The Canadian Medical Association (CMA) is pleased to make submissions on Bill S-4. CMA has followed the history of PIPEDA and participated in the studies of various Standing Committees, most notably and recently in 2007 to the House of Commons Standing Committee on Access to Information, Privacy and Ethics. CMA is pleased that amendments to PIPEDA are once again being considered.
The Canadian Medical Association represents over 80,000 physicians in Canada. Privacy is an important value to physicians and the patients to whom they serve. This is reflected in our Code of Ethics and policies, in particular, Principles for the Protection of Patients' Personal Health Information and Statement of Principles: The Sale and Use of Data on Individual Physicians' Prescribing. Physicians are also required to abide by privacy and confidentiality standards of practice. Thus, the CMA has a strong interest and valuable insights into the topic of personal information and privacy with respect to health information.
We thank the Standing Committee for the opportunity to comment on the proposed amendments to PIPEDA. Our key comments are outlined below:
CMA supports the existing legislative framework on the collection, use and disclosure of personal information produced by an individual in the course of their employment, business or profession ("work product") and suggests further amendments focus on strengthening it further.
CMA supports the current standing of work products, that work products are considered to be personal information. That is, we support the framework defining personal information as information about an identifiable individual and that there is no carved out definition or exemption for "work product".
CMA supports the position of the Office of Privacy Commissioner's following its 2007 investigation on work products, that they should not be exempted for two main reasons:
* The exemption is not needed, and it would be inconsistent with the balanced approach in the current definition of personal information. The current definition of personal information and the approach to deciding issues based on that definition have worked well. They have promoted a level of privacy protection that balances the right of privacy in personal information with the needs of organizations for the reasonable and appropriate collection, use and disclosure of personal information. ...Because the concept of "work product" is ambiguous, excluding it from the definition of personal information could have unpredictable consequences that would diminish privacy unnecessarily.
It is the CMA's position that work products should be considered personal information and given the section 7 amendments, work products should only be collected, used or disclosed without consent only if it is consistent with the purposes for which the information was produced.
In the case of physicians, a prime example of a physician's work product is prescribing information. Prescribing information is a synthesis of assessing patients - by probing into their health, familial, social and sometimes financial background - infused with medical knowledge, skill and competencies resulting in a diagnosis and treatment plan, which often includes prescribing a medication or test. Not only is the physician's prescribing information a product of physicians' work but would not exist but for a trusting physician-patient relationship wherein the patient's private and personal information are shared under circumstances of vulnerability and trust. The outcome is that this is personal information. Prescribing information is about an individual: it includes the name of the patient, the name of the prescribing physician, and the drug name, dosage, amount and frequency; giving major clues as to what the patient's health issue(s) are.
For further clarity, however, CMA recommends that physician information, and physician work products, should be specifically recognized within the legislation as personal information. To this end, we would propose that the following addition be made to the definition section under personal health information:
Section 2.(1) "personal health information", with respect to an individual, whether living or deceased, means .....(d) information that is collected or is the outcome of collecting information in the course of providing health services to the individual;
CMA supports the amendments to subsections 7(1)-(3) of the Act that any subsequent collection, use and disclosure of work products without consent must be related to the original purpose (of collection, use and disclosure). This relationship reflects the government's understanding and faithfulness to privacy principles. This is particularly critical when dealing with health information, and is even more critical in today's world given the ease of linking information through advancements in technology. In the absence of a causal relationship, personal information should not be used for system performance, commercial enterprise, data brokering, research, assessment or other purposes.
CMA recommends that the legislation should go further and allow persons who believe that protection cannot be afforded under the legislation that they have the authority to refuse to communicate the information. This is the conceptual approach taken in Quebec's Act Respecting the Protection of Personal Information in the Private Sector wherein persons have an opportunity to refuse that professional information (as defined therein) be used for commercial purposes. Physicians are constantly writing prescriptions and such information should only be used for other purposes in the interests of patients and the health care system, and not to serve commercial interests or marketing strategies. If physicians do not feel that such protection is afforded patients, then they should be permitted to refuse that such information be collected, used or disclosed. Patient privacy should be primary.
