Journal of Medical Internet Research 2001 - Review Of = Internet Health Information Quality Initiatives

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ISSN=20 = 1438-8871

Journal of Medical Internet=20 Research 2001;3(4):e28.

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Table of = Contents

2002 (Vol. = 4)=20
Iss. = 1/March
Iss.=20 2/June

2001 (Vol. = 3)=20
Iss.=20 4/Dec
Iss. = 3/Sept
Iss.=20 2/June
Iss. = 1/March

2000 (Vol.=20 2)
  Iss.=20 3/Sept
   Supplement=20 2
  Iss.=20 2/June
  Iss.=20 1/March

1999 (Vol.=20 1)
  Iss.=20 2/Dec
  Iss.=20 1/Sept
    Supplement=20 1

Editorial=20 Board

Instructions for authors

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Review

Review of Internet Health Information = Quality=20 Initiatives

Ahmad Risk, Joan Dzenowagis

Corresponding Author:
Ahmad = Risk
World Health=20 Organization
Department of Health Information Management and=20 Dissemination
20 Avenue Appia
CH-1211 Geneva=20 27
Switzerland
E-mail: riska@who.ch

Abstract=20 and Keywords=20

Introducti= on=20

Methods=20

Results
= o eHealth Code = of=20 Ethics
o Health=20 Internet Ethics (Hi-Ethics)
o URAC = Health Web=20 Site Accreditation Program
o MedPICS=20 Certification and Rating of Trustworthy and Assessed Health = Information=20 on the Net (MedCERTAIN)
o TNO = Quality Medical=20 Information and Communication (QMIC)
o Health on the=20 Net Foundation Code (HON Code)
o EC=20 (European Community) Quality Criteria for Health-related=20 Websites
o Organizing = Medical=20 Networked Information (OMNI)
o DISCERN
= o=20 American Medical=20 Association (AMA): Guidelines for Medical and Health Information = Sites=20 on the Internet: Principles Governing AMA Web Sites
o British = Healthcare=20 Internet Association (BHIA): Quality Standards for Medical = Publishing on=20 the Web
o The = Health Summit=20 Working Group-Criteria for Assessing the Quality of Health = Information=20 on the Internet: IQ Tool (HSWG IQ Tool)
o The = International=20 Federation of Pharmaceutical Manufacturers Associations (IFPMA) = Code of=20 Marketing

Discussion=20

Acknow= ledgements=20

References=20

Abbreviat= ions=20

ABSTRACT

Background: The massive growth of health information on = the=20 Internet; the global nature of the Internet; the seismic shift = taking=20 place in the relationships of various actors in this arena, and = the=20 absence of real protection from harm for citizens who use the = Internet for=20 health purposes are seen to be real problems. One response to many = of=20 these problems has been the burgeoning output of codes of conduct = by=20 numerous organizations trying to address quality of health=20 information.
Objectives: Review the major = self-regulatory=20 initiatives in the English-speaking world to develop quality and = ethical=20 standards for health information on the Internet. Compare and = analyze the=20 approaches taken by the different initiatives. Clarify the issues = around=20 the development and enforcement of standards.
Methods: = Quality=20 initiatives selected meet one or more of the following criteria:=20 Self-regulatory. A reasonable constituency. Diversity (eg, of = philosophy,=20 approach and process)-to achieve balance and wide representation, = and to=20 illustrate and compare different approaches. Historic value. A = wider reach=20 than a national audience, except when its reach is a significant = sector of=20 the Internet health information industry.
The initiatives were = compared=20 in 3 ways: (1) Analysis and comparison of: key concepts, = mechanism, or=20 approach. Analysis of: the obligations that a provider has to meet = to=20 comply with the given initiative, the intended beneficiaries of = that=20 initiative, and the burdens imposed on different actors. These = burdens are=20 described in terms of their effect on the long-term sustainability = and=20 maintenance of the initiative by its developers. Analysis of the=20 enforcement mechanisms. (2) Analysis and comparison by type of = sponsoring=20 organization, the reach of the initiative, and the sources of = funding of=20 the initiative or the sponsoring organization. (3) How the various = initiatives fall under 1 of 3 key mechanisms and comparison of the = advantages and disadvantages of these key = mechanisms.
Results:=20 The issues that affect the initiatives and future work on the = quality=20 of health information on the Internet are identified and analyzed. = These=20 issues are:
(a) Three key mechanisms used in the quality = initiatives=20 (b) Sustainability issues that affect the initiatives: Burdens = placed on=20 health information providers, citizens and others. Currency and=20 maintenance issues of the initiatives. Funding. Cost. Acceptance. = Market=20 conditions. User indifference or ambivalence. (c) Enforcement = issues=20 surrounding the initiatives (d) Adequacy of approach, scope, = reach, and=20 enforcement provisions of the various quality initiatives (e) Gaps = that=20 need to be addressed to achieve good quality of health information = on the=20 internet
Conclusions: Ten conclusions are presented. A = framework=20 of action to be undertaken by the World Health Organization in the = field=20 of quality of health information on the Internet is = recommended.

(J Med Internet Res=20 2001;3(4):e28)

See also editorial and commentary.

KEYWORDS

Internet/standards; Ethics, Professional; Social Control, = Formal;=20 Health Care Quality; Quality Assurance; Health Care/standards;=20 Commerce/standards; Information Management/standards; Medical=20 Informatics/standards; Quality control; Guidelines; Privacy; = Informed=20 Consent

Current situation of health information on the Internet
A global medium and a seismic shift
There is an explosion in the amount of health information = available on=20 the Internet. This increase does not show signs of slowing down. = For=20 example, entering the word "health" in a generic search engine = like Google=20 (www.google.com) currently yields over 60 million pages.
The sources of that information are numerous and varied. For = the first=20 time in history, we have a global medium that transcends geography = and=20 operates across cultures and languages.
The Internet has been the catalyst for the seismic shift that = is=20 happening in the doctor-patient relationship. It continues to have = a=20 profound impact on other relationships among health care actors. = This=20 shift has been in access to knowledge, and consequently in access = to power=20 [1,2].
Numbers vary and none are very accurate, but it is estimated = that there=20 are over 100,000 health-related Web sites on the Internet today. = These=20 vary from highly-academic sites, online peer-reviewed journals,=20 governmental sites, and health-provider-institutions' sites to = countless=20 individual contributions from citizens, patients, and health=20 professionals.
There is also an unmeasured number of industry-related Web = sites,=20 ranging from large and small pharmaceutical company sites to a = multitude=20 of commercial sites disseminating information or selling products = and=20 services in a variety of bewildering ways.
Recent surveys estimate the number of Internet = health-information=20 seekers to be about 86% of the estimated 168 million American = adults who=20 have access to the Internet [3], and = that 55%=20 (Germany) to 90% (United States) of primary-care physicians had = ever used=20 the Internet (P/S/L Research [4] i-MD = 2000 Survey.=20 2nd Quarter 2000; currently, survey is not available at the P/S/L = Research=20 Web site). These surveys indicate that the trend towards use of = the=20 Internet for health purposes is rising.
In addition, we are beginning to witness the large-scale entry = of=20 mainstream health care organizations into the field of the health=20 Internet. There are an increasing number of purchaser = organizations and=20 health-care-funding governments that are exploring the use of the = Internet=20 as a tool for containing the spiraling cost of health care and = improving=20 the quality of care to citizens.
Numerous surveys and studies paint a picture of dubious = information=20 quality, widespread practice of fraud, potentially-dangerous = claims, and=20 the risk of exposure of citizens to harm. One good example of such = surveys=20 is the study conducted by RAND health [5].
Even when information appears to be of high quality it can = cause=20 unintentional harm to citizens [6]. This = can happen=20 for a number of reasons:

Language and complexity barriers [7]=20
Inappropriate audience or context=20
Unavailability of certain services or products in different = parts of=20 the world=20
Difficulty in interpreting scientific data=20
Accuracy and currency of information=20
Potential for source bias, source distortion, and = self-serving=20 information
No real protection
Amid all this disorder, there is a common concern among many=20 individuals and institutions interested in the health Internet. = This=20 concern is for the prevention of physical, mental, and emotional=20 harm-caused by wrong, misleading, inappropriate, false, = fraudulent, or=20 self-serving information-to people who use the Internet to seek or = receive=20 health information, products, and services.
Yet, in a large number of Web sites currently offering health=20 information we cannot find credible and enforceable protection of = citizens=20 from potential harm.
While there is some degree of protection provided either by = national=20 regulatory mechanisms or through self-regulation, this modest = protection=20 is currently only afforded to a small number of people.
The response
One response to many of these problems has been the burgeoning = output=20 of codes of conduct from numerous organizations trying to address = quality=20 of health information. All of these codes have a primary goal of = citizen=20 protection, and some have a secondary goal of protecting the = company's=20 "good name," thus succeeding in competition based on quality. = These=20 initiatives derive from different philosophies and apply different = approaches and processes.
This paper
This paper reviews and compares major self-regulatory = initiatives for=20 health information quality and ethics developed in the = English-speaking=20 world.
Scope
This paper analyzes the major quality initiatives for health=20 information on the Internet. The criteria for inclusion in the = review are=20 discussed in "Methods, " below.
The focus of this study is health information, while being = mindful of=20 the inevitable overlaps between information and products and = services.=20 This study adopts the definition of health information of the = eHealth code=20 of Ethics in view of its accuracy and completeness. The eHealth = Code of=20 Ethics defines health information as:

