New FDA Approved Digital Pill Raises Ethical Concerns

On November 13, 2017, the Food and Drug Administration approved its first digital pill.

Abilify MyCite is the first drug with a digital ingestion tracking system on the market. The embedded sensor records if and when the prescribed medication is taken. It does this by sending a message from the sensor to a wearable patch. The patch then transmits the data to a mobile application, where the physician and individuals designated by the patient, can access the information electronically.

The original drug, Abilify, is an anti-psychotic prescribed to individuals with schizophrenia, bipolar disorder, and as an add-on treatment for adult depression. Many patients with these conditions do not comply with their treatment plans, leading to severe consequences and significant avoidable costs. The approval signifies a new era in the development of digital health technologies, to address the issue of medication nonadherence. Medication nonadherence costs the United States healthcare system almost $100 billion dollars annually. Considering the current rates of nonadherence, digital pills could lead to significant cost savings from improved outcomes.

The development of digital medication holds much promise for improving population health and well-being. However, it also raises equally important ethical and regulatory concerns regarding patient rights, as well as data privacy and security. One of the major debates surrounding Abilify MyCite’s approval is regarding informed consent. Many physicians have expressed that the patient population, which may be distrustful or experiencing paranoia, might not be as receptive to the idea. They might be coerced into treatment by caregivers or family, without true consent. It is also widely acknowledged that there are significant risks to patient privacy, when passively collecting sensitive health data. With advancements in digital technologies, comes the need for tools to minimize risks.

The Connected and Open Research Ethics (CORE) Project at the University of California San Diego is tackling these ethical and regulatory issues in digital health. CORE is a growing network of over 450 researchers, technologists and ethicists who are shaping ethical best practices for digital health research. These include the aforementioned issues of confidentiality, privacy and security raised by Abilify MyCite’s approval. If you are not a member already, visit www.thecore.ucsd.edu to join today and engage with digital health leaders across sectors!

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