eHealth Regulations in the US: Understanding the Evolving US Legislative Landscape

Introduction

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. 

Scope

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

Highlights

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. 

The new guidance ensures that 21 CFR Part 11 is interpreted more narrowly than in the past. As a result, pharmaceutical companies can conduct independent documented risk assessment and, based on those results, implement aspects of the regulation in a way that accounts for the unique needs of the company. 

Reasons to Purchase

Understand the current and prospective eHealth regulatory environment in the US and where the key opportunities for your company lie

Bolster your company's eMarketing campaign within the US by providing personalized and relevant health-related information online

Understand the limitations and opportunities presented by future regulations and hasten compliance by developing forward-looking eHealth strategies. 

20th May 2004, 55 Pages Format: PDF 

Publisher: Datamonitor eHealthcare Pharma 2004 

To order go to this URL: http://www.bioportfolio.com/cgi-bin/acatalog/Datamonitor_eHealthcare_Pharma_2004.html#a587