Health information includes information for = staying=20 well, preventing and managing disease, and making other = decisions=20 related to health and health care. It includes information for = making=20 decisions about health products and health services. It may be = in the=20 form of data, text, audio, and/or video. It may involve = enhancements=20 through programming and interactivity.
This paper does not address:

Provision of organized health care services=20
The practice of telemedicine=20
Laws and regulatory instruments=20
Quality initiatives developed or being developed by = non-English=20 speaking groups or organizations
The review does not perform a competitive analysis of the = various=20 initiatives.
This paper avoids the use of the neologism eHealth = because of=20 its ambiguity. Rather, it uses the terms health Internet, = health=20 Internet information, or health information referring = broadly=20 to the use of information and communication technologies to = create,=20 deliver, or receive health information with particular reference = to=20 Internet technologies.
Objectives
Provide a comprehensive review of the key efforts to develop = quality=20 and ethical standards for health information on the Internet.
Provide comparison and analysis of the approaches taken by the=20 different initiatives.
Clarify the issues around the development and enforcement of = standards=20 for health information on the Internet.

Introduction

Methods

The selection of quality initiatives for review and comparison = in this=20 paper is based on meeting one or more of the following = criteria:

The initiative is an expression of a self-regulatory = mechanism. This=20 study focuses on those initiatives that aim to provide models of = self-regulation of the health Internet industry. Legal and = regulatory=20 mechanisms are the subject of a separate paper. Self-regulation = of the=20 health Internet remains a powerful driver of the pursuit of = quality=20 standards for health information on the Internet.

The initiative has a reasonable constituency, that is, a = body of=20 developers and followers who are keen on sustaining and = maintaining the=20 initiative-or the initiative has been developed by a broad = spectrum of=20 people. Issues of sustainability and maintenance are important=20 components of the comparisons that follow.

Diversity of philosophy, approach and process, and other=20 characteristics-to achieve balance and wide representation, and = to=20 illustrate and compare different approaches.

The initiative has some historic value representing an early = example=20 of thinking on quality standards. This criterion resulted in the = inclusion of two early examples from 1996 whose current = utilization is=20 unknown.

The initiative has a wider reach than a national audience, = except=20 when its reach is a significant sector of the Internet health=20 information industry, for example, pharmaceutical Web sites or = large=20 commercial consortia. Many initiatives did not reach beyond = national=20 constituencies. In some cases, the geographical reach is not = easily=20 defined or crosses 2 different boundaries. For example, the = MedCERTAIN=20 project is classified in this paper as having a regional reach = (in view=20 of its European base and funding) but it also has ambitions to = develop=20 the project into an international standard. Another example is = the code=20 of conduct of the American Medical Association (AMA). Although = it is=20 intended to cover those sites under the control of the AMA, it = also=20 states that it can be utilized by any medical website. =

The process of identifying the initiatives reviewed was based = on=20 personal knowledge of, involvement with, and exposure to the field = of=20 quality-of-health-information on the Internet.

The initiatives were compared in 3 ways:

Analysis and comparison of the different key concepts, = mechanisms,=20 or approaches. The analysis also looks at the obligations that a = provider has to meet in order to comply with the given = initiative, the=20 intended beneficiaries of that initiative, and the burdens = imposed on=20 different actors. These burdens are described in terms of their = effect=20 on the long-term sustainability and maintenance of the = initiative by its=20 developers. Finally, the enforcement mechanisms applicable to = the=20 initiatives are looked at. (Table = 1)=20
Analysis and comparison by type of sponsoring organization, = the=20 reach of the initiative, and the sources of funding of the = initiative or=20 the sponsoring organization. (Table = 2)=20
Finally, how the various initiatives fall under one of 3 key = mechanisms are looked at (Table = 3). The=20 advantages and the disadvantages of these key mechanisms are = compared in=20 the "Discussion" section. Briefly, these key modes are: =

Codes of conduct=20
Third-party certification=20
Tool-based evaluation (for example, questionnaires that are = filled=20 by hand or embedded software that automatically gives access to = the=20 quality attributes of the site)

Review of the initiatives

Much of the information about the initiatives has come from the = published initiative; discussions with some of the key players in = each=20 initiative, and attendance at conferences on quality of health = information=20 on the Internet

For each initiative, the review is divided into the following = areas=20 (however, review of some initiatives did not involve discussion of = all the=20 areas):

Launch date=20
Responsible organization=20
Key players=20
Intended target users=20
Objectives=20
Approach=20
Process=20
Implementation mechanisms=20
Sustainability issues

The actual text of the initiatives was used to describe the = various=20 aspects of the work on many occasions. On other occasions, the = author=20 provided descriptions and interpretations based on his own sources = of=20 information and his current understanding

This review looks at these initiatives:

eHealth Code of Ethics=20
Health Internet Ethics (Hi-Ethics)=20
URAC Health Web Site Accreditation Program=20
MedPICS Certification and Rating of Trustworthy and Assessed = Health=20 Information on the Net (MedCERTAIN)=20
TNO Quality Medical Information and Communication (QMIC)=20
HON Code=20
EC (European Community) Quality Criteria for Health-related = Websites=20
Organizing Medical Networked Information (OMNI)=20
DISCERN=20
American Medical Association (AMA): Guidelines for Medical = and=20 Health Information Sites on the Internet: Principles Governing = AMA Web=20 Sites=20
British Healthcare Internet Association (BHIA): Quality = Standards=20 for Medical Publishing on the Web=20
The Health Summit Working Group-Criteria for Assessing the = Quality=20 of Health Information on the Internet: IQ Tool (HSWG IQ Tool)=20
The International Federation of Pharmaceutical Manufacturers = Associations (IFPMA) Code of Marketing

[enlarge] Table=20 1. Characterization of quality=20 initiatives

[enlarge] Table=20 2. Quality initiatives: Sponsors, Scope, and=20 Funding

[enlarge] Table=20 3. Quality Initiatives: Key=20 Mechanisms

eHealth Code of Ethics [8,9]

Launch date
24 May 2000.

Responsible organization
The Internet Healthcare=20 Coalition.

Key concept: the Code sets out ethical concepts that inform the = processes of self-assessment and compliance based on = interpretation and=20 specification.

The Internet Healthcare Coalition is a not-for-profit = organization=20 whose mission is to enhance quality health care resources on the = Internet.=20 It aims to achieve its mission by consumer and provider education, = self-regulation, and the nurturing of on-line communities that = promote=20 ethical, innovative, and high-quality sources of health care = information=20 and services.

Membership of the Coalition comprises publishers of = professional and=20 consumer health care information; academic institutions and other=20 accredited educational providers; medical libraries and database=20 providers; medical specialty and special-interest societies; = patient=20 advocacy and support groups; manufacturers of regulated drugs and = medical=20 devices; and commercial developers and providers of Internet-based = health-related education, information, and services.

The Coalition is funded by membership fees, unrestricted = educational=20 grants and donations, and proceeds from conferences and = educational=20 activities.

Intended target users
The eHealth Code of Ethics is = developed=20 as a set of guiding principles aimed at health Internet = stakeholders=20 worldwide. These stakeholders include health-application = developers; site=20 sponsors; managers; Webmasters; clinicians; laypeople who seek = health=20 information, products or services via the Internet; policy makers; = academics; and publishers.

Objectives

Protect from harm=20
Create ethical environment=20
Ensure fairness and synergy amongst the various entities =

The goal of the eHealth Code of Ethics is to ensure that = "people=20 worldwide can confidently and with full understanding of known = risks=20 realize the potential of the Internet in managing their own health = and the=20 health of those in their care."

Thus, the Code has the overarching goal of identifying the = values that=20 are important in creating conditions of trust. The Code defines = the kinds=20 of conduct that support those values in practice. This becomes the = foundation for enabling people to use the health Internet with=20 confidence.

Approach
The approach is geared towards producing a = set of=20 overarching ethical principles for the health Internet that can = provide=20 guidance to further interpretation, specification, and development = of=20 ethical codes of conduct.

