Giuseppina D’Agostino,1 Chris Hinds,2 Marina Jirotka,3 Charles Meyer,4 Tina Piper,5
Mustafizur Rahman,6 David Vaver7
Introduction
eScience and eHealth aim to use data and computational resources in new ways. The notion that
patient data, gathered during the course of primary care activities, should be used for medical
research is of course familiar. eScience, however, seeks to use this data for new kinds of
collaborative research. The challenges to both technology and medical practice that this programme
presents are made both timely and relevant by efforts toward the development of a national
Integrated Health Record. While these challenges will undoubtedly present issues of concern for
both technology and medical practice, there may also be issues of wider concern to resolve before
such systems can become widespread. Our area of concern relates to the legal structures that may
help to underpin the building of such systems. More specifically, we wish to highlight the
importance of Intellectual Property (IP) rights and how these relate to medical data held in
databases of the kind required by the Integrated Health Record, and particularly where such data
may be used in line with the eScience research vision.
The sharing of patient data is fundamental to medical research. A level of trust, often based on longterm research relationships, has allowed health service and universities to share data and engage in
mutually beneficial collaborations. Also of critical importance to medical research are
collaborations with commercial organisations. It is quite normal for these collaborations to involve
some degree of benefit for the health service department involved, such as the provision of state-ofthe-art equipment or technical support from the commercial partner. In both situations, medical data
is a vital resource which is used to ensure maximum benefit for the health service. However, the
current state of play of these arrangements is often ad hoc and made on a local basis.
The eScience vision of the seamless national or even international sharing of data for research,
presents specific challenges to these current localized arrangements. The technological possibilities
for sharing data within the health service raise issues such as: who should be entitled to make deals
with external researchers and organisations. Who should benefit from such deals and how? What
interest do external organisations acquire in shared data and do the rights of data custodians
change? A lack of clarity on these issues could lead to either a complete unwillingness to share data,
or conversely, result in costly litigation when conflicting claims come to light. For this reason the
IMaGE project (Intellectual property rights in Medical databases for a Grid Environment), a one
year collaboration between computer scientists, social scientists and lawyers, was set up to
understand and evaluate current law and social practice, and to develop recommendations for how
the law should operate in the future. In order to consider this issue in concrete terms, rather than in
the abstract, IMaGE focuses on a retrospective study of eDiaMoND (the eScience Digital
Mammography National Database), a recently completed, high-profile eScience project.
Our approach can be described in terms of three phases. In the first phase, a retrospective study of
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Research Associate to the Oxford Intellectual Property Research Centre and Senior Policy Analyst to the
Department of Canadian Heritage, Copyright Policy
Research Associate to the Oxford University Computing Laboratory
Co-Principal Investigator and University Lecturer in Requirements, Oxford University Computing Laboratory.
Research Associate to the Oxford Intellectual Property Research Centre.
Research Associate to the Oxford Intellectual Property Research Centre and Assistant Professor, McGill University,
Canada.
ICT Engineering Institute, Oxford University Begbroke Science Park.
Co-Principal Investigator and Reuters Professor of Intellectual Property Law, University of Oxford.
the eDiaMoND project was conducted; this was based on the analysis of documents produced by
the project and on unstructured interviews with key members of the eDiaMoND team, and its
stakeholders. These materials have provided: a critical background to the project and its aims, a
sense of the challenges that it faced, and a catalogue of the agreements that were reached during the
project with its partners. In parallel with this a thorough review was conducted of relevant
jurisprudential research relating to the ownership of (IP) rights. The second phase is ongoing and
focuses on the development and evaluation of different models for the ownership such rights, and
the final phase will disseminate our findings.
Background to the Case Study
eDiaMoND aimed to develop a next generation Grid enabled prototype to demonstrate the potential
benefits of a national infrastructure to support digital mammography. It was a large interdisciplinary
e-Science project, jointly funded to approximately £4.25m; it involved a core of 30-35 staff spread
over 12 locations, including: 5 Universities, 4 NHS Trusts, a multi-national company, and a rapidly
expanding university spin-out enterprise. The project received extensive public interest, including
articles published by Wired, the BBC, and even a press statement by Prime Minister Tony Blair.8
The context for this project was the UK National Breast Screening Programme, which currently
examines women from the ages of 50 to 64 every three years. Under the programme, at a screening
clinic, a woman will have a series of these mammograms taken by a radiographer. After the films
have been developed, they are displayed on a light-box so that they can be examined for potential
signs of cancer by two radiologists. The radiologists' abilities to identify potential cancers in these
mammograms are central to the diagnostic process. Radiology is a complex skill that is taught
through a mix of scientific theory and apprenticeship.9
Currently, one in nine women in Britain develop breast cancer in her lifetime.10 Some 1.5 million
women are screened each year and it is hoped that the programme will be extended to screen
women up to and including the age of 70 (a 50% increase in workload). There is, however, a
national shortage of radiologists.11 eDiaMoND would allow radiologists to share expertise and
reading work between clinics, irrespective of the geographical location of the radiologists involved.
