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Amendments to PIPEDA, Bill S-4

https://policybase.cma.ca/en/permalink/policy11194
Date
2014-06-09
Topics
Health information and e-health
Ethics and medical professionalism
  1 document  
Policy Type
Parliamentary submission
Date
2014-06-09
Topics
Health information and e-health
Ethics and medical professionalism
Text
The Canadian Medical Association (CMA) is pleased to make submissions on Bill S-4. CMA has followed the history of PIPEDA and participated in the studies of various Standing Committees, most notably and recently in 2007 to the House of Commons Standing Committee on Access to Information, Privacy and Ethics. CMA is pleased that amendments to PIPEDA are once again being considered. The Canadian Medical Association represents over 80,000 physicians in Canada. Privacy is an important value to physicians and the patients to whom they serve. This is reflected in our Code of Ethics and policies, in particular, Principles for the Protection of Patients' Personal Health Information and Statement of Principles: The Sale and Use of Data on Individual Physicians' Prescribing. Physicians are also required to abide by privacy and confidentiality standards of practice. Thus, the CMA has a strong interest and valuable insights into the topic of personal information and privacy with respect to health information. We thank the Standing Committee for the opportunity to comment on the proposed amendments to PIPEDA. Our key comments are outlined below: Issue 1: CMA supports the existing legislative framework on the collection, use and disclosure of personal information produced by an individual in the course of their employment, business or profession ("work product") and suggests further amendments focus on strengthening it further. CMA supports the current standing of work products, that work products are considered to be personal information. That is, we support the framework defining personal information as information about an identifiable individual and that there is no carved out definition or exemption for "work product". CMA supports the position of the Office of Privacy Commissioner's following its 2007 investigation on work products, that they should not be exempted for two main reasons: * The exemption is not needed, and it would be inconsistent with the balanced approach in the current definition of personal information. The current definition of personal information and the approach to deciding issues based on that definition have worked well. They have promoted a level of privacy protection that balances the right of privacy in personal information with the needs of organizations for the reasonable and appropriate collection, use and disclosure of personal information. ...Because the concept of "work product" is ambiguous, excluding it from the definition of personal information could have unpredictable consequences that would diminish privacy unnecessarily. * (http://www.priv.gc.ca/parl/2007/sub_070222_03_e.asp) It is the CMA's position that work products should be considered personal information and given the section 7 amendments, work products should only be collected, used or disclosed without consent only if it is consistent with the purposes for which the information was produced. In the case of physicians, a prime example of a physician's work product is prescribing information. Prescribing information is a synthesis of assessing patients - by probing into their health, familial, social and sometimes financial background - infused with medical knowledge, skill and competencies resulting in a diagnosis and treatment plan, which often includes prescribing a medication or test. Not only is the physician's prescribing information a product of physicians' work but would not exist but for a trusting physician-patient relationship wherein the patient's private and personal information are shared under circumstances of vulnerability and trust. The outcome is that this is personal information. Prescribing information is about an individual: it includes the name of the patient, the name of the prescribing physician, and the drug name, dosage, amount and frequency; giving major clues as to what the patient's health issue(s) are. For further clarity, however, CMA recommends that physician information, and physician work products, should be specifically recognized within the legislation as personal information. To this end, we would propose that the following addition be made to the definition section under personal health information: Section 2.(1) "personal health information", with respect to an individual, whether living or deceased, means .....(d) information that is collected or is the outcome of collecting information in the course of providing health services to the individual; CMA supports the amendments to subsections 7(1)-(3) of the Act that any subsequent collection, use and disclosure of work products without consent must be related to the original purpose (of collection, use and disclosure). This relationship reflects the government's understanding and faithfulness to privacy principles. This is particularly critical when dealing with health information, and is even more critical in today's world given the ease of linking information through advancements in technology. In the absence of a causal relationship, personal information should not be used for system performance, commercial enterprise, data brokering, research, assessment or other purposes. CMA recommends that the legislation should go further and allow persons who believe that protection cannot be afforded under the legislation that they have the authority to refuse to communicate the information. This is the conceptual approach taken in Quebec's Act Respecting the Protection of Personal Information in the Private Sector wherein persons have an opportunity to refuse that professional information (as defined therein) be used for commercial purposes. Physicians are constantly writing prescriptions and such information should only be used for other purposes in the interests of patients and the health care system, and not to serve commercial interests or marketing strategies. If physicians do not feel that such protection is afforded patients, then they should be permitted to refuse that such information be collected, used or disclosed. Patient privacy should be primary. And finally, addressing work products in legislation clears up past differences of interpretation by Privacy Commissioners thus, providing certainty and clarity to the public. Recommendation 1: That Section 2. (1) "personal health information", be amended to read as follows: "personal health information", with respect to an individual, whether living or deceased, means .....