Inconsistencies in federal or provincial legislation and regulations threaten the interoperability of the electronic health record. In devising potential governance models, it is necessary to consider the interests of each stakeholder group, and balance the interests of society in promoting medical research, and the diagnosis, treatment and prevention of disease. Drawing from a previous study,[70] there are at least three potential governance models: hospital/clinic-centred governance, patient-centred governance and an independent organization model.
A. Hospital / Clinic-Centred Governance
The hospital/clinic-centred governance model most resembles the status quo. As a deemed owner of the IP, the hospital would retain local control and responsibility for protecting data. This model would leave patient EHR interests such as access rights unchanged.
A policy document would be required for all hospitals specifying the permitted uses of the IP in the data. Under this model, the hospital would remain one of the beneficiaries of any database created using its data. Researchers seeking to utilize the EHR data would negotiate with each individual hospital to obtain required data. An alternative, although perhaps more ambitious scenario would see hospitals adopt an open access approach, implemented through creative commons or public licence-type contracts.
There are both advantages and disadvantages to the hospital-centred governance model. This approach is the least disruptive, as it requires little or no legislative changes. There would, however, be no central control. Consequently, the previously addressed issue of multiple owners and creators would remain.
B. Patient-Centred Governance
Considered a radically different model, patient-centred governance would allow patients to own the IP in their medical records. Contracts between all parties could be standardized to assign all IP to patients. Similarly, legislation amendments could vest all IP in the context of medical data to patients. As in the music industry, a collecting organization could be established to manage patients’ new rights and act as a conduit. In addition, patients could be obliged to license their data through compulsory licensing.
This proposed model represents a substantial change from the status quo, as currently patients have no ownership rights in the EHR. Granting patients ownership rights runs contrary to the default state of the law, and therefore may be met with scepticism. In addition, a patient-centred governance model may make it difficult to establish research projects and commercial partners. This concern is further augmented if only a limited sample of patients permit the use of their health data for secondary purposes despite the potential monetary gain. Indeed, the very idea of patients making money from their data in a public healthcare system is undesirable. Furthermore, patient desire for such a model may not exist. Some patients have suggested that ownership is not needed provided there is a sufficient safeguard in the law to regulate the use and dissemination of data, and in particular to ensure that data remains sufficiently anonymized.
C. Independent Organization Governance
The third and seemingly most promising model proposes to assign IP rights in the EHR to a central organization. Medical records could be created as the result of clinician’s work at multiple healthcare sites, researchers might draw on records originating all over the country, and the exploitation of these records could then be handled by a single national body. It may be possible to implement this model using contracts; however, a more compelling alternative would be legislative reform, where for example a sui generis law on medical data in research collaborations could vest ownership in a national body. Although legislative reform is complicated and often cumbersome, a centralized governance model delivered by a neutral body would render the EHR more accountable and transparent. Furthermore, this model would best address the complexities that arise when multiple parties have ownership interests in the EHR. The drawbacks of this model are notable and namely, agency capture as seen with the failings of Ontario’s eHealth initiative. If more accountability and transparency were enforced, then this model might hold greater promise.
Questions:
What are the implications of each of the pre-described governance models for clinicians, patients, researchers, private entities and other stakeholders?
What policy goals should the ideal model strive to attain? How should these be prioritized?
Given the current EHR landscape in Ontario and nation-wide, of the three governance strategies proposed, which would most facilitate Canada’s goal of an interoperable electronic health record?
Are there other models that should be considered?
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