In this regard, the technology was intended to improve the training of radiologists and patient care
throughout the U.K.
eDiaMoND focused on the application of Grid technologies within the UK National Health Service
Breast Screening Programme. Central to this vision was an expected shift from film-based to digital
mammography technologies. Once mammograms were in digital form, it was anticipated that a
database would be required to store and manage them. eDiaMoND sought to develop such a
database on a national level, and then apply Grid technology to manage a series of services to utilize
those data. The Grid presents a series of potential benefits for digital mammography: radiologists
will be able to share images and expertise in new ways; new Grid enabled Computer Aided
Decision algorithms will be developed and used to assist in the reading process; and
epidemiologists will be able to use vast stores of accumulated image data for new kinds of cancer
research.
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Full details of press coverage available at: http://www.ediamond.ox.ac.uk.
Hartswood, M., R. Procter, M. Rouncefield and R. Slack 'Performance Management in Breast Screening: A Case
Study of Professional Vision and Ecologies of Practice'. Journal of Cognition, Technology and Work, vol. 4, no. 2,
pp. 91–102 (2002). Hartswood, M., R. Procter, M. Rouncefield and R. Slack 'Cultures of Reading in
Mammography'. In D. Francis and S. Hester (eds.) Orders of Ordinary Action: Respecifying Sociological
Knowledge. Aldershot: Ashgute Publishing (2003).
Boseley, S. Breast Cancer; 'The Relentless Rise.' The Guardian, January 15th 2004.
Geldman, A. 'NHS Staff: The Issue Explained.' The Guardian, June 26th 2002.
In order to demonstrate the eDiaMoND vision it was necessary to obtain a significant volume of
patient data. However, setting up the agreements that lead to the acquisition of this data was far
from straightforward. In many cases clinics were keen to participate and willingly contributed data.
However, one of the clinics requested explicit contractual terms before their data would be released.
The negotiations between this clinic, their partner University, and Oxford, the coordinating
institution, took over a year to settle and hence significantly delayed the project’s data collection
effort. IP rights were central to these negotiations. A lack of certainty with respect to IP ownership
rights thus poses a very significant barrier to the success of future eScience projects. eDiaMoND
was therefore of interest to IMaGE, not just because it was considered to be a high-profile eScience
exemplar, but because it appeared to exhibit a real challenge with respect to IP. Our analysis
consequently focused on this process of acquisition and the agreements that were forged to facilitate
it.
eDiaMoND acquired 1600 digital mammograms and related medical information from four clinics.
Once ethical clearance had been given, this information was obtained from clinics via a university
intermediary which then liaised with Oxford, to upload it into the project’s database. The
commercial partners provided the technology to acquire data and place it in standardized form on
the Grid. The mammograms used included those already pre-selected for training or
epidemiological purposes in addition to those taken directly from patients in the clinic. The majority
of mammograms were film-based x-rays. Patient records were generally on paper. Thus much of
the effort of acquisition was expended on the scanning and data entry that was necessary to digitize
these. However, a number of cases were taken directly from digital equipment. This complex
collection and use of data is critical when one considers the IP rights involved.
At the top level, eDiaMoND was based on a three way collaboration agreement between Oxford
and the two major commercial partners. This agreement laid out, for example, what would happen
to any IP that was developed in the form of software during the project. However, it made no
mention of medical data. The data was to come from the participating clinics. Each of these clinics,
in collaboration with their individual university partner, was to acquire data and upload it into the
project's Grid database. Unlike the main collaboration agreement, the relationship between each
participating university and their clinic, and between those universities and Oxford, were ad hoc,
and in some cases quite informal. As the following will describe, this makes the ownership of that
data much harder to define.
