Are Federal Regulations Stifling Disruptive Healthcare Technologies in the US?

Screen Shot 2014-08-28 at 11.38.01 AMIn the past few years, we’ve seen headline after headline marveling at the advancements of medical technology. From wearable tech and micro sensors to 3D printing and health-oriented apps, it’s evident that technology and medicine have merged into an industry that’s pushing healthcare to a new level.

Yet many in the health tech industry are also voicing concerns about government regulators and their standards for healthcare technology. Some have even gone as far as accusing the FDA of “stifling” the creativity of healthcare tech and hindering the value these devices and apps could bring to the public.

In early 2014, legislation was introduced in an attempt to redesign the regulatory framework for certain types of technologies and lessen the FDA’s control over this growing industry. But are the FDA’s standards and actions so bad?

I’m in the tech field myself, and while I’ve heard many arguments against the FDA’s regulations, I strongly feel that it’s completely within its rights as a regulatory agency to place limits on medical technology. The FDA’s standards are put in place to protect consumers and to correct disingenuous manufacturer claims — an alarmingly frequent trend in today’s digital world.

The FDA Isn’t the Bad Guy

In the tech world, I often hear “It’s easier to ask for forgiveness later” as an excuse for consciously crossing the line. But when it comes to the medical field, overstepping boundaries could be a matter of life or death.

Too often, companies rush to release new products and technologies to beat competitors or cash in on a trend rather than out of consumer need. Regulations aimed at slowing these companies down to maintain patient safety are completely justified.

With the increased interest in all things health and wellness, we’re seeing more healthcare apps pop up in Apple’s and Google’s app stores. Many apps claim to be able to provide accurate biometric readings using the native tools on smartphones, but buried deep within the fine print (that people don’t read) are explanations that these apps are for “recreational purposes” and are “not FDA-cleared medical devices.”

Apps like these are dangerous and misleading to consumers who might trust their readings.

When it comes to medical safety regulation, the FDA is the most thorough regulatory body in the world. But even it doesn’t have the time and resources to constantly monitor the more than 97,000 healthcare apps that are currently available.

If app manufacturers and regulatory agencies work together to build, approve, and regulate healthcare apps, the entire process could be less burdensome.

How to Improve the Regulation and Approval Process

There are a number of things that both the regulatory agencies and the tech manufacturers can do to improve the tech regulation and approval process overall, including:

  • Adhere to preset standards. Medical technology companies can adhere to the standards set by the FDA Safety and Innovation Act when developing products. This will inevitably delay product launches and add expenses, but that’s a reasonable price to pay for the health and safety of consumers.

Additionally, the Office for Civil Rights should verify that medical technology manufacturers are held to HIPAA standards and pinpoint companies that are both good and bad at this.

  • Expedite the approval process. The FDA can create a program to help accelerate the review and approval of medical apps — which could include a peer review of new products by healthcare professionals — to attempt to keep pace with today’s innovation. 

Since many of these tools help with aspects of preventive care, safe and effective apps should be able to reach consumers quickly.

  • Take actions to eliminate dangerous apps. The FDA should make it a priority to get medical apps that aren’t FDA-approved either eliminated from public app stores or clearly relabeled as “for entertainment only.” If actions aren’t taken to better classify apps, consumer health and safety could be seriously jeopardized.
  • Grow funding toward research. The NIH and other organizations could increase grants going toward research in medical technology. This would increase funding while allowing these organizations to ensure that research and development follows proper standards and protocols.

While many speak against the FDA’s stifling regulations surrounding healthcare technology, I believe we need regulations to keep dangerous and misleading devices, apps, and manufacturers from harming the public. If the FDA and tech manufacturers would only improve their collaborative efforts, we could reform the regulatory process, produce even more innovative technology, and better educate consumers on the good (and bad) in the healthcare tech world.

Tim Maliyil is the CEO and data security architect for AlertBoot. AlertBoot protects customers from data breaches that damage their credibility, reputation, and business. The company’s managed full disk encryption, email encryption, and mobile security services deploy within minutes to customers’ PCs, smartphones, and tablets, providing tremendous insight, visibility, and control.

