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Joint statement on preventing and resolving ethical conflicts involving health care providers and persons receiving care

https://policybase.cma.ca/en/permalink/policy202
Last Reviewed
2019-03-03
Date
1998-12-05
Topics
Ethics and medical professionalism
  1 document  
Policy Type
Policy document
Last Reviewed
2019-03-03
Date
1998-12-05
Topics
Ethics and medical professionalism
Text
JOINT STATEMENT ON PREVENTING AND RESOLVING ETHICAL CONFLICTS INVOLVING HEALTH CARE PROVIDERS AND PERSONS RECEIVING CARE This joint statement was developed cooperatively and approved by the Boards of Directors of the Canadian Healthcare Association, the Canadian Medical Association, the Canadian Nurses Association and the Catholic Health Association of Canada. Preamble The needs, values and preferences of the person receiving care should be the primary consideration in the provision of quality health care. Ideally, health care decisions will reflect agreement between the person receiving care and all others involved in his or her care. However, uncertainty and diverse viewpoints sometimes can give rise to disagreement about the goals of care or the means of achieving those goals. Limited health care resources and the constraints of existing organizational policies may also make it difficult to satisfy the person’s needs, values and preferences. The issues addressed in this statement are both complex and controversial. They are ethical issues in that they involve value preferences and arise where people of good will are uncertain of or disagree about the right thing to do when someone's life, health or well-being is threatened by disease or illness. Because everyone’s needs, values and preferences are different, and because disagreements can arise from many sources, policies for preventing and resolving conflicts should be flexible enough to accommodate a wide range of situations. Disagreements about health care decisions can arise between or among any of the following: the person receiving care, proxies,<1> family members, care providers and administrators of health care authorities, facilities or agencies. This joint statement deals primarily with conflicts between the person receiving care, or his or her proxy, and care providers. It offers guidance for the development of policies for preventing and resolving ethical conflicts about the appropriateness of initiating, continuing, withholding or withdrawing care or treatment. It outlines the basic principles to be taken into account in the development of such policies as well as the steps that should be followed in resolving conflicts. The sponsors of this statement encourage health care authorities, facilities and agencies to develop policies to deal with these and other types of conflict, for example, those that sometimes arise among care providers. I. Principles of the therapeutic relationship<2> Good therapeutic relationships are centered on the needs and informed choices of the person receiving care. Such relationships are based on respect and mutual giving and receiving. Observance of the following principles will promote good therapeutic relationships and help to prevent conflicts about the goals and means of care. 1. The needs, values and preferences of the person receiving care should be the primary consideration in the provision of quality health care. 2. A good therapeutic relationship is founded on mutual trust and respect between providers and recipients of care. When care providers lose this sense of mutuality, they become mere experts and the human quality in the relationship is lost. When persons receiving care lose this sense of mutuality, they experience a perceived or real loss of control and increased vulnerability. Because persons receiving care are often weakened by their illness and may feel powerless in the health care environment, the primary responsibility for creating a trusting and respectful relationship rests with the care providers. 3. Sensitivity to and understanding of the personal needs and preferences of persons receiving care, their family members and significant others is the cornerstone of a good therapeutic relationship. These needs and preferences are diverse and can be influenced by a range of factors including cultural, religious and socioeconomic backgrounds. 4. Open communication, within the confines of privacy and confidentiality, is also required. All those involved in decision-making should be encouraged to express their points of view, and these views should be respectfully considered. Care providers should ensure that they understand the needs, values and preferences of the person receiving care. To avoid misunderstanding or confusion, they should make their communications direct, clear and consistent. They should verify that the person receiving care understands the information being conveyed: silence should not be assumed to indicate agreement. The person receiving care should be provided with the necessary support, time and opportunity to participate fully in discussions regarding care. 5. The competent person<3> must be involved in decisions regarding his or her care. 6. The primary goal of care is to provide benefit to the person receiving care. The competent person has the right to determine what constitutes benefit in the given situation, whether with respect to physical, psychological, spiritual, social or other considerations. 7. Informed decision-making requires that the person receiving care or his or her proxy be given all information and support necessary for assessing the available options for care, including the potential benefits and risks of the proposed course of action and of the alternatives, including palliative care. 8. The competent person has the right to refuse, or withdraw consent to, any care or treatment, including life-saving or life-sustaining treatment. 9. Although parents or guardians are normally the primary decision-makers for their minor children, children should be involved in the decision-making process to the extent that their capacity allows, in accordance with provincial or territorial legislation. 10. When the person receiving care is incompetent, that is, lacking in adequate decision-making capacity with respect to care and treatment, every effort must be made to ensure that health care decisions are consistent with his or her known preferences. These preferences may be found in an advance directive or may have been communicated orally. In jurisdictions where the issue of decision-making concerning care and medical treatment for incompetent persons is specifically addressed in law, the requirements of that legislation should be met. 11. When an incompetent person’s preferences are not known and there is no family member or proxy to represent the person, decisions must be based on an attempt to ascertain the person's best interests, taking into account: (a) the person's diagnosis, prognosis and treatment options, (b) the person's known needs and values, (c) information received from those who are significant in the person's life and who could help in determining his or her best interests, and (d) aspects of the person's culture, religion or spirituality that could influence care and treatment decisions. 12. When conflicts arise despite efforts to prevent them, they should be resolved as informally as possible, moving to more formal procedures only when informal measures have been unsuccessful. 13. In cases of disagreement or conflict, the opinions of all those directly involved should be given respectful consideration. 14. Disagreements among health care providers about the goals of care and treatment or the means of achieving those goals should be clarified and resolved by the members of the health care team so as not to compromise their relationship with the person receiving care. Disagreements between health care providers and administrators with regard to the allocation of resources should be resolved within the facility or agency and not be debated in the presence of the person receiving care. Health care authorities, facilities and agencies should develop conflict resolution policies for dealing with such issues and monitor their use. 15. When the needs, values and preferences of the person receiving care cannot be met, he or she should be clearly and frankly informed of the reasons for this, including any factors related to resource limitations. 16. Health care providers should not be expected or required to participate in procedures that are contrary to their professional judgement<4> or personal moral values or that are contrary to the values or mission of their facility or agency.<5> Health care providers should declare in advance their inability to participate in procedures that are contrary to their professional or moral values. Health care providers should not be subject to discrimination or reprisal for acting on their beliefs. The exercise of this provision should never put the person receiving care at risk of harm or abandonment. 17. Health care providers have a responsibility to advocate together with those for whom they are caring in order that these persons will have access to appropriate treatment. II. Guidelines for the resolution of ethical conflicts Health care organizations should have a conflict resolution process in place to address problems that arise despite efforts to prevent them. There may be need for variations in the process to accommodate the needs of different settings (e.g., emergency departments, intensive care units, palliative care services, home or community care, etc.). The conflict resolution policy of a health care authority, facility or agency should incorporate the following elements, the sequence of which may vary depending on the situation. The policy should designate the person responsible for implementing each element. That person should work closely with the person receiving care or his or her proxy. Anyone involved in the conflict may initiate the resolution process. 1. Clarify the need for an immediate decision versus the consequences of delaying a decision. If, in an emergency situation, there is insufficient time to fully implement the process, it should be implemented as soon as possible. 2. Gather together those directly involved in the conflict; in addition to the person receiving care and/or his or her proxy, this might include various health care providers, family members, administrators, etc. 3. If necessary, choose a person not party to the conflict to facilitate discussions. It is imperative that this person be acceptable to all those involved and have the skills to facilitate open discussion and decision-making. 4. Identify and agree on the points of agreement and disagreement. While ensuring confidentiality, share among those involved all relevant medical and personal information, interpretations of the relevant facts, institutional or agency policies, professional norms and laws. 5. Establish the roles and responsibilities of each participant in the conflict. 6. Offer the person receiving care, or his or her proxy, access to institutional, agency or community resources for support in the conflict resolution process, e.g., a patient representative, chaplain or other resource person. 7. Determine if the group needs outside advice or consultation, e.g., a second opinion, use of an ethics committee or consultant or other resource. 8. Identify and explore all options and determine a time line for resolving the conflict. Ensure that all participants have the opportunity to express their views; the lack of expressed disagreement does not necessarily mean that decision-making is proceeding with the support or consent of all involved. 9. If, after reasonable effort, agreement or compromise cannot be reached through dialogue, accept the decision of the person with the right or responsibility for making the decision. If it is unclear or disputed who has the right or responsibility to make the decision, seek mediation, arbitration or adjudication. 10. If the person receiving care or his or her proxy is dissatisfied with the decision, and another care provider, facility or agency is prepared to accommodate the person's needs and preferences, provide the opportunity for transfer. 11. If a health care provider cannot support the decision that prevails as a matter of professional judgement or personal morality, allow him or her to withdraw without reprisal from participation in carrying out the decision, after ensuring that the person receiving care is not at risk of harm or abandonment. 12. Once the process is completed; review and evaluate: (a) the process, (b) the decision reached, and (c) implementation of the decision. The conclusions of the evaluation should be recorded and shared for purposes of education and policy development. III. Policy development Health care authorities, facilities and agencies are encouraged to make use of an interdisciplinary committee to develop two conflict resolution policies: one for conflicts among health care providers (including administrators) and the other for conflicts between care providers and persons receiving care. Membership on the committee should include care providers, consumers and administrators, with access to legal and ethics consultation. The committee should also develop a program for policy implementation. The successful implementation of the policy will require an organizational culture that encourages and supports the principles of the therapeutic relationship as outlined in this joint statement. The implementation program should include the education of all those who will be affected by the policy with regard to both the principles of the therapeutic relationship and the details of the conflict resolution policy. It should also include measures to ensure that persons receiving care and their families or proxy decision-makers have access to the policy and its use. The policy should be reviewed regularly and revised when necessary in light of relevant clinical, ethical and legal developments. Because policies and guidelines cannot cover all possible situations, appropriate consultation mechanisms should be available to address specific issues promptly as they arise. Notes 1. The term "proxy" is used broadly in this joint statement to identify those people who are entitled to make a care and treatment decision for an incompetent person (in some provinces or territories, the definition of proxy is provided in legislation). This decision should be based on the decision the person would have made for himself or herself, to the best of the proxy’s (substitute decision maker’s) knowledge; or if this is unknown, the decision should be made in the person’s best interest. 2. The term "therapeutic relationship" is used broadly in this document to include all professional interactions between care providers, individually or as a team, and recipients of care. 3. Competence can be difficult to assess because it is not always a constant state. A person may be competent to make decisions regarding some aspects of life but not others; as well, competence can be intermittent: a person may be lucid and oriented at certain times of the day and not at others. The legal definition and assessment of competence are governed by the provinces or territories. Health care providers should be aware of existing laws relevant to the assessment and documentation of incompetence (e.g., capacity to consent and age-of-consent legislation). 4. Professional judgement will take into account the standard of care that a facility or agency is committed to provide. 5. On this matter, cf. Guiding Principle 6 of the Joint Statement on Resuscitative Interventions (Update 1995), developed by the Canadian Healthcare Association, the Canadian Medical Association, the Canadian Nurses Association and the Catholic Health Association of Canada, “There is no obligation to offer a person futile or nonbeneficial treatment. Futile and nonbeneficial treatments are controversial concepts when applied to CPR (cardiopulmonary resuscitation). Policymakers should determine how these concepts should be interpreted in the policy on resuscitation, in light of the facility's mission, the values of the community it serves, and ethical and legal developments. For the purposes of this joint document and in the context of resuscitation,'futile' and 'nonbeneficial' are understood as follows. In some situations a physician can determine that a treatment is 'medically' futile or nonbeneficial because it offers no reasonable hope of recovery or improvement or because the person is permanently unable to experience any benefit. In other cases the utility and benefit of a treatment can only be determined with reference to the person's subjective judgement about his or her overall well-being. As a general rule a person should be involved in determining futility in his or her case. In exceptional circumstances such discussions may not be in the person's best interests. If the person is incompetent the principles for decision making for incompetent people should be applied.” © 1999, Canadian Healthcare Association, Canadian Medical Association, Canadian Nurses Association and Catholic Health Association of Canada. Permission is granted for noncommercial reproduction only. Copies of the joint statement can be obtained by contacting: Membership Services, Canadian Medical Association, PO Box 8650, Ottawa ON K1G 0G8, tel 888 855-2555, fax 613 236-8864 or by visiting the Web site www.cma.ca/inside/policybase (English) or www.cma.ca/inside-f/policybase (French); or Customer Services, Canadian Healthcare Association, 17 York Street, Ottawa ON K1N 0J6, tel 613 241-8005, x253, fax 613 241-9481, or by visiting the Web site www.canadian-healthcare.org; or Publication Sales, Canadian Nurses Association, 50 The Driveway, Ottawa ON K2P 1E2, tel 613 237-2133, fax 613 237-3520, or by visiting the Web site www.cna-nurses.ca; or Publications, Catholic Health Association of Canada, 1247 Kilborn Place, Ottawa ON K1H 6K9, 613 731-7148, fax 613 731-7797, or by visiting the Web site www.net-globe.com/chac/.
