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.