This overview of the Regulatory Practices and Requirements for the Mobile Healthcare Industry discusses the various aspects of mobility and the good practice and related regulatory requirements that come into play, especially with respect to record keeping.

1. Regulatory Requirements for the Mobile Healthcare Industry
Executive Summary
This overview of the Regulatory Practices and Requirements for the Mobile Healthcare Industry
discusses the various aspects of mobility and the good practice and related regulatory
requirements that come into play, especially with respect to record keeping.
Specifically this report seeks to address the following questions:
 What are the Good Practice Requirements or GxP in the healthcare industry and how do
they impact an organization as it considers leveraging the mobile opportuity?
 What are some of the other mandatory and optional requirements that come into play?
 What record keping are imposed by these regulations on the healthcare industry as it
enables mobility?
Table of Contents
Executive Summary
Good Practice Requirements in the Mobile Healthcare Industry
GxP or Good “x” Practice
Predicate Rules
GCP: Good Clinical Practice
GLP: Good Laboratory Practice
GLP: Good Laboratory Practice
cGMP: Current Good Manufacturing Practice
GAMP: Good Automated Manufacturing Practice
Record Keeping Requirements
2Title 21 CFR Part 11
Impact to Mobile Healthcare
Overall Requirements
Software Design
Software Manufacture
System Tests
Deployment and Distribution
Endeavour’s Recommendations
HIPAA
Impact of HIPAA on Mobile Healthcare
Impact of HIPAA on software development
CIA: Corporate Integrity Agreements

2. CIA and Mobile Healthcare Providers
CIA and Software Development
Conclusion
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