Documents
Less detail

Convention on the Rights of the Child on the Involvement of Children in Armed Conflict

https://policybase.cma.ca/en/permalink/policy10173
Last Reviewed
2018-03-03
Date
2011-08-24
Topics
Ethics and medical professionalism
Health care and patient safety
Resolution
GC11-64
The Canadian Medical Association calls for federal government adherence to the United Nations’ "Optional Protocol to the Convention on the Rights of the Child on the Involvement of Children in Armed Conflict."
Policy Type
Policy resolution
Last Reviewed
2018-03-03
Date
2011-08-24
Topics
Ethics and medical professionalism
Health care and patient safety
Resolution
GC11-64
The Canadian Medical Association calls for federal government adherence to the United Nations’ "Optional Protocol to the Convention on the Rights of the Child on the Involvement of Children in Armed Conflict."
Text
The Canadian Medical Association calls for federal government adherence to the United Nations’ "Optional Protocol to the Convention on the Rights of the Child on the Involvement of Children in Armed Conflict."
Less detail

Principles for the protection of patient privacy

https://policybase.cma.ca/en/permalink/policy13833
Date
2017-12-09
Topics
Health information and e-health
Ethics and medical professionalism
  2 documents  
Policy Type
Policy document
Date
2017-12-09
Replaces
PD11-03 Principles for the Protection of Patients' Personal Health Information
Topics
Health information and e-health
Ethics and medical professionalism
Text
Patients have a right to privacy and physicians have a duty of confidentiality arising from the patient-physician relationship to protect patient privacy. The right to privacy flows from the principle of respect for patient autonomy, based on the individual's right to conduct and control their lives as they choose.1 When approaching any ethical question around privacy, the principle of respect for patient autonomy must be balanced against other competing principles (e.g. beneficence, non-maleficence). The protection of privacy and the concomitant duty of confidentiality are essential to foster trust in the patient-physician-relationship, the delivery of good patient care and a positive patient care experience. Privacy protection is an important issue for Canadians,2 and research suggests that patients may withhold critical health information from their health care providers because of privacy concerns.3 Patients will be more willing to share complete and accurate information if they have a relationship of trust with their physician and are confident that their information will be protected.4 In today's ever-evolving technological environment and due to the shift away from the traditional (paternalistic) physician-patient relationship, patients, physicians and other public and private stakeholders are using and sharing personal health information in new and innovative ways. This raises new challenges for clinical practice and, crucially, how to navigate expanded uses of data via the use of new technologies and the requirements of patient privacy. Institutions, clinics, and physician-group practices may share responsibility with the physician for the protection of patient information. There is thus a tension between physician and institutional responsibilities to protect patient information, challenged by the rapidly changing use and adoption of new technologies. While this will continue to redefine expectations of privacy and confidentiality, there are several foundational principles that remain unchanged. SCOPE OF POLICY The Canadian Medical Association (CMA) Principles for the Protection of Patients' Personal Health Information aim to provide guidance on key ethical considerations pertinent to the protection of patient information in a way that takes into account a physician's (including medical learner) ethical, professional, and legal obligations. The Principles are not designed to serve as a tool for legislative compliance in a particular jurisdiction or to provide a standard of care. Physicians should be aware of privacy legislation in the jurisdiction in which they practice, the standards and expectations specified by their respective regulatory authorities (including Privacy Commissioners), publications and risk management education provided by the CMPA as well as policies and procedures of any given setting (e.g., a regional health authority or a hospital). SUBSTANTIVE PRINCIPLES THAT GUIDE THE OBLIGATIONS OF THE PHYSICIAN TO PROTECT PATIENT PRIVACY 1. Trust * Trust is the cornerstone of the patient-physician relationship and plays a central role in providing the highest standard of care. * Physicians and their patients build relationships of trust that enable open and honest dialogue and foster patients' willingness to share deeply personal information (often) in conditions of vulnerability. * Physicians can cultivate and maintain patient trust by, unless the consent of the patient has been obtained to do otherwise, collecting health information only to benefit the patient, by sharing information only for that purpose, and by keeping patient information confidential; patient trust has been found to be the most powerful determinant of the level of control patients want over their medical records.5 * To maintain trust, physicians must consider the duty to care and the duty not to harm the patient in evaluating privacy requirements. * The extent to which a patient expects (and may tolerate a loss of) privacy and confidentiality is culturally and individually relative.6 2. Confidentiality * Physicians owe a duty of confidentiality to their patients; there is both an ethical (respect for autonomy) and a legal basis imposed by privacy legislation) for this duty. * The duty to maintain patient confidentiality, like trust, is fundamental to the therapeutic nature of the patient-physician relationship; it creates conditions that allow patients to openly and confidently share complete health information, resulting in a stronger physician-patient relationship and better delivery of care.7 * The duty to maintain patient confidentiality means that physicians do not share the health information with anyone outside of the patient's circle of care, unless authorized to do so by the patient.1,8 There are varying interpretations of what constitutes the patient's circle of care; this depends on the facts of the situation and the jurisdiction.9 * Privacy requirements raise complex issues in learning environments and quality improvement initiatives. It is desirable that any of the patient's physicians who will have ongoing care interactions with the patient can remain included in information-sharing about the patient. * Shared electronic health records present challenges to confidentiality. For example, patients may wish to limit some aspects of their record to only some providers within their circle of care.10 * In practice, respecting privacy and the duty of confidentiality govern the physician's role as data steward, responsible for controlling the extent to which information about the person is protected, used or disclosed.11 A central rule to balancing a patient's right to privacy and the duty of confidentiality is the "minimum necessary" use and disclosure of personal health information, whereby a data steward should use or disclose only the minimum amount of information necessary to fulfil the intended purpose. In some circumstances, de-identifying or aggregating personal health information before use or disclosure can minimize the amount of information disclosed.12 * The duty to maintain patient confidentiality is not absolute and is subject to exceptions in limited circumstances,13 i.e., when required or permitted by law to disclose information (see below in Data Stewardship: Collection, use and disclosure of personal health information). 3. Consent * Patient consent is an important mechanism for respecting patient autonomy; obtaining voluntary and informed consent to share patient information is fundamental to the protection of privacy and the duty of confidentiality. * Physicians are generally required to obtain informed consent from the patient before they can disclose the patient's personal health information. Consent is only informed if there is disclosure of matters that a reasonable person in the same circumstances would want to know, including 1) to whom the patient information will be disclosed, 2) whether it could be disclosed to other third parties, and 3) the purpose for which it could be used or disclosed. * While informed consent is required as a general rule, physicians may infer that they have the patient's implied consent to collect, use, disclose and access personal health information 1) for the purpose of providing or assisting in providing care (i.e., share only the necessary information with those involved within the patient's circle of care); and 2) to store personal health information in a medical record (i.e., paper, electronic, or hospital-based). Physicians will want to consider if it is appropriate in the circumstances to advise the patient when a disclosure has been made. * When the patient is a minor, the physician must consider whether it is the parent or the child who determines the use and disclosure of the minor's personal health information. A young person who is deemed to understand fully the implications of a decision regarding proposed collection, use or disclosure of personal health information is generally deemed to have control over their personal health information with respect to the decision. * Where the patient is not capable to provide the required consent (e.g. is deemed to be incompetent), physicians must seek consent from the patient's substitute decision-maker. 4. Physician as data steward * As data stewards, physicians have the responsibility to understand their role in protecting patient privacy and appropriate access to patient information. * The information contained in the medical record belongs to the patient who has a general right of access to their personal health information, and the right to control the use and further disclosure and to the continued confidentiality of that information. * A data steward (e.g., physician, institution or clinic) holds the physical medical record in trust for the care and benefit of the patient.14 * Physicians should provide their patients access to their medical record, if requested.15 (See below in Data Stewardship: Access to personal information). * Physicians ought to have appropriate access to personal health information and have the ability to provide their patients with access to their medical record. Appropriate access should be interpreted to include access for patient follow up (as part of the duty to care) and review for the purpose of improving patient care. * Physicians should consider consulting available resources to assist them in fulfilling their duties as data stewards. PROCEDURAL PRINCIPLES THAT GUIDE THE APPLICATION OF PHYSICIAN OBLIGATIONS Physicians must manage personal health information in compliance with relevant legislation that establishes rules governing the access, collection, use, disclosure, and retention of personal health information, provincial privacy laws, and professional expectations and regulations specified by their respective regulatory authorities. 1. Data Stewardship: Access to personal information * Patients have a right of reasonable access to the personal health information in their medical record (i.e., paper, electronic, or hospital-based) under the control or in the custody of a physician, institution, or clinic. * In exceptional situations, physicians can refuse to release the information in the patient's medical record. 2. Data Stewardship: Collection, use and disclosure of personal health information * There are circumstances where there are required (e.g., monitoring of claims for payment, subpoenas) and permitted disclosures of personal health information without patient consent (e.g., where the maintenance of confidentiality would result in a significant risk of substantial harm to the patient or to others). * Security safeguards must be in place to protect personal health information in order to ensure that only authorized collection, use, disclosure or access occurs. * Physicians play an important role in educating patients about possible consensual and non-consensual uses and disclosures that may be made with their personal health information, including secondary uses of data for, e.g., epidemiological studies, research, education, and quality assurance, that may or may not be used with explicit consent. 3. Data Stewardship: Retention of personal health information * Personal health information should be retained for the period required by any applicable legislation and as specified by their respective regulatory authorities. It may be necessary to maintain personal health information beyond the applicable period where there is a pending or anticipated legal proceeding related to the care provided to the patient. * Likewise, physicians should transfer and dispose of personal health information in compliance with any applicable legislation and professional expectations outlined by their respective regulatory authorities. * Physicians are encouraged to seek technical assistance and advice on the secure transfer, disposal, and/or selling of electronic records.15 4. Data Stewardship: Use of technology * Physicians should obtain patient consent to use electronic means and/or devices for patient care (e.g., sending digital photographs) and for communicating patient information (e.g., the use of email). To obtain informed consent, physicians should explain to patients that there are necessary benefits and risks in using technologies in clinical contexts. The CMPA has provided a written consent form to that effect that can be included in the patient's medical record. * As a general practice, physicians are encouraged to make use of technological innovations and must evaluate whether the technology is appropriate for patient care and has reasonable safeguards to protect patient privacy. Approved by the CMA Board of Directors December 2017 See also Background to CMA Policy Principles for the Protection of Patient Privacy REFERENCES 1 Martin JF. Privacy and confidentiality. In: ten Have H, Gordijn B (Eds). Handbook of global bioethics. New York: Springer, Dordrecht; 2014. p.119-37. 2 Office of the Privacy Commissioner of Canada. Canadians and privacy final report. Gatineau: Office of the Privacy Commissioner of Canada; 2009. Available: https://www.priv.gc.ca/information/por-rop/2009/ekos_2009_01_e.asp (accessed 2017 Nov 17). 