Published on 31.03.00 in Vol 2, No 1 (2000): Theme Issue on eHealth Ethics
Preprints (earlier versions) of this paper are available at http://preprints.jmir.org/preprint/788, first published Mar 31, 2000.
Ethical and Legal Issues in Interactive Health Communications: A Call for International Cooperation
J Med Internet Res 2000;2(1):e8
Cyberspace is a fast-changing, globally-networked, multicultural, and multilingual information environment with vast possibilities [- ]. It calls into question national and international borders, cultural and ethical standards, regulations, and laws, which it bypasses and challenges [ - ]. In the health sector, self-care, drugs sold over the Internet, and providing access to technical knowledge and alternative forms of healthcare to the general public have destabilized drug regulatory mechanisms and the traditional physician-patient relationship.
The Internet offers unprecedented power to provide users of healthcare information - patients, professionals, families, caregivers, educators, researchers, insurers, regulators, and policymakers - with data of unprecedented timeliness, accuracy, depth, and diversity. The very qualities that make the Internet such a rich marketplace of ideas - its decentralized structure, global reach, leveling of access to the tools of publication, immediacy of response, and ability to facilitate free-ranging interchange - also make it an exceptional channel for potential misinformation, unethical use, concealed bias, covert self-dealing, fraudulent practices, and evasion of legitimate regulation.
There are many inadequacies concerning national and international controls and legislation, especially regarding the issue of jurisdiction; and urgent need for an internationally accepted policy framework that addresses basic rights and responsibilities of users and providers. Freedom of access to information and expression and the protection of users' data security and privacy are especially critical topics. Decisions and initiatives related to cyberspace law and ethics issues in health and healthcare must necessarily involve experts from a variety of knowledge domains involving civil and criminal law, medical ethics (bioethics), computing ethics, medical computing, and legal medicine.
Given the sensitive nature of health care information, and the high degree of dependence of health professionals on reliable records, the issues of integrity, security, privacy, and confidentiality are of particular significance and must be clearly and effectively addressed by health and health-related organizations and professionals. Two factors make the matter a subject of preeminent significance: the intrinsically sensitive nature of patient data; and the growing use of network computing, particularly the Internet, for healthcare information processing. The growth of off-site processing and storage of electronic health records by application services providers (ASPs) adds a new dimension to those issues.
Maintaining and safeguarding the integrity and physical protection of data and systems, privacy and confidentiality of individual health information, quality of content, and the protection of consumers and online health industry commercial interests against unethical practices, are the areas of greatest concern in the implementation and use of Internet and other interactive applications in health and healthcare.
Privacy involves many aspects [- ], and the issue has been consistently one of the top concerns of users. The emergence of health data banks has given rise to fears related to privacy, right of access, and intended use of personal data. In many countries, proposals and actual reform of the laws have been enacted, according to which individuals are entitled to know what information is stored about them, who accessed that information, and what mechanisms are available to correct erroneous information [ , - ]. Authenticity, reliability, and accuracy of the health-related information available on the more than 20,000 health sites that are available are major issues. Many websites are profit-driven, others promote unproven and even dangerous forms of treatment or products, while others may be good intentioned but contain misleading or false information. To ascertain the credibility, motives, sponsorship, and eventual conflicts of interest of websites is an extremely difficult task [ , , - ]. In the center of this "free-for-all," physicians are increasingly confronted with Internet-savvy patients who come to the consultation with a heap of downloaded material, ready to discuss his self-diagnosed condition and the latest mainstream or alternative treatments [ , ].
Electronic transactions involve important regulatory and legal issues not yet fully addressed. Vigilance in the maintenance of legal and ethical standards in the advertising, promotion, and sale of medical products through the Internet is required. Those standards include: approval of products, devices, and drugs by regulatory agencies at the site where the purchaser resides; the determination where the transaction occurred - in the purchaser's or the vendor's jurisdiction; and which courts and law will govern any disputes .
Although there is a general agreement among conscientious professionals that all health websites should be held to the same standard and that the introduction of some form of "seal of approval" is an interesting proposition, enforcement is still a nebulous area. Particularly in the international setting there are complex issues of jurisdiction not yet addressed by laws or agreements.
