Apple's ResearchKit draws massive interest (and some reservations)

A new crop of mobile apps built with Apple's new ResearchKit framework are moving fast into medical research. The entry of the consumer electronics juggernaut may democratize participation in clinical trials but also has raised concerns that the hype will mask the risks.

Ethicists and patient-safety advocates are optimistic about the promise but also point to limitations and potential downsides, especially if the tools aren't carefully rolled out by healthcare providers and software developers. The research, they say, should be subject to the supervision of institutional review boards and the same rules of informed consent as traditional studies.

When manufacturers “make this jump, they are now dealing with human subjects,” says Art Caplan, a bioethicist and founding director at NYU Langone Medical Center's population health department. “They're not dealing with just consumers anymore."

Apple announced ResearchKit Monday during an event that also revealed new details about the much-hyped Apple Watch. The company described ResearchKit as an open-source software framework that will allow physicians and scientists to collect and monitor medical data from patients using iPhones.

By Tuesday, Stanford University already had more than 11,000 people sign up for a cardiovascular study using the tool, according to a Bloomberg report.

The University of Rochester (N.Y.) Medical Center and the Icahn School of Medicine at Mount Sinai, New York, are also already taking advantage of the new Apple technology. Using it, they say, will lead to greater understanding of the impact disease has on patients' lives.

“This is definitely a new era,” said Dr. Yvonne Chan, director of personalized medicine and digital health at Mount Sinai.

The hospital uses an app called Asthma Health—developed with Apple's ResearchKit by Mount Sinai and San Jose, Calif.-based LifeMap Solutions. It's intended to encourage patient education, self-monitoring and behavioral changes, ultimately leading to better asthma symptom control, improved quality of life and less need for healthcare services.

“If that were to happen, that would be the ultimate positive reinforcement to continue using the app,” Chan said.

The asthma study at Mount Sinai is overseen by a multidisciplinary institutional review board led by Dr. Jeffrey Silverstein, senior associate dean for research at Mount Sinai Hospital. The researchers assembled a team of experts for the review board who could assess the application from a variety of perspectives, including statistics and ethics.

The University of Rochester is using a mobile app built on Apple's ResearchKit called Parkinson mPower, which allows patients with Parkinson's disease to track real-time changes in balance, gait, voice tremors and other symptoms.

“There is unmet demand for tools by which individuals can measure the course of their disease and receive feedback on how they're doing,” University of Rochester neurologist Dr. Ray Dorsey said in a news release this week.

Perhaps the biggest reservation in the broader medical community is the sense that most new technology comes with unexpected glitches. Several studies have documented the dangers of the rapid introduction of new technologies in healthcare.

“When everybody is looking at the hype, we (researchers) are always thinking of what's going to be in the disillusionment part of the hype cycle,” says Dr. Hardeep Singh, of the Center for Innovations in Quality, Effectiveness and Safety at the Michael E. DeBakey VA Medical Center in Houston.

Though the technology can provide great new opportunities, he worries about the quality of the information obtained. The apps are available for download on Apple's app store to anyone interested in using them.

“Ultimately, it's about data quality and reliability,” Singh says. Use of mobile technology does not happen in a controlled environment, and with potentially hundreds of thousands of data points obtained, "You can lose control in this virtual environment of big data.”

Caplan raised another downside: The results might skew toward the population of people who can afford iPhones. “It's not necessarily representative of the problems of the poor, or the health habits of the uninsured or underemployed,” he said.

Mount Sinai is aware of those “potentially tricky” limitations, Chan said. But she also noted that traditional medical research, conducted in supervised settings, has its own drawbacks. It is often skewed toward men of higher socio-economic classes; tends to be limited in geography and scope; and is generally more costly and time-consuming to conduct.

The larger sample size available through use of mobile devices can actually help expand the diversity of people participating in trials, Chan said. “The benefits and access to the broader population outweighs whatever limitation posed by the inability to afford an iPhone,” Chan said.

Dr. Monique Anderson, a cardiologist and professor at Duke University Medical Center who researches the transparency of clinical trial data, said it remains to be seen if this type of data can be trusted. But if use of these types of “pragmatic clinical trials” do pan out, she said, they might bring about revolutionary changes to the way research is conducted.

“This is an exciting time,” Anderson said. “In today's world, we need that additional information. The more participants who can contribute to minimal-risk, big-data research that contributes to the public good, the better.”

Follow Sabriya Rice on Twitter: @SabriyaRice