FDASIA mHealth regulations: Whither EHR usability?

It's time the feds grab health IT software developers by the lapels and address poor EHR usability. FDASIA mHealth regulations present an opportunity.

Taking questions before an intimate gathering at Boston's Harvard Club in 2012, then-National Health IT Coordinator Farzad Mostashari, M.D., answered my question about the state of EHR usability by furrowing his brow, scowling and dropping an s-bomb. A year later at HIMSS 2013, he told me he'd seen some improvement, but there was a ways to go.

Don FluckingerDon Fluckinger

Physicians and nurses frequently complain about how difficult health IT applications are to use, most recently at a panel in April convened by Nuance Communications, Inc.

NIST issued usability guidelines a couple of years ago. Supposedly software developers can follow them while coding their next rev and make their software safer in the process. At a National Institute of Standards and Technology (NIST) conference on health IT usability in 2010 as the guidelines were under construction, a free-form panel including representatives from ONC, NIST, FDA and other agencies brainstormed how they might go about regulating health IT usability. In the end it was clear that, while FDA might be concerned with the safety ramifications of poor software design, the agency didn't have the labs or expertise to oversee such an ambitious program.

The latest FDA project that touches the issue of health IT usability is a new report outlining the framework for future regulations, which will determine how mobile health apps are regulated -- it appears that it will be according to their risk to patients. A joint effort of the FDA, ONC and FCC, Congress mandated the framework in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA).

Upon unveiling the report, representatives from the three agencies fielded questions from reporters on a conference call. On the matter of health IT usability, Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health and Jodi Daniel, director of the ONC's Office of Policy and Planning confirmed that usability is part of the framework.

It's time for Shuren and ONC to grab the software vendor-sphere by the lapels and shake some sense into the worst offenders.

This new program encourages the development of standards, best practices, measurement of safety and usability that can be tested at a public-private Health IT Safety Center that would "convene stakeholders in order to focus on activities that promote health IT as an integral part of patient safety with the ultimate goal of assisting in the creation of a sustainable, integrated health IT learning system that avoids regulatory duplication and leverages and complements existing and ongoing efforts." Search for the word "usability" in the report and you'll see a road paved with good intentions.

Some patient advocates I know will find this "voluntary spirit of cooperation" stuff weak, lame bureaucrat-speak for maintaining the status quo of health IT systems. Systems whose interfaces look like rats' nests of pull-downs, radio buttons, pop-up dialog boxes and/or clicking through endless screens to get to relevant data during a patient visit. The kind of software applications that currently breed medical errors in certain care settings at their worst and at best force frustrated physicians to apologize to the patient and mutter something along the lines of, "just a minute while I catch the computer up here." It's the kind of software that would cause a national HIT coordinator to scowl and drop an s-bomb just thinking about their usability.

Shuren pointed out that provider IT staffs play a role in health IT safety, too; it's not just on the software developers.

"You can't look at a lot of these technologies in isolation. In fact, that's been one of the challenges to date. You can have software that, itself, is just fine. But then it gets reconfigured to meet the needs of a particular provider as it goes into their system, and at that point the software is changed and a risk is introduced." That's where the safety center comes in and the best practices for using particular applications.

That is, technically, a move toward fostering better health IT usability. But not on par with mandating it and levying fines on vendors still brash enough to roll out hard-to-navigate applications that look like they should be running on Windows 95. On one hand, who can blame the FDA? Creating usable software is a nebulous art. Regulating it would involve metrics and measurement and would open up FDA to endless criticism in whatever they did. Especially in this era of noxious political debate -- what a hornet's nest that would be.

On the other hand, patients' lives depend on it. That's the FDA's job, to protect patients from medical practices, research firms, pharmaceutical companies and now health IT vendors who would cut corners and trade the well-being of patients for profits. Judging by how well the spirit of public-private health IT cooperation is fixing all the health data interoperability problems in U.S. healthcare -- which is to say, it isn't -- it's time for Shuren and ONC to grab the software vendor-sphere by the lapels and shake some sense into the worst offenders, and even to some who aren't quite as bad. Because when it comes to usability, from what front-line clinicians tell us over and over again, leaving the free market to its own devices ain't getting it done.

Unless this is an unfairly pessimistic reading of the FDASIA framework, it looks like the FDA and ONC likely won't take strong action on usability until they're asked to. And guess what? You have the opportunity to do just that. The FDA is seeking comment on the FDASIA framework until July 7. If you're a physician, CIO or other party who understands how EHR usability and patient safety correlate, raise your hand and be heard.

Let us know what you think about the story; email Don Fluckinger, news director or contact @DonFluckinger on Twitter.

This was first published in April 2014

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