Digital Medical Technology Research Articles

Application of Innovative Digital Medical Technologies of Bioquantum Medicine and Therapy in Elimination of Allergy Symptoms

In recent years, there has been an increasing integration of alternative medical technologies, particularly those involving digital medical technologies based on quantum and bioquantum medicine, frequency and wave therapy, and bioquantum therapy, for treating COVID-19, post-COVID, and long-COVID conditions as outlined in ICD-11. This study aimed to experimentally evaluate the latest digital medical technologies, specifically focusing on bioquantum therapy, for allergy treatment. A comprehensive review of existing literature on the application of bioquantum medicine in allergy therapy was conducted. The findings confirm that bioquantum therapy is an effective treatment option for mild to moderate allergies, significantly enhancing symptoms and overall quality of life. BICOM devices are recommended for managing mild to moderate allergies and associated complications. Furthermore, the study highlights that BICOM therapy is not only effective but also safe, with no serious adverse effects observed throughout the year-long study period. Given these promising results, it is recommended that healthcare professionals pursue specialized training, including master classes and continuous professional development in bioquantum medicine and therapy. Obtaining the necessary licenses and permits to work with BICOM devices is essential for ensuring the safe and effective application of this innovative treatment method. As the field continues to evolve, staying updated on the latest advancements in bioquantum medicine will be crucial for medical practitioners.

Industry diversity in entrepreneurial ecosystems – A longitudinal study of industrial composition and firm locations in Tel Aviv, Israel

This study contributes to understanding the evolution of entrepreneurial ecosystems by examining changes in industry composition and business locations within a specific ecosystem from its inception to 2020. Using longitudinal data from Tel Aviv-Jaffa, Israel, we investigate shifts in industries within the region and the location decisions of individual entrepreneurs within the city. By integrating these factors, we assess whether the ecosystem consists of distinct, industry-specific sub-ecosystems. Our findings highlight the significant role played by the 'social media and advertising' sector in shaping the ecosystem. Furthermore, we identify a trend of entrepreneurs clustering their businesses in a concentrated area within the city, suggesting enhanced communication and collaboration among entrepreneurs across different industries. However, we note an exception in the 'digital health and medical technologies' industry, where proximity to research institutions, multinational corporations, and hospitals holds greater significance than proximity to entrepreneurs from other sectors.

A Population-Based Tumor-Volume Model for Head and Neck Cancer During Radiation Therapy With a Dynamic Oxygenated Compartment

PurposeWith the coming era of digital wisdom medical technology, mathematical modelling of tumor becomes a key step to optimize and realize precision radiotherapy. The purpose of this study is to develop a mathematical model for simulating the change of head-and-neck tumor (HN) volume during radiotherapy. Methods and MaterialsA formula is developed to describe the dynamic change of oxygenated compartment within a tumor, which is combined with the LPL model to describe various cell processes during radiotherapy, including potentially lethal lesion repair and misrepair, cell proliferation/loss, and tumor reoxygenation. Parameter sensitivity analysis is performed to evaluate the impacts of the lesion-related and repair-related biological factors on radiotherapy outcome. ResultsWe tested our model on 14 available HN cancer patients and compared the performance with three other models. The mean error of our model for the twelve good fit cases is 12.2%, which is considerable smaller than that of the LQ model (19.7%), GLQ model (19.1%) and FLCP model (16.6%). Correlation analysis results reveal that for small tumors, there is a positive correlation (correlation coefficient r=0.9416) between hypoxic fraction and tumor volume, whereas the correlation becomes negative and not significant (r=−0.4365) for large tumors. It is demonstrated from sensitivity analysis that the production rate of lethal lesions (ηl) has a far greater impact on tumor volume than other parameters. The hypoxic fraction has insignificant impact on tumor volume, but it has notable influence on the volume of surviving cells. The final volume of surviving cells athf=0.5 is almost 8 ×102 times that of hf=0.01. The potentially lethal lesion-related parameters (ηpl,εpl, ε2pl) have rather small impacts (<1%) on both tumor volume and the volume of surviving cells, which indicates that the repaired and misrepaired sublethal cells only take up a small portion of the total cancer cell population. ConclusionsA population-based tumor-volume model for HN cancer during radiotherapy with a dynamic oxygenated compartment was developed in this study. Comprehensively considering the damage process of tumor cells caused by radiation therapy, the accurate prediction of the volume change of head-and-neck tumors during treatment has been revealed. Meanwhile, various cell activities and their principles in the process of anti-tumor treatment were reflected, and it has positive clinical reference significance for radiobiology.

