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Best practices for smartphone and smart-device clinical photo taking and sharing

https://policybase.cma.ca/en/permalink/policy13860
Date
2018-03-03
Topics
Health information and e-health
Ethics and medical professionalism
  1 document  
Policy Type
Policy document
Date
2018-03-03
Topics
Health information and e-health
Ethics and medical professionalism
Text
Clinical photography is a valuable tool for physicians. Smartphones, as well as other devices supporting network connectivity, offer a convenient, efficient method to take and share images. However, due to the private nature of the information contained in clinical photographs there are concerns as to the appropriate storage, dissemination, and documentation of clinical images. Confidentiality of image data must be considered and the dissemination of these images onto servers must respect the privacy and rights of the patient. Importantly, patient information should be considered as any information deriving from a patient, and the concepts outlined therefore apply to any media that can be collected on, or transmitted with, a smart-device. Clinical photography can aid in documenting form and function, in tracking conditions and wound healing, in planning surgical operations, and in clinical decision-making. Additionally, clinical photographs can provide physicians with a valuable tool for patient communication and education. Due to the convenience of this type of technology it is not appropriate to expect physicians to forego their use in providing their patients with the best care available. The technology and software required for secure transfer, communication, and storage of clinical media is presently available, but many devices have non-secure storage/dissemination options enabled and lack user-control for permanently deleting digital files. In addition, data uploaded onto server systems commonly cross legal jurisdictions. Many physicians are not comfortable with the practice, citing security, privacy, and confidentiality concerns as well as uncertainty in regards to regional regulations governing this practice.1 Due to concern for patient privacy and confidentiality it is therefore incredibly important to limit the unsecure or undocumented acquisition or dissemination of clinical photographs. To assess the current state of this topic, Heyns et al. have reviewed the accessibility and completeness of provincial and territorial medical regulatory college guidelines.2 Categories identified as vital and explored in this review included: Consent; Storage; Retention; Audit; Transmission; and Breach. While each regulatory body has addressed limited aspects of the overall issue, the authors found a general lack of available information and call for a unified document outlining pertinent instructions for conducting clinical photography using a smartphone and the electronic transmission of patient information.2 The discussion of this topic will need to be ongoing and it is important that physicians are aware of applicable regulations, both at the federal and provincial levels, and how these regulations may impact the use of personal devices. The best practices supported here aim to provide physicians and healthcare providers with an understanding of the scope and gravity of the current environment, as well as the information needed to ensure patient privacy and confidentiality is assessed and protected while physicians utilize accessible clinical photography to advance patient care. Importantly, this document only focusses on medical use (clinical, academic, and educational) of clinical photography and, while discussing many core concepts of patient privacy and confidentiality of information, should not be perceived as a complete or binding framework. Additionally, it is recommended that physicians understand the core competencies of clinical photography, which are not described here. The Canadian Medical Association (CMA) suggests that the following recommendations be implemented, as thoroughly as possible, to best align with the CMA policy on the Principles for the Protection of Patient Privacy (CMA Policy PD2018-02). These key recommendations represent a non-exhaustive set of best practices - physicians should seek additional information as needed to gain a thorough understanding and to stay current in this rapidly changing field. KEY RECOMMENDATIONS 1. CONSENT * Informed consent must be obtained, preferably prior, to photography with a mobile device. This applies for each and any such encounter and the purpose made clear (i.e. clinical, research, education, publication, etc.). Patients should also be made aware that they may request a copy of a picture or for a picture to be deleted. * A patient's consent to use electronic transmission does not relieve a physician of their duty to protect the confidentiality of patient information. Also, a patient's consent cannot override other jurisdictionally mandated security requirements. * All patient consents (including verbal) should be documented. The acquisition and recording of patient consent for medical photography/dissemination may be held to a high standard of accountability due to the patient privacy and confidentiality issues inherent in the use of this technology. Written and signed consent is encouraged. * Consent should be considered as necessary for any and all photography involving a patient, whether or not that patient can be directly recognized, due to the possibility of linked information and the potential for breach of privacy. The definition of non-identifiable photos must be carefully considered. Current technologies such as face recognition and pattern matching (e.g. skin markers, physical structure, etc.), especially in combination with identifying information, have the potential to create a privacy breach. * Unsecure text and email messaging requires explicit patient consent and should not be used unless the current gold standards of security are not accessible. For a patient-initiated unsecure transmission, consent should be clarified and not assumed. 