Wearable Health Tech Legal & Regulation

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 digestible, implantable nanotech health care.

Hence the title of this post: The Next Healthcare Revolution is Inside You: Wearable Health Tech Legal & Regulatory Issues Will Astound Us.

The poet Walt Whitman once wrote:

I bequeath myself to the dirt, to grow from the grass I love; if you want me again, look for me under your boot soles.

You could look there, to the micro-organisms, to the DNA, to proteomics or genomics, or to silicon chips beneath your feet, gathered to make our robot companions (think human-looking cyborgs, not some chunk of metal clattering, “yes, Imperious Leader!” (or “danger, Will Robinson!”).

The trajectory of medicine is from the visible, physical world of pharmaceutical pills and surgery and onsite doctors, to general wellness devices, remote viewing by tele-presence, the Internet of things, and advances we can’t yet imagine.

How will healthcare law and regulation adapt to this rapidly changing health and wellness landscape?

In part, current law will adapt to evolutionary trends in healthcare by modifying current legal rules.

Who knows whether licensing, despite its monopolistic overtones, will ever disappear; or whether FDA will go away and let consumers decide everything for themselves (informed, for example, by robots who can instantly crunch the data from clinical trials, detect any false advertising, and issue a “karma ticket” if the product is not adequately substantiated, thus deflecting the consumer from purchase in the ultimate free market economy).

For now, medical device laws get adapted to mobile medical apps, general wellness low-risk devices, and in other ways by which regulators hope to encourage innovation while still engaging in consumer protection.

Let’s take the broad view of health and wellness law. Think of health and wellness as occupying a spectrum, from high-touch (such as a yoga class) to high-tech (such as a colonoscopy). Along the way, consumers make choices, informed by the doctors they see whether in-person or on their smart-phone wrist-watches (or earrings, or whatever fits on the lapel; someone should market a fitness device that’s shaped like the piece worn by Star Trek officers).

Think of the multi-trillion dollar, healthcare industry as falling into two categories:

Healthcare (health and wellness) Products
Healthcare (health and wellness) Services

Within healthcare products, are:

Medical devices, diagnostics
OTC drugs, Rx drugs, homeopathic drugs & remedies
Cosmetics (cosmeceuticals)
Dietary supplements (nutraceuticals)
Biologics, vaccines

Consider these are mostly within the category of consumer products regulated by FDA in terms of pathway to market, and by FTC in terms of advertising claims.

Within healthcare services, consider

Healthcare practices and practitioners (medical doctors, osteopaths, nurses, psychologists, dentists, social workers, etc.)
Healthcare clinics, medical groups
Specialty healthcare practices (concierge medicine, integrative medicine, functional and anti-aging medicine)
Specialty wellness practices (yoga studios, medical spas)
Healthcare management companies
Laboratories, pharmacies, hospices, hospitals, other institutional health service and product providers
Evolving types of delivery (telemedicine, mobile health, retail clinics)

To be adept within this enormous marketplace requires knowledge of the full spectrum of interventions, therapies, modes of delivery, and the way these are regulated (by which agency and according to which legal rules).

It’s one thing to market your product, another to be sure there is a clear path to market in light of the most current FDA framework.

Let our healthcare and FDA attorneys guide you through the maze of health and wellness regulation. The market is huge – and there’s lots more to tap, but careful navigation produces best results.