And finally, addressing work products in legislation clears up past differences of interpretation by Privacy Commissioners thus, providing certainty and clarity to the public.
That Section 2. (1) "personal health information", be amended to read as follows: "personal health information", with respect to an individual, whether living or deceased, means .....(d) information that is collected or is the outcome of collecting information in the course of providing health services to the individual;
CMA is pleased to see a section on breaches of security safeguards and recommends greater specificity.
As noted above, physicians have responsibilities as data stewards and custodians of health information. As such, CMA supports breach notification measures that would enhance and protect patient privacy. In principle, we support the proposed amendments of breach disclosures to the Privacy Commissioner, to individuals and to organizations.
However, CMA is concerned that meeting the requirements may be confusing. For example, in the health care context, it is easy to surmise that all health information is "sensitive". A far more difficult matter is determining whether the risk reaches the threshold of "significant harm" and the "probability" that the information "will be misused". The result being that incidental disclosures will be reported causing unnecessary concern and confusion in the patient population. Further specificity is recommended and we suggest something akin to Ontario's Personal Health Information Protection Act, 2004 (PHIPA).
The PHIPA is an act specifically dealing with personal health information. One of its purposes is "to establish rules for the collection, use and disclosure of personal health information about individuals that protect the confidentiality of that information and the privacy of individuals with respect to that information, while facilitating the effective provision of health care" (section 1a ). The PHIPA notification provision states that the individual shall be notified "...at the first reasonable opportunity if the information is stolen, lost or accessed by unauthorized persons", [section 12(2)]. CMA is unaware of any concerns with this approach.
The language of PIPIEDA is one of reasonable belief of real risk of significant harm to an individual. The issue is the test for required notification of patients for incidental inadvertent breaches and decreasing "notification fatigue". To illustrate the issue, if physicians were told today that patient data could be retrieved from the drums of discarded photocopiers and printers, it would be inappropriate for legislation to suggest that the entire patient population during the life of the photocopier or printer be notified. To this end, we recommend that there be acknowledgement that in some circumstances notification may not be required. The probability of misuse under PIPEDA is more ambiguous than the PHIPA test. Under PHIPA, the approach is more objective in that the data must be stolen, lost or accessed by unauthorized persons. To our knowledge, the Ontario model has been in place for almost a decade with no significant issues and thus we submit is one that works.
In other jurisdictions (eg., Newfoundland and Labrador, Nova Scotia, New Brunswick) with health privacy legislation, there is acknowledgement of trying to balance notification and those breaches unlikely to result in harm by directly indicating when notification is not required.
CMA recommends that the statute move towards a more objective test and acknowledge that there are situations when notice is not required.
CMA supports disclosure without consent under limited circumstances, but finds the current list of disclosures overly inclusive.
Health information is considered highly sensitive information and is initially collected for the purpose of individual patient health care. It should only be disclosed with consent and in only some exceptions without consent. The PIPEDA amendments for disclosure without consent have been broadened.
Privacy, confidentiality and trust are the foundations of the patient-physician relationship. Without these fundamental values in play, open and honest communications cannot occur and patients would not receive the care they require. Both the patient and the physician have significant investment in the relationship. CMA respects the requirements to disclose information without consent under certain premises, such as required by court order or statute. However, any kind of activity requiring physicians to disclose patient's information without consent for the purposes of advancing a government or institution's goal could jeopardize the relationship.
Both the patient's consent and the physician's consent should be required if there is potential to disturb this relationship. The physician is fiduciary of the relationship and is appropriately situated to assess and determine whether disclosure will disturb the relationship.
