We conducted an ethical analysis of a Patient Empowerment Tool. The identified relevant ethical aspects were organized in ethical requirement clusters. These were further analysed for consequences for the structure of the tool and a suitable user interface of the Patient Empowerment Service. A central role that will be played by the Patient Empowerment Service is to guarantee patient autonomy and informed patient’s decisions. A User Interface Model that addresses our ethical concerns will allow user access channeled through a series of adaptable profiles that enable autonomy and present data in an understandable way with build-in support by help and guidance functions. In this way, it becomes possible to ensure patient autonomy even under adverse conditions, like access to unfavoable information, negative diagnoses, incomprehensible risk / benefit display, and other factors that impede the informed decision potential of the patient.

1. Ethical concerns caused by
integrative patient empowerment
solutions for personalized medicine
Ethical concerns caused by
integrative patient empowerment
solutions for personalized medicine
Wolfgang Kuchinke
Annual International Conference of the IEEE Engineering in
Medicine and Biology Society, 3-7 July 2013 in Osaka, Japan

2. W. Kuchinke 2013
2
Summary
• The highly integrative nature of Patient Empowerment
Service raises ethical concerns
• Employing special features in user interfaces of the
Service
– it is possible to ensure patient autonomy even
under adverse conditions
– like access to unfavoable information, negative
diagnoses, incomprehensible risk/benefit display,
and other factors that impede the decision
potential of the patient

3. W. Kuchinke 2013
3
Personalized medicine
• Personalized medicine promises targeted treatments with
high therapeutic effectiveness
• It requires an unmatched degree of participation of the
patient
• To enable this high degree of patient empowerment, the
project p-medicine developed a Patient Empowerment Tool
that is part of a clinical research infrastructure
• Patient autonomy is enhanced by giving patients access to
their data and by providing means for informed choices and
consent.

4. W. Kuchinke 2013
4
p-medicine project
• FP7 project p-medicine: From data sharing and
integration via VPH models to personalized medicine
– IT infrastructure to accelerate personalized
medicine and personal clinical research
• Patient Empowerment Tool is an integrative part of the
infrastructure
• It helps patients to understand their medical
documentation and to empower them to make
informed decisions

5. Patient Empowerment Service

6. W. Kuchinke 2013
6
Patient Empowerment Service
• p-medicine will develop an Patient Empowerment Tool
called Interactive Empowerment Service (IemS)
• Aim
– Help patients to understand their medical documentation
– Empower them to make informed choices and decisions
– Support personalized clinical trials
– Enables patients to understand the whole data set that the
hospital has collected about them

7. W. Kuchinke 2013
7
Patient Empowerment
• Patient Empowerment implies that patients are able to
understand medical statements and the data requested,
as well as legal and ethical considerations
• For this purpose, the Empowerment Service has to
– help patients understand their data and documents
– monitor and implement donors’ decisions on research
to be performed on their data and samples

8. W. Kuchinke 2013
8
Patient interactivity
• One of the key features of the empowerment service
will be patient interactivity
• The patient will have the possibility
– to view data organized according to her / his
perception of the domain,
– to retrieve patient-understandable information
– to state decisions
• Such patient empowerment will put patients in control
over the use of their data

9. Approach and Method
• Ethical analysis of the Patient Empowerment
Tool by legal and ethical experts in the p-
medicine group and literature search
• Identification of relevant ethical aspects
organized in ethical requirement clusters
• User interface model addressing these
concerns

10. The four Traditional Pillars of Medical Ethics
• Beneficience / Non-malefience
• Privacy / Confidentiality
• Autonomy
• Justice

11. W. Kuchinke 2013
11
Ethical analysis
• Ethical analysis of the Patient Empowerment Tool by
legal and ethical experts in the p-medicine group
• Identification of relevant ethical aspects based on the
4 Pillars of Medical Ethics in relation to the use of the
p-medicine infrastructure
• Ethical aspects were organized in ethical requirement
clusters
• The ethical requirements were further analysed for
consequences for the structure of the user interface of
the Patient Empowerment Service

