As Ontario ’s health budget closes in on $30 Billion while hospital deficits mount and hopes for a truly integrated health care system dwindle, the challenge lies not in crafting better laws to regulate the silos but rather to re-examine the conceptual frame of reference driving government policy.
Although both levels of government will continue in progressive states to acknowledge and uphold citizens’ rights to have health protected, it is increasingly a reality that the delimitation of the standards and conditions for such rights will be subject to a wide variety of constraints, some of which will be regarded as contentious and volatile of individual claims and entitlements. Whereas some commentators are prepared to couch arguments about the right to health as natural and absolute for all citizens, governments are not able to afford these rights in all circumstances.
The task of government is to guarantee as far as possible, access to health as fundamental to living in a democratic, socially responsive environment, while observing, based on principles of a fair-minded pragmatism, that it will be in the realistic setting of limitations that the threshold of health can best be protected for all citizens.
In practical terms, this means that certain curtailments unfamiliar to the normal practices of professionals will be-come the vehicle through which government can prove its social responsiveness. In return for such guarantees as subsidized education and no bad debts, professionals may, in discrete circumstances, be called upon to service populations whose needs are in jeopardy and whose level of reliance may be great.
Equally, institutions cannot effectively survive if their services are redundant and costly for limited populations. This is the case where these groups are in an unfair advantage because of urban locations of historical accident, or represent special interests within medicine; for example, where a particular disease has or was given priority because of a specific history such as a connection to an institution or projects of research. Government must take on the responsibility of setting the structures for allowing the diverse demands being made upon the public purse through being engaged as a broker of both interests and costs.
In the economic sector, government must quickly learn to experiment with contending models for the delivery of high quality services to the largest possible population at the least cost that can be made available in the marketplace. Whether a version of the HMO American model, or the tendering system of health costing and novel instruments of physician payment emergent in the U.K., various models of regional delivery systems, or creative contractual agreements amongst providers, Canada, like every other industrialized nation, will have to find its own justified moral authority through a painstaking process of experimentation and self-critique.
The main issue is how government will keep its social conscience in dealing in a marketplace which hitherto was not dictated by group conflict and issues of financial resiliency.
Due to the fact that governments and their allied institutions have reached a level of growth that may be in conflict with effective means of delivery, it is imperative that governments develop flexible arrangements with others in co-operative ventures that will achieve the collective needs of citizens. This does not mean that governments must retreat from the responsibility of surveillance and monitoring.
On the contrary, governments’ mandate in health means that governments should remain the conscience of the system while negotiating on an ongoing basis the best means of providing care from every point of view, including the management of professionals in the system. Needless to say, such a presence will inevitably lead to a host of difficulties. But any retreat from such responsibility would be for governments to lapse in one of their most important undertakings.
It is accepted throughout the industrialized nations that unprecedented demands are being made upon health care systems, throwing into strong debate the priorities and commitments made in times of unbridled fiscal spending. Given the global trends toward downsizing and streamlining services provided by governments of welfare states for their citizens in the postwar years, these strains upon institutions, and more particularly on individuals, have made it necessary for governments to approach the public with two goals in mind: firstly, to assess the limits of their capacity to deliver services in a manner deemed accountable to structural constraints that are now built into the reorganized budgets of leaner economies; and secondly, to ensure that the administration of available services is based upon public sensitivity to the health needs of dependent members of the community. With respect to the latter, it is a challenge to ensure that the procedures be equitably accessible and administered while achieving the preferred goal of efficiency.
There is no doubt that some sacrifices have become part of the necessity of governing, bringing to the fore questions about the proper role of government as a guardian of both individual and collective interests. But whereas in earlier decades such tensions were resolvable based upon the prowess of government to fulfill all needs simultaneously, such availability in recent years has fallen short of the mark of expectation. The balancing of a series of interests which can often be found in conflict among public representatives, bureaucrats, professional interest groups and consumers, has become in fact the mandate of health ministries throughout Canada and other like nation states.
