Digital medicine refers to the application of advanced digital technologies, such as artificial intelligence, machine learning, and big data analytics, to improve patient outcomes and healthcare delivery. It involves the integration of technology and medicine to facilitate the creation, storage, analysis, and dissemination of health information, with the aim of enhancing clinical decision-making, improving patient care, and reducing costs. Digital medicine encompasses a wide range of disciplines, including techbio, healthtech, and biomedical engineering. It involves the use of digital tools and platforms to collect, store, and analyze patient data, including electronic health records, genomic data, and medical imaging. This data can then be used to develop new analytics and treatment approaches, personalize healthcare interventions, and optimize healthcare delivery. Digital medicine is evidence-based, and its approach is rooted in rigorous scientific research and clinical evidence. It is designed to augment and complement traditional medical practices, providing physicians and other healthcare professionals with the tools and resources they need to make more informed decisions and provide better care to patients.

Differentiation from similar disciplines

Digital medicine is sometimes confused with similar disciplines, including the broader category of digital health, as well as

digital therapeutics Digital therapeutics, a subset of digital health, are evidence-based therapeutic interventions driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. Digital therapeutic companies should publish trial re ...

, another digital health subset. Digital health offerings use digital technologies to enhance human health in some capacity but often lacking the required evidence base to qualify as digital medicine. 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.

Approval pathways

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 A digital pill (also known as smart pill, ingestible sensor) is a pharmaceutical dosage form that contains an ingestible sensor inside of a pill. The sensor begins transmitting medical data after it is consumed. The technology that makes up the pil ...

, 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.

Indications

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 Hypertension (HTN or HT), also known as high blood pressure (HBP), is a long-term medical condition in which the blood pressure in the arteries is persistently elevated. High blood pressure usually does not cause symptoms. Long-term high bl ...

diabetes Diabetes, also known as diabetes mellitus, is a group of metabolic disorders characterized by a high blood sugar level ( hyperglycemia) over a prolonged period of time. Symptoms often include frequent urination, increased thirst and increased ap ...

, hypercholesterolemia,

heart failure Heart failure (HF), also known as congestive heart failure (CHF), is a syndrome, a group of signs and symptoms caused by an impairment of the heart's blood pumping function. Symptoms typically include shortness of breath, excessive fatigue, a ...

Hepatitis C Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV) that primarily affects the liver; it is a type of viral hepatitis. During the initial infection people often have mild or no symptoms. Occasionally a fever, dark urine, a ...

mental health Mental health encompasses emotional, psychological, and social well-being, influencing cognition, perception, and behavior. It likewise determines how an individual handles stress, interpersonal relationships, and decision-making. Mental health ...

HIV The human immunodeficiency viruses (HIV) are two species of ''Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune ...

, 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.

Ethical concerns

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.

References

{{reflist Drug delivery devices Health informatics