Process

Grass root participation in development=20
Democratic broad stakeholder consensus=20
Professional-ethicists input=20
Prior identification of the issues of concern through an = on-line=20 questionnaire undertaken by the Internet Healthcare Coalition=20
Supply-side and public education=20
Preparation and collection of case studies and = interpretative=20 guidelines

Implementation mechanisms
The Code together with its = case=20 studies and interpretative materials components is used in a = number of=20 ways:

As the basis for a number of operational implementation = activities,=20 for example, those being developed by URAC, Kaiser Permanente, = and the=20 USA National Mental Health Association.=20
As the basis for the series of eHealth Ethics workshops = organized by=20 the Coalition to inform and educate organizations that provide = health=20 information on the Internet on the issues of ethics and quality. =
The process deployed in developing the eHealth Code of = Ethics is=20 being used in developing other initiatives. Examples include the = MedCERTAIN project and the European Commission's workshop on = quality=20 criteria for health-related Web sites=20
The cochairs of the Summit and its Steering group, in common = with=20 the key players of the other initiatives reviewed here, play key = roles=20 in dissemination of the guiding principles of the Code, = encouraging the=20 adoption and adaptation of the Code and facilitating the = development of=20 standards in many international arenas.

Sustainability issues:
The eHealth Code of Ethics = places a=20 burden on other organizations developing quality standards for = Internet=20 health information in terms of those organizations having to (a) = interpret=20 and specify the Code according to the constituency addressed, as = these=20 activities will have to be supported by commitment of time and = resources;=20 and (b) be in compliance with the Code in broad terms.

Sustainability of the Code itself and its further development = is=20 vulnerable to scarcity of resources and commitment.

The burden of codes of conduct in general is ultimately passed = onto the=20 citizen. In the absence of real enforcement citizens are required = to be=20 interested, knowledgeable, and caring, with the desire and = commitment to=20 apply critical appraisal of sites proclaiming to be in compliance = of a=20 particular code.

Health Internet Ethics (Hi-Ethics) [10]

Launch date
7 May 2000.

Responsible organization
Hi-Ethics Inc [11].

Key concept: third-party certification.

Hi-Ethics Inc is a not-for-profit consortium of US-based = commercial=20 health Internet companies. Current membership is 15 companies. = Member=20 companies provide the funding for the initiative through = membership fees.=20 Current membership fees are $6000.

Intended target users
US-based commercial Web sites: = that=20 offer or plan to offer health services, products, and information = to=20 consumers; that comply with the Hi-Ethics Principles; and that pay = the=20 applicable membership fee.

Objectives
The rules developed by Hi-Ethics are = intended to=20 assure that:

Internet health services reflect high quality and ethical = standards=20
Health information is trustworthy and up-to-date=20
Personal information is protected=20
Consumers are able to distinguish on-line health services = that=20 follow the Hi-Ethics principles from those that do not=20
Member companies' good names are maintained=20
Self-regulation remains the primary mode of oversight=20
Conformance with the applied principles serves as a means of = legal=20 defense and for verification procedures

Approach
The founding members of Hi-Ethics were = motivated to=20 approach the issue of health Internet ethics following media and = consumer=20 criticisms of commercial Web site practices, particularly in the = areas of=20 trust, privacy, and confidentiality. Other areas of concern that = triggered=20 the Hi-Ethics initiative were editorial integrity and advertising=20 policies. Some argue that the founder of drkoop.com called for the = initiative following specific criticism of his company.

This approach required: emphasis on high ethical standards, = gaining the=20 trust and confidence of the consumer, self-regulation, a framework = for=20 legal defense, and the establishment of a set of clear rules of = conduct=20 that sometimes go into great operational detail.

Hi-Ethics Inc also sees the need for governmental policy = setting as=20 well as the corporation's engagement in lobbying and educational=20 activities.

Process
Establishing the Hi-Ethics Principles = required the=20 cooperation and collaboration of large commercial Web companies = that were=20 often in direct competition with one another, and whose business = models=20 and technology infrastructure were often very different from one=20 another.

To ensure a level playing field and to address the issues of=20 competition and the different business models of its members, = Hi-Ethics=20 Inc chose to have all decision-making processes require unanimous=20 agreement. The law firm of Hogan and Hartson was retained to = ensure that=20 the Hi Ethics Principles could stand up to the rigor of any = verification=20 requirements either by regulatory authorities or through = third-party=20 certification.

It can be argued that the founding members of Hi-Ethics have = acted with=20 enlightened self-interest to obtain unanimous consent of the = consortium in=20 order to achieve the goal of setting the governing principles for = the=20 intended users.

Implementation mechanisms
Direct implementation by = health=20 Internet companies who meet membership criteria, and undergo a = third-party=20 certification process through the cooperative program between = Hi-Ethics=20 Inc and URAC for website accreditation.

The number of companies who have implemented the Hi-Ethics = principles=20 fully is not known.

Sustainability issues
Sustainability of the Hi-Ethics = code of=20 conduct is vulnerable to the burdens placed on citizens, member = companies,=20 prevailing market conditions, and the ability of Hi-Ethics Inc to = maintain=20 the currency of the principles.

This will be explored further in the "Discussion" section.

MedCERTAIN [12,13]

MedPICS [14]=20 Certification and Rating of Trustworthy and Assessed Health = Information on=20 the Net
MedPICS is now replaced with HIDDEL (Health Information = Disclosure, Description and Evaluation Language) [15]

Launch date
2000.

Responsible organization
This is an EU (European=20 Union)-funded demonstration project under the "Action Plan on = Promoting=20 Safer Use of the Internet by Combating Illegal and Harmful Content = on=20 Global Networks" [16].

MedCERTAIN is a system based on metadata tagging technology, = standard=20 quality vocabulary, and content filtering labels. It relies on the = cooperation of individuals and organizations that evaluate, = assess,=20 accredit, or recommend health information on the Internet to apply = these=20 technologies to their production processes.

The project is managed by a Project Consortium, which comprises = 3 core=20 partners:

The University of Heidelberg, Department of Clinical Social = Medicine=20
The University of Bristol, Institute for Learning and = Research=20 Technology at the University of Bristol (ILRT)=20
Finnish National Research and Development Centre for Welfare = and=20 Health (STAKES) / The Finnish Office for Health Care Technology=20 Assessment (FinOHTA)

In addition, the project draws on the resources of the = "Heidelberg=20 Collaboration,", a loose collaboration based on the "Collaboration = for=20 Critical Appraisal of Internet Health Information," proposed in = 1997.

Intended target users
Information providers and = rating=20 organizations (which include every organization, portal, or = subject=20 gateway active in recommending, evaluating, or endorsing health=20 information or health-information providers), and ultimately, the = end user=20 of health information.

Objectives

Establish self and third-party rating systems that enable = consumers=20 to filter harmful health information and to identify and select=20 high-quality information ("downstream filtering") through Web = site=20 content labels=20
Creation of an enforcement infrastructure=20
Consumer education=20
Active encouragement of information providers to conform to = ethical=20 codes of conduct=20
Information providers and rating facilities achieve this = through the=20 application of meta tags and labeling technologies

Approach

Metadata self-labeling by information providers=20
Third-party rating and the award of a trust mark=20
Standard metadata vocabulary, which draws on other quality=20 initiatives like the eHealth Code of Ethics and the DISCERN=20 questionnaire

Process

Standard European Commission project management routines=20
Input from the Heidelberg Collaboration=20
Feedback from medical Webmasters on the MedPICS draft = metadata=20 vocabulary and rating criteria

Implementation mechanisms

Information providers describe their content using the = standard=20 quality vocabulary and meta data technologies, for example, XML=20 (Extensible Markup Language )=20
These descriptors would act as labels that allow users to = filter=20 content according to personal criteria=20
The same labels would also feed through to labeling bureaus = by=20 third-party rating facilities (for example, URAC), search = engines, and=20 health Internet Web sites=20
Trust mark: MedCERTAIN defines 4 levels for the award of a = trust=20 mark:
Level I: Transparency Mark = (self-certification)
Level II:=20 Verification of Level I claims and formal assessment of the Web = site by=20 professional volunteers based on the quality criteria
Level = III:=20 Third-party assessment and rating of content
Level IV: = Outcome=20 evaluation

Sustainability issues
Sustainability of MedCERTAIN is = dependent on certain conditions that have to be met. These = are:

Sufficient acceptance and implementation of meta tags by = providers=20
Correct interpretation and specification of the extensive = quality=20 vocabulary by information providers=20
The emergence of strong third-party description and = annotating=20 organizations=20
Progress in browser technology (to allow user-specified = quality=20 preferences) and wide acceptance of XML and meta tags standards=20
Citizens being aware of the quality labels, having an = interest in=20 using them, and being able to interpret them

MedCERTAIN places burdens on citizens, providers, and = third-party=20 certification bodies.

Update
MedCIRCLE (Collaboration for Internet Rating,=20 Certification, Labeling and Evaluation of Health Information) will = use=20 HIDDEL to describe other Web sites as "inner circle" and a loose=20 collaboration of other subcontractors or non-funded partners as = "outer=20 circle," all using HIDDEL. MedCIRCLE is a collaboration of 3 = national=20 gateways in: Germany (=C4rztliche Zentralstelle = Qualit=E4tssicherung-German=20 Medical Association), Spain (Medical College of Barcelona), and = France=20 (CISMeF) [17].