12. Ethical requirements
Literature search
Interviews
Analysis of p-medicne infrastrcuture
Requirements analysis process
Search for applicable
ethical concepts 4 Ethical pillars
Recommendations
for user interfaces
relevant aspects /
requirements
Relations of requirements
to p-medicine tools
Ethical use cases

13. The four Traditional Pillars of Medical Ethics
• The described main ethical principles (the 4
pillars of medical ethics) were put into relation to
ethical concepts and topics relevant for the
conduct of clinical trials and the working of the p-
medicine infrastructure
• They were arranged to highlight relationships
– Focus was on relationships between these ethical
concepts and p-medicine tools that will be used in
GCP clinical trials

14. Ethical requirement clusters
• Requirements cluster are indicated as blue
circles
– The diagram depicts that for p-medicine
trials the main relationships with ethical
concern are between the patient (informed
consent, vulnerable populations, paediatric
trials, serious diseases) the IRB/Ethics
Committees (AE reporting, risk for patient,
inspections), the data protection framework
(data privacy, data monitoring) and the
investigator (financial relationship, data
falsification, quality)

15. W. Kuchinke 2013
15
Ethical requirement
clusters

16. Relations between ethical
requirement clusters
• The patient empowerment tool connects
requirements for informed consent with the
ones for vulnerable populations
• p-medicine contracts / agreements connect
requirements for personal data with
investigator related requirements

17. Requirement for Patient
Empowerment
• A central role will be played by the Patient
Empowerment tool in
– Improving patient autonomy and
patient’s decisions
– Enriching personalised medicine trials
– Ensuring data privacy and confidentiality

18. Ethical requirements for patient empowerment
• Many terms related to the principles of autonomy and
justice cluster around patient empowerment and the
user web portal
• The terms “inability to give informed consent”,
“informed consent”, “equipoise”, “treatment after end
of trial”, “research benefit”, “premature termination”
and “critically ill participants” are clustered around
Patient empowerment.
• “Recruitment and sample size” and “follow-up” are
clustered around the portal

19. Ethical requirements for patient empowerment
• There is a considerable overlap of ethical issues of
autonomy / justice with patient empowerment and the
user portal
• For the concepts of “commercial sponsorship” and
“publication ethics” no direct relation to the p-
medicine tools were found
• The identified ethical requirements were evaluated for
their importance for the Patient Empowerment Tool
and organised around the Patient Empowerment
concept according to their importance
• Ethical requirements were expressed as concerns to
address improvements of the user interface

20. W. Kuchinke 2013
20
Ethical Consideration

21. Ethical Concerns
• The use of all p-medicine tools and
the entire infrastructure must be
safe for the patient

22. Ethical Concerns
• Capture of patient data by p-medicine tools has
to be accurate, reliable and correct
• The entry of inaccurate data may occur because
of typographical or logical errors
• The system should provide validating functions
to avoid errors
• Functions to point the investigator’s attention to
noticeable problems
• The CDMS should also provide a logging tool
which tracks any changes to the data

23. Ethical concerns
• Security of the portal so that unauthorised
person do not have access to the data
• The security of the network will be considered
and necessary measures taken to fortify it,
depending on the risks represented by the
processing and the nature of the data
• Psychological issues where a trial participant
accesses data from the portal and is not
comfortable with the result
– For example diagnostic imaging may reveal
diseases that were not under investigation
and for which there is no available cure

24. Ethical concerns
• Right “not-to-know”
– Patients may not want to know that they
(will) suffer from an incurable disease
• Should the design of image technologies enable
selective imaging of the patient’s body
• Controversial is also the issue of brain imaging
– Which can reveal a person’s mental state or
plans for action
• The use of the portal will have to be adequately
regulated and help functions provided