(d) information that is collected or is the outcome of collecting information in the course of providing health services to the individual; Issue 2: CMA is pleased to see a section on breaches of security safeguards and recommends greater specificity. As noted above, physicians have responsibilities as data stewards and custodians of health information. As such, CMA supports breach notification measures that would enhance and protect patient privacy. In principle, we support the proposed amendments of breach disclosures to the Privacy Commissioner, to individuals and to organizations. However, CMA is concerned that meeting the requirements may be confusing. For example, in the health care context, it is easy to surmise that all health information is "sensitive". A far more difficult matter is determining whether the risk reaches the threshold of "significant harm" and the "probability" that the information "will be misused". The result being that incidental disclosures will be reported causing unnecessary concern and confusion in the patient population. Further specificity is recommended and we suggest something akin to Ontario's Personal Health Information Protection Act, 2004 (PHIPA). The PHIPA is an act specifically dealing with personal health information. One of its purposes is "to establish rules for the collection, use and disclosure of personal health information about individuals that protect the confidentiality of that information and the privacy of individuals with respect to that information, while facilitating the effective provision of health care" (section 1a ). The PHIPA notification provision states that the individual shall be notified "...at the first reasonable opportunity if the information is stolen, lost or accessed by unauthorized persons", [section 12(2)]. CMA is unaware of any concerns with this approach. The language of PIPIEDA is one of reasonable belief of real risk of significant harm to an individual. The issue is the test for required notification of patients for incidental inadvertent breaches and decreasing "notification fatigue". To illustrate the issue, if physicians were told today that patient data could be retrieved from the drums of discarded photocopiers and printers, it would be inappropriate for legislation to suggest that the entire patient population during the life of the photocopier or printer be notified. To this end, we recommend that there be acknowledgement that in some circumstances notification may not be required. The probability of misuse under PIPEDA is more ambiguous than the PHIPA test. Under PHIPA, the approach is more objective in that the data must be stolen, lost or accessed by unauthorized persons. To our knowledge, the Ontario model has been in place for almost a decade with no significant issues and thus we submit is one that works. In other jurisdictions (eg., Newfoundland and Labrador, Nova Scotia, New Brunswick) with health privacy legislation, there is acknowledgement of trying to balance notification and those breaches unlikely to result in harm by directly indicating when notification is not required. Recommendation 2: CMA recommends that the statute move towards a more objective test and acknowledge that there are situations when notice is not required. Issue 3: CMA supports disclosure without consent under limited circumstances, but finds the current list of disclosures overly inclusive. Health information is considered highly sensitive information and is initially collected for the purpose of individual patient health care. It should only be disclosed with consent and in only some exceptions without consent. The PIPEDA amendments for disclosure without consent have been broadened. Privacy, confidentiality and trust are the foundations of the patient-physician relationship. Without these fundamental values in play, open and honest communications cannot occur and patients would not receive the care they require. Both the patient and the physician have significant investment in the relationship. CMA respects the requirements to disclose information without consent under certain premises, such as required by court order or statute. However, any kind of activity requiring physicians to disclose patient's information without consent for the purposes of advancing a government or institution's goal could jeopardize the relationship. Both the patient's consent and the physician's consent should be required if there is potential to disturb this relationship. The physician is fiduciary of the relationship and is appropriately situated to assess and determine whether disclosure will disturb the relationship. While CMA acknowledges that certain situations may require that disclosure occur without consent (eg. purposes of investigating fraud, national security, abuse or as legally required), disclosure for less malicious activities (e.g., breaches of an agreement, insurance claims) ought to require a court order or warrant. For example, under the proposed section 7(3)(d.1) if a physician were in default of a contract with a technology company supplying electronic medical record software or app to his/her clinic, the company could disclose health information without consent for the "purposes of investigating a breach of an agreement". While we appreciate that there is a caveat that disclosure without