Ownership Interests and Electronic Health Records: A Critical Tool
for Governance
Jessica Patton
Ownership Interests and Electronic Health Records: A Critical Tool
for Governance
Table of Contents
Science and Law: The Underlying Philosophies 4
Challenges in e-Health 7
The Canadian Position on Intellectual Property in EHRSs 11
Copyright Laws 14
Ownership, Assignments, and Licences 17
Medical Record 18
Databases 21
eDiamond 23
A Clinicians Perspective on Databases 24
An International Perspective on Databases: 27
Conclusion 30
The adoption of electronic databases to manage health information is happening across the globe. The current leaders in the development and implementation of electronic health records are Canada, the United Kingdom (U.K.), and Australia.[1] However all of these projects appear to be side-stepping questions of ownership interests and governance. Intellectual property (IP) is a critical tool for the governance of electronic health (e-health) information contained in these databases.
Current laws are ambiguous with respect to Electronic Health Records (EHRs). Electronic Health Record Systems (EHRSs) are essentially databases composed of EHRs. Canada has a vision to create a national EHR database. Achieving this goal will require the collaboration of federal and provincial governments, health care providers, legal professionals, and private institutions from a number of industries including computer software and research firms. Each of these collaborators as well as individual patients will have an interest in either the information stored in the databases or components of the database itself. While the development of EHRSs appears well underway, there is very little discussion with respect to how these interests will be assigned and managed.
Medical databases have the potential to revolutionize public health research and epidemiological studies. These secondary uses of the data increase its commercial value and the necessity for effective governance to protect privacy rights. EHRSs raise a multitude of questions such as concerns for privacy, security, access, and consent. Many of the answers will hinge on questions of ownership and governance. There is a growing body of literature on EHRS challenges, but the intellectual property laws that will govern EHRSs have been virtually ignored.
The common law provides that medical records are the property of the physician, but patients are entitled to a right of access.[2] However EHRs, blur the traditional view of physicians owning their paper files and records. Moreover, the Canadian threshold of originality to trigger copyright protection of databases is high and unresponsive to health information and by extension, EHRSs.
This paper criticizes the leaders of this national project for their oversight with respect to copyright and ownership interests and seeks to promote these issues to policymakers, health care providers, legal practitioners and the public at large.
The analysis of copyright in medical databases is conducted using a variety of methods. In order to provide a perspective on the issues, the underlying philosophies of science and intellectual property law are briefly discussed so as to highlight their differences. A more detailed description of medico-legal issues emerging as a result of EHRSs in other jurisdictions in then considered, followed by a review of Canadian federal policies on intellectual property in EHRS development.
The body of this paper reviews relevant provisions of the Copyright Act, the common law principle of medical record ownership, and the copyright protection of databases. The interaction of these legal principles will significantly impact the governance and ownership interests in EHRs. The discussion is brought to a more practical level by reviewing a U.K. case study as well as the documented findings of an interview with a prominent Canadian clinical researcher and practicing physician. In closing, the current directions of database laws are reviewed prior to consideration of three possible models for IP ownership in e-health.
Science and Law: The Underlying Philosophies
The scientific research community functions on principles of open access and community collaboration. The classic principle of open science was best articulated by Robert Merton in the late twentieth century.[3] The Mertonian norms of science consist of five principles or expectations; universalism, disinterestedness, communality, organized skepticism, and originality.
Universalism is the expectation that scientists will judge empirical claims according to impersonal criteria, without regard to the identity of the author. Disinterestedness is the expectation that scientists will subordinate their own biases and interests to the advancement of knowledge. Communality is the expectation that discoveries will be freely shared and disseminated to the community of scientists. Organized skepticism is the expectation that scientists will subject empirical claims to systematic scrutiny and validation. Originality is the expectation that contributions to the fund of scientific knowledge will be valued for their novelty. Collectively these principles result in a norm to produce the reputational rewards for open science[4].
