Finding examples of the glacial pace of government relying on atrophied rules moving slower than technological advance is pretty easy, but the best example might just be health IT, or more broadly, health tech. An increasing chorus of voices are demanding an update to federal regulations when it comes to low risk health tech. The U.S. Senate has joined in as Senators Fischer and King introduced the PROTECT Act, designed to “provide a risk-based regulatory framework for health IT – all while protecting jobs and boosting patient safety,” by reigning in the sprawling regulatory growth of the Food and Drug Administration (FDA). This proposal separates the low risk from the high risk technology providing different, more sensible treatment of each. For its part, the House of Representatives has already passed the SOFTWARE Act. This Act would more tightly focus FDA authority over products that pose a potential risk to human health.
So why the FDA focus? Because the FDA has been aggressively moving to gain regulatory oversight of mobile health apps, of which there are somewhere around 100,000 available in Apple’s iTunes store alone, and at the same time has moved to limit individual access to personal health information. Getting technology tied up within the FDA leads to squelched innovation because of the FDA’s risk avoidance approach hindering the flow of health related information.
As Senator Fischer wrote in a recent USA Today op-ed, “The current, overly broad definition of a medical device – written in 1976 – gives the Food and Drug Administration (FDA) authority to regulate a wide range of health information technologies entering the marketplace. The FDA claims it has discretion to regulate things like mobile wellness apps with the same rules it uses to review complex, invasive medical machines. This defies common sense. As a result, many of the products posing little risk to human health fall victim to a long, costly regulatory process. This stalls progress and unnecessarily burdens inventors and entrepreneurs.”
Certainly the FDA plays an important role in keeping Americans safe, but its grinding regulatory pace increasingly hinders the safety of Americans. But, not to be outdone, the FCC has decided to add another layer of government, expressing a desire to “help” healthcare organizations adopt the latest technology.
As recently reported in The Hill FCC Chairman Tom Wheeler has said, “We must leverage all available technologies to ensure that advanced health care solutions are readily accessible to all Americans, from rural and remote areas to underserved inner cities. By identifying regulatory barriers and incentives and building stronger partnerships with stakeholders in the areas of tele-health, mobile applications, and tele-medicine, we can expedite this vital shift.”
Government “partnership” and the suggestion that government will leverage technologies to help the private sector fly in the face of the facts; that is, technological advance has needed very little help from government. Rather, it is bureaucracy and government “study” that is slowing the advance, not a lack of government.
The challenges are known and the Senate can join with the House to fix the problems which allow the FDA and FCC to end the mission creep and focus on the truly critical.