healthcare and FDA laws regulate exponential technologies

Is there a Moore’s law for law? Can healthcare and FDA laws regulate convergent, exponential technologies?

Dinosaur Rules in an Era of Post Humans

If you’re looking at the evolution of healthcare law and FDA law and wondering about how to get your product to market, understand that you’re dealing with dinosaur legal rules in the era of trans and post humans.

Navigating through the Jurassic Park of legislation and litigation requires:

good business judgment
astute legal counsel
a star business team
influential mentors and advisers
a good bubble of light and periodic aura cleansing

(The lawyer in Jurassic Park had none of these, and he didn’t fare too well. When Albert Brooks, in Defending Your Life, glimpses himself in ancient times, fleeing from a wild beast, and has to say what he was in a past life, his answer is: “Dinner!” Hence my final bullet above.)

I am only half-joking when I say that when I served on faculty at Harvard Medical School as a non-MD lawyer, I used the mantra “evidence-based” every other sentence.

When in Roman do as the Romans do, and render unto Cesar. I didn’t speak of “energy fields” to the Deans, certainly not about auras. This was only for the sympaticos, or for the researchers of “biofield therapies.”

Language is important and the arts of reading / interpreting, and speaking / advocating / negotiating, are the mainstay of what we do as healthcare counsel.

Legalasaurus Rex

Dinosaur laws exist in the form of:

licensing laws that criminalize the practice of “medicine” and define the practice of medicine in sweeping terms that come from the politics of the late 19th-century
legal rules that create epistemological chaos (i.e., language confusion) around the distinction between disease claims and acceptable claims for dietary supplements
HIPAA, a morass of complexity and technicality
healthcare laws and judicial opinions that are unnecessarily paternalistic
fee-splitting rules that are designed to prevent over-utilization and conflict of interest, but don’t necessarily work in an era of telemedicine, IOT, robotic applications in medicine, the Singularity, virtual reality health tech, and the “appification” of healthcare

Notwithstanding the good work that legislators and regulators have done to protect the public against unscrupulous practitioners and practices (even this is very old language), and the clear guidance FDA offers on its well-developed website, there are still many untenable and archaic legal concepts that permeate healthcare law and stymie innovation while muddying and unnecessarily complicating legal decision-making.

We have anachronistic health care laws that stifle competition, diminish scientific progress, and clash with humanistic values.

Dystopian futures can’t be “put in a box” by moratoriums or legal fictions.

From The Federalist No. 51:

If men were angels, no government would be necessary. If angels were to govern men, neither external nor internal controls on government would be necessary. In framing a government which is to be administered by men over men, the great difficulty lies in this: you must first enable the government to control the governed; and in the next place oblige it to control itself.

Now, as a lawyer representing healthcare startups and established companies in Silicon Valley and around the world, I use the following mantras:

disruptive
convergent and exponential

Also it’s important to talk about “founders,” “vested shares,” getting to a “billion dollar valuation” and/or serving a “billion” customers, and other matters of interest to healthcare tech startups.

Of course, physician clients still appreciate hearing the term “evidence-based.” It’s not only meaningful but also comforting. We’re going to do and promote therapies that are genuinely helping patients.

Where’s the Box?

However, we’re not only thinking outside the box; with convergent, exponential medical technologies there’s no longer a regulatory box.

See our prior posts:

Let’s start with where we are.

Imagine a world where you spend as much time in virtual reality as in physical reality.
Sensors on your eyeglasses pull in the news while you carry on business conversations in strange virtual worlds.
Your smartphone projects incoming messages on your palm and prompts to take virtual safari at lunchtime.
Sensors on your shirt monitor your vitals. They create personalized workout routines to increase your longevity.
Your car records all your conversations and suggests resources to improve your productivity, and relationships.
You get robo-therapy from your virtual assistant, optimizing your mental state, while your kitchen automatically assembles ideal meal for taste & nutrition.
Welcome to the Internet of Everything.

Are we in the box, or have totally transcended 3D thinking?

