Digital health, which includes digital care programs, is the convergence of digital technologies with health, healthcare, living, and society to enhance the efficiency of healthcare delivery and make medicine more personalized and precise. The discipline involves the use of information and communication technologies to help address the health problems and challenges faced by people under treatment. These technologies include both hardware and software solutions and services, including telemedicine, web-based analysis, email, mobile phones and applications, text messages, wearable devices, and clinic or remote monitoring sensors. Generally, digital health is concerned about the development of interconnected health systems to improve the use of computational technologies, smart devices, computational analysis techniques, and communication media to aid healthcare professionals and their clients manage illnesses and health risks, as well as promote health and wellbeing. Digital health is a multi-disciplinary domain involving many stakeholders, including clinicians, researchers and scientists with a wide range of expertise in healthcare, engineering, social sciences, public health, health economics and data management.
Elements
As an outgrowth of the Digital Revolution characterized by "the mass production and widespread use of digital logic circuits, and its derived technologies, including the computer, digital cellular phone, and the Internet," key elements of digital health include wireless devices, hardware sensors and software sensing technologies, microprocessors and integrated circuits, the Internet, social networking, mobile/cellular networks and body area networks, health information technology, genomics, and personal genetic information.
National digital programs exist to support healthcare, such as those of Canada Health Infoway built on core systems of patient and provider registries, clinical and diagnostic imaging systems, clinical reports and immunizations. By 2014, 75% of Canadian physicians were using electronic medical records. In Uganda and Mozambique, partnerships between patients with cell phones, local and regional governments, technologists, non-governmental organizations, academia, and industry have enabled mHealth solutions. In the United Kingdom, the National Health Service has commissioned a report on how to integrate digital healthcare technologies into the next generation of medicine. The "Topol Review" recommended an expansion of education for both patients and providers of next-generation technologies such as Whole Genome Sequencing, and has also created Digital Fellowships for health professionals. On the other hand, the implementation of these innovations has also brought to light societal risks and regulatory needs, which are certainly challenging the current governance structures in the health sector.
Innovation cycle
The innovation process for digital health is an iterative cycle for technological solutions that can be classified into five main activity processes from the identification of the healthcare problem, research, digital solution, and evaluating the solution, to implementation in working clinical practices. Digital health may incorporate methods and tools adopted by software engineering, such as design thinking and agile software development. These commonly follow a user-centered approach to design, which are evaluated by subject-matter experts in their daily life using real-world data.
U.S. Food and Drug Administration
In 2019, the FDA published a Digital Health Innovation Action Plan that would reduce inefficiencies for physicians in an effort to cut overhead costs, improve access, increase quality of service, and make medicine more easily adapted for each person. Topics within the innovation plan are wireless devices, telemedicine, software, and cybersecurity, among others. According to FDA guidelines, if you release an app designed to help someone with a medical condition then that is considered a medical device. The FDA cannot regulate all healthcare apps, so they use “enforcement discretion,” and up until 2020, have chosen not to regulate all digital care programs and apps. However, programs that use the word treatment, seek to diagnose or treat a condition, or are deemed unsafe, are and will be regulated by the FDA. During the COVID-19 pandemic, regulations and enforcement of digital psychiatry apps were relaxed to facilitate use and reduce in-person contact.
Digital healthcare has been a major focus of American healthcare policy after the passage of the Affordable Care Act and HITECH Act. This has resulted in an explosion in the number of physicians who interface with digital healthcare tools known as Electronic Medical Records. However, physicians are highly critical of the utility of EMRs for patient care, and point to their rising use as a significant component in physician burnout.
At the global level, the implementation of digital health solutions depends on large data systems, ranging from vital statistics that record every birth and death to more sophisticated systems that track diseases, outbreaks, and chronic conditions. More specifically, data is patient records, blood test results, EKGs, MRIs, billing records, drug prescriptions, and other private medical information. These are the information medical professionals need to make decisions about patient care. In this sense, a crucial debate has arisen amongst stake-holders about one of the challenges imposed by these solutions: the ownership of health data. In most cases, governments and big data and tech companies are holding citizens’ information, leaving an imminent preoccupation with transparency and privacy.
