The pharmaceutical industry is experiencing an increased level of government regulatory intervention. Achieving compliance is of primary concern to every company in the industry. In order to successfully implement eHealth regulations and avoid federal investigations, the pharmaceutical industry must maintain a balance between the rights of the customer and the requirements of the business. When designing an eMarketing campaign, pharmaceutical companies must look at the needs of their specific target audience in order to gain the greatest ROI. Compliance issues also need to be respected. Companies should bear in mind that regulatory compliance is critical to consumer confidence, which is, in turn, key to increased sales of products.
It is in the pharmaceutical industry's best interest to achieve HIPAA compliance. By doing so, the industry will send a message to the general public that protection of personal identifiable information (PII) is an important objective, and it will also prepare the industry to adopt increasingly stringent future regulations.
Highlights
- Analyzes the changing eHealth regulatory environment in the US, including general strategies for successful compliance
- Defines aspects of an eMarketing campaign that are important to an increased return on investment as well as regulatory compliance
- Explores current regulations involving data protection practices and privacy policies
- Looks at the change in the FDA's interpretation of 21 CFR Part 11 and discusses what the newly issued guidances will mean for the industry
TABLE OF CONTENTS
ACTION POINTS
Outline of the brief
EHEALTH REGULATORY ENVIRONMENT IN THE US
Introduction
Overview of the Pharmaceutical Marketing Controls
Self-regulatory organizations
International Federation of Pharmaceutical Manufacturers Associations (IFPMA)
Pharmaceutical Research and Manufacturers of America (PhRMA)
State Pharmaceutical Trade Association (e.g. Health Care Institute of New Jersey)
Regulatory organizations
World Health Organization (WHO)
US Government
State-level Government (e.g. New Jersey)
Regulations involving eMarketing
Direct-to-consumer (DTC)
Risk information disclosures
Disease awareness communications
Marketing via email
The CAN-SPAM law
Dot-mail Internet domain name
eDetailing
Office of the Inspector General’s (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers
Specific risk areas
Regulations involving personally identifiable information (PII)
HIPAA as a model for online policy
De-identification of Health Information
FTC’s Recommendations
FTC’s Fair Information Practice Principles
Regulations Involving 21 CFR Part 11
THE FUTURE DECODED
Outlook for eHealth regulatory compliance
A general strategy for regulatory compliance
APPENDIX
Datamonitor’s eHealthInsight Business Unit
List of figures
Methodology
References
Relevant links
How to contact experts in your industry
55 pages
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