Uncovering the IP in eHealth Records: Who Should Own Your Medical History?

Steven Zuccarelli is a 2012 J.D Candidate at Osgoode Hall Law School

As technology in health care races ahead, individuals will readily imagine innovative, cutting edge medical techniques that may cure them of an ailment, or perhaps extend the length of their years.  However, an often-overlooked feature of technologically advanced health care is a unified, secure, and accessible network of patient health data.  Electronic Medical Records (EMRs) may provide enormous benefit to the health of individuals, as the longitudinal nature of EMRs means that one could track the health history of an individual or even an entire population of individuals across their lives. 

Housing EMRs in a system that would provide easy access to medical health professionals, researchers, pharmaceutical manufacturers and patients themselves would yield quantifiable health benefits to the population.  While one can easily think of potential security and confidentiality issues that may arise from compiling large EMR databases, less obvious, while no less threatening to a successful implementation of EMRs, is the potential ownership issues associated with the Intellectual Property within EMRs.

In the Supreme Court of Canada decision McInerney v. MacDonald, the Court determined the doctor as the owner of an individual’s medical record.  This was limited to the physical copy of the record.  However, their recognition of a relationship of special trust between the patient and doctor allows a patient to maintain a “beneficial interest” in his or her own health record, thereby allowing access to the record.  What is still left unclear though is the ownership status of a record suspended in an interconnected system, such as an EMR.  Within such a network, there may be thousands of patients, with each patient’s record comprised of multiple health professional’s work, with each employing multiple employees (i.e.: a Radiologist’s technician who performed an ultrasound).  Therefore, there are multiple creators, owners, subjects and users.  With all of these individuals able to make a claim for ownership of part of the record, who has the best claim of ownership? An even better question may be whose ownership would facilitate the formation of the EMR system that best achieves its goals of progressive health care?

Marc Rodwin of Suffolk University Law School argues that the answer to that question is public ownership, in his paper entitled Patient Data: Property, Privacy & the Public Interest found here.  Rodwin points to an increasing trend in U.S EMRs whereby data collected by physicians or hospitals is given or sold to Medical Information Organizations (MIOs) that compile the data.  These organizations, of which IMS Health is the largest in the U.S, then sell this data, stripped of personal identifiers, to pharmaceutical companies, the FDA, health economists, other hospitals and even back to the U.S Government itself.  This aggregated and de-identified data marketing has led to revenues of up to $2 billion annually for IMS Health.  Consequently, the interest held by MIOs in the ERMs is fiercely protected, especially from competing MIOs.  This behavior therefore limits the dissemination of EMRs to researchers, regulatory bodies and medical professionals to the detriment of patients, according to Rodwin.  It leads to potential monopolies where the price of data is superficially high, and where tensions between private companies withholding data for their own benefit creates tension with public bodies, since no obligation to share their “proprietary” data exists (i.e.: if a medical device manufacturer would expose health risks to the FDA by sharing the entirety of its data).  Rodwin also argues this impedes the construction of a nation-wide comprehensive EMR database, since there is little incentive for MIOs to share data.  Further, the data that is collected by the MIOs is recorded and compiled using different standards, making it difficult if not impossible to reconcile afterwards.

At this point, one wonders whether the MIOs, due to their compilation of patient data, do not obtain some proprietary interest, and are therefore justified in limiting access to EMRs.  Rodwin does point out that while legislation to give compilers protection from others making use of the data was explored in the U.S and Europe in the 1990’s, ultimately it was not given.  In addition, the U.S Supreme Court expressed that only those compilations that demonstrate creativity should be given any protection.  Rodwin argues that courts are unlikely to recognize this creativity, and therefore MIOs hold no legally protected interest in the EMRs they sell.