2. TRANSMISSION * Transmission of photos and patient information should be encrypted as per current-day gold standards (presently, end-to-end encryption (E2EE)) and use only secure servers that are subject to Canadian laws. Explicit, informed consent is required otherwise due to privacy concerns or standards for servers in other jurisdictions. Generally, free internet-based communication services and public internet access are unsecure technologies and often operate on servers outside of Canadian jurisdiction. * Efforts should be made to use the most secure transmission method possible. For data security purposes, identifying information should never be included in the image, any frame of a video, the file name, or linked messages. * The sender should always ensure that each recipient is intended and appropriate and, if possible, receipt of transmission should be confirmed by the recipient. 3. STORAGE * Storing images and data on a smart-device should be limited as much as possible for data protection purposes. * Clinical photos, as well as messages or other patient-related information, should be completely segregated from the device's personal storage. This can be accomplished by using an app that creates a secure, password-protected folder on the device. * All information stored (on internal memory or cloud) must be strongly encrypted and password protected. The security measures must be more substantial than the general password unlock feature on mobile devices. * Efforts should be made to dissociate identifying information from images when images are exported from a secure server. Media should not be uploaded to platforms without an option for securely deleting information without consent from the patient, and only if there are no better options. Automatic back-up of photos to unsecure cloud servers should be deactivated. Further, other back-up or syncing options that could lead to unsecure server involvement should be ascertained and the risks mitigated. 4. Cloud storage should be on a Canadian and SOCII certified server. Explicit, informed consent is required otherwise due to privacy concerns for servers in other jurisdictions. 5. AUDIT & RETENTION * It is important to create an audit trail for the purposes of transparency and medical best practice. Key information includes patient and health information, consent type and details, pertinent information regarding the photography (date, circumstance, photographer), and any other important facts such as access granted/deletion requests. * Access to the stored information must be by the authorized physician or health care provider and for the intended purpose, as per the consent given. Records should be stored such that it is possible to print/transfer as necessary. * Original photos should be retained and not overwritten. * All photos and associated messages may be considered part of the patient's clinical records and should be maintained for at least 10 years or 10 years after the age of majority, whichever is longer. When possible, patient information (including photos and message histories between health professionals) should be retained and amalgamated with a patient's medical record. Provincial regulations regarding retention of clinical records may vary and other regulations may apply to other entities - e.g. 90 years from date of birth applies to records at the federal level. * It may not be allowable to erase a picture if it is integral to a clinical decision or provincial, federal, or other applicable regulations require their retention. 6. BREACH * Any breach should be taken seriously and should be reviewed. All reasonable efforts must be made to prevent a breach before one occurs. A breach occurs when personal information, communication, or photos of patients are stolen, lost, or mistakenly disclosed. This includes loss or theft of one's mobile device, texting to the wrong number or emailing/messaging to the wrong person(s), or accidentally showing a clinical photo that exists in the phone's personal photo album. * It should be noted that non-identifying information, when combined with other available information (e.g. a text message with identifiers or another image with identifiers), can lead to highly accurate re-identification. * At present, apps downloaded to a smart-device for personal use may be capable of collecting and sharing information - the rapidly changing nature of this technology and the inherent privacy concerns requires regular attention. Use of specialized apps designed for health-information sharing that help safeguard patient information in this context is worth careful consideration. * Having remote wipe (i.e. device reformatting) capabilities is an asset and can help contain a breach. However, inappropriate access may take place before reformatting occurs. * If a smartphone is strongly encrypted and has no clinical photos stored locally then its loss may not be considered a breach. * In the event of a breach any patient potentially involved must be notified as soon as possible. The CMPA, the organization/hospital, and the Provincial licensing College should also be contacted immediately. Provincial regulations regarding notification of breach may vary. Approved by the CMA Board of Directors March 2018 References i Heyns M†, Steve A‡, Dumestre DO‡, Fraulin FO‡, Yeung JK‡ † University of Calgary, Canada ‡ Section of Plastic Surgery, Department of Surgery, University of Calgary, Canada 1 Chan N, Charette J, Dumestre DO, Fraulin FO. Should 'smart phones' be used for patient photography? Plast Surg (Oakv). 2016;24(1):32-4. 2 Unpublished - Heyns M, Steve A, Dumestre DO, Fraulin FO, Yeung J. Canadian Guidelines on Smartphone Clinical Photography.
