Last week the U.S. Food and Drug Administration issued an exhaustive document that details how its regulations will soon apply to up-and-coming mobile medical applications. This is a particularly touchy topic for lots of people probably because such applications are likely to usher in a new era of digital information vulnerability. Remember when you purchased your favorite pair of shoes on the Internet back in the day (and hey, perhaps you still do)? Can you remember the wave of credit card theft and identity fraud that followed, and that still happens today? Software developers have been working to create applications for iPhones and other devices that will soon allow physicians and patients to share medical records and other HIPAA-sensitive data with the touch of a button.
If history is to repeat itself, medical patients could be in for something far worse than waking to find their bank accounts dry.
What’s interesting about the FDA’s “draft guidance document” is that it’s open for public comments. The FDA wants manufacturers and the general public to read the draft and provide feedback on its details, which is a step in the right direction. But is this truly effective? How many people will actually spend the time reading through the FDA’s lengthy, dense documentation to pick out the information relevant to them? And better yet, how many people will understand that information with enough clarity to articulate thoughtful feedback?
In the end, this FDA document means very little to the general population that relies upon the accessibility of mobile software to achieve day-to-day tasks. In the end, the draft guidance document will become final and patients will be in the dark about how their information is transferred and about the laws that govern that transferal. Patients that will use these medical mobile apps in the future will probably gloss through that dreaded “terms of use” section, where FDA regulations trickle down through commercial filters. Soon, medical information will be one step closer to the prying hands and eyes of fraudulent hackers and digital pirates looking for gold.
This is bad news for a global society that has essentially plugged itself into a modern mobile matrix. Lots of people wouldn’t think twice about installing medical apps on their iPhone or tablet, and lots of people would even find these apps terribly convenient. Medical information will begin to travel through new online conduits. Doctors’ offices and, probably, the FDA will ensure you that your information is safe and protected—but it’s not a guarantee they can uphold with any surety. There will always be an ingenious hacker who discovers a new way to penetrate the security that keeps that information safe. And the day when a medical mobile app’s software fails or is hacked into will be a sad day indeed. This won’t be your social security number or your credit card digits displayed all over the Internet.
This will be your personal health records. This will arguably be your most private information, the details that tons of regulatory agencies work so hard to keep under wraps. There are still an absurd number of people who today fall prey to online scams, but the severity of the information released in these scams is going to take a sharp turn for the worse with the proliferation of medical mobile applications.
Before you rely on technology to make your life more convenient, make sure you completely understand the implications of using apps that share sensitive data. Read the FDA’s draft guidance document and, if you can, provide your feedback. Regulatory agencies work hard to keep this information safe for a reason—never lose sight of that.