DAER= I=20 [18] = (Database=20 of Adverse Events Related to the Internet) project, which is not = directly=20 part of MedCERTAIN, is somewhat related to the subject of this = study in=20 terms of providing useful feedback to quality processes. This is = achieved=20 through the collection of case studies of situations where = patients have=20 been harmed by information on the Internet.

URAC Health Web Site Accreditation = Programme [19,20]

Launch date
August 2001.

Responsible organization
URAC (formerly known as the = American=20 Accreditation Healthcare Commission) [21].

URAC is a not-for-profit organization founded in 1990 to = establish=20 standards for the managed care industry. URAC's broad-based = membership=20 includes representation from all the constituencies affected by = managed=20 care: employers, consumers, regulators, health care providers, and = the=20 workers' compensation and managed care industries.

Member organizations of URAC participate in the development of=20 standards, and are eligible to sit on the Board of Directors. URAC = offers=20 10 different accreditation programs for managed care = organizations.

More recently, URAC embarked on developing a program for the=20 accreditation of health-related Web sites. The formulation of the = program=20 is now completed and it has been approved by the board of = directors of=20 URAC. It has undergone beta testing by selected health Internet=20 organizations and is fully operational as of August 2001.

URAC primarily derives its funding from fees paid by applicants = for=20 accreditation,

Intended target users
Health-related Web sites, = initially=20 those organizations providing managed care=20 services.

Objectives

Address the concerns of consumers and other health care = stakeholders=20
Provide a tool to identify Web sites that meet high = standards for=20 quality and accountability

Approach
URAC approached the development for this=20 accreditation program in the same way it approaches other = non-Internet=20 accreditation programs.

This approach involved appointing an advisory committee = composed of=20 expert representatives of all stakeholders. This committee follows = standard URAC procedures in its work.

The approach relies on adaptation of existing quality = initiatives;=20 interpretation and specification for the target constituency; = consensus;=20 and public consultation and drafting, until a fully-operational = program=20 can be presented to the URAC Board of Directors for approval.

Process
URAC brings together experts in the field to = debate=20 and discuss what standards are appropriate for a particular aspect = of=20 health Internet information. The standards-development process is=20 inclusive and broad-based-URAC membership itself includes a = balance of=20 organizations representing providers, regulators, businesses, = consumers,=20 and the health Internet information industry.

Implementation mechanisms
Health Web site = organizations that=20 wish to seek accreditation from URAC submit documentation of = compliance=20 with each standard. A member of URAC accreditation staff reviews = this=20 document, working closely with the applicant to resolve any issues = that=20 have been identified. URAC staff visits the applicant to ensure = that its=20 operations are consistent with the documentation submitted. = Finally, the=20 Accreditation Committee and the Executive Committee review the=20 application. These committees are composed of representatives of = URAC's=20 member organizations.

An important requirement of the accreditation program is that = the=20 applicant demonstrates that it has established an organizational = quality=20 committee to oversee the ethical Internet operations of the=20 organization.

URAC has set preliminary accreditation fees of $2000 to $5000, = plus=20 travel fees for URAC certifiers, for on-site inspections.

Sustainability issues
The success of the URAC program = depends=20 on:

Sufficient acceptance by fee-paying customers to make the = program=20 viable=20
Favorable market conditions in the health care industry in = general=20 and the health Internet sector in particular=20
The ability of URAC to maintain the currency of its program = of=20 accreditation=20
The value, if any, attached to accreditation by citizens =

URAC places burdens on citizens through the need to understand = and=20 assess the quality criteria applied to the sites and the = accreditation=20 process behind it, and on its customers through financial and=20 organizational burdens.

TNO Quality Medical Information and = Communication=20 (QMIC)-Quality for medical information communication and = transactions

Launch date
January 2001.

Responsible organization
Health Trust, part of the=20 Netherlands TNO Prevention and Health Institute [22].

TNO (Applied Scientific Research) Institutes are independent=20 organizations that were set up by the Netherlands government to = act as=20 bridges between science and society. The institutes are partly = funded by=20 public funds and partly by fees for services.

QMIC aspires to be the Netherlands Trusted Independent Party = (TIP),=20 while it hopes to become an "international facilitator for domain = specific=20 trusted independent parties." The scope and functions of the = latter role=20 lack clarity.

This will be a fee-for-service system; such fees will be in = line with=20 conventional ISO (International Organization for Standardization)=20 accreditation fees. TNO sees the need for accreditation = aggregators that=20 could offer services at much-reduced rates to small = enterprises.

Intended target user
Trusted Independent Third = Parties (TIPs)=20 whether existing or yet to emerge.

Objectives
Perform a capability assessment of the = information=20 suppliers on their ability to verify conformity with the = requirements=20 ("self-certification with external reference").

Approach
The TNO approach is third-party = certification.

The core team of TNO QMIC comprised 3 individuals whose = backgrounds are=20 from the certification and accreditation industries.

This core team was later expanded to 10 people to include IT=20 specialists and other conformity, standards, and process-flow = specialists.=20 The team is advised by an unknown number of physicians and = informatics=20 specialists.

Process
Classic International Organization for=20 Standardization (ISO) process routines based on consensus, = industry-wide=20 solution, and voluntary compliance [23].

The process involves 6 stages:

Proposal=20
Preparatory=20
Committee=20
Enquiry=20
Approval=20
Publication

Implementation mechanisms
QMIC is an instrument based = on the=20 ISO 9000 and ISO 2000 accreditation procedures and has its roots = in the=20 certification and accreditation culture within the framework of = the=20 European New Approach Directives.

The system relies on 2 types of bodies: an intra-organizational = Notified Body Function (NBF) (a compliance committee) and an = external=20 Trusted Independent Third Party (TIP) that performs the audits and = accreditation.

TNO QMIC accreditation involves the following procedures:=20
Initial audit of the organization applying for = accreditation=20 conducted by the TIP:=20

Capability assessment (information-domain specific). The=20 capability assessment is a dynamic and incremental process = that=20 determines the level of authorization that the NBF would = receive from=20 the TIP=20
Risk assessment of the impact of the health information = under=20 examination=20
Regulatory compliance if applicable

The Notified Body Function is an independent = intra-organizational=20 body that deals with quality functions. The main functions of = the NBF=20 are the scrutiny of documents produced by the organization, = confirmation=20 of compliance with standards set, and ultimate release of = documents for=20 publishing onto the Web site. The TIP supervises all activities = of the=20 NBF.=20
The organization would "'notify" the TIP, which in turns = carries out=20 the capability assessment and issues the necessary = "certification.".=20 Additionally, the NBF issues the organization with = self-certificates for=20 the day-to-day management of the organization.=20
Organizations apply for reaccredidation on a yearly=20 basis.

According to TNO, QMIC "sets a low ceiling for quality = standards that=20 is balanced by robust feedback mechanisms that can access the = provider as=20 well as the TIP's databases," that is, although the quality = standards=20 themselves might not be too onerous for information providers,=20 nonetheless, the standards will be validated through strong = feedback=20 mechanisms by citizens and third-party certifying companies.

Sustainability issues
See under "URAC," above.

HON Code [24,25]

Launch date
1996.

Responsible organization
Health on the Net (HON) = Foundation=20 in Geneva Switzerland [26].

The HON Code is probably the earliest quality initiative on the = health=20 Internet. The HON Code logo can be found on more than 3000 = health-related=20 websites. Nevertheless, despite the profound changes taking place = in the=20 health Internet sector, the HON Code has not been updated since = its=20 creation.

The Foundation is a not-for-profit organization established in = 1995,=20 funded primarily by the State of Geneva and the Geneva Ministry of = Health.=20 HON receives additional support and donation and grant money from = a=20 variety of sources, including the Swiss Institute for = Bioinformatics and=20 Sun Microsystems.

More recently, the Foundation is seeking formal recognition by = the=20 United Nations as a Non-Governmental Organization.

Intended target users
Health information providers,=20 consumers, and medical practitioners.

Objectives
Guide laypersons and medical practitioners = to=20 useful and reliable online medical and health information.

Approach
Self-regulatory quality seal displayed on = sites that=20 conform to the HON Code.

This is the approach definition used by HON: "The HONcode is = not an=20 award system, nor does it intend to rate the quality of the = information=20 provided by a Web site. It only defines a set of rules to:

Hold Web site developers to basic ethical standards in the=20 presentation of information;=20
Help make sure readers always know the source and the = purpose of the=20 data they are reading

Process
The HON Code was developed as an internal = process in=20 consultation with Webmasters, information providers, patients, and = citizens.

Implementation mechanisms
The HON Code sets 8 = principles for=20 basic ethical standards for the health Internet. Sites that = conform to=20 those 8 principles are allowed to display the active HON Code logo = on=20 their pages.

This is a self-certification system that has little control of = how the=20 logo is used. However, HON does try to police the use and abuse of = its=20 logo through the following mechanisms:

An alert of breach is sent to the provider=20
A warning is issued to the offending site=20
Removal of the live link between the HON logo on the = provider site=20 and the HON site

HON also provides an online checklist questionnaire = (Site-Checker) that=20 can help consumers assess whether a given site conforms to the HON = Code=20 principles.