While CMA acknowledges that certain situations may require that disclosure occur without consent (eg. purposes of investigating fraud, national security, abuse or as legally required), disclosure for less malicious activities (e.g., breaches of an agreement, insurance claims) ought to require a court order or warrant. For example, under the proposed section 7(3)(d.1) if a physician were in default of a contract with a technology company supplying electronic medical record software or app to his/her clinic, the company could disclose health information without consent for the "purposes of investigating a breach of an agreement". While we appreciate that there is a caveat that disclosure without advising the patient can only occur if there is a reasonable expectation that the disclosure would compromise the investigation, we submit that leaving the determination of what is "reasonable" to an interested party to the breach is unfair to all. Another example, if a physician is a witness to a dispute between an employer and union representing an employee for denial of long term disability by an insurance company, and has filed a witness statement which includes a medical report he/she wrote to the employer's insurance company, under the proposed section 7(3)(e.1) disclosure of health information without consent is permitted in order to assess, process or settle an insurance claim.
CMA is concerned that the disclosure amendments are overly broad and do not differentiate sufficiently between highly time sensitive or grossly malicious situations, and those where it is merely expedient or an administrative encumbrance to seek consent.
In addition, the disclosure requirements are framed in permissive (ie., may) and not mandatory language (ie., shall). This is very problematic when the "organization" is a physicians' clinic unless the physician's own consent is made as a pre-condition. CMA believes this suggestion is a progressive one in keeping with the broadened disclosure amendments. Physicians are in a relationship of trust and take seriously the protection of patient privacy and confidentiality, for which they are trained and are ethically and legally required to protect.
To place physicians in a position which might entail breaching this trust may impact the confidence of the physician and the patient in the patient-physician relationship which is required to properly formulate appropriate treatment plans; thus, negatively impacting the health of Canadians.
That disclosures of health information without consent require a warrant or subpoena or court order. Furthermore, disclosures of health information require the physician's consent that in his/her opinion the disclosure does not harm the patient-physician relationship. And, finally any broadened disclosure situations be restricted to criminal activity or that impacting national security.
Once again, CMA appreciates the opportunity to provide comment as part of the committee's study of Bill S-4. CMA is prepared to work with Parliament, governments, health professionals and the public in ensuring legislative frameworks for the collection, usage and disclosure of personal information for legitimate and reasonable purposes.
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.
* 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.
* 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.
* 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.
* 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
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.
The Canadian Medical Association will work with the Canadian Life and Health Insurance Association to review insurance industry medical information requirements and ensure that the disclosure of personal health information is restricted to that which is reasonably necessary.
The Canadian Medical Association will work with the Canadian Life and Health Insurance Association to review insurance industry medical information requirements and ensure that the disclosure of personal health information is restricted to that which is reasonably necessary.
The Canadian Medical Association will work with the Canadian Life and Health Insurance Association to review insurance industry medical information requirements and ensure that the disclosure of personal health information is restricted to that which is reasonably necessary.
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
* 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
* 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).
* 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
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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
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.
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
See also CMA Policy on Principles for the Protection of Patient Privacy
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.
Vision for e-Prescribing: a joint statement by the Canadian Medical Association and the Canadian Pharmacists Association
By 2015, e-prescribing will be the means by which prescriptions are generated for Canadians.
e-Prescribing is the secure electronic creation and transmission of a prescription between an authorized prescriber and a patient's pharmacy of choice, using clinical Electronic Medical Record (EMR) and pharmacy management software.
Health Information Technology (HIT) is an enabler to support clinicians in the delivery of health care services to patients. The Canadian Medical Association (CMA) and the Canadian Pharmacists Association (CPhA) each have identified e-prescribing as a key tool to deliver better value to patients. The integration of HIT into clinics and health care facilities where physicians and pharmacists provide care is a priority for both associations1.
As part of its Health Care Transformation initiative, the CMA highlighted the need to accelerate the introduction of e-prescribing in Canada to make it the main method of prescribing. In its policy on optimal prescribing the CMA noted that one of the key elements was the introduction of electronic prescribing. The CPhA, as part of its Blueprint for Pharmacy Implementation Plan, highlights information and communication technology, which includes e-prescribing, as one of five priority areas.