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CMA Policy Endorsement Guidelines

https://policybase.cma.ca/en/permalink/policy14021
Date
2018-03-03
Topics
Ethics and medical professionalism
  1 document  
Policy Type
Policy document
Date
2018-03-03
Topics
Ethics and medical professionalism
Text
These Guidelines constitute an implementation tool of seven recommendations and are informed by Guidelines for CMA’s Activities and Relationships with Other Parties (aka CMA’s Corporate Relationships Policy) and CMA’s Advertising and Sponsorship Policy. 1. Scope These Guidelines apply to the Canadian Medical Association (and not to its subsidiaries). As these are Guidelines, exceptions may be necessary from time to time wherein staff may use their discretion and judgment. 2. Definition Endorsement is an umbrella term encompassing “policy endorsement”, “sponsorship1” and “branding”. Policy endorsement includes: (a) CMA considering upon request, non-pecuniary public approval, which may include the use of CMA’s name and/or logo, of an organization’s written policy, on an issue that aligns with CMA policy, where there is no immediate expectation of return; or, (b) CMA adopting the policy of another organization as our policy; or (c) CMA asking another organization to publicly support our policy. 3. Process (a) Criteria: For policy endorsement requests from another organization to endorse their policy2 the following criteria shall be applied: i) we have a policy on the subject-matter and ii) we are actively working on advancing that policy position and iii) the organization has a follow-up action plan associated with its request. (b) Approval: Where policy exists, approval requires a policy staff member (with portfolio responsibility) and the VP of Medical Professionalism, or the policy staff member (with portfolio responsibility) and the Chief Policy Advisor. Where no policy exists, approval of the Board of Directors is required. (c) Annual confirmation: Where CMA adopts the policy of another organization3, CMA staff shall confirm annually, or more frequently if circumstances dictate, that the policy has not been altered by the other organization. (d) Requests: Pursuit of personal endorsement requests are not appropriate. Wherever possible, requests should come from an organization and not an individual. 4. Results (a) Where CMA adopts the policy of another organization, the adopted policy shall become CMA policy, and will include a notation on the document as being an adopted policy of [organization]. (b) All adopted policies will be housed in an accessible searchable database. (c) All requests by organizations for CMA to endorse their policy will be tracked in a central location, along with any response. 1 Sponsorship means, to consider upon request, pecuniary public approval, which may include the use of CMA’s name and/or logo, of an organization’s event (eg., conference), on an issue that is supported by CMA policy or that promotes CMA brand awareness, where there is an immediate expectation of return. 2 That is, part (a) of the definition in Section 2. 3 That is, part (b) of the definition in Section 2.
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Equity and diversity in medicine

https://policybase.cma.ca/en/permalink/policy14127
Date
2019-12-07
Topics
Ethics and medical professionalism
  3 documents  
Policy Type
Policy document
Date
2019-12-07
Topics
Ethics and medical professionalism
Text
The objective of this policy is to provide guidance to physicians and institutions by identifying a set of guiding principles and commitments to promote equity and diversity in medicine (as defined in the Guiding Principles section). We address equity and diversity in medicine to improve circumstances and opportunities for all physicians and learners as part of our efforts to create a more collaborative and respectful culture and practice of medicine. To achieve this, we must redress inequities, bias, and discrimination in learning and practice environments. Individual protection from bias and discrimination is a fundamental right of all Canadians. By embracing the principles of equity and diversity, we can systematically address root causes and reduce structural barriers faced by those who want to enter the medical profession and those practicing medicine. In so doing, we improve their opportunities for advancement, health, and livelihood. The principles of equity and diversity are grounded in the fundamental commitment of the medical profession to respect for persons. This commitment recognizes that everyone has equal and inherent worth, has the right to be valued and respected, and to be treated with dignity. When we address equity and diversity, we are opening the conversation to include the voices and knowledge of those who have historically been under-represented and/or marginalized. It is a process of empowerment—where a person can engage with and take action on issues they define as important. Empowerment involves a meaningful shift in experience that fosters belonging in the profession and draws on community supports. As part of equity and diversity frameworks, inclusion is often articulated to refer to strategies used to increase an individual’s ability to contribute fully and effectively to organisational structures and processes. Inclusion strategies are specific organisational practices or programs focused on encouraging the involvement and participation of individuals from diverse backgrounds to integrate and value their perspectives in decision-making processes. Robust processes for inclusion are a vehicle to achieving equity and diversity. Thus, in this policy, the process of inclusion is understood to be positioned at the nexus of the overarching principles of equity and diversity. Equity and diversity initiatives can be carefully structured to complement and strengthen merit-based approaches. Enhanced support and appropriate methods of evaluation that increase equity of opportunity (for example, equity in training, hiring processes, and in access to resources) provide all physicians and learners with a fair opportunity to cultivate and demonstrate their unique capabilities and strengths, and to realize their full potential. Promoting equity and diversity fosters a just professional and learning culture that cultivates the diverse perspectives within it, reflects the communities physicians serve, and promotes professional excellence