Regulations that enable innovation? How can that be?? Don't regulations inhibit or even prevent innovation?
Yes they do. Wouldn't it be nice if there were a way to write regulations that enabled innovation? Well, there is a way to do it! It's actually easier to write regulations that enable innovation than the usual way. There are fewer of them. They're easier to understand, and easier to keep up to date. They're more effective at regulating what you could reasonably want to regulate, while at the same time keeping the door open for inventive people to find better ways to get things done, while still conforming to the regulations.
So why isn't this the standard way of writing regulations? Inertia. Lack of understanding. Fear. Bureaucratic intransigence. The usual reasons.
Regulations that Enable Innovation
Practically all regulations tell you, in varying levels of detail, tending to the excruciating, How you're supposed to do the regulated thing. The more detail, the less innovation.
By sharp contrast, regulations that enable innovation tell you What you're supposed to do or avoid doing. The less said about how to reach the goal, the wide the door for innovation.
Suppose the point of a regulation was to make sure you got to work on time. Typical how-type regulations would tell you exactly when to leave your apartment and exactly what streets and avenues to walk until you got to the office. It would allow for red lights. The regulations would have to change to allow for construction and other changes. If you deviated from the prescribed route or used a different method of transportation, you'd be in violation.
What-type regulations for the same thing are simple: dude, get to the office on time! How? You figure it out, it's your problem! But it's also your opportunity for learning and evolution. You could try walking, and try different routes. You could try the bus and subway. Taxi and Uber. Different ones under different circumstances. So long as you got to work on time, you'd meet the regulation!
For more detail on What vs. How, see this.
If this sounds crazy to you, you should realize that there is a whole, vast area of our legal system that works in just this way: the criminal law. See this for more.
I wouldn't be advocating for change if how-type regulations worked. They usually don't get the job done. They prevent innovation. Worse, when you satisfy all the regulations, you're under the illusion that things are fine. Except that they're usually not. The ongoing cyber-security disasters we have experienced are prime examples of this.
Cutting down the number of regulations
Lots of people complain about regulations. Some people want to reduce their number. For good reason! Have a look at this to see the scale of regulations.
I hope it's now clear that reducing the number of How-type regulations won't make a big difference. It may even make things worse. It's better to replace a whole pile of How-type regulations with a couple of simple, goal-oriented What-type regulations.
An example of regulatory innovation prevention
The rhetoric of regulations and licensing is that they protect us poor, innocent consumers from the awful products and services that would be inflicted on us in their absence. The reality is that they are a massive effort that increases the costs of everyone already providing a product or service, while putting up huge barriers to competition from fast, light-footed innovators who have figured out a better way to do things. Regulation, certification and licensing do almost nothing to protect consumers, but are remarkably effective incumbent protection programs.
While this dynamic plays out in many industries, nowhere is it more harmful to our health and well-being as it is in healthcare.
The FDA is supposed to protect our health. It's even what they say they do:
One of the many ways they do this is by heavily regulating the software that goes into all medically-related devices.
The right way, the What-type way of regulating that software, would be like a criminal law:
Your software has to perform all its intended functions in a timely and effective way, without error. When updates are made, no errors or other problems should be introduced.
Now that's just a first draft. But I bet the final goal-oriented "regulation" wouldn't be too far from this.
This simple regulation states what everyone really wants: the software should do what it's supposed to do. Period.
The FDA does the opposite of simple and effective. It tells you exactly how you're supposed to develop software, and in gruesome detail. Here's the overview of the regulation:
The sections are listed on the left. Each explodes into many sub-sections, some of which are further divided. Each one is long, detailed and brooks no variation (or innovation). On the right in the image above, you see just some of the bibliography, the many underlying documents you'd better get and understand if you're going to be in regulatory compliance.
Here's a diagram that gives an overview of what is required:
Here are the section headings from the software planning part of the document:
As this makes clear, you'd better not write a line of software until you've spent boatloads of time and effort in planning -- exactly what people do when they build buildings using steel and poured concrete, but exactly the opposite of the iterative approach that is the standard among fast-paced, innovative organizations. I mean little upstarts with a high failure rate, like Google, for example.
If the FDA were serious about their stated mission, "protecting and promoting your health," they would immediately blow up IEC 62304 and the who-knows-how-many-other mountains of how-type regulations they oh-so-lovingly promulgate and enforce, and replace them with simple goal-type, what-type "regulations." It would unleash a torrent of health-promoting innovation and open the lobbyist-loving incumbents to much-needed competition. To the benefit of nearly everyone, except a bunch of progress-preventing bureaucrats employed both by the government and by their corporate "homies."
Conclusion
We need regulations. The last thing any of us wants is for corporations to build crappy equipment that doesn't work or deliver services that deceive or hurt us. There are bad and incompetent people in the world, and without appropriate regulations that are vigorously enforced, we'd be worse off. And in extreme cases, dead when we could be thriving.
Which is why it is so upsetting that major organizations like the FDA keeping waddling along, crowing about what a great job they're doing, when it's just not true.
I wish it were just the FDA. Most major sectors of society that are supposed to be protected by regulations are instead hobbled by incumbent-protecting, innovation-killing, ineffective how-type regulations.
The path to regulation that is both effective and enables innovation is clear. Let's do it!!!