These principles are rather theoretical and impractical due to financial pressures since academic research is typically funded by private institutions, detracting from their independence.[5] However, Dan Burk, a specialist on on the intellectual property implications of global computer networks, observes that the Mertonian framework nonetheless continues to resonate with the scientific community and has provided a useful lens through which to view the collision of open science and proprietary intellectual property.[6]
Intellectual property law, by its very nature restricts access to information. Broadly speaking, the term intellectual property refers to three discrete areas of law; copyright, patents, and trade secrets. Intellectual property provides the legal basis to exclude, mimicking the physical phenomenon that arises naturally with tangible objects or real property. Tangible property and intellectual property however are distinct interests in any piece of property. For example, can physically own a book upon its purchase but the purchase of the book grants no rights to the intellectual property it contains.
The two most common justifications for the legal protections of intellectual property, and more specifically copyright protection, are utilitarian and natural rights.[7] The utilitarian approach views intangible property rights as an economic incentive for more creation which is useful to society; whereas the natural rights approach is much like the labor theory seeking to reward creators for their work. The justification for intellectual property rights run afoul to the community shared behavior that thrives in scientific research. Scientists are expected to freely share and contribute their discoveries with the community; such contributed knowledge is vetted through criticism and peer review of published papers or reports.[8] The motives to achieve the collaborative goals in science are not traditionally fuelled by monetary incentives. The proprietary interests of intellectual property are viewed by some scientists as at best, unnecessary and at worst, counterproductive.[9]
An excellent illustration of this disconnect arose with the Genome Mapping Project. During the sequencing of the genome, controversy arose with respect to who would own the patent. Sequencing was time consuming and undertaken by a combination of public and private institutions. The U.S. government originally sought to patent the sequence to block private patenting attempts. The initiative was abandoned due to opposition by the scientific community because it violated the Mertonian norms of communality.[10] Subsequent efforts to patent the sequences by private industry were met with hostility. Publicly funded sequencing laboratories agreed on a collective patent-defeating strategy which required academic researchers to deposit their sequence data in publicly available repositories on the Internet within hours of the data generation.[11] This rendered any attempt to patent the sequence invalid because it vitiated the novelty requirement of patent law. The scientific community was successful in their strategy and in reinforcing the commitment to open science.
The differences in the underlying philosophies in intellectual property and open science reflect the inherent difference in use and practice. While both philosophies are arguably dated and open to review, they are nevertheless relevant to e-health issues because the differences will to a considerable extent, serve as a partial explanation about the lack of unity between public and private research interests.
Clinicians and health care institutions have traditionally given little regard to the formalities of intellectual property and ownership rights. This issue will be explored in more detail in the latter half of this paper through the U.K. project, IMaGE.
It was reported in the IMaGE project, that current practices of medical data sharing occurs on a level of trust, often based on long-term research relationships.[12] These relationships involve data-sharing and are beginning to increasingly involve private industry for funding. However the ways in which these arrangements are orchestrated are often ad hoc and made on a local basis.[13] Ultimately, a lack of clarity on these issues will either lead to a complete unwillingness to share data or costly litigation upon conflicting claims.[14]
Challenges in e-Health
The concept of e-Health is continually adapting to changes in the health care system. Broadly speaking e-Health encompasses any area of health care that is shifting from a paper based format to an electronic format. More formally, it is the delivery of both health care services and health care information by electronic medium through the use of information technologies.[15] An understanding of e-health therefore encompasses a broad spectrum of activities, yet observers do not consider e-health as encompassing health service delivery that is completely or even primarily on the Internet.[16] For the purposes of this paper, the sector of e-health in focus is that relating to patient medical information obtained by clinicians and stored in an electronic database, often referred to as the electronic health record (EHR) or a part thereof.
