The AHA today submitted comments on the Food and Drug Administration鈥檚 Medical Device Safety Action Plan. Released in April, the  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. 鈥淭he AHA supports these steps, which would make important improvements to the FDA鈥檚 oversight of medical device manufacturers with respect to the security of their products,鈥 the association said. 鈥淲e urge the FDA to move as quickly as possible to implement them and make public its timeline for the benefit of all stakeholders.鈥 With respect to guidance, AHA said device manufacturers 鈥渕ust 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.鈥 The association also recommended including health care providers as a partner on an expert board being contemplated by the agency.

Related News Articles

Headline
A 60-day appeal window has passed for the Food and Drug Administration to appeal a federal court ruling that invalidated its final rule to regulate laboratory-鈥
Headline
The AHA May 12 responded to the Office of Management and Budget's April 11 request for information on regulatory relief, making 100 suggestions to the Trump鈥
Headline
The Government Accountability Office yesterday released a report calling for the Department of Health and Human Services to improve its efforts responding to鈥
Headline
The AHA Living Learning Network is launching the Quality Exchange, a virtual collaborative for health care quality and patient safety professionals at鈥
Headline
The U.S. District Court for the Eastern District of Texas March 31 ruled that the Food and Drug Administration does not have the authority to regulate鈥
Headline
As part of the AHA's Patient Safety Initiative, a dedicated webpage features case studies showing how hospitals and health systems across the nation are鈥