Main Legal Issues
The main legal issues examined are copyright and database rights, and how these relate to the
medical data used in eDiaMoND. Two main factors affect these ownership rights (1) the contractual
relationship between the parties; and (2) custom and practice regarding the ownership of IP and
access to data. Although we recognize the importance of ethical, confidentiality, data access and
privacy concerns, we do not directly address these issues. Rather, we focus on IP ownership
questions in the UK. Other jurisdictions have been consulted for comparative purposes.12
Copyright Law
A key objective of copyright is to grant exploitation rights to owners of original works. Thus under
the UK Copyright, Designs and Patents Act 1988 (CDPA),13 copyright initially grants various
enumerated exploitation rights to the ‘author’ who ‘creates’ a work.14 The concept of ‘originality’
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Note IMaGE does not focus on physical ownership issues (eg which entity is best able to store the physical boxes of
data) the focus is on the intangible aspect of such property, the IP.
Copyright, Designs and Patents Act 1988 c 48 as amended.
CDPA s 2(1) exploitation rights delineated further in Part II. For comparative purposes to Canada’s Copyright Act
is an important prerequisite to the grant of copyright protection.15 The test for a work's originality
is a matter of degree depending on the amount of skill, judgement, or labour involved in its
making.16 Consequently, not only must creative intellectual activity produce the right kind of work,
but ‘the author’s input must satisfy a certain minimum standard of effort.’17 The author is an
individual who is solely responsible and exclusively deserving of the credit for the creation of a
work.18
The CDPA grants protection to a number of categories of works. For instance, a literary work is
defined in the CDPA as a written work, other than dramatic or musical, that may include computer
programs or compilations.19 The IMaGE project examined the ownership right in mammograms as
artistic works and the data and software as literary works. An individual mammogram may have
three types of copyright attached: copyright in the actual image, copyright in the annotations, and
copyright in the entire record. Copyright is also vested in eDiaMoND’s entire database of
mammogram data. Copyright ownership in each may vary depending on the general rules of
copyright.20
Determining Copyright Ownership
The first owner of copyright is typically the creator but there are exceptions. One of the main
exceptions relevant to the eDiaMoND project deals with employees. While 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 UK, the CDPA governs copyright
transfers and licences. A licence may be express, oral or implied by conduct and may be exclusive
or non-exclusive. Similar in scope to assignments,22 exclusive licences must be in writing
authorizing, the licensee to exercise a right to the exclusion of all other persons including the
licensor.23 Non-exclusive licences imply that other licensees may be appointed to compete with one
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RSC 1985 c C-42 (‘CCA’) s 3, copyright means the sole right to reproduce, perform or publish a work and procure
any profits therefrom.
University of London Press Ltd v University Tutorial Press Ltd [1916] 2 Ch 601, 608: ‘the Act does not require that
the expression must be in an original or novel form, but that the work must not be copied from another work—that it
should originate from the author’. Or as J Litman ‘The Public Domain’ (1990) 39 Emory LJ 965–1023, 1000
states, originality is used for dividing works ‘privately-owned from the commons and to draw lines among the
various parcels of private ownership.’ There are various views on the subject that elide clear definitions.
WR Cornish Intellectual Property (5th edn Sweet & Maxwell London 2003) 388; CCH v Law Society of Upper
Canada [2004] 1 SCR 339: ‘What is required to attract copyright protection in the expression of an idea is an
exercise of skill and judgment.’ See also Slumber-Magic Adjustable Bed Co v Sleep-King Adjustable Bed Co and
others (1984) 3 CPR (3d) 81 (BCSC).
WR Cornish Intellectual Property (5th edn Sweet & Maxwell London 2003) 388; Ladbroke(Football) Ltd v William
Hill(Football) Ltd [1964] 1 All ER 465 (HL).
M Woodmansee ‘The Genius and the Copyright: Economic and Legal Conditions of the Emergence of the
“Author”’ Eighteenth-Century Studies 425–48, 426.
CDPA s 3(1).
Despite these differences, copyright persists for seventy (70) years from the time of first fixation.
CDPA s 11(2); in Canada, Copyright Act RSC 1985 c C-42 s 13(3); in the US, Copyright Act 1976 17 USC s 101
‘works made for hire’.
The distinction between licences and assignments ‘is not always so clear-cut’; an exclusive licence of all rights to
run until the rights expire is in practical effect like an assignment. And so, ‘it is not so much what the contract is
called but the effect of the transaction which decides whether there is an assignment or a licence.’ H Pearson and C
Miller Commercial Exploitation of Intellectual Property (Blackstone Press Limited London 1990) 344.
CDPA s 92(1).
another and the independent contractor.24 It also means that, in contrast to assignments, which
transfer ownership, the independent contractors retain the right to exclude everyone other than the
licensees from use of their works.25 Licences can be limited by time, scope, use and duration.
