Every day, we rely on the health care system to provide us with the necessary means to live a healthy life and every day, new health care technologies come to life. The thing is that this sort of innovation rarely respects the traditional boundaries between the different health care professions. Check out this based on my master's thesis on a new screening technology for diabetic eye disease.

1. THE DEONTOLOGICAL PARADOX
When health care ethics and health care
innovation collide

2. 1
ABSTRACT
Every day, we rely on the health care system
to provide us with the necessary means to
live a healthy life and every day, new health
care technologies come to life. However,
this sort of innovation rarely respects the
traditional boundaries between the different
professions, nor their ethical views. So
what happens when health care innovation
collides with health care ethics? How can
we assure evaluation and integration of new
technologies and at the same time guarantee
safety through health care ethics? This
question reveals a paradox of health care
ethics, a deontological paradox.
This article is based on my master’s thesis
on the deontological paradox in health care.
The theory of this paradox was applied to
a qualitative case study in France where a
Danish company tries to introduce their
screening technology for signs of diabetic
eye diseases. The study showed that the
deontological paradox stems from different
ethical views in health care and that an
ethical approach to health care innovation
therefore is needed.
Bertel Kirkeby, School of Business and Social Sciences,
Aarhus University, Denmark, 2015.

3. 2
THE
DEONTOLOGICAL
PARADOX
Introduction
Health care ethics, or deontology, has
two responsibilities: to keep up with
technological progress and to protect
citizens against potentially harmful
technologies and devices. But what happens
when health care innovation collides with
health care ethics? A good example of this
is the case in France where medical ethics
seem to differ from other European countries
in certain areas. The Danish company
RetinaLyze System A/S tries to introduce their
screening technology for the diabetic eye
disease diabetic retinopathy, the leading
cause of blindness in France for people
under 65. This screening method allows
non-medical staff to perform an automated
analysis that can detect early signs of
diabetic retinopathy and refer patients in
need of further examination and treatment
to an ophthalmologist. However, the
technology collides with medical practices
and health care ethics in France where only
ophthalmologists are allowed to screen for
this kind of eye disease due to deontological
constraints. The French case clearly
demonstrates how the two responsibilites
of health care ethics can end in conflict and
stifle innovation.
What happens when health care
innovation collides with health
care ethics?
DESIGN
The results in this article are the results of
my master’s thesis, which was designed as a
qualitative case study including qualitative
interviews and text analysis. The study was
based on the theory of a deontological
paradox, developed through use of ethical
theory. Two qualitative, single-person
interviews were conducted (four were
intended but two respondents refused
to participate, see the Discussion section
on the final page). The interviewees were
the CEO of RetinaLyze System A/S and
the vice-president of the National Union
of Ophthalmologists in France. A number
of texts from health care professionals,
health authorities, health advisers, national
unions and political bodies in France were
analysed. The study also built on innovation
theory, discourse communities theory and
stakeholder management theory.
In order to understand the theoretical
foundation of the deontological paradox, it
is useful to shortly distinguish some of the
ethical theories and in particular medical
ethics theories. Ethical principles naturally

4. 3
MISSION
Medical deontology is a set of moral rules
that must ensure safe practice and keep up
with technological progress.
SECURITY PROGRESS
APPLICATION
Medical deontology must consider
contextual as well as universal
ethical principles.
RELATIVISM UNIVERSALISM
EVALUATION
Medical deontology must consider the
intentions as well as the consequences
of an act.
DEONTOLOGY UTILITARIANISM
The deontological paradox
play an important part here. The need for
security is rooted in the principle of not
doing harm to patients (non-maleficence),
while the need for progress is about doing
good (beneficence). Ethical relativists
claim that ethical principles are entirely
context-dependend and cannot transcend
social and gegraphical realities while
ethical universalism claims the existence
of universal, ethical principles that we all
must comply to. According to deontological
ethics, the intentions of an act determine
the nature and value of this act while the
utilitarian or consequentialist approach
consider only the actual consequences
of this act. These somewhat contradicting
notions come to life every day when people
make decisions and they led me to assume
the existence of a deontological paradox in
the very mission of a medical deontology, a
conflict between security and progress. This
conflict, I assumed, must hold implications
for both health care innovation, for medical
practices and for strategic communication
within the health care sector.
The illustration below sums up the different
ethical positions. This model was used
directly in the analyses of the case study.