Sustainability issues
The HON Code places a burden on = citizens through the need by those citizens to verify for = themselves what=20 is essentially a claim by the information provider. It is = vulnerable to=20 availability of funding for HON Foundation, which will be required = to=20 maintain the currency of the Code.

European Commission: Quality = Criteria=20 for Health Related Websites [27]

Launch date
June 2001.

Responsible organization
European Commission
DG=20 Information Society: Information Society Technologies: Systems and = Services for the Citizen
DG Health and Consumer Protection: = Public=20 Health

Intended target users
European Union member states. =

Objectives
Produce a European Commission = Communication on=20 Good Practice Guidelines for the Health Internet. The scope of = this=20 Communication will be health-related information society services, = and=20 covers health information and services on the Internet. This scope = does=20 not extend to the category of products.

A European Commission Communication differs from a Directive in = that it=20 has no binding power on the member states to incorporate into = domestic=20 law. It is issued for guidance and to recommend a particular = course of=20 action. A Communication, however, can be used in legal arguments = and a=20 judge may cite it in cases of non-compliance.

Approach
EC "soft power" based on consensus building = and=20 guidance to member states on a voluntary code of conduct based on = quality=20 criteria.

Process

Expert, stakeholder and EC civil servants workshop=20
Drafting Group=20
Online discussion=20
Public consultation

Implementation mechanisms
Non-binding EC = Communication=20 guidance to member states.

Sustainability issues:

Acceptance and implementation by member states will = determine=20 usefulness=20
Like codes of conduct, it places a burden on citizens =

OMNI [28,29]

OMNI, Organizing Medical Networked Information, is part of the = BIOME=20 gateway hub.

Launch date
1996.

Responsible organization
UK (United Kingdom) Joint=20 Information Services Committee (JISC), which also funds the = program.

Intended target users
OMNI targets medical students,=20 researchers, academics, and practitioners. OMNI is currently = widening its=20 appeal to consumers and is developing a set of quality-evaluation = criteria=20 for complementary and alternative medicine.

Objectives
Provide access to evaluated, quality = Internet=20 resources in the health and life sciences, aimed at students, = researchers,=20 academics, and practitioners.

Approach
Expert third party evaluation of networked = medical=20 information based on the OMNI "Evaluation Guidelines" created by = the OMNI=20 "Advisory Group on Evaluation Criteria."

Process

OMNI Evaluation Guidelines created by the OMNI "Advisory = Group on=20 Evaluation Criteria=20
Description and cataloging of resources based on the BIOME=20 "Cataloguing Guidelines"=20
Collection development policy

Implementation mechanisms
OMNI uses a standard web = interface=20 to search the catalogs of reviewed resources. It has catalogued=20 approximately 4000 sites to date.

Sustainability issues
The OMNI team faces a Herculean = task in=20 keeping up with new sites, products, and services that are = emerging all=20 the time, let alone keeping the original evaluation up to date. =

This places a burden on the team in terms of human and = financial=20 resources and at the same time, the OMNI program places a burden = on=20 citizens in terms of their need to understand and assess the = quality=20 criteria applied to the catalogs.

DISCERN [30,31]

Launch date
1999.

Responsible organization
The DISCERN Project Team = based at=20 the Division of Public Health and Primary Care at the Institute of = Health=20 Sciences of the University of Oxford England. DISCERN is funded by = UK=20 National Health Service Executive Research and Development = Programme.

Intended target users:

Citizens seeking information on treatment choices for = certain=20 conditions=20
Authors and publishers of information on treatment choices =

Objectives

Enable consumers to judge the quality of written information = on=20 treatment choices=20
Facilitate the production of high quality evidence-based = patient=20 information

Approach
Citizen evaluation of Web sites carrying = treatment=20 information based on an aggregated assessment derived from a = predefined=20 questionnaire (the instrument).

Process

Expert panel analysis. Panel composition: clinical = specialists,=20 self-help group representatives, general practitioners, consumer = health=20 information expert, lay medical publisher, health journalist, = health=20 consumer representative, Community Health Council = representative, Plain=20 English Campaign representative, and NHS Centre for Reviews and=20 Dissemination representative=20
Development of draft instrument=20
Instrument testing=20
Selected stakeholder testing=20
National pilot=20
Development of a standardized quality index derived from the = questionnaire

Implementation mechanisms
Subjective rating system = for=20 decisions on treatment choices based on the questionnaire.

Sustainability issues
DISCERN places a burden on the=20 citizens, as they would have to (a) understand the quality = criteria behind=20 the questionnaire, (b) have the commitment to fill in the = questionnaire,=20 and(c) have the ability to understand the meaning of the score = value.

Guidelines for Medical and Health Information = Sites on the=20 Internet - Principles Governing AMA Web Sites [32,33]

Launch date
2000.

Responsible organization
American Medical Association = (AMA)=20

Intended target users
Web sites of the American = Medical=20 Association, Medem ( http://www.medem.com/ ) and=20 other providers and users of medical information on the Web.

Objectives
Govern the Web sites of the AMA, AMA = Publications,=20 and Medem.

Approach
Rules of conduct that govern health = information on=20 the Web are based on those that govern medical journals, including = rules=20 of peer review, authorship, full disclosure of funding and = sponsorship,=20 editorial independence, separation of content and advertising, and = the=20 principles of privacy and confidentiality based on the principle = of=20 informed consent.

Process
The development of these guidelines began in = 1999. An=20 AMA staff committee, composed of the listed authors, was organized = to=20 review the existing individual guidelines and draft a single = document that=20 would provide principles to govern the presentation and = functionality of=20 the 4 major areas for which quality standards were needed: = content,=20 advertising and sponsorship, privacy and confidentiality, and = e-commerce.=20

Committee members reviewed initial drafts and consensus was = reached on=20 the content of each of the 4 principles. The document was then = reviewed=20 internally and externally by experts in ethics, publishing, = government=20 regulations, law, and medical informatics, and by the AMA Online = Oversight=20 Panel. After subsequent revision, the document was reviewed by the = Executive Committee of the AMA Board of Trustees and was approved = on=20 February 28, 2000. The guidelines underwent peer review and were = published=20 in JAMA on March 22, 2000.

Implementation mechanisms
These are governance tools = intended=20 for use by the developers of the AMA's Web sites and of the Medem = Web=20 site. Other organizations have adopted these guidelines or used = them as=20 the basis for their guidelines. The AMA does not ensure compliance = with=20 the guidelines for organizations other than itself and Medem.

Quality Standards for Medical Publishing on the = Web=20 [34] =

Launch date
1996.

Responsible organization
British Healthcare Internet=20 Association (BHIA).

This is a not-for-profit organization whose mission is better = health=20 care through the application of Internet technologies. It is = funded by=20 membership fees. The membership is open to anyone who supports the = mission=20 of the organization, and currently comprises clinicians, = publishers, Web=20 site developers, information providers, information technology=20 professionals, health care managers, government officers, and = academics.=20 The BHIA has 120 members. The organization is currently not = active.

Intended target users
Medical Webmasters and medical=20 information providers.

Objectives
Better quality of medical information on = the web.=20

Approach
A set of quality criteria for improving the = quality=20 of on-line medical information focusing on the content of Web = sites.

Process
Paul Galloway authored the draft of the = quality=20 standards. That draft was submitted to the membership for comments = and=20 amendments. The final document was approved by the membership as a = BHIA=20 Recommendation in an online consensus process.

Implementation mechanisms
Guidance to medical = Webmasters.=20

There has been no further development of the criteria and it is = not=20 known if they are used in practice and, if they are used, it is = not known=20 how they are used.

The Health Summit Working Group (HSWG) = Criteria for=20 Assessing the Quality of Health Information on the Internet: IQ = Tool [35]

Launch date
1997/1998.

Originally funded by Mitretek Systems Inc [36], the = HSWG IQ=20 Tool is one of the earliest tools-based scoring methods for = assessing the=20 quality of health websites.

Mitretek Systems Inc, although it morally supports the use of = the tool,=20 no longer funds the project. The project is no longer developed or = maintained by any organization.

The tool was developed using an expert-group consensus process. = The=20 work resulted in a set of criteria that have a weighted scoring = system.=20

Users deploy the tool when visiting a Web site they wish to = evaluate=20 and have to go through the process of completing the questionnaire = in=20 order to arrive at a quality score.

It is not know whether this tool is in use.

The International Federation of Pharmaceutical = Manufacturers Associations (IFPMA) Code of Marketing [37]

Launch date
1981/1982.
Last major revision: 1994. =

The IFPMA Code of Marketing sets out universal principles for = ethical=20 marketing conduct for use in countries where a more-demanding = national=20 code of conduct does not exist.

The Code applies to ethical pharmaceutical products and = stresses the=20 need to respect local and national laws; however, its scope also = includes=20 the controversial issue of direct-to-consumer marketing of ethical = pharmaceutical products.

