Resources
for You and Your Team
FTC Finalizes Changes to Health Breach Notification Rule: What Digital Health Companies and App Developers Need to Know
The Federal Trade Commission (FTC) finalized changes to the Health Breach Notification Rule (HBNR), clarifying its applicability to health apps and similar technologies, including those that are not subject to HIPAA. In 2023, FTC began enforcing the HBNR in earnest, with an expanded interpretation of their authority under the HBNR. In the 2024 Final Rule (the 2024 Final Rule), the agency conforms the HBNR to this expanded interpretation, clarifying its breadth for industry and the public.
Invest in LGBTQ+ Founders
Nixon Law Group’s List of Venture Funds and Accelerators for LGBTQ+ Founders
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.
Colorado’s New AI Law Sets “National Standard” for Healthcare AI: 5 Things Developers and Deployers Need to Know, Now
Last Friday, Colorado’s governor signed into law the Colorado AI Act (“CAIA”). For digital health companies building with artificial intelligence, CAIA sets the first comprehensive national benchmark for minimum rights and protections for users of healthcare AI, effective February 1, 2026.
2024 List of Venture Funds And Accelerators for Women
Invest in Black Founders (2024 Edition)
The Top 3 Legal Considerations for Pediatric Digital Health Companies
Your Guide to Virtual Reality Reimbursement in the U.S. Healthcare Market
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.
FDA Issues Final Guidance on Clinical Decision Support Software and Software as a Medical Device: Key Takeaways and What it Means for Digital Health Companies
Digital Health Companies: How to choose a business model to bring your consumer-centric care to the market
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
Tips on a Successful 510(K) Submission for Smaller Companies
Pharmacy Innovation Series: the DEA Steps into Telepharmacy Regulation
For the first time, the Drug Enforcement Agency (“DEA”) is becoming directly involved in the telepharmacy space, an industry that the DEA has not previously regulated aside from the loose application of its existing regulations governing online pharmacies. Find out what this means for your business and how you can submit comments to the DEA directly in this post.