3 Canadian Medical Protective Association (CMPA). Privacy and a wired world - Protecting patient health information. Ottawa: CMPA; 2011 Dec. Available: https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2011/privacy-and-a-wired-world-protecting-patient-health-information (accessed 2017 Nov 17). 4 Royal College of Physicians and Surgeons of Canada (RCPSC). Duty of confidentiality. Ottawa: RCPSC; 2017. Available: http://www.royalcollege.ca/rcsite/bioethics/cases/section-3/duty-confidentiality-e (accessed 2017 Dec 15). 5 Damschroder LJ, Pritts JL, Neblo MA, Kalarickal RJ, Creswell JW, Hayward RA. Patients, privacy and trust: patients' willingness to allow researchers to access their medical records. Soc Sci Med 2007;64:223-35. 6 Campbell JI, Eyal N, Musiimenta A, Haberer JE. Ethical questions in medical electronic adherence monitoring. J Gen Intern Med 2016;31:338-42. Available: https://link.springer.com/content/pdf/10.1007%2Fs11606-015-3502-4.pdf (accessed 2017 Nov 17). 7 Crook MA. The risks of absolute medical confidentiality. Sci Eng Ethics 2013;19:107-22. 8 Cohen I, Hoffman A, Sage W (Eds). The Oxford Handbook of U.S. Health Law. New York: Oxford University Press; 2015. 9 Canadian Medical Protective Association (CMPA). The voice of professionalism within the system of care. Ottawa: CMPA; 2012 Oct. Available: https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2012/the-voice-of-professionalism-within-the-system-of-care (accessed 2017 Nov 17). 10 Canadian Medical Protective Association (CMPA). Did you know? Patients can restrict access to their health information. Ottawa: CMPA; 2017 Nov. Available: https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2017/did-you-know-patients-can-restrict-access-to-their-health-information (accessed 2017 Nov 17). 11 Francis JG, Francis LP. Privacy, confidentiality, and justice. J Soc Philos 2014;45:408-31. 12 Burkle CM, Cascino GD. Medicine and the media: balancing the public's right to know with the privacy of the patient. Mayo Clin Proc 2011;86:1192-6. 13 Canadian Medical Protective Association (CMPA). When to disclose confidential information. Ottawa: CMPA; 2015 Mar. Available: https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2015/when-to-disclose-confidential-information (accessed 2017 Nov 17). 14 Canadian Medical Protective Association (CMPA). Releasing a patient's personal health information: What are the obligations of the physician? Ottawa: CMPA; 2012 Oct. Available: https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2012/releasing-a-patient-s-personal-health-information-what-are-the-obligations-of-the-physician (accessed 2017 Nov 17). 15 Canadian Medical Protective Association (CMPA). Protecting patient health information in electronic records. Ottawa: CMPA; 2013 Oct. Available: https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2013/protecting-patient-health-information-in-electronic-records (accessed 2017 Nov 17). (c) 2017 Canadian Medical Association. You may, for your non-commercial use, reproduce, in whole or in part and in any form or manner, unlimited copies of CMA Policy Statements provided that credit is given to Canadian Medical Association. BACKGROUND TO CMA POLICY PRINCIPLES FOR THE PROTECTION OF PATIENT PRIVACY See also CMA Policy on Principles for the Protection of Patient Privacy Context The advent of Electronic Medical Records, the rapid spread of mobile health apps, and the increasing use of social media within the health care community, have each created new challenges to maintaining a duty of confidentiality within the physician-patient relationship. These technologies present both opportunities and challenges with respect to medical professionalism.1 The permeation of these types of interactions into everyday life now places physicians in new situations that some find difficult to navigate.2 These challenges will only increase in the coming years, as the use of online technologies in health care is continuously growing.3 Canada is only in the early stages of managing the emerging issues of technology-induced errors that compromise privacy in the health care setting.4 Therefore, this paper will briefly discuss the importance of protecting privacy, followed by an overview of the main challenges to maintaining privacy as the physician-patient relationship evolves at the backdrop of emerging technologies. Privacy and Confidentiality The overlapping, but not identical, principles of the protection of privacy and the duty of confidentiality are essential to the physician-patient relationship. These principles not only foster trust, but also the delivery of effective and lasting care. Rooted in the Hippocratic Oath, the modern-day right to privacy flows from the principle of autonomy, which attributes to individuals the right to conduct and control their lives as they choose.5 Privacy protection is an important issue to Canadians,6 with research suggesting that patients may even withhold critical health information because of privacy concerns.7 Health care professionals are bound by legal and ethical standards to maintain privacy and confidentiality of patient information.8 Physicians must therefore be aware of the implications of privacy legislation specific to their jurisdiction.7 The duty to protect patient privacy is important to uphold, as health information can potentially be identifiable and sensitive; the confidentiality of this information must therefore be protected to ensure that patient privacy is not breached. 9 While the traditional, and largely obsolete, models of the physician-patient relationship involve a unidirectional flow of information, the ease at which patients can now access medical information through the Internet, and the use of social media within the health care community, have reinterpreted how information is communicated from physician to patient, and vice versa.10 We must therefore re-define expectations of privacy and confidentiality, first by distinguishing one from the other. The terms "privacy" and "confidentiality" are often used interchangeably by both researchers and clinicians. Several bioethics discussions on the distinction between these terms places confidentiality under the umbrella of privacy.11 While confidentiality involves the information itself, which is disclosed or not, privacy is about the impact of that disclosure on the person.9 Privacy seems to be more intimately linked to the individual, focusing on the circumstances under which the information is used.12-13 Confidentiality, on the other hand, is a duty that health professionals have towards their patients to not share the information exchanged during their encounter, unless authorized by the patient.5,12 In practice, the duty of confidentiality governs the physician's role as data stewards, responsible for controlling the extent to which information about the person is protected, used or disclosed.14 As one paper describes, "privacy is invaded, confidentiality is breached."13 From a patient perspective, it is important to respect and protect privacy because it allows individuals time and space to share their concerns without feeling judged or misunderstood,11 resulting in a stronger physician-patient relationship and better delivery of care. However, from a research perspective, a fine balance must be struck between using accurate information while still upholding the privacy rights of individuals.11 As such, the argument for absolute confidentiality puts a near impossible burden on research clinicians.11 Moreover, from a public safety perspective, a physician may be morally and legally required to break confidentiality in order to protect both the patient and others who may be involved. The challenge is to balance the traditional goal of confidentiality - to protect patient privacy and interest - with that of third parties and public health.5 Therefore, a central rule to balancing confidentiality with a patients' right to privacy is the "minimum necessary" use and disclosure of personal health information, whereby a data steward should use or disclose only the minimum amount of information necessary to fulfil the intended purpose.8 It is equally important to recognize that the extent to which a patient may tolerate a loss of privacy is culturally and individually relative.15 Health care providers have a legal and ethical obligation to keep patient health information private, sharing it only with the authorization of the patient.16 Informed consent, therefore, appears to be a fundamental requirement to upholding confidentiality and patient privacy rights. Issues While emerging privacy issues touch many areas of practice, this section will emphasize three of the most prominent issues in recent literature: access and use of information, electronic medical and health records and, online communication and social media. 1. Technological change and institutional data stewardship In today's ever-evolving technological environment, including the emergence of shared electronic health records, online communication, social media, mobile applications, and big data, physicians, patients and other public and private stakeholders are using and sharing personal health information in new and innovative ways. The traditional (paternalistic) model of the physician-patient relationship involved a bidirectional flow of information. However, the ease at which patients can now access medical information from alternative sources via the Internet, and the use of social media within the health care community, has redefined how information is communicated from physician to patient, and vice versa.10 This raises new challenges for clinical practice, specifically how to navigate expanded access of data via the use of new technologies and the requirements of patient privacy by effectively managing security concerns. In many situations, the physician may not be the sole or primary custodian of (i.e., control access to) the patient's records once the health information is collected. Institutions, clinics, and physician-group practices may also have responsibility for patient information and therefore play an important role in ensuring it is protected. There is thus a grey area between physician and institutional responsibilities to protect patient information, challenged by the rapidly changing use and adoption of new technologies, such as electronic health and medical records. While this will continue to redefine expectations of privacy and confidentiality, there are several foundational principles that remain unchanged. 2. Electronic medical and health records Medical records are compiled primarily to assist physicians and other health care providers in treating patients.16 Yet, they are particularly vulnerable to privacy breaches when this information is exposed to secondary uses, including epidemiological studies, research, education and quality assurance. As contemporary information management and stewardship have had to evolve in response to emerging technology, the parameters of the "medical record" have grown increasingly ambiguous.17 With the proliferation of a wide variety of new health information technology (including electronic health and medical records), concerns about quality and safety have been raised.4 There is evidence that if such technology is not designed, implemented and maintained effectively, it may result in unintended consequences, including technology-induced errors and breaches of patient privacy.4 Reports involving Canada Health Infoway have even pointed to health information technology as a tool that may sometimes reduce rather than enhance patient safety, most often due to human factors. 4 As a result, recommendations have been made to develop a reporting system that would allow health professionals to anonymously report human errors resulting from the use of health information technology - a challenge in itself, as the distinction between human and technological error is often blurred.4 In Canada, a number of efforts have been undertaken by several organizations, including Health Canada and Canada's Health Informatics Organization.4 Yet, services aimed at improving health information technology safety, from a national level, remain poor.4 As a result, organizations like Canada Health Infoway have promoted the need for collaborative efforts to improve health information technology safety standards in Canada, 4 so to ensure that the current and future uses of "medical record" data are accurate and respectful of patient privacy. 3. Access and use of personal health information for research The courts have long established that health information belongs to the patient.18 As a result, privacy ownership refers to the belief that patients own their private information as well as the right to control access to this information.19 As in other jurisdictions, the overarching challenge in Canada is to strike a balance between enabling access to health and health-related data for research while still respecting Canadians' right to privacy and control over the confidentiality of their information.20 The integrity of healthcare information is fundamental, given that it is the basis on which treatment decisions are made both in research and in clinic. 9 There are three principles upon which information security is based: 9 1) only authorized people have access to confidential information; 2) information must be accurate and consistent, may only be modified by authorized people in ways that are appropriate; 3) information must be accessible by authorized users when needed. Canadian research ethics have demonstrated that beneficial work can be done while maintaining confidentiality to sensitive personal health information.21 Yet, the challenge remains to create a uniform system for accessing data and performing data-based research due to 1) the lack of consistency and clarity in Canada's ethical and legal framework and, 2) varied interpretations of key terms and issues across the country.21 For example, the term "non-identifiable data" remains ambiguous across provinces and is subject to interpretation by data custodians, who may consider their legal duty to protect privacy as precluding access to data.21 This lack of legal clarity has contributed to varied cautious and conservative interpretations of data access legislation.21 National uniform guidelines on the appropriate access, disclosure and use of personal health data would allow data stewards to advance their research while respecting their patients' right to privacy. 