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.
GUIDING PRINCIPLES FOR PHYSICIAN ELECTRONIC MEDICAL RECORDS (EMR) ADOPTION IN AMBULATORY CLINICAL PRACTICE
The following principles outline what is important to physicians and why as they make the decision to adopt electronic medical record systems (EMRs) in ambulatory clinical practice.
Physician adoption of the EMR has the potential to transform patient care and the quality of health statistics and health research in Canada, as long as the right conditions are met and the guiding principles outlined here are adhered to. Adoption of EMRs in clinical ambulatory practices will lead to significant improvements in data comprehensiveness, clinical relevance and quality — and this, in turn, will lead to improved clinical decision support, core data sets and health statistics that meet the primary goal of enhancing health care delivery, treatment and outcomes.
Privacy. A physician’s ethical and legal responsibility as data steward of the patient’s medical information must be protected and enhanced.1
Choice. There must be appropriate independence of choice that respects physicians’ professional and business autonomy. Physicians must be free to choose the EMR product that best meets the needs of their practice model, type and size.
Voluntary. Physician adoption of EMRs must be voluntary, not mandated or coerced.
Non-discriminatory. Programs designed to offset physicians’ costs or encourage them to adopt EMRs must be non-discriminatory (i.e., not tied to a single EMR product or health care practice model). While such restrictions may be attractive to some payors and administrators, they discriminate against physicians who do not meet their criteria and risk creating two “classes” of physicians and patients.
Outcome-related incentives. Incentives for EMR adoption should be tied to clinical benefits and outcomes, not driven by cost containment. Financial incentives or bonuses that are tied to clinical outcomes may encourage EMR utilization and optimize the use of these systems in ambulatory clinical practices.
1 For more detail on the physician’s ethical responsibilities as data steward of patient information please refer to the CMA Code of Ethics and Professionalism, Guiding Principles for the Optimal Use of Data Analytics by Physicians at the Point of Care, and Guiding Principles for Physicians Recommending Mobile Health Applications to Patients.
Unrestricted. Funding for EMRs in physician offices must be equally available to all physicians, and not restricted to a single EMR product or physician practice model.
Funding. Cost analyses have determined that the majority of the benefits from EMRs accrue to the health care system (i.e., payors and patients) and not to individual physicians. It is only reasonable that those who benefit most should assume the costs.
Comprehensive. The cost of implementing an EMR system goes beyond acquisition of hardware and software. Funding for physician adoption of EMRs must be comprehensive and include costs associated with the initial purchase, as well as implementation, change management, ongoing operation, and evergreening of the system.
Save harmless. Early adoptors who need to update or replace their existing systems, as well as physicians whose EMR vendor goes out of business, must not be disadvantaged. These physicians must not be penalized or excluded from funding programs, and should be provided with the necessary transition support.
Vendor sustainability. Vendor stability is critical to EMR adoption by physicians. This can be achieved through vendor compliance with technical and business requirements that address fiscal sustainability as well as EMR product quality, technical standards and capabilities.
Due diligence. Because physician practices vary in type, size and needs, there is no “one-size-fits-all” EMR solution. Physicians must assess the needs of their individual practice to determine the best product.
Workflow re-engineering. Implementation of EMRs in ambulatory clinical practice may require workflow adjustment or re-engineering. Assessments of workflow and practice needs must be part of EMR change management programs.
HR impact. Adoption of EMRs in ambulatory clinical practices will have an impact on human resources. Provision should be made for physician and office staff retraining, retention and turnover.
Support and service agreements. Physician use of EMRs in ambulatory clinical practice requires appropriate support and service agreements not only to provide the necessary infrastructure and connectivity, but also to guarantee ongoing, accessible and reliable technical support. Physicians must be able to access patient records in their EMR system at all times, regardless of where the records are physically stored (e.g., off-site with an alternate service provider, or onsite in a local client server).
Risk management strategies (liability and insurance) tied to EMR adoption must address the privacy, security, business continuity and professional liability requirements of physician practice in an electronic environment.
Change management and transition
Critical to success. To fully realize the benefits from EMR adoption, the move from paper to electronic records requires change management support and services geared specifically to physician EMR adoption.
Ongoing. Change management is a key success factor in driving both uptake and optimal utilization of EMRs in ambulatory clinical practice. To realize the full benefits of EMR adoption on health care outcomes, physician change management programs must be ongoing, not one-time.
