- AAMI TIR57, Principles for medical device security – risk management
- Guidance on Risk Analysis Requirements under the HIPAA Security Rule
- IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities
- ISO 14971 Medical devices — Application of risk management to medical devices
- FDA Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance
- FDA Postmarket Management of Cybersecurity in Medical Devices
- Framework for Improving Critical Infrastructure Cybersecurity (NIST Cybersecurity Framework)
- NIST Cybersecurity Framework
- NIST SP1800-8, Securing Wireless Infusion Pumps in Healthcare Delivery Organizations – DRAFT
- NIST SP 800-30 Rev 1, Guide for Conducting Risk Assessments
- NIST SP 800-37 Rev1, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach
- NIST SP 800-39, Managing Information Security Risk Organization, Mission, and Information System View
“Performing the Risk Analysis is a daunting task each year. Clearwater provides the step-by-step workflow, detailed help and assistance back to NIST and HIPPA/HITECH references that allow for a clear and defined process.”
“Can you imagine how nice our lives would be if all software vendors were like Clearwater? We ask a question, we get an answer. We need training, they provide it. Software works as advertised. What a concept!”
Clearwater’s compliance tools, such as IRM|Analysis™, have created an internal infrastructure that allows us to meet the most rigorous demands of Compliance annually. The service support we receive across all their products has been exceptional from the first day we began working with them.
Contact us today to speak to one of our experts about how Clearwater Compliance can help your organization.