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:
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.
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.
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;
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.
CMA recommends that the statute move towards a more objective test and acknowledge that there are situations when notice is not required.
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.
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.
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.
Dear Members of the Federal External Panel:
On behalf of the Canadian Medical Association (CMA), I appreciate the opportunity to provide input toward the Federal External Panel's national consultation to support the federal government's legislative response following the Supreme Court of Canada's ruling in Carter v. Canada.
As the national professional association representing Canada's physicians, the CMA has played an important role in leading the public dialogue on end-of-life care, including assisted dying. In 2014, the CMA led a national consultation on end-of-life care which included a series of public and member town hall consultations across the country. This national dialogue focused on three main issues: advance care planning, palliative care, and physician-assisted dying. As highlighted in the summary report (enclosed as Appendix 1), the Canadian public emphasized the need for strict protocols and safeguards if the law on physician-assisted dying were to change.
This initial consultation provided valuable insights to inform the concurrent CMA's in-depth and comprehensive consultation with its membership as well as medical and health stakeholders as an intervener before the Supreme Court and following the Carter decision. This consultation included engagement of the CMA's Ethics Committee, policy debates as part of the CMA's Annual Meetings in 2014 and 2015, in-person member forums across the country, and an online dialogue. The consultation was critical to the development of the CMA's Principles-based Recommendations for a Canadian Approach to Assisted Dying (enclosed as Appendix 2).
These recommendations, guided by a set of ten foundational principles, address patient eligibility for access to and assessment for assisted dying, procedural safeguards for eligibility criteria, the roles and responsibilities of the attending and consulting physicians, and the issue of conscientious objection. Taken together, these recommendations form the CMA's position on the forthcoming legislative and regulatory framework to govern assisted dying in Canada.
In addition to our recommendations, we would like to highlight key points that are of particular relevance to physicians:
NATIONAL, PAN-CANADIAN LEGISLATIVE AND REGULATORY FRAMEWORK
The CMA strongly recommends the establishment of national and coordinated legislative and regulatory processes and systems in response to the Carter decision.
The CMA is deeply concerned that in the absence of federal action to support the establishment of national guidelines for assisted dying, a patchwork of differing and potentially conflicting approaches could emerge across jurisdictions. Legislative action at the federal level is needed to provide further clarity for physicians and their patients and support the promulgation of a coordinated and consistent approach across all jurisdictions in Canada. The CMA has been working with the medical regulatory colleges at the national level to mitigate this risk through the development of the CMA's Principles-based Recommendations for a Canadian Approach to Assisted Dying which has encouraged similar efforts by the regulatory colleges. In addition to these initiatives, federal action is required.
As the Federal External Panel is aware, the Carter decision emphasizes that any regulatory or legislative response must seek to reconcile the Charter rights of patients (wanting to access assisted dying) and physicians (who choose not to participate in assisted dying on grounds of conscientious objection). The notion of conscientious objection is not monolithic. While some conceptions of conscience encompass referral, others view referral as being connected to, or as akin to participating in, a morally objectionable act.
It is the CMA's position that an effective reconciliation is one that respects, and takes account of, differences in conscience, while facilitating access on the principle of equity. To this end, the CMA's
membership strongly endorses the recommendation on conscientious objection as set out in section 5.2 of the CMA's enclosed Principles-based Recommendations for a Canadian Approach to Assisted Dying.
The CMA recognizes, and supports addressing, the need to develop education materials for physicians. To this end, the CMA is actively developing education modules for physicians following an environmental scan of existing courses and discussions with other jurisdictions (e.g., the Royal Dutch Medical Association). The CMA has the support of the Royal College of Physicians and Surgeons of Canada, the College of Family Physicians of Canada, and the Canadian Medical Protective Association to lead this initiative.
Finally, as previously stated, the CMA strongly encourages the federal government to make the report of the Federal External Panel publicly available once final. The CMA urges the members of the Federal External Panel to support this recommendation to the federal government.
Thank you once again for the opportunity to provide input. The CMA looks forward to our meeting with the Federal External Panel on October 20, 2015.
Cindy Forbes, MD, CCFP, FCFP
Jeff Blackmer MD, MHSc, FRCPC
Vice-President, Medical Professionalism
Appendix 1 - Summary Report: End-of-Life Care A National Dialogue (please see pdf for link to document)
Appendix 2 - CMA's Principles-based Recommendations for a Canadian Approach to Assisted Dying
Principles-based Recommendations for a Canadian Approach to Assisted Dying
On Feb. 6, 2015, the Supreme Court of Canada unanimously struck down the law prohibiting assisted dying. The court suspended that decision for 12 months. This has provided an opportunity for the Canadian Medical Association (CMA) to build on its past work and pursue further consultation with provincial and territorial medical associations, medical and non-medical stakeholders, members, legislatures and patients for processes, whether legal, regulatory or guidelines, that respect patients' needs and reflects physicians' perspectives.