We applaud the ongoing efforts of Canada Health Infoway, provinces and territories to establish Drug Information Systems (DIS) and the supporting infrastructure to enable e-prescribing. We urge governments to maintain e-prescribing as a priority and take additional measures to accelerate their investments in this area.
It is our joint position that e-prescribing will improve patient care and safety. e-Prescribing, when integrated with DIS, supports enhanced clinical decision-making, prescribing and medication management, and integrates additional information available at the point of care into the clinical workflow.
The following principles should guide our collective efforts to build e-prescribing capability in all jurisdictions:
* Patient confidentiality and security must be maintained
* Patient choice must be protected
* Clinicians must have access to best practice information and drug cost and formulary data
* Work processes must be streamlined and e-prescribing systems must be able to integrate with clinical and practice management software and DIS
* Guidelines must be in place for data sharing among health professionals and for any other use or disclosure of data
* The authenticity and accuracy of the prescription must be verifiable
* The process must prevent prescription forgeries and diversion
* Pan-Canadian standards must be set for electronic signatures
Benefits of e-Prescribing
A number of these benefits will be realized when e-prescribing is integrated with jurisdictional Drug Information Systems (DIS).
o Improves patient safety and overall quality of care
o Increases convenience for dispensing of new and refill prescriptions
o Supports collaborative, team-based care
o Supports a safer and more efficient method of prescribing and authorizing refills by replacing outdated phone, fax and paper-based prescriptions
o Eliminates re-transcription and decreases risk of errors and liability, as a prescription is written only once at the point-of-care
o Supports electronic communications between providers and reduces phone calls and call-backs to/from pharmacies for clarification
o Provides Warning and Alert systems at the point of prescribing, supporting clinician response to potential contraindications, drug interactions and allergies
o Facilitates informed decision-making by making medication history, drug, therapeutic, formulary and cost information available at the point of prescribing
* Health Care System:
o Improves efficiency and safety of prescribing, dispensing and monitoring of medication therapy
o Supports access to a common, comprehensive medication profile, enhancing clinical decision-making and patient adherence
o Increases cost-effective medication use, through improved evidence-based prescribing, formulary adherence, awareness of drug costs and medication management
o Improves reporting and drug use evaluation
While evidence of the value of e-prescribing is established in the literature, its existence has not fostered broad implementation and adoption. In Canada, there are a number of common and inter-related challenges to e-prescribing's implementation and adoption. These include:
* Improving access to relevant and complete information to support decision-making
* Increasing the level of the adoption of technology at the point of care
* Focusing on systems-based planning to ensure continuum-wide value
* Integrating e-prescribing into work processes to gain support from physicians, pharmacists and other prescribers
* Increasing leadership commitment to communicate the need for change, remove barriers and ensure progress
* Updating legislation and regulation to support e-prescribing
Enabling e-Prescribing in Canada
CMA and CPhA believe that we can achieve the vision that is set out in this document and address the aforementioned challenges by working collectively on five fronts:
* Health care leadership in all jurisdictions and clinical organizations must commit to make e-prescribing a reality by 2015
* Provinces and territories, with Canada Health Infoway, must complete the building blocks to support e-prescribing by increasing Electronic Medical Record (EMR) adoption at the point of care, finishing the work on the Drug Information Systems (DIS) in all jurisdictions and building the connectivity among the points of care and the DIS systems
* Pharmacist and medical organizations in conjunction with provinces, territories and Canada Health Infoway must identify clear benefits for clinicians (enhancing the effectiveness of care delivery and in efficiencies in changing workflows) to adopt e-prescribing and focus their efforts on achieving these benefits in the next three years
* Provinces, territories and regulatory organizations must create a policy/regulatory environment that supports e-prescribing which facilitates the role of clinicians in providing health care to their patients
* Provinces and territories must harmonize the business rules and e-health standards to simplify implementation and conformance by software vendors and allow more investment in innovation.
1 Health Care Transformation in Canada, Canadian Medical Association, June 2010; Blueprint for Pharmacy Implementation Plan, Canadian Pharmacists Association, September 2009