Many industries require specialized licensure in order to be an industry practitioner.  You cannot be a surgeon without passing requisite schooling, completing a residency and ultimately securing a medical license.  Lawyers must pass the bar exam in states in which they practice. According to a study conducted by George Mason University, 188 different occupations require a license to practice in North Carolina, representing 22% of the state’s workforce. You may be surprised to know that sign language interpreters, floor sanders and locksmiths are all regulated professions.

It is a debate for another day to consider whether we really need such broad government oversight in so many areas of the workforce. But taking the existing landscape for what it is, it is interesting to consider how these industries are evolving.

Keep in mind that most – and eventually all – professions are becoming real-time data and analytics driven. Data is coming from sensors and smart devices and outcomes are being driven by AI and analytics. A lot of the data innovation is by companies that have not traditionally worked in regulated industries. And by coming from the outside, companies are finding ways to conduct business outside of these existing regulatory systems.

Ridesharing is a great example. Ridesharing wasn’t developed by the traditional taxi industry from an in-house innovation program. It was a disruption from the outside, by tech professionals who laughed at the concept of getting a taxi license. There have been debates both for requiring centralized or government licensure of gig-economy ridesharing drivers (public trust, safety) and for allowing free markets to self-regulate (accelerated market growth, profitability).

Future examples might seem frivolous.  Let’s say someone develops “smart scissors” that automatically ensure that your hair is cut to exactly the right length and style. That device is sort of cool and some people might trust it, but should the scissor manufacturer have to get approval for their device to be used by cosmetologists (who need a license to cut hair).

What if the product is our food supply?  Should smart sensors in a field that are advising nutrient and water schedules go through a regulatory review to assure accuracy and efficacy? How much trust do we put in data and automation as it impacts the health quality of the food we eat? There are numerous regulations and licenses in the agricultural supply chain, but most of the smart device and AI companies are operating outside of that existing framework.

It is hard to envision a ‘one size fits all’ determinant for whether a new device, data set or AI tool should require regulatory oversight or industry licensure.  But one industry almost certainly needs more regulation that exists today: Healthcare.

Dozens of companies have created hundreds of devices that help us to monitor our heart rate, blood pressure, respiratory rate, sleep quality, stress level and many other conditions. A small minority of these new, connected devices have gone through FDA regulatory approval.  Putting a product through the FDA process is slow, expensive and opens companies to specific liability risks.

Instead of taking the difficult FDA path, most electronics companies have chosen instead to provide “reference” data, allowing us as individuals to receive health information that is specifically not diagnostic. In other words, your smart watch is not making medical recommendations or medical interpretations of the information you received. The red/green/yellow style of feedback on your sleep quality is not tied to a doctor’s protocol decision tree.

But from a practical standpoint the sensor readings from these consumer products can be just as high quality as the “medical data” that comes off an FDA approved device.  Even if the precision is not as accurate – the simple fact that we are getting data 24/7/365 instead of 1-2 times per year at a doctor’s office means that the “reference” data is perhaps far more meaningful for making healthcare decisions.

Guest column: Customer-first healthcare could be the next big disruption

Is it fair for consumer device companies to simply slap a statement into their end user license agreement and be free and clear of liability when people take it upon themselves to make health decisions based on the data these devices provide? Is it ethical?

The question is where to draw the line. When consumer product companies tout that we can live healthier lives by using these devices, should they go through a process of licensure process and data validation similar to those our human doctors and nurses must complete?  Is there an intermediate level that is beneath a full FDA clearance, but more than “we’ll just trust the manufacturer to self-validate”?

The legal framing today is actually fairly clear, making it easy for device manufacturers to avoid regulatory oversight. But those protocols were developed in a time before persistent, highly accurate, low-cost sensing was the norm. And it never envisioned powerful AI, trained by years and years of healthcare data.

The healthcare industry is difficult to tackle, because of the complexity of the system and the many opaque elements of liability, insurance and payors. But as difficult as it is, the time is right to reassess. The potential benefits are too high. Lives can be extended and saved when we put low-cost, accurate “medical” information in the hands of everyone. For now, however, the most the industry will own up to is lifestyle AI. All the risk from decisions we make based on these products is on the consumer.

Next week, my colleague, Rachael Newberry will pen a guest article to discuss how close we are getting to truly personalized healthcare. We are approaching a point when we can collect enough data about ourselves and our environment, persistently and in real time, leading to truly individualized health management. I hope you’ll tune in to read her thoughts. If this topic is of interest, there is a free event in Cary on April 16 where several startup companies that are inventing the future of personalized healthcare will describe their vision, demonstrate their technology and answer your questions. You can register to join here.