advising the patient can only occur if there is a reasonable expectation that the disclosure would compromise the investigation, we submit that leaving the determination of what is "reasonable" to an interested party to the breach is unfair to all. Another example, if a physician is a witness to a dispute between an employer and union representing an employee for denial of long term disability by an insurance company, and has filed a witness statement which includes a medical report he/she wrote to the employer's insurance company, under the proposed section 7(3)(e.1) disclosure of health information without consent is permitted in order to assess, process or settle an insurance claim. CMA is concerned that the disclosure amendments are overly broad and do not differentiate sufficiently between highly time sensitive or grossly malicious situations, and those where it is merely expedient or an administrative encumbrance to seek consent. In addition, the disclosure requirements are framed in permissive (ie., may) and not mandatory language (ie., shall). This is very problematic when the "organization" is a physicians' clinic unless the physician's own consent is made as a pre-condition. CMA believes this suggestion is a progressive one in keeping with the broadened disclosure amendments. Physicians are in a relationship of trust and take seriously the protection of patient privacy and confidentiality, for which they are trained and are ethically and legally required to protect. To place physicians in a position which might entail breaching this trust may impact the confidence of the physician and the patient in the patient-physician relationship which is required to properly formulate appropriate treatment plans; thus, negatively impacting the health of Canadians. Recommendation 3: That disclosures of health information without consent require a warrant or subpoena or court order. Furthermore, disclosures of health information require the physician's consent that in his/her opinion the disclosure does not harm the patient-physician relationship. And, finally any broadened disclosure situations be restricted to criminal activity or that impacting national security. Conclusion Once again, CMA appreciates the opportunity to provide comment as part of the committee's study of Bill S-4. CMA is prepared to work with Parliament, governments, health professionals and the public in ensuring legislative frameworks for the collection, usage and disclosure of personal information for legitimate and reasonable purposes.
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Notes for an address by Dr. Eugene Bereza, Chair, Committee on Ethics, Canadian Medical Association : Bill C-6 (An act respecting assisted human reproduction) : Presentation to the Senate Standing Committee on Social Affairs, Science and Technology

https://policybase.cma.ca/en/permalink/policy2007
Last Reviewed
2011-03-05
Date
2004-02-18
Topics
Ethics and medical professionalism
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2011-03-05
Date
2004-02-18
Topics
Ethics and medical professionalism
Text
My name is Dr. Eugene Bereza. I am a physician and clinical ethicist at McGill University Health Centre in Montreal and Chair of the Canadian Medical Association’s Committee on Ethics. I am accompanied today by Dr. Jeff Blackmer, our Director of Ethics. I am here today representing the CMA, but I would also like to advocate on behalf of those patients affected by infertility and those patients suffering, or who will suffer, from the myriad diseases for which medical science is searching out a cure. While there has been considerable debate over the past decade on the moral and ethical issues associated with assisted human reproduction, discussion of this as a health issue has been overlooked all to often. We must remember this is about the practice of medicine and above all, the health of Canadians. My remarks today will focus on the inappropriateness of using criminal sanctions to deal with medical and scientific activities. The Issue It is important to make it clear at the outset that the CMA does not oppose the prohibition of certain medical and scientific activities. Others here today are in a better position to address concerns regarding the specific prohibitions proposed under Bill C-6. Our issue is the means chosen to give effect to these prohibitions and their potential impact on the ability of a physician to ensure the welfare of his or her patients. Criminal law is a blunt instrument. As parliamentarians, you know how difficult it can be to change the law. For some activities prohibited under the criminal law, such as murder and theft, change is not an issue. However, the science of medicine evolves constantly, doubling every 18-24 months. Advances in science and medical practice, coupled with the difficulty of anticipating new developments, make it difficult to adjust the law to remove criminal prohibitions as science and society changes. In the context of prohibiting medical and scientific activities, it is the CMA’s position that the use of criminal law is inappropriate, as it would ultimately not serve our patient’s best interests. Prohibitions, specifically those listed as prohibited activities under Bill C-6, (formerly Bill C-13) could be secured through much less drastic means than criminalization. The CMA proposes that the determination of permissible activities, temporarily or for the longer-term, should be made by the proposed Regulatory Agency working with up-to-date scientific information while providing for public input and ethical review. The Regulatory Agency, as proposed in the Bill, would determine if and when changes in health and safety considerations, public attitudes and values might justify allowing certain formerly prohibited activities to take place under specific conditions. Questions to Consider Bill C-6 begins with the statement: “This enactment prohibits assisted reproduction procedures that are considered to be ethically unacceptable.” However, many Canadians, especially