The U.S. FDA has ruled that there is insufficient evidence to currently “justify imposing additional/different burdensome regulatory requirements” on third-party servicers of medical devices. The decision appeared in the agency’s report on the quality, safety, and effectiveness of medical device servicing—which was mandated as part of the FDA Reauthorization Act of 2017.
Read More
According to a recent report in the HIPAA Journal, healthcare data breaches are caused by hacking IT incidents, improper disposal of electronic protected health information, and more. Here, seasoned biomed German (John) Baron analyzes some of these causes and makes reference to security controls, which may help to address the identified vulnerabilities.
Read More
The National Electrical Manufacturers Association (NEMA) published NEMA CPSP 2-2018 Cyber Hygiene Best Practices, which outlines industry best practices and guidelines for electrical equipment and medical imaging manufacturers to raise their level of cybersecurity sophistication in manufacturing facilities and engineering processes.
Read More
For the last few years, the shape of HTM academic programs in the United States has been, well, rough. Last year, for example, several programs closed due to low enrollment numbers, heightened expenses, and a lack of qualified faculty members willing to teach. Fortunately, in 2018 and beyond, the future is looking brighter.
Read More
Security firm Symantec has discovered a new hacking group called Orangeworm, which is deliberately and systematically targeting the healthcare sector. Specifically, Orangeworm is installing a custom backdoor dubbed Trojan.Kwampirs within large healthcare companies in the United States, Europe, and Asia.
Read More