Transcript Internetable Health Care in a Borderless Society

7/17/2015
Internetable Health Data in a
Globalized Society
Challenges and Solutions
Presented by:
Renato M.E. Sabbatini, PhD
Director, Center for Biomedical Informatics
Chairman of Medical Informatics, Medical School
State University of Campinas
Brazil
The Fundamental Issue
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The existence of interactive global networks has
made possible, for the first time, the practice of
medicine across borders, without physical contact
between patient and health care provider;
The ethical and legal issues are tantalizing and
remain largely unsolved.
The Key Facts
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Internet has dissolved geographical
boundaries, but not political ones
Community standards and legislation varies
greatly from place to place
A borderless networked society is a totally
new experience and removes empowerment
from traditional communities
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Main Types of Distance
Medical Practice
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Patient education
Patient screening and referral
Clinical case discussion
Second-opinion consultation
Distance diagnosis and therapy
Telemedicine is Beneficial
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Distance medicine technology enables greater
continuity of care by improving access and
supporting the coordination of activities by a
clinician.
Electronic Communication With Patients.
Evaluation of Distance Medicine Technology.
E. Andrew Balas, MD, PhD; Farah Jaffrey, MSc; Gilad J.
Kuperman, MD, PhD; Suzanne Austin Boren, MHA; Gordon D.
Brown, PhD; Francesco Pinciroli, LEE; Joyce A. Mitchell, PhD
JAMA 278(2): 152-159, 1997.
Main Barriers to Telemedicine
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Reimbursement for Telemedicine Services
Licensure and Credentialing
Medical Malpractice Liability
User Identification and Accountability
Confidentiality
The Practice of Medicine
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[a]ny person shall be regarded as practicing
medicine or surgery . . . who shall
diagnose or attempt to diagnose, treat or
attempt to treat, operate or attempt to
operate on, or prescribe for or administer to,
or profess to treat any human ailment,
physical or mental, or any physical injury to
or deformity of another person [.]
A Possible Scenario
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Dr. X, from the USA, teams up with Dr. Y, from
an African country, to carry out clinical trials with
a large malpractice potential, using experimental
drugs and/or devices.
All clinical data belong to Dr. X;
The costs are much lower than in the USA;
Dr. X is never required to leave the USA;
Dr. X is safe from prosecution in the country
where the study was performed
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Another Scenario
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Dr. Y, from a Latin America country, offers
high quality email and chat-based
psychiatric advice to American patients, at
20 dollars per consultation.
He is being forced out of business by cutrate cybertherapists from the former East
block, who are charging 5 dollars only.
Statement
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Accountability of users and liability of
information providers are probably the two
most important issues to resolve if
computer-mediated communication is to
become the accepted and most prevalent
form of communication on the electronic
superhighways of tomorrow.
Anne Wells Branscomb
7/17/2015
The Looming Questions
How one may implement and enforce
accountability and liability across
international borders ?
There is no clear answer
 Are health care providers going to exploit
the loopholes in this situation in order to
increase revenues without incurring
liabilities ?
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In some cases yes
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International Telemedicine
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Evasion of malpractice liability
Evasion of drug/device regulation
Evasion of human research ethics
Evasion of database copyright issues
Economic Advantages of
International Telemedicine
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Expansion of the market base
Capture of more private practice
Evasion of capitation, medical rationing and
related issues
Decrease in costs
Added value in health insurance plans (e.g.,
international second opinion)
International Issues
The collection, use, reuse and
communication of data determines issues
such as data governance, property and
confidentiality
 The absence of international laws and
proper court of justice twarts the legal
enforcement of moral/ethical desiderata
 There is a need to define better the social
goals of a global information infrastructure
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International Issues
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How to synchronize regulations and legislation in
different countries ?
How to enforce standards and quality of care ?
How to improve data governance in an
international scale ?
– disclosure and retention of patient data;
– copyrights of medical database
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How to protect patient confidentiality in an
international scale ?
What We Need
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The Global Information Infrastructure needs
a new framework, or rather a set of new
frameworks, regarding the generation,
storage, use and transmission of information
across borders
The general framework will be construed
with basis on local frameworks
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A Framework for GII
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a unifying vision;
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a code of ethics;
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guidelines for fair use;
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management structures; and
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law-enforcement coordination.
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A Framework for GII
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a unifying vision;
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a code of ethics;
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guidelines for fair use;
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management structures; and
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law-enforcement coordination.
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Workable in an
international setting,
within a community
Presently unworkable
in an international
setting
Possible Solutions
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Special licensing procedures for
professionals from other countries involved
in telehealth procedures
Adherence to universal patient data
protection standards
An international advisory committee of
experts in telemedicine law and ethics
How to Solve the Licensing
Problem ?
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AMA recommendations:
– Licensing should be required in the state where the
patient is receiving treatment
– Need for licensing may be waived in cases of medical
emergency or when telemedical activity is occasional
– Special multistate licensing should be issued for
telemedical practice by the Federation of State Boards
of Medical Examiners
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There is no easy equivalence for the international
situation
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How to Solve the Liability
Problem ?
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All breaches of conduct or of law which
occur by virtue of data flow across state
lines shall be investigated, prosecuted and
judged by federal agencies and courts
There are some equivalents for the
international situation (e.g., Interpol,
extradiction treaties, international court of
justice), but not for data flow situations.
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How to Solve the
Accountability Problem ?
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Legal enforcement very difficult, especially
across international borders
Implementation of foolproof user
authentication schemes (e.g., VeriSign)
Implementation of no-download, nocaching protocols, with data owner enabling
Implementation of digital watermarks
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Some Guidelines
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A distinction should be made between
moral responsibility and legal responsibility
The sender of the message rather than the
messenger is responsible for the content of
the message
Any electronic community should promote
awareness of the moral standards it requires
for behavior within its own boundaries
Mark Frankel (AAAS)
7/17/2015
Desirable Codes of Ethics
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The public and private use of networked
information should be defined only by its
owners
Intellectual ownership and copyrights
should be respected for all materials
available through the Internet
Data may be altered or added only by its
owners
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Codes of Conduct for
Medical Sites
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The Health on the Net Foundation
http://www.hon.ch
Medical Matrix
http://www.medmatrix.org
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The HON Code of Conduct
for Medical Websites
Medical advice is provided by qualified professionals only
 Information is provided to support, not to replace patient
care
 Patient confidentiality is respected according to the rules of
the country where the information is located
 Information is supported by clear reference to its source
 Claims for benefit or performance is based on evidence
 Contact and authorship information is provided
 Sponsorship is clearly identified
 Advertisement policy is stated and the information
provided by is clearly separated from the rest
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Internet Resources
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Center for Telemedicine Law
http://www.ctl.org/
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NLM BioethicsOnLine Search
http://www.healthgate.com/AMA/search.html
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Arent Fox Telemedicine Home Page
http://arentfox.com/telemedicine
University of Wisconsin’s Bioethics On-Line
http://www.mcw.edu/bioethics/
MedWeb’s Bioethics
http://www.gen.emory.edu/MEDWEB
Contact
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Renato M.E. Sabbatini
[email protected]
http://nibgw.unicamp.br/~sabbatin
Center for Biomedical Informatics
State University of Campinas, Brazil
PO Box 6005, ZIP 13081-970
Voice (0055 19) 239-9800 ext. 141
Fax (0055 19) 788-4717
7/17/2015