Comprehensive. Comprehensive change management for physicians who adopt EMRs must include the tools and services to assist with system needs assessment, EMR selection, implementation, workflow adjustment, and training for physicians and staff, as well as suggestions to maximize use of the EMR.
Physician driven and designed. Change management must meet the real and individual needs of physicians as they move to an EMR-based practice. This requires flexibility (not one-size-fits-all), “just in time” capacity and delivery, and a mechanism for evaluating the program.
Payor funded and delivered. Delivery and costs of these programs should be borne by payors as part of any physician EMR funding programs or agreements.
Usability and human factors
User interface and usability. User interface and usability of EMR systems are critical success factors for physician acceptance and optimal utilization of EMRs in clinical practice.
Workflow. EMR adoption requires changes to physician workflow, such as history-taking and charting. Done properly, workflow changes related to EMRs should result in administrative efficiencies and improved clinical outcomes.
Core principles of practice must be respected. The EMR must allow the physician to practice comprehensive care, efficiently manage patients with multiple problems and respect the doctor-patient relationship where the patient’s values, wishes, advance directives and physical and social function are integral to medical care.
Training and education. Training in the use, benefits, shortcomings and opportunities of an EMR must become part of the medical education curricula in all stages of physician practice: undergraduate, postgraduate and continuing medical education.
Standardized data. Large data sets that record every observation are unworkable in practice. The EMR must allow the physician to record and access data in a standardized way.
Data quality. Data quality is critical to patient care. Physicians require access to accurate, clinically relevant data. Inaccurately recorded and unfiltered data does not benefit patient care.
Clinical patient care
Management of patient records. EMR systems allow physicians to quickly access and manage patient data in an organized fashion (e.g., search, sort and retrieve data, spot trends, or flag charts). This leads to more efficient practices and enhances care delivery.
Referrals and patient summaries. The ability to transmit referral requests and reports electronically using an EMR greatly facilitates the consultation process. Core clinical data sets generated from the EMR can be used to share or hand off patient care among providers, facilitating both continuity of care and emergency access to relevant data.
Drugs and lab reports. Physician use of an EMR permits drug and lab data to be recorded and shared more accurately and efficiently. Benefits to patient care include automated prescription renewals, quick identification of patients affected by drug alerts, and collation of lab data to show trends.
Decision support. EMR adoption in ambulatory clinical practice makes clinical decision support (i.e., access to timely, appropriate, evidence-based information) possible at the point of care. This has the potential to enhance patient safety, care delivery and health outcomes.
Patient values and autonomy. Patient values and autonomy cannot become secondary to the "data management" requirements of the EMR. An EMR must provide the same (or better) standards of patient confidentiality as traditional paper-based records.
Accessibility. Patient data must always be collected and stored in an EMR with the primary goal of improving individual patient care. Data accessibility for clinical care is more important than compiling a large common data set.
Standardized data. Primary care is driven by symptoms, not diagnoses, and both must be recorded in the EMR in a standardized way.
Clinical coding. Primary care disorders are low-prevalence and will require a high degree of precision when data are coded.
Evidence-based care models. The episode-of-care data model demonstrates how symptoms and symptom clusters evolve over time. It is possible to derive the sensitivity and specificity of symptoms and symptom clusters to improve pre-test likelihood and avoid unproductive testing.
Core and aggregate data. Standardized data means that core data sets can be combined, and their aggregation allows identification and analysis of rarer conditions.
Principles concerning physician information (CMA policy – approved June 2002)
In an environment in which the capacity to capture, link and transmit information is growing and the need for fuller accountability is being created, the demand for physician information, and the number of people and organizations seeking to collect it, is increasing.
Physician information, that is, information that includes personal health information about and information that relates or may relate to the professional activity of an identifiable physician or group of physicians, is valuable for a variety of purposes. The legitimacy and importance of these purposes varies a great deal, and therefore the rationale and rules related to the collection, use, access and disclosure of physician information also varies. The Canadian Medical Association (CMA) developed this policy to provide guiding principles to those who collect, use, have access to or disclose physician information. Such people are termed “custodians,” and they should be held publicly accountable. These principles complement and act in concert with the CMA Health Information Privacy Code (1), which holds patient health information sacrosanct.