8 replies »

  1. Amen. The F D and C Act is intended to protect the safety of the public from devices and medicines. I could not agree with you more.

    The conversation has been started years ago, in the Health Care Renewal Blog. However, the vempndors have lobbied Congress and the Potus to have the FDA give a free pass to the vedors.

    EHRs, CPOEs, CDS’s and Mobile Med Apps are the only devices in the US that have not had to undergo premarket vetting and post market surveillance for safety, efficacy, and usability.

    Dangerous. See the Leapfrog propaganda of August 31.

  2. Thank you everyone for the feedback. I’m glad to see the article started a discussion around the topic.

    I will start off that I’m not a fan of proving Darwin’s theory. ☺ That is why we have regulations in the first place. We can already see some of the dangers with WebMD in the hands of a hypochondriac, and Bubba above brings up a key point.

    An app that incorrectly tells you your blood pressure is safe when you might be on the verge of a dangerous health situation should have some serious consequences on the app maker and/or the store that hosts it.

    Getting FDA approval on each app is an extreme, but seeing a proposal like that in Congress will definitely get app makers and the app store owners motivated to get involved in finding a middle ground level of regulation.

    Apple and the other phone manufacturers are investing heavily in health related hardware to better read and monitor what is going on with your body. They should also invest in the regulatory body for the medical apps that are in their stores. They already do it for porn and gambling, and if Apple or the other app store markets could potentially suffer from the regulatory and financial pitfalls from letting a faulty app into the store, I know the quality of medical apps in those stores would be top notch.

  3. Caveat emptor is correct. Many of my older patients cannot remember most of the important details of their medical history. They do not understand much when it comes to complex care. Now give them an app they understand either, but trust. I guess it will be Darwin in action.


  4. While I agree with a few of Tim’s ideas, trying to put more responsibility in the hands of regulators who have little to no experience working with technologies many barely know exist is not one I can support. The notion that the FDA could “fast track approvals” would run counter to their very nature. Besides, what technologist worth his or her “salt” would accept a government paycheck (even though their paychecks continue to grow!) when they could potentially make much more in the private sector? The FTC has a similar problem with Wall Street. Every time I watch a webinar sponsored by CMS, HRSA, and/or SAMHSA discussing “cutting-edge” technology and how to apply it in practice, I am stunned by the lack of knowledge of what cutting edge truly is.

    Should there be consumer protection for fitness/healthcare-related apps? Maybe. Should there be regulations or standards for clinical applications acquired by hospitals, providers or payers for use in clinical settings with and by patients? Sure. Laws/regulations already exist on the books with regulators to enforce them.

    Living in Washington, DC, I get to see up-close how these departments/agencies operate because I have many friends/colleagues who work for them so I get to hear the most interesting stories about their reality. If the FTC can’t hire regulators who can understand complex trading algorithms and properly protect American citizens from outright fraud and graft on Wall Street much less actually punish anyone, how on earth is the FDA going to do it?

    I like Tim’s ideas of clearer labels in the online app stores, but I place the impetus on Apple, Google, etc. and their consumers to self-police. I also like his idea of standards and guidelines, but they should be created by industry with input from the Feds not the other way around simply because the Feds don’t have the expertise to do so nor the speed to keep up.

    Very nicely written article Tim! I hope you get a chance to write more.

  5. Bubba: I say let the markets work.

    If people use apps, caveat emptor. If you hurt yourself using an app, sue the maker. Good luck in the Romanian, Bulgarian, Turkish, Russian, Croatian, etc. courts and the courts of other countries from which so many apps come, trying to get compensation for a self-inflicted injury aided and abetted by an app and its manufacturer’s false claims.

    At some point, it has to be about judgment and responsibility and lessons learned. They don’t give out Darwin Awards each year for no reason.

  6. This is a huge great big massive freaking deal. I’ve been running into a lot of stories about app makers using the “entertainment purposes only” defense.

    This wired story about an app that claims to monitor blood pressure but is wildly inaccurate is sobering ..


    The FDA needs to sit down and have a nice little talk with Apple