A number of organizations, government agencies, and scientific publishers have been active in the establishment of standards and methods to measure and assure credibility of health websites. One of the first players is the Health on the Net Foundation, established in 1996 [, ]. Another very active independent group more recently constituted, and congregating a large number of international stakeholders, is the Internet Healthcare Coalition [ , ]. Other groups include Internet [ - ] and scientific medical publishers [ ], the American Medical Association, and European medical societies: for a discussion see [ ]. Quality-assurance methodologies range from peer-review and professional authorship to open discussion in an open moderated or non-moderated forum and many approaches have been proposed in the evaluation, categorization, and labeling of health websites [ , - ], the central issue being how to best protect the public interest.
Although security, privacy, and confidentiality are matters of concern in telecommunication-based clinical applications, and indeed major features of it, such applications raise new challenges regarding professional conduct and accountability, technical standards, licensure, and reimbursement [, ]. Liability, model of care, and medical malpractice must be seen under a novel perspective as telemedicine involves more than one provider, usually geographically distant and subject to diverse practice and legal value systems.
The society and public authorities have the responsibility to make information considered as of "public good" universally available for educational, cultural, and social needs. The challenge is to define and implement concepts, such as public domain contents and universal access to networks and services; and to promote public welfare while encouraging private initiatives and protecting human dignity, personal rights, fair use, intellectual property rights, and rightful economic interests.
Traditionally, local standards are considered the yardstick against which health practice is evaluated, and they determine the parameters for eventual litigation. Remote conduction of health interventions brings forth, however, a whole new range of issues and ethical aspects in the telecare patient-provider relationship. Those issues have been reviewed and recommendations regarding a code of practice proposed [, ]. Guidelines regarding the ethical and legal aspects of telemedicine are in the process of being developed by national and international trade, professional, and technical organizations and by national regulatory agencies. Medical software is increasingly considered as another form of a medical device. An extensive review of the legal aspects of telemedicine practice in the U.S. has recently been compiled in the Compendium of Telemedicine Laws [ ].
Licensing and professional standards of care providers and regulation of e-commerce is done in many countries on a regional or state level. Validation of professional licensure, alternative and non-approved health practice, contending with fraudulent practice and misleading claims, regulation, and legal jurisdiction problems on a national and international basis are major regulatory and quality assurance problems in these circumstances.
The health sector has not addressed information security in a comprehensive manner. Healthcare organizations face a great variety of security, privacy, and confidentiality risks and must be made fully responsible for maintaining all aspects of security and confidentiality of data and information. Eventual conflicts between data sharing, data security, and confidentiality must be addressed early in the process of systems procurement and development and after implementation. Some health organizations have implemented security features in their information systems, but most organizations do not have written rules or procedures for their employees who are authorized to access client's information, such as policies on disclosure of sensitive information, or personnel policies dictating the types of disciplinary actions that will be taken if staff violate policies. Nevertheless, regulations and technical standards for privacy assurance and maintenance of data integrity and access security must be reasonable, in terms of recognizing the realities of health care delivery, the variability of application environments, and the diversity of national ethical values and legal systems.
Developing countries are particularly affected by the rapid expansion of interactive communication technologies - increasingly, governments, professional organizations, advocacy groups, and users in developing countries have expressed their concerns about the impact of such happenings. Particularly, there is great apprehension about the reliability of healthcare information, new forms of health practice, advertising and commercial processes, content appropriateness, and privacy, as they pertain to the Internet. Multilateral or international agencies and national technical cooperation agencies are promoting the deployment of IHC applications, but have mainly focused on technological infrastructure development; little has been done regarding contents, human resources, impact evaluation, and ethical and legal aspects [, , , - ].
Ethical and regulatory questions, and national and international legislation addressing the many issues related to quality of information in the Internet, e-commerce, and telemedicine are a matter of present concern of many international organizations. The United Nations, and particularly UNESCO, the International Telecommunications Union (ITU), the World Health Organization (WHO), the World Trade Organization (WTO), regional trade blocks (European Community, NAFTA, MERCOSUR), and multilateral agencies such as the World Bank and the Inter American Development Bank have been in the forefront of initiatives directed to the promotion of exchanges in this area.
