Digital medicine

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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.

Contents

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, 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. [1] 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. [2]

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. [3] This approval has been accompanied by FDA 510(k) clearances. [3] The ingestible sensor is CE marked in Europe. [4] 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. [5]

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. [2]

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, diabetes, hypercholesterolemia, heart failure, Hepatitis C, mental health, HIV, TB and organ transplantation. [6] [7] [8]

In January 2016, Barton Health became the first institution to commercially offer digital medicines to patients with chronic medical conditions. [9] In 2016, Children's Health in Dallas, Texas became the first to commercially use digital medicines with pediatric patients. [10]

Ethical concerns

Bioethicists have expressed concerns around technologies that log and share information about patients’ medication-taking behavior. [11] 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. [12] 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. [13]

Related Research Articles

<span class="mw-page-title-main">Over-the-counter drug</span> Medication available without a prescription

Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.

<span class="mw-page-title-main">Pharmacy</span> Clinical health science

Pharmacy is the science and practice of discovering, producing, preparing, dispensing, reviewing and monitoring medications, aiming to ensure the safe, effective, and affordable use of medicines. It is a miscellaneous science as it links health sciences with pharmaceutical sciences and natural sciences. The professional practice is becoming more clinically oriented as most of the drugs are now manufactured by pharmaceutical industries. Based on the setting, pharmacy practice is either classified as community or institutional pharmacy. Providing direct patient care in the community of institutional pharmacies is considered clinical pharmacy.

Prescription drug list prices in the United States continually rank among the highest in the world. The high cost of prescription drugs became a major topic of discussion in the 21st century, leading up to the American health care reform debate of 2009, and received renewed attention in 2015. One major reason for high prescription drug prices in the United States relative to other countries is the inability of government-granted monopolies in the American health care sector to use their bargaining power to negotiate lower prices, and the American payer ends up subsidizing the world's R&D spending on drugs.

<span class="mw-page-title-main">Prescription drug</span> Medication legally requiring a medical prescription before it can be dispensed

A prescription drug is a pharmaceutical drug that is permitted to be dispensed only to those with a medical prescription. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.

Many countries have measures in place to limit advertising by pharmaceutical companies.

eHealth describes healthcare services which are supported by digital processes, communication or technology such as electronic prescribing, Telehealth, or Electronic Health Records (EHRs). The use of electronic processes in healthcare dated back to at least the 1990s. Usage of the term varies as it covers not just "Internet medicine" as it was conceived during that time, but also "virtually everything related to computers and medicine". A study in 2005 found 51 unique definitions. Some argue that it is interchangeable with health informatics with a broad definition covering electronic/digital processes in health while others use it in the narrower sense of healthcare practice using the Internet. It can also include health applications and links on mobile phones, referred to as mHealth or m-Health.

<span class="mw-page-title-main">Off-label use</span> Use of pharmaceuticals for conditions different from that for which they were approved

Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.

In medicine, patient compliance describes the degree to which a patient correctly follows medical advice. Most commonly, it refers to medication or drug compliance, but it can also apply to other situations such as medical device use, self care, self-directed exercises, or therapy sessions. Both patient and health-care provider affect compliance, and a positive physician-patient relationship is the most important factor in improving compliance. Access to care plays a role in patient adherence, whereby greater wait times to access care contributing to greater absenteeism. The cost of prescription medication also plays a major role.

A Patient Safety Organization (PSO) is a group, institution, or association that improves medical care by reducing medical errors. Common functions of patient safety organizations are data collection, analysis, reporting, education, funding, and advocacy. A PSO differs from a Federally designed Patient Safety Organization (PSO), which provides health care providers in the U.S. privilege and confidentiality protections for efforts to improve patient safety and the quality of patient care delivery

In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis is the assessment that a particular [medical] condition is present while an indication is a reason for use. The opposite of an indication is a contraindication, a reason to withhold a certain medical treatment because the risks of treatment clearly outweigh the benefits.

