Internetable Health Data in a Globalized Society 11/17/2018 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 2

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

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 11/17/2018

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

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): 152-159, 1997. 10

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

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

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 11/17/2018

Another Scenario 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 cut-rate cybertherapists from the former East block, who are charging 5 dollars only. 6

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

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 11/17/2018

International Telemedicine Evasion of malpractice liability Evasion of drug/device regulation Evasion of human research ethics Evasion of database copyright issues 5

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

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 11/17/2018

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

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 11/17/2018

A Framework for GII a unifying vision; a code of ethics; guidelines for fair use; management structures; and law-enforcement coordination. 11/17/2018

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 11/17/2018

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

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 11/17/2018

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. 11/17/2018

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 11/17/2018

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

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 11/17/2018

Codes of Conduct for Medical Sites The Health on the Net Foundation http://www.hon.ch Medical Matrix http://www.medmatrix.org 11/17/2018

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 11/17/2018

Internet Resources Center for Telemedicine Law http://www.ctl.org/ NLM BioethicsOnLine Search http://www.healthgate.com/AMA/search.html 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 14

Contact Renato M.E. Sabbatini sabbatin@nib.unicamp.br 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 11/17/2018