4. Online communication with patients and social media Social media and online communication is pervasive in Canadian society; from Facebook to Twitter, social media has changed the way people interact and disseminate information.21 There is currently widespread discussion among health care professionals and academics regarding the role that social media and online communication should play in the physician-patient relationship.22 A growing number of physicians have embraced the opportunities of interconnectivity that social media affords, implementing their own privacy procedures to reflect this new type of data collection, use and storage.7 While evidence has been lacking on whether the use of social media does improve patient outcomes,22 there is no denying that patients are seeking health care information from online platforms, including social media.22 This type of communication poses a unique set of opportunities and challenges for physicians: while the use of social media could increase physician reach and patient engagement, it can also blur boundaries between one's personal and professional life.22 Although patient-physician online communication is currently limited, physicians still feel that they are encountering an ethical dilemma, especially when they find themselves in boundary crossing situations, like a friend request from a patient.2 Physicians are particularly concerned that, through online communication, they may be exposed to medico-legal and disciplinary issues, especially with respect to patient privacy.2 Given different studies have suggested that unprofessional uses of social media are not uncommon,23 physicians who choose to communicate with patients online or through social media must remember that they are still governed by the same ethical and professional standards that remain paramount.22 As technology continues to evolve, so too will the traditional parameters of the patient-physician relationship. The physician's ethical and professional obligation to protect patient privacy, however, must remain paramount at the backdrop of technology use. Simply banning social media and online communication would neither eliminate risk, nor benefit patient care outcomes. 24 Instead, institutions should establish stringent policies that outline how to prevent or minimize the effects of privacy breaches associated with social media and online communication.25 This should also include a tracking mechanism to help balance the obligation to privacy with evolving technology.25 December 2017 See also CMA Policy on Principles for the Protection of Patient Privacy REFERENCES 1 Farnan JM, Snyder Sulmasy L, Worster BK, Chaudhry HJ, Rhyne JA, Arora VM. Online medical professionalism: patient and public relationships: policy statement from the American College of Physicians and the Federation of State Medical Boards. Ann Intern Med 2013;158(8):620-627. 2 Brown J, Ryan C. How doctors view and use social media: a national survey. J Med Internet Res 2014;16:e267. Available: https://doi.org/10.2196/jmir.3589 (accessed 2017 Nov 17). 3 Lambert KM, Barry P, Stokes G. Risk management and legal issues with the use of social media in the healthcare setting. J Healthc Risk Manag 2012;31(4):41-47. 4 Kushniruk AW, Bates DW, Bainbridge M, Househ MS, Borycki EM. National efforts to improve health information system safety in Canada, the United States of America and England. Int J Med Inform 2013;82(5):e149-160. 5 Martin JF. Privacy and confidentiality. In: ten Have H, Gordijn B (Eds). Handbook of global bioethics. New York: Springer, Dordrecht; 2014. p.120-1. 6 Office of the Privacy Commissioner of Canada. Canadians and privacy final report. Gatineau: Office of the Privacy Commissioner of Canada; 2009. Available: https://www.priv.gc.ca/information/por-rop/2009/ekos_2009_01_e.asp (accessed 2017 Nov 17). 7 Canadian Medical Protective Association (CMPA). Privacy and a wired world - Protecting patient health information. Ottawa: CMPA; 2011 Dec. Available: https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2011/privacy-and-a-wired-world-protecting-patient-health-information (accessed 2017 Nov 17). 8 Burkle CM, Cascino GD. Medicine and the media: balancing the public's right to know with the privacy of the patient. Mayo Clin Proc 2011;86:1192-6. 9 Williams PA. Information security governance: a risk assessment approach to health information systems protection. Stud Health Techol Inform 2013;193:186-206. 10 Borza LR, Gavrilovici C, Stockman R. Ethical models of physician-patient relationship revisited with regard to patient autonomy, values and patient education. Rev Med Chir Soc Med Nat Iasi 2015;119(2):496-501. 11 Crook MA. The risks of absolute medical confidentiality. Sci Eng Ethics 2013;19(1):107-122. 12 Cohen I, Hoffman A, Sage W (Eds). The Oxford handbook of U.S. health law. New York: Oxford University Press; 2015. 13 Francis L. Privacy and confidentiality: the importance of context. The Monist; 91(1);2008:52-67. 14 Francis JG, Francis LP. Privacy, confidentiality, and justice. J Soc Philos 2014;45:408-31. 15 Campbell JI, Eyal N, Musiimenta A, Haberer JE. Ethical questions in medical electronic adherence monitoring. J Gen Intern Med 2016;31:338-42. Available: https://link.springer.com/content/pdf/10.1007%2Fs11606-015-3502-4.pdf (accessed 2017 Nov 17). 16 Canadian Medical Association (CMA). Medical record confidentiality, access and disclosure. Ottawa: CMA; 2000. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/policy-research/CMA_Policy_The_medical_record_confidentiality_access_and_disclosure_Update_2000_PD00-06-e.pdf (accessed 2017 Oct 30). 17 Fenton SH, Manion F, Hsieh K, Harris M. Informed Consent: Does anyone really understand what is contained in the medical record? Appl Clin Inform 2015;6(3):466-477. 18 Canada. Supreme Court. McInerney v MacDonald. Dom Law Rep. 1992 Jun 11;93:415-31. 19 Petronio S, Dicorcia MJ, Duggan A. Navigating ethics of physician-patient confidentiality: a communication privacy management analysis. Perm J 2012;16(4):41-45. 20 Council of Canadian Academies (CCA). Accessing health and health-related data in Canada. Ottawa: The Expert Panel on Timely Access to Health and Social Data for Health Research and Health System Innovation, Council of Canadian Academies; 2015. Available: http://www.scienceadvice.ca/uploads/eng/assessments%20and%20publications%20and%20news%20releases/Health-data/HealthDataFullReportEn.pdf (accessed 2017 Nov 17). 21 Canadian Medical Association (CMA). Social media and Canadian physician: Issues and rules of engagement. Ottawa: CMA; 2011. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/CMA_Policy_Social_Media_Canadian_Physicians_Rules_Engagement_PD12-03-e.pdf (accessed 2017 Oct 30). 22 Eysenbach G. Medicine 2.0: Social networking, collaboration, participation, apomediation, and openness J Med Internet Res 2008;10(3):e22. 23 Mayer MA, Leis A, Mayer A, Rodriguez-Gonzalez A. How medical doctors and students should use social media: A review of the main guidelines for proposing practical recommendations. Stud Health Technol Info 2012;180:853-857. 24 Moses RE, McNeese LG, Feld LD, Feld AD. Social media in the health-care setting: Benefits but also a minefield of compliance and other legal issues. Am J Gastroenterol 2014;109(8):1128-1132. 25 Yang YT, Silverman RD. Mobile health applications: The patchwork of legal and liability issues suggests strategies to improve oversight. Health Aff (Millwood) 2014;33(2):222-227.
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Charter of Shared Values: A vision for intra-professionalism for physicians

https://policybase.cma.ca/en/permalink/policy13858
Date
2017-12-09
Topics
Ethics and medical professionalism
  2 documents  
Policy Type
Policy document
Date
2017-12-09
Replaces
CMA Charter for Physicians (Update 1999)
Topics
Ethics and medical professionalism
Text
What is it? The CMA Charter of Shared Values aims to identify shared values and commitments to each other and to the profession to which physicians and learners can commit to promote trust and respect within the profession and for each other, and identify opportunities for engagement and leadership to promote civility and confront incivility within the profession. Why does it matter? The Charter is intended to further strengthen professional responsibilities in support of a unified and aligned profession. We achieve the highest degree of both individual and collective success when we work together, commit together and believe together; when we share a clearly articulated set of common values, virtues and principles; and when we subscribe to the same explicit and implicit understandings. Commitments to Each Other: Our most important shared values RESPECT As a physician, I will strive to be respectful; I will recognize that everyone has inherent worth, is worthy of dignity, and has the right to be valued and respected, and to be treated ethically; I will respect others and their personal and professional dignity; and I will aim to promote and model respect through collaborative training and practice. INTEGRITY As a physician, I will strive to act with integrity; I will act in an honest and truthful manner, with consistency of intentions and actions; and I will act with moral concern to promote and model effective leadership and to achieve a good outcome for patients. RECIPROCITY As a physician, I will strive to cultivate reciprocal relationships; I will be kind with my physician colleagues, and expect them to respond similarly; I will share and exchange my knowledge and experience with them; and I will be generous with them in spirit and in time. CIVILITY As a physician, I will strive to be civil; I will respect myself and others, regardless of their role, even those with whom I may not agree; I will enter into communication with my physician colleagues with an attitude of active and open listening, whether it be in person, in writing, or virtually; and I will accept personal accountability. Commitments to the Profession 1. Commitment to promoting a culture of respect and collegiality As a physician, I will strive to build a culture based on mutual respect and collegiality where physicians treat each other as people in a shared endeavor, and promote civility. I will strive to:
Cultivate respectful, open, and transparent dialogue and relationships
Take responsibility for promoting civility and confronting incivility within the profession
Recognize the relative value among family medicine and specialties and across the educational spectrum, and of the profession’s shared contributions within health systems
Model healthy and supportive training and practice environments 2. Commitment to promoting a culture of self-care and support As a physician, I will strive to build a culture of self-care and support where physicians are empowered to ask for help and are supported to care for their own physical, mental, and social well-being. I will strive to:
Value physician health and wellness and promote a professional culture that recognizes, supports, and responds effectively to your needs and colleagues in-need
Cultivate an environment of physical and psychological safety, conducive to challenging the status quo, as well as encouraging help-seeking behaviours, without fear of negative reprisal
Recognize that both individual and system-level barriers contribute to health and wellness-related issues and advocate for cultural and systemic change to remove barriers 3. Commitment to promoting a culture of leadership and mentorship As a physician, I will strive to foster a culture of leadership and mentorship across the career life cycle. I will strive to:
Encourage and enable opportunities and participation in leadership roles across all levels of training, practice, and health system delivery
Promote and enable formal and informal mentorship opportunities and leadership training across all levels of training and practice
Value the exchange of knowledge and experience and encourage reflective relationships (bi-directional) across all levels of training and practice 4. Commitment to promoting a culture of inquiry and reflection As a physician, I will strive to foster a culture of inquiry and reflection that values and enables reflective practice, individually and collectively. I will strive to:
Value and enable collective inquiry and self-reflection to effect meaningful change
Foster curiosity and exploration to identify strengths and capabilities of teams and health systems to generate new possibilities for action
Cultivate strong connections and relationships between, and meaningful interactions with, colleagues 5. Commitment to promoting a culture of quality As a physician, I will strive to foster a culture of quality and quality improvement. I will strive to:
Foster intra- and inter-professional collaborations and promote collaborative models of care
Provide high quality patient care and have a view to continuous improvement at the practice and system level, and commit to developing and applying the skills and techniques of quality improvement
Understand that quality improvement is a critical and life-long part of education and practice; participate in maintaining professional standards in myself and my colleagues
Engage patients, families, and caregivers in the process of improvement 6. Commitment to valuing a culture of diversity As a physician, I will strive to foster a community of practitioners that reflects the diversity of the communities they serve. I will strive to:
Promote diversity within the profession to be receptive and responsive to the evolving (physical, emotional, cultural, socioeconomic) needs of our patient populations
Foster a training and practice environment where diverse and unique perspectives, across generations, cultures and abilities, are heard and appreciated
Foster diversity in leadership across the full spectrum of leadership roles within the profession and health systems
Value the importance of these perspectives within the medical profession, even when they may not be my own patients, families, and caregivers in the process of improvement cma.ca/medicalprofessionalism
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Federal Genetic Non-Discrimination Act

https://policybase.cma.ca/en/permalink/policy13707
Date
2017-08-23
Topics
Ethics and medical professionalism
Health care and patient safety
Resolution
GC17-09
The Canadian Medical Association urges provincial and territorial governments to support the Federal Genetic Non-Discrimination Act (Bill S-201) by enacting corresponding legislation that echoes privacy protection.