and social accountability as means to better serve patients. An increasingly diverse medical population provides opportunities for underserviced populations to receive better access to medical services and bolsters the management of clinical cases through the contribution of different points of view. Evidence indicates that when demonstrably more equity and diversity in medicine is achieved, physicians experience greater career satisfaction, health and wellness, and a sense of solidarity with the profession while patients experience improved care and a more responsive and adaptable health care system. Evidence further indicates that realizing the full potential of human capital is an essential driver of innovation and health system development. This policy is consistent with the CMA Code of Ethics and Professionalism and the CMA Charter of Shared Values and strives to be in the spirit of the recommendations relevant to health made in the report of the Truth and Reconciliation Commission of Canada. The policy is informed by a body of evidence described in the accompanying Background document that includes a Glossary of terms. GUIDING PRINCIPLES A clear set of principles and commitments to improving equity and diversity demonstrates that we hold ourselves accountable to recognizing and challenging behaviours, practices, and conditions that hinder equity and diversity and to promoting behaviours, practices, and conditions that will achieve these goals. Achieving equity in medicine Equity refers to the treatment of people that recognizes and is inclusive of their differences by ensuring that every individual is provided with what they need to thrive, which may differ from the needs of others. It is a state in which all members of society have similar chances to become socially active, politically influential, and economically productive through the absence of avoidable or remediable differences among groups of people (defined socially, economically, demographically, or geographically). Equity in the medical profession is achieved when every person has the opportunity to realize their full potential to create and sustain a career without being unfairly impeded by discrimination or any other characteristic-related bias or barrier. To achieve this, physicians must 1) recognize that structural inequities that privilege some at the expense of others exist in training and practice environments and 2) commit to reducing these by putting in place measures that make recruitment, retention, and advancement opportunities more accessible, desirable, and achievable. To that end, physicians must apply evidence-based strategies and support applied research into the processes that lead to inequities in training and practice environments. Fostering diversity in medicine Diversity refers to observable and non-observable characteristics which are constructed—and sometimes chosen—by individuals, groups, and societies to identify themselves (e.g., age, culture, religion, indigeneity, ethnicity, language, gender, sexuality, health, ability, socio-economic and family status, geography). The barriers to diversity in medicine are broad and systemic. Individuals and groups with particular characteristics can be excluded from participation based on biases or barriers. Even when they are included, they are often not able to use the full range of their skills and competencies. As with improving equity, the benefits of a more diverse medical profession include improved health outcomes, system-level adaptation, and physician health and wellness. To achieve these benefits, the medical profession must become increasingly diverse by striving to create, foster, and retain physicians and learners who reflect the diversity of the communities they serve and it must be responsive to the evolving (physical, emotional, cultural, and socioeconomic) needs of patients. Promoting a just professional and learning culture Physicians value learning and understand that it reflects, and is informed by, the professional culture of medicine. A just professional and learning culture is one of shared respect, shared knowledge, shared opportunity, and the experience of learning together. An environment that is physically and psychologically safe by reducing bias, discrimination, and harassment is critical to creating and sustaining such a culture. To achieve this, the profession must strive to integrate cultural safety by fostering and adopting practices of cultural competence and cultural humility. Physicians and leaders across all levels of training, practice, and health settings, and through formal and informal mentorships, must also promote and foster environments where diverse perspectives are solicited, heard, and appreciated. In this way, diverse individuals are both represented in the professional culture of medicine and actively involved in decision-making processes in all aspects of the profession. Fostering solidarity within the profession Solidarity means standing alongside others by recognizing our commonality, shared vulnerabilities and goals, and interdependence. It is enacted through collective action and aims. To show solidarity within the profession means making a personal commitment to recognizing others as our equals, cultivating respectful, open, and transparent dialogue and relationships, and role modelling this behaviour. Solidarity enables each of us to support our colleagues in meeting their individual and collective responsibilities and accountabilities to their patients and to their colleagues. Being accountable to these goals and to each other means taking action to ensure the principles that guide the medical profession are followed, responding justly and decisively when they are not, and continually searching for ways to improve the profession through practice-based learning and experience. Promoting professional excellence and social accountability Engaged and informed research and action on equity and diversity is critical to promoting professional excellence and social accountability in medicine as means to better serve patients. Professional excellence is a fundamental commitment of the profession to contribute to the development of and innovation in medicine and society through clinical practice, research, teaching, mentorship, leadership, quality improvement, administration, and/or advocacy on behalf of the profession or the public. Social accountability is a pillar of