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used in consumer smart wearables has not been certified or validated independently. Only 1 in 10 technologies has been validated with clinical research. Therefore, quality of data smart consumer wearables is debatable and interpretation of such data is questionable [12]. In contrast, clinical- or medical-grade wearables are approved or certified by health regulatory authorities like the FDA and are used with the advice of healthcare professionals or on prescription of a doctor. Accuracy of these devices can enable diagnosis and management of diseases.
1.3.2 Clinical-Grade Wearables
Medical-grade or clinical-grade wearables are those certified by the regulatory authorities like FDA for use by healthcare professionals. They can be used at home or in a clinic or hospital and expected to improve quality of life in chronic diseases and reduce the cost of long-term care.
With advances in technology, consumer wearables are slowly moving to the accuracy of medical-grade devices. A study by the Stanford University using the Apple watch with 4lac users showed that atrial fibrillation could be detected in accurately to a high degree. The users were alerted about the arrhythmia by the smart watch and resulted in half of them consulting a doctor [13]. But this study was not ideal as it was not controlled and subjects were not randomized [14]. Increasing number of high quality Medical-grade wearables are slowly turning the focus of smart wearables from fitness and activity trackers to clinical-grade devices which can be used by medical professionals [15]. The Apple Watch 4 has a medical-grade sensor approved by the FDA [16].
Current Health (Edinburgh, Scotland) has created a wireless AI device for monitoring patients in hospital and also at home. This device monitors patient’s vital parameters like pulse rate, respiratory rate, oxygen saturation, temperature, and patient mobility. It provides doctors with continuous data regarding health of their patient in real time. Current Health uses machine learning for analysis of this data and generates useful information and detect any significant changes [17]. An insertable cardiac monitor named Confirm Rx developed by Abbott healthcare can monitor ECG continuously for up to 2 years and can connect to a smartphone app (myMerlin) wirelessly through Bluetooth. It can also automatically send information to the doctor who can correlate symptoms with the heart rhythm [18]. Wrist-worn wearable devices as developed by researchers at the University of Michigan can also can detect circulating cancer cells in the blood, thereby revolutionizing cancer care [19].
A wearable cardiac defibrillator (WCD) is a portable device which is worn on the body and can deliver life saving shocks to terminate life-threatening ventricular arrhythmias. This can be used in lieu of an implantable cardioverter defibrillator (ICD) in patients who are not candidates for an ICD or early after a Myocardial infarction or are on the cardiac transplant list. In a study on uninsured patients with ischemic or nonischemic cardiomyopathy, WCD was shown to prevent unnecessary ICD implants in the subgroup of patients whose cardiac function subsequently improves following recovery thereby saving costs [20]. WCD can also be used in patients who are at high risk of ventricular arrhythmias and sudden cardiac death early after myocardial infarction. In a study of more than 8000 patients who had a WCD, 1.6% received shocks and 91% were revived from a cardiac arrhythmia. There was high rate of successful shock resulting in survival of 84%–95% of patients who received shocks [21]. WCD can also reduce the implantation rate of ICD in patients with heart failure who are diagnosed with cardiomyopathy, listed for transplant or on inotropic support. In a study on 89 patients with congestive heart failure with the above criteria, it was seen that 34% received an ICD, while 41.5% patients improved with a WCD who would have otherwise received an ICD [22].
Wearable waterproof sensors can also monitor the electrolytes in sweat and can analyze an athlete even underwater and monitor state of hydration and need for electrolytes. This can help enhance athletes performance [23]. Data from devices monitoring the mechanics of walking and the speed, symmetry of gait, and the length of stride can predict the development Alzheimer’s disease in patients. Patients can be monitored remotely by such mobile devices [24].
1.4 Smart Pills
Smart pills are medications that have minute sensors incorporated inside which can be ingested and can be used to monitor patient compliance. The sensors are activated by the acid in the stomach and connect to a smart wearable device which relays data to a smartphone application. The Abilify MyCite was a revolutionary smart pill which ultimately failed commercially. This contained aripiprazole (Abilify, Otsuka Pharmaceuticals) an antipsychotic medication used in psychiatric disorders like schizophrenia and was approved by the FDA in 2017 [25]. It incorporated the Proteus ingestible event marker (IEM) made from dietary minerals in very small quantities. The integrated circuit is the size of a grain of sand and is embedded in each medication tablet [26]. Activation of the sensor results in emission of a signal to the tablet computer indicating successful ingestion of the medication and ticks the checklist for dosing along with the time of ingestion. This ensures that the elderly are compliant with much needed medications. But the smart pill also necessitates wearing a smart device using a tablet computer which the elderly may find difficult. This smart pill was supposed to revolutionize medication dosage but the company Proteus Digital Health ran into financial troubles and filed for bankruptcy in 2020 after being unable to find funds due to the COVID-19 crisis after the drug major Otsuka pharmaceutical withdrew financial support from the project [27]. This may indicate that smart pills may not be financially viable despite their promise of technology and medicine merging to offer better compliance [28].
Studies of medications with sensors in chronic diseases like diabetes and hypertension demonstrate that digital health improves compliance by reminding patients to take their dose of medication at the appropriate time and also improve medication safety [29]. Newer ingestible or injectable nanosensors may one day be the early warning systems for diseases. But such embedded wearables also raise legal and ethical issues regarding privacy and security. An implantable chip containing medical records of a patient which were implanted in some Alzheimer’s patients in 2002 raised several issues resulting in banning of forced implants resulting in the technology being shelved [30].
1.5 Reduction of Hospital-Acquired Infections
Control of hospital-acquired infections is very important in hospital setting and hand hygiene plays a vital role. The monitoring of compliance to hand hygiene practices has been automated by AeroScout solution by Stanley Healthcare which monitors hand washing by each staff and can identify breaks in infection control practices. This can potentially save billions of dollars spent in combating hospital-acquired infections every year [31]. In a study which compared automated hand hygiene compliance system with human observers, it was found that automated system collected better data and resulted in compliance goals being met although the reduction in hospital-acquired infections was not significant [32]. Automated compliance systems have also resulted in better health for the hospital staff resulting in less employee absenteeism [33].
1.5.1 Navigation Apps for Hospitals
Patients getting lost in huge hospital complexes result in thousands of cancelled appointments and millions of dollars in cost in big hospitals. Data from the National Health Service from the UK in 2013 shows that about 7 million appointments were messed every year due to visitors and patients losing their way in and around hospitals [34]. In a study at the University of Nottingham, all junior doctors reported to have got lost on the way to in an emergency and crucial time was wasted [35]. Children’s Hospital Boston has developed a GPS-based app named MyWay which guides patients and even staff to their location in the shortest way and has reduced stress for visitors and patients in navigating through the hospital [36]. There is a need for the healthcare facilities to plan configuration of design and use technology and characteristics of future users in developing navigation facilities in healthcare centers with special emphasis on people who are challenged visually or cognitively with a need to develop a universal symbol system for healthcare [37].
1.6 In-Home Segment
Technology can also be used to increase the rapidity of emergency response