Policy Type
Policy resolution
Date
2017-08-23
Topics
Ethics and medical professionalism
Health care and patient safety
Resolution
GC17-09
The Canadian Medical Association urges provincial and territorial governments to support the Federal Genetic Non-Discrimination Act (Bill S-201) by enacting corresponding legislation that echoes privacy protection.
Text
The Canadian Medical Association urges provincial and territorial governments to support the Federal Genetic Non-Discrimination Act (Bill S-201) by enacting corresponding legislation that echoes privacy protection.
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Victims of human trafficking

https://policybase.cma.ca/en/permalink/policy13708
Date
2017-08-23
Topics
Ethics and medical professionalism
Health care and patient safety
Resolution
GC17-17
The Canadian Medical Association supports increased physician awareness and education in identifying and supporting victims of human trafficking.
Policy Type
Policy resolution
Date
2017-08-23
Topics
Ethics and medical professionalism
Health care and patient safety
Resolution
GC17-17
The Canadian Medical Association supports increased physician awareness and education in identifying and supporting victims of human trafficking.
Text
The Canadian Medical Association supports increased physician awareness and education in identifying and supporting victims of human trafficking.
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Legislative changes to protect migrants and refugees

https://policybase.cma.ca/en/permalink/policy13720
Date
2017-08-23
Topics
Ethics and medical professionalism
Health care and patient safety
Resolution
GC17-13
The Canadian Medical Association promotes legislative changes to protect migrants and refugees from arbitrary and indefinite detention in jails and jail-like facilities in Canada
Policy Type
Policy resolution
Date
2017-08-23
Topics
Ethics and medical professionalism
Health care and patient safety
Resolution
GC17-13
The Canadian Medical Association promotes legislative changes to protect migrants and refugees from arbitrary and indefinite detention in jails and jail-like facilities in Canada
Text
The Canadian Medical Association promotes legislative changes to protect migrants and refugees from arbitrary and indefinite detention in jails and jail-like facilities in Canada
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Direct-to-consumer genetic testing

https://policybase.cma.ca/en/permalink/policy13696
Date
2017-05-27
Topics
Ethics and medical professionalism
CMA Policy PD17-05 Direct-to-Consumer Genetic Testing Some direct-to-consumer (DTC) genetic tests
  2 documents  
Policy Type
Policy document
Date
2017-05-27
Topics
Ethics and medical professionalism
Text
While genetic testing is typically provided in a clinical setting through the referral of a health care professional (HCP) or a regulated research project, a number of private companies now offer genetic testing services directly to consumers over the Internet. Direct-to-consumer (DTC) genetic testing is distinguished from clinical genetic testing ordered by a HCP in several ways: 1. DTC genetic tests are not regulated in Canada. The clinical validity and reliability of these tests varies widely, but DTC genetic testing companies make them available to consumers without distinguishing between those that may be useful to the management of one's health, those that have some limited health value, and those that are meant purely for recreational use. 2. Many of the tests advertised and sold via the Internet have not undergone clinical evaluation. 3. Marketing materials for these tests often imply that they have health value, but the terms of reference of some of the companies that offer them state that the tests are to be used for recreational purposes and many vendors do not guarantee the validity or reliability of their results. 4. Resale of personal health information and/or DNA samples is often an important part of the business model of companies that offer DTC genetic testing, raising concerns about patient privacy and insufficient or unclear disclosure of privacy terms. 5. Unlike genetic tests ordered and administered by HCPs, DTC genetic tests are ordered directly by the consumer, who most often has not consulted with a HCP as part of a clinical assessment, and the testing may not be clinically indicated. Some companies only agree to do testing if it has been ordered by a physician, but they will provide a phone conversation with one of their physicians (not based in Canada) if a consumer does not have access to a physician. When the testing is ordered by a physician, it will sometimes be ordered by the patient's personal physician. In such cases, this does not truly represent DTC genetic testing. 6. Without appropriate pre- and post-testing counselling by a HCP, consumers are left to interpret and act upon their results on their own. They might suffer psychological consequences if they overestimate their disease risk as a result of DTC. 7. As access to DTC genetic testing increases, Canadian HCPs (specifically primary care physicians) are faced with the challenge of appropriately counselling patients when they receive their test results. However, few physicians feel they have the necessary training and knowledge in genomics to provide adequate care in this area. Furthermore, these tests may have no clinical indication, produce uncertain results with ambiguous clinical applicability and have tenuous legal status, but they can potentially influence a patient's sense of well-being. GENERAL PRINCIPLES 1. The CMA is concerned with understanding, raising awareness of, and mitigating potential patient and societal harms that may arise from DTC genetic testing. 2. The CMA emphasizes the importance of the principle of protection of patient privacy and supports the right of Canadians to understand how their health information is being used by third parties, including insurance and DTC genetic testing companies. 3. The CMA believes that patients have the right to be fully informed about what a DTC genetic test can and cannot say about their health and that the scientific evidence on which a test is based should be clearly stated and easy to understand. 4. The CMA recommends regulation of both DTC genetic tests and the marketing of these tests through the development of a national framework that would include a combination of government and industry regulation with input from medical experts. 5. The CMA believes that unnecessary genetic testing should be avoided to ensure more appropriate use of health care resources. Even if a consumer pays directly for testing, any test result, even an incidental finding from a DTC genetic testing laboratory without clinical certification, may trigger a cascade of clinical investigations and lead to further unnecessary testing and inappropriate use of resources. 6. The CMA supports educational initiatives on DTC genetic testing for physicians practising in all specialties so that they can respond to patient queries about these tests and, when necessary, their results. PROTECTION OF PRIVACY * Privacy and confidentiality of patients' personal health information must be maintained. * Before a patient submits a sample to a DTC genetic testing company, the company should obtain express informed consent from the patient concerning the way in which their data will be collected and used, who will have access to the data and the interpreted results, what safeguards are in place to protect it, and how it will be disposed of in the event of a company/laboratory closure. * Patients have the right to a clear understanding of who owns the sample and the generated data, in particular whether their data will be sold or shared with third parties. If resale of personal health information and/or DNA samples is an important part of the business model of DTC-GC companies, this should be stated explicitly in terms understandable by the consumer. * DTC-GC companies that solicit Canadian consumers should be subject to the Personal Information Protection and Electronic Documents Act (PIPEDA). * The CMA encourages physicians to become familiar with privacy legislation affecting the use of DTC genetic tests by insurance companies and employers. ROLE OF PHYSICIAN * Physicians should generally avoid using DTC genetic tests unless they have been clinically and empirically validated. * Physicians who are presented with a patient's DTC genetic test results should take the following actions: o They should explain to their patient the limits of the specific test the patient used. If a physician does not know this information he/she should discuss with the patient the fact that DTC genetic test results are not necessarily obtained from an accredited laboratory or interpreted in a standardized way; therefore, the validity and clinical utility of the results may be highly variable for certain tests. o They should disclose their level of comfort in providing an accurate interpretation of the results. o They should assess whether the test results are clinically significant in the context of that patient's symptoms, signs, medical history and family history before deciding whether it is appropriate to formally consult a specialty provider such as a medical geneticist. o If a physician wishes to use the results of a test in their clinical assessment, they should ensure that the laboratory performing the test guarantees analytical reliability and validity. * Physicians should adhere to the following principles related to medically indicated genetic testing: o Physicians should generally avoid recommending and/or ordering DTC genetic tests if they do not have a clear understanding of the validity and limitations of the tests they select. o Physicians should follow best practice guidelines and make use of clinically valid tests, accredited laboratories and specialist referral(s), when appropriate. o Physicians must obtain informed consent from the patient before ordering any genetic test, assist the patient in interpreting the results, support the individual with respect to psychological and biological implications of the results, and refer the patient to appropriate resources. o Many genetic tests require pre- and post-test counselling, particularly (but not limited to) tests involving children, tests establishing carrier status or tests considered to be predictive. If a provider decides to order such testing, they also accept the responsibility for facilitating access to pre- and post-test counselling. ROLE OF GOVERNMENT * The CMA calls on the government to enact regulations based on Bill S-201 (An Act to prohibit and prevent genetic discrimination) that establish clear boundaries for the marketing, distribution, accreditation and third-party use of DTC genetic tests. * The CMA believes that it is the government's responsibility to ensure that Canadians are only offered reliable, accurate and medically relevant genetic testing services. * The CMA encourages the development of national standards for the reliability and validity of DTC genetic tests by relevant federal government agencies, in conjunction with interested stakeholders (e.g., geneticists and laboratory scientists, genetic counsellors, physicians, private and public laboratories, industry, and patient groups). * The CMA encourages the government to enact standards that can keep pace with the rapid development of technological innovation in genetic testing and genetics more generally. * The CMA encourages the government to enact standards that hold companies accountable for being transparent about their uses of data/DNA and the potential resale of such material. * The CMA encourages the government to enact standards that mandate that the type of testing (e.g., single-nucleotide polymorphism [SNP] analysis, targeted mutation testing, sequencing) be clearly labelled and that a clear explanation be provided of the type of information that can (or cannot) be obtained from such testing. SYSTEMS INFRASTRUCTURE * Genetic testing and the interpretation of the results of such testing are highly technical and complex