Transcript eHealth Marketing - University of Pennsylvania

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*
Progress will not be linear; at times
there will be plateaus and even a
reversal or two
Benefits
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.
Benefits
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
Dangerous products*
hydrazine sulfate
oil of wormwood
Inaccurate information**
Health Fraud
Violation of professional practice
standards
Privacy violations
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
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
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
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
86% say they are concerned that healthrelated 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
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
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
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
Unfair and deceptive acts or
practices
False advertisements for foods,
drugs, devices, cosmetics and
services
In or affecting commerce
Examples
False statements
Deceptive omissions of material fact
Lack of a reasonable basis
Unfair practices*
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
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 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
http://www.ftc.gov/bcp/conline/pubs/busp
ubs/dietsupp.htm.
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
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
www.ftc.gov, www.consumer.gov
Links to reliable sources of health information,
including healthfinder.gov
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
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
Metatags
CONTENT="cancer, cancer treatments, Essiac
ESSIAC Essiac essiac essiac TEA tea tea tea
CANCER CANCER Cancer cancer CURES
Cures cures cures information, brain tumors,
lymphoma help, essiac, ESSIAC teas,
natural colon treatments, natural remedies
remedies REMEDIES remedies remedies
REMEDY Remedy remedy remedy
Androgen Supplements
FTC v. AST Nutritional Concepts
Research, Inc. (Colorado) (99-WI2197) (May 4, 2000) (Stipulated
Order)
FTC v. Met-Rx (SAC V-99-1407) (C.
Dist. Cal.) (Nov. 24, 1999) (Stipulated
Order).
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
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
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 practices inconsistent with
privacy policy
Inconsistent statements
Unintelligible policy
Third party access or collection not
disclosed
Information leakage
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
Health on the Net
AMA
Hi-Ethics/Trustee
eHealth Code/URAC
Address issues transparency,
blurring, privacy, professional
standards, and accuracy
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
Gatekeeper
Online pharmacies, contact lenses,
medical information, alternative and
complimentary medicine
Consumer demand
Education
Limits to consumer protection model
Online Pharmacies
Buying prescription drugs on line
Congressional hearings
State actions
Federal Actions
Criminal charges
FTC v. Rennert
The Global Net
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 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
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 Shock
Is this a technology we need?
Will it improve health?
Will consumers accept it?
What are the ethical implications?
Summary
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