Legal and Ethical Legal and Ethical Issues in Telemedicine
Legal and Ethical Legal and Ethical Issues in Telemedicine
Legal and Ethical Legal and Ethical Issues in Telemedicine
issues in Telemedicine
EHRA,
25th March 2010
Petra Wilson
Director Connected Health
Director,
Internet Business Solutions Group
• An implanted medical
device
• Software
S ft ffor d
data
t
collection and sharing
• A consumer medical
d i
device
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Medical Devices
Dir 90/385/EEC – Active implantable Medical Devices,
amended
d d by
b 2007/47/EC
¾ Must be safe
¾ Must be accredited with CE mark
¾ Must be supplied with and used in accordance
with manufacturer’s
manufacturer s instructions
¾ Manufacturer must foresee all reasonable uses
¾ Includes anyy software intended byy its manufacturer
to be used specifically for diagnostic and/or
therapeutic purposes
¾ Generally
G ll manufacturer
f t will
ill b
be strictly
t i tl liliable
bl ffor
harm arising from product
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Medical Devices - the doctors’ and
hospitals’ duties
hospitals
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Data Protection and Privacy
• on-line
on line PHR
• shared with cardiologist
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Data Protection and Privacy
Directive 95/46 on Data Protection
¾ Objective: to facilitate internal market through
free movement of data, through harmonized
rules, within a framework of respect for privacy
and personal life (ECHR – art 8)
¾ Provide special protection for sensitive data,
including medical data (art 8)
o informed
i f d consentt
o for medical treatment
o by a healthcare professional
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Data Protection - the doctors’ and
h
hospitals’
it l ’ duties
d ti
Doctor must:
¾ Ensure consent is informed, specific and
freely given.
¾ Ensure patient knows who has access to
what data and for what purpose.
¾ ensure that nominative data is treated
securely
¾ Ensure that ‘technical’ data is treated
securely or anonymised
¾ Enure that specific consent is obtained for
any research
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Data Protection - the doctors’ and
hospitals’ duties
Controller must:
¾ ensure secure storage, processing and
transmission
¾ ensure that processors are fully under his
control.
control
¾ provide access and rectifcation opportunity.
¾ notify supervisory authority
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Telemedicine Services
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Information Society Services
Directive 2000/31 on Information Society
Services and Electronic Commerce
• Applies to some medical services
• Country
C t off origin
i i principle
i i l applies
li
• For regulated professions - detail of
local accreditation, and local applicable
rules
• Special rules on contract formation – right
to rescind
• Telecoms service provider is a ‘mere
conduit’, not liable for the information
transmitted
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Information Society Services II
Directive 2005/36 on Mutual Recognition
of Professional qualifications
• applies to doctors, nurses, midwives,
dentists pharmacists …
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Telemedicine Service Providers’ Duties
Service provider must:
¾ Obtain informed consent of patient
¾ Ensure patient understands country of origin
principle if applicable
¾ Ensure secure storage,
storage processing and
transmission
¾ Ensure medical staff are fully briefed
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Telemedicine Service - doctors’ and
hospitals’ Duties
Healthcare providers must:
¾ Obtained informed consent of patient
¾ Ensure patient understands limits of the
services
¾ Ensure adequate coverage
¾ Ensure adequate training
¾ Ensure
E adequate
d t insurance
i
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End of Life Issues
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End of Life Issues II
• Terminally ill patients
¾ Life sustaining or life enhancing
¾ In patients’ best interests
¾ D i specific
Device ifi
¾ Doctrine of double effect
• Personnel involved
¾ Technical or medical staff
staff, remains
medical responsibility
¾ Gu
Guidelines
de es needed
eeded ((ACC/AHA/HRS
CC/ / S
2009)
¾ Training needed
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Telemedicine - Public Trust is Key
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Thank you
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