Those are urgent and controversial issues that must be addressed jointly and comprehensively by international organizations, national and international scientific and technical societies, service providers, industry organizations, and users' interest groups, and not only from the viewpoint of legal or commercial interests. The United Nations specialized agencies, government organizations, independent and nonaligned consensus groups [, , , - ], and trustworthy service and content providers [ , - ] are particularly well positioned to spearhead the discussions leading to the development of innovative policies for the area and the establishment of an ethical code of conduct focused on content, advertising and privacy issues, and fraud detection designed to ensure that consumers are provided with health information that is reliable and safe.
Roberto J. Rodrigues, Member, JMIR Editorial Board
Regional Advisor in Health Services Information Technology, Essential Drugs and Technology Program, Division of Health Systems and Services Development, Pan American Health Organization / World Health Organization, Washington, D.C., USA
Conflicts of Interest
- ; United Nations Educational, Scientific and Cultural Organization (Document CII/USP/ECY/99/01). Report of the Experts Meeting on Cyberspace Law. Monte-Carlo, Principality of Monaco; Sep 29, 1998.
- Mclellan F. "Like hunger, like thirst": patients, journals, and the internet. Lancet 1998 Oct;352 Suppl 2(SII):SII39-SII43 [FREE Full text] [Medline] [CrossRef]
- Kiley R. Consumer health information on the Internet. J R Soc Med 1998 Apr;91(4):202-203. [Medline]
- Wilson SM. Impact of the internet on primary care staff in Glasgow. J Med Internet Res 1999 Nov 19;1(2):e7 [FREE Full text] [Medline] [CrossRef]
- Mack J. The Internet Healthcare Coalition. J Med Internet Res 2000 Mar 5;2(1):e3 [FREE Full text] [Medline] [CrossRef]
- Lehmann CU. Consumers and the Medical Internet. 1997. URL: http://www.ihealthcoalition.org/content/MWM_present5a.html
- Sosa-Iudicissa M, Oliveri N, Gamboa CA, Roberts J. Internet, Telematics and Health. In: Studies in Health Technology and Informatics Volume 36. PAHO/WHO and IMIA: IOS Press; 1997.
- ; Pan American Health Organization. Information Systems and Information Technology in Health - Challenges and Solutions for Latin America and the Caribbean. Washington(DC): Health Services Information Systems Program, Division of Health Systems and Services Development; 1998.
- Eng TR, Gustafson DH. Wired for Health and Well-Being - The Emergence of Interactive Health Communication. In: US Department of Health and Human Services: Science Panel on Interactive Communication and Health; Office of Public Health and Science. Washington(DC): US Printing Office; 1999.
- Stanberry BA. Legal and ethical issues in European telemedicine. European Telemedicine 1998/99:20-25.
- Goodman KW, editor. Ethics, Computing, and Medicine: Informatics and the Transformation of Health Care: Cambridge University Press; Jan 15, 1998.
- Hodge JG, Gostin LO, Jacobson PD. Legal issues concerning electronic health information: privacy, quality, and liability. JAMA 1999 Oct 20;282(15):1466-1471. [Medline] [CrossRef]
- Eysenbach G. Towards ethical guidelines for dealing with unsolicited patient emails and giving teleadvice in the absence of a pre-existing patient-physician relationship systematic review and expert survey. J Med Internet Res 2000 Feb 24;2(1):e1 [FREE Full text] [Medline] [CrossRef]
- Mendel B. Online identity crisis. Infoworld 1999 Oct(18):36-37.
- Culnan MJ. Privacy and the top 100 web sites: A report to the Federal Trade Commission. Washington, DC: McDonough School of Business, Georgetown University; 1999. URL: http://www.msb.edu/faculty/culnanm/GIPPS/oparpt.pdf
- ; US Department of Health and Human Services. Proposed Standards for Privacy of Individually Identifiable Health Information. 1999. URL: http://aspe.hhs.gov/admnsimp/pvcsumm.htm
- Ethics Survey of Consumer Attitudes about Health Web Sites. EHealth Reports (Sponsored by the California HealthCare Foundation and the Internet Healthcare Coalition, conducted by Cyber Dialogue in cooperation with the Institute for the Future). 2000 Jan.
