On Monday, the Food and Drug Administration approved Abilify MyCite, a pill that contains a sensor that detects when patients have swallowed it. Abilify is used to treat schizophrenia, some forms of bipolar disorder and is also used  as an additional treatment for depression. The new “digital” pill is the first of its kind to be approved, and can track if patients are taking their medications when they’re supposed to.

Here’s how it works: When the pill’s sensor, known as an Ingestible Event Marker, comes into contact with stomach juices, it sends a message—with the date and time of the ingestion, as well as physiological data such as the user’s activity level—to a wearable patch. The patch then communicates that data to a mobile app which can be accessed (if the patient allows) by his or her doctor, caretakers, or family members.

Although the Abilify MyCite is the first digital pill approved by the FDA, it’s not the only connected medical product. Other technologies include devices that can tell if a patient has had an epileptic seizure, taken a fall, or can monitor blood glucose in diabetics. As more devices monitor patients’ behavior and collect data, experts see the potential for better care, as well as privacy risks.

Photo: Proteus

The Potential Benefits

According to Orly Avitzur, M.D., Medical Director to Consumer Reports, there are many reasons patients may not take their medicine—and not tell their doctors. “It’s really easy to forget to take medication,” she says. “Especially when we feel a lot better and we aren’t paying attention to things.”

In the case of serious mental health issues like those that Abilify is meant to address, some patients may be trying to avoid unwanted side effects.

“It is a more acute problem with behavioral health because some people are resistant about treatment,” says Avitzur. “The medications, in fairness, do have side effects, and those side effects can be unpleasant. The worse the side effects, there more likely there is to be noncompliance. That’s the reason most of us stop taking medications.”

A statement from Otsuka Pharmaceuticals and Proteus Digital Health, the companies that worked together to develop Abilify MyCite, stresses the digital pill technology has not been proven to improve compliance.

But according to Avitzur, the technology could help improve the communication between doctors and their patients. “The beauty of this kind of drug app is that physicians would potentially get an accurate understanding of what the patient is or isn’t taking,” Avitzur says. “Then we can have related conversations with patients, ask them if there’s a reason they’re not taking it."

"Of course, the patient would have to give us permission to monitor compliance first," she adds. "And this raises myriad ethical considerations such as informed consent, privacy issues, and data stewardship.”

According to Avitzur, if digital pills do eventually prove to help compliance, they could be helpful for patients with complicated health care regimens. “The more medications a person is on, the more difficult it is to comply properly with treatment, for example, taking the right pill at the right time," she says.

Privacy Concerns

Despite the potential benefits, privacy advocates have expressed concern about who could eventually get the health information from connected medical devices, and what might be done with it.

“I can certainly see the benefits for incapacitated patients who have trouble taking medicine on a timely basis,” says Justin Brookman director of consumer privacy and technology policy for Consumers Union, the policy and action arm of Consumer Reports. “But I worry that patients might be compelled to share this information with insurers or employers. Will premiums or employee contributions go up if you miss a dose, or if a signal isn't picked up?”

According to Otsuka and Proteus, patients opt in to the Abilify MyCite program, and can discontinue sharing some information from the system—or opt out altogether—at any time. They can also revoke data privileges for anyone else they’ve authorized via the mobile app.