25. User Interface Model that Addresses
Ethical Concerns
• Principles to consider ethical demands
– User access channeled through a series of
adaptable profiles that enable autonomy and
present data understandable
– Build-in support by help and guidance functions
– Consideration of different levels of medical
literacy
– Profiles for cancer patients, patients with life-
threatening diseases, paediatrics trials, and
chronic diseases
• Result is built-in ethics in the Patient Empowerment

26. Built-in ethics
User Interface
Patient Empowerment
Tool
p-medicine infrastructure
and databases
personalisation
guidancehelp
hiding /
protection
User interface
adapts to the
needs of the user
Built-in functions that
establish ethical
requirements

27. User Interface Model that Addresses
Ethical Concerns
• Patient profiles for patients with different psycho-
cognitive profiles were created
• Filters assign portal users to a specific profile
– Patients can modify profiles and change
specifications
●
e.g. define which information should be
hidden
– Specific display of information about risks,
alternatives, benefits
– Specific help and guidance by fatal diagnosis

28. Profile based
personalised
User Interface

29. W. Kuchinke 2013
29
Data input for Patient
Empowerment
• Data input covers
– patient data, biobank data, clinical trials data, and
informed consent (IC) data
– psycho-cognitive data of the patient
• Output data covers decision support, data about
available clinical trials, biobank information
• Informed consent management, information on clinical
trials

30. W. Kuchinke 2013
30
Patient’s point of view
• The patient has the opportunity to have
access to such her / his clinical data
• In the Patient Health Record the patient
can follow the journey of his/her data
• The patient can base on the data her / his
decision process

31. Ethical concerns based on functional
integration
• With the p-medicine portal that provides many
incorporated functions for data and sample
management, imaging and Patient
Empowerment a new level of data integration is
reached
• Resulting also in a new level of ethical concern
– Example: patient participating in a trial and
using access to unfavorable clinical
information, negative diagnosis, high health
risks, etc.
– Patient may become unable to derive at a
decision

32. Examples of ethical concerns
• From the ethical point of view, sufficient guidance, special
help for users from vulnerable populations, special
help/guidance for patients with life threatening disease
should be provided when the patient is using the tool
• The system should check all steps and information provided
for correctness, so that the display of wrong information, e.g.
a fatal diagnosis, is prevented
– Results with negative or fatal diagnosis should be
checked for correctness
• Access to information about life threatening information or
negative prognoses should be done in a sensitive way
• The patient has the right to “not-to know”
– The Patient Empowerment tool should consider this
option and provide a corresponding user interface
– Ability to hide information may be wished for

33. Novel possibilities for
interoperability
• The p-medicine platform offers many novel
possibilities for interoperability and sharing in
clinical trials
• The Patient Empowerment Service and Portal
tools may play a role in Adverse Event reporting,
maintaining relationships with IRB/EC, Quality of
Life recording and in special support of
vulnerable populations and trial participants with
serious diseases
• The data protection framework may also be used
to prevent data falsification and financial
conflicts of interest by the investigators

34. W. Kuchinke 2013
34
Reference
• Kuchinke W. Ethical concerns caused by integrative
patient empowerment solutions for personalized
medicine. Annu Int Conf IEEE Eng Med Biol Soc.
2013;2013:4775-8. doi: 10.1109/EMBC.2013.6610615.
PMID: 24110802.

35. W. Kuchinke 2013
35
Literature
• D5.2 Report on legal and ethical issues regarding data
warehouse, data mining and IP issues
• D5.3 Report on legal and ethical issues regarding access to
biobanks
• D5.4 Report on legal and ethical issues regarding patient
empowerment

36. wokuchinke@outlook.de
wolfgang.kuchinke@uni-duesseldorf.de
More information about the patient empowerment tool: www.p-medicine.eu
Wolfgang Kuchinke
Heinrich-Heine University, Duesseldorf, Germany
Presentation accompanying the poster and
contains additional explanatory material
Contact