The IFPMA Code does not have specific clauses on Internet = health=20 information; however, it includes the addendum below addressing = the issue=20 of the Internet in a vague and general way:

Addendum 1:
Use of the Internet
The = research based=20 pharmaceutical industry, represented by the IFPMA, strongly = supports the=20 right to use the Internet as a means of providing accurate and=20 scientifically reliable information on medicines in a = responsible=20 manner, for the benefit of patients, healthcare professionals = and other=20 appropriate parties. Recognizing patient safety is of paramount=20 importance, IFPMA's goal is to encourage the appropriate use of = the=20 Internet.
The IFPMA considers that there should be open = access to all=20 information put on the Internet by pharmaceutical companies. It = accepts=20 that there are national differences in the laws and regulations=20 governing the promotion of medicines.
Many pharmaceutical = companies=20 have established corporate sites on the Internet, which provide=20 information about the company. Non-product related information = is=20 outside the scope of the IFPMA Code.
The IFPMA = recognizes that=20 certain uses of the Internet may fall within the scope of the = IFPMA Code=20 of Pharmaceutical Marketing Practices. The following points = concern=20 product-related information:
The identity of the = pharmaceutical=20 company and of the intended audience should be readily apparent. = The=20 content should be appropriate for the intended audience. Links = should be=20 appropriate and apparent to the intended audience. = Country-specific=20 information must comply with local requirements. =

The IFPMA Marketing Code, does not specify in detail what = aspects of=20 the Code apply to health information (on, for example, diseases = and=20 conditions) attached to products or produced and published by=20 pharmaceutical companies on the Internet.

It would be interesting to determine the level of acceptance = and=20 implementation by member pharmaceutical companies. It is important = to=20 determine how this guidance from the IFPMA differs from any = criteria set=20 by pharmaceutical companies for their own internal processes in = general.=20

Other pharmaceutical organizations that may have an impact on = quality=20 of Internet health information

Listed below are some of the organizations that may have an = impact on=20 quality of Internet health information of pharmaceutical companies = in the=20 relevant jurisdictions. Almost all of these organizations will = have some=20 sort of reference to quality standards of health information = published by=20 their constituencies on the Internet. The list below was adapted = with=20 permission from the InPharm Web site http://www.inpharm.com/db= /ieindex.html.=20

All Web sites in this list: [accessed 2001 Oct 4].

General Pharmaceutical Inspectorate (Belgium) URL: http://www.afigp.fgov.be/ =
Medicines Evaluation Board (Netherlands) URL: http://www.cbg-meb.nl= /uk/overcbg/index.htm=20
European Agency for the Evaluation of Medicinal Products = URL: http://www.emea.eu.int/=20
European Department for the Quality of Medicines-European=20 Pharmacopoeia on the Web URL: http://www.pheur.org/=20
European Society of Regulatory Affairs URL: http://www.esra.org/Resource.phx/community/mainpage/mainpage.htx=20
US Food and Drug Administration (FDA)-Center for Drug = Evaluation and=20 Research URL: http://www.fda.gov/cder/=20
US Food and Drug Administration URL: http://www.fda.gov/=20
IDRAC, International Drug Registration URL: http://www.eu.imshealth.com/i= drac/=20
International Conference on Harmonisation of Technical = Requirements=20 for Registration of Pharmaceuticals for Human Use URL: http://www.ifpma.org/ich1.html=20
Irish Medicines Board URL: http://www.imb.ie/=20
UK Medicines Control Agency URL: http://www.mca.gov.uk/=20
UK National Institute for Biological Standards and Control = URL: http://www.nibsc.ac.uk/=20
Pharmaceutical and Medical Devices Evaluation Center (Japan) = URL:=20 http://www.nihs.go.jp/pm= dec/outline.htm=20
Prescription Pricing Authority (UK) URL: http://www.ppa.org.uk/=20
Regulatory Affairs Professionals Society (RAPS) URL: http://www.raps.org/=20
Medical Products Agency (Sweden) URL: http://www3.mpa.se/ie_engind= ex.html=20
The United States Pharmacopoeial Convention Inc URL: http://www.usp.org/

The discussion is organized into:

Key mechanisms of the health information quality initiatives =
Sustainability issues=20
Enforcement issues=20
Adequacy of approach and enforcement provisions=20
Scope and reach=20
Gaps that need to be addressed
Key mechanisms of the health information quality initiatives =
The starting block of all the initiatives is a set of quality = criteria.=20 These sets of criteria range from the simple common-sense = perspective of=20 Paul Galloway and the peer-review journal approach of William = Silberg et=20 al [38], to the=20 extensive and elaborate sets of quality criteria of URAC and = MedCERTAIN.=20
All the sets of criteria derive from very similar roots and = differ only=20 in the language and expression of those roots. Briefly, these = roots are=20 the principles of honesty, privacy, confidentiality, accuracy, = currency,=20 provenance, consent, disclosure, and accountability.
The initiatives' developers chose different mechanisms to = transform=20 these sets of quality criteria into programs of Internet health=20 information governance. On the surface, these key mechanisms seem = to be=20 many; however, a closer look reveals that these key mechanisms (or = philosophies) belong to one of 3 underlying mechanisms.
These 3 key mechanisms can be summarized as follows:
Codes of conduct or ethics
These are based on principles of ethical behavior and sets of = quality=20 criteria. Almost all the quality criteria used by the initiatives = converge=20 at some point or another. It is only the language used to describe = the=20 criteria that is different. For example, the ehealth Code of = Ethics=20 states: "Disclose information that if known by consumers would = likely=20 affect consumers' understanding or use of the site or purchase or = use of a=20 product or service" in the "Candor and honesty," section, whereas = we find=20 Hi-Ethics Inc states: "We will inform consumers who use our = Internet=20 health services of the risks, responsibilities, and reasonable=20 expectations associated with their use of our services" in the=20 "Transparency of Interactions, Candor and Trustworthiness" = section.
Codes of conduct rely on self-certification by participating = Web sites,=20 for example, those displaying the HON Code. This = self-certification=20 process is nothing more than a claim or a pledge that has little=20 enforceability.
Third-party certification
This requires recurrent validation of compliance with a set of=20 standards. These standards may or may not be based on some of the = codes of=20 conduct and ethics discussed here. In all cases, third-party = certification=20 requires payment of fees to the certifying company.
Special note on the metadata element of the MedCERTAIN = initiative:

The MedCERTAIN initiative is essentially a third-party = certification=20 program. However, the developers describe the program as = third-party=20 description and annotation rather than certification. Thus, it = would=20 seem that the MedCERTAIN process contains both elements of=20 "self-description" and third-party evaluation.=20
The program uses sets of detailed quality tags (quality = vocabulary)=20 embedded in the technical infrastructure of documents to = describe the=20 content on offer (similar in concept to food labels) [39].=20
Users of health information would be able to filter the = content they=20 receive or view based on, initially, being aware of the metadata = sheet,=20 and later, automatically via the setting of personal preferences = within=20 the browser environment (downstream filtering).=20
Third parties endorsing, describing, or evaluating other = sites, for=20 example, gateways and libraries (such as MedlinePlus or OMNI);=20 professional associations; or certifying organizations (such as = URAC),=20 can use this metadata language to describe information content = or=20 information providers.
Tool-based evaluation
This is mostly based on a predefined questionnaire that would = yield a=20 certain "quality score" for the content under evaluation.
Tool-based evaluation is primarily intended for use by = citizens, who=20 would invoke the particular tool to assess the quality of a given = site.=20 This process differs from self-certification and logo-bearing = sites, for=20 example, under the HON or MedCERTAIN programs [Comment added by = the=20 editor: However, note that MedCERTAIN enables the development of=20 intelligent "next generation" tools aggregating and interpreting = metadata,=20 see editorial]
Advantages and disadvantages of the three key mechanisms are = listed in=20 Table 4.

Discussion

[enlarge] Table=20 4. Advantages and Disadvantages of the 3 Key = Mechanisms of=20 the Health Information Quality=20 Initiatives

Sustainability issues

The following unresolved issues cast doubts over the ability of = the=20 various quality initiatives to survive what is largely an = unregulated and=20 often anarchic medium.

Burdens

All the quality initiatives under discussion place a number of = burdens=20 on producers and users of health information and on others. These = burdens=20 are seen as a serious threat to the sustainability and maintenance = of the=20 quality standards. The burdens fall on one or more of the = following:

Citizens: by having to care about, bother about, understand, = and=20 apply the methodology of any given initiative=20
Providers of health information: by having to understand, = interpret,=20 and specify the program, and apply the program to their = operations=20
Third-party accreditation organizations: by having to = acquire=20 sufficient knowledge and a customer base to make their business = viable=20
Organizations that sponsor initiatives: by having to develop = and=20 maintain their programs, often under very adverse financial = conditions,=20 for example, many of these organizations rely on donations and = grant=20 money that might not always be forthcoming=20
Clinicians and other health care workers: by having to care = about,=20 bother about, understand, and apply the methodology of any given = initiative

Currency and maintenance

The ability of the organizations sponsoring the quality = initiatives to=20 maintain their initiatives up to date can be vulnerable to = scarcity of=20 funding (for voluntary and non-profit organizations and for-profit = and=20 fee-based organizations alike), and to low acceptance of quality = programs.=20 This is particularly acute at times of rapid change in the health = Internet=20 or market downturns that affect donor contribution or membership = gains=20 adversely.