<span class="mw-page-title-main">First Databank</span>

First Databank (FDB) is a major provider of drug and medical device databases that help inform healthcare professionals to make decisions. FDB partners with information system developers to deliver useful medication- and medical device-related information to clinicians, business associates, and patients. FDB is part of Hearst and the Hearst Health network.

mHealth Medicine and public health supported by mobile devices

mHealth is an abbreviation for mobile health, a term used for the practice of medicine and public health supported by mobile devices. The term is most commonly used in reference to using mobile communication devices, such as mobile phones, tablet computers and personal digital assistants (PDAs), and wearable devices such as smart watches, for health services, information, and data collection. The mHealth field has emerged as a sub-segment of eHealth, the use of information and communication technology (ICT), such as computers, mobile phones, communications satellite, patient monitors, etc., for health services and information. mHealth applications include the use of mobile devices in collecting community and clinical health data, delivery/sharing of healthcare information for practitioners, researchers and patients, real-time monitoring of patient vital signs, the direct provision of care as well as training and collaboration of health workers.

Medication costs, also known as drug costs are a common health care cost for many people and health care systems. Prescription costs are the costs to the end consumer. Medication costs are influenced by multiple factors such as patents, stakeholder influence, and marketing expenses. A number of countries including Canada, parts of Europe, and Brazil use external reference pricing as a means to compare drug prices and to determine a base price for a particular medication. Other countries use pharmacoeconomics, which looks at the cost/benefit of a product in terms of quality of life, alternative treatments, and cost reduction or avoidance in other parts of the health care system. Structures like the UK's National Institute for Health and Clinical Excellence and to a lesser extent Canada's Common Drug Review evaluate products in this way.

Electronic prescription is the computer-based electronic generation, transmission, and filling of a medical prescription, taking the place of paper and faxed prescriptions. E-prescribing allows a physician, physician assistant, pharmacist, or nurse practitioner to use digital prescription software to electronically transmit a new prescription or renewal authorization to a community or mail-order pharmacy. It outlines the ability to send error-free, accurate, and understandable prescriptions electronically from the healthcare provider to the pharmacy. E-prescribing is meant to reduce the risks associated with traditional prescription script writing. It is also one of the major reasons for the push for electronic medical records. By sharing medical prescription information, e-prescribing seeks to connect the patient's team of healthcare providers to facilitate knowledgeable decision making.

Digital health is a discipline that includes digital care programs, technologies with health, healthcare, living, and society to enhance the efficiency of healthcare delivery and to make medicine more personalized and precise. It uses information and communication technologies to facilitate understanding of health problems and challenges faced by people receiving medical treatment and social prescribing in more personalised and precise ways. The definitions of digital health and its remits overlap in many ways with those of health and medical informatics.

<span class="mw-page-title-main">Health information on the Internet</span>

Health information on the Internet refers to all health-related information communicated through or available on the Internet.

Specialty drugs or specialty pharmaceuticals are a recent designation of pharmaceuticals classified as high-cost, high complexity and/or high touch. Specialty drugs are often biologics—"drugs derived from living cells" that are injectable or infused. They are used to treat complex or rare chronic conditions such as cancer, rheumatoid arthritis, hemophilia, H.I.V. psoriasis, inflammatory bowel disease and hepatitis C. In 1990 there were 10 specialty drugs on the market, around five years later nearly 30, by 2008 200, and by 2015 300.

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 results inclusive of clinically meaningful outcomes in peer-reviewed journals. The treatment relies on behavioral and lifestyle changes usually spurred by a collection of digital impetuses. Because of the digital nature of the methodology, data can be collected and analyzed as both a progress report and a preventative measure. Treatments are being developed for the prevention and management of a wide variety of diseases and conditions, including type 1 & type II diabetes, congestive heart failure, obesity, Alzheimer's disease, dementia, asthma, substance abuse, ADHD, hypertension, anxiety, depression, and several others. Digital therapeutics often employ strategies rooted in cognitive behavioral therapy.