- Goldman J, Hudson Z, Smith RM. Privacy: Report on the Privacy Policies and Practices of Health Web Sites. A California HealthCare Foundation preliminary report to the eHealth Summit Meeting. In: EHealth Reports. Washington(DC); Feb 1, 2000.
- ; European Commission Group on Ethics in Science and New Technologies. Ethical Issues of Healthcare in the Information Society. Report #13, Prof. Ina Wagner (Rapporteur) . 1999 Jul 30. URL: http://europa.eu.int/comm/secretariat_general/sgc/ethics/en/opinion13.pdf
- ; IITF(1995). Privacy and the NII: Safeguarding Telecommunications-Related Personal Information. In: Report of the Information Infrastructure Task Force (IITF). Washington, DC: US Department of Commerce, National Telecommunications and Information Agency; Oct 1995.
- ; Council of Europe. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. 1995 URL: http://www.privacy.org/pi/intl_orgs/ec/eudp.html
- Walker P. Status of Data Protection in the United Kingdom. 1998. URL: http://www.ehto.org/
- Impicciatore P, Pandolfini C, Casella N, Bonati M. Reliability of health information for the public on the World Wide Web: systematic survey of advice on managing fever in children at home. BMJ 1997 Jun 28;314(7098):1875-1879 [FREE Full text] [Medline]
- Silberg WM, Lundberg GD, Musacchio RA. Assessing, controlling, and assuring the quality of medical information on the Internet: Caveant lector et viewor--Let the reader and viewer beware. JAMA 1997 Apr 16;277(15):1244-1245. [Medline] [CrossRef]
- Eysenbach G, Diepgen TL. Towards quality management of medical information on the internet: evaluation, labelling, and filtering of information. BMJ 1998 Nov 28;317(7171):1496-1500 [FREE Full text] [Medline]
- Adelhard K, Obst O. Evaluation of medical internet sites. Methods Inf Med 1999 Jun;38(2):75-79. [Medline]
- Boulding M, Silber D. Internet Healthcare Coalition's 1998 Annual Meeting: Healthcare Information Quality on the Internet. Washington, DC; 1998. URL: http://www.ihealthcoalition.org/content/ihc_articel.html
- Ward B. "Internet-positive patients" driving you crazy? Find out how to get online and cope. Internet Medicine 1999;4(7):1-6.
- ; Ziff-Davis Inc. The Standard for Internet Commerce, Version 1.0. URL: http://www.gii.com/standard [accessed 1999]
- Silber D. Pharmaceutical Industry Presence on the WWW. URL: http://www.ihealthcoalition.org/content/MWM_present6.html [accessed 1997]
- Magaziner IC. The Framework for Global Electronic Commerce: A Policy Perspective.(interview with presidential adviser Ira C. Magaziner)(Interview) : An article from: Journal of International Affairs. Washington(DC): ; Jul 1, 1997.
- Health on the Net Code of Conduct: HONcode. URL: http://www.hon.ch/HONcode/ [accessed 2000]
- Boyer C, Baujard O, Aurel S, Selby M, Appel RD. Health On the Net automated database of health and medical information. Int J Med Inform 1997 Nov;47(1-2):27-29. [Medline] [CrossRef]
- ; e-Health Ethics Initiative. e-Health Ethics Draft Code. J Med Internet Res 2000;2(1):e2 [FREE Full text] [Medline] [CrossRef]
- ; Internet Healthcare Coalition. Minutes of the Internet Healthcare Coalition e-Health Ethics Summit. 2000 Presented at: Internet Healthcare Coalition e-Health Ethics Summit; 2000 Jan 31-Feb 2; Washington(DC) URL: http://www.ihealthcoalition.org/ethics/summary.html#Draft
- ; British Healthcare Internet Association. Quality Standards for Medical Publishing on the Web. BHIA Documents. 1996. URL: http://www.bhia.org/reference/documents/recommend_webquality.htm
- Leading e-Healthcare Companies Form Alliance to Benefit Internet Consumers. Hi-Ethics (Health Internet Ethics Alliance) Press Release. New York (NY); 1999 Nov 4. URL: http://www.drkoop.com/aboutus/media/press_releases/1999/110499_wegotethics.html
- The Ethics of the Medical Internet Medscape's Advertising Policy [editorial]. Medscape MedGenMed. 1999 Sep 10. URL: http://www.medscape.com/medscape/GeneralMedicine/journal/1999/v01.n09/mgm0910.lund/mgm0910.lund.html
- Uniform Requirements for Manuscripts Submitted to Biomedical Journals: The Vancouver Guidelines. 1997. URL: http://www.windsor.igs.net/~nhodgins/uniform_requirements.html
- Darmoni SJ, Leroux V, Daigne M, Thirion B, Santamaria P, Duvaux C. Critères de qualité de l'information de santé sur l'Internet. Santé et Réseaux Informatiques, Informatique et Santé 1998;10:162-174.