Consequently, Rodwin proposes that this trend of false privatization must be stopped for the benefit of EMRs to be realized.  Certainty in the marketplace must be given, and this requires acknowledging the ownership of IP contained within the EMRs.  He argues that while private ownership of property is typically needed to incite use, creativity, efficiency and financial award, this is not needed for EMRs.  The data is collected already, and will continue to be collected by medical professionals due to the need for records of patient health, pharmaceutical prescriptions and of course, billing.  Therefore, with no need of further property interests to provide incentive for data collection, public ownership of EMRs would be the best solution.

To achieve this goal would require legislative reform mandating the uniform collection and submission of all relevant health data to a single entity.   This would avoid any issues of firms selectively providing data in order to maintain a competitive advantage in their market and would also avoid antitrust law issues, whereby a single private firm maintains a monopoly over patient data.  With public ownership, access would be given to researchers, organizations and health professionals without barriers, and without undue cost or complexity.  Rodwin also points out that public ownership of EMRs would also avoid the potential phenomenon known as the “tragedy of the anti-commons”.  The phenomenon exists when private ownership of a resource leads to its underuse.  He suggests that in a system where multiple owners each have a right to exclude others, the resource will not be used efficiently.  In the case of EMRs, he suggests that the continued proliferation of MIOs would achieve this end.  While it is possible that these different firms would simply purchase and sell each other blocks of EMRs, Rodwin argues that the high transaction costs of buying and selling EMRs between multiple private owners would hamper the functioning of an EMR system.

However, if private ownership of the EMRs were transferred to patients themselves, and not to the organizations compiling the data or the government, would we also avoid the aforementioned problems?  It is likely that patients would not seek to withhold any of their data knowing its dissemination would be for their own along with society’s benefit.  Coordinating the license of their data to users may pose problems considering the sheer number of individuals, though.  However, as Professor Giuseppina D’Agostino of IP Osgoode made note of in her background paper presented on January 28 before the Law Commission of Ontario Symposium on eHealth Law and Policy, it could be imagined (however likely) that licensing of patient rights could be handled by collecting organizations acting as a conduit, similar to what is currently found in the music industry when we look towards solutions for enhanced patient-tailored governance.

There are issues with a patient centered model though.  Many more than a minority may seek to withhold their EMR, and would therefore jeopardize the aggregation of the system.  Further, competition between data compilers seeking to license the data from patients may lead to unnecessary transaction costs, and inefficiency.  A public system would prevent holdouts, and would also minimize transaction costs and prevent competition between multiple compilers from decreasing efficiency.  Were the government to have ownership, competition in the marketplace between compilers would not be necessary to maintain accurate prices.

It will be no surprise if public ownership of EMRs is resisted.  Considering the income of existing compilers at risk, many large, powerful and financially strong organizations will seek to impede any government steps to move toward public ownership of EMRs.  However, allowing EMRs to continue to be commoditized and fragmented will, according to Rodwin, erect barriers to the distribution of the data and will prevent patients and governments from fully realizing any improvement in health care.  Nevertheless, the ambiguity that is created by a lack of legislative certainty regarding the ownership of EMR’s must be resolved, whether a public or private ownership scheme is adopted.

Canadian provinces are currently implementing EMR systems independently, with oversight by the federally appointed organization Canada Health Infoway Inc.  In Ontario, the provincial eHealth initiative is responsible for developing a unified EMR database.  However, amid significant scandal and the “waste” of up to $1 billion of Ontario tax dollars, the goal is far from fruition.  A recent Auditor General of Ontario report confirms that Ontario trails behind its provincial eHealth counterparts, and that it lacks the most essential ingredient to a functional EMR system, “…although a network is in place, it is underutilized as there is insufficient health‐information contained within the system.”  The debilitating effect of a lack of health information is a testament to the need to have a system that fosters the uniform collection, compilation and dissemination of EMRs.  To achieve this, it is absolutely necessary to have clear legislative certainty of who the EMRs belong to, how they are to be collected, compiled and accessed.  While legislative change may be difficult to achieve, Marc Rodwin may be right in suggesting that public ownership is the best way forward.