Legal and Ethical Legal and Ethical Issues in Telemedicine

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Legal and Ethical

issues in Telemedicine

EHRA,
25th March 2010

Petra Wilson
Director Connected Health
Director,
Internet Business Solutions Group

Petra Wilson © 2009 Cisco Systems, Inc. All rights


Cisco reserved.
Confidential 1
Adam’s Story

Adam has had some problems in the


past with his cardiac and general
health:
¾ He is overweight (BMI 29)
¾ He has mild hypertension (average BP
140/100)
¾ He has a recent history ventricular
y
tachycardia
¾ He has been diagnosed as at risk of
recurrent ventricular tachycardia
Joost Drieman © 2006 Cisco Systems, Inc. All rights reserved. Cisco Confidential 2
Adam’s Story
ƒ After consultation with his cardiologist Adam has now
entered a ‘Supported Heart Health Programme’ which has
the following components:
¾Implanted cardioverter defibrillator with data report and
remote reset functionality
¾ Personal use sphygmomanometer with wireless data
report functionality
¾ Web based PHR which obtains heart rhythm and BP
data from devices wirelessly
¾ Automated physician alert tool in PHR activated when
parameters are exceeded
¾ Targeted dietary advice provided through the PHR
p g to the p
webpage patient.
¾ Integration of PHR data into EHR
Joost Drieman © 2006 Cisco Systems, Inc. All rights reserved. Cisco Confidential 3
Legal Issues in Adam’s Programme
Medical Devices
(Dir 90/385/EEC – Active implantable Medical Devices, amended by
2007/47/EC)
• Duties of a medical device manufacturer or vendor
• Duties of a device user (patient and professional)
Data Protection and Privacy
(Dir 95/46/EC – Data Protection)
• Rights of a patient or consumer • Snapshot
• Duties of a data controller
• Duties of the device manufacturer • EU level law only
Liability for Goods and Services •No
No general medical
(Dir. 85/374/EC & Directive 1999/34/EC - law
Liability for Defective Products;
Dir. 2001/95/EC - Product Safety; y • End-of-life
do e
Dir. 1999/44/EC - Sale of Goods;
Dir. 2000/31/EC – eCommerce)
issues
• Duties of a manufacturer or vendor
• Rights of a purchaser
• Duties of an eServices supplier
Joost Drieman © 2006 Cisco Systems, Inc. All rights reserved. Cisco Confidential 4
Medical Devices Regulation

• An implanted medical
device

• Software
S ft ffor d
data
t
collection and sharing

• A consumer medical
d i
device

Joost Drieman © 2006 Cisco Systems, Inc. All rights reserved. Cisco Confidential 5
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

Joost Drieman © 2006 Cisco Systems, Inc. All rights reserved. Cisco Confidential 6
Medical Devices - the doctors’ and
hospitals’ duties
hospitals

¾ Ensure that it is used within


manufacturer’s guidelines
¾ Ensure that any software used with it is
duly accredited as a part of the device or as
an accessory
¾ Ensure the patient understands how to
use the
th d device
i - possible
ibl contributory
t ib t
liability of patient

Joost Drieman © 2006 Cisco Systems, Inc. All rights reserved. Cisco Confidential 7
Data Protection and Privacy

• on-line
on line PHR
• shared with cardiologist

Joost Drieman © 2006 Cisco Systems, Inc. All rights reserved. Cisco Confidential 8
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

Directive 2002/58 Electronic Communications


• Security of networks and services
• Confidentiality of communications

Joost Drieman © 2006 Cisco Systems, Inc. All rights reserved. Cisco Confidential 9
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

Joost Drieman © 2006 Cisco Systems, Inc. All rights reserved. Cisco Confidential 10
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

Joost Drieman © 2006 Cisco Systems, Inc. All rights reserved. Cisco Confidential 11
Telemedicine Services

• Remote Physician Alert


• Web
W b based
b d patient
ti t
advice

Joost Drieman © 2006 Cisco Systems, Inc. All rights reserved. Cisco Confidential 12
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
Joost Drieman © 2006 Cisco Systems, Inc. All rights reserved. Cisco Confidential 13
Information Society Services II
Directive 2005/36 on Mutual Recognition
of Professional qualifications
• applies to doctors, nurses, midwives,
dentists pharmacists …

Directive 1997/7 on distance contracts


• right to restrict certain trade on basis of
public safety

Directive 2001/83 on medicinal products


for human use
• No direct to consumer advertising of
POM

Joost Drieman © 2006 Cisco Systems, Inc. All rights reserved. Cisco Confidential 14
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

Joost Drieman © 2006 Cisco Systems, Inc. All rights reserved. Cisco Confidential 15
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

Joost Drieman © 2006 Cisco Systems, Inc. All rights reserved. Cisco Confidential 16
End of Life Issues

¾ Advance Directives and


Living Wills
¾ Patients
Patients’ Right to Decide
¾ Patients’ capacity to
decide
¾ Ensuring patient
understands what will
happen
¾ Life sustaining or life
enhancing
¾ Personnel to be involved

Joost Drieman © 2006 Cisco Systems, Inc. All rights reserved. Cisco Confidential 17
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

Joost Drieman © 2006 Cisco Systems, Inc. All rights reserved. Cisco Confidential 18
Telemedicine - Public Trust is Key

Joost Drieman © 2006 Cisco Systems, Inc. All rights reserved. Cisco Confidential 19
Thank you

Petra Wilson, Director Connected Health


Internet Business Solutions Group,
Group Cisco

Presentation_ID © 2006 Cisco Systems, Inc. All rights reserved. Cisco Confidential 20

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