FDA regulating software, what a dumb idea.

Kevin MD: “There’s a storm brewing around the regulation of medical apps. The FDA has been skirting the issue for too long and it’s having detrimental effects on the potential for such apps. Recent FDA hearings have revealed that the agency is watching the apps stores for potential alarms and that they are drafting guidance. Whatever that means.”

The thought of the FDA regulating software is a bit of a joke. That’s like allowing a Software Developer to prescribe medications. Sure, we could do it, but it wouldn’t be nearly as effective as someone trained to deal with it.

How in the world would the FDA propose to evaluate applications? Here’s how it would work. They’d start with great intentions. After a while companies would become buddy-buddy with someone responsible for evaluation and before you know it one company has a competitive advantage over another, even if that company is not worthy.

Let the market decide. If Pharmacists, Doctors, and Nurses use the software daily and notice mistakes they’re not going to put up with it for very long. If medical care professionals don’t know enough about their industry to notice a mistake then shame on them. Software, like the human body, is quite simple, yet it can become quite complex. Regulation is not the answer. It will reduce choice and competition in the marketplace, and that’s not a great model for success.

Business Life

You want it? You got it.

SFGate: “They see the megafarms squeezing out the little guy on economies of scale, industrializing the crop the way big business has done to food and creating monocultures in a pot industry that now grows hundreds of varieties.”

The Marijuana debate in California rages on. The folks that want to legalize it are now up in arms because the big guys are going to jump in and crush them. Hey, welcome to American Capitalism. If you got busy building a business instead of smoking your product you’d have been ready for such an eventuality.

As you can tell, I’m a bit opinionated about the use of pot, but to each his own. I still say we should do one of two things, but of course it’s not as easy as this.

  1. Regulate it at the Federal level and dispense it via pharmacies.
  2. Legalize it and allow it to be sold through Government approved, and regulated, facilities.

If it’s to be treated as a medicine we have a dispensing mechanism that works, use it. If it’s to be completely legalized and treated like alcohol, we should monitor it, like we do alcohol, and tax it.

I’m not an expert on the matter, take what you want away from this. It’s my opinion of the situation, but don’t cry when your “dreams come true” and you realize it’s not what you expected.