Physicians have legitimate interests in what information about them is collected, on what authority, by whom and for what purposes it is collected, and what safeguards and controls are in place. These interests include privacy and the right to exercise some control over the information; protection from the possibility that information will cause unwarranted harm, either at the individual or the group level; and assurance that interpretation of the information is accurate and unbiased. These legitimate interests extend to information about physicians that has been rendered in non-identifiable or aggregate format (e.g., to protect against the possibility of individual physicians being identified or of physician groups being unjustly stigmatized). Information in these formats, however, may be less sensitive than information from which an individual physician can be readily identified and, therefore, may warrant less protection.
The purposes for the use of physician information may be more or less compelling. One compelling use is related to the fact that physicians, as members of a self-regulating profession, are professionally accountable to their patients, their profession and society. Physicians support this professional accountability purpose through the legislated mandate of their regulatory colleges. Physicians also recognize the importance of peer review in the context of professional development and maintenance of competence.
The CMA supports the collection, use, access and disclosure of physician information subject to the conditions outlined below.
Purpose(s): The purpose(s) for the collection of physician information, and any other purpose(s) for which physician information may be subsequently used, accessed or disclosed, should be precisely specified at or before the collection. There should be a reasonable expectation that the information will achieve the stated purpose(s). The policy does not prevent the use of information for purposes that were not intended and not reasonably anticipated if principles 3 and 4 of this policy are met.
Consent: As a rule, information should be collected directly from the physician. Subject to principle 4, consent should be sought from the physician for the collection, use, access or disclosure of physician information. The physician should be informed about all intended and anticipated uses, accesses or disclosures of the information.
Conditions for collection, use, access and disclosure: The information should:
be limited to the minimum necessary to carry out the stated purpose(s),
be in the least intrusive format required for the stated purpose(s), and its collection, use, access and disclosure should not infringe on the physician’s duty of confidentiality with respect to that information.
Use of information without consent: There may be justification for the collection, use, access or disclosure of physician information without the physician’s consent if, in addition to the conditions in principle 3 being met, the custodian publicly demonstrates with respect to the purpose(s), generically construed, that:
the stated purpose(s) could not be met or would be seriously compromised if consent were required,
the stated purpose(s) is(are) of sufficient importance that the public interest outweighs to a substantial degree the physician’s right to privacy and right of consent in a free and democratic society, and
that the collection, use, access or disclosure of physician information with respect to the stated purpose(s) always ensures justice and fairness to the physician by being consistent with principle 6 of this policy.
Physician’s access to his or her own information: Physicians have a right to view and ensure, in a timely manner, the accuracy of the information collected about them. This principle does not apply if there is reason to believe that the disclosure to the physician will cause substantial adverse effect to others. The onus is on the custodian to justify a denial of access.
6. Information quality and interpretation: Custodians must take reasonable steps to ensure that the information they collect, use, gain access to or disclose is accurate, complete and correct. Custodians must use valid and reliable collection methods and, as appropriate, involve physicians to interpret the information; these physicians must have practice characteristics and credentials similar to those of the physician whose information is being interpreted.
7. Security: Physical and human safeguards must exist to ensure the integrity and reliability of physician information and to protect against unauthorized collection, use, access or disclosure of physician information.
8. Retention and destruction: Physician information should be retained only for the length of time necessary to fulfill the specified purpose(s), after which time it should be destroyed.
9. Inquiries and complaints: Custodians must have in place a process whereby inquiries and complaints can be received, processed and adjudicated in a fair and timely way. The complaint process, including how to initiate a complaint, must be made known to physicians.
10. Openness and transparency: Custodians must have transparent and explicit record-keeping or database management policies, practices and systems that are open to public scrutiny, including the purpose(s) for the collection, use, access and disclosure of physician information. The existence of any physician information record-keeping systems or database systems must be made known and available upon request to physicians.
11. Accountability: Custodians of physician information must ensure that they have proper authority and mandate to collect, use, gain access to or disclose physician information. Custodians must have policies and procedures in place that give effect to the principles in this document. Custodians must have a designated person who is responsible for monitoring practices and ensuring compliance with the policies and procedures.
(1) Canadian Medical Association. Health Information Privacy Code. CMAJ 1998;159(8):997-1016.