The AHA today submitted comments on the Food and Drug Administration’s Medical Device Safety Action Plan. Released in April, the plan outlines new pre- and post-market authorities, guidance and an expert board under consideration by the agency to improve device security and how device makers disclose and respond to vulnerabilities. “The AHA supports these steps, which would make important improvements to the FDA’s oversight of medical device manufacturers with respect to the security of their products,” the association said. “We urge the FDA to move as quickly as possible to implement them and make public its timeline for the benefit of all stakeholders.” With respect to guidance, AHA said device manufacturers “must be held accountable to proactively minimize risk by building security into products by design, providing security tools to their end-users and updating and patching devices as new intelligence and threats emerge.” The association also recommended including health care providers as a partner on an expert board being contemplated by the agency.
The Centers for Disease Control and Prevention today activated its Emergency Operations Center to support the interagency response to the Ebola outbreak in…
Insights and Analysis
Alaska State Hospital & Nursing Home Association’s Hultberg leads with achievements in sustainability, quality and collaboration
AHA board member Becky Hultberg hopes to help the AHA create solutions for rural hospitals, among other initiatives.
The House Energy and Commerce Committee today held a hearing on its discussion draft of bipartisan legislation to address surprise medical bills.
The World Health Organization has confirmed the first cases of Ebola in Uganda since 2013.
Insights and Analysis
AHA board member Delvecchio Finley leads Alameda (Calif.) Health System in bringing more services to the community it serves, meeting patients where they are…
AHA’s Institute for Diversity and Health Equity helps organizations build a diverse pipeline of leaders
In this AHA Stat blog, Institute for Diversity and Health Equity President and CEO Duane Reynolds highlights various resources, programs and efforts to help…