Nanotech, Wearable Health & Emerging Healthcare Technologies

As healthcare and FDA lawyers, we bridge past, present and future—we stand committed to the total evolution of healthcare, as emerging healthcare technologies change the face of what it means to be human. 

Whether healthcare is physical, wearable, digital; whether it involves “smart” technologies, Artificial Intelligence (AI) or Augmented Intelligence; nanotechnology or mobile medical apps; fitness trackers and digital health or the Internet of Things; robotics, genomics, software, quantum bits, or that next healthcare evolution that is yet to come, our healthcare legal team tracks technological changes and stands ready to counsel companies pioneering new and emerging healthcare technologies.

GNR Technologies

Nanotechnology, a core piece of the GNR (Genetics – Nanotech – Robotics) revolution, requires skillful navigation of emerging and complex legal arenas, from environmental law to careful transactional strategy and drafting. Nanotechnology involves parties in the nanometer (one-billionth of a meter) world. Nanotech legal services require knowledge of many healthcare law, FDA law, and business law areas, including:

  • Understanding of FDA regulation of nanotechnology
  • Understanding of related FDA legal rules concerning medical devices, cosmetics, OTC products (such as sunscreens), and new dietary ingredients (NDIs) in dietary supplements
  • Review of nanotech and nano-engineered rules related to labeling, production and handling
  • Analysis of FTC rules relating to product advertising and substantiation of claims
  • Other federal and state government regulation
  • Intellectual property protection of nanotech or nanobot products
  • Corporate law and corporate governance of nano-medicine companies

Our lawyers are skilled in regulatory and transactional aspects of the medical device, cosmetics, OTC drug, and healthcare and life sciences industries. We are futurists, looking forward to the integration of many sciences as humanity evolves to the next level.  Our work ranges from chatbots to nanobots.

Our FDA medical device and FDA cosmetics attorneys can help you understand FDA guidance documents about nanotechnology. As FDA notes:

Nanotechnology, used to make nanomaterials, allows scientists to create, explore, and manipulate materials measured in nanometers (equal to one-billionth of a meter). Such materials can have chemical, physical, and biological properties that differ from those of their larger counterparts. Importantly, properties of a material might change in ways that could affect the performance, quality, safety, and/or effectiveness, if applicable, of a product that incorporates that specific nanomaterial.

Classic FDA legal rules of adulteration and misbranding will also apply to nanotechnology, with special attention to the scientific and safety issues underlying nanotech products.

Whether you are building industrial nanobots or nano-materials for assembly into other nano-machines, we can review regulatory compliance risks and advise you on bringing your nanotechnology product to market.

The Internet of Things

In fung shei, there is saying that everything is talking to us, all the time.  Of course, this is on the level of spiritual energy.

With the Internet of Things, all of our devices will be communicating with one another in ways today’s brain can hardly fathom.  We will be absorbed, as it were, into the digital, mobile, wearable, and quantum world of a universal data bank.  Who can say what implications this will have for human consciousness?

As thought leaders in healthcare, we not only advise clients on archaic laws and vestiges of 20th– and even 19th– century thinking and how these rules and regulations affect their healthcare practice, business or venture.  We also stay on top of technological developments in healthcare and how these affect the planet.  We speak at conferences and connect with other thought leaders to learn how all these changes will affect our clients.

We also understand, and advise our clients, how contemporary legal rules will come into play as new technologies enter the marketplace. For example, cybersecurity, and privacy and security laws, will dominate much of the regulatory landscape as devices become increasingly interconnected.

To the extent the product is regulated as a medical device, FDA will impose its regulatory structure and the device (unless exempt) will require either a 510(k) or possibly even premarket approval (PMA).  FDA will continue to exercise its enforcement discretion in the case of a consumer market that does not fall within the more highly regulated, medical device category.

FTC and the law of false advertising also will govern the claim that businesses with emerging healthcare technology can make.  Already, for example, FTC has taken enforcement action against companies that have collected geolocation data, without the user’s consent.  Similarly, FTC has investigated and taken enforcement action against companies making unsubstantiated claims about a product’s ability to track sleep, improve brain health and memory, or reduce other processes associated with aging. FTC will continue to be active in the area of emerging technologies, to ensure that claims companies make are truthful and not deceptive or misleading to the ordinary consumer.

Our healthcare legal team knows the Singularity is near (to quote Ray Kurzweil), and as legal professionals, we make it a priority to anticipate health technology industry developments so that we can be proactive in guiding our clients.

Resources

“From Physical to Mobile to Wearable Healthcare: How Government Regulation of User-Generated Health Data Affects Ventures and Consumers”

Healthcare & FDA lawyer Michael H Cohen speaks at the Silicon Valley Forum on Healthcare IT Leadership on legal issues affecting Sensors, Wearables, and Interoperability…

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?

The Internet of Things (IOT) Legal and Regulatory Issues

The Internet of Things (IOT) raises legal and regulatory challenges, mainly in the area of privacy and security.

How The Internet of Things Will Change Healthcare: Artificial Intelligence & Wellness Harness Information to Augment Your Experience

Once you “friend” your refrigerator on Facebook (because it’s that smart, and knows about your dietary and nutritional habits than your doctor), healthcare will be unrecognizable even to fans of […]

The Next Healthcare Revolution is Inside You: Wearable Health Tech Legal & Regulatory Issues Will Astound Us

If you want to know where the next healthcare revolution will come from, look inside. Physical medicine becomes virtual medicine, becomes mobile healthcare, becomes wearable health and then […]

Wearable Health Technology: Health Care Dream or Privacy Nightmare? (published by LegalZoom)

LegalZoom published Wearable Health Technology: Health Care Dream or Privacy Nightmare, on the heels of Apple’s announcement of the Apple Watch. The article makes the point that the Apple Watch…

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