Compliance is expensive. Now, go get validated!

I was recently catching up on some of my reading, when I bumped into an article about the FDA cracking down on medical diagnosis apps. Bloomberg talks about an iPhone application that lets users check for blood, protein and other substances in their urine. As the article states, “The app relies on users, such as diabetics checking their glucose, to dip test strips in urine and use the smartphone’s camera to allow the system to processes and generate automated results.”

I am a biReproducible results and testing are key to device safetyg proponent of the use of personal technology to enhance people’s ability to check their health status themselves, and to do so in an economic, responsible and reliable way. I define “reliable” here as “tested, proven and reproducible.” This of course is the foundation of good science, and in order to ensure that no bias is introduced into the testing, the process must be open, transparent and verifiable. After all, you would not have wanted to bet the farm on cold-fusion, or chosen a cancer therapy based on flawed testing.

The FDA has, over time, developed specific guidelines on how medical devices need to be mass-developed, tested and maintained. These guidelines, even if terribly cumbersome, are there to maximize the probability that the results of great inspiration and creativity are safe and trustworthy. While the guidelines cannot guarantee that a medical device will not be harmful to some, they greatly reduce this possibility. Following these guidelines is even more critical when applied to self-testing applications. Here, we are faced not only with the reliability of the device/application, but with the fact that the average consumer may reach inaccurate and possibly harmful conclusions based on the resulting output. After all, we are in the age of “the Internet said it, so it must be true.”

This is not to say that we must accept the most restrictive interpretation of every regulation. Guidance is there to delineate acceptable, lower risk paths, not to prevent the journey. Examples abound of how simple and legalistic interpretations of regulations (by non-regulators!) can lead to a complete blockage of progress. A prime example is the fear and misinterpretation of HIPAA. Instead of understanding the regulator’s intent to define necessary privacy safeguards, many have taken it upon themselves to prevent perfectly legal and necessary information flow, under the banner of “protecting the institution.” The movie Minority Report comes to mind. There is no contradiction in saying that regulations designed to protect patients are there for good reason, while at the same time warning that their uninformed application will slow progress down significantly.

Technology and innovation feed on each other. Innovation in healthcare requires a unique rigor that calls for the responsible use of technology. Without regulatory compliance, technology in healthcare misses the mark. The most successful advances in healthcare have taken this responsibility seriously, incorporating compliance into their DNA. As one would imagine, this investment is significant. Smartphone apps are poised to revolutionize how healthcare is applied, making diagnostics much more accessible and inexpensive. Having these apps be validated is a small price to pay for an extraordinary human benefit.

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