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Amendments to PIPEDA, Bill S-4

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

https://policybase.cma.ca/en/permalink/policy2007
Last Reviewed
2011-03-05
Date
2004-02-18
Topics
Ethics and medical professionalism
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2011-03-05
Date
2004-02-18
Topics
Ethics and medical professionalism
Text
My name is Dr. Eugene Bereza. I am a physician and clinical ethicist at McGill University Health Centre in Montreal and Chair of the Canadian Medical Association’s Committee on Ethics. I am accompanied today by Dr. Jeff Blackmer, our Director of Ethics. I am here today representing the CMA, but I would also like to advocate on behalf of those patients affected by infertility and those patients suffering, or who will suffer, from the myriad diseases for which medical science is searching out a cure. While there has been considerable debate over the past decade on the moral and ethical issues associated with assisted human reproduction, discussion of this as a health issue has been overlooked all to often. We must remember this is about the practice of medicine and above all, the health of Canadians. My remarks today will focus on the inappropriateness of using criminal sanctions to deal with medical and scientific activities. The Issue It is important to make it clear at the outset that the CMA does not oppose the prohibition of certain medical and scientific activities. Others here today are in a better position to address concerns regarding the specific prohibitions proposed under Bill C-6. Our issue is the means chosen to give effect to these prohibitions and their potential impact on the ability of a physician to ensure the welfare of his or her patients. Criminal law is a blunt instrument. As parliamentarians, you know how difficult it can be to change the law. For some activities prohibited under the criminal law, such as murder and theft, change is not an issue. However, the science of medicine evolves constantly, doubling every 18-24 months. Advances in science and medical practice, coupled with the difficulty of anticipating new developments, make it difficult to adjust the law to remove criminal prohibitions as science and society changes. In the context of prohibiting medical and scientific activities, it is the CMA’s position that the use of criminal law is inappropriate, as it would ultimately not serve our patient’s best interests. Prohibitions, specifically those listed as prohibited activities under Bill C-6, (formerly Bill C-13) could be secured through much less drastic means than criminalization. The CMA proposes that the determination of permissible activities, temporarily or for the longer-term, should be made by the proposed Regulatory Agency working with up-to-date scientific information while providing for public input and ethical review. The Regulatory Agency, as proposed in the Bill, would determine if and when changes in health and safety considerations, public attitudes and values might justify allowing certain formerly prohibited activities to take place under specific conditions. Questions to Consider Bill C-6 begins with the statement: “This enactment prohibits assisted reproduction procedures that are considered to be ethically unacceptable.” However, many Canadians, especially those who are infertile, do not consider some or all of these procedures to be ethically unacceptable nor do the many physicians charged with their care. The CMA questions whether criminal prohibitions are appropriate for dealing with activities about which there is considerable ethical disagreement among Canadians. Legislators in Canada have been justifiably reluctant to use criminal law to deal with medical and scientific issues such as abortion, withdrawal of life-sustaining treatment and the conduct of medical research. Why is an exception being made for assisted reproduction? What sort of precedent will this set for other controversial bioethical issues? What about the chilling effect criminalization will have on research in this important area? For the CMA, the most important question is: what about the patients? What about patients suffering from conditions for which research is banned but may lead to a cure? Should they be denied the opportunity to benefit from this research? Just as Bill C-6 unfairly targets patients, so too does the Bill’s penalties for infractions. Jail terms of up to 10 years and fines up to $500,000 will create a climate of fear and excessive caution for physicians and scientists working in this area. The chill created by these penalties will be such that scientists may well avoid any activity potentially covered by the bill even to the detriment of patient care. The CMA recognizes the good faith among parliamentarians in proposing statutory bans to prohibit certain activities. However, we are convinced in this case the potential for harm outweighs the potential benefits. There is a better way to prohibit these activities while still facilitating important research and necessary treatments. An Alternative Solution Instead of instituting criminal prohibitions within the legislation, the CMA suggest the Assisted Human Reproduction Agency of Canada manage procedures deemed permissible by moving the procedures listed under “Prohibited Activities” to “Controlled Activities.” We recommend that criminal sanctions apply to breaches of agency directives such as performing activities prohibited by the agency and performing controlled activities without a license. Such an approach would have the dual advantage of being able to both prohibit activities deemed unethical while still providing the flexibility to ensure legitimate medical and scientific progress in the treatment of infertility. The regulatory agency should be established as soon as possible and should build on the experience and expertise of existing assisted reproduction organizations and structures that deal with practice standards, education, certification and accreditation. Conclusion The CMA’s overriding concern in addressing this legislation is the well-being of patients, in this case patients who are infertile and patients afflicted by conditions for which medical research offers significant promise of treatment. We support government efforts to regulate assisted human reproduction and related activities, including the prohibition of certain practices temporarily or permanently where necessary. However, we do not believe that criminalization of medical and scientific activities named in the bill is an appropriate way to achieve those objectives. We believe we have advanced a workable alternative within the spirit of the Bill. Thank you.
