Within the field of digital health, digital medicine is a category of pharmaceuticals which combines a prescription medication with an ingestible sensor component. Digital medicines are designed to communicate to mobile and/or web-based applications that a patient has taken a specific dose of medication at a certain time. Because of the ingestible sensor component and association with prescription pharmaceuticals, products in this category require regulatory oversight and clinical validation.
Differentiation from similar disciplines
Digital medicine is sometimes confused with similar disciplines, including the broader category of digital health, as well as digital therapeutics, another digital health subset. Digital health offerings use digital technologies to enhance human health in some capacity. Within this broader category, programs that include a prescription medication with an ingestible sensor component are considered digital medicines. By contrast, digital therapeutics are associated mainly with web-based health management tools and stand-alone health apps, generally without a prescription medication element.
The ingestible sensor component associated with digital medicines was originally approved in 2012 by the U.S. Food and Drug Administration (FDA) through the Center for Devices and Radiological Health via a de novo pathway for novel, low-risk medical devices. This approval has been accompanied by FDA 510(k) clearances. The ingestible sensor is CE marked in Europe. A New Drug Application for the first fully integrated pharmaceutical with ingestible sensor component, Otsuka Pharmaceutical's ABILIFY MYCITE® (aripiprazole with Proteus ingestible sensor), was approved by the FDA in November 2017.
With its approval of the digital pill, the FDA confirmed that the review of digital medicines includes assessment of the ingestible device component, and that no additional safety and efficacy data is required for the original pharmaceutical.
Digital medicines are being used for a variety of conditions in commercial and clinical settings. Medications with ingestible sensors are being prescribed in the treatment areas of hypertension, diabetes, hypercholesterolemia, heart failure, Hepatitis C, mental health, HIV, TB and organ transplantation.
In January 2016, Barton Health became the first institution to commercially offer digital medicines to patients with chronic medical conditions. In 2016, Children's Health in Dallas, Texas became the first to commercially use digital medicines with pediatric patients.
Bioethicists have expressed concerns around technologies that log and share information about patients’ medication-taking behavior. These concerns exist from the perspective of both individual and collective patient rights. However, proponents note that participation in digital medicine programs are voluntary, comply with all applicable laws and standards, and protect patient data in accordance with applicable state and federal privacy regulations, as with other data generated and stored in electronic medical records. Experts add that digital medicine programs show promise as a solution to medication adherence, and help physicians more accurately titrate dosages and determine how well the medication worked.
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