JMIR Biomedical Engineering

Many commodity pulse oximeters are insufficiently calibrated for patients with darker skin. We demonstrate a quantitative measurement of this disparity in peripheral blood oxygen saturation (SpO₂) with a controlled experiment. To mitigate this, we present OptoBeat, an ultra–low-cost smartphone-based optical sensing system that captures SpO₂ and heart rate while calibrating for differences in skin tone. Our sensing system can be constructed from commodity components and 3D-printed clips for approximately US $1. In our experiments, we demonstrate the efficacy of the OptoBeat system, which can measure SpO₂ within 1% of the ground truth in levels as low as 75%.

Lung cancer is the world’s leading cause of cancer deaths, and diagnosis remains challenging. Lung cancer starts as small nodules; early and accurate diagnosis allows timely surgical resection of malignant nodules while avoiding unnecessary surgery in patients with benign nodules.

Advances in mobile phone technologies coupled with the availability of modern wireless networks are beginning to have a marked impact on digital health through the growing array of apps and connected devices. That said, limited deployment outside of developed nations will require additional approaches to collectively reach the 8 billion people on earth. Another consideration for development of digital health centered around mobile devices lies in the need for pairing steps, firmware updates, and a variety of user inputs, which can increase friction for the patient. An alternate, so-called Beyond the Mobile approach where medicaments, devices, and health services communicate directly to the cloud offers an attractive means to expand and fully realize our connected health utopia. In addition to offering highly personalized experiences, such approaches could address cost, security, and convenience concerns associated with smartphone-based systems, translating to improved engagement and adherence rates among patients. Furthermore, connecting these Internet of Medical Things instruments through next-generation networks offers the potential to reach patients with acute needs in nonurban regions of developing nations. Herein, we outline how deployment of Beyond the Mobile technologies through low-power wide-area networks could offer a scalable means to democratize digital health and contribute to improved patient outcomes globally.

The COVID-19 pandemic has illuminated multiple challenges within the health care system and is unique to those living with chronic conditions. Recent advances in digital health technologies (eHealth) present opportunities to improve quality of care, self-management, and decision-making support to reduce treatment burden and the risk of chronic condition management burnout. There are limited available eHealth models that can adequately describe how this can be carried out. In this paper, we define treatment burden and the related risk of affective burnout; assess how an eHealth enhanced Chronic Care Model can help prioritize digital health solutions; and describe an emerging machine learning model as one example aimed to alleviate treatment burden and burnout risk. We propose that eHealth-driven machine learning models can be a disruptive change to optimally support persons living with chronic conditions.

Modern environmental health research extensively focuses on outdoor air pollutants and their effects on public health. However, research on monitoring and enhancing individual indoor air quality is lacking. The field of exposomics encompasses the totality of human environmental exposures and its effects on health. A subset of this exposome deals with atmospheric exposure, termed the “atmosome.” The atmosome plays a pivotal role in health and has significant effects on DNA, metabolism, skin integrity, and lung health.

Software as a medical device (SaMD) has gained the attention of medical device regulatory bodies as the prospects of standalone software for use in diagnositic and therapeutic settings have increased. However, to date, figures related to SaMD have not been made available by regulators, which limits the understanding of how prevalent these devices are and what actions should be taken to regulate them.

The majority of medications used in treating asthma and chronic obstructive pulmonary disease (COPD) are taken through metered-dose inhalers (MDIs). Studies have reported that most patients demonstrate poor inhaler technique, which has resulted in poor disease control. Digital Health applications have the potential to improve the technique and adherence of inhaled medications.

The COVID-19 pandemic has demonstrated the possibility of severe ventilator shortages in the near future.

Mindfulness-based stress reduction has demonstrated some efficacy for chronic pain management. More recently, virtual reality (VR)–guided meditation has been used to assist mindfulness-based stress reduction. Although studies have also found electroencephalograph (EEG) changes in the brain during mindfulness meditation practices, such changes have not been demonstrated during VR-guided meditation.

Transcranial magnetic stimulation (TMS), when applied over the primary motor cortex, elicits a motor-evoked potential (MEP) in electromyograms measured from peripheral muscles. MEP amplitude has often been observed to fluctuate trial to trial, even with a constant stimulus. Many factors cause MEP fluctuations in TMS. One of the primary factors is the weak stationarity and instability of cortical activity in the brain, from which we assumed MEP fluctuations originate. We hypothesized that MEP fluctuations are suppressed when TMS is delivered to the primary motor cortex at a time when several electroencephalogram (EEG) channels measured on the scalp are highly similar in the frequency domain.

Numerous virtual reality (VR) systems have received regulatory clearance as therapeutic medical devices for in-clinic and at-home use. These systems enable remote patient monitoring of clinician-prescribed rehabilitation exercises, although most of these systems are nonimmersive. With the expanding availability of affordable and easy-to-use head-mounted display (HMD)-based VR, there is growing interest in immersive VR therapies. However, HMD-based VR presents unique risks. Following standards for medical device development, the objective of this paper is to demonstrate a risk management process for a generic immersive VR system for remote patient monitoring of at-home therapy. Regulations, standards, and guidance documents applicable to therapeutic VR design are reviewed to provide necessary background. Generic requirements for an immersive VR system for home use and remote patient monitoring are identified using predicate analysis and specified for both patients and clinicians using user stories. To analyze risk, failure modes and effects analysis, adapted for medical device risk management, is performed on the generic user stories and a set of risk control measures is proposed. Many therapeutic applications of VR would be regulated as a medical device if they were to be commercially marketed. Understanding relevant standards for design and risk management early in the development process can help expedite the availability of innovative VR therapies that are safe and effective.

Ultrasound-based radiomic features to differentiate between benign and malignant breast lesions with the help of machine learning is currently being researched. The mean echogenicity ratio has been used for the diagnosis of malignant breast lesions. However, gray scale intensity histogram values as a single radiomic feature for the detection of malignant breast lesions using machine learning algorithms have not been explored yet.