Internetable Health Data in a Borderless Society.

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Presentation transcript:

Internetable Health Data in a Borderless Society

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

A Few Facts t Internet has dissolved geographical boundaries, but not political ones t Community standards and legislation varies a lot from place to place t A borderless networked society is a totally new experience and removes empowerment of traditional communities

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.

Statement t 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

A Possible 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 in the country where the study was performed

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 [.]

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

“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

Another Free-for-All Scenario t Dr. Y, from a Latin America country, offers high quality 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.

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)

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): , 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.

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

What We Need t 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 t The general framework will be construed with basis on local frameworks

A Framework for GII t a unifying vision; t a code of ethics; t guidelines for fair use; t management structures; and t law-enforcement coordination.

A Framework for GII t a unifying vision; t a code of ethics; t guidelines for fair use; t management structures; and t law-enforcement coordination. Workable in an international setting, within a community Workable in an international setting, within a community Presently unworkable in an international setting Presently unworkable in an international setting

Some Guidelines t A distinction should be made between moral responsibility and legal responsibility t The sender of the message rather than the messenger is responsible for the content of the message t Any electronic community should promote awareness of the moral standards it requires for behavior within its own boundaries Mark Frankel (AAAS)

Borderless Issues t The collection, use, reuse and communication of data determines issues such as data governance, property and confidentiality t The absence of international laws and proper court of justice twarts the legal enforcement of moral/ethical desiderata t There is a need to define better the social goals of a global information infrastructure

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

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

Codes of Conduct for Medical Sites t The Health on the Net Foundation t Medical Matrix

The HON Code of Condut for Medical Websites t Medical advice is provided by qualified professionals only t Information is provided to support not to replace patient care t Patient confidentiality is respected according to the rules of the country where the information is located t Information is supported by clear reference to its source t Claims for benefit or performance is based on evidence t Contact and authorship information is provided t Sponsorship is clearly identified t Advertisement policy is stated and the information provided by is clearly separated from the rest

Desirable Codes of Ethics t The public and private use of networked information should be defined only by its owners t Intellectual ownership and copyrights should be respected for all materials available through the Internet t Data may be altered or added only by its owners

Internet Resources t Center for Telemedicine Law t NLM BioethicsOnLine Search t Arent Fox Telemedicine Home Page t University of Wisconsin’s Bioethics On-Line t MedWeb’s Bioethics

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