Resources
for You and Your Team
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.
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.
Pharmacy Innovation Series: Exploring Integration of Primary Care Services, Telehealth, and Telepharmacy for Pharmacies of all Sizes
Get our legal breakdown of the Walgreens/VillageMD partnership and how it relates to integration of primary care services, telehealth, and telepharmacy for pharmacies of all sizes. Subscribe to get the entire series.