AHA Friday voiced support for the Protecting and Transforming Cyber Health Care Act (S. 3983/H.R. 7084), legislation that would require medical device manufacturers to meet certain cybersecurity requirements when seeking approval for devices that are internet connected or include software. For example, the bill would require medical device manufacturers to monitor and identify post-market vulnerabilities in a timely manner, develop a plan for coordinated vulnerability disclosure, and provide lifetime cybersecurity support of the device. It also would provide a “software bill of materials” for all software contained in the device, including third-party software. 
  
“Manufacturers should be accountable for developing products with appropriate security controls, as well as updating devices as cyber threats continue to evolve,” AHA said in  letters of support to the House and Senate sponsors, Sens. Bill Cassidy, R-La., and Tammy Baldwin, D-Wisc., and Reps. Michael Burgess, R-Texas, and Angie Craig, D-Minn. “We also encourage the inclusion of a provision to clarify that FDA approval of devices would not be jeopardized as manufacturers provide these updates.” 
 

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