool #3 - Health Information Auditor
Good idea. Too often there is a disconnect between epidemiology / research and privacy, where the ethics and scientific methods of research are not seen as also addressing issues of privacy. Rather than looking at research ethical issues and privacy issues together, they are looked separately and by individuals who understand one or other of issues. These need to be brought together. A Health Information Auditor should understand both health research and privacy together. This should be an ongoing function to ensure consistency and continuity. It should be more that looking at specific issue with a magnifying glass - rather it should be a Continuous Quality Improvement process / approach (could be an ongoing audit process that is part of an evaluation framework).
Tool #4 - Accountable Individual Within Health Canada
Should this not be the responsibility of the whole organization and the Minister is the accountable person?
Tool #5 - Review Committee
Yes, a Research Committee is a good idea. It would provide consistency from one project to the next. However it needs to have a streamlined process with a clear process for people to follow. There may be some policy processes that could be developed that allow dialogue to guide researchers in whether there may be problems with proposal in advance of submission.
Tool #6 - Dispute Resolution
Yes, a mechanism is important. Needs clear criteria.
back to top
G2.6 Consent
General Comments
Consent is a tool for transparency and thus addressed multiple important concepts. Consent should not compromise the ability of Health Canada to do health surveillance and protect the health of Canadians.
Q. 124 Do you agree with what is being proposed?
Q. 125 If not, what would you suggest instead?
Q. 126 Do these provisions contain sufficient safeguards to protect the privacy of an individual's health information?
Specific Recommendations
Informed Consent and Informed choice are important concepts. This section should appear earlier in Section g of this proposed act so this it precedes the earlier references. G2.6.1.1 - Add "...informed and understood" to this statement. It should be clear that informed consent includes the concept of the individual understanding what the information is that has been provided to them. G2.6.2 - Add in "and at a minimum there is a baseline consent that is acceptable". For example does someone nodding their head equal a signature on a consent form?
It will be important to clarify in regulation:
what constitutes informed consent? in which circumstance informed consent is needed or not.
G 2.6.3 The specification of if and up to what point the withdrawal of information will be possible needs to be included in informed consent process. This should be specified / clarified through regulation. 4.G2.6.5 - The related regulations should address this issue.
Are there other acts or regulations that define this? Need to ensure that this fits with other regulations / legislation at federal and provincial/territorial levels. Somewhere there should be a clear definition of who can give consent for which group of people and the length of time that consent can apply. (I think we should give an example here of what we mean by "group of people") Either the Minister of Health or the Privacy Commissioner should define the list. The list should be consistent with legislation / regulation elsewhere in Canada.
back to top
G3 - Confidential Commercial Information
Q. 127 Do you agree with what is being proposed?
Q. 128 If not, what would you suggest instead?
Questions Raised
Clarification is needed: "to achieve the public health purpose" - Does this "purpose" apply to an individual or small groups or only population wide?
regarding G3.4 p 165: General Comments
Dispute resolution regarding disclosure of commercial information needs to be at arms length, however a "commission" is not the answer. Some situations need a process that is that can act quickly e.g. when there exists a significant health risk requiring immediate action. Other, less urgent issues can have the longer time frame for a "commission" type of group to deliberate.
Specific Recommendations
For urgent issues an expert panel could advise the Minister who delivers the decision. The expert panel would need to be flexible, timely. Expert panel could be made up of the Chief Nursing Officer, Chief Medical Officer, and other individuals with expertise in the area of concern. It is important to identify the person with the greatest authority to make the identified action happen. If the Minister is the one who authorizes that a product be recalled then that's the person. It is important to ensure there is a seamless process between the Federal, Provincial/Territorial and local levels of governments in actions taken.
back to top |