processes. For this reason, the CMA believes that clinical testing laboratories that are used by DTC genetic testing companies must be accredited if the companies are to claim that their testing is valid. * The CMA believes that scientific evidence describing the validity and utility of a DTC genetic test should be clearly stated in language that is easy to understand. This information should include a clear statement of what a test can or cannot diagnose or infer, and statements about the validity of a specific test should be supported with references. A company that does not guarantee the reliability or validity of its test should not be allowed to make any (implicit or explicit) claims about the potential medical utility of its test and/or its potential to improve health. EDUCATION AND PUBLIC ENGAGEMENT * The CMA supports public education initiatives to increase patient awareness of the potential implications and limitations of DTC genetic testing for health purposes. The CMA supports increased genetics training for physicians to help them to further appreciate the complex issues involved and keep pace with the rapid changes in molecular genetics. Such training would support physicians to counsel patients who seek follow-up for their DTC genetic test results. Approved by the CMA Board of Directors May 2017 See also Background to CMA Policy on Direct-to-Consumer Genetic Testing BACKGROUND TO CMA POLICY DIRECT-TO-CONSUMER GENETIC TESTING See also CMA Policy PD17-05 Direct-to-Consumer Genetic Testing Some direct-to-consumer (DTC) genetic tests, such as "compatibility testing" for online dating, are purely recreational. Other tests, however, are marketed both as being for recreational use and as producing results that are useful to the management of one's health. This document concerns this second category of tests. The characteristics of these tests differ widely, and some of the companies that offer them clearly state that they do not guarantee the validity and reliability of their tests. As of January 2016, 246 companies offered some form of DNA test online.1 Many DTC genetic tests have started to penetrate the Canadian market, especially after the U.S. Food and Drug Administration issued a warning letter instructing some companies in the U.S. to cease providing unreliable health information that could potentially lead consumers to make misinformed decisions about their health, which caused some of these companies to seek out alternative markets.2 The increasing availability of DTC genetic tests in Canada presents several challenges, as the predictive value of most of the DTC genetic tests currently on the market is very low. Moreover, there is no standard model for the delivery and interpretation of the results of these tests. Greater regulatory guidance and protection is needed to ensure that individuals who choose to submit samples to DTC genetic testing companies are not adversely affected by information that is not necessarily predictive or even accurate. Survey research indicates that the general public is overwhelmingly interested in genetic testing technologies.3 Researchers predict that an increasing number of individuals will use DTC genetic testing as testing technologies continue to become more affordable and efficient.3 Since genetic issues tend to cross medical specialties, it often falls on primary care physicians to understand the role of genetics in clinical care.4 In fact, genetic testing companies often direct patients to discuss their results with their primary care physician.5 Patients not only seek out their primary care providers to discuss their genetic test results and obtain appropriate follow-up but also expect them to be able to answer questions about personal genome test results.6 Despite these expectations, health professionals' awareness and knowledge of DTC genetic tests remains low.7 Although DTC genetic tests are marketed under similar names, the genetic tests available in Canada have very different characteristics. Three types of tests are offered: (1) single-nucleotide polymorphism (SNPs) analysis, which assesses an individual's risk for common multifactorial diseases (e.g., diabetes, myocardial infarction), (2) targeted mutation analysis and (3) sequencing. Some are ordered directly by the consumer while others are pre-ordered by the consumer and the order is co-signed by a physician (the patient's physician or a physician who has never met the patient and whose services are provided by the company). SNP testing assesses for a number of genetic variants that are common in the general population and that have been identified in association studies to modify (increase or decrease) the risk of a given disease. Some DTC genetic testing companies explicitly state in their terms of service that they do not guarantee the accuracy or reliability of the test. This is due in part to deficiencies in the science underlying the tests and their interpretation. For example, the interpretation of SNPs analysis for common multifactorial diseases can only be as good as the science behind it. The scientific community has a long way to go before it will have identified all of the significant genetic risk factors and protective factors for these diseases. Because of this, a given consumer could receive greatly divergent risk interpretations.3 In the case of targeted mutation analysis and sequencing, the specific panels offered by DTC genetic testing companies may not include all of the clinically relevant genes and mutations. This could result in a consumer receiving harmful false reassurance. Test results may include information on genetic changes that are only weakly associated with disease, leading to undue anxiety. As such, the clinical and health value of DTC genetic testing continues to be debated despite consumer uptake of, and enthusiasm for, DTC genetic testing offered online. Currently, most DTC genetic testing services exist in regulatory limbo, benefiting from laws that tend to lag behind technological innovation. Questions about access to the information yielded by these tests have emerged as a particular concern. For some companies, an important part of the business model is to sell consumers' DNA along with the clinical information that the consumers provide via their interactive websites. Most Canadians are unaware of this: they pay for a test and do not expect that their data will later be sold. ISSUES ARISING IN CLINICAL CONTEXTS Studies have shown that physicians see a number of benefits with DTC genetic testing, but they also have concerns. The benefits physicians have identified include convenience, promotion of preventive medicine and the provision of personalized services.5 They are concerned about the reliability of test results, the provision of adequate information/counselling, patient anxiety if the results are misunderstood, inappropriateness of advertising, discrimination with respect to employment and insurance, the possible spread of beliefs such as genetic determinism, and the inappropriate disclosure of patients' genetic information.5 The following sections will address primary concerns identified by research and in practice. 1. Patient privacy Privacy is one of the top concerns of the general public about genetic testing.8 According to a 2010 report commissioned by the Office of the Privacy Commissioner of Canada, approximately 60% of patients indicated that privacy and discrimination fears would influence their decision to undergo genetic testing.9 The average Canadian consumer is not adequately informed that an important part of the business model of many DTC genetic testing companies is to build and sell their database of phenotypic information and DNA accumulated from their clients to third parties, such as biobanks or pharmaceutical companies. 1.1 Informed consent The increasing quantity, complexity and diversity of DTC genetic testing services pose challenges for informed consent because both specific and generic models do not meet ethical standards when applied to this type of service.10 Many companies bind their consumers to contracts that are activated once the website is viewed, a practice that challenges the adequacy of consent, as it is common for people to view a website without reading or even seeing its terms of reference.1 Consumers who present to genetic clinics tend not to question the validity of the results they have received from DTC genetic testing,11 which can be interpreted as an indication that consumers give their consent without reading or understanding the disclaimers made by the companies.11 Physicians are concerned that this lack of informed consent could compromise the confidentiality of personal health information, encourage requests for unnecessary medical tests and potentially cause distress to patients. 1.2 Insurance The insurance industry is of particular concern in the context of privacy and DTC genetic tests. A study of patients' perceptions of DTC genetic tests found that participants were concerned that genetic results could affect their health insurance premiums or lead to denial of coverage.12 Private insurance is fundamentally rooted in the practice of discriminating between clients on the basis of risk. While insurers have generally been entitled to request genetic information in the form of family history, to access medical files and to conduct medical tests,13 consumers have expressed the view that the rules governing access to genetic information should be stricter than for access to other forms of personal information.3 While there are studies that report cases of genetic discrimination, it is often unclear whether such treatment is perceived or actual.14. Thus, the consequences of genetic testing remain uncertain. Of particular concern is the potential for discrimination on the basis of results that may not be accurate and/or reliable. Although there is presently no evidence of widespread use of genetic testing by insurance companies,14experts agree that in the next 10 years public acceptance of the use of information from genetic testing will increase and it will become possible to more accurately interpret data from genetic tests (K. Boycott, J. Davies and K. Morin, CIHR Café Scientifique, unpublished remarks), threatening to alter the currently limited role that genetic testing plays in insurance company decision-making. Before policy-makers tackle the potential issues related to the use of DTC genetic testing, it is imperative that they start at ground level and explore options to regulate insurance companies' access to such tests. 2. Patient response 2.1 Interpretation of results and changes in behaviour Proponents of DTC genetic testing point to the potential for patients to make positive changes to their health as a result of learning about their genetic susceptibility to certain diseases. Findings of studies in this area, however, are inconsistent to date. While some studies have reported that there are some behaviour changes, it is important to keep in mind that early adopters of these services are likely to also be among those most motivated to make health-related changes.15 Recent evidence suggests the opposite response: the general population has a tendency to decrease healthy practices upon learning about a lower health risk, and they do not increase healthy practices when they learn that they have an increased health risk.15 Indeed, patients may make poorer health decisions if they are under the impression that they are not at risk for developing a certain disease; for example, they may avoid routine screening for breast or prostate cancer, or they may not follow exercise and diet advice. 