FDA approves first ‘digital’ pill that tracks when it was swallowed

The FDA approved the first digital pill that tracks if and when patients have taken their medication. This digital ingestion tracking system is meant to track if mentally ill patients take their medicine.

And of all the possible places to start, the FDA approved this for a drug that can be used to treat schizophrenia, which can cause acute paranoia without the addition of a medication being tracked when it is swallowed.

The drug is Abilify MyCite. In addition to treating schizophrenia, it can be used to treat bipolar I disorder and can be used as an add-on to treat depression. Oddly enough, even though the FDA approved a drug with a digital ingestion tracking system for the first time, the agency noted, “The ability of the product to improve patient compliance with their treatment regimen has not been shown. Abilify MyCite should not be used to track drug ingestion in ‘real-time’ or during an emergency because detection may be delayed or may not occur.”

How secure is the digital prescription tracking system?

The entire digital medical system is made up for four parts: the Abilify MyCite pill, a MyCite patch, the MyCite app and a web-based portal. None of the press releases delved into the security of those moving parts or mentioned if pen testers have been allowed to look for security holes in the app or web-based portal.

The Abilify pill includes an embedded ingestible senor that is the size of a grain of sand. After the Ingestion Event Marker (IEM) sensor hits stomach fluids, it generates a timestamped ID signal and sends a message to a wearable patch that the medication was taken. The patch, which is meant to be worn on the left rib cage and must be replaced once a week, wirelessly sends the recorded date and time to the mobile MyCite app.

The point of this whole system is to ensure patients take their medicine. However, according to the infographic included in the press release, “It can take 30 minutes to two hours to detect ingestion of the tablet. Sometimes the system might not detect that the medication has been taken. If the MyCite app does not indicate that the Abilify MyCite tablet was taken, do not repeat the dose.”

The percentage of times the pill-tracking system might fail was not mentioned, but if a paranoid person would agree to take the “digital” pills, it doesn’t seem like it would be helpful for the “proof” of taking the medication to disappear.

The MyCite app can also record activity level, as well as allow the patient to add details about their mood and quality of rest. It should be noted that the FDA approved only the drug tracking ingestion functionality of the app.

Access to the pill-tracking data

Via the app, the patient chooses with whom they want to share the ability to track their pill-taking. The patient can grant or deny permissions about who can access the information at any time. Approved doctors, care givers and family can access the pill-tracking information through a web-based portal. The ability to use the app to instantly yank permissions about who can see some or all of the data is meant to address privacy concerns.

Not much information is given about the online access portal. Otsuka Pharmaceutical, which makes the Abilify pills, and Proteus Digital Health, which is responsible for the sensor embedded in the pills, described the portal only by saying, “Secure web-based dashboards give the healthcare provider access to medication ingestion patterns over time. With patient consent, it can allow selected members of the care team and family to view the patient’s shared data. The hope is to provide additional clarity to better inform physicians and their patients.”

Biomedical Big Brother

As Dr. Jeffrey Lieberman, chairman of psychiatry at Columbia University and New York-Presbyterian Hospital, pointed out to The New York Times, though, “There’s an irony in it being given to people with mental disorders that can include delusions. It’s like a biomedical Big Brother.”

Otsuka said it did not intend for the digital medical system to be used for coercion, for any circumstances in which a patient might somehow be forced to take pills that digitally track if medication is taken or else.

However, Lucia Savage, a former privacy officer at the Department of Human and Health Services, told Bloomberg that the pill monitoring system “creates a looking-over-your-shoulder effect.” And since information about mental illness is especially sensitive, she suggested that patients and doctors ask question such as, “How is the data flowing? Where does the signal go? If it goes to somebody’s server, whose server is that? What are the business arrangements?”