Saturday, June 4th: 3:30 p.m.- 4:15 p.m.
Informing FDA Regulatory Policy for Cybersecurity through Software Testing
In recent years, the FDA has been challenged with keeping pace with the rapidly changing cybersecurity threat landscape in the medical device sector. As awareness of these issues grows, the community of healthcare stakeholders would hope to see regulatory policy continue to be informed by advances in regulatory science coupled with industry best practices. The purpose of this session is to describe how the FDA can use results generated by software security and robustness testing tools and methodologies to gather data that can be used to determine cybersecurity risks associated with medical devices and healthcare systems, and to apply the knowledge in developing regulatory requirements. This session proposes a method that employs the more traditional regulatory science approach.
Mike Ahmadi, Synopsys, Inc. Anura Fernando, UL LLC
- See more at: http://www.aami.org/annualconference/content.aspx?itemnumber=1796&navItemNumber=1123#sthash.o9YbxKBu.dpuf
Sunday, June 5th: 2:00 p.m.- 2:30 p.m.
Five Years of EHR Design Research in 60 Minutes: Best Practices for Electronic Health Record and Medical Software Design
The human factors discipline has thousands of user interface design principles and dozens of effective design processes to offer medical software developers intent on ensuring the safe, effective, and satisfying use of their products. The widespread adoption of electronic health records (EHRs) prompted the National Institute of Standards and Technology to fund a five-year research effort focused specifically on EHRs. In this session, the team who completed this effort will describe how on-site research in clinical settings, usability tests, and additional human factors analyses generated the guidance presented in their report titled “Technical Basis for User Interface Design of Health IT” that includes a design process framework and over 300 empirically-based user interface design guidelines. Additionally, we will share how these resources can be used to shape the development of EHRs and medical-related software (e.g., therapy compliance applications, wellness tracking websites, and software user interfaces within standalone devices).
Michael E. Wiklund, PE, CHFP, UL, LLC Limor Hochberg, Human Factors Specialist, UL-Wiklund
- See more at: http://www.aami.org/annualconference/content.aspx?itemnumber=1797&navItemNumber=1123#sthash.xSSXpydB.dpuf