the commitment to professional excellence by focusing those efforts on fostering competence to address the evolving health needs of the patients and communities physicians are mandated to serve. For care to be socially accountable, and to achieve professional excellence, physicians must provide leadership through advocacy and through action: advocacy about the benefits of addressing equity and diversity to achieve equitable health outcomes; and actions to be responsive to patient, community, and population health needs through high-quality evidence-based patient care. RECOMMENDATIONS To accomplish equity and diversity in medicine, organizational and institutional changes will be required across many facets of operation and culture including leadership, education, data gathering/analysis, and continuous improvement through feedback and evaluation of policies and programs. To achieve this, the CMA seeks to provide direction on broad action areas that require further specific actions and development measures in specific recruitment, training, and practice contexts. The CMA recommends: All medical organizations, institutions, and physician leaders: A. Take a leadership role in achieving greater equity and diversity by co-creating policies and processes that apply to them, and the individuals therein, in an accountable and transparent manner. This includes: 1. Identifying and reducing structural inequities, barriers, and biases that exist in training and practice environments to create fair opportunities for all physicians and learners; and providing the appropriate platforms, resources, and training necessary to do so to effect change collaboratively. 2. Practicing and promoting cultural safety, cultural competence, and cultural humility. 3. Providing training on implicit bias, allyship, cultural safety, cultural competence, and cultural humility, structural competence, and the value of diversity in improving health outcomes. 4. Ensuring a process is in place to review all workforce and educational policies, procedures, and practices toward considering their impact on equity and diversity. Areas of consideration include (but are not limited to) recruitment, promotion, pay, leave of absence, parental leave, resources and support, and working/learning conditions and accommodations. 5. Ensuring safe, appropriate, and effective avenues exist for those who may have experienced discrimination, harassment, or abuse in training and practice environments to report these events outside of their supervisory/promotional chain. Those experiencing these events should also be able to seek counselling without the fear of negative consequences. 6. Working towards creating and appropriately funding equity and diversity Chairs, Committees, or Offices with a mandate to investigate and address issues in equity and diversity. 7. Promoting and enabling formal and informal mentorship and sponsorship opportunities for historically under-represented groups. B. Encourage the collection and use of data related to equity and diversity through research and funding, and, specifically, review their data practices to ensure: 1. Historically under-represented groups are meaningfully engaged through the co-development of data practices. 2. Data regarding the representation of under-represented groups is being systematically and appropriately collected and analyzed. 3. Information collected is used to review and inform internal policy and practice with the aim of reducing or eliminating system-level drivers of inequity. 4. Findings relating to these data are made accessible. C. Support equity and diversity in recruitment, hiring, selection, appointment, and promotion practices by: 1. Requesting and participating in training to better understand approaches and strategies to promote equity and diversity, including implicit bias and allyship training that highlights the roles and responsibilities of all members of the community with emphasis on self-awareness, cultural safety, and sensitivity to intersectionalities. 2. Studying organizational environments and frameworks and identifying and addressing hiring procedures, especially for leadership and executive positions, that perpetuate institutional inequities and power structures that privilege or disadvantage people. 3. Adopting explicit criteria to recruit inclusive leaders and to promote qualified candidates from historically under-represented groups in selection processes. Additional recommendations for institutions providing medical education and training: 1. Establishing programs that espouse cultural safety, cultural competence, and cultural humility. 2. Encouraging all instructors develop competencies including non-discriminatory and non-stereotyping communication, awareness of intersectionality, and cultural safety. 3. Providing training programs, at the undergraduate level onwards, that include awareness and education around stereotypes (gender and otherwise), intersectionalities, and the value of diversity in improving health outcomes. 4. Providing diversity mentorship programs that aim to support diverse candidates through education and training to graduation. 5. Promoting and funding student-led programs that create safe and positive spaces for students and principles of equity and diversity. 6. Ensuring recruitment strategies and admission frameworks in medical schools incorporate more holistic strategies that recognize barriers faced by certain populations to enable a more diverse pool of candidates to apply and be fairly evaluated. 7. Developing learning communities (such as undergraduate pipelines described in the background document) to promote careers in medicine as a viable option for individuals from historically under-represented communities. Approved by the CMA Board of Directors December 2019
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Federal monitoring of medical assistance in dying regulations

https://policybase.cma.ca/en/permalink/policy13856
Date
2018-02-13
Topics
Ethics and medical professionalism
  1 document  
Policy Type
Response to consultation
Date
2018-02-13
Topics
Ethics and medical professionalism
Text