Funding

Most of the initiatives rely on donation and grant money to = maintain=20 and develop their work. This makes them vulnerable to conditions = outside=20 the their control at best, and to potential undue influence at = worst.

Cost

The initiatives most likely to command credibility are those in = which=20 there is independent third-party certification. Yet, third-party=20 certification places a financial burden on the organization = seeking=20 certification, because of the high level of fees charged for = accreditation=20 or certification as well as the cost of the required = organizational=20 change. There are no credible means of offsetting that cost or=20 ameliorating it for small yet useful providers.

Acceptance

Most of the initiatives rely on establishing a critical mass of = acceptance. It remains difficult to assess the degree of current = or future=20 acceptance for any given initiative.

Market conditions

Prevailing market conditions play a crucial role in determining = corporate policies. There is a real fear that market downturns = would=20 affect quality implementation adversely. Equally, in times of = plenty,=20 corporate sights might be set on other things. In market = downturns,=20 quality and ethics might be victims of cutbacks. In times of = plenty,=20 quality and ethics might be relegated behind profit making, unless = they=20 are seen to be a competitive advantage.

User indifference or ambivalence

Users need to care about, bother about, understand, and = implement the=20 requirements of the quality initiatives; but, users

might not be aware of the issues of quality or the existence = of=20 quality initiatives and programs=20
might care about and be aware of the quality initiatives, = but not=20 understand the initiatives and the requirements these = initiatives place=20 on them=20
might not care too much about quality issues=20
might be aware of and care about quality of health = information, yet=20 not bother too much about following what is required of them by = the=20 various initiatives

Enforcement issues

All except one of the quality initiatives discussed here are = based on=20 self-regulation systems that are applied voluntarily and which = have=20 enforcement mechanisms that rely on the unconvincing notions of=20 self-declaration, self-certification, or withdrawal of = accreditation. The=20 exception is the initiative by the American Medical Association's = program,=20 which is enforced by the AMA corporate body.

Even when third-party certification and revalidation are the=20 requirements, it seems that the only enforcement sanction is = withdrawal of=20 accreditation, which might not be a very effective enforcement = sanction or=20 might have a weak impact on the Web site in question.

Enforcement provisions of the voluntary initiatives discussed = here do=20 not seem to be adequate in view of the lack of credible sanctions = for=20 non-compliance and worthy rewards for compliance.

There are so many disparate constituencies within the domain of = Internet health information that it is quite difficult to see how=20 sector-specific self-regulation can be successful without further = and=20 deeper characterization, interpretation, and specification to = identify the=20 needs of specific sectors of information providers.

Enforcement mechanisms used are summarized as follows:

None=20
Self-certification or a pledge, without validation=20
Third-party withdrawal of accreditation and revalidation by = a third=20 party

Adequacy of approach and enforcement provisions

The following inadequacies in the approach and enforcement = provisions=20 have been identified.

The potential high cost of implementing quality standards, = particularly=20 by small and voluntarily-funded entities.

The inability to formulate mechanisms that address the quality = of the=20 "pseudo-health" sector:

The existence of the pseudo-health segment of information = producers=20 and users complicates efforts to introduce quality standards for = health=20 information on the Internet. This is the "gray market" of health = information and it includes practices and remedies that have not = yet=20 been proven empirically or anecdotally; some unproven wellness = products;=20 misleading nutrition information; dubious mineral, plant and = animal=20 alternatives to pharmaceuticals; and the dissemination of = untypical=20 personal experiences.

This pseudo-health sector presents the most challenges in = ensuring=20 the dissemination of good quality health information and = practices.=20 Whereas reputable producers of health information on the = Internet would=20 not have many problems complying with most of the quality = criteria under=20 discussion, the pseudo-health sector will probably remain = outside the=20 philosophy of applying quality standards in a self-regulatory = manner.=20 This is because much of the motivation for this sector is mainly = financial gain through fraud and deception.

It is important to distinguish this sector from the = alternative and=20 complementary health-care sector. Many of the disciplines in the = latter=20 sector have an important and legitimate role to play in the = health and=20 well-being of many people.

The lack of credible incentive and deterrence in implementing = quality=20 policies by information providers.

The size of the burden placed on the various players.

The absence of strategies for auditing utilization of the = initiative's=20 implementation.

The absence of adequate sector characterization and = specification.

Lack of clarity of the language and terminology of quality [40].

Absence of any clear mechanisms for cooperating with regulatory = authorities to implement programs of co-regulation.

Absence of clear strategies to extend the proposed protection = measures=20 on a global scale.

Inadequate response to liberal and conservative arguments = against=20 development of standards for health information on the = Internet.

Scope and reach

Most of the initiatives target citizens as the ultimate = beneficiaries=20 without recognizing the scale and practical challenges of=20 citizen-education issues and the diverse levels of critical = appraisal=20 skills among citizens.

That focus on citizens ignores the other participants in the = matrix of=20 health information: for example, clinical services providers, = research=20 communities, public health institutions, and policy makers = worldwide. It=20 also neglects the crucial role of doctors and other health-care = workers as=20 effective arbiters of quality of health information.

Many of the initiatives do not have a universal reach, for = example,=20 Hi-Ethics Principles and the AMA Guidelines.

All the initiatives stem from a Western orthodox view of health = and=20 health information. This is particularly noticeable whenever = evidence is=20 mentioned. Examination of quality initiatives originating from = non-English=20 speaking organizations might provide a different view.

None of the initiatives address the issues and needs of = communities=20 that are still catching up with, deprived of, or oblivious of the=20 information revolution because of poverty, lack of access to = content and=20 connectivity, or the capacity to produce and disseminate health=20 information.

With the exception of the eHealth Code of Ethics, MedCERTAIN, = and the=20 HON Code, the initiatives are published in the English language = only. Not=20 only does that limit the benefits accrued to non-English speaking=20 citizens, but it also prohibits non-English speakers from = contributing to=20 the formulation of Internet health information standards.

Gaps that need to be addressed

Many of the gaps that need to be addressed in future quality=20 initiatives are discussed above. In summary, these gaps are (in = order of=20 priority):

Enforcement provision=20
Burdens=20
Sustainability=20
Scope=20
Reach=20
Definition of quality=20
Language and terminology=20
Meaningful dialogue with regulatory authorities and entities = outside=20 the health Internet sphere=20
Strategic and operational programs of co-regulation=20
Audience characterization and specification=20
Provider education=20
Language and readability barriers=20
Audit strategies for quality-program utilization=20
The pseudo-health sector=20
The needs of clinicians and other health-care workers=20
The role of clinicians and other health care workers as = effective=20 intermediaries of health information quality

Conclusions

The complexity of the issues surrounding quality of health = information=20 in the context of the health Internet has been shown.

Some of the key self-regulation initiatives of Internet health=20 information quality have been described and analyzed. The various=20 initiatives have been compared in a number of ways.

The "Discussion" section, above, clarifies and discusses the = issues and=20 requirements for the further development of Internet health = information=20 quality.

Conclusion 1

Internet health quality initiatives discussed here have 1 of 3=20 mechanisms. It seems that 1 or more of 3 mechanisms would underpin = future=20 development of quality initiatives. These key mechanisms are:

Codes of conduct or ethics=20
Third-party certification of compliance (accreditation)=20
Tool-based evaluation of quality

Conclusion 2

Based on the analysis of quality initiatives and the discussion = above,=20 it is proposed that a successful quality program has these 3 = essential=20 elements:

A set of health information quality criteria=20
An educated, interested, and active citizen=20
Credible enforcement instrument(s)

None of the initiatives discussed in this paper comprise all 3 = elements=20 convincingly.

These 3 elements must be taken into account in any future = developments=20 and implementation of health information standards.

Conclusion 3

The current batch of quality initiatives for Internet health=20 information reveals many gaps that need to be addressed. These = gaps are=20 discussed and listed in this paper. The most serious of these gaps = are the=20 excessive burdens placed upon citizens and the cost of = implementing=20 credible programs providing accreditation and enforcement.

Further examination and the addressing of these gaps is = essential for=20 any future development work on Internet health information = governance.

Conclusion 4

More research is needed to further clarify the complexities of = Internet=20 health information. Of special interest are the governance = mechanisms that=20 need to address quality of information content and information = value, the=20 context and relevance of the content of information, the educated=20 interested citizen, and the desired instruments that would = strengthen any=20 envisaged enforcement provision.

