FDA Issues Medical Device Cybersecurity Warning, FTC Blocks Hospital Merger
The FDA issued an urgent cybersecurity warning about several medical devices, and the FTC is supporting a lawsuit against an HCA/Steward Healthcare merger in Utah.
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By - FDA and FBI officials are sharing their cybersecurity knowledge as the pace of healthcare cyberattacks picks up.
From the FDA, an urgent message issued a warning to organizations that may be vulnerable to cybersecurity holes affecting Illumina medical devices. And at a conference in Boston, the director of the FBI indicated that an Iranian-backed cybersecurity attack against Boston Children’s Hospital was narrowly thwarted last year.
Meanwhile, the FTC blocked a significant hospital merger between Steward Health Systems and HCA in Utah that would have consolidated care in that state.
FDA Issues Urgent Patch Warning for Illumina Devices
FDA officials are urging organizations to patch cybersecurity vulnerabilities that have impacted several Illumina In Vitro diagnostic devices. The exploits laid bare by the cybersecurity holes could allow a user to take remote control of devices and gain administrative access to its functions. The Cybersecurity and Infrastructure Security Agency (CISA) released a detailed advisory about the vulnerabilities. The agency noted that Illumina developed a patch to protect against remote exploitation and is “actively working to provide a permanent software fix for current and future instruments.” READ MORE.
FBI Reveals a Thwarted Cyberattack Against Boston Children’s
Director of the FBI, Christopher Wray, revealed that Iranian-backed hackers attempted to target Boston Children’s Hospital with a cyberattack last year. In a speech delivered at a Boston cybersecurity convention, Wray described the situation: “Our folks got the hospital’s team the information they needed to stop the danger right away. We were able to help them ID and then mitigate the threat. And quick actions by everyone involved, especially at the hospital, protected both the network and the sick kids who depend on it.” The year prior, 493 provider organizations reported data or security breaches. READ MORE.
FDA Amends Pfizer Vaccine EUA
Last month Pfizer-BioNTech’s coronavirus vaccine received approval for a third dose in children aged 5 to 11 years of age. The FDA’s decision to issue amended approval was based on a study of 67 participants that showed antibody increase. FDA officials also noted the safety profile of the vaccine study, citing no serious adverse events after transfusion. Pfizer is now seeking another amendment to its vaccine approval in children aged 6 months and older. READ MORE.
FTC Aims to Block Utah Hospital Merger
The FTC authorized a lawsuit that would block the proposed merger of HCA Healthcare and Steward Health Care’s Utah branch. HCA is one of the largest health systems in the United States, and the proposed merger would incorporate five of Steward Health’s Utah hospitals into the HCA system. FTC officials characterized the merger as uncompetitive and claimed that joining the two systems would have negative consequences for patients throughout Utah. READ MORE.
HHS, CMS Extend HCBS ARP Funding for Additional Year
The Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) chose to extend American Rescue Plan (ARP) funding to states’ home and community-based care (HCBS) for an additional year. “Thanks to extended funding from President Biden’s American Rescue Plan, we are expanding home- and community-based services for millions of aging Americans and people with disabilities across the country. We are working hand-in-hand with states to ensure they have the time and support they need to strengthen their home care systems and workforce,” HHS Secretary Xavier Becerra stated in the press release. READ MORE.