The process of restructuring is the concretization of any governmental undertaking of accountability. However, once this commitment is made in principle, governments inevitably and intractably place themselves in a position of publicly exposing the hard and sometimes tragic choices which be-come visible and the subject of open and indeed oftentimes acrimonious dispute. Public policy in the sector of health care planning unfortunately cannot, and should not, given the economic realities that have imposed themselves on the reduction of size in the name of public interest, be made in a piecemeal and merely reactive fashion. This means that an overarching system of evaluation and delivery must be concretized in such a manner that a threshold of health care, reflective of wide-ranging community needs, is maintained and defended while simultaneously taking decisions that in certain circumstances may entail a cost-benefit analysis affecting minority interests, which seen apart from the general picture could be deemed unfair or discriminatory. In fact, it will be the reality of decision-making in health care that the earliest scales of efficiency, based upon clear public scrutiny and ongoing debate, will ultimately and more swiftly, if the process can be streamlined, protect incrementally the heaviest burdens proffered by a small minority of consumers.
It should not be forgotten that momentous changes were undertaken in health care systems, especially in the 1960s, that reflected progressive instincts that provided, for example in Canada, legendary standards of quality in health, including the utilization of state-of-art technology in all sectors. Since that time, the burgeoning of health technology and the rapidly escalating costs in the training of health professionals, coupled with a quantum leap in bureaucratic and advocacy costs mustered to defend and articulate consumer demands, have placed before governments a new set of realities for which they have become almost universally the subject of attack and critique. Therefore, governments must have the moral responsibility to put themselves under surveillance to systematically review the costs pertaining to every aspect of the health care system.
An assessment of component costs in some cases will lead to a dramatic revision of thinking, to a recharging of some institutions while directing the closure or amalgamation of others. Such massive revisions in the system will bring both direct and indirect costs, part of which will be the empowering of communitarian interests, attached to the hand of government, to be rationalized as a right of intervention in the private sphere. Specifically, this means entitling government to question the acts of institutions and citizens to use public resources in the name of individual rights. No government in the western world remains in a position to avoid these difficult areas of inquiry. In fact, confronting these questions may be seen as a preamble to the necessity of radical and effective change in health care.
It is through governments’ cautious utilization of its primary tools-funding and legislation-as both carrot and stick, that competing visions can be resolved in a drive towards a functional system for health care that is responsive to the needs of those who most require it as well as the demands of those desiring to access it for non-essential reasons. The latter should be expected to contribute to supplement governmental commitments, but only in an environment susceptible of proper accountability. To accomplish the foregoing, Ministries of Health must be structured in a manner responsive to a shared vision amongst both providers and consumers that recognizes a multi-disciplinary public delivery system supported, where appropriate, by a multiplicity of funding sources, both public and private. A failure to demonstrate courage now will result in the most serious dereliction of responsibility. Rather than attempting to legislate accountability in health care, governments should lead by example.
Provincial Health Ministers must demonstrate a willingness to tackle contentious issues or the federal government will continue to erode their jurisdiction as it has already demonstrated in such areas as privacy and the regulation of IVF clinics. The balance of this paper will examine in some detail how one government’s arguably inadvertent incursion into another’s domain can create significant impediments for health care delivery.
The Personal Information Protection and Electronic Documents Act (PIPEDA) regulates the collection, use and disclosure of personal information by organizations in the course of commercial activities and now applies to significant parts of the health system.
The legislation was prepared without specific and adequate consultation with the health care sector. For example, the health sector was not represented on the Technical Committee responsible for the Canada Standards Association’s Code ("CSA Code") for Protection of Personal Information, which is the basis for the Bill.
PIPEDA uses a consent-based system with very narrow exceptions that do not reflect how health care is delivered and managed. It creates problems in three key areas: health care delivery, planning and management of the health system and research.
Problems in health care delivery may be illustrated in the following example. A woman goes to her doctor about some symptoms she has been experiencing. Her physician sends a requisition and the patient’s blood and urine samples to a private medical laboratory for analysis. The legislation requires the lab to obtain consent from the woman, even though no direct contact is made between her and the lab. The lab might need to send the woman’s information to another lab for further analysis or verification of results. The legislation requires the lab to explain to her the likely uses and disclosures of the information and to obtain consents to such uses and disclosures. The explanation must occur at the time of collection, even before the health care is provided, or, if after collection, before use.
