Privacy & Security
The agency is seeking stakeholder feedback on the guidance, which seeks to clearly outline its recommendations for premarket submission content when it comes to cybersecurity concerns.
The addition of its technology will help secure third-party digital identities – "critical, but often overlooked and vulnerable points of access."
"They have already compromised healthcare organizations and have no reason to stop," said the Health Sector Cybersecurity Coordination Center about the group known as Lapsus$.
Clinicians at dozens of Defense Department, Coast Guard and Veterans Affairs sites were unable to update medical records for hours this past Wednesday.
Experts say preparedness is stymied by funding gaps and complexity, according to Brussels-based Frieda Klotz.
The State of Connecticut Auditors of Public Accounts found that the Connecticut Health Insurance Exchange experienced 44 breaches between July 2017 and March 2021.
As cyber threats increase, this RFI aims to help the agency support implementation of security best practices and better share enforcement funds with individuals harmed by HIPAA violations.
The bipartisan bill would put in place baseline cybersecurity requirements for device manufacturers applying for FDA approval and require plans to monitor and address post-market vulnerabilities.
When implemented correctly, these programs can effectively crowdsource security research and testing services to help uncover real world exploitable vulnerabilities.
Two are part of its Right of Access initiative – bringing the number of cases to 27 since the project began – and two stem from impermissible disclosure of protected health information.