Assignments and licences can be partial. For example, independent contractors may license only
print rights. In the UK, future copyright can be assigned,26 thereby vesting copyright in the
assignee once the future work comes into existence. Moral rights can be waived in writing but
cannot be assigned.27 So if independent contractors intend to grant assignments or exclusive
licences, these must be in writing.
eDiaMoND Ownership Rights
Determining where the IP rights reside is of critical importance to the eDiaMoND project. There are
copyrights in the original medical data: the stipulated diagnoses included in a fixed form in the
medical record are the result of the radiologists’ skilled and careful judgements. Similarly,
mammograms are the result of the skilled and careful work of radiographers. Whether the actual
radiologists and radiographers own the rights to these works will depend on whether they
performed such work in the course of their employment, in which case, the data would belong to
their employer; or whether they performed the work as independent contractors in which case, they
would be presumed to own the resulting data unless contracted otherwise. What is further unclear is
whether the digital form of these data triggers a new (and second layer) of copyright. The mere act
of transforming a work from an analogue to digital format may not be sufficient to constitute an
original work.28 However, there is at least some skill involved in the eDiaMoND process of
acquisition. For example, even what initially seemed like straightforward data-entry required the
assistant to rearrange and transform a given set of clinical data-fields so that they could be entered
into the ‘unified’ schema required by the eDiaMoND database. Thus it was vital that the assistant
was able to read and understand the clinic’s original medical records. Ascertaining the requisite
level of skill and judgement to trigger copyright protection is a difficult question. Nevertheless,
investigating the possibilities of copyright ownership in these new digital images is important – not
least for other digitization-based projects to which it may be relevant.
In eDiaMoND, the Trusts have been found to retain copyright over the original images and possibly
the digitized images. This ownership has been vested in two different ways (1) by express
agreement and (2) implied licence. The first case of express agreement was less common; only in
one trust-university relationship (Clinic-1 and University-1, respectively), was IP ownership
specified. A clause in the agreement clearly specified that the data be retained by Clinic-1 with
University-1 enjoying use rights for the eDiaMoND project only. In the case of the other three trustuniversity relationships, there was an absence of any written contracts. However, there was still an
implied licence between those parties. As independent contractors, the Trusts retain the data
because they are the creators of the data. So despite the lack of a contract, ownership rights can still
be implied. Even so, the exact scope of this licence is unclear (eg whether the data can be used for
commercial purposes or for other non-commercial purposes). Going forward more certainty in
ascribing ownership rights is necessary.
Most of the radiologists who scanned and/or annotated the images were employees of the Trusts. As
such, because of the absence of any contractual agreement, all IP generated by them belongs to the
Trusts. However, several radiologists were not employees but independent contractors and thus
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D Vaver Copyright Law (Irwin Law Toronto 2000) 238.
Pearson and Miller (n 14) 343.
CDPA s 91.
CDPA ss 94–95.
Indeed, it may in fact attract copyright infringement; see in the US Tasini v New York Times 533 US 483, 121 S Ct
2381 (2001).
raise ownership concerns. For instance, in the Clinic-1 / University-1 relationship, despite the
contractual certainty in the flow of IP rights among these entities, the work of an independent
clinical assistant who scanned images supplied by Clinic-1 and entered data of clinical records for
University-1 raised ambiguity. The clinical assistant was paid by University-1 but worked at Clinic1, and although she was bound by an honorary contract with the clinic, this made no explicit
mention of IP rights.29 The data generated can therefore be owned either by the assistant as an
independent contractor or by the University. It seems clear that this was not an outcome intended by
those involved.
The project used a number of independent contractors, and similar concerns may arise where
research associates were involved with the digitization of data. These issues are obviously of
concern to eDiaMoND, and possibly to other eScience projects. However, they would seem
relatively easy to resolve, for example, by using express language regarding IP in the honorary
contracts and ensuring that any rights generated in the process of digitization remains with the
Trust.
Greater certainty in this area is obviously extremely important to the ongoing success of projects
like eDiaMoND. However, the notion that Trusts should own the IP in any medical data it creates,
raises issues of its own, particularly in light of programmes such as 'Connecting for Health.'30 A
national electronic medical record may make it technically easy for researchers with adequate
ethical clearance, to build a cohort of patients. However, if such a cohort includes data from many
Trusts, each of whom must be handled individually, important relationships with commercial
partners may become difficult to establish.