It is often difficult to obtain consents, to determine who consents for children and incapable adults and to respond to refusals to consent when services are still needed. In addition, PIPEDA does not identify who would be responsible for determining capacity to consent or for obtaining the consents and does not create a process for substitute decision making.
It is unacceptable to argue that implied consent could be relied upon or that one can obtain a blanket consent in advance. Consent in health care must be comprehensive and in the context of information, can only be truly informed if obtained after all the subject information to be disclosed has been compiled and disclosed to the person giving consent. Ontario recently attempted to address the issue of recognizing the need for information flow within the circle of care while supporting the consent principle through the definition of "knowledgeable consent." However, in an attempt to pay "lip service" to consent but in fact to dispense with it within the circle of care, the difinition of knowledgeable consent lacks the critical element of informed consent. Bill 31 also substantially alters the concept of mental capacity by removing the need to understand and appreciate the nature and consequences of the subject matter or essence of the information. These new definitions coupled with a reliance on implied consent and assumptions of consent significantly lessen consumer protection, particularly in regard to third party disclosures.
PIPEDA will impede the planning and management of the health system. Provincial Ministries or Departments of Health have broad responsibilities that are not limited to the programs and services that they fund. To fulfill this mandate and to improve public accountability, the Ministries and health planners with whom they work need to collect and analyze a broad range of health information to track and to determine the unmet and changing health care needs of the population. As well, information is required for utilization management, guideline development and quality management, to ensure that resources are used appropriately and cost effectively. In addition, information is necessary to detect and prevent fraud.
Some people may question why information needs to be in identifiable form for management purposes. When health system planners are unable to access and link information from diverse sources, their ability to address health system problems is severely limited. For planning and management purposes, it is necessary to differentiate individuals, e.g., to analyze patterns of services used by individual cancer patients, so that a connection can be made between services received by those individuals at different times. Once the data has been linked, the identifiers can be removed or encrypted.
PIPEDA would not advance these goals. The Bill has no provision permitting personal information collected for health care delivery to be used without consent for purposes of planning and management of the health system. There is not even a provision permitting use without consent for a "consistent purpose". This creates numerous difficulties. For example, there is great interest in knowing how hospitals perform. This data currently comes from the Canadian Institute of Health Information ("CIHI"). CIHI obtains identifiable patient data from hospitals under the provisions of, e.g., Ontario’s Public Hospitals Act. Without such data, issuing "report cards" on hospitals would not be possible. A similar availability of patient information is needed to obtain a comprehensive view of other parts of the health system. The consent requirements of PIPEDA will impede CIHI’s ability to collect comprehensive patient data.
Section 7(1) of PIPEDA does not permit the collection of personal information by a researcher without patient consent. Furthermore, ss. 7(2)(c) and 7(3)(f) do not allow use or disclosure of health information for research purposes without proof that it is "impracticable to obtain consent" and without informing the federal Privacy Commissioner of such a use or disclosure. Provincial legislation has long recognized the public interest served by research, permitting disclosure of health information without consent for research purposes. A consent model would result in less than complete data that could undermine the validity of the work.
There is even confusion as to the scope of PIPEDA. It applies to organizations that collect, use or disclose health information in the course of commercial activities. There continues to be uncertainty as to the impact that PIPEDA will have on the health system, those parts of the system to which the Bill applies and those parts not affected by it, a troubling situation given that it now applies to health care within provinces.
As an example, if a plastic surgeon removes a basal carcinoma from a patient’s cheek – a procedure covered by provincial health insurance plans – and at the same time removes a mole – a cosmetic procedure not so covered – does PIPEDA apply to the uninsured service provided by the physician?
