1. Internetable Health Data in a Globalized Society
11/17/2018
Internetable Health Data in a Globalized Society
Challenges and Solutions

2. Presented by: Renato M.E. Sabbatini, PhD
Director, Center for Biomedical Informatics
Chairman of Medical Informatics, Medical School
State University of Campinas
Brazil 2

3. The Fundamental Issue
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. 3

4. The Key Facts
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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5. Main Types of Distance Medical Practice
Patient education
Patient screening and referral
Clinical case discussion
Second-opinion consultation
Distance diagnosis and therapy 9

6. Telemedicine is Beneficial
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): , 1997. 10

7. Main Barriers to Telemedicine
Reimbursement for Telemedicine Services
Licensure and Credentialing
Medical Malpractice Liability
User Identification and Accountability
Confidentiality 11

8. The Practice of Medicine
[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 [.] 8

9. A Possible Scenario
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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10. Another Scenario
Dr. Y, from a Latin America country, offers high quality and chat-based psychiatric advice to American patients, at 20 dollars per consultation.
He is being forced out of business by cut-rate cybertherapists from the former East block, who are charging 5 dollars only. 6

11. Statement
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
11/17/2018

12. 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 ?
In some cases yes
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13. International Telemedicine
Evasion of malpractice liability
Evasion of drug/device regulation
Evasion of human research ethics
Evasion of database copyright issues 5

14. Economic Advantages of International Telemedicine
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) 7

15. 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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16. International Issues
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
How to protect patient confidentiality in an international scale ? 12

17. What We Need
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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18. A Framework for GII a unifying vision; a code of ethics;
guidelines for fair use;
management structures; and
law-enforcement coordination.
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19. A Framework for GII a unifying vision; a code of ethics;
guidelines for fair use;
management structures; and
law-enforcement coordination.
Workable in an international setting,
within a community
Presently unworkable
in an international
setting
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20. Possible Solutions
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 13

21. How to Solve the Licensing Problem ?
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
There is no easy equivalence for the international situation
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22. How to Solve the Liability Problem ?
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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23. How to Solve the Accountability Problem ?
Legal enforcement very difficult, especially across international borders
Implementation of foolproof user authentication schemes (e.g., VeriSign)
Implementation of no-download, no-caching protocols, with data owner enabling
Implementation of digital watermarks
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24. Some Guidelines
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)
11/17/2018

25. Desirable Codes of Ethics
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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26. Codes of Conduct for Medical Sites
The Health on the Net Foundation
Medical Matrix
11/17/2018

27. 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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28. Internet Resources Center for Telemedicine Law http://www.ctl.org/
NLM BioethicsOnLine Search
Arent Fox Telemedicine Home Page
University of Wisconsin’s Bioethics On-Line
MedWeb’s Bioethics 14

29. Contact
Renato M.E. Sabbatini
Center for Biomedical Informatics State University of Campinas, Brazil PO Box 6005, ZIP
Voice ( ) ext. 141 Fax ( )
11/17/2018