A. Intellectual Property and Electronic Health Records
The intellectual property implicated in electronic health records are mainly the copyrights and patents. Most contentious, however, are the copyrights as they directly relate to issues relevant to medical record ownership, and are often the most ambiguous. Copyright protection arises automatically upon fixation of a tangible original expression, arising from an author, and requiring some intellectual effort. Section 5(1) of the Copyright Act[17] stipulates that copyright shall subsist in Canada for original literary, dramatic, musical and artistic works.[18] In the EHR context, a single medical scan (e.g. MRI) is protected under copyright law as an artistic work, and the radiologist’s notations on the medical record are protected as literary works. In addition, Section 2 of the Copyright Act protects compilations or, “works resulting from the selection or arrangement of literary, dramatic, musical or artistic works or parts thereof, or of data.”[19] Databases, or in this case the electronic medical archive may, therefore, be protected as compilations should the gathering and sorting of data involve original and creative selection and arrangement.
Although medical information is not considered intellectual property, the expression of these records in a fixed form is. Healthcare providers who possess and compile medical records may own their tangible embodiment.[20] The EHR context, however, presents a unique scenario as several healthcare providers may have contributed to an individuals’ health record. Consequently, there may be several owners with proprietary interests in different pieces of a patient’s medical history. Furthermore, when records are linked through EHR systems the number of potential authors or creators increases exponentially.
B. Determining Copyright Ownership
Central to the ownership question of the EHR is determining who the owner is for copyright purposes. The first owner of copyright is typically the creator, but there are exceptions. One of the main exceptions particularly relevant to the EHR deals with employees. Whilst independent contractors retain copyright over their works (unless an express or implied contract provides otherwise), employees’ copyright ownership of their works resides with their employers pursuant to the “course of employment” doctrine[21]. Contract law governs the management of copyrights. In the context of the EHR, most of the radiographers or technicians who scan and/or annotate the images are employees of the clinics or hospitals. Because of the absence of any contractual agreement, all intellectual property generated by them belongs to the respective employer institutions. However, some healthcare professionals might not be employed but have independent contractor arrangements, and unless there is a contract or clear policy clarifying these rights, ownership will reside with these individuals or at best be ambiguous. As uncovered in the noted UK study on point, the results can be devastating as there is confusion on ownership and consequently, the inability to properly manage (and share) the data with other collaborators.[22]
Questions:
· To what extent is determining ownership of EHR data important? Consider the interests of each stakeholder group: healthcare professionals, patients, government, the public, innovators and other groups.
· Do you think that the uncertainty with regards to who owns and controls what could hinder the benefits of eHealth?
· Would this uncertainty compromise the forming of public-private partnerships that drive innovation and research in Ontario?
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