Unlike other sectors, healthcare directly impacts lives. This necessitates rigorous vetting and careful implementation of any new technology. Technology plays a pivotal role in enhancing patient care, streamlining operations, and ensuring compliance with stringent regulations. Managed IT services have emerged as a cornerstone for healthcare providers, offering a proactive, reliable, and cost-effective solution to manage […]
Software as a Medical Device (SaMD) represents a transformative segment in healthcare technology, where software independently performs medical tasks. Let’s explore the essentials of SaMD development, focusing on key concepts, challenges, and compliance with international standards such as IEC 62304 and IEC 82304-1. What is SaMD? SaMD refers to software designed to function as a […]
AI and machine learning are revolutionizing healthcare, especially in the realm of medical devices, bringing in new ways to diagnose and treat patients. But with this fast-paced innovation comes the tricky task of regulating technology that’s constantly evolving. Agencies like the FDA in the U.S. and regulatory bodies in Europe are working to keep up, […]
FISMA, or the Federal Information Security Modernization Act, was created in 2002 in response to the 9/11 attacks and growing cybersecurity threats. It’s a law that requires government agencies and private companies working with the government to protect their information systems from cyber threats. FISMA applies to federal agencies, their contractors, and organizations that receive […]
SOX Compliance is all about following the rules set by the Sarbanes-Oxley Act of 2002, a U.S. law designed to protect investors by making sure companies report their financial information accurately. This law came into play after major scandals like those at Enron and WorldCom shook public trust in corporate finances. By enforcing stronger internal […]
The HITECH (Health Information Technology for Economic and Clinical Health) Act has changed how healthcare providers handle patient information by promoting the use of Electronic Health Records (EHR) and creating a strong compliance framework. A key part of this framework is the audit process, which ensures that healthcare organizations follow HIPAA’s rules on privacy, security, […]
