1. Ethical and Legal Issues in Internetable Health Care Across Borders The Issues The Barriers The Resources The 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

3. The Fundamental Issue t 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; t The ethical and legal issues are tantalizing and remain largely unsolved because they require international law and court of justice.

4. A Free-for-All Scenario t 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. t All clinical data belongs to Dr. X; t The costs are much lower than in the USA; t Dr. X is never required to leave the USA; t Dr. X is safe from prosecution

5. “Advantages” of International Telemedicine t Avoidance of malpractice liability t Avoidance of drug/device regulation t Avoidance of human research ethics t Avoidance of database copyright issues

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

7. Economic Advantages of International Telemedicine t Expansion of the market base t Capture of more private practice t Avoidance of capitation and related issues t Decrease in costs t Added value in health insurance plans (international second opinion)

8. The Practice of Medicine t [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 [.]

9. Main Types of Distance Medical Practice t Patient education t Patient screening and referral t Clinical case discussion t Second-opinion consultation t Distance diagnosis and therapy

10. Telemedicine is Beneficial t 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. 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.

11. Main Barriers to Telemedicine t Reimbursement for Telemedicine Services t Licensure and Credentialing t Medical Malpractice Liability t Confidentiality

12. International Issues t The status of regulations and legislation in different countries t How to enforce standards and quality of care t Data governance in an international scale: –disclosure and retention of patient data; –copyrights of medical database t Protection of patient confidentiality in an international scale

13. Possible Solutions t Special licensing procedures for professionals from other countries involved in telehealth procedures t Adherence to universal patient data protection standards t An international advisory committee of experts in telemedicine law and ethics

14. Internet Resources t Center for Telemedicine Law http://www.ctl.org/ t NLM BioethicsOnLine Search http://www.healthgate.com/AMA/search.html t Arent Fox Telemedicine Home Page http://arentfox.com/telemedicine t University of Wisconsin’s Bioethics On-Line http://www.mcw.edu/bioethics/ t MedWeb’s Bioethics http://www.gen.emory.edu/medweb/medweb.html

15. Contact t Renato M.E. Sabbatini sabbatin@nib.unicamp.br http://nibgw.unicamp.br t Center for Biomedical Informatics State University of Campinas, Brazil PO Box 6005, ZIP 13081-970 t Voice (0055 19) 239-9800 ext. 141 Fax (0055 19) 788-4717