The goal of this process is twofold: (a) discussion and recommendations on a suite of ethical-legal principles and (b) input on specific issues that are particularly physician-sensitive and are worded ambiguously or not addressed in the Court's decision. The touch points are reasonable accommodation for all perspectives and patient-centeredness.
For purposes of clarity, CMA recommends national and coordinated legislative and regulatory processes and systems. There should be no undue delay in the development of these laws and regulations. The principles are not designed to serve as a tool for legislative compliance in a particular jurisdiction or provide a standard of care. Rather, the CMA wishes to provide physicians with guidance and a vision of what physicians might strive for to further their professional and legal obligations in a complex area.
The CMA recommends adopting the following principles-based approach to assisted dying in Canada:
The following foundational principles underpin CMA's recommended approach to assisted dying. Proposing foundational principles is a starting point for ethical reflection, and their application requires further reflection and interpretation when conflicts arise.
1. Respect for patient autonomy: Competent adults are free to make decisions about their bodily integrity. Specific criteria are warranted given the finality of assisted dying.
2. Equity: To the extent possible, all those who meet the criteria for assisted dying should have access to this intervention. Physicians will work with relevant parties to support increased resources and access to high quality palliative care, and assisted dying. There should be no undue delay to accessing assisted dying, either from a clinical, system or facility perspective. To that end, the CMA calls for the creation of a separate central information, counseling, and referral service.
3. Respect for physician values: Physicians can follow their conscience when deciding whether or not to provide assisted dying without discrimination. This must not result in undue delay for the patient to access these services. No one should be compelled to provide assistance in dying.
4. Consent and capacity: All the requirements for informed consent must clearly be met, including the requirement that the patient be capable of making that decision, with particular attention to the context of potential vulnerabilities and sensitivities in end of life circumstances. Consent is seen as an evolving process requiring physicians to continuously communicate with the patient.
5. Clarity: All Canadians must be clear on the requirements for qualification for assisted dying. There should be no "grey areas" in any legislation or regulations.
6. Dignity: All patients, their family members or significant others should be treated with dignity and respect at all times, including throughout the entire process of care at the end of life.
7. Protection of patients: Laws and regulations, through a carefully designed and monitored system of safeguards, should aim to minimize harm to all patients and should also address issues of vulnerability and potential coercion.
8. Accountability: An oversight body and reporting mechanism should be identified and established in order to ensure that all processes are followed. Physicians participating in assisted dying must ensure that they have appropriate technical competencies as well as the ability to assess decisional capacity, or the ability to consult with a colleague to assess capacity in more complex situations.
9. Solidarity: Patients should be supported and not abandoned by physicians and health care providers, sensitive to issues of culture and background, throughout the dying process regardless of the decisions they make with respect to assisted dying.
10. Mutual respect: There should be mutual respect between the patient making the request and the physician who must decide whether or not to perform assisted dying. A request for assisted dying is only possible in a meaningful physician-patient relationship where both participants recognize the gravity of such a request.
Based on these principles, the Supreme Court decision in Carter v. Canada (2015)1 and a review of other jurisdictions' experiences, CMA makes the following recommendations for potential statutory and regulatory frameworks with respect to assisted dying. We note that this document is not intended to address all potential issues with respect to assisted dying, and some of these will need to be captured in subsequent regulations.
1. Patient eligibility for access to assisted dying
1.1 The patient must be a competent adult who meets the criteria set out by the Supreme Court of Canada decision in Carter v. Canada (2015.
1.2 Informed decision
* The attending physician must disclose to the patient information regarding their health status, diagnosis, prognosis, the certainty of death upon taking the lethal medication, and alternatives, including comfort care, palliative and hospice care, and pain and symptom control.
* The attending physician must be satisfied that:
- the patient is mentally capable of making an informed decision at the time of the request(s)
- the patient is capable of giving consent to assisted dying, paying particular attention to the potential vulnerability of the patient in these circumstances
- communications include exploring the priorities, values and fears of the patient, providing information related to the patient's diagnosis and prognosis, treatment options including palliative care and other possible interventions and answering the patient's questions
* If either or both the attending physician or the consulting physician determines that the patient is incapable, the patient must be referred for further capacity assessment.
* Only patients on their own behalf can make the request while competent.
* The attending physician must be satisfied, on reasonable grounds, that all of the following conditions are fulfilled:
- The patient's decision to undergo assisted dying has been made freely, without coercion or undue influence from family members, health care providers or others.
