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.

Still, your legal strategy has to be quick and nimble to get to market and even faster to stay on top, and bridge the gap between health tech ascending and regulators responding.

Exponential, converging health tech sets the pace

Moore’s  law – a rule about the exponential growth of technology – continues to hold in the digital and mobile healthcare space.

Al Gore recently reaffirmed this at Connect 2016, a conference on digital health, bridging U.S. and China mobile business.

This year brings continued convergence of trends accelerating the transmutation of healthcare from physical, brick-and-mortar visits to human doctors to:

• wearable health with increasing self-care and self-monitoring
• advances in the Internet of Things, bringing health and wellness tips into ordinary consumer devices
• health tech advances such as on-demand gene editing, use of genomic information for personalized care, robot-led mental healthcare, and drone delivery of medication
• increasing interpenetration of ever-stronger AI into health and wellness, with more and more partnerships between human-led corporations and intelligent machines (such as IBM Watson)
• the accelerating demise of privacy (ubiquitous recording and sensors reading everything)

Some predictions for 2016 include:

• medication adherence, enhanced by sensors
• better conversational interfaces, telling us (for example) what to eat and not eat
• predictive analytics speaking to patients and their clinicians (not just payers)
• disease detection on your smartphone
• digital healthcare planning (setting goals, case management, rehabilitation, psychological health, exercise, nutrition, pregnancy planning and sexual health, and use for advance care directives)
• interoperable, portable, and comprehensive health data, creating deeper patient engagement
• virtual helpers (“Siri meets Dr. Watson”)

Whatever your particular list, you will be the “CEO of your own health” with assists from human and machine, and with prevention leading the way.

Integrative medicine will get a boost as physical, psychological, social, and environmental factors will be taken into account by your app, program, robot, or machine intelligence algorithm, while it makes health recommendations tailored to you.

Legal strategy considerations

We all know that privacy and security are core concerns for the health and wellness industry.

HIPAA plays a huge role in legal departments’ compliance efforts, as businesses become aware that failure to do due diligence can result in unpleasant data breaches, bad press, and steep enforcement penalties.

As well, companies should become more aware of state laws governing privacy and security, which place the enforcement burden on businesses large and small to protect not only “sensitive” customer data, but any information that is identifiable to a given consumer, whether or not it is health-related.

IT consultants will benefit from this trend, as well as lawyers that specialize in privacy and security legal issues.

But there are other trends swirling around the digital healthcare revolution.

Linear laws, exponential lawyering

While technology converges and accelerates exponentially, health and wellness law move at the speed of legislators, regulatory agencies, and judges.

Legislation requires consensus and political will.

Regulatory agencies often go through a process of public comment.

Cases take a long time, as litigators put on witnesses, introduce exhibits, exhort the jury (or there is a settlement process outside the courtroom and no new law is actually produced).

Meanwhile:

• The Terminator is ripping up the town
• TAYLOR has done his threat assessment and dispatched his Humanics robo-soldiers across the world
• ULTRON is hurling fury at the Avengers’
• The Klingons have jumped into hyperspace
• Agent Smith has buttonholed Neo in an alley
• HAL has taken over the ship
• AVA has maneuvered Caleb into a locked room and has escaped into the world
• The Death Star maneuvers its awful destructive rays

Choose your film version.

There’s still room for an exponential lawyer, though. Let’s clear the path for positive, healthcare industry developments.

Healthcare services are becoming healthcare products

Someone, maybe Chris Surdak, coined the term Appification, to describe the packaging of products as apps. (In my view, Surdak crushed this issue).

Just add the words “-as-a-service” and you’ve described what is happening.

In The Appification of Everything, a Wall Street Journal article prophesied:

Companies that tackle the network, the device or the app as a service – rather than a one-time purchase or a stand-alone phenomenon – will lead the pack in the coming years.

We saw the trend start with the advent of apps, which have multiplied – now becoming integrated with wearable health technology and a myriad of sensors – escalating into the Internet of Things where everything is interconnected.

The upshot is that if you think you have a healthcare service, think again.

At the very least, you’ll be thinking about concierge and telemedicine models of clinical practice.

Your business strategy will require in-depth review of the way legal rules structure your market opportunities.

If you’re a healthcare services professional (for example, a medical doctor or chiropractor), your primary legal concerns (in addition to HIPAA) are probably on the state law end of the spectrum.  For example:

• licensure and scope of practice
• Board discipline
• standard of care and malpractice / liability risk assessment

Or, if in a multidisciplinary model of care (or integrative care system), you might be looking at:

• self-referral and Stark
• anti-kickback and fee-splitting
• corporate practice of medicine

But as soon as healthcare shifts to putting these services on a device or product, you’re suddenly looking at:

• FDA regulation of medical devics
• FTC regulation of digital advertising

FDA has weigh in with a number of guidance documents, to better communicate to businesses when FDA will take issue with their product and subject it to greater regulation.  These include:

• FDA guidance on mobile medical apps
• FDA guidance on low-risk, general wellness products

FTC also has weighed in with guidance documents on everything from privacy and security in the Internet of Things, to disclosures required for mobile apps.

See our prior posts including:

• The Internet of Things (IOT) Legal and Regulatory Issues
• Alternative Medicine Fraud Remains an FDA Staple, Despite FDA Guidance on Low-Risk, General Wellness
• 4 Ways to Minimize the Risk of an FDA, FTC or Private Plaintiff, Healthcare Fraud Label When Marketing Healthcare Products
• Advertising health products online? Check FTC endorsement guides for dos and don’ts
• The Next Healthcare Revolution is Inside You: Wearable Health Tech Legal & Regulatory Issues Will Astound Us
• How The Internet of Things Will Change Healthcare: Artificial Intelligence & Wellness Harness Information to Augment Your Experience
• Ride the Information Tidal Wave: Crush or Be Crushed
• When marketing healthcare products, review websites and materials for FTC and liability risk
• How integrative medicine, telemedicine and mobile medical apps are shaping our future
• Health apps as medical devices: what is means for consumers

The bottom line

Because of appification and the interconnecivity of everything via the Internet of Things, healthcare practitioners:

• will find themselves looking for ways to appify their practice and convert services into products
• will find themselves competing with apps, wearables, and Internet-connected devices
• will be looking at FDA and FTC laws as they promote their offerings
• will entering into the new human-machine era of Artificial Intelligence and Augmented (Human) Intelligence

Deep neural networks will connect all of us ever more intimately.

What does it mean?

To quote Cyber in The Matrix:

It means buckle your seatbelt, Dorothy because Kansas is going bye bye.

On second thought, this may be overstated – you can still visit Kansas in virtual reality.

Remember to check in periodically from your VR headset, though.  The regulatory agencies will still be there on the physical plane; so will the deals, even though they may involve bits of coin electronically.

When designing your business strategy for an appified, transmogrified healthcare environment, seek legal counsel that is one step ahead and can straddle convergent, exponential health technologies on one hand, and regulatory and transactional legal complexities on the other.

When digital health advances set healthcare law on edge, and companies transform their services into products, those who get the legal landscape right will have a competitive advantage.