The Canadian Medical Association (CMA) is pleased to provide input on the proposed regulations of the federal monitoring of Medical Assistance in Dying in Canada. The CMA fully supports the proposed intent of the regulations, in particular, public accountability and transparency and safeguards for vulnerable patient populations. Tracking trends and carrying out research is very important to monitor the implementation and implications of medical assistance in dying. The CMA further supports the intent to provide electronic reporting and guidance documents, and to leverage any synergies between the federal and provincial/territorial governments, especially to prevent duplication and to promote consistency in reporting across the country. The CMA would like to raise the following critical areas for your consideration: 1. Definitions/parameters of terms There continues to be a need to more clearly define several terms to ensure consistency of reporting. For example: a. Who constitutes a “practitioner”? One can argue that there is a broad scope of who is “a medical practitioner or nurse practitioner”. Is it the practitioner who provides MAiD? Or he practitioner who first reads a patient’s request for MAiD? Or is the first practitioner? Or second practitioner who assesses the patient? b. What constitutes a therapeutic relationship (as one of the eight proposed items to be collected about the practitioner)? A therapeutic relationship is not required to access MAiD. This criterion should be removed and if not, given the differences in opinion in the health professions as to what constitutes a therapeutic relationship includes, it should be clearly defined. c. What constitutes a request, a written request, the receipt of a request? If reporting obligations are “triggered” by a patient’s “written request”, at what point is that request actually triggered? The very first practitioner who receives the patient’s written request? Or the practitioner who conducts the eligibility assessment upon receipt of the written request? Or the practitioner who provides the prescription or carries out the procedure? d. On a related point, without clear definitions, any future comparative analysis of research or trends will be difficult as there will be no common starting point. e. There continues to be confusion on how to count or when to start counting the required 10 clear days. There are many reasons why this requires more clarity. 2. Collection and protection of data We applaud Health Canada for further reducing and revising data requirements. We submit, however, that further reductions are required for several reasons, including adherence to privacy best practices that require the collection of the least amount of data necessary to achieve reasonable purposes. In particular: a. In view of the quantity and highly personal and sensitive data that will be collected about patients and practitioners, data sharing agreements should be required; for example, agreements between the federal government and provincial/territorial governments or between researchers and others requesting use of the data to facilitate the appropriate sharing of data. b. Collection of personal information should be limited to what is relevant to the purpose of monitoring medical assistance in dying. Personal information, such as the patient’s full postal code, marital status, or principal occupation is beyond the scope of the eligibility criteria outlined in the legislation and thus beyond the scope of the purpose of monitoring the impact of the legislation. c. Any “characteristics” of the patient should refer only to the eligibility criteria. If other data will be collected beyond that scope, the justification for doing so, and the characteristics themselves, should be clearly outlined. d. The scope of the information collected about the practitioner could be narrowed. As is, it is very broad – a list of eight items – while the Quebec regulations, as a comparator, have only three-four items that must be collected in relation to the physician who administers MAiD. 3. Additional requirements Schedule 4 [section 2(i)] of the proposed regulations requires that the practitioner opine as to whether the patient met, or did not meet, all of the eligibility criteria outlined in the legislation – with two significantly expanded requirements; the requirements that the practitioner: 1) provide an estimate as to the amount of time MAiD shortened the patient’s life; and 2) indicate the anticipated likely cause of natural death of the patient. These additional requirements are beyond the letter and spirit of the legislation and, in many ways, are in direct contradiction to the legislation. The Legislature was not unaware when it drafted the Act that it did not follow other jurisdictions’ criteria requiring either a terminal illness or a prognosis of time within which the practitioner believed the patient would die, e.g., “within the next 6 months”. It is specifically the lack of a timeframe that makes the legislation unique and provides flexibility for both patients and practitioners. By adding these two additional criteria for reporting, in effect, they become additional criteria for eligibility which is, as stated above, beyond the scope, and in contradiction to, the legislation. 4. Lack of clarity of reasons for ineligibility There is a potential for misunderstanding as to whether reasons are required when the patient does not meet the criteria under Schedule 4, section 2(a) – (h). The introduction to section 2 speaks to the practitioner giving an indication as to (a) whether the patient met or (b) did not meet the criteria. However, in the itemized criteria [2(a)-(h)] it only speaks to the practitioner having to provide reasons when the patient meets the criteria (and not when the patient has not met the criteria). It would be helpful to specify that reasons should be required when the patient does and does not meet the criteria. This is also crucial for the publication of the Minister of Health’s annual report requiring that the reasons, and which eligibility criteria were not met, be addressed. Conclusion The CMA recognizes the importance of regulations to capture the provision, collection, use, and disposal of information for the purpose of monitoring MAiD. The CMA cautions against introducing reporting requirements that are beyond the scope of the legislation. As noted in the legislation, practitioners who fail to provide information under the regulations may be found guilty under the Criminal Code and subject to possible imprisonment. It is thus imperative that the federal government drafts clear regulations that respect the legislation, privacy, research ethics, and a de minimus approach. .
