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eHealth Marketing. Benefits, Risks, Challenges Richard Cleland Senior Attorney Federal Trade Commission. Introduction. What a difference a year makes! 17,000 Internet health sites 52 million Internet health seekers*

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ehealth marketing

eHealth Marketing

Benefits, Risks, Challenges

Richard Cleland

Senior Attorney

Federal Trade Commission

  • What a difference a year makes!
    • 17,000 Internet health sites
    • 52 million Internet health seekers*
    • Progress will not be linear; at times there will be plateaus and even a reversal or two
  • Enables a large number of people to quickly access medical and other information that was never available to the general public before.
  • Empowers consumers to take a more active role in their health care management.*
  • New information can be disseminated quickly to the public and medical community.
  • Easier for researchers and others to share information, avoid duplication, and pool resources.
  • Potential for delivery of services and products more efficiently and cost effectively.
  • Facilitates b/b and b/c commercial transactions.*
potential harm
Potential Harm
  • Dangerous products*
    • hydrazine sulfate
    • oil of wormwood
  • Inaccurate information**
  • Health Fraud
  • Violation of professional practice standards
  • Privacy violations
consumer attitudes
Consumer Attitudes
  • Consumer attitudes toward technology are important.
  • Internet users may be one of the most studied populations in history.
pew internet and american life project study
Pew Internet and American Life Project Study
  • 52 million American adults have used the Internet to look for health information.
    • 23% used the Internet within the last week
    • 35% used within the last month.
    • Looking for information about specific diseases and conditions
    • Convenience, quantity of information, and anonymity
internet use
Internet Use
  • Primary use of the internet is to supplement conventional medicine, not to replace it.
    • 2% of Internet health users reported that they used the Internet instead of seeing a physician
    • 61% said they looked for health information for themselves either before or after visiting a doctor or clinic
  • Only 10% said they bought medicine or vitamins on the Internet.*
consumer satisfaction
Consumer Satisfaction
  • 90% report that the information they found was useful
  • 80% said they learned something new
  • 55% say it improved the way they get medical information
  • 48% say it improved the way they care for themselves
  • 47% of persons who sought information for themselves say that the information affected their decisions
concerns privacy
Concerns: Privacy
  • 86% say they are concerned that health-related web site will sell or give away information about what they did online
  • 60% say that maintaining medical records online would be a bad thing, because they would worry about other people seeing their health records
concerns accuracy
Concerns: Accuracy
  • 86% say they are concerned about accuracy
    • 44% said that they believe some of what they see on the Internet
    • 35% said they believe most
    • 16% said they believe almost all
  • 70% report trouble distinguishing credible information from untrustworthy information*
ftc s ehealth mission
FTC’s eHealth Mission
  • Help consumers find truthful and accurate health information
  • Provide consumers with the tools and information needed to distinguish legitimate health products from health scams
  • Protect vulnerable consumers from injury
  • Foster the growth of internet commerce
ftc ehealth initiatives
FTC eHealth Initiatives
  • Consumer protection
  • Privacy
  • Industry self-regulation
ftc or fda
  • Federal Trade Commission
    • Advertising of OTC drugs, foods, dietary supplements, cosmetics, devices and services
  • FDA
    • Advertising of prescription drugs and restricted medical devices
    • Labeling of prescription drugs, medical devices, OTC drugs, foods, dietary supplements, and cosmetics
prohibited acts practices
Prohibited Acts & Practices
  • Unfair and deceptive acts or practices
  • False advertisements for foods, drugs, devices, cosmetics and services
  • In or affecting commerce
  • False statements
  • Deceptive omissions of material fact
  • Lack of a reasonable basis
  • Unfair practices*
reasonable basis reguirement
Reasonable Basis Reguirement
  • FTC Act requires that an advertiser making an objective performance or efficacy claim for a product or service have a reasonable basis to make that claim.*
  • Most common advertising violation (on and off the Net)
determining reasonable basis
Determining Reasonable Basis
  • Reasonable basis varies
    • Level advertiser claims
    • Type of product
    • Type of claim
    • Benefits of a truthful claim
    • Costs and feasibility of developing substantiation for a claim
    • Consequences of a false claim
    • Amount of substantiation that experts in the field believe is reasonable
health claims
Health Claims
  • Health claims generally require competent and reliable scientific evidence* to support the claim.
    • Totality of the evidence
    • Well-controlled clinical studies
  • See Dietary Supplements: An Advertising Guide for Industry. This document is available at
health fraud on the net
Health Fraud on the Net
  • Operation Cure.All (June 1999)
    • target deceptive and misleading online marketing of products and services being promoted as cures or treatments for serious diseases
    • consumer and business education
    • law enforcement
    • FDA & several state attorneys general.
health claim surf days
Health Claim Surf Days
  • What is a surf?
  • Over 1,000 sites identified – tip of the iceberg
  • Therapies and devices, but the vast majority of products are supplements
  • Compliance advisory letters**
  • Random sampling
consumer education
Consumer Education
    • Links to reliable sources of health information, including
    • Consumer education tips such as those found in “Virtual Treatments” and “Fraudulent Health Claims.”
  • Teaser sites like “Arthriticure” and “Virility Plus.”
  • Goal: Real time consumer education
law enforcement
Law Enforcement
  • The FTC has filed seven Operation Cure.All cases since June of 1999.
  • Cat’s Claw
  • Shark cartilage
  • Glycoalkaloid cream
  • Cetylmyristoleate (CMO)
  • Essiac tea
  • Magnetic therapies