5. 4
CASE STUDY
Screening for signs of diabetic eye
disease in France
Growing screening demand
There are 387 million diabetics in the world
in 2015. This number is expected to rise to
nearly 600 milllion by 2035. In France, there
are 4,5 million diabetics. Up to 165 000 of
them have diabetic retinopathy but less than
half are screened regularly due to a lack of
medical staff.
This progression is particularly alarming
because diabetic retinopathy can progress
for years without symptoms, resulting in
irreparable vision loss. Given the financial
costs for society associated with blindness,
not to mention the socio-emotional costs
for the patient, finding a solution to this
development is paramount for national
health care systems around the world.
... but lacking ressources
The low screening rate is a direct result of
the contradicting progression illustrated
below: the number of diabetics is on the
rise while the number of ophthalmologists is
falling. This leads to longer waiting lists and
geographical ‘medical deserts’ as described
by the French Senate in 2014: “The medical
deserts, as well as the prospect of a strong
decrease in the number of doctors in
the years to come, make it necessary to
investigate the possibilities of delegating
tasks to other health care professions in order
to free up medical time and to allow doctors
to focus on core tasks of their profession and
their specific added value.”
2015 2025
5.000.000
6.000.000
5.000
6.000
4.000.000 4.000
3.000.000 3.000
2.000.000 2.000
1.000.000 1.000
4.500.000
5.656
3.840
5.100.000
Number of diabetics in France
Number of ophthalmologists in France
Sources:
National Institute for Statistics and Economic Studies in France
National Union of Ophthalmologists in France
changingdiabetesbarometer.com

6. 5
This is where the automated RetinaLyze
screening method can be used. With a
specialised camera, medical as well as non-
medical staff can take a photo of the back
of the eye (retina-photo) and upload the
image for analysis online. The results are
ready within minutes and will tell whether
or not the algorithm has found lesions on
the retina. If more than three lesions are
detected, the patient is immediately refered
to an ophthalmologist. If three lesions or less
are detected, a new screening is scheduled
within an appropriate time frame.
Freeing up medical time
Using this screening technique, only patients
who need to see a doctor are referred
to one, and the doctor can avoid seeing
hundreds of people who have no illness.
This pre-screening can therefore ensure a
higher screening rate, free up medical time,
allow doctors to focus on core medical tasks
and thereby prevent blindness caused by
diabetic retinopathy.
What is needed is therefore a delegation of
certain tasks from medical to non-medical
staff. In France, there are 3,000–4,000
orthoptists, 5-6,000 ophthalmologists
and 25,000 opticians. Opticians have
shorter educations and are not bound
by deontology, which is why they are not
allowed to perform these screenings in
France as they are in other countries where
the technology is used such as Denmark,
Sweden and Spain.
Orthoptists could perform the screenings
as they are bound by the vow of silence
and they normally work closely with
ophthalmologists when overseeing
the treatment prescribed by the
ophthalmologist. Recently, orthoptists
have been allowed to take retina-photos
which are then sent digitally to analysis
by an ophthalmologist. So far, however,
suggestions to allow orhoptists to perform
ophthalmological pre-screenings have been
refused by the French health authorities.
Innovation in health care in France
To sum up, demographic changes (ageing
population and physical inactivity) raise
A retina-photo is taken by medical or non-medical staff.
The photo is analysed by the RetinaLyze algorithm.
If 0-3 lesions are
found, the patient
returns within
3-12 months to be
screened again.
If more than 3
lesions are found,
the patient is
immediately
refered to an
ophthalmologist.
RetinaLyze®
HOW IT WORKS
the number of diabetics, both diagnosed
and non-diagnosed. An incongruity exists
between the need for eye screenings and
the long waiting lists in France to get an
appointment. New knowledge is transformed
into a new screening technology in health
care by RetinaLyze System A/S in order to
amend this incongruity. This new technology
may stimulate a change in how medical tasks
are delegated between different professions.
When a change in the health care apparatus
is needed, the conflicting nature of health
care ethics shows itself. The conflicts of
interest, rooted in ethical views, become
evident, as is the case in the French health
care sector.

