The Digital Operational Resilience Act (DORA) and the Network and Information Security Directive (NIS2) have transformed ICT risk from an IT problem into a board-level, legally enforceable responsibility for European financial and critical-infrastructure organisations. With full compliance deadlines already passed (NIS2: 18 Oct 2024; DORA: 17 Jan 2025), the regulatory era has moved from preparation […]
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, […]
What is Software as a Medical Device (SaMD)?Software as a Medical Device (SaMD) is software intended to perform medical functions independently of a physical medical device. This includes mobile apps, AI diagnostic platforms, and cloud-based monitoring systems that diagnose, treat, or prevent diseases. Let’s explore the essentials of SaMD development, focusing on key concepts, challenges, […]
What is SOX compliance and why does it matter?SOX compliance refers to adhering to the Sarbanes-Oxley Act of 2002, a U.S. law requiring public companies to maintain accurate financial reporting and strong internal controls. Non-compliance can lead to severe penalties, reputational damage, and executive liability. SOX Compliance is all about following the rules set by […]
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, […]
Healthcare technology solutions must navigate a complex web of regulations designed to protect patient data and maintain confidentiality, integrity, and availability. Six significant compliance frameworks that healthcare providers and technology developers must adhere to are HIPAA, CCPA, GDPR, NIST, HiTECH, and PIPEDA. Let’s take a closer look at each of those frameworks: HIPAA Compliance The […]
