TT03 Digital Life Science

IT has progressed beyond promoting healthier behaviors and supporting medicine. Devices for monitoring enable at-will diagnosis and changes the way people engage medical care. IT involvement in genetic and cerebral disorders have also initiated research in incurable diseases and life extension.

Growing Role of IT in Healthcare

In September 2018, the Apple Watch Series 4 was released. This update increased the watch’s significance not only with performance improvement, but also in the field of healthcare. The reason is that advancement in heart rate sensors led to the U.S. Food and Drug Administration (FDA) approval of the watch’s sensors for electrocardiograms and detection of irregular heart rhythms, enabling users to monitor their own conditions. Traditionally, electrocardiograms were taken when patients noticed a change in heart rhythm and went to the hospital for observation. Other patients would be given a Holter monitor to wear to measure their activity, during which the symptom might not recur. Now patients can take their own electrocardiograms. A similar device that received FDA approval is a smartwatch that senses movement and electrical fluctuations in the skin to detect an epileptic seizure.

It is now becoming a reality for individually owned devices to detect certain physical conditions through regular monitoring. Moreover, an increase in the use of these devices will allow the continuous collection of physical activity logs and biological information, which in turn will enable the understanding of idiosyncratic, abnormal conditions increasing detection accuracy. In the near future, it will likely be possible to identify the factors that cause abnormalities and to use devices to detect pathological signs.

Next Generation Healthcare

Another significant change is occurring to the diagnostic equipment used in hospitals. While AI was used previously to assist physicians with diagnoses, in April 2018, the FDA approved the sale of equipment that uses AI for diagnosis without a physician. This particular AI diagnoses diabetic retinopathy. If it determines that retinopathy is present, it recommends a visit to an expert. If the AI finds that retinopathy is not present, it advises the patient to take another test within a year. Despite the need for a physician to provide final diagnostic verification, this approval by the FDA is expected to significantly change the role of AI in healthcare. More devices that enable diagnosis by AI only will become available in the future, transforming the physician’s role and potentially the structure of the healthcare industry.

Due to the increasing number of medical software programs, it is now inefficient to inspect the software every time it updates functions. As a result, in 2017, the FDA launched a pilot program called Digital Health Software Precertification. This pilot was launched to establish a system to streamline the inspection of medical software by precertifying companies that develop such software and simplifying the information submitted to the FDA. It is anticipated that this trend will further expand the participation of IT companies in the clinical realm.

Growing Hopes for Digital Medicine

The world’s dementia patient population is estimated to be 50 million in 2018 and predicted to reach 152 million by 20501. In 2018, however, a series of major pharmaceutical companies announced the discontinuation of dementia drug development. One factor influencing this decision is the long progression time of dementia, which necessitates study periods lasting several decades. Another factor is the lack of objective, quantitative indices for the assessment of drug efficacy as well as the need for costly, physician interviews to assess patients.

Given this situation, a new approach garnering attention is digital therapeutics, which is a non-drug treatment that works by combining software and devices. While there are no radical therapies established for dementia, there are symptomatic therapies that slow its progression by recalling past experiences and memories. One hypothesis is that the memory itself is not lost, but that access to the memory is disabled for patients with Alzheimer’s disease, which accounts for about 60% of the dementia population. If this hypothesis is correct, it might be possible to recover the access by repeatedly looking at past memories to help retrain the brain. To assist with this, a system is being developed that stores digital data about people, places, things and daily routines. This system would enable the automatic monitoring and evaluation of a patient’s condition using questions and games about past memories.

Digital therapeutics using video games is also under development to treat Attention-Deficit Hyperactivity Disorder (ADHD). This video game treatment is based on cognitive science that uses games to provide sensory and locomotor stimulation, thereby improving perceptual, visual and simultaneous execution. An experiment on more than 300 children reported that their attention ability improved using this therapy. Approval by the FDA would enable these treatments to be prescribed just like conventional drugs to patients.

By using technologies readily available in everyday life, digital therapeutics allow intervention not only in the ailments of patients, but also in their lifestyle habits and consciousness regardless of place and time. This means that patient adherence can be expected to improve as individuals become willing to actively and continuously receive therapies. Digital therapeutics and digital medicines also enable patients to share data with their physicians via digital devices. Accumulation of more data can lead to more effective therapeutic drugs, and the use of wearable devices will enable analysis that incorporates biological information. These possibilities will likely create the kind of healthcare that unifies prevention, diagnosis and therapy, while contributing to the control of social and monetary expenses.

1Alzheimer’s Disease International, London, World Alzheimer Report 2018

Digital Intervention in Gene and Brain Sciences

The power of digital technology is being extensively used in sciences related to the brain and genes. One of these technologies is a therapy that uses brain information in the form of neurofeedback. In the past, neurofeedback, which monitors the status of brain waves to train the brain, was used to treat ADHD and depression. In recent years, the emergence of low-cost headsets that measure brain waves and the permeation of smartphones have facilitated neurofeedback therapy using a mobile application, regardless of location.

Gene editing technology is also raising hopes in the treatment of intractable diseases. Such technology may assist in the diagnosis of diseases using blood, saliva and urine, and it has already been successful in detecting Zika and Dengue fever and other diseases. Requiring only a disposable test strip, gene editing technology can quickly diagnose a variety of diseases at low cost.

Biotechnology and digital technology is also being used to produce body parts. This method creates living tissues and organs by means of bio-inks, which are biomaterials that make up living cells and used by a 3D printer. For example, a portable 3D printer is being developed to build skin tissue layers to cover a wound. In addition, a study successfully produced a 3D-printed cornea and some companies are working on producing 3D-printed lungs. As a result of these advancements a day may come when all organs can be artificially created, overcoming the severe shortage of donors.

On the other hand, the birth of gene-edited babies is generating significant ethical and safety controversies. Any attempts to produce intellectually and/or physically enhanced children may result in widespread eugenics. Modification of bacteria and viruses could also be utilized to create new bioweapons. The ways in which society addresses such challenges, including the establishment of ethical guidelines and principles as well as countermeasures for threats, may hold the key to the resolution of life-related issues for humans.

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