7. 6
It is in this context that I have examined how
the paradox of health care innovation and
health care ethics is constructed. Everyone
involved in this area of society somehow
contributes to one of these two missions in
health care ethics. To examine this, I conducted
two in-depth interviews and analysed a
number of texts from health care professionals,
health advisers, national unions, French health
authorities and other political institutions. The
interviews were analysed thematically using
meaning condensation while the texts were
analysed using a combination of linguistic
analysis, argumentation analysis and discourse
analysis. The model of the deontological
paradox was used in both of the analytical
phases. The following section illustrates
how the interview data was thematised
and condensed and how the model of the
deontological paradox was then used directly
in the analysis. The textual analyses are not
exemplified here but can be found in full
lenght in my master’s thesis (see final page for
reference).
MISSION
Distrust and uncertainty are human reactions to anything new, according to the RetinaLyze
System CEO. The need for security is the main priority for the ophthalmologist vice-president. The
perceived risks mentioned during the interviews (fear of initial user errors, financial loss, increase
in number of non-interpretable retina-photos) in fact stress the need for security, according to the
vice-president. Being bound by the vow of silence is not enough to perform medical acts, which
underscores the importance of security concerns and of the perception of the act in question.
APPLICATION
Both interviewees rely on universal ethics in the form of ethical principals: The CEO proposes an
adaptation of the educational system to match those in other countries in order to improve the
health care system while the vice-president encourages a universal human morality and a moral
selfregulation that can guide the agents’ decisions.
EVALUATION
The CEO focuses on the effects and the potentials of the technology, following a utilitarian
approach. The vice-president focuses on how other health care professions can become more
deontological according to a deontological approach, focused on intentions, procedures and pre-
established rules, especially since common morality seems to be completely missing within the
health care industry today, according to the vice-president.
INTERVIEW 1: CEO, RETINALYZE SYSTEM A/S
THEME
Sub-theme
SEGMENT CONDENSED MEANING
CAUSES
Gaps between professions
“So this is reflected in society and it creates a
situation where these gaps between professions
are allowed to exist much more firmly than they
might in other countries, right?”
The gaps between professions are
very articulated in France.
INTERVIEW 2: VICE-PRESIDENT, NATIONAL UNION OF OPHTHALMOLOGISTS IN FRANCE
THEME
Sub-theme
SEGMENT CONDENSED MEANING
CAUSES
Industry image
“The industry has a major role to play in
innovation but it remains commercial. So it
innovates in order to sell. In this way, it’s role
is clear, they are salespeople, they are in the
business, and their business is to always be the
best.”
Companies innovate in order to
sell.

8. 7
RESULTS
Ethical conflict
The deontological paradox stems from the different ethical views that can be found
within the health care system (non-maleficence/security vs. beneficence/progress). These
ethical views also determine the vision and agenda of a given health care profession (or
professional) which makes them work against each other instead of with each other.
Amplifier
The paradox becomes even more evident in the case of contradicting progressions in
society (health care needs vs. available ressources vs. health care innovation).
Paradox co-creation
All participate in the (re-)production of the deontological paradox. Public and private
health care agents share the same challenges and apply the same strategies.
Need for ethical approach
An ethical approach to health care innovation is not only useful, but necessary. This
is evident in the application of the model of the deontological paradox where ethical
conflicts are revealed on all three levels (MISSION, APPLICATION and EVALUATION).
Perception is everything
The perception of a profession or a specific act can be essential for ressort delegation and
hence for health care innovation. That is why some corporate communication tools are
useful in the health care sector.

9. 8
CONCLUSION
AND SUGGESTIONS
Conclusion
When new technology or new practices
within health care are introduced, health
care innovation and health care ethics may
collide due to contradicting, ethical views,
but also mistrust. One example of this is the
health care industry’s image, often associated
with self-interest, individual gain and profit.
The contradicting ethical views lead the
individual agents, unions and professions to
stress their own position in relation to others
by communicating these views. Health care
innovation is stifled as a result.
Suggestions
The study as well as the litterature on health
care innovation made it possible to give
some suggestions for evaluating new health
care technologies. First, differences in the
educational system between countries
can be diminished since these differences
lead to differences in professional
medical deontology and hence create
individual health care professions across
countries. Health Technology Assessment,
a screening method including horizon
scanning for new technologies, is also
recommended, especially in cooperation
with international review agencies like
EUnetHTA and EuroScan. A higher
degree of intra- and interorganisational
collaboration is encouraged, both internally
between those responsible for innovation,
deontology and market access and between
organisations. It is clear from this and other
case studies that timely evaluation of new
technologies is often hindered due to a lack
of interdisciplinary collaboration. Finally,
economic evaluation of new technologies
is recommended at the regional level
to perform cost-efficiency tests and
potentially use the results at a national scale
subsequently.
The need for strategic communication
in health care innovation
A holistic, interpretative approach to the
health care sector is needed. Corporate
communication offers pertinent tools for pre-
diagnostic and analysis and for stakeholder
identification, analysis and management.
The ultimate, shared goal for the health care
sector is to ensure the safety and welbeing
of citizens, and to do this, corporate
communicaton as a strategic discipline
can evoque predominant, social norms,
demonstrate harmony between apparently
contradicting ethical views and articulate
these shared goals of the individual health
care professions.