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Review of the Personal Information Protection and Electronic Documents Act (PIPEDA) : CMA's Presentation to the House of Commons Standing Committee on Access to Information, Privacy and Ethics - December 13, 2006

https://policybase.cma.ca/en/permalink/policy8668
Last Reviewed
2019-03-03
Date
2006-12-13
Topics
Health care and patient safety
Health information and e-health
Ethics and medical professionalism
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2019-03-03
Date
2006-12-13
Topics
Health care and patient safety
Health information and e-health
Ethics and medical professionalism
Text
The Canadian Medical Association (CMA) is pleased to be here today to participate in your review of the Personal Information Protection and Electronic Documents Act, or PIPEDA. The CMA has had a long-standing interest in privacy-related matters, including enhancing measures to protect and promote the privacy of health information. We welcome the opportunity to share our policies and thoughts on these vital matters. As a pediatric oncologist from Winnipeg and Chair of the CMA's Committee on Ethics, I come here today with one bottom line: Physicians have always- and continue to - take their patients' privacy very seriously. This is the cornerstone of the special bond between patients and their doctor and has been thus since the time of Hippocrates. In recognition of the importance of privacy, the CMA has produced such documents as the CMA Code of Ethics and the CMA Health Information Privacy Code to guide our more than 64,000 members across the country. These documents existed before the federal government introduced PIPEDA. It is out of our concern for protecting and ensuring the privacy of medical information that we speak to you today. There are three specific areas which we would like to raise: 1) Recognition in law of the unique nature of health care; 2) Physician information as "work product"; and 3) Emerging Privacy and Health information issues. 1. Recognition in law of the unique nature of health care I would like to highlight the importance of recognizing in law the special circumstances of protecting health information. In fact, when PIPEDA was first being debated, CMA posed questions about the scope of the Act and was told that the legislation, originally designed for commerce and the private sector, would not capture health information. We were also told that even if it did, PIPEDA wouldn't change how we practiced medicine. The passing of PIPEDA generated enough concern and uncertainty that government agreed to delay its application to health for 3 years. For example, PIPEDA failed to clarify the issue of implied consent for the sharing of patient information between health professionals providing care. For example, when the family physicians says to a patient "I'm going to send you to see an oncologist to run some tests" and the patient agrees and follows that course of action, then clearly there is "consent" to the sharing of their health information with others. As an oncologist I assume there is consent to send the test results to other specialists that I may need to consult in order to advance the patient's care in a timely fashion. This, however, needed to be addressed before PIPEDA was applied to health care. The delayed application allowed the federal government and health care community to work together and develop a set of guidelines for how PIPEDA would be applied. The resulting PIPEDA Awareness Raising Tools, known as PARTs, contain a series of questions and answers that make up guidelines for health care providers. They answered many of our concerns, provided necessary definitions and allowed for the implied consent model to continue to be used within the circle of care. The CMA applauds the government for this collaborative effort and the resulting guidelines have been used by health care providers ever since. However, we remain concerned that the PARTs guidelines have no legal status. This limitation creates a degree of uncertainty that the CMA would like this legislative review to see addressed by ensuring the PARTs series of questions and answers are referenced in PIPEDA. In addition to participating in the PARTS initiative, since PIPEDA's implementation, the CMA has designed practical tools for physicians and patients: * adopted the CMA policy Principles Concerning Physician Information to address the importance of protecting the privacy of physician information; * produced Privacy in Practice: a handbook for Canadian physicians to help physicians maintain best practices in the protection of patient health information; and * created the PRIVACYWIZARD(tm) designed to help physicians record their current privacy practices, communicate these to patients and identify possible areas for enhancement. 