Government Regulation and Medical Apps: An Interview with Jonathan Kohl


Years ago I read a piece by Brian Marick where he described that less depth across multiple models of coverage tends to be more effective than really thorough depth in one particular model of coverage. I've used that as a guideline ever since. I never just take the requirements or spec and use that as my only model; it's often foolhardy, frequently too narrow to catch anything but the obvious, and I find it boring. I've had much more success testing with multiple models. It helps uncover missing requirements, larger project assumptions, and helps us find problems that other people hadn't thought of looking for. That's how we add value as testers, by looking for things others wouldn't think of. In medical, or other mission critical areas, it is incredibly important to test as much as we can in as many ways, approaches, or perspectives in order to find important information quickly and get it dealt with. That's my dad, mom, sister, wife, or me who will be negatively impacted if we get it wrong; or if not mine, someone else's family.

JV: It’s common knowledge that the government is used to dealing with old technology and may not be as up-to-date with the latest trends in computing like the rest of the software world. That being said, do you get a sense that the government is taking steps modernizing the way they work with software?

JK: Absolutely. Many of them use mobility tools in their own lives, or for productivity, so they understand it. They are trying their best, but government agencies don't get the funding they should, especially in difficult economic times. I have worked in several regulated environments and I usually find the auditors to be fair-minded people. They are a bit scary because they have an important job and walk with a big stick so to speak, but most of them are intelligent and working hard to do the best they can.

It can be frustrating that they don't move at the pace we would like them to, or in line with technology, but they have a very important job to do. Without oversight, we'd be back to the days of snake-oil salesmen and leeches. Sometimes their decisions are controversial and people get upset, but to my view, these agencies do more good than harm.

JV: This article from the Healthcare Information and Management Systems Society points to the ways the medical app industry is maturing and the author believes that the new FDA regulations will give it credibility. How do you think the mobile medical app world might change once the regulations go in place?

JK: I see less to do with the regulations here in this piece  and more of an acceptance of mobility as important technology for health care. It's not that the mobile medical app world will change as much as the medical world will be changed by mobility apps and services.

With the apps I was working on, we had to have FDA clearance for them to be sold to healthcare professionals in the USA, as well as with related regulatory bodies in other countries. That was a requirement for usage. To see practitioners faces light up as they used our software and recognized its potential was huge. It’s hard to describe the feeling of being part of something that important. So my read on this is that now that the FDA has developed regulations, there is much more opportunity to create applications and systems that will make our lives better. I don't say that lightly.

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