10. 9
Sources and further reading
Académie Française d’Ophtalmologie (2011): Les besoins en ophtalmologistes d’ici 2030.
Paris: Académie Française d’Ophtalmologie.
Bason, C. (2010): Leading public-sector innovation: Co-creating for a better society (2nd
ed.). Chicago: The Policy Press.
Beauchamp, T. L. (2007): The ‘four principles’ approach to health care ethics. In R. E.
Ashcroft, A. Dawson, H. Draper & J. R. McMillan (Eds.): Principles of health care ethics (2nd
ed., pp. 3-10). West Sussex: John Wiley & Sons Ltd.
Direction Générale de la Santé (2005): La prévention des complications du diabète. Paris,
Ministère de la Santé et des Solidarités
To study the way the paradox materialises in
society, two more interviews were intended
with two organisations central to the research
questions. One was the French National
Agency for Medicines and Health Products
Safety who, after several conversations by
telephone refused to participate in the
study, partly because they did not have a
section or division in charge of the interface
between innovation and deontology. The
other, The French Union for Opticians,
also refused to participate. The difficulty of
obtaining interviews with key organisations
in this context can be seen as an example of
the equivalent difficulties in evaluating new
technologies within health care.
While qualitative case studies do not seek
statistical generalisations, they do allow
theoretical and analytical generalisations
of their propositions. The theory of a
DISCUSSION POINTS
paradox innate in a concept such as medical
deontology can therefore be applied to
other case studies within the health care
sector and to other social systems based on
professional ethics.
To do this, the model of the deontological
paradox would need to be adapted and
elaborated. Furthermore, in its current form,
it simplifies complex ethical positions, and
the same model is used in different social
contexts. Future research could elaborate
these ethical positions and combine several
case studies in a multiple, mixed methods
case study on the evaluation of new health
technologies across health care systems.
Click here to access the master’s thesis
online.

11. 10
European Council (2007): Directive 93/42/CCE
Hartley, J., Sørensen, E., & Torfing, J. (2013): Collaborative innovation: A viable alternative
to market-competition and organizational entrepreneurship. Public Administration Review,
73(6), 821-830.
Haute Autorité de Santé (2012a): Protocole de coopération : Réalisation d’examens de
dépistage ophtalmologique par une orthoptiste.
Haute Autorité de Santé (2013): Réalisation de photographies du fond d’œil dans le cadre
du dépistage de la rétinopathie diabétique par orthoptiste ou infirmier
Heath, J. (2008): Following the rules: Practical reasoning and deontic constraint. London:
Oxford University Press.
Institut National de la Statistique et des Études Économiques (2014a): Les coûts humains et
financiers du diabète sont très élevés.
International Diabetes Federation (2014): Diabetes in france.
Kirkeby, Bertel (2015): Le paradoxe déontologique - Lorsque la déontologie médicale et
l’innovation de santé se heurtent. Aarhus, Business and Social Sciences, Aarhus University
Pellegrino, E. D. (1993): The metamorphosis of medical ethics. Journal of the American
Medical Association, 269(9), 11581162.
Rao, S. V. (2008): Postmarket evaluation of breakthrough technologies. American Heart
Journal, 156(2), 201-208
Sah, S. (2013): Essays on conflicts of interest in medicine. Business & Society, , 666-678
Sénat français (2014a): Formation des opticiens en trois ans.
Sénat français (2014b): Proposition de loi tendant à favoriser l’accès aux soins oculaires sur
tout le territoire par l’organisation d’une filière de formations en santé visuelle
Syndicat National Autonome des Orthoptistes (2013): Démographie des orthoptistes
Vinck, I., Neyt, M., Thirry, N., Louagie, M., Ghinet, D., Cleemput, I., et al. (2006): Procédure
d’évaluation des dispositifs médicaux émergents. No. 44B. Bruxelles: Centre fédéral
d’expertise des soins de santé
World Health Organization (2015): Diabetes