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 a firm focused on digital health and pharmacy law, Sauchik & Giyaur, P.C. understands the friction between cutting-edge technology and legacy healthcare frameworks. We provide practical 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, helping them comply 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 help them meet stringent federal ePHI data privacy and security rules without stifling software functionality.

Grounded in Healthcare: Our background in the heavily regulated world of healthcare informs how we approach the legal complexities of modern MedTech. We bring that same data-security and compliance experience to digital health startups facing regulatory challenges.