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, […]
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 […]
Compliance monitoring is the ongoing process of checking that an organization is following all the rules, regulations, and standards that apply to its operations. In simple terms, it’s about making sure a company is “playing by the rules” set by governments, industry bodies, or its own policies This practice is critical in several industries, including: […]
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. What are managed IT services in healthcare?Managed IT services in healthcare involve outsourcing critical IT tasks, such as network management, […]
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 […]