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androgen supplements
Androgen Supplements
  • FTC v. AST Nutritional Concepts Research, Inc. (Colorado) (99-WI-2197) (May 4, 2000) (Stipulated Order)
  • FTC v. Met-Rx (SAC V-99-1407) (C. Dist. Cal.) (Nov. 24, 1999) (Stipulated Order).
hiv rapid tests
HIV Rapid Tests
  • FTC v. Cyberlinx, Inc. and Jeffrey S. Stein
  • FTC v. Medimax, Inc. and David Rothbart
  • FTC v. Alfa Scientific Designs, Inc.
  • FTC v. Sovo Tec Diagnostics, Inc.
  • FTC v. Chembio Diagnostic Systems, Inc.
  • Joint FTC/FDA consumer warnings
  • Privacy is critical – 89% of health seekers are concerned!
  • Significant deterrent to Internet development
  • Gaps in self-regulation – 40% of health products sites have no policy
  • Gaps in HIPPA
  • Privacy is an Internet wide public relations problem
  • Notice of privacy policy is critical to building consumer confidence
  • Compliance with privacy policies is critical to maintaining consumer confidence
privacy common mistakes
Privacy – Common Mistakes
  • Privacy practices inconsistent with privacy policy
  • Inconsistent statements
  • Unintelligible policy
  • Third party access or collection not disclosed
  • Information leakage
privacy deceptive practices
Privacy – Deceptive Practices
  • Consumer told that information is not individually identifiable when it is
  • Information used for a purpose other than the one disclosed
  • Consumer told that information is encrypted when its not
  • FTC v. Rennert
self regulation
  • Self-regulation is the predominant form of regulation on the Internet
  • FTC fully supports self-regulation efforts
    • Compliment to effective law enforcement.
  • Standards
    • Employ high standards
    • Vigorously enforced
    • Meaningful independent oversight
  • A question of harm
online ethical codes seals
Online Ethical Codes/Seals
  • Health on the Net
  • AMA
  • Hi-Ethics/Trustee
  • eHealth Code/URAC
  • Address issues transparency, blurring, privacy, professional standards, and accuracy
death of the gatekeeper
Death of the Gatekeeper?
  • Historic role of physicians and government regulators as gatekeepers
  • Primary care provider
  • Governments play a predominant role in determining what health products could be sold and under what conditions (e.g., prescription drugs)
  • Little need to educate consumers of the rationale behind the system
  • Online pharmacies, contact lenses, medical information, alternative and complimentary medicine
  • Consumer demand
  • Education
  • Limits to consumer protection model
online pharmacies
Online Pharmacies
  • Buying prescription drugs on line
  • Congressional hearings
  • State actions
  • Federal Actions
    • Criminal charges
    • FTC v. Rennert
  • The Global Net
health literacy
Health Literacy
  • 90 million U.S. adults are functionally illiterate or marginally literate.
  • Difficulty understanding the health care information they need and receive.
  • How is the Internet serving these people?
  • Internet depends primarily on search engines and health portals to deliver users to text-based content.
  • Written at a level that may be beyond many current and future Internet users.
health literacy44
Health Literacy
  • Reliable health content (not just advertising) available at all levels
  • Develop alternatives to text based communications (technology)
  • Navigational aids that go beyond text-based queries
  • Improvements in health, medical & scientific literacy
efuture shock
eFuture Shock
  • Future will not look like the past
    • Telemedicine
    • At home health monitoring
    • Product sales
    • Online medical records
    • Education
    • Advances in evidence based medicine
    • Reducing medical errors
efuture shock46
eFuture Shock
  • Is this a technology we need?
  • Will it improve health?
  • Will consumers accept it?
  • What are the ethical implications?
  • Help consumers find truthful and accurate health information
  • Provide consumers with the tools and information needed to distinguish legitimate health products from health scams
  • Protect vulnerable consumers from injury
  • Foster the growth of internet commerce