- The patient has a clear and settled intention to end his/her own life after due consideration.
- The patient has requested assisted dying him/herself, thoughtfully and repeatedly, in a free and informed manner.
2. Patient eligibility for assessment for decision-making in assisted dying
Stage 1: Requesting assisted dying
1. The patient submits at least two oral requests for assisted dying to the attending physician over a period of time that is proportionate to the patient's expected prognosis (i.e., terminal vs non-terminal illness). CMA supports the view that a standard waiting period is not appropriate for all requests.
2. CMA recommends generally waiting a minimum of 14 days between the first and the second oral requests for assisted dying.
3. The patient then submits a written request for assisted dying to the attending physician. The written request must be completed via a special declaration form that is developed by the government/department of health/regional health authority/health care facility.
4. Ongoing analysis of the patient's condition and ongoing assessment of requests should be conducted for longer waiting periods.
Stage 2: Before undertaking assisted dying
5. The attending physician must wait no longer than 48 hours, or as soon as is practicable, after the written request is received.
6. The attending physician must then assess the patient for capacity and voluntariness or refer the patient for a specialized capacity assessment in more complex situations.
7. The attending physician must inform the patient of his/her right to rescind the request at any time.
8. A second, independent, consulting physician must then also assess the patient for capacity and voluntariness.
9. Both physicians must agree that the patient meets eligibility criteria for assisted dying to proceed.
10. The attending physician must fulfill the documentation and reporting requirements.
Stage 3: After undertaking assisted dying
11. The attending physician, or a physician delegated by the attending physician, must take care of the patient until the patient's death.
3. Role of the physician
3.1 The attending physician must be trained to provide assisted dying.
3.2 Patient assessment
* The attending physician must determine if the patient qualifies for assisted dying under the parameters stated above in Section 1.
* The attending physician must ensure that all reasonable treatment options have been considered to treat physical and psychological suffering according to the patient's need, which may include, independently or in combination, palliative care, psychiatric assessment, pain specialists, gerontologists, spiritual care, and/or addiction counseling.
3.3 Consultation requirements
* The attending physician must consult a second physician, independent of both the patient and the attending physician, before the patient is considered eligible to undergo assisted dying.
* The consulting physician must
- Be qualified by specialty or experience to render a diagnosis and prognosis of the patient's illness and to assess their capacity as noted in Stage 2 above.
3.4 Opportunity to rescind request
* The attending physician must offer the patient an opportunity to rescind the request at any time; the offer and the patient's response must be documented.
3.5 Documentation requirements
* The attending physician must document the following in the patient's medical record:
- All oral and written requests by a patient for assisted dying
- The attending physician's diagnosis and prognosis, and their determination that the patient is capable, acting voluntarily and has made an informed decision
- The consulting physician's diagnosis and prognosis, and verification that the patient is capable, acting voluntarily and has made an informed decision
- A report of the outcome and determinations made during counseling
- The attending physician's offer to the patient to rescind the request for assisted dying
- A note by the attending physician indicating that all requirements have been met and indicating the steps taken to carry out the request
3.6 Oversight body and reporting requirements
* There should be a formal oversight body and reporting mechanism that collects data from the attending physician.
* Following the provision of assisted dying, the attending physician must submit all of the following items to the oversight body:
- Attending physician report
- Consulting physician report
- Medical record documentation
- Patient's written request for assisted dying
* The oversight body would review the documentation for compliance
* Provincial and territorial jurisdictions should ensure that legislation and/or regulations are in place to support investigations related to assisted dying by existing provincial and territorial systems
* Pan-Canadian guidelines should be developed in order to provide clarity on how to classify the cause on the death certificate
4. Responsibilities of the consulting physician
* The consulting physician must verify the patient's qualifications including capacity and voluntariness.
* The consulting physician must document the patient's diagnosis, prognosis, capacity, volition and the provision of information sufficient for an informed decision. The consulting physician must review the patient's medical records, and should document this review.
5. Moral opposition to assisted dying
5.1 Moral opposition by a health care facility or health authority
* Hospitals and health authorities that oppose assisted dying may not prohibit physicians from providing these services in other locations. There should be no discrimination against physicians who decide to provide assisted dying.
5.2 Conscientious objection by a physician
* Physicians are not obligated to fulfill requests for assisted dying. There should be no discrimination against a physician who chooses not to participate in assisted dying. In order to reconcile physicians' conscientious objection with a patient's request for access to assisted dying, physicians are expected to provide the patient with complete information on all options available to them, including assisted dying, and advise the patient on how they can access any separate central information, counseling, and referral service.
1 Carter v. Canada (Attorney General),  1 SCR 331, 2015 SCC 5 (CanLII)