Is there a Moore’s law for law? Can healthcare and FDA laws regulate convergent, exponential technologies?
Is there a Moore's law for law? Can healthcare and FDA laws regulate convergent, exponential technologies?
Cosmetic or drug? Claims matter for body sculpting and slimming products
Cosmetic or drug? Claims matter for body sculpting and slimming products, and all health and wellness products.
False and misleading educational products incur FTC wrath
False and misleading educational products incur FTC wrath, particularly when it comes to claims about training pr protecting or improving the brain, treating ADD and ADHD, and marketing to children.
FDA medical device guidance – substantial equivalence
According to FDA medical device guidance - substantial equivalence in the 510(k) premarket notification process can be clearly determined if you know the underlying legal rules. One of the [...]
FDA’s Tobacco Products Deeming Rule: Establishment Registration & Product Listing
FDA's tobacco products Deeming rule imposes many regulatory requirements on tobacco products retailers, manufacturers, distributors, importers,including establishment registration and product listing.
Understanding FDA tobacco compliance – legal requirements, warnings, advertisements, and other regulatory restrictions
FDA's tobacco products deeming rule hits companies with many compliance obligations for both existing tobacco products and new products "deemed" to be subject to FDA jurisdiction. This is a [...]
FDA Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act: A brief overview
If you are a retailer, manufacturer, distributor, or importer of tobacco products, become familiar with the final rule by FDA Deeming Tobacco Products to be Subject to the Federal Food, Drug, and [...]
Digital health advances set healthcare law on edge
Digital health advances set healthcare law on edge because health tech develops exponentially while laws grow linearly.
Is my app an FDA-regulated medical device?
Is my app an FDA-regulated medical device? That depends, in part, on whether it makes medical claims and whether the app itself, in FDA's view, diagnoses and treats disease.
FTC Big Data regulation tells companies how to use big data legally and responsibly
FTC Big Data regulation tells companies how to use big data legally and responsibly, in FTC’s report, Big Data: A Tool for Inclusion or Exclusion? Understanding the Issues,
FTC tackles native advertising and sponsored content
FTC tackles native advertising and sponsored content in an Enforcement Policy Statement on Deceptively Formatted Advertisements.
Dietary supplement legal review could save your company
If you want to sell healthcare products online, the legal hurdles can be steep.
“The Doctor Weighs In” Features Interview on FDA Mobile Medical App Regulation
Blogger Patricia Salber, MD MBA featured Understanding whether a medical app needs FDA regulation can be tricky on The Doctor Weighs In. In this videotaped interview, held at the 2015 Stanford [...]
FTC false advertising legal traps – walk the compliant side of marketing healthcare products
FTC false advertising legal traps can hurt any business, small or established. Here's how to walk the compliant side of marketing healthcare products.
A Benevolent Artificial Intelligence Will Usher In Utopia
A benevolent AI (artificial intelligence) could usher in utopia... but will augmented intelligence destroy it?
Dietary Supplements, Cosmetics, Medical Devices – Why Substantiating Claims Matters
Substantiating claims matters whenever you bring a dietary supplement, cosmetic (or skin care product), or medical device to market - why?
Alternative Medicine Fraud Remains an FDA Staple, Despite FDA Guidance on Low-Risk, General Wellness
Healthcare fraud remains a broad regulatory category that enforcement authorities can use against the manufacturer or distributor of a healthcare product that raises questions in the minds of [...]
What does Consciousness have planned for us when the Singularity arrives?
Two trends are colliding: artificial intelligence (AI) is becoming more pervasive with machine intelligence outpacing human intelligence, and consciousness is waking up. Which one will trump--or [...]
Digital health personalizes medicine, revolutionizes healthcare, and makes healthcare law anachronistic
By putting healthcare in the hands of patients, healthcare technology is not only revolutionizing the way we think about medicine, but also the way laws shape personal health.
4 Ways to Minimize the Risk of an FDA, FTC or Private Plaintiff, Healthcare Fraud Label When Marketing Healthcare Products
Whenever you market a healthcare product, beware of potential FDA and FTC enforcement as well as private plaintiffs who can sue for false advertising, unfair competition, deceptive and misleading [...]
