Two prominent medical device organizations have announced a new collaboration to advance medical device cybersecurity practices across the entire medical device lifecycle. The Association for the Advancement of Medical Instrumentation (AAMI) and the Archimedes Center for Medical Device Security will work together to connect their networks of medical device and health technology professionals across the country.
“Cybersecurity is a major area of concern for medical device safety, and it’s an area where AAMI has been active and will be even more active in the future,” said Robert Burroughs, AAMI senior vice president of education. “Our collaboration with Archimedes will expand the reach of some of the world’s leading experts in the area of cybersecurity and lead to new education offerings and resources that will drive patient safety. We welcome them as members to the AAMI community.”
AAMI is a nonprofit community of more than 9,000 professionals working to support the health care community in the development, management, and use of safe and effective health technology. Founded in 1967, the organization is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support and guidance for health technology and sterilization professionals.
Archimedes was the first of its kind to bring together the different stakeholders from the medical devices industry – including health care providers, medical device manufacturers, security researchers and regulators – for the purpose of solving security challenges. Housed at the University of Michigan’s computer science and engineering department, the unique center is funded by 17 institutional members to support graduate students and train health care professionals to better integrate security engineering into medical device design, procurement and operation.
Representatives at AAMI cite a growing focus on security across the medical devices industry as a major motivation behind the collaboration.
“There are a few things happening in the future that are really crucial for medical devices,” Burroughs said. “In an Internet-of-Things world, cybersecurity is already here today as an issue and it’s only going to grow in importance.”
The two organizations intend to connect their membership and stakeholder networks to work on advancing security practices for these life-saving devices. Potential outcomes of this initiative include a standardized health care and medical device security curriculum for manufacturers and healthcare delivery organizations.
“We appreciate how AAMI represents thousands of experts in healthcare technology, sterilization and medical device manufacturing,” said University of Michigan Professor Kevin Fu, chief scientist and founder of the Archimedes Center. “The Archimedes cybersecurity collaboration with AAMI will help us to significantly grow our broader impact on society for trustworthy, safe and effective delivery of health care.”
The organizations are considering additional joint activities to promote their overlapping work, including an annual innovation award for medical device security.
“In the end the goal is to increase awareness, improve education and have influence across the industry,” said Sarah Peña, Archimedes senior operations and business development manager.
AAMI, Archimedes, and their members have a long history of collaboration. Fu previously co-chaired the AAMI Working Group on Medical Device Security, which developed the FDA-recognized technical information report AAMI TIR57:2016, that outlines core principles for medical device security and risk management.
Beyond their past collaborations, the two organizations share a common vision for providing more resources in the health care and device security space. Archimedes offers security expertise and a close network of leaders who are driving the industry, while AAMI has connections and resources spanning the field of medical instrumentation.
“Each group brings something valuable, so the collaboration is a natural fit,” said Peña. “We know that in order to make meaningful progress and have an impact in a rapidly changing industry, we are better together.”
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