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Organ and tissue donation and transplantation

https://policybase.cma.ca/en/permalink/policy14126
Date
2019-12-07
Topics
Ethics and medical professionalism
Health care and patient safety
  2 documents  
Policy Type
Policy document
Date
2019-12-07
Replaces
Organ and tissue donation and transplantation (update 2015)
Topics
Ethics and medical professionalism
Health care and patient safety
Text
Organ and Tissue Donation and Transplantation (OTDT) is a rapidly changing area of medical science and practice. Organ and tissue transplantations represent significant lifesaving and life-enhancing interventions that require careful consideration by multiple stakeholders spanning medical disciplines. Technological and pharmacological advancements have made organ and tissue transplantation increasingly viable for treating related medical conditions. Changing social norms have also led to shifting perceptions of the acceptability of organ and tissue donation. Within this context, there is a need for renewed consideration of the ethical issues and principles guiding organ and tissue donation and transplantation in Canada. The overarching principle that guides OTDT is public trust, which requires that the expressed intent either for or against donation will be honoured and respected within the donation and medical systems, and that the best interests of the potential donor are always of paramount importance; policies and mechanisms that guide OTDT should aim to maintain and foster that public trust. The CMA acknowledges and respects the diverse viewpoints, backgrounds, and religious views of physicians and patients and therefore encourages physicians to confront challenges raised by OTDT in a way that is consistent with both standards of medical ethics and patients’ values and beliefs. SCOPE This policy identifies foundational principles to address the challenges surrounding deceased and living donation. In conjunction with applicable laws and regulations in Canada, the Declaration of Istanbul, the World Health Organization (WHO) Guiding Principles on Human Cell, Tissue and Organ Transplantation, and leading clinical practices this policy aims to inform physicians and other interested parties on the guiding principles of OTDT in Canada. This policy is intended to address OTDT in adult populations; the challenges, considerations, legislation, and policy surrounding pediatric and neonatal OTDT are unique and deserve focused attention. Physicians should be aware of relevant legislation, regulatory requirements, and policies in the jurisdiction in which they practice. Physicians are encouraged to refer to the various Canadian specialty societies that deal directly with OTDT for up-to-date information and policy, as well as innovative techniques and approaches. GUIDING PRINCIPLES The practice of OTDT is of great value to patients and society. The CMA supports the continued development of greater capacity, efficiency, and accessibility in OTDT systems in co-ordination with comprehensive and compassionate end-of-life care for Canadians while acknowledging the importance of justice, informed consent, beneficence, and confidentiality to this practice. 1. JUSTICE There is a continuous need to improve the efficiency and effectiveness of OTDT in an effort to narrow the gap between demand and supply in what remains a scarce, lifesaving resource. The principle of justice should continue to guide the equitable allocation of organs and tissues in a manner that is externally justifiable, open to public scrutiny, and balances considerations of fairness (e.g., medical need or length of time on the wait-list) with medical utility (e.g., transplantation success). There should be no discrimination based on social status or perceived social worth. Lifestyle or behavioral factors should only be considered when clear evidence indicates that those factors will impact the medical probability of success. OTDT should also not rely on the patient’s ability to pay; such actions are inconsistent with the principles that underlie Canada’s publicly-funded health system. Of note, living donation to a loved one or acquaintance (via a directed donation) is regarded as ethically acceptable if potential donors are informed of all options, including that of donating in a non-directed fashion. All levels of government should continue to support initiatives to improve the OTDT system, raise public awareness through education and outreach campaigns, and fund ongoing research, such that any Canadian who may wish to donate their tissues or organs are given every reasonable opportunity to do so. Potential donor identification and referral, while legislated in many jurisdictions, is an important area of continued development as failure to identify donors deprives families of the opportunity to donate and deprives patients of potential transplants. To diminish inequities in the rates of organ donation between jurisdictions, federal and provincial governments should engage in consultations with a view to implementing a coordinated, national strategy on OTDT that provides consistency and clarity on medical and legal standards of informed consent and determination of death, and institutes access to emerging best practices that support physicians, providers, and patients. Efforts should be made to ensure adequate engagement with potential donors from communities that have historically had lower living donor rates to help reduce inequities in access to living donation. Policymakers should also continue to explore and appraise the evidence on policy interventions to improve the rates of organ donation in Canada – for example, see a brief overview of opt-in vs. opt-out donation systems in the background to this policy. 2. INFORMED CONSENT AND VOLUNTARINESS Organ and tissue donation must always be an autonomous decision, free of undue pressure or coercion. By law, the potential organ donor, or their substitute decision-maker, must provide informed consent. Physicians should direct patients to appropriate resources if that patient has expressed interest to become a donor after their death. If a potential donor has not made an expression of intent for or against donation, substitute decision-makers, families, or loved ones may be approached to provide authorization for donation. It should also be noted that consent indicates a willingness to donate, but that donation itself hinges on factors such as medical suitability and timing. End-of-life decisions must be guided by an individual's values and religious or philosophical beliefs of what it means to have a meaningful life and death. The autonomy of an individual should always be respected regarding their wish, intent, or registered commitment to become a donor after death. Input from family and loved-ones