By Gabrielle King
With all of the increasing technological advancements, there is now a new pill that can help patients adhere to their medication regimen by sending certain data to their health care providers. Specifically, on November 13, 2017, the Food and Drug Administration approved the “digital pill” named Abilify MyCite. See Mary Beth Quirk, New Digital Pill Tracks When You Swallow It, Consumer Reports (Nov. 14, 2017). This pill contains a sensor and a type of tracking device that can detect when the pill has been swallowed by an individual. As beneficial as this new pill may sound to some, there are also concerns about using this type of technology that may be considered intrusive.
It is well known that adhering to medication is a common problem facing health care professionals today. Although there are many reasons why a patient may not strictly comply with their drug regimens, in many cases, it can be extremely important to fully comply with doctor’s orders. In addition, when patients do not take their medicine as prescribed, it leads to more costs and expenses overall as they are likely to require more treatment in the future. Abilify MyCite was developed mainly to address individuals suffering from certain mental illnesses such as schizophrenia and bipolar disorder. There may be unwanted and unpleasant side effects when taking medication used to treat these mental illnesses, and therefore, patients may see this as a reason to stop taking their medication on a regular basis as ordered by their doctor. This digital pill was developed with the hopes of being able to ensure that patients suffering from these illnesses are taking their medication as prescribed. See Matthew Perrone, U.S regulators approve first digital pill to track patients, The Daily News (Nov. 21, 2017).
How does this digital pill work? The patient needs to have a cellular device with a specific mobile app and a wearable “patch” with sensors. After a patient swallows the pill that contains the tracking device and it comes into contact with their stomach contents, it sends a message to the wearable patch. The patch, in turn, sends data to the mobile app such as the date and time of ingestion. Allegedly, the patient may consent to share this data with other individuals and their health care providers by allowing them to access this information. Doctors would now have the ability to see, firsthand, if patients are taking their medication or not by monitoring them through this new technology.
Evidently, there are privacy concerns raised by this new technology. The two companies that developed Abilify MyCite, Otsuka Pharmaceuticals and Proteus Digital Health, have stated that patients have the option to “opt out” of this data sharing at any time. However, while data is actively being shared to health care providers or others, there is concern that other entities or individuals could gain access to this personal information. In addition, if doctors do happen to notice that their patient is not taking their medication, how should the doctors proceed? Will this promote communication between patient and doctor, or could the patient see this as a coercive tool? Another potential issue is competence and consent, specifically when dealing with mental illnesses such as schizophrenia and bipolar disorder. It is clear that patients would need to be lucid, fully competent, and understand what this digital pill technology actually does before consenting to allow others to access and share this personal information.
There are individuals who see this as unnecessarily intrusive, and would feel uncomfortable allowing doctors to monitor the date and time that they ingest a pill. However, it is also possible that this digital pill may become popular and widely used among patients who are looking to stay on track and take their pills as scheduled. It will be important to track usage and follow up to see if this new medical technology is effective in improving compliance with drug regimens.
Student Bio: Gabrielle is a Book Review Editor on the Journal of High Technology Law. She is currently a 3L at Suffolk University Law School. She holds a B.A. in Politics and Law from Bryant University.
Disclaimer: The views expressed in this blog are the views of the author alone and do not represent the views of JHTL or Suffolk University Law School.