Where Disruptive Innovation Meets Legacy Healthcare Regulation.

When software becomes a clinical tool, standard technology law is no longer sufficient. Digital health is the most aggressively regulated frontier in the modern economy. At the intersection of code and patient care, innovators face a compounding maze of FDA oversight, HIPAA privacy strictures, and the Corporate Practice of Medicine (CPOM).

As pioneers in digital health and pharmacy law, Sauchik & Giyaur, P.C. uniquely understands the friction between cutting-edge technology and legacy healthcare frameworks. We provide battle-tested counsel for innovators building the future of medicine.

Our Digital Health & MedTech Services

• Telemedicine & Digital Health Platforms: We build the legal infrastructure for multi-state telehealth platforms, ensuring compliance with asynchronous prescribing laws, CPOM doctrines, and remote patient monitoring (RPM) billing frameworks.

• AI-Driven Diagnostics & FDA SaMD: We counsel health-tech developers on the classification of their software, helping innovators navigate the FDA’s Software as a Medical Device (SaMD) pathways and clinical decision support exemptions.

• Automated Pharmacy Networks: Leveraging our deep roots in New York and federal pharmacy law, we advise on the deployment of automated dispensing systems, AI-driven inventory management, and electronic prescribing integrations.

• HIPAA & Cloud Compliance: We structure Business Associate Agreements (BAAs) and audit cloud-hosted healthcare applications to ensure they meet stringent federal ePHI data privacy and security rules without stifling software functionality.

The Ultimate Training Ground: Our deep background in the hyper-regulated world of healthcare makes us uniquely equipped to handle the legal complexities of modern MedTech. If we can secure data and ensure compliance in the medical sector, we can protect your digital health startup against any regulatory challenge.