those who are infertile, do not consider some or all of these procedures to be ethically unacceptable nor do the many physicians charged with their care. The CMA questions whether criminal prohibitions are appropriate for dealing with activities about which there is considerable ethical disagreement among Canadians. Legislators in Canada have been justifiably reluctant to use criminal law to deal with medical and scientific issues such as abortion, withdrawal of life-sustaining treatment and the conduct of medical research. Why is an exception being made for assisted reproduction? What sort of precedent will this set for other controversial bioethical issues? What about the chilling effect criminalization will have on research in this important area? For the CMA, the most important question is: what about the patients? What about patients suffering from conditions for which research is banned but may lead to a cure? Should they be denied the opportunity to benefit from this research? Just as Bill C-6 unfairly targets patients, so too does the Bill’s penalties for infractions. Jail terms of up to 10 years and fines up to $500,000 will create a climate of fear and excessive caution for physicians and scientists working in this area. The chill created by these penalties will be such that scientists may well avoid any activity potentially covered by the bill even to the detriment of patient care. The CMA recognizes the good faith among parliamentarians in proposing statutory bans to prohibit certain activities. However, we are convinced in this case the potential for harm outweighs the potential benefits. There is a better way to prohibit these activities while still facilitating important research and necessary treatments. An Alternative Solution Instead of instituting criminal prohibitions within the legislation, the CMA suggest the Assisted Human Reproduction Agency of Canada manage procedures deemed permissible by moving the procedures listed under “Prohibited Activities” to “Controlled Activities.” We recommend that criminal sanctions apply to breaches of agency directives such as performing activities prohibited by the agency and performing controlled activities without a license. Such an approach would have the dual advantage of being able to both prohibit activities deemed unethical while still providing the flexibility to ensure legitimate medical and scientific progress in the treatment of infertility. The regulatory agency should be established as soon as possible and should build on the experience and expertise of existing assisted reproduction organizations and structures that deal with practice standards, education, certification and accreditation. Conclusion The CMA’s overriding concern in addressing this legislation is the well-being of patients, in this case patients who are infertile and patients afflicted by conditions for which medical research offers significant promise of treatment. We support government efforts to regulate assisted human reproduction and related activities, including the prohibition of certain practices temporarily or permanently where necessary. However, we do not believe that criminalization of medical and scientific activities named in the bill is an appropriate way to achieve those objectives. We believe we have advanced a workable alternative within the spirit of the Bill. Thank you.
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Notes for an address by Dr. Eugene Bereza, Chair, Committee on Ethics, Canadian Medical Association : Bill C-13 - An act respecting assisted human reproduction : Presentation to the House of Commons Standing Committee on Health

https://policybase.cma.ca/en/permalink/policy1963
Last Reviewed
2010-02-27
Date
2002-11-20
Topics
Ethics and medical professionalism
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2010-02-27
Date
2002-11-20
Topics
Ethics and medical professionalism
Text
BILL C-13 - AN ACT RESPECTING ASSISTED HUMAN REPRODUCTION Presentation to the House of Commons Standing Committee on Health Ottawa, Ontario November 20, 2002 BILL C-13 - AN ACT RESPECTING ASSISTED HUMAN REPRODUCTION Madame Chair and Members of the Committee: My name is Dr. Eugene Bereza. I am a physician and clinical ethicist at the Royal Victoria Hospital in Montreal and Chair of the Canadian Medical Association Committee on Ethics. I am here today representing our members, more than 54,000 physicians from across Canada. I also wish to speak as a advocate for our patients, especially those affected by infertility and those who are or will suffer from diseases for which medical science is searching for cures. I am accompanied today by Dr. John Williams, our Director of Ethics. You will recall that we appeared before this Committee on October 23, 2001 in company with representatives from eight other national health provider and scientific organizations to present our views on draft legislation on assisted human reproduction. Although we were pleased that your December 2001 report recommended the establishment of an assisted reproduction regulatory body outside the Department of Health, we were disappointed that you did not find favour with other recommendations we put forward. The government responded to your report with Bill C-56, now Bill C-13. It is this bill that we are here to address today. Although there are many details in the bill on which we would like either clarification or changes, we intend to focus our remarks on the issue that we consider of greatest importance for our patient’s wellfare and the practice of medicine. That issue is the use of the criminal power to deal with medical and scientific activities. The Standing Committee Report and Bill C-13 In your December 2001 report, you acknowledged our position on this issue: “Some witnesses recommended the elimination of the prohibited activities category altogether. Citing the benefits of regulatory flexibility, they felt that all activities should come under the controlled activity category, including the more reprehensible activities like