Database Law
European databases are governed by a complex legal regime. The EC Database Directive31
provides the most comprehensive legal protection of databases. Its provisions have been
implemented and modified in the U.K. by the Database Regulations.32 Two other legal instruments
also apply to databases: the U.K. Copyright, Designs and Patents Act in s. 3A and Article 5 of the
World Intellectual Property Organization (WIPO) Copyright Treaty. The Database Directive and
U.K. Regulations are the most applicable protections to the eDiaMoND database.
There are three tiers of substantive legal protection of databases in intellectual property law: (1) the
database itself is protected by copyright; (2) the investment in databases is guarded by the database
right; and (3) the contents of the database may be protected by copyright or other IP rights (such as
patents and trademarks). The copyright in the database was already discussed – the first two will be
addressed in turn.
The UK Regulations define a database as ‘a collection of independent works, data or other materials
which (a) are arranged in a systematic or methodical way, and (b) are individually accessible by
electronic or other means’.33 The Explanatory Memorandum describes the contents of the database
as ‘“information” in the widest sense of that term’ and this definition of a database has recently
been explored by the European Court of Justice.34 The eDiaMoND collection, as well as some of
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34
The actual contract was not available to us, however similar honorary contracts from this NHS Trust make no
mention of IP.
http://www.connectingforhealth.nhs.uk/
Directive 96/9/EC of the European Parliament and the Council of 11 March 1996 on the legal protection of
databases.
Copyright and Rights in Databases Regulations 1997 (S.I. 1997 No. 3032).
Reg. 6.
Fixtures Marketing Ltd v. Organismos Prognostikon Agonon Podosfairon AE (OPAP) [2004] ECR I-10549.
the pre-existing databases held by the Trusts, meets the legal definition of a database.35 They are
collections of images that are separable from one another without affecting their value that have
been systematically or methodically arranged to be independently accessible from a fixed hardcopy
or electronic base.36
Databases are protected by copyright if they are the author’s ‘own intellectual creation’.37 The
creativity required for protection is in the selection and/or arrangement of the contents of the
database.38 Copyright protection of the database requires a relatively high standard of originality.
The author holds the right which extends to rights of reproduction, distribution and making
available to the public.
While the question of whether the various databases qualify as a ‘literary work’ remains an open
question; preliminary conclusions can be drawn about copyright that may be held by various project
stakeholders. Two of the clinics contributed pre-existing local databases to the eDiaMoND project.
They had already selected various typical images for teaching purposes and had arranged those
images according to their internal filing system. These databases would likely meet the threshold
for copyright protection. The other two clinics assembled their local databases by choosing patients
in the waiting room who consented to the use of their images for the purposes of the eDiaMoND
project. This level of selection and arrangement less convincingly meets the threshold for copyright
for protection. The eDiaMoND project that created a database, incorporating the databases of the
participating Trusts delegated selection to the local Trusts. eDiaMoND coordinated the scanning,
sorting of information fields and overall layout of the data in the database and would thus meet the
standard of ‘arrangement’. Thus the larger database as well as some of the participant databases
would likely have some claim to copyright over their databases.
The creator is also protected against unauthorized extraction or utilization from the database by the
so-called ‘sui generis’ database right in the Database Directive. Its protections have been imported
and modified in U.K. law by the U.K. Database Regulations and recently extensively addressed by
the European Court of Justice.39
The database right belongs to the person who takes the initiative and assumes the risk in investing,
obtaining, verifying or presenting the contents of a database.40 That investment must be substantial
in a quantitative and qualitative sense and cannot be solely in the creation of the data but must
reflect an investment in the collection and organisation of the data into the database.41 Employees
are excluded from the database right unless their inclusion is specified by contract.42 The right can
be held jointly and by many parties. The database right protects against substantial extraction or reutilisation of all or a substantial part of the database without consent.43 The term of the database
right is 15 years from the date when the database was completed, but any substantial change to the
contents of a database qualifies the resulting database for its own term of protection.44 The database
right also allows a right of fair dealing with the database for research for non-commercial purposes.
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Note that the database right does not protect the computer software driving the database: Article 1(3). Computer
programs are protected independently by the European Software Directive of 1991: Council Directive 91/250 on the
legal protection of computer programs, OJ L 122/42 of 17 May 1991.
Ibid [29] – [36].
Database Directive, Article 3.
Article 3(1).
Fixtures Marketing v. Svenska AB C-338/02; OPAP (n 34); Fixtures Marketing Ltd. v. Oy Veikkaus Ab C-46/02;
British Horseracing Board Ltd v. William Hill Organization Ltd C-203/02 (BHB).
