What is a Legal Strategy Session?
What is a Legal Strategy Session and why do we do it?
Compliance Laws for Mobile Health Apps
An interactive questionnaire for mobile health app and medical device developers that covers compliance issues for HIPAA, the FDA&C Act, and the FTC Act
BioIdentical Hormones Consent Forms & Legal Issues
In today’s video, we address legal issues and legal risk mitigation for clinical practices that prescribe bioidentical hormones or have a functional medicine or integrative medicine approach.
Digital Health and FDA – Part Two
Medical practices and developers need to understand the federal regulations that govern the development and use of digital health products including medical device data systems, mobile medial [...]
FDA Says Context Can Create Implied Disease Claims for Your Dietary Supplements
In today’s video, we talk about even more common labeling mistakes that dietary supplement manufacturers and distributors make when making marketing claims for their products.
Digital Health and FDA – Part One
The FDA does have authority to regulate medical devices – including digital health technologies that qualify as medical devices. Digital health includes SaMD, AI, ML, medical mobile apps, and [...]
Dietary Supplement Labeling Claims: Implied Disease Claims
In today’s video, we return to one of my favorite subjects, common labeling mistakes that dietary supplement manufacturers and distributors make when creating marketing claims for their products.