- Eng TR, Gustafson DH, Henderson J, Jimison H, Patrick K. Introduction to evaluation of interactive health communication applications. Science Panel on Interactive Communication and Health. Am J Prev Med 1999 Jan;16(1):10-15. [Medline] [CrossRef]
- Jadad AR, Gagliardi A. Rating health information on the Internet: navigating to knowledge or to Babel? JAMA 1998 Feb 25;279(8):611-614. [Medline] [CrossRef]
- Kim P, Eng TR, Deering MJ, Maxfield A. Published criteria for evaluating health related web sites: review. BMJ 1999 Mar 6;318(7184):647-649 [FREE Full text] [PMC] [Medline]
- Eysenbach G, Diepgen TL. Labeling and filtering of medical information on the Internet. Methods Inf Med 1999 Jun;38(2):80-88. [Medline]
- ; Internet Healthcare Coalition. Tips For Health Consumers Finding Quality Health Information on the Internet. 2000. URL: http://www.ihealthcoalition.org/content/tips.html
- Rippen H. Criteria for Assessing the Quality of Health Information on the Internet. 1997. URL: http://www.ihealthcoalition.org/content/MWM_present4b.html
- Boulding M. Self-Regulation vs. Government Regulation; Legal Issues. 1997. URL: http://www.ihealthcoalition.org/content/MWM_present3.html
- Grenade P. Telemedicine: a look at the legal issues confronting a new delivery system. Kilpatrick & Cody Medical Law Update 1996 Winter.
- Schanz SJ, et al. 1999 Compendium of Telemedicine Laws - Selected Statute Excerpts and Article Citations Relating to Telemedicine. Raleigh(NC): Legamed, Inc; 1999.
- ; United Nations Educational, Scientific and Cultural Organization. Right to universal access to information in the 21st century - Some major issues (Document CII/INF-11/00) 2000.
- ; World Health Organization. A Health Telematics Policy in support of WHO's Health-for-All Strategy for Global Health Development. In: Report of the WHO Group Consultation on Health Telematics (Publication WHO/DGO/98.1 1998) Dec 11, 1997.
- Lown B, Bukachi F, Xavier R. Health information in the developing world. Lancet 1998 Oct;352 Suppl 2:SII34-SII38 [FREE Full text] [Medline]
- ; Pan American Health Organization. Setting Up Healthcare Services Information Systems - A Guide for Requirement Analysis, Application Specification, and Procurement. Washington(DC): Essential Drugs and Technology Program, Division of Health Systems and Services Development; 1999.
- ; Institute of Electrical and Electronics Engineers - USA. Principles for Privacy, Confidentiality, and Security of Personal Health Information. 1998. URL: http://www.ieeeusa.org/forum/positions/healthinfo.html
- ; British Medical Association. Confidentiality and Disclosure of Health Information. 1999. URL: http://web.bma.org.uk/public/ethics.nsf/39f32339ff78cd6b802566a6003f3311/31488f35ae7ea9718025681700509a63?OpenDocument
- Jadad AR. Promoting partnerships: challenges for the internet age. BMJ 1999 Sep 18;319(7212):761-764 [FREE Full text] [Medline]
Edited by G. Eysenbach; This is a non-peer-reviewed article. published 31.03.00
© Roberto J Rodrigues. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 31.3.2000. Except where otherwise noted, articles published in the Journal of Medical Internet Research are distributed under the terms of the Creative Commons Attribution License (http://www.creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited, including full bibliographic details and the URL (see "please cite as" above), and this statement is included.