16 These variations in behaviour can be largely attributed to the fact that there is an overarching risk that patients will misinterpret the data they receive from the testing companies. The problem with susceptibility tests in the context of DTC genetic testing is not only that the test results may cause psychological or physical harm but also that there is a possibility that patients will over-interpret their disease risk.10 Without expert guidance, the patient may not be able to evaluate their test results accurately enough to make informed health decisions.14 There is very little evidence to suggest that receipt of a DTC genetic test result produces sustained behavioural change.17 In fact, studies on psychological theories related to motivation do not consider disease risk information a useful tool for motivating patients to change their behaviour.15 Therefore, while receipt of DTC genetic test results may encourage patients to see their family physician and possibly undergo further consultation, the health care resources invested in interpreting results with limited clinical validity may not produce sustained behavioural changes, good or bad. 3. Resource allocation One of the stated goals of personalized medicine is to save health care systems money by facilitating the use of fewer but more effective treatments.18 However, greater demand for genetic testing, whether public or private, could produce the opposite effect: consumption of health care resources may increase as patients consult with their regular physician about results they obtained through a DTC company.16 Furthermore, physicians who are presented with DTC genetic test results by their patients have a legal and ethical obligation to do their due diligence and carry out a complete, clinically valid investigation, which may ultimately negate the cost savings that personalized medicine is expected to produce.16 Patients who participate in DTC genetic testing are likely to drive up the utilization of health care providers, as they seek out their primary care provider to discuss their results and they obtain follow-up care from a genetic counsellor.19,5 At least one study has suggested that there is an expectation that physicians will help patients to interpret their DTC genetic test results, and DTC genetic testing companies frequently direct patients to discuss their results with their physicians before acting upon their testing information.5 Consequently, the responsibility falls on primary care providers to discuss this technology with their patients.5 Primary care providers, however, believe that genetic specialists are the most appropriate providers of counselling for DTC genetic tests.14 While they acknowledge the benefits of DTC genetic tests, including the potential for test results to encourage patients to be more involved in their care and take responsibility for their health, they also agree that test results may encourage patients to seek unnecessary and potentially expensive follow-up tests.14 As a result, additional health care resources may be required to cope with the increased demand for medical follow-up.20 4. Physician education Although DTC genetic testing companies have been around since the early 2000s, levels of awareness among health care professionals vary, and knowledge and understanding of the services generally remain low.21 Research suggests that few physicians feel they have the necessary training and knowledge in genomics to provide adequate care in this area.17 A perceived lack of clinical utility appears to be a barrier to learning more about DTC genetic testing.6 Increased genetics training and awareness may allow physicians to better appreciate the complex issues involved and help them to better counsel patients who seek follow-up for their DTC genetic test results. 4.1 Topics that physicians want to learn about Most physicians are concerned about the privacy implications of DTC genetic testing, specifically health insurance and employment discrimination, which may affect their patients who present with a DTC genetic test.5 Therefore, important discussion points to include in a physician education program would be information on the risks of insurance and employment discrimination, legislation currently in place to protect against genetic discrimination, and guidelines for managing risk.6 Given the ease with which patients can access DTC genetic testing, it is essential to provide health professionals with appropriate education on the potential benefits and risks of DTC genetic testing and help them develop an approach to interpreting the results of such testing, so that they can protect their patients from harm and arrange follow-up appropriately.19 5. Legislative landscape in Canada Before May 2017, Canada did not have a law to specifically protect against genetic discrimination. Existing human rights and privacy law could only be ambiguously and tenuously applied to DTC genetic testing issues, including genetic discrimination and information collection, use and disclosure.14 The laws that regulate medical devices, such as the Food and Drugs Act, did not clearly apply in the context of DTC genetic tests either,2 because consumers are not purchasing genetic testing kits but rather they are purchasing testing services, which fall outside the scope of that legislation.22 As a result, there was limited evidence to form the regulations necessary to ensure the validity and utility of these tests. Fortunately, on May 4, 2017, Bill S-201 (hereinafter termed S-201), An Act to prohibit and prevent genetic discrimination,23 received Royal Assent and will soon become law. S-201 provides a basis for the creation of regulations concerning the validity and utility of DTC genetic tests. The bill prohibits the requirement that an individual submit to genetic testing or disclose the results of genetic tests in order to receive goods or services or in order to enter into or continue a contract or agreement, and it prohibits submission to genetic testing or disclosure of test results from being used as the basis of any specific conditions in a contract or agreement. S-201 amends the Canada Labour Code to protect employees from being required to undergo or disclose the results of genetic testing and amends the Canadian Human Rights Act to prohibit discrimination on the grounds of genetic characteristics.21 Legislation at a provincial level, however, may still be required. Private Member's Bill 127, An Act to amend the Human Rights Code with respect to genetic characteristics,24 was presented to the Legislative Assembly of the Province of Ontario in 2013 but did not move past the first reading. Federal and provincial privacy legislation (such as the federal Personal Information Protection and Electronic Documents Act, or PIPEDA) also plays a role in protecting against genetic discrimination by requiring an individual to consent to the collection, use or disclosure of personal information.25 Currently, the Office of the Privacy Commissioner of Canada does not support amending the Privacy Act or PIPEDA, on the grounds that these laws sufficiently apply to genetic information.23 While this legislative framework might provide some protection against genetic discrimination, there is a lack of clarity as to whether it strikes the appropriate balance between consumers' rights to privacy and the interests of insurers. Furthermore, the courts have yet to provide an opinion regarding the constitutionality of S-201 or to assist in the interpretation of privacy legislation in the context of DTC testing, because of the novelty of the service. It is uncertain if and how Bill S-201 will inform future regulations placed upon employers and insurers. Significant gaps in the legislative framework remain; in particular, privacy protection in Canada has yet to counterbalance the lack of consumer protection in Canadian insurance laws.22 While existing legislation may offer some protection, the absence of legal precedents creates uncertainty and leaves consumers to engage in DTC testing services at their own risk. May 2017 See also CMA Policy PD17-05 Direct-to-Consumer Genetic Testing REFERENCES 1 Phillips AM. Only a click away - DTC genetics for ancestry, health, love ... and more: a view of the business and regulatory landscape. Appl Transl Genom 2016;8:16-22. 2 US Food and Drug Administration. Warning letter. Silver Spring (MD): The Administration; 22 Nov 2013. Available: www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm (accessed 2017 May 19). 3 Caulfield T. Direct-to-consumer testing: if consumers are not anxious, why are policy makers? Hum Genet 2011;130:23-5. 4 Delaney SK, Christman MF. Direct-to-consumer genetic testing: perspectives on its value in healthcare. Clin Pharmacol Ther 2016; 99(2):146-8. 5 Powell KP, Cogswell WA, Christianson CA, et al. Primary care physicians' awareness, experience and opinions of direct-to-consumer genetic testing. J Genet Couns 2012;21(1):113-26. 6 Powell KP, Christianson CA, Cogswell WA, et al. Educational needs of primary care physicians regarding direct-to-consumer genetic testing. J Genet Couns 2012;21(3):469-78. 7 Jackson L, Goldsmith L, Skirton H. Guidance for patients considering direct-to-consumer genetic testing and health professionals involved in their care: development of a practical decision tool. Fam Pract 2014;31(3): 341-8. 8 Caulfield T, McGuire AL. Direct-to-consumer genetic testing: perception, problems, and policy responses. Annu Rev Med 2012; 63:23-33. 9 Office of the Privacy Commissioner of Canada. Analysis of privacy policies and practices of direct-to-consumer genetic testing companies: private sector databanks and privacy protection norms. Ottawa: The Office; March 2010. p. 6. 10 Bunnik EM, Janssens AC, Schermer MH. Informed consent in direct-to-consumer personal genome testing: the outline of a model between specific and generic consent. Bioethics 2014;28(7):343-51. 11 Brett GR, Metcalfe SA, Amor DJ, et al. An exploration of genetic health professionals' experience with direct-to-consumer genetic testing in their clinical practice. Eur J Hum Genet 2012;20(8):825-30. 12 Wasson K, Sanders TN, Hogan NS, Cherny S, Helzlsouer KJ. Primary care patients' views and decisions about, experience of and reactions to direct-to-consumer genetic testing: a longitudinal study. J Community Genet. 2013;4:495-505 13 Lemmens T, Pullman D, Rodal R. Revisiting genetic discrimination issues in 2010: policy options for Canada [PowerPoint presentation]. Ottawa: Genome Canada; 15 June 2010. Available: www.genomecanada.ca/sites/default/files/pdf/en/gps_speakers_presentation/trudo-lemmens-daryl-pullman.pdf 14 Zinatelli F. Industry Code: Genetic testing information for insurance underwriting [Internet]. Toronto, ON: CLHIA; 2017 Jan 11. Available from https://www.clhia.ca/domino/html/clhia/CLHIA_LP4W_LND_Webstation.nsf/page/E79687482615DFA485257D5D00682400/$file/Industry%20Code%20Genetic%20Testing%20-%20Updated.pdf 15 Adams SD, Evans JP, Aylsworth AS. Direct-to-consumer genomic testing offers little clinical utility but appears to cause minimal harm. N C Med J 2013;74(6): 494-8. 16 Ram S, Russell B, Gubb M, et al. General practitioner attitudes to direct-to-consumer genetic testing in New Zealand. N Z Med J 2012;125(1364):14-26. 17 Caulfield T. Obesity genes, personalized medicine and public health policy. Curr Obes Rep 2015;4(3):319-23. 18 Caulfield T, Zarzeczny A. Defining 'medical necessity' in an age of personalised medicine: a view from Canada. Bioessays 2014;36(9):813-7. 19 Bloss CS, Schork NJ, Topol EJ. Direct-to-consumer pharmacogenomic testing is associated with increased physician utilisation. J Med Genet 2014;51(2):83-9. 20 Daly AK. Direct-to-consumer pharmacogenomic testing assessed in a US-based study. J R Coll Physicans Edinb 2014;44:212-3. 21 Jackson L, Goldsmith L, Skirton H. Guidance for patients considering direct-to-consumer genetic testing and health professionals involved in their care: development of a practical decision tool. Fam Pract 2014;31(3):341-8. 22 Mykitiuk R. Caveat emptor: direct-to-consumer supply and advertising of genetic testing. Clin Invest Med 2004;27(1):23-32. 23Parliament of Canada. Legislative summary of Bill S-201: An Act to prohibit and prevent genetic discrimination. Ottawa: Parliament of Canada; 2016 24 Parliament of Canada. Bill 127: An Act to amend the Human Rights Code with respect to genetic characteristics, 2nd Sess, 40th Leg, Ontario, 2013. 25 Personal Information Protection and Electronic Document Act (PIPEDA), S.C. 2000, C.5, para 5(3).
