Only about 20 randomized clinical trials involving mHealth tools or services have been conducted in the United States since 2008 under the auspices of the National Institutes for Health. And more than half of them have failed to document clear evidence of improved outcomes.

 Francis Collins, MD, the NIH's director, delivered the message to attendess at the 2012 mHealth Summit in his closing keynote on Dec. 5. Collins pointed out that the lack of trial-based evidence is hindering acceptance of the technology by a healthcare industry that could really use these tools.

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"We have a ways to go," said the former director of the National Human Genome Project and recipient of the Presidential Medal of Freedom and National Medal of Science. "Small numbers are a real problem, however."

Collins, whose organization helped launch the mHealth Summit roughly five years ago before ceding control earlier this year to HIMSS, noted that mHealth "is getting into the mainstream rather quickly," with roughly 200 NIH-funded projects now under way on mobile phone-related research. He'd even volunteered as a participant in AliveCor's tests of its mobile Heart Monitor, which connects to an iPhone to deliver a single-channel ECG and which recently received 510(k) clearance from the U.S. Food and Drug Administration.

But while everyone is testing or using mHealth devices and solutions, he pointed out, "we need to be sure that we're collecting the right evidence."

"The plural of anecdotes is not data," he added.

Collins also noted that the mHealth field is evolving so rapidly that oftentimes the technology used in trials is outdated by the time the trials are completed. For that reason, he said, the scientific and healthcare communities have to work together to fine-tune the process, producing viable results in a timely manner.

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The alternative? Forge ahead with mHealth without evidence that mHealth is improving healthcare.

"To skip over that step would be unfortunate," he said.

Collins suggested creating a national research network of millions of people, linked through electronic medical records platforms. This, he said, would link the scientific world to a database of real-time data that would  produce quick – and compelling – clinical results.

"It's a real opportunity to do clinical research in a real way in the real world," he said.