Comprehensive Review on Current and Future Regulatory Requirements on Wearable Sensors in Preclinical and Clinical Testing

Ravizza, Alice; Maria, Carmelo De; Pietro, Licia Di; Sternini, Federico; Audenino, Alberto; Bignardi, Cristina

doi:10.3389/fbioe.2019.00313

Cited by 43 publications

(21 citation statements)

References 24 publications

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“…Sensor and wearable technologies have not been adopted significantly to date, partly due to security, affordability, user-friendliness, compatibility with EHR systems (Bennett et al 2012 ; Dinh-Le et al 2019 ), and financial and policy issues that have not been resolved even though virtual care codes were approved for some services in the U.S. in 2019 (Hilty et al 2020 ). Manufacturers and healthcare providers also must consider certification and approval requirements related to US, European Union, and other international regulatory standards (Loncar-Turukalo et al 2019 ; Ravizza De Maria et al 2019 ).…”

Section: Resultsmentioning

confidence: 99%

Sensor, Wearable, and Remote Patient Monitoring Competencies for Clinical Care and Training: Scoping Review

Hilty

Armstrong²,

Edwards‐Stewart

et al. 2021

J. technol. behav. sci.

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Sensor, wearable, and remote patient monitoring technologies are typically used in conjunction with video and/or in-person care for a variety of interventions and care outcomes. This scoping review identifies clinical skills (i.e., competencies) needed to ensure quality care and approaches for organizations to implement and evaluate these technologies. The literature search focused on four concept areas: (1) competencies; (2) sensors, wearables, and remote patient monitoring; (3) mobile, asynchronous, and synchronous technologies; and (4) behavioral health. From 2846 potential references, two authors assessed abstracts for 2828 and, full text for 521, with 111 papers directly relevant to the concept areas. These new technologies integrate health, lifestyle, and clinical care, and they contextually change the culture of care and training-with more time for engagement, continuity of experience, and dynamic data for decision-making for both patients and clinicians. This poses challenges for users (e.g., keeping up, education/training, skills) and healthcare organizations. Based on the clinical studies and informed by clinical informatics, video, social media, and mobile health, a framework of competencies is proposed with three learner levels (novice/advanced beginner, competent/proficient, advanced/expert). Examples are provided to apply the competencies to care, and suggestions are offered on curricular methodologies, faculty development, and institutional practices (e-culture, professionalism, change). Some academic health centers and health systems may naturally assume that clinicians and systems are adapting, but clinical, technological, and administrative workflow-much less skill development-lags. Competencies need to be discrete, measurable, implemented, and evaluated to ensure the quality of care and integrate missions.

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Section: Resultsmentioning

confidence: 99%

Sensor, Wearable, and Remote Patient Monitoring Competencies for Clinical Care and Training: Scoping Review

Hilty

Armstrong²,

Edwards‐Stewart

et al. 2021

J. technol. behav. sci.

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“…[ 198 ] Thanks to the superiority of bioprinting technology in the precise deposition of cells and biomaterials in a 3D orientation fashion, clinical applications of this approach in fabricating appropriate wound dressings promise an auspicious skin regeneration alternative for large skin size defects compared to previous conventional approaches. [ 199 ]…”

Section: D Printing Technologies For the Development Of Wound Dressingsmentioning

confidence: 99%

“…[ 197 ] Although, different strategies have been considered for enhancing the therapeutic properties of nanofiber‐based wound dressings further investigation is needed to evolve this highly efficient substrate as a smart wound dressing ( Figure ). [ 198,199 ]…”

Section: Fibrillar Network As Wound Dressings Materialsmentioning

confidence: 99%

Wound Healing: From Passive to Smart Dressings

Farahani

Shafiee

2021

Adv Healthcare Materials

414

219

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The universal increase in the number of patients with nonhealing skin wounds imposes a huge social and economic burden on the patients and healthcare systems. Although, the application of traditional wound dressings contributes to an effective wound healing outcome, yet, the complexity of the healing process remains a major health challenge. Recent advances in materials and fabrication technologies have led to the fabrication of dressings that provide proper conditions for effective wound healing. The 3D‐printed wound dressings, biomolecule‐loaded dressings, as well as smart and flexible bandages are among the recent alternatives that have been developed to accelerate wound healing. Additionally, the new generation of wound dressings contains a variety of microelectronic sensors for real‐time monitoring of the wound environment and is able to apply required actions to support the healing progress. Moreover, advances in manufacturing flexible microelectronic sensors enable the development of the next generation of wound dressing substrates, known as electronic skin, for real‐time monitoring of the whole physiochemical markers in the wound environment in a single platform. The current study reviews the importance of smart wound dressings as an emerging strategy for wound care management and highlights different types of smart dressings for promoting the wound healing process.

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“…Food and Drug Administration or the CE Marking in Europe. 109 Importantly these regulations are to be adhered to even if the devices are not intended to be used for medical evaluation, risk stratification or patient treatment. Consequently, the present expert statement should be understood as an attempt to foster standards in validations of PPG-based consumer wearables.…”

Section: Consensus Statementmentioning

confidence: 99%

Recommendations for determining the validity of consumer wearable heart rate devices: expert statement and checklist of the INTERLIVE Network

et al. 2021

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Assessing vital signs such as heart rate (HR) by wearable devices in a lifestyle-related environment provides widespread opportunities for public health related research and applications. Commonly, consumer wearable devices assessing HR are based on photoplethysmography (PPG), where HR is determined by absorption and reflection of emitted light by the blood. However, methodological differences and shortcomings in the validation process hamper the comparability of the validity of various wearable devices assessing HR. Towards Intelligent Health and Well-Being: Network of Physical Activity Assessment (INTERLIVE) is a joint European initiative of six universities and one industrial partner. The consortium was founded in 2019 and strives towards developing best-practice recommendations for evaluating the validity of consumer wearables and smartphones. This expert statement presents a best-practice validation protocol for consumer wearables assessing HR by PPG. The recommendations were developed through the following multi-stage process: (1) a systematic literature review based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses, (2) an unstructured review of the wider literature pertaining to factors that may introduce bias during the validation of these devices and (3) evidence-informed expert opinions of the INTERLIVE Network. A total of 44 articles were deemed eligible and retrieved through our systematic literature review. Based on these studies, a wider literature review and our evidence-informed expert opinions, we propose a validation framework with standardised recommendations using six domains: considerations for the target population, criterion measure, index measure, testing conditions, data processing and the statistical analysis. As such, this paper presents recommendations to standardise the validity testing and reporting of PPG-based HR wearables used by consumers. Moreover, checklists are provided to guide the validation protocol development and reporting. This will ensure that manufacturers, consumers, healthcare providers and researchers use wearables safely and to its full potential.

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Comprehensive Review on Current and Future Regulatory Requirements on Wearable Sensors in Preclinical and Clinical Testing

Cited by 43 publications

References 24 publications

Sensor, Wearable, and Remote Patient Monitoring Competencies for Clinical Care and Training: Scoping Review

Sensor, Wearable, and Remote Patient Monitoring Competencies for Clinical Care and Training: Scoping Review

Wound Healing: From Passive to Smart Dressings

Recommendations for determining the validity of consumer wearable heart rate devices: expert statement and checklist of the INTERLIVE Network

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