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Medical assistance in dying

https://policybase.cma.ca/en/permalink/policy13698
Date
2017-05-27
Topics
Ethics and medical professionalism
  1 document  
Policy Type
Policy document
Date
2017-05-27
Replaces
EUTHANASIA AND ASSISTED DEATH (UPDATE 2014)
Topics
Ethics and medical professionalism
Text
The legalization of medical assistance in dying (MAiD) raises a host of complex ethical and practical challenges that have implications for both policy and practice. The CMA supports maintaining the balance between three equally legitimate considerations: respecting decisional autonomy for those eligible Canadians who are seeking access, protecting vulnerable persons through careful attention to safeguards, and creating an environment in which practitioners are able to adhere to their moral commitments. Recognizing the educational, legislative, regulatory and practice changes that will result, the CMA recommends that legislative and regulatory processes be coordinated at the federal and provincial/territorial levels to consistently guide health systems, practitioners and patients. To that end, the CMA calls for rigorous information gathering at all levels and for experience with and research on the impacts of this new practice to be reported as it unfolds. The CMA encourages medical schools to incorporate reflective training opportunities at the undergraduate and postgraduate levels that address all aspects of medical practice that might be affected by this new intervention. Further, CMA recognizes the opportunity that exists for all health systems and practitioners to facilitate effective patient access to information about all end-of-life care options. The CMA acknowledges the importance of understanding that other acts within the realm of end-of-life care are distinct from the practice of medical assistance in dying. Further, the provision of specific assessments for eligibility to access medical assistance in dying is a distinct service unrelated to consultations for general palliative end-of-life care. It is important that physicians be aware of this distinction and the relationship between legal, medical and ethical norms with respect to medical assistance in dying. The judicial and legislative branches of government have made changes to Canadian law in this area. Society has placed assistance in dying within the realm of regulated medical practitioners. Physicians' ethical norms and duties, arising from long-standing traditions that entail moral commitments to preserve and protect life, have not changed. The CMA supports the right of all physicians to follow their conscience when deciding whether to provide or otherwise participate in assistance in dying as per the legislation governing medical assistance in dying. The CMA equally supports conscientious participation in and conscientious objection to assistance in dying by physicians. SCOPE OF POLICY This policy aims to provide guidance on key considerations in a way that is consistent with a physician's ethical, professional and legal obligations. Physicians should be aware of the federal and provincial laws in the jurisdiction in which they practise, the standards and expectations outlined by their respective regulatory authority, advice from the Canadian Medical Protective Association as well as the policies and procedures of the setting(s) in which they practise (e.g., regional health authority or hospital). RELEVANT FOUNDATIONAL CONSIDERATIONS The following considerations underpin the CMA's position on what ought to constitute the basis of any evolving legislation, regulation or guideline on the implementation of medical assistance in dying. These considerations are not ranked according to priority or importance. As with any foundational considerations, they provide a starting point for ethical reflection, and their application requires further thought and interpretation when conflicts arise. 1. Respect for autonomy: The CMA upholds the importance of respect for decisional autonomy by competent patients - such persons are free to make informed choices and autonomous decisions about their bodily integrity, their personal aims and their care that are consistent with their personal values and beliefs. CMA also asserts that persons have inherent dignity regardless of their circumstances. Services ought to be delivered, and processes and treatments ought to be applied, in ways that strive to preserve and enhance dignity. End-of-life care strives to maintain the integrity of personhood even as bodily functions deteriorate in advance of death. 2. Respect for vulnerability: In consideration of the importance of a patient's decision regarding medical assistance in dying, and the permanence of death if medical assistance in dying is chosen by a patient, the CMA believes that careful and non-judgmental exploration with patients of the reasons they are seeking assistance in dying is always warranted. Care in this regard assists physicians to fulfill the duty to ensure that conditions of vulnerability have been identified and addressed satisfactorily. Physicians should maintain diligent attention to identifying undue coercive influences on the patient. Legislation 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. 3. Respect for freedom of conscience: The CMA believes that physicians must be able to follow their conscience without discrimination when deciding whether or not to provide or participate in assistance in dying. The CMA supports physicians who, for reasons of moral commitments to patients and for any other reasons of conscience, will not participate in decisional guidance about, eligibility assessments for, or provision of medical assistance in dying. To enable physicians to adhere to such moral commitments without causing undue delay for patients pursuing this intervention, health systems will need to implement an easily accessible mechanism to which patients can have direct access. Further, the CMA believes that physicians' general employment or contract opportunities should not be influenced by their decisions to participate in, or not participate in, any or all aspects of medical assistance in dying with patients. The right of patients to seek medical assistance in dying does not compel individual physicians to provide it. Learners should be equally free to follow their conscience without risk to their evaluations and training advancement. 4. Accountability: Physicians providing or otherwise participating in assistance in dying must ensure they have the requisite training and the appropriate competencies, and the ability to assess a patient's decisional capacity or the ability to consult with a colleague to assess capacity in more complex situations. Physicians are expected to use appropriate medical judgment to make a determination of eligibility by (1) assessing the capacity of an adult to consent to the termination of life and (2) determining whether the patient has explored their options (and the putative impacts of any of the options). If the patient wishes to continue seeking medical assistance in dying, physicians are expected to use appropriate medical judgment to determine whether s/he meets the eligibility criteria as per the legislation governing medical assistance in dying. This ought to be a shared decision, and it should be made as part of a deliberative process in the context of the patient-physician relationship. The CMA encourages physicians to participate in accountability processes within their jurisdictions that ensure equitable access to all end-of-life options, including palliative and end-of-life care provided by skilled practitioners, in service of their patients' needs and values. To that end, the CMA believes that a federal oversight body and reporting regime should be established to ensure that all processes are followed. ADDITIONAL CONSIDERATIONS: PHYSICIAN DUTIES 5. Duty of non-abandonment: Physicians have an obligation to respond to a request for assistance in dying, regardless of how their moral commitment is expressed. Patients should never be abandoned and must always be supported by their physician and other members of their care team. The patient's physician ought to explore the reasons motivating the request and be sensitive to issues of culture and background throughout the dying process, regardless of the decisions the patient makes with respect to assistance in dying. There should be no undue delay in providing access to assistance in dying and all other end-of-life options, either from a clinical, system or facility perspective. For those who choose to provide assistance in dying, the duty of non-abandonment means that physicians have a duty to be available to patients during the act of ending their life. Physicians should be present or immediately available to manage any unexpected complications during the medical procedure, whether the chemical administration is done by the patient or by a regulated practitioner. 6. Duty to support interdisciplinary teams: The CMA advocates that physicians work within, and support other members of, interdisciplinary teams, pay close attention to the impacts of participation and non-participation in medical assistance in dying on their non-physician colleagues, and demonstrate solidarity with their team members as they navigate new legal and ethical territory together. 7. Duty to learners: The CMA recognizes the importance of unique moral considerations within learning environments. Learners are encouraged to reflect on their moral understanding of and views about assistance in dying and to seek a wide range of views and experiences from their patients and from their teachers and colleagues. ADDRESSING ADHERENCE TO MORAL COMMITMENTS CMA's position on conscientious participation and conscientious objection aims to harmonize two legitimate considerations: (1) effective patient access to a legally permissible medical service and (2) protection of physicians' freedom of conscience (or moral integrity) in a way that respects differences of conscience. a. The CMA believes that physicians are not obligated to fulfill a patient's request for assistance in dying but that all physicians are obligated to respond to a patient's request. This means that physicians who choose not to provide or otherwise participate in assistance in dying are: i. not required to provide it, or to otherwise participate in it, or to refer the patient to a physician or a medical administrator who will provide assistance in dying to the patient; but ii. are still required to fulfill their duty of non-abandonment by responding to a patient's request for assistance in dying. There should be no discrimination against a physician who chooses not to provide or otherwise participate in assistance in dying. b. The CMA believes that physicians are obligated to respond to a patient's request for assistance in dying in a timely fashion. This means that physicians are obligated to, regardless of their beliefs: i. provide the patient with complete information on all options available, including assistance in dying; ii. advise the patient on how to access any separate central information, counselling and referral service; and iii. transfer care of the patient to another physician or another institution, if the patient requests it, for the assessment and treatment of the patient's medical condition and exploration of relevant options. If relevant, such options may include palliative care, mental health care and, if the patient meets the eligibility criteria, provision of assistance in dying. The duty of non-abandonment still applies in all other aspects of the patient's care. c. Physicians are expected to make available relevant medical records (i.e., diagnosis, pathology, treatment and consults) to the physician accepting care of the patient when authorized by the patient to do so. d. Physicians are expected to act in good faith. They are expected to never abandon or discriminate against a patient requesting assistance in dying and to not impede or block access to a request for assistance in dying. Physicians should inform their patients of the fact and implications of their conscientious objection. No physician may require a patient to make a commitment not to seek assistance in dying as a condition of acceptance or retention of the patient. GLOSSARY WHAT MEDICAL ASSISTANCE IN DYING (MAID) ENCOMPASSES 1. Medical assistance in dying encompasses the assessment of a patient for eligibility for assistance in dying, deliberation with the patient, accompaniment of the patient through the process of deciding and, if so chosen by the patient, the provision of assistance in dying, which refers to: a. The administering by a medical practitioner or nurse of a substance to a person, at their request, that causes their death; or b. The prescribing or providing by a medical practitioner or nurse practitioner of a substance to a person, at their request, so that they may self-administer the substance and in doing so cause their death. 2. The Supreme Court of Canada in Carter used the terms physician-assisted dying and physician-assisted death. These terms refer to both of the following: a. Voluntary euthanasia, or physician-administered assistance in dying: The physician takes the final act that will end the individual's life via, usually, the intravenous administration of a lethal substance, at the request and with the consent of a patient b. Assisted suicide, or physician-prescribed, self-administered assistance in dying: An individual performs the final act to end their life by, usually, ingesting a lethal substance prescribed or provided by the physician, at the request and with the consent of the patient. 3. Other commonly used terms are hastened death, physician-administered hastened death and physician-prescribed, patient-administered hastened death. a. These terms are proposed to make a clear distinction between palliative care and other practices that hasten or bring about death, such as through the legitimate removal of life-sustaining interventions or via the provision or administration of chemicals. 4. Medical aid in dying has a distinct technical and legal meaning within Quebec, described in Bill 52, and is limited to physicians administering the lethal substance at the request of the individual. WHAT IT DOES NOT ENCOMPASS 1. Palliative care is an integrated approach that aims to relieve suffering and improve the quality of life of those facing life-limiting acute or chronic conditions by means of early identification, assessment and treatment of pain and other symptoms. 2. Continuous palliative sedation therapy1 refers to complete sedation, with the intent of rendering the patient unable to experience the environment, sensation or thoughts, until the patient dies naturally from the underlying illness. 3. Withdrawing or withholding treatment or treatment cessation refers to withdrawing or withholding life-prolonging treatment where it is no longer indicated or desired. 4. Voluntary refusal of hydration and nutrition is the conscious and active choice to refuse and to discontinue food and fluid, orally or parenterally, with the intention of hastening death. Approved by the CMA Board of Directors May 2017 1 Consensus statement on continuous palliative sedation therapy: www.chpca.net/media/343120/final_cpst_framework.pdf. ---------------
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Federal Monitoring and Reporting Regime for MAID

https://policybase.cma.ca/en/permalink/policy13853
Date
2017-05-15
Topics
Ethics and medical professionalism
  1 document  
Policy Type
Response to consultation
Date
2017-05-15
Topics
Ethics and medical professionalism
Text
Substantive recommendations 1. Protection and disclosure of the information This is a foundational component of any regulatory framework for both practitioners and patients/requestors. The CMA recommends placing greater emphasis on the protection of privacy by a. conducting a privacy impact assessment, with input from the Federal Privacy Commissioner (if that hasn't already been done). b. requiring, as part of the regulations, privacy/data sharing agreements in instances when o data is shared to meet the objectives outlined (p. 2); and o information collected under the framework will be made available to designated provincial and territorial government bodies for their use (p. 3). This is particularly important given that this involves the collection of identifiable (private) information about practitioners and patients/requestors. c. using aggregate data where applicable. d. providing greater detail on how the "Rigorous protection of all personal information (patient and practitioner) will be a paramount feature of the monitoring regime" - such detail is essential even in the preliminary stages of developing a monitoring and reporting system. 2. Further specification of what constitutes a request As is currently stated, what constitutes a request is not sufficiently defined, i.e., what constitutes a "written request"? Is any written request a request? What about for those who can't (or who can no longer) write? Further specifying what constitutes a request is especially important since the practitioner has to document the circumstances of the request in every instance, including where follow-up is required and a report has to be filed as part of a follow-up. 3. Timeframe A timeframe of 10 days to file a report is alarmingly short. It is commonly known that physicians already feel burdened by paperwork and it is highly likely that they would find it nearly impossible to meet this requirement. This could conceivably deter physicians from choosing to provide assistance in dying or participate in an assessment under threat of criminal sanction, potentially significantly impacting patient access. Procedural recommendations 4. Inegibility Information required for this category includes "results of the eligibility assessment". It should be required to explicitly include reasons why the patient/requestor was deemed ineligible. 5. MAiD self-administered a. The application of safeguards should be a specific category requiring reporting (and not simply used an example). b. To assess (in)consistency of emerging practices and the variability of provincial legislative or regulatory requirements, it would be worthwhile to require stating whether the practitioner was present during the self-administration. 6. Coroners and medical examiners When the monitoring regime (periodically) requests information from Chief Coroners or Medical Examiners: To assess (in)consistency of emerging practices and the variability of provincial legislative or regulatory requirements, it would be worthwhile to gather data on who completes the death certificate and the information included on the death certificate.
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10 records – page 1 of 1.