The mobile healthtech industry is exploding. There is an estimated $42 billion annual market for personalized medicine and a mad dash to come up with the “next big thing” to take advantage of the deep pockets.
The tech world is built and rewarded on hockey-stick growth, wild valuations, beta launches and speed: Google, Facebook, Twitter, Uber. The faster, the better. This culture collides with mobile health; the Zuckerberg mantra “move fast and break things” is great for social media, but in medicine when we move fast, we break people.
While countless companies have emerged with important missions that are solving real problems, there could be serious implications when these technologies and businesses are not vetted properly. Plenty of companies have rushed to market — claiming to screen for cancer or decrease depression, only to be proven wrong or inconsistent — using unverified methods or a loophole to make claims that the technology can’t back up.
Luckily, there is good news for the consumers of these mobile healthtech startups. The FDA recently announced a partnership with the FTC to begin regulating mobile healthcare applications. The program was created to open a channel of communication with developers about the specifics behind mobile healthtech apps. Developers answer high-level questions about how the app works, then receive information about laws and regulations of standards that the app will need to meet.
For instance, how much personal information does the app collect? Depending on the answer, the app could need to be HIPAA and/or COPPA compliant. The FTC’s program can show developers how to make sure the application they are building meets those standards — giving consumers access to apps that help monitor and benefit their health in a safe and secure manner.
This regulation is critical to consumer health. Consumers don’t necessarily research or understand the science behind the latest up-and-coming healthtech fads. It’s up to the companies themselves and the regulating bodies to do that due diligence on their behalf. Transformative digital health companies have the potential to improve our health and enrich our lives, but not if they are built on false data. When people without medical degrees rely on data from companies that may not have FDA approval, there’s a risk that they could make dangerous decisions about their own health.
Healthcare is regulated for a reason.
At a recent pitch contest, one founder attempted to “sell” an idea for an electroencephalogram (EEG) that provided biofeedback for a chronic medical problem. While I am a firm believer in giving people access to their brain vitals, this particular product didn’t measure the indicators necessary to monitor the medical condition he was promising to address.
There may be many reasons for that disconnect, but one indicator of trouble for this company was the lack of any medical professional on the founding team or the board. Without any kind of regulation, this product could be mass-produced, cost investors and consumers millions of dollars, and, even worse, produce inaccurate results about vital health functions.
The disconnect between healthcare and tech is also shown in the unrealistic expectations pushed on certain entrepreneurs based on a system that knows and rewards only one speed: fast.
Healthcare is regulated for a reason. Perhaps popular culture would cause you to believe that regulations are there to place a barrier between the consumer and the latest methods of care. In truth, these regulations — licenses, or FDA approvals, for instance — were put in place not so long ago to stop unethical practitioners from harming people.
The Tuskegee Study in Alabama is a great, albeit extreme, example of what happens in an unregulated healthcare market. From 1932-1972, a sample of African-American men were promised free healthcare but not told they had been diagnosed with syphilis. These men were not treated for the disease, even after penicillin was discovered as a treatment in the 1940s.
The unethical nature of this study led to federal laws and regulations requiring Institutional Review Boards to oversee research protocols. Other such examples of unethical medical practice abound, and regulations were put in place to protect consumers, most of whom have very little knowledge of science, anatomy and pharmacology.
Technology and innovation shouldn’t overthrow years of progressive medical regulation intended to protect the consumer just because it moves faster than laws can be passed. A recent article in the Los Angeles Times makes this point really well, stating, “Experts see almost unlimited promise in the rise of mobile medical apps, but they also point out that regulation is sometimes lagging the pace of innovation, which could harm consumers.”
And let’s be clear, consumers in mobile health are you, your parents, your children, your spouse and your loved ones. If a transportation app fails to deliver it is inconvenient, but not life altering. When a mobile health app makes false promises or claims, the cost could very well be a person’s life.
All 50 states require a license to practice medicine or psychology. The simple act of moving healthcare to a mobile app should not change the fact that a licensed professional needs to be overseeing that care. The FTC and FDA’s dedication to regulating fast-paced tech advancements, especially when it comes to consumer health, is what makes this such an interesting time in our history.
We are also at a precarious juncture. As consumers adopt these apps with the promise of better health, disease prevention or diagnosis, our industry holds both consumer health and trust in its hands. And these will be impossible to rebuild if broken. We must not value speed-to-market over the importance of delivering on the promises and claims we are making.
While healthcare is now one of the most regulated industries in the world, technology has a long way to go to meet its goal of improving quality of life as a whole. Patients should have unlimited access to information about what’s going on in their bodies, and mobile health technology is a great means to achieve that.
Similar to the way you read the ingredients in the food you buy, I urge more consumers to understand the processes and science behind the mobile apps they are adopting. But what we really need is for healthtech companies to be held to the highest standard. Done right, we can make great strides in screening, treating and preventing disease with the touch of a button.