Understanding the latest trends, tools and challenges in access management empowers cybersecurity professionals to make better choices in safeguarding their systems. Following we look at emerging trends, regulatory requirements and how shifts in the workplace are impacting the risk of cyber attacks.
The FDA announced that on October 1, 2023, it would begin to Refuse to Accept (RTA) medical device premarket submissions that do not comply with PATCH Act requirements. Erez Kaminski, former head of AI with Amgen and founder of Ketryx, and Paul Jones, former FDA official and Executive Vice President of Ketryx, provide an overview of challenges companies face as they work to comply with the new cybersecurity regulations and standards.
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions provides recommendations on what information to include in premarket submissions and emphasizes that cybersecurity is a component of quality system regulation.
On August 11, the FDA released a Final Guidance on Off-the-Shelf Software Use in Medical Devices, which supersedes Off-The-Shelf Software Use in Medical Devices issued September 27, 2019.
Healthcare cyberattacks are becoming more common and more costly—both financially and to patient care continuity. Internet-connected IoMT devices and equipment remain a security concern for healthcare delivery organizations. Deeper collaboration between HDOs, medical device manufacturers and security providers is needed to reduce risk and vulnerability.
The use of artificial intelligence in medical device design is already transforming health care. In this article we look at areas of greatest promise as well as the challenges that must be addressed to realize the promise of AI in device design and engineering.
The dramatic increase of medical devices in patient care has yielded many benefits. However, this technology also carries various risks, including risks to patient privacy, that must be addressed.
The recently announced “Refuse to Accept Policy” signed into law under section 524B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the FDA more traction to encourage the medical device manufacturing industry to utilize software bills of materials that help to incorporate supply chain security. The ISA/IEC 62443 series of standards defines a secure product lifecycle process that can be adopted by medical device manufacturers to identify and manage the security risks of all external components used within the product.
When it comes to testing, the most significant difference between CSV and CSA is that CSV focuses on a “test everything” approach, while CSA encourages us to use critical thinking to test more effectively. The following article outlines how companies can identify the appropriate degree of testing rigor for risk-based CSA validation to ensure the least burdensome approach.
Smart hospitals are revolutionizing health care with the help of AI, IoT and robotics. Following are the latest technology and data analytics tools and trends that are helping these hospitals of the future provide safer, more personalized care.