A digital pill 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 pill, as well as the data transmitted by the pill's sensor, are considered to be part of digital medicine. The purpose of the sensor is to determine whether the person is taking their medication or not. There are privacy concerns with respect to who receives the data and what is done with it.

<span class="mw-page-title-main">Drug labelling</span>

Drug labelling is also referred to as prescription labelling, is a written, printed or graphic matter upon any drugs or any of its container, or accompanying such a drug. Drug labels seek to identify drug contents and to state specific instructions or warnings for administration, storage and disposal. Since 1800s, legislation has been advocated to stipulate the formats of drug labelling due to the demand for an equitable trading platform, the need of identification of toxins and the awareness of public health. Variations in healthcare system, drug incidents and commercial utilization may attribute to different regional or national drug label requirements. Despite the advancement in drug labelling, medication errors are partly associated with undesirable drug label formatting.

References

  1. ↑ "Definition of Digital Health - Paul Sonnier". Paul Sonnier - Story of Digital Health. Retrieved 2018-04-27.
  2. 1 2 Michie, Susan; Yardley, Lucy; West, Robert; Patrick, Kevin; Greaves, Felix (2017-06-29). "Developing and Evaluating Digital Interventions to Promote Behavior Change in Health and Health Care: Recommendations Resulting From an International Workshop". Journal of Medical Internet Research. 19 (6): e232. doi: 10.2196/jmir.7126 . ISSN   1438-8871. PMC   5509948 . PMID   28663162.
  3. 1 2 "EVALUATION OF AUTOMATIC CLASS III DESIGNATION (DE NOVO) FOR PROTEUS PERSONAL MONITOR INCLUDING INGESTION EVENT MARKER" (PDF). FDA.gov.
  4. ↑ "Qualification opinion on ingestible sensor system for medication adherence as biomarker for measuring patient adherence to medication in clinical trials" (PDF). European Medicines Agency. Feb 2, 2016. Retrieved April 27, 2018.
  5. ↑ Commissioner, Office of the. "Press Announcements - FDA approves pill with sensor that digitally tracks if patients have ingested their medication". www.fda.gov. Retrieved 2018-04-27.
  6. ↑ Frias, Juan; Virdi, Naunihal; Raja, Praveen; Kim, Yoona; Savage, George; Osterberg, Lars (2017-07-11). "Effectiveness of Digital Medicines to Improve Clinical Outcomes in Patients with Uncontrolled Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-Randomized Pilot Clinical Trial". Journal of Medical Internet Research. 19 (7): e246. doi: 10.2196/jmir.7833 . ISSN   1439-4456. PMC   5527253 . PMID   28698169.
  7. ↑ Holly, Robert. "This 'smart pill' can help Rush patients remember their meds". chicagotribune.com. Retrieved 2018-07-05.
  8. ↑ "This digital pill wants to make following your prescription easier". PBS NewsHour. 2018-05-23. Retrieved 2018-07-05.
  9. ↑ MD, Robert Glatter. "Barton Health First To Offer New Digital Medicine Developed By Proteus Digital Health". Forbes. Retrieved 2018-07-05.
  10. ↑ "Children's Health Dallas testing 'digitized drugs' with sensors inside". Dallas News. 2016-08-19. Retrieved 2018-07-05.
  11. ↑ Belluck, Pam (2017-11-13). "First Digital Pill Approved to Worries About Biomedical 'Big Brother'". The New York Times. ISSN   0362-4331 . Retrieved 2018-04-27.
  12. ↑ "Digital Pill That Tracks Use When Swallowed Gets FDA Approval". Bloomberg.com. 2017-11-14. Retrieved 2018-04-27.
  13. ↑ "The Digital Pill Era Is Here—And It Could Help Solve a $300 Billion Health Care Problem". Fortune. Retrieved 2018-04-27.
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