should always be considered in the context of the potential donor’s wishes or commitments – these situations must be handled on a case-by-case basis with respect for cultural and religious views while maintaining the autonomously expressed wishes of the potential donor. Physicians should make every reasonable effort to be aware and considerate of the cultural and religious views of their patients as they pertain to OTDT. Likewise, Canadian medical schools, relevant subspecialties, and institutions should provide training and continuing professional development opportunities on OTDT, including both medicolegal implications and cultural competency. To protect the voluntariness of the potential donor’s decision, public appeals to encourage altruistic donation should not seek to compensate potential donors through payment and should not subvert established systems of organ allocation. Any exploitation or coercion of a potential donor must be avoided. However, remuneration from officially sanctioned sources for the purpose of reimbursement of costs associated with living donation (e.g., transfer to another location or lost wages during the procedure), may be considered when no party profits financially from the exchange. The CMA supports proposed amendments to the Criminal Code and the Immigration and Refugee Protection Act that criminalizes or otherwise seeks to prevent the coercive collection and transplantation of organs domestically and internationally (i.e., organ trafficking – see relevant guidelines on trafficking ). The CMA also discourages Canadians from participating in organ tourism as either a recipient or donor; physicians should not take part in transplantation procedures where it is reasonable to suspect that organs have been obtained without the donor’s informed consent or where the donor received payment (from WHO Guiding Principle 7); however, in accordance with physicians’ commitment to the well-being of the patient and the professional responsibilities relating to the patient-physician relationship in the CMA Code of Ethics and Professionalism, physicians have an obligation to treat a post-tranplant patient if requested after the patient has participated in organ tourism; physicians should be aware of any legal or regulatory obligations they may have to report a patient’s organ tourism to national authorities, taking into consideration their duties of privacy and confidentiality to the patient. , 3. BALANCING BENEFICENCE AND NON-MALEFICENCE Balancing beneficence and non-maleficence means to: Consider first the well-being of the patient; always act to benefit and promote the good of the patient; provide appropriate care and management across the care continuum; take all reasonable steps to prevent or minimize harm to the patient; disclose to the patient if there is a risk of harm or if harm occurs; recognize the balance of potential benefits and harms associated with any medical act; and act to bring about a positive balance of benefits over harms. Deceased Donation Prospective donors can benefit from the knowledge that they can potentially save lives after their own deaths. However, potential donors must not be harmed by the act of donating. In accordance with the Dead Donor Rule, organ or tissue procurement should never be the cause of death. Moreover, the care of the dying patient must never be compromised by the desire to protect organs for donation or expedite death to allow timely organ retrieval. Physicians determining that a potential donor has died should not be directly involved in tissue or organ removal from the donor or subsequent transplantation procedures, nor should they be responsible for the care of any intended recipients of such tissues and organs (from WHO Guiding Principle 2). Leading clinical criteria, in conjunction with legally prescribed definitions of death and procedures, should inform the determination of death before donation procedures are initiated. DCD should be practiced in compliance with the regulations of individual transplant centers, relevant legislation, and leading Canadian clinical guidelines including the national recommendations for donation after cardiocirculatory death in Canada and the guidelines for the withdrawal of life-sustaining measures. Patients undergoing medical assistance in dying (MAiD) may also be eligible for organ and tissue donation – see relevant policy guidelines. Living Donation Living donors are motivated to act primarily for the benefit of the recipient. The perceived acceptability of living donation varies from person to person; living donation is deemed to be ethically acceptable when the potential benefits outweigh the potential risks of living donation; living donation is not ethically acceptable where there is a material risk of death of the donor; living donors must provide informed consent, meet medical and psychological requirements, and receive appropriate follow-up care. It is not necessary for the potential donor to be biologically or emotionally related to the recipient. 4. CONFIDENTIALITY AND PRIVACY Current practice protects the privacy of both donor and recipient and does not allow donation teams, organ donation organizations, or transplant teams to inform either party of the other’s identity. The continuation of this practice is encouraged at the present time to protect the privacy of both donors and recipients. In addition, healthcare providers should consider the privacy and confidentiality implications of practices employed throughout the assessment and post-operative periods – patient consent should be obtained for practices involving any loss of privacy or confidentiality (e.g. group education sessions, etc.). Deceased Donation A person’s choice about whether or not they intend to donate organs and tissues after their death is individual and, like other health-related information, should be considered private. The right to privacy regarding personal health information extends beyond the declaration of death. Living Donation Whenever possible, potential donor and recipients should be cared for and evaluated by separate medical teams. In the case of non-directed donations, it may be necessary for information to be shared between donor and recipient teams (e.g. recipient’s underlying disease and risk for recurrence); however, such information should be limited to what is necessary for making an informed choice. Conversely, the CMA recognizes that the choice and process of directed donation is one that is deeply personal, which is likely to result in the intersection of both donor and recipient pathways of care. In such cases, the same onus of confidentiality may not apply given the choices of the donor and recipient involved. Approved by the CMA Board of Directors December 2019
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