Canada: Personal Health Information - The Patient's File - Refresher 2011(2)

Previously published in Telehealth Law, June/July 2011 Volume 11, No. 4

As we see information systems in the healthcare setting mature and become more widely integrated, we believe that there is value in revisiting our understanding of record-keeping by healthcare professionals with respect to their patients. This involves understanding that information is different from the media on which it is stored or displayed, that healthcare delivery systems require portions of that information for efficient and effective operations, payors need access to portions of that information, governments and very large provider organizations require epidemiologic and "best practices" analyses of the information.

However, all of those system, efficiency, epidemiologic and best-practices interests must be balanced against the protection of the trust relationship between a patient and his or her physician which is based at least partially upon the patient's expectation that disclosures made to a physician during a healthcare encounter will remain confidential and will be used only to the patient's best interests as the patient conceives of those interests.

Implications for New Information Environments and New Care Paradigms

When we look at the changing informational environment, the how, where and why health information is collected, used, stored and distributed, the way that medical professionals are now organized and paid, the increasing specialization of caregivers and the increased number of professions involved in providing medical care (and using and collecting personal health information), the increased involvement of patients in the keeping and disclosing of their own health information, and the increasingly distributed medical testing and monitoring devices and resultant records, a number of questions arise, including:

• is the relationship between a patient and the medical provider system the same as it was when the relationship was between a patient and his or her physician? Does the interposition of a larger number of contact points between the patient and a whole constellation of healthcare providers modify the patient's expectation about how that patient's personal health information will be managed? Is the "system" a fiduciary in the same way that a single physician was a fiduciary or trustee for her patient?
• is it meaningful to the analysis of patients' relationships with physicians that increasingly, the primary care contact between a patient and the healthcare system takes place in an anonymous-seeming drop-in clinic or emergency room setting?
• is increased specialization within the physician population, increasingly managed by the patient and not a primary care "family doctor", causing multiple patient-caregiver relationships each of which might have a different expectation of patient confidentiality for the information that they interact with?
• will it matter that patient interaction with healthcare will increasingly involve precision medicine (machine diagnostic tests and images, genetic profiling, etc), remote monitoring and testing (and networked electronic reporting equipment and devices), and non-physician caregivers following "best practices" treatment protocols developed as "evidence- based medicine"?
• when patients engage with services over a public network (like the internet) which are provided by private corporations which are not caregivers, in order to manage the patient's health information, does that tell us anything about the reasonable expectations of the patient population about how personal health information will be managed?
• how are lock-box and similar "do not share" flagging systems working? Is the patient ever locked out of personal health information by default, or potentially locked out without ever being capable of finding that out? Are patient-requested locking flags effective or easily over-ridden? How are these aspects logged and audited?
• how do we weigh the net benefit of data-mining personal health information in terms of discovery of best-practices, epidemiological evidence of either disease or susceptibility to disease, "evidence-based" treatment protocols and standards of care, error-reduction (in things like prescription writing errors due to handwriting recognition error) against each individual patient's interest in confidentiality of sensitive personal health information and data privacy? What will our patient population expect is a reasonable balance? Does it change if we are looking for physician behaviors, errors and patterns or fraud-detection in billing or prescribing, or pattern recognition to detect or prevent patient compliance, non-compliance or system abuses?
• if a patient wishes to "look at his or her chart or file", what is it now possible to show them? Increasingly, the "chart" is a report built on-the-fly from what is essentially a customized query of a large database (or several) to provide a specific- purpose, edited report. In other words, there often is no chart! What is the extent of the provider's obligation to give the patient full access to the patient's health information? The answer to this question has consequences for providers' systems and human resources, and in current large-scale healthcare IT solutions, the question remains: has the patient been, to any significant extent, disenfranchised from free and full access to his or her own information?

How we deal with these and other interesting questions about patients' access and control over their own personal health information will depend upon how we choose to understand the legal analyses of our highest Courts, and how we interpret our information regulation regimes (see Chart for details of Canada's health information regulatory environment). However that shakes out, it is important to do the thinking and keep the logic and analysis open and transparent, so that different views are heard, changing landscapes and environments and needs are considered, and so that all parties' expectations can be understood and accommodated or adjusted as we learn.

Why Revisit This Topic Today?

While no new ground-breaking court decision has been rendered nor significant new legislation adopting a radically new approach proclaimed (see Chart), it is worth revisiting this topic today as there has been, and will likely continue to be, a widespread adoption within the healthcare provider community of large-scale information and communication infrastructures, installation and implementation at larger healthcare organizations (and within regions) of shared service networks dealing with personal health information (such as PACS, but also including large-scale integrated systems having to do with hospital, clinic, and regional delivery of both acute and chronic care services to patient populations). The next large-scale changes appear to be coming from two directions: the patient community is pulling care providers toward provision of electronic communications and records systems, and the primary care physician community is becoming or being motivated to adopt electronic systems in their medical practices.

Further, the pervasiveness of wired and wireless network access, the availability of computing power and large-scale storage, and the build-out of health-specific networks and storage infrastructure is changing the way patients, caregivers, policy-makers and regulators must conceive of the "patient record". Encounters are not discrete information events, there is no single source of truth which is even analogous to a paper file, the portrayal or display of a patient's health information is ephemeral and provided by ephemeral and summarized reports displaying only selected information accessed from a number (sometimes a large number) of disparate data types and sources by equipment that is not currently accessible by the patient without intervention by the information systems' masters.