Conclusion 5

There is an urgent requirement to examine the needs of the = developing=20 world and the info-poor in relation to quality of Internet health=20 information, products, and services. This is a reflection on how = poorly=20 the current batch of quality initiatives have addressed those = needs.

This examination would include determining whether or how = quality=20 standards can help developing countries, especially where = regulatory=20 agencies are weak or nonexistent; or where there is excessive, = uninformed,=20 or onerous regulation.

Conclusion 6

There are no current mechanisms for ensuring the quality of = Internet=20 health information in relation to the pseudo-health sector. This = sector=20 will probably remain outside the efforts to implement governance = of health=20 information quality.

Conclusion 7

The quality initiatives discussed here have not addressed the = thorny=20 issue of alternative and complementary disciplines outside the = orthodox=20 view of health care.

These disciplines differ from those of the pseudo-health sector = in that=20 they have a legitimate place in health care, whereas the = pseudo-health=20 sector is essentially about fraud and quackery.

Conclusion 8

Language, whether in tongue or in syntax, remains a major = obstacle to=20 the dissemination of good practices and the education of citizens = and=20 information providers alike.

Conclusion 9

There is a need for coordination and harmonization of the = efforts=20 striving towards quality health information on the Internet. This = extends=20 to the key players in both the self-regulation and the mainstream = and=20 regulatory camps, and includes regional and international bodies, = the=20 health care products industry, foundations with an explicit = interest in=20 Internet health information, private and corporate interests, and = citizen=20 and country representation and participation.

Conclusion 10

There are concerns and criticisms directed against establishing = models=20 of governance for Internet health information quality. These = arguments=20 come from different perspectives and take different routes but = arrive at=20 the same destination. These concerns include:

Users are ambivalent or indifferent about quality through = ignorance,=20 lack of caring, or low priority=20
Quality programs that are not rigorously enforced and = validated=20 might produce a false sense of security=20
Traditional media did not require quality standards; = therefore=20 neither should the new media=20
Brand loyalty is more important than quality seals; the = Internet has=20 no center; therefore, it does not need central control; and, = kitemarking=20 (referring to the application of a kite-shaped mark granted for = use on=20 goods approved for use by the British Standards Institution) the = Internet is like "kitemarking the west wind" [41].=20
Freedom of speech=20
Free market forces=20
The enormous practical and logistical difficulties = associated with=20 implementing quality programs are a barrier to implementation =

As arguments, they are in no way compelling or well thought = out.=20 Indeed, they seem more to be descriptions of behavior for which no = rationale for taking them seriously is given by those who invoke = them.

It is concluded that these arguments should be countered with a = coherent strategy for health information quality governance that = can unite=20 the stakeholders in an effort to reduce the risk of harm to = citizens=20 throughout the world (see "Recommendations," below).

Recommendations

In any new field of human endeavor there emerges at the = beginning a=20 group of individual pioneers, visionaries, and entrepreneurs. = These=20 individuals, by their nature, kick-start the standards setting = process for=20 that new field. They tend to do this either as individuals or = through=20 forming into associations. These are mostly voluntary = organizations that=20 rely on the enthusiasm and energy of their members, and often = struggle to=20 meet the financial and management demands that are placed upon = them.

The new field of and the early work in standards development = eventually=20 attract the attention of society's mainstream players or the gap = between=20 the pioneers and the mainstream players narrows enough for the = mantle to=20 pass onto the mainstream players.

The health Internet has been no different. We are probably at = the cusp=20 of that convergence to the extent that it has become imperative to = bring=20 together the 2 camps of active pioneers and mainstream players in = a=20 coherent and coordinated process to develop the next generation of = quality=20 standards.

The need for global leadership

Quality of Internet health information is important, because it = has the=20 potential to benefit or harm a large number of people. It has this = potential because of the nature of the Internet and the Internet's = rapid=20 worldwide spread.

The quality of Internet health information is too important to = be left=20 to the anarchy of the Internet or the vagaries of the free market, = or to=20 be conducted in a haphazard uncoordinated way.

The absence of clear, credible, and trusted leadership in the = sphere of=20 Internet health information compounds the problems of quality and = trust=20 relationships among people who use the Internet for health = purposes.

The author believes that there is a need for clear leadership = on a=20 global scale to achieve the yet-unfulfilled promise of information = and=20 communication technologies of better health for all.

This global leadership needs to take the following steps to = assume that=20 leadership role:

Bring together the key players of both the pioneer and = mainstream=20 camps in a coherent effort that can benefit all citizens of the = world=20
Harmonize a global framework for Internet health information = quality=20 standards=20
Act as intellectual and technical knowledge resource for the = world=20
Provide custody and good stewardship of the evolving = standards=20
Implement a program to ensure the prevention of harm to = communities=20 and nations yet to be exposed to powerful free-market-economy = forces=20
Safeguard the interests of the info-poor=20
Provide impartial advice and guidance not constrained by = politics or=20 geography=20
Facilitate the dialogue between the interested parties of=20 self-regulation and the regulatory authorities towards the = creation of=20 programs of co-regulation=20
Work towards "the global public good" and the benefit of all = citizens of the world

The role of the World Health Organization (WHO)

In line with the WHO's global role in setting norms and = standards and=20 assisting member states to implement these norms and standards, = the=20 organization has a crucial role to play in developing norms and = standards=20 for Internet health information quality.

We recommend that the WHO's activity in this sphere should = include the=20 following terms of reference:

The fulfillment of 3 crucial requirements:
o Increase the = understanding of Internet health information quality = standards
o=20 Assess the impact of implementation of such standards at country = level
o Recommend a framework of action for Internet health=20 information quality=20
Bringing together key players from the stakeholder = communities in a=20 coherent and coordinated manner.=20
Ensuring good stewardship of ethics and quality standards=20 development.=20
Consensus building among the various interested parties.=20
Facilitating the steering of these programs towards the=20 establishment of universally-agreed quality standards for = Internet=20 health information.=20
Providing a world resource for Internet health information = quality=20 thinking and research.=20
Coordinating educational and training activities relating to = quality.=20
Disseminating good practices throughout the world and = assisting=20 member states in the implementation of those good practices.=20
Working with the private sector to help advance the cause of = quality=20 of Internet health information.

Acknowledgements

Susan Holck (Director of Information Management and = Dissemination,=20 WHO)
For commissioning this research project.

Tim Nater
For providing me with valuable external review of = this=20 paper and the fruitful and insightful exchanges of thought that = helped me=20 in so many ways.

Bette Crigger (The Hastings Center)
For providing very = valuable=20 external review of this paper, her very helpful comments, and her = ruthless=20 editorial scrutiny.

All the colleagues and friends in the health Internet community = who=20 helped shape and guide my thinking in this field over many years = (AR).=20

Conflicts of Interest

This work was commissioned by the World Health Organization. AR = and JD=20 were engaged as a Consultant at the World Health Organization to = carry out=20 this and other research.

AR is a member of the Board of Directors of the Internet = Healthcare=20 Coalition and cochairs its eHealth Code of Ethics Initiative. AR = also has=20 taken part in a number of workshops and meetings organized by some = of the=20 organizations represented here. These organizations include = MedCERTAIN,=20 URAC, and the European Commission. This work was unpaid.

Tim Nater (external reviewer) was Executive Director of the = Health on=20 the Net Foundation (HON) until last year, and remains a member of = the=20 eHealth Code of Ethics Steering Group.

Bette Crigger (external reviewer) served as the Project Editor = for the=20 eHealth Code of Ethics, and had prepared a comparison of that code = and=20 those of the American Medical Association, HON, and Hi-Ethics, for = the=20 benefit of the eHealth Code of Ethics Steering Group.

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* Reference 40: Web site requires free=20 registration.

Abbreviations

AMA: American Medical Association

BHIA: British Healthcare Internet = Association

EC: European Community

EU: European Union

HIDDEL: Health Information Disclosure, Description = and=20 Evaluation Language

HON: Health on the Net

HSWG: The Health Summit Working Group

HSWG IQ Tool: The Health Summit Working Group-Criteria = for=20 Assessing the Quality of Health Information on the Internet: = IQ=20 Tool

IFPMA: International Federation of Pharmaceutical=20 Manufacturers Associations

ISO: International Organization for=20 Standardization

IT: Information Technology

NBF: Notified Body Function

OMNI: Organizing Medical Networked = Information

QMIC: TNO Quality Medical Information and=20 Communication

TIP: Trusted Independent Party

UK: United Kingdom

US: United States

WHO: World Health Organization

XML: Extensible Markup = Language

Submitted 17.9.2001, peer-reviewed by C. Baur, M.J. = Deering and=20 G. Eysenbach, comments to author 24.9.2001, revised = version=20 received 2.10.2001, accepted 2.10.2001, published = 26.12.01=20 [publication delayed due to late arrival of copyright=20 clearance]

Please cite = as:
Risk A, Dzenowagis J. Review of Internet Health = Information Quality Initiatives.
Journal of = Medical=20 Internet Research 2001;3(4):e28
<URL:=20 http://www.jmir.org/2001/4/e28/>

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