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Operating at Scale: Legal Considerations for Growth-Stage Health AI Companies
Scaling a healthcare AI company? Learn the top legal strategies for growth-stage digital health companies—from FDA SaMD analysis and HIPAA compliance to state AI laws and AI governance.
Navigating Uncertainty: How Healthcare Innovators can Lead in Times of Change
Now is the time for action. Those who embrace uncertainty, focus on enduring industry needs, and leverage technology to enhance the system will lead this next era of healthcare innovation.
Navigating the Future of AI in Healthcare: 3 State Law Trends to Watch
Explore how state laws are shaping the future of AI in healthcare, focusing on transparency, consumer rights, and algorithmic fairness. As regulations evolve, healthcare AI innovators must adapt to ensure compliance and equitable outcomes in a multi-jurisdictional landscape.
AI in Healthcare 2025: Navigating New Frontiers in Innovation and Regulation
The rapid growth in investment and adoption of AI in healthcare in 2024 brings a new wave of legal and regulatory developments. As we kick off 2025, those deploying AI in healthcare must be cognizant of new compliance requirements under federal and state law.
Venture Debt: Considerations for Healthcare Innovation Companies
Explore how venture debt can offer healthcare innovation companies non-dilutive capital to fuel growth, bridge equity rounds, and scale operations, while navigating key legal and financial considerations to maximize value.
CMS Proposes New Reimbursement for Advanced Primary Care Management Services
FDA Enforcement Discretion: A Strategic Path to Market for Digital Health and Digital Therapeutics Companies
Healthcare delivery is changing, and digital health is revolutionizing healthcare, creating a burgeoning market opportunity for software-as-a-medical-device (SaMD) and digital therapeutic (DTx) products.
Your Guide to Virtual Reality Reimbursement in the U.S. Healthcare Market
Reimbursement for Chronic Pain Management in the 2023 Medicare Physician Fee Schedule: New Opportunities for Patients and Providers
A Primer on Telepharmacy
Gain a high-level understanding of telepharmacy and how you can use and implement telepharmacy to positively impact patients, pharmacies, and healthcare providers
How to Integrate Direct-to-Consumer (DTC) Lab Testing into Your Telemedicine Model
There are two primary structures in use in the DTC space: (1) Outsourcing and (2) Insourcing.
In this article, you’ll gain an overview of each structure, discover the limitations regarding billing and revenue model, and walk away with key operational considerations.
How to Build Your Multi-Jurisdictional Telemedicine Company in the US
This article outlines the basics of the model and considerations for those contemplating building a virtual care network. It also contains a simple graphic of the model, which can be helpful for visual learners
3 Key Challenges Facing Tele-dentistry Companies and How to Approach Them
Dentistry is one of a number of clinical specialties that is taking a creative and innovative approach to delivering care using digital health tools. Most of us are now familiar with Byte, SmileDirectClub, and Candid—these companies are pioneers in the space. However, tele-dentistry has far more potential applications than retail clear aligner services. Tele-dentistry entrepreneurs are building solutions for remote examination of sore or swollen teeth and gums, screening for certain oral diseases and cancers, mobile dental hygiene, dental hygiene education, and more.
Intellectual Property for Digital Health Companies: How a Multi-Faceted Strategy Balances Patentability Barriers
If you’re building a digital health company, it is especially important to develop a multi-faceted intellectual property protection strategy. Here’s why: a strategy that includes multiple pathways for IP protection allows you to protect both tangible assets, like proprietary hardware, software, and documentation, as well as intangible assets, like branding, customer-facing website designs, pricing strategies, business models and projections.
What is a Value-Based Enterprise? New Opportunities for Digital Health and Healthcare Innovation
Dramatic changes to the Anti-Kickback Statute and the Stark Physician Self-Referral Law regulations present an unprecedented opportunity for healthcare providers and digital health companies to create new business arrangements that align incentives around care coordination and patient engagement. Such arrangements are the foundation of the Value-Based Enterprise.