Now we do have regulation around IOT. The Senate Committee on Commerce, Science and Transportation recently resolved that the US should “incentivize the development of the Internet of Things … to maximize the promise connected technologies hold to empower consumers….”

Also government agencies have begun to try to box in these technology trends. For example, FDA and FTC have rules and guidance around:

privacy in medical devices and related health tech
cybersecurity
collecting the minimum data necessary from consumers
giving consumers notices about data breaches
giving consumers a choice to opt out of notices

FDA has clarified some of its enforcement around mobile medical apps, and as result, we have quite a few FDA-cleared mobile medical apps, including:

the Kinsa smart thermometer (transmits data through an app)
Samsung cardiology signal transmitter
Propeller Health platform that includes a smart inhaler for asthma
QardioArm blood pressure monitor
McKesson Cardiology ECG mobile
Gauss Surgical: app uses iPad’s camera to measure blood lost during surgery

FDA has also clarified that it intends to back off enforcement on low-risk, general wellness products.

However, FDA retains enforcement discretion, leaving considerable ambiguity for industry.

And there’s much more to be concerned about. What if someone hacks into your refrigerator and then controls all the appliances in your home? Or your self-driving car? (Been there, done that — Will Smith in I, Robot).

Shrink-Wrapped Regulation

When we think about applying relatively static laws to a dynamic market, we have two opposing trends: technology wants to make you the “CEO of your own health;” while the innovators see the legal system as trying to shrink-wrap regulation around innovation.

Also, there’s nothing FDA, FTC, the AG, or anything a government regulator can do if an AI decides to turn the world into a paperclip manufacturing facility. See our posts:

Medical technology spearheads human transformation. Because our methods of delivering care, coincide with this epic transition in human identity, from the biological self toward increasing integration with our own technology

Although creative regulatory developments clarify the rules and help get products to market, three issues loom.

The regulatory landscape is a giant puzzle that’s hard for companies to piece together. Do I have a regulated device? Am I practicing medicine? What legal strategy will get me to market most effectively and efficiently?
The line between data, and medicine, is difficult to draw. This is a legal challenge for ventures (whether providing a telemedicine platform for doctors, creating mobile healthcare apps, designing wearable technology, or using machine intelligence to diagnose). Difficult to pretend where health and wellness ends, medicine begins.
Medical technology accelerates exponentially; whereas legal change evolves in a linear fashion. (Law proceeds at the rate of humans with conflicting beliefs, opinions, and rules. Machines can self-replicate and evolve generationally.) Consequently, the market is almost always way ahead of the legal rules.

If anyone can splice genes by using an app, will a moratorium be effective? When I download a copy of myself onto a nanoscale computer and travel the universe-how will FDA regulate that?

We’re at a crossroads where law itself is inadequate. Technology evolves faster than law, and eclipses our ability to regulate.

Still, law mediates technology’s entry into the marketplace. Laws determine who gets to market, and with what level o

Since medical technology and law evolve at different rates, we need wisdom as well as rules. After all, this isn’t just about healthcare law; it’s about who we’re becoming as a species. And the definition of health, according to the World Health Organization, encompasses not only physical, but also mental and social well-being. There is no social wellbeing in a universe of paperclips – unless, that is, you’re a paperclip!

The Need for Wisdom

On a deeper level, this suggests a race for our future as a species: accelerating technology on one hand, consciousness on the other.

As I said at Health 2.0, Stanford MedX, and elsewhere:

We need regulation, and we need wisdom. As innovators, healthcare startups at the forefront of this change. We need products that not only work, they also transform.

Ultimately, the evolution of medicine and law and health is about the evolution of humanity itself. It’s more than getting rid of disease – it’s about transforming our bodies and minds into vessels that can survive into the millenia ahead, and protect and express our rich cosmic endowment.

A Call to Action for your Robo-Dialer

If you’re bringing an FDA-regulated product, or healthcare practice or company, to market before the Singularity — or, the ideas in this post intrigue you, then contact us about keynote speaking or legal representation, and help usher in the utopia.