By definition, databases are a compilation of information arranged in a systematic way and offering a means of finding specific elements it contains, often today by electronic means.[17] EHR is an expansive term referring to an interoperable electronic patient record that collects information from numerous systems, including computer-based patient records (CPRs), electronic medical records (EMRs) and electronic patient records (EPRS) that reside in various provider settings.[18] The broadest term is electronic health record systems (EHRSs) which refers to a collection of EHRs .[19]
EHRSs have been the subject of increasing attention of the last decade in both the medical and business worlds. The number of mentions of EHRSs in PubMed has increased by about 3000 annually, totalling over 36, 000 mentions in the last ten years. However, the proportion of EHRS references representing scientific research is lower, indicating that the focus has been largely on implementation and practice.[20] In business literature, there was only a total of 950 mentions in the last 10 years. However the number of mentions doubled from 100 to over 200 in 2003. [21]
The world of research, particularly biomedical research, has undergone significant changes in the face of new technology and data sharing. Collaborations in research have the potential for substantial benefits but also present numerous legal issues. Undefined ownership issues will curtail the utility of medical databases and collaborative projects if left unaddressed until a dispute erupts. Dan Burke states:
Crucial aspects of these determinants are centered upon ownership and control of the information and tools associated with e-science. And, while it is by no means the only legal regime that will affect these aspects of e-science, intellectual property law is expected to play a major role in determining such ownership and control.[22]
Two recent examples can be used to demonstrate how undefined collaboration can halt progress in EHRS development. In December of 1998 the parliament of Iceland passed a Bill that allowed for the creation of a centralized database of all the Icelandic peoples' genealogical, genetic, and personal medical information. In 2000 Iceland’s Ministry of Health granted an exclusive license to DeCode, a genetic biotechnology company, to access the national health records and create the Icelandic Health Sector Database. The rights granted included not only the right to analyze the data but also the rights to commercializing and market the personal medical records. Prior to the passage of the Bill, deCode had signed an agreement with Hoffman-LaRoche, a Swiss pharmaceutical giant, in anticipation of the contract.[23] The commercial value of this genetic data arises as a result on the unique gene pool of Icelanders. Icelanders' genes remain largely unchanged from Viking days, and modern DNA techniques provide science a golden chance to unravel the roots of major ailments by charting the progress of a cancer or heart disease through a family and isolating DNA markers from relatives.[24]
The contract with DeCode was opposed by on two fronts. First, the medical community and citizens had serious concerns ethics, privacy, and security. Second, the scientific research community was also opposed to a legalized monopoly of genetic research on the basis that it would threaten academic freedom in Iceland.[25] The health database currently appears to remain empty.[26] The debacle illustrates that medical data may has different importance and value to each of its potential users.[27] Further, the Iceland experience raised important questions as to how the secondary use and access to databases by third party organizations and bodies will be will be governed.[28]
The second example recently occurred in the Australian EHRS initiative. In an attempt to establish data standards for communication between pharmacies, consumers and government agencies, the Australian Department of Health funded a project to be carried out by the pharmacy guild and a private consulting firm. The project, known as “Better e-Dispensing” and “e-Claiming”, exceeded the government budget of $3 million by $1.5 million. However, in 2002 the guild and the consulting firm jointly applied for worldwide patents for a “method and system for sharing personal health data.”[29] Australia IT reported that the bid sparked outrage from doctors, consumers, and industry groups also collaborating on local e-health initiatives. In July of 2007, the guild assigned its interest to the Commonwealth and in August of 2007 the government withdrew the application prior to formal determination by the IP regulatory body.[30]
If it has been successful, the patent would have had numerous impacts on the development of EHRSs. The guild could have charged royalties on government IT systems such as the HealthConnect, the national EHRS initiative, as well as charging licensing fees to software developers for using medication management features.
The Canadian Position on Intellectual Property in EHRSs
The Canadian initiative to modernize health care began in the early 1990’s upon recommendation of the Information Highway Advisory Council (“IHAC”). In 1999 the IHAC released their final report, ‘Canada Health Infoway: Paths to Better Health’, which recommended the establishment of a nationwide health infoway, to improve the quality, accessibility and efficiency of health services across the entire spectrum of care in Canada.[31] In the 105 page document, the single reference to intellectual property issues reads as follows.