Does this qualify as a "commercial activity"? In January 2000, at a Canadian Bar Association conference on Privacy, Raymond Doray, in his paper "Quebec ’s Personal Information Act: 5 Years of Compliance Experience and Expected Over-laps with the Federal Personal Information Protection and Electronic Documents Act," stated that:
Although according to a certain common law jurisprudence, professional services (lawyers, physicians, etc.) could have been considered not to be of a commercial nature, it is doubtful, in our view, that these services are excluded from the application of PIPEDA.
It thus appears to be a live issue as to whether physicians and other providers are subject to the application of PIPEDA.
Section 26(2) of PIPEDA provides that the Governor in Council may, by order, exempt an organization, activity or class from application of Part 1 of the Bill if it is "satisfied that legislation of a province that is substantially similar to this part applies." The designation of "substantially similar" is at the discretion of the federal government of the day. No criteria are set out as to what is meant by this term. The Honourable John Manley said that Quebec ’s Personal Information Act is substantially similar. No reasons were provided for this decision. Raymond Doray notes in his article that "in some respects, the federal legislation goes farther that the Quebec legislation and is more severe or demanding than the latter."
The implementation of the Canada Health Infoway and other such initiatives will become difficult to realize. There are several reasons for this, including the uncertainty of how the legislation will affect the national health system; the inflexible consent-based approach to the protection of personal health information; the lack of ability to collect, use and disclose such information without consent for the purposes of health and health care delivery; the inadequate rules for research; and the application of the legislation to cross-border transfers of health information.
In addition, initiatives such as the development of such provincial initiatives as smart systems for health, smart cards, primary care reform, Well-Net and SHIN, will be negatively impacted.
Some have suggested that the world has changed, somehow implying that the protections in provincial health sector legislation are no longer sufficient. Their position ignores the reality of the operation of the health care system. Often greater protection and security mechanisms can be created from within that system rather than through the inflexible approach taken in laws such as PIPEDA. The application of this legislation could lead to serious medical errors resulting from providers having inadequate information unless they defy the law.
Under PIPEDA and without sector specific health information legislation reflective of the needs of the health care system, independent health networks will continue to proliferate, wasting resources, further entrenching fragmentation and escalating management costs.
Communication between networks will continue to be problematic because of technical incompatibility. Confidentiality of personal health information will continue to be compromised because of inadequate security in some networks.
A consequence of such legislation will be to retard initiatives for the development and implementation of new technologies and processes. Some consequences are (i) the loss to the tax-payer of earliest access to the latest technologies in areas such as diagnostics, and (ii) the loss of potential new revenue streams to the institutions and the professionals within our healthcare system.
For example, commercial enterprises and academic institutions need friendly environments within which to develop, test and initially market the results of their research and development for subsequent commercialization on a global basis. Revenue in the form of royalties and the like can and do flow back to initial customers, which in this case could constitute the hospitals and other institutions within our healthcare system. However, such an innovation process is not fostered within an environment which places concerns about immediate capital cost ahead of long-term profitability and has an absence of standards. The result for such a jurisdiction is a significant reduction in revenue potential for partnering healthcare institutions and the creation of a ''late adopter'' culture, which leaves the tax-payer without the forms of medical care which he or she knows to exist elsewhere.
By way of further example, the mining of statistical patient information, if performed on a wide and standardized basis, can reveal new applications for existing drugs in a manner which greatly reduces the time and cost of getting these ''new'' drugs to market. The benefits to patients are obvious and the value of reducing research time to pharmaceutical companies is significant. They are willing to pay the health care professionals and institutions which originate the data; payments which can be recycled into the system for the benefit of all.
While it is clear that governments must take the lead in very carefully regulating such uses and must take into account the public's concerns, they must also bear some responsibility for educating the public as to the countervailing positive benefits and they must structure balanced systems.
Attempts to pilot rationale models are captured by day to day political realities. That high quality health care exists at all is a testament to the determination of the provider community. As systemic cracks become crevices, risk managers are more challenged to address burgeoning concerns around medical errors and their consequences. In selecting internal decision makers, governments must prioritize such qualities as vision, health sector experience and credibility with providers over management skills and bureaucratic longevity. Governments must respond to the reasonable expectations of its citizens or our judges will ultimately make the rules compelling governments to guarantee a timely, accessible health care safety net.