As Technology Expands Medical Access, Government Restricts It

Posted: Oct 06, 2014 11:15 AM

Innovation is a remarkable thing. It makes everything faster, cheaper, and more accessible to average people. Innovation lifts all boats, but especially those of the underprivileged. The rich will always have access to the very best, but innovation levels the playing field by bringing formerly out-of-reach luxuries to the masses.

Necessity is the mother of invention, and so we tend to see the most creativity in the areas where the need is greatest. Nowhere is there greater need than in 21st century America’s tangled mess of a health care system.

The emerging mobile app market has provided tremendous opportunity for medical innovation. You can now use your smartphone for anything from monitoring your heart rate and counting calories to checking how different medicines will interact with one another and viewing retina or MRI scans.

These sorts of products don’t just benefit consumers. Doctors are increasingly using them to help with their practices, as well as turning to online resources such as WebMD or even Wikipedia. The sheer quantity of medical tools and information available to the public has exploded.

It’s exploded so quickly, in fact, that the government can’t begin to keep up.

The Food and Drug Administration (FDA), ever nervous about the prospect of a pie uninvaded by its collective finger, has decided to treat mobile health apps as medical devices for the purposes of regulation, meaning that a great many of these resources will have to be reviewed and approved before being allowed to be sold to the public.

Setting aside for a minute the absurdity of regulating a blood pressure monitor in the same way as a defibrillator, one of the main issues here is that the FDA is painfully, unreasonably slow and inefficient in discharging its duty.

At last count, the FDA had only reviewed and approved 103 different health apps, and is scheduled to review just 20 additional apps each year, a number with falls drastically below the current rate of innovation. Several developers have admitted that the regulatory structure no longer makes it worth their while to invest in developing new medical technologies.

The costs - measured in both time and money - are just too great.

Defenders of the FDA’s policies will cite safety concerns, claiming that the government has a responsibility to make sure the products sold are not dangerous to the public. It’s hard to imagine how much danger a smartphone could really pose to an adult human, but more important is the calculation of how many people are prevented from getting potentially life-saving help due to regulatory delay.

Every month a medical app spends waiting to be reviewed by the FDA is a month in which it is not performing its designated function of helping people to be healthier. The damage caused in this way must at least be weighed against the rare, but far more visible cases of a dangerous product actually being released and causing harm.

The FDA’s restrictive regulations would be bad enough on their own, but as the effects of the Affordable Care Act begin to be more fully seen, consumers’ health options will diminish still further.

Surveys of physicians show that doctors are planning to retire or scale back services at increasing rates. Already, one in three is over fifty years old, with a smaller share of the younger generation being trained to replace them. In fact, nearly half of all doctorssay they would not choose medicine as a career if they had to do it all over again, citing the changes brought by the Affordable Care Act as a major reason.

Last fall, around 6 million Americans received notices that their health insurance policies were being cancelled for not complying with ACA mandates, and a new wave of cancellations, starting with 250,000 in Virginia, is just beginning. Under the ACA, insurance premiums have increased at a faster rate than wages, both for private and public sector workers. The law’s stipulations of what must be covered are reducing consumer choice across the board.

At a time when technology is expanding access to health care faster than ever, the government is fixated on doing the exact opposite, acting to ensure that consumers face higher prices, fewer doctors, and less choice. If regulators really care about Americans’ health half as much as they claim to, they should be encouraging innovation rather than trying to stifle it.

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