2. Physician Practice Information as "Work Product" I referred earlier to CMA's Policy document on physician information. The CMA strongly believes that physicians have legitimate privacy concerns about the use by third parties of information - such as prescribing and other practice data for commercial purposes. Currently deemed "work product" this information can be collected, used and disclosed without consent. We feel PIPEDA inadequately protects this information. We recognize that it is information generated out of the patient-physician relationship. We disagreed with findings of the previous Privacy Commissioner that physician prescribing information is not subject to PIPEDA's privacy protection provisions for "personal information". The CMA has consistently advocated that physician prescribing data and other practice information is personal information and appeared as an intervener in a Federal Court review of this issue that was ultimately settled by the main parties. Also, insufficient regard for the privacy of prescribing and other physician data could have a negative impact on the sanctity of the physician-patient relationship. Patients confide highly sensitive information to physicians with the expectation this information will be kept in the strictest confidence. This expectation exists because they know that physicians are under ethical and regulatory dictates to safeguard their information and that physicians take this responsibilities very seriously. The perceived and indeed actual loss of control by physicians over information created in the patient encounter, such as prescribing data, could undermine the confidence and faith of our patients that we are able to safeguard their health information. This concern is not hypothetical. For physicians, so called "work product" information also encompasses practice patterns such as discharge rates, referral rates, billing patterns, hospital length of stays, complaints, peer review results, mortality and re-admittance rates. With the advent of electronic medical records and growth in pay-for-performance and outcome-based incentive programs for physicians, there is an enormous potential for the resulting physician "performance" data or "work product" to be "mined" by other parties and used to influence performance review (traditionally the purview of the medical licensing authorities) as well as decisions around treatment funding and system planning. The lack of transparency in the sale and compilation of physicians' prescribing and other performance data means that physicians might find themselves to be the unwitting subject and targets of marketing research. We believe practice decisions must be made in the best interest of patients and not the bottom-line interests of businesses and marketers. CMA therefore recommends a legislative change to include physician information as personal information under PIPEDA. Legislation in Quebec provides an example that is consistent with CMA's approach since it requires regulatory oversight and gives individuals the right to opt out of the collection, use and disclosure of "professional" information. 3. Emerging Privacy and Health information issues With budgetary and demographic pressures, our health care system is under strain and physicians are striving to deliver timely, quality care to patients, often with competing and multiple demands. Physicians are therefore seeking assurances from law makers that any amendments to PIPEDA will take into account the potential impact on them and their patients. Therefore, we seek assurances that: * health care is recognized as unique when it comes to the disclosure of personal information before the transfer of a business (one physician transferring his/her practice to another) because it is regulated at the provincial level through the appropriate licensing body. As a general rule, physicians must give notice to the public, whether via a newspaper ad or a notice in the office about the change in practice. * the federal government will consider the impact of the trans-border flow of personal information on telehealth and Electronic Health Record activities. Communications between patients and physicians via electronic means are likely to increase and to move across geographic boundaries with increasing frequency; and * the federal government will study the issue of international cross border data flows, particularly among Canadian researchers who receive funding from US drug companies. These arrangements should be governed by Canadian law (PIPEDA) not American (HIPAA or the US Patriot Act). In closing, the privacy protection of personal health information is a responsibility that my colleagues and I do not take lightly. It is a key pillar of our relationship with Canadians, they not only expect it-they deserve it. I look forward to taking questions from Committee members. Canadian Medical Association Ottawa, December 13, 2006
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