Contents:

DATAMONITOR HEALTHCARE ACTION POINTS Outline of the brief Three key things you need to know about operating within the eHealth Regulatory Environment in the US Ensuring the security of data records and the quality of audit trails are the key characteristics of a functional system used to collect and manage electronic data In order to help the FDA review data and reconstruct studies, data retrieval should be facilitated by maintaining older systems or migrating data to newer systems In designing DTC product websites, marketers should focus on creating content that will not be deemed as misleading to consumers so as not to draw negative media coverage eHEALTH REGULATORY ENVIRONMENT IN THE US Introduction Regulations involving electronic records and signatures 21 CFR Part 11 FDA Guidance: Computerized Systems Used in Clinical Trials Systems to collect and manage electronic data records Regulations involving online direct-to-consumer marketing Overview of the Pharmaceutical Marketing Controls Self-regulatory organizations Regulatory legislation Providing balanced information online THE FUTURE DECODED Outlook for eHealth regulatory environment A general strategy for regulatory compliance Navigating through the evolving regulatory landscape APPENDIX Datamonitor’s eHealthInsight Business Unit Table of figures References 21 Code of Federal Regulations Part 11 PhRMA Policy Stance on Direct-To-Consumer Advertising Relevant links SPP writing team How to contact experts in your industry