Reg. 14(1).
BHB (n 39).
Reg. 14(2).
Reg. 16(1).
Reg. 17(3).
Two of the Trusts took particular efforts to create their pre-existing collections by selecting
representative mammograms, verifying their accuracy and use as typical cases and presenting them
in the database according to their internal filing system. Two other clinics have a weaker claim to
database protection over their pre-existing collections because those collections were largely
incident to the creation of data, as discussed in the previous section. Thus some of the Trusts have a
strong claim to rights in their databases. In terms of the larger eDiaMoND database, a large range
of organisations took the initiative and assumed the risk in investing in and obtaining data in
database form through coordinating standardized annotation and scanning, as well as verifying and
presenting the contents of the database. In particular, various funding institutions made a significant
financial investment,45 and the core-project team itself took substantial initiative in obtaining and
verifying data.
In sum, two of the Trusts have a strong claim to copyright and database rights in their databases due
to their pre-existing collection activities. The creators of the eDiaMoND database also likely have
copyright and database rights in the databases of mammogram images. It is interesting to note that
the database right is not well tailored to the case of a mixed public and privately funded initiative.
Alternative Models of IP Ownership
A critical part of our project has been to develop some alternative approaches to the ownership of IP
rights in medical data. It this regard we have begun to consider different models of ownership, how
those models might receive legal implementation, and the consequences of such changes for the
various stakeholders. By way of an overview, just three possibilities are outlined below.
NHS Trusts
One possibility is to maintain what effectively is the status quo, namely, vesting ownership of data
with the NHS Trusts. This outcome is possible through contracts between the Trust and parties
involved collecting and using the data. For example, express language could and perhaps should be
used in honorary contracts to vest any and all IP generated in whatever form with the Trust. Also,
an upfront ‘Grid’ contract could be prepared with the parties explicitly delineating a uniform IP
policy to be executed before allowing any Trust data to be used in a database. For expediency, it is
perhaps this model which may in the short-term best serve eScience projects.
Patients
A radically different model would be to allow patients to own the IP in their medical record.
Although patients have clear statutory rights to access and control the use of their data, they do not
currently hold ownership rights to any IP in their own record. Giving them such ownership rights
may be problematic for a number of reasons: (1) it runs contrary to the default state of the law, (2) it
may make it more difficult to establish research projects with commercial partners, and most
importantly, (3) it runs contrary to NHS policy on the exploitation of IP.46 Additionally, some
patients have suggested that ownership is not needed provided there remain sufficient safeguards in
the law to regulate the use and dissemination of such data.
Centralization
A promising alternative might be to assign IP rights in the medical record to a central organisation
(or for example, to the Secretary of State for Health). This would be a sensible alternative for the
kind of national database proposed by 'Connecting for Heath'. Medical records could be created as
the result of clinicians’ work at multiple NHS trusts, researchers might draw on records originating
45
46
Although questions may remain over the threshold for finding “substantial investment”.
See, NHS Framework and Guidance on the Management of IP in the NHS,
http://www.innovations.nhs.uk/pdfs/77169_doh_nhsinnovative_origfinal.pdf
all over the country, and the exploitation of these records could then be handled by a single national
body. In cases where clinicians have established their own collections of records, for research or
training purposes, the exploitation of such collections can be protected by the database right.
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. Alternatively, legislation could be enacted
to provide a limited exception to infringement in the CDPA (eg, in the form of fair dealing or for
use of the work for purely educational or research purposes). Although legislative reform, may be
more effective and result in a broader, especially in the longer term, it is time-consuming and
difficult to attain. Consequently, such an approach will require careful study.
Conclusions
Although eDiaMoND failed to establish a clear notion of IP ownership during its initial planning,
its innovative nature makes this understandable. Confusion over ‘who owned the data,’ was evident
from the outset and confirmed through interviews and documentary evidence. This confusion has
resulted in: (1) time consuming negotiations which delayed the process of acquisition; and (2) much
disagreement regarding who has the authority to decide the future research purposes to which the
data may be put. Our aim is not just to provide clarity to eDiaMoND and other eScience initiatives,
but for the longer term we hope to inform national initiatives such as 'Connecting for Health.' Our
research seeks models of ownership that maximize the benefits to all parties involved whilst
protecting patient rights in the control of their medical data and the rights of researchers and
commercial entities in their intellectual creations in the public interest. In conclusion, we believe
that establishing a clear framework for the exploitation of the IP in medical data will be vital to the
future of eScience in the healthcare domain.