EMERGING TECHNOLOGY AND MODERNIZING THE ARMY
MAJOR ASSESSMENT
Jaques Reifman, Ph.D., far right, director of U.S. Army MRDC’s BHSAI, is with Henry M. Jackson Foundation staff in support of BHSAI who worked with Reifman to develop the APPRAISE-HRI. From left, the staff are Fransico Vital-Lopez, Ph.D., research scientist; Andrew Frock, software developer; and Valmik Desai, software development manager. (Photo courtesy of BHSAI)
corruption and other concerns. BHSAI used funding from MRDC’s Medi- cal Materiel Development Activity to conduct another round of validation on the APPRAISE-HRI algorithm, which was performed independently and blindly on vital-sign data from nearly 6,000 patients collected from nine sites, includ- ing in-hospital and pre-hospital data. Te results of this independent analysis corrob- orated the algorithm’s performance.
In issuing a clearance for the APPRAISE- HRI, the FDA stressed that the device is intended to provide military healthcare providers with “situational awareness” about potentially hemorrhagic patients, not to be used to “diagnose or direct treatment.” The FDA concluded that APPRAISE-HRI is “a useful tool to aid in discriminating hemorrhage risk in the trauma population.”
CONCLUSION Reifman says the experience of develop- ing the APPRAISE-HRI algorithm and working with the FDA to approve the device provided valuable lessons for him and his team.
“We have high standards of scientific rigor at BHSAI, but working with the FDA showed me that there are things that I could be even more rigorous about,” Reifman said. “Our focus is on develop- ing technologies. But the FDA focuses on risk and how to mitigate it. Tat’s not how scientists usually think about technology. Te more I worked with them, the more I understood that their approach is just as scientifically rigorous as ours. I think that alerted me to the understanding that I still have room to grow in terms of my own definition of scientific rigor, as well as how we apply it to the things we do in our organization.”
Tat broader perspective is already being distilled into BHSAI’s current practices, Reifman added, and because many of the scientists there are still in the early stages of their careers, he is hopeful that it will permeate BHSAI’s institutional culture.
“We have a lot of software development projects, and I encouraged my team to think about how we can incorporate these concepts and processes when we’re plan- ning those projects,” Reifman said. “For
https://asc.ar my.mil 49
example, now we think about cybersecu- rity from the start, which is something we wouldn’t normally do as part of pure research. All those things that we didn't pay attention to because we didn't think were important, we are now implement- ing throughout the organization whenever possible to increase the scientific rigor that we apply to every single project.”
For more information about the Biotech- nology High Performance Computing Software Applications Institute, go to
https://bhsai.org.
PAUL LAGASSE is a public affairs writer with USAMRDC. He has an M.A. in history and an M.L.S. in archival studies from the University
of Maryland, and
a B.A. in history from Regis University. Before working in public affairs for the Army and Navy, he was a newspaper reporter and a freelance writer and editor.
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