Many digital health solutions lack evidence: How physicians can help


Technology makes this an exciting time for health care. Not only are technological advances making health care better, they’re also making it more affordable. To get a taste of the potential of where health and technology are going, you only need to look as far the recent Fortune article titled, “Prepare for a Digital Health Revolution,” or to search through the more than 300,000 health apps available today.

But is all this excitement just hype? Opinions differ. Last year the CEO of the American Medical Association (AMA), the nation’s largest association of physicians, described many of the current digital tools as “the digital snake oil of the early 21st century.” That bold statement is certainly founded in some amount of reality, since many of the tools currently available have not been validated by clinical studies. And for risky medical products, such as implantable devices, testing is critical. But there are other health tech products, such as mobile-based education programs, that carry far less risk—and may not need the same rigorous clinical study standards before hitting the market. Yet, in all things, the lines between risky and safe products are blurry. And even in products that pose low levels of risk, the medical community should look for proof of efficacy and cost-effectiveness before adopting and recommending a digital tool.

On the surface, the answer seems simple: every medical tool should be required demonstrate efficacy through large, robust clinical studies. Unfortunately, however, that might not always be a viable option. For many small startups, every dollar has to be spent wisely. Time is literally money. For a young company, having a study delayed for weeks or months could be the difference between success and failure—regardless of how the product actually performs. That may be why many companies don’t perform outcome studies—they are under pressure to move fast and generate sales, so teams determine that there isn’t enough time to show outcomes. Starting a business is tough. Many fail. In fact, recent statistics show only 3 percent of startups make it to year five. And in the tough technology startup field, even well-intentioned companies may have to make tough tradeoffs to stay afloat.

Much like traditional health care, the digital health industry has a responsibility to substantiate outcomes. That shouldn’t be up for debate. But on the flipside, the medical community also has a responsibility to work alongside digital health companies to make clinical studies work within startup timelines and budgets. Together, these communicates can reduce the friction for startups running clinical studies—making sure the best tools are validated quickly, and the ineffective tools are flagged before hitting the market. And that can get the best possible digital health tools to the patients who need them.

One way to keep study costs relatively low is to conduct online clinical studies.  These studies don’t require specific clinical sites for recruiting or visits, which decreases costs to digital health companies, while still getting them the clinical proof to be medically relevant. This helps reduce the overall burden to startups, making it more attractive to provide evidence-based digital health tools into the market. And that, of course, means less snake oil.”

Even when studies are conducted online, which eliminates geographical restrictions, recruiting patients for clinical trials is still a huge challenge for startups. Luckily, the medical community is in the perfect position to step in with support. With online studies, screening and consent take place online, which means a physician only needs to spread the word about these studies to patients and within their areas of influence. Once the word is spread, recruitment can be handled online, and individual institution IRB approval isn’t necessary.

Digital health is a new and evolving sector. Already, it has created new, valuable tools for improving patient outcomes while decreasing overall costs. But to fully support this emerging field, we need to work together to help lower the barrier for clinical studies — allowing us to get the evidence needed to demonstrate efficacy and safety for all patients. If we, as physicians, are willing to support emerging opportunities in digital health and share clinical study opportunities with our patients, we can help digital health companies generate evidence of efficacy. We can help validate the best tools out there and influence the evolution of health care in the digital age. We can’t afford not to.

Bronwyn Harris is a pediatric cardiologist and CEO, Tueo Health. They are currently enrolling children for an online randomized clinical study.

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