reproductive cloning for which licences, arguably, would never be allowed under the regulations” (page 9). However, you rejected this view on the grounds that “a licence-related prohibition of this sort would not carry the same weight or degree of social censure as the statutory prohibition…. An outright statutory ban signals more clearly that certain activities are either unsafe or socially unacceptable. The use of the statutory ban also signals that these activities are of such concern to Canadians that their status as a prohibited activity may not be altered except with the approval of Parliament” (page 9). Bill C-13 reflects your views on this matter. We recognize your good faith in proposing and defending this position but we are convinced that its potential for harm outweighs its potential benefits. And so we are pleased to have this opportunity to reiterate the reason why the CMA believes that Bill C-13 will adversely affect the patient-physician relationship and the advance of medical science. Need to Change Bill C-13 As you know, our position on this matter is supported by legal scholars such as Patrick Healy, McGill University Faculty of Law, Tim Caulfield, Director of the University of Alberta Health Law Institute, and Bartha Knoppers, Université de Montréal Centre de Recherche en Droit Publique. In essence, our position is that the criminal law is a blunt instrument and very difficult to change and is therefore appropriate for activities whose status is unlikely to change over time, such as murder and theft, rather than medical and scientific activities that are constantly developing. The latter are better left to a representative regulatory body to determine if and when changes in health and safety considerations and public attitudes and values might justify allowing certain formerly prohibited activities to take place under specific conditions. Bill C-13 begins with the statement: “This enactment prohibits assisted reproduction procedures that are considered to be ethically unacceptable.” This echoes the conclusions in your report. However, as the transcripts of your hearings demonstrate, many Canadians, especially those who are infertile, do not consider some or all of these procedures to be ethically unacceptable. As a matter of public policy, should Canadians who hold this view be denied access to medical treatment for infertility because others consider such treatments to be ethically unacceptable? Should patients who suffer from conditions for which research that is forbidden in Bill C-13 might lead to a cure be denied that opportunity? We question whether criminal prohibitions are appropriate for dealing with activities on which there is considerable ethical disagreement among Canadians. In Canada legislators have been justifiably reluctant to use the criminal law to deal with medical and scientific issues such as abortion, withdrawal of life-sustaining treatment and the conduct of medical research. Why is an exception being made for assisted reproduction? What sort of precedent will this set for other controversial bioethical issues? We are also concerned about the bill’s penalties for infractions: jail terms up to 10 years and fines up to $500,000. These are disproportionate to the penalties for crimes that injure persons or property and, as such, will create a climate of undue fear and excessive caution for physicians and scientists working in this area, such that they will avoid any activity that is potentially covered by the bill, even to the detriment of patient care. Given the rapid advance of science and medical practice and the difficulty of anticipating new developments, it will be difficult to adjust the law to deal with new applications of prohibited activities that may be ethically acceptable. An Alternate Solution The CMA has stated repeatedly that we are not opposed to the prohibition of certain assisted human reproduction activities. Instead of instituting criminal prohibitions within the legislation, we remain convinced that an independent body on an ongoing basis should determine the activities that are permissible or prohibited on the basis of up-to-date scientific research, public input and ethical review. This can be accomplished very easily in Bill C-13 by moving the procedures listed under “Prohibited Activities” (sections 5-9) to “Controlled Activities” and adding the words “except in accordance with the regulations and a licence” to each of the provisions in sections 5-9. Consistent with this recommendation we consider that the regulatory agency should be established as soon as possible and be given as much authority as possible over the matters that Bill C-13, section 65, reserves to regulations of Governor in Council. We hope that the agency will build upon the experience and expertise of existing organizations and structures in the field of assisted reproduction that deal with practice standards, education, certification and accreditation. Conclusion To summarize, we strongly support government efforts to regulate assisted human reproduction and related activities, including the prohibition of certain practices either temporarily or permanently. However, like others who have appeared before this Committee, we do not believe that criminalizing the medical and scientific activities named in the bill is an appropriate way to achieve those objectives. We consider that the objectives could be as well achieved by far less drastic means than criminalization and, moreover, that criminalization would create major obstacles to legitimate medical and scientific progress in the treatment of infertility. We recommend that the proposed agency be empowered to regulate these practices and that the criminal power be invoked when controlled activities are performed without authority of a licence from the agency or in defiance of the licensing conditions established by the agency. Thank you, Madame Chair and members of the Committee. We will be pleased to respond to your questions.
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