Internetable Health Data in a Internetable Health Data in a Borderless SocietyBorderless Society

Presented by:Presented by:

Renato M.E. Sabbatini, PhDDirector, Center for Biomedical InformaticsChairman of Medical Informatics, Medical SchoolState University of CampinasBrazil

A Few FactsA Few Facts

Internet has dissolved geographical Internet has dissolved geographical boundaries, but not political onesboundaries, but not political ones

Community standards and legislation varies Community standards and legislation varies a lot from place to placea lot from place to place

A borderless networked society is a totally A borderless networked society is a totally new experience and removes empowerment new experience and removes empowerment of traditional communitiesof traditional communities

The Fundamental IssueThe Fundamental Issue

The existence of interactive global networks has The existence of interactive global networks has made possible, for the first time, the practice of made possible, for the first time, the practice of medicine across borders, without physical contact medicine across borders, without physical contact between patient and health care provider;between patient and health care provider;

The ethical and legal issues are tantalizing and The ethical and legal issues are tantalizing and remain largely unsolved because they require remain largely unsolved because they require international law and court of justice.international law and court of justice.

StatementStatement

Accountability of users and liability of Accountability of users and liability of information providers are probably the two information providers are probably the two most important issues to resolve if most important issues to resolve if computer-mediated communication is to computer-mediated communication is to become the accepted and most prevalent become the accepted and most prevalent form of communication on the electronic form of communication on the electronic superhighways of tomorrow. superhighways of tomorrow.

Anne Wells BranscombAnne Wells Branscomb

A Possible ScenarioA Possible Scenario

Dr. X, from the USA, teams up with Dr. Y, from Dr. X, from the USA, teams up with Dr. Y, from an African country, to carry out clinical trials with an African country, to carry out clinical trials with a large malpractice potential, using experimental a large malpractice potential, using experimental drugs and/or devices. drugs and/or devices.

All clinical data belongs to Dr. X;All clinical data belongs to Dr. X; The costs are much lower than in the USA; The costs are much lower than in the USA; Dr. X is never required to leave the USA;Dr. X is never required to leave the USA; Dr. X is safe from prosecution in the country Dr. X is safe from prosecution in the country

where the study was performedwhere the study was performed

The Practice of MedicineThe Practice of Medicine

[a]ny person shall be regarded as practicing [a]ny person shall be regarded as practicing medicine or surgery . . . who shall medicine or surgery . . . who shall diagnose or attempt to diagnose, treat or diagnose or attempt to diagnose, treat or attempt to treat, operate or attempt to attempt to treat, operate or attempt to operate on, or prescribe for or administer to, operate on, or prescribe for or administer to, or profess to treat any human ailment, or profess to treat any human ailment, physical or mental, or any physical injury to physical or mental, or any physical injury to or deformity of another person [.]or deformity of another person [.]

Main Types of Distance Main Types of Distance Medical PracticeMedical Practice

Patient educationPatient education Patient screening and referral Patient screening and referral Clinical case discussionClinical case discussion Second-opinion consultation Second-opinion consultation Distance diagnosis and therapyDistance diagnosis and therapy

““Advantages” of International Advantages” of International TelemedicineTelemedicine

Avoidance of malpractice liabilityAvoidance of malpractice liability Avoidance of drug/device regulationAvoidance of drug/device regulation Avoidance of human research ethicsAvoidance of human research ethics Avoidance of database copyright issuesAvoidance of database copyright issues

Another Free-for-All ScenarioAnother Free-for-All Scenario

Dr. Y, from a Latin America country, offers Dr. Y, from a Latin America country, offers high quality email and chat-based high quality email and chat-based psychiatric advice to American patients, at psychiatric advice to American patients, at 20 dollars per consultation.20 dollars per consultation.

He is being forced out of business by cut-He is being forced out of business by cut-rate cybertherapists from the former East rate cybertherapists from the former East block, who are charging 5 dollars only.block, who are charging 5 dollars only.

Economic Advantages of Economic Advantages of International TelemedicineInternational Telemedicine

Expansion of the market baseExpansion of the market base Capture of more private practiceCapture of more private practice Avoidance of capitation and related issuesAvoidance of capitation and related issues Decrease in costsDecrease in costs Added value in health insurance plans Added value in health insurance plans

(international second opinion)(international second opinion)

Telemedicine is BeneficialTelemedicine is Beneficial

Distance medicine technology enables greater Distance medicine technology enables greater continuity of care by improving access and continuity of care by improving access and supporting the coordination of activities by a supporting the coordination of activities by a clinician. clinician.

Electronic Communication With Patients. Electronic Communication With Patients. Evaluation of Distance Medicine Technology.Evaluation of Distance Medicine Technology.E. Andrew Balas, MD, PhD; Farah Jaffrey, MSc; Gilad J. E. Andrew Balas, MD, PhD; Farah Jaffrey, MSc; Gilad J. Kuperman, MD, PhD; Suzanne Austin Boren, MHA; Gordon D. Kuperman, MD, PhD; Suzanne Austin Boren, MHA; Gordon D. Brown, PhD; Francesco Pinciroli, LEE; Joyce A. Mitchell, Brown, PhD; Francesco Pinciroli, LEE; Joyce A. Mitchell,

PhDPhD JAMAJAMA 278(2): 152-159, 1997. 278(2): 152-159, 1997.

