Clinical Trial Management Packages
HIPAA Compliance for Clinical Research & Clinical Trials Companies
For companies who perform, manage, and / or oversee clinical research and trials, we can help you maintain HIPAA compliance.
Is your clinical trial company looking for a hassle-free way to stay HIPAA compliant? Our HIPAA compliance package has got you covered. We've put together everything you need to protect your patients' information and avoid legal issues.
Our package includes customizable policies, forms, and posters that make it simple for you and your staff to follow HIPAA regulations. Plus, we've got a comprehensive manual that covers everything from the Privacy Rule to the HITECH Act.
Documentation Kit
- Risk analysis and management policy and worksheets
- Workforce and training policy
- Computer system management policy
- Facility controls policy
- Facility maintenance log for HIPAA
- HIPAA contingency and security incident policy
- HIPAA monitoring policy
- Protected health information use and disclosure policy
- Release of protected health information policy
- Notice of privacy practices
Welcome Kit
- Directions on using your HIPAA compliance package
- HIPAA FAQs
- HIPAA regulatory text and guidance
- Digital form of the HIPAA policies and patient forms
- HIPAA training outline, written test, answer key and certificate template
- HIPAA compliance checklist
- HIPAA handouts
- HIPAA Patient Rights Poster
- HIPAA Workforce Security Reminders Poster
- Instructions on updating your kit if and when there are changes
Manual
- Privacy Rule, Security Rule, HITECH Act and Omnibus Rule
- HIPAA Background
- Who must comply with HIPAA
- What information is protected by HIPAA
- Patient Rights
- HIPAA Safeguards
- Breaches and what to do in the event of a breach
- HIPAA enforcement
- Administrative Simplification Rule
- 5 stage process for HIPAA compliance, and more!