The Rush to Regulate Health IT
Some policymakers, regulators and others in government still treat technology as a separate policy issue. But, technology is so deeply embedded in virtually everything we do, from communications to transportation to manufacturing, that to see “technology” as a stand-alone issue makes little sense. Just look at health care. Or cyber-security, where current debate is really about the mode of attack than about what might be attacked, such as a utility, military installation, hospital system or corporate database with sensitive information.
Others in government see the use of more technology in government-regulated processes as a non-event, that regulations and regulatory processes designed to take years to develop should still operate the same way, such as approval of medical devices taking years, while technology advances in a matter of weeks or months. The impact can hardly be overstated—investment decreases, innovation seizes, consumers are left with fewer and inferior options. The rapid dwindling of the promise of health technology would result.
A third group seems to believe that the health technology market is so mature that it is time to begin arbitrarily taxing medical devices at 2.3 percent, as mandated by ObamaCare.
None of these views are correct, yet policymakers continue to blindly stumble forward with policy prescriptions that at best address their concerns with blunt force, often resulting in ineffective, outdated or dramatically restrictive policies.
So what is the right answer? First, policymakers need to realize and internalize that we are at the very beginning of what will likely be a huge transformation in health care. The state of information technology in health care stands somewhere similar to where the state of information technology stood in business in the 1960s. The advances in how data are collected and used, such as with wearable devices that transmit information about vital signs regularly to an information hub for use by you and your medical professionals, will sprint ahead light years in the next decade.
Next, when sensible time-outs are called they should be supported, such as the one proposed by Senators Bennett and Hatch, to pause the eager advance of the FDA to regulate mobile health apps.
Finally, simply have a little patience. Life will go on just fine without a sprawling regulatory regime crushing the beginning of a new age in health care technology. Those who are disturbed by the seeming chaos of invention and innovation need to pause and let technological progress, not regulation, lead.