Main Barriers to TelemedicineMain Barriers to Telemedicine

Reimbursement for Telemedicine Reimbursement for Telemedicine Services Services

Licensure and Credentialing Licensure and Credentialing Medical Malpractice Liability Medical Malpractice Liability Confidentiality Confidentiality

What We NeedWhat We Need

The Global Information Infrastructure The Global Information Infrastructure needs a new framework, or rather a set of needs a new framework, or rather a set of new frameworks, regarding the generation, new frameworks, regarding the generation, storage, use and transmission of storage, use and transmission of information across bordersinformation across borders

The general framework will be construed The general framework will be construed with basis on local frameworkswith basis on local frameworks

A Framework for GIIA Framework for GII

a unifying vision;a unifying vision; a code of ethics;a code of ethics; guidelines for fair use;guidelines for fair use; management structures; andmanagement structures; and law-enforcement coordination.law-enforcement coordination.

A Framework for GIIA Framework for GII

a unifying vision;a unifying vision; a code of ethics;a code of ethics; guidelines for fair use;guidelines for fair use; management structures; andmanagement structures; and law-enforcement coordination.law-enforcement coordination.

Workable in aninternational setting,within a community

Workable in aninternational setting,within a community

Presently unworkablein an internationalsetting

Presently unworkablein an internationalsetting

Some GuidelinesSome Guidelines

A distinction should be made between moral A distinction should be made between moral responsibility and legal responsibilityresponsibility and legal responsibility

The sender of the message rather than the The sender of the message rather than the messenger is responsible for the content of the messenger is responsible for the content of the messagemessage

Any electronic community should promote Any electronic community should promote awareness of the moral standards it requires for awareness of the moral standards it requires for behavior within its own boundariesbehavior within its own boundaries

Mark Frankel (AAAS)Mark Frankel (AAAS)

Borderless IssuesBorderless Issues

The collection, use, reuse and communication The collection, use, reuse and communication of data determines issues such as data of data determines issues such as data governance, property and confidentialitygovernance, property and confidentiality

The absence of international laws and proper The absence of international laws and proper court of justice twarts the legal enforcement court of justice twarts the legal enforcement of moral/ethical desiderataof moral/ethical desiderata

There is a need to define better the social There is a need to define better the social goals of a global information infrastructuregoals of a global information infrastructure

International IssuesInternational Issues

The status of regulations and legislation in The status of regulations and legislation in different countriesdifferent countries

How to enforce standards and quality of careHow to enforce standards and quality of care Data governance in an international scale: Data governance in an international scale:

– disclosure and retention of patient data; disclosure and retention of patient data;

– copyrights of medical databasecopyrights of medical database Protection of patient confidentiality in an Protection of patient confidentiality in an

international scaleinternational scale

Possible SolutionsPossible Solutions

Special licensing procedures for Special licensing procedures for professionals from other countries involved professionals from other countries involved in telehealth proceduresin telehealth procedures

Adherence to universal patient data Adherence to universal patient data protection standardsprotection standards

An international advisory committee of An international advisory committee of experts in telemedicine law and ethicsexperts in telemedicine law and ethics

Codes of Conduct for Codes of Conduct for Medical SitesMedical Sites

The Health on the Net FoundationThe Health on the Net Foundationhttp://www.hon.chhttp://www.hon.ch

Medical MatrixMedical Matrixhttp://www.medmatrix.orghttp://www.medmatrix.org

The HON Code of Condut for The HON Code of Condut for Medical WebsitesMedical Websites

Medical advice is provided by qualified professionals onlyMedical advice is provided by qualified professionals only Information is provided to support not to replace patient careInformation is provided to support not to replace patient care Patient confidentiality is respected according to the rules of Patient confidentiality is respected according to the rules of

the country where the information is locatedthe country where the information is located Information is supported by clear reference to its sourceInformation is supported by clear reference to its source Claims for benefit or performance is based on evidenceClaims for benefit or performance is based on evidence Contact and authorship information is providedContact and authorship information is provided Sponsorship is clearly identifiedSponsorship is clearly identified Advertisement policy is stated and the information provided Advertisement policy is stated and the information provided

by is clearly separated from the restby is clearly separated from the rest

Desirable Codes of EthicsDesirable Codes of Ethics

The public and private use of networked The public and private use of networked information should be defined only by its information should be defined only by its ownersowners

Intellectual ownership and copyrights Intellectual ownership and copyrights should be respected for all materials should be respected for all materials available through the Internetavailable through the Internet

Data may be altered or added only by its Data may be altered or added only by its ownersowners

Internet ResourcesInternet Resources

Center for Telemedicine LawCenter for Telemedicine Lawhttp://www.ctl.org/http://www.ctl.org/

NLM BioethicsOnLine SearchNLM BioethicsOnLine Searchhttp://www.healthgate.com/AMA/search.htmlhttp://www.healthgate.com/AMA/search.html

Arent Fox Telemedicine Home PageArent Fox Telemedicine Home Pagehttp://arentfox.com/telemedicinehttp://arentfox.com/telemedicine

University of Wisconsin’s Bioethics On-LineUniversity of Wisconsin’s Bioethics On-Linehttp://www.mcw.edu/bioethics/http://www.mcw.edu/bioethics/

MedWeb’s BioethicsMedWeb’s Bioethicshttp://www.gen.emory.edu/medweb/medweb.htmlhttp://www.gen.emory.edu/medweb/medweb.html

ContactContact

Renato M.E. SabbatiniRenato M.E. Sabbatinisabbatin@nib.unicamp.brsabbatin@nib.unicamp.brhttp://nibgw.unicamp.brhttp://nibgw.unicamp.br

Center for Biomedical InformaticsCenter for Biomedical InformaticsState University of Campinas, BrazilState University of Campinas, BrazilPO Box 6005, ZIP 13081-970PO Box 6005, ZIP 13081-970

Voice (0055 19) 239-9800 ext. 141Voice (0055 19) 239-9800 ext. 141Fax (0055 19) 788-4717Fax (0055 19) 788-4717