Why Scaling HealthTech is Hard, but Worth It The digital health boom isn’t slowing down. Fueled by rising consumer expectations and post-pandemic demand, Statista projects the digital health market to reach $258 billion by 2029. But here’s the twist: building an MVP is easy, but scaling it successfully — not. At Gart Solutions, we’ve helped […]
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 […]
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 […]