In short, it is time to revisit and refresh due to a number of significant changes in the environment within which personal health information is collected, used, shared, stored and eventually disposed of.

Having said that, in addition to the purpose-built statutory regulatory schemes which attempt to deal with some of these new issues (see Chart), there is still a great deal of guidance provided by our courts. In Canada, that means that we should interpret the regulatory guidance and the obligations of healthcare providers with respect to patient information in light of our Supreme Court of Canada's analysis of the issue in the McInerney v. MacDonald case (discussed below), which has been adopted, applied, and approved by a large number of more recent cases, but remains the leading exposition of underlying principles and analysis.

Underlying Legal Theory of Ownership, Control, Right to Access

McInerney v. MacDonald, [1992] S.C.J. No. 57 The McInerney case arose because a patient's request that her physician provide her with copies of her medical file had been refused. The physician had agreed to provide all notes and reports the physician had prepared, but refused to provide copies of consultants' reports and records from other physicians the patient had seen in the past.

The refusal was predicated on the argument that full disclosure would be unethical since the balance of the patient's medical information was the "property" of the other physicians. Of note, even before the advent of pervasive and highly integrated shared data systems, there was a tendency to analyze "control" in terms of property rights and ownership — an analytical perspective that Canada's Supreme Court found unsatisfactory when dealing with personal health information.

Prior to reaching the Supreme Court, New Brunswick courts had ordered the physician to provide the patient with copies of the entire file. The Supreme Court of Canada dismissed the physician's appeal from those orders.

In McInerney, the Supreme Court of Canada noted the increasing importance and sensitivity of medical records due to increased physician specialization, increased patient mobility, increased referrals, the "army" of potential caregivers contributing to the care of a single patient and patients' needs to ensure the accuracy of their medical records. Due in part to increased dissemination of medical records to insurance companies, government payers, law enforcement, welfare departments, schools, researchers and employers, this case was important in recognizing concern about disclosure and accuracy of these records, well before the onset of purpose- built regulatory regimes protecting health information and providing protected ways of sharing information for patient care.

At the time (the facts took place in the 1980s), there was an absence of legislative guidance, although the Court's end result was consistent with a relevant Canadian Medical Association Policy.

The Supreme Court concluded that a fiduciary duty (meaning in part that the physician was in a position of trust and confidence and the patient was in a position of reliance and dependence) exists between patients and their own physicians. Physicians owe certain duties to patients including duties to act with the utmost good faith, loyalty, to hold the patient's Health Information in confidence and to make proper disclosure of the information to the patient.

There is a broad public interest in ensuring the confidentiality of the information entrusted by the patient to her doctor. Were it otherwise, the patient's healthcare may be compromised by her reluctance to be forthright and complete in discussing her health with her caregivers.

Additionally, physicians (and health care providers generally) are in the position of having more specialized knowledge and skill, and thus patients must rely upon the caregiver's good faith in seeking, collecting, and disclosing (and keeping) personal health information. As well, caregivers are very much more in control of, and knowledgeable about, the systems (including IT systems) engaged with respect to health information in patient interactions.

The health information shared by the patient was said to ultimately remain her own.

Generally, the duty to provide access to medical records is grounded in the nature of the patient's interest in receiving the information and having a type of proprietary interest in the contents of her own medical file (the information, but not necessarily the media). The Court said that, although a patient has these interests in the contents of her medical files (the "informational component") the physician owns the actual record or physical file.

However, the Court commented that the right to one's own Health Information is not absolute.

A physician may deny access to a medical file in those very rare situations where the physician reasonably believes that it would not be in the patient's best interest to receive a copy if, for example, there was a risk of potential injury to the patient or a third party. The onus will be heavily on the physician to justify any exception to the rule of disclosure.

Thus, the physician's role as fiduciary or trustee of the patient's informational well-being (as well as health care) comes into play, giving rise to these enhanced duties of good faith, loyalty, and care when dealing with a dependant patient's information.

Conclusion

As noted at the beginning of this article, the goal has been to provide a refresher about the control of patient records and the law in that regard, in Canada. The other goal was to point to some thinking that needs to be done as we deploy increasingly integrated information systems to serve a changing patient population with maturing informational expectations while assisting a changing population of physicians and other caregivers. The answers to the questions raised are not all obvious, but the problems are not intractable — we have a regulatory and legal framework within which to find those answers.

SIDE BAR: Statutory Regulation of Protection of Personal Health Information in Canada

The following table provides a summary of some of the various legislative regulatory regimes that may apply to the protection of personal health information in Canada. Please note that the table is not intended to provide a definitive list of regulatory regimes which could apply in every case. For example, other legislation may be involved where the relevant health information may cross borders, include mixed uses of such information (such as employment v. insurance v. medical uses of the same information), involve law enforcement, or give rise to mental health or public safety issues.

Please note that British Columbia now regulates health information primarily under its relatively new E-Health (Personal Health Information Access and Protection of Privacy) Act. Alberta's regulation of health information is primarily under its HIA legislation, with some activities falling under its PIPA. Ontario's regulation of health information is primarily under its PHIPA legislation. Some regimes treat health information at the large institutional level more like "government-controlled" databanks, while others deal more specifically with healthcare-specific data handling rules.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.