Robot-assisted surgery and artificial intelligence-based tumour diagnostics: social preferences with a representative cross-sectional survey

BackgroundThe aim of this study was to assess social preferences for two different advanced digital health technologies and investigate the contextual dependency of the preferences.MethodsA cross-sectional online survey was performed among the general population of Hungary aged 40 years and over. Participants were asked to imagine that they needed a total hip replacement surgery and to indicate whether they would prefer a traditional or a robot-assisted (RA) hip surgery. To better understand preferences for the chosen method, the willingness to pay (WTP) method was used. The same assessment was conducted for preferences between a radiologist’s and AI-based image analysis in establishing the radiological diagnosis of a suspected tumour. Respondents’ electronic health literacy was assessed with the eHEALS questionnaire. Descriptive methods were used to assess sample characteristics and differences between subgroups. Associations were investigated with correlation analysis and multiple linear regressions.ResultsAltogether, 1400 individuals (53.7% female) with a mean age of 58.3 (SD = 11.1) years filled in the survey. RA hip surgery was chosen by 762 (54.4%) respondents, but only 470 (33.6%) chose AI-based medical image evaluation. Those who opted for the digital technology had significantly higher educational levels and electronic health literacy (eHEALS). The majority of respondents were willing to pay to secure their preferred surgical (surgeon 67.2%, robot-assisted: 68.8%) and image assessment (radiologist: 70.9%; AI: 77.4%) methods, reporting similar average amounts in the first (p = 0.677), and a significantly higher average amount for radiologist vs. AI in the second task (p = 0.001). The regression showed a significant association between WTP and income, and in the hip surgery task, it also revealed an association with the type of intervention chosen.ConclusionsIndividuals with higher education levels seem to accept the advanced digital medical technologies more. However, the greater openness for RA surgery than for AI image assessment highlights that social preferences may depend considerably on the medical situation and the type of advanced digital technology. WTP results suggest rather firm preferences in the great majority of the cases. Determinants of preferences and real-world choices of affected patients should be further investigated in future studies.

Initial implementation of surgical guide design utilizing digital medicine for lateral orbital decompression surgery

ObjectiveThis study aimed to assess the feasibility of utilizing a surgical guide, designed through digital medical technology, in lateral orbital decompression surgery. MethodsIn total, 18 patients with thyroid-associated ophthalmopathy (TAO), who underwent orbital balance decompression surgery at the Affiliated Eye Hospital of Nanchang University between September 2018 and August 2022, were included. Orbital CT scanning was performed on all patients with TAO, and Mimics 21.0 software was used to reconstruct a three-dimensional model of the orbit based on the CT data. The osteotomy guide plate for lateral orbital decompression surgery was designed using 3-matic 13.0 software, adhering to the criteria of surgical effectiveness and safety. The surgical positioning guide was designed using Geomagic Wrap 21.0. Once printed, the surgical guide was sterilized with low-temperature plasma and applied during surgery. ResultsOf the nine patients treated using a surgical navigation system, three cases experienced cerebrospinal fluid leakage complications during the procedure, and two exhibited inadequate bone removal along the lateral wall. In contrast, among the nine patients treated with surgical guides, no intraoperative cerebrospinal fluid leakage or evidence of insufficient lateral wall bone removal was observed, highlighting a statistically significant distinction between the two cohorts (p = 0.046). Postoperative improvements were notable in best-corrected visual acuity (BCVA) and exophthalmos for patients afflicted with extremely severe TAO. ConclusionThe surgical guide, designed with digital medical technology, has been shown to be an effective and secure auxiliary tool in lateral orbital decompression surgery. It not only aids in reducing the incidence of intraoperative complications, but also enhances the accuracy and safety of surgery. These improvements offer robust support for continued exploration in this field within clinical practice.

Early Detection of Parkinson's Disease Using Deep NeuroEnhanceNet With Smartphone Walking Recordings.

With the development of digital medical technology, ubiquitous smartphones are emerging as valuable tools for the detection of complex and elusive diseases. This paper exploits smartphone walking recording for early detection of Parkinson's disease (PD) and finds that walking recording empowered by deep learning is a valid digital biomarker for early-recognizing PD patients. Specifically, the inertial sensor data is preprocessed, including normalization, scaling, and rotation, and then the processed data is fed into the proposed deep NeuroEnhanceNet. Finally, determine the individual prediction score using the PD-prone strategy and generate the detection results. The proposed deep NeuroEnhanceNet, specifically designed for inertial sensor data, can focus on both the long-term data characteristics within a single channel and the inter-channel correlations. Our method obtains a low false negative rate of 0.053 for the early detection of PD. We further analyze and compare the effectiveness of digital biomarkers captured from the walking and resting processes for early detection of PD. All the code for this work is available at: https://github.com/heyiyia/NeuroEnhanceNet.

Bringing Medical Workers to Disciplinary Responsibility: Current Problems in context of Introduction of Digital Technologies in Medical Activities

Digital technologies have become an integral part of modern life. Digital medical services is one of the forms of activity of almost any medical organization. For this reason, the problems of implementation of the work function of medical personnel are relevant. When a medical worker is performing a medical intervention using digital medical technologies, other criteria for evaluating the proper performance of their work function should be taken into account. The specifics of these criteria have an impact on the establishment of grounds for bringing a medical professional to disciplinary responsibility. The work of medical workers is of special social significance. Nowadays, almost no medical intervention is performed without the use of artificial intelligence, artificial intelligence technologies, robots, applications, bots, etc. They became widespread during the introduction of remote labor formats and lock downs, when various software tools were used for remote provision of medical services.The labor legislation establishes general grounds for bringing medical workers to disciplinary responsibility, as well as traditional disciplinary measures. We believe that bringing medical workers to disciplinary responsibility has a strongly pronounced specificity. This is especially evident in the context of introduction of digital technologies in medical activities.Based on the analysis of modern legislation and law enforcement practice, we have identified special grounds for bringing medical workers to disciplinary responsibility, analyzed typical cases of labor discipline violations by medical workers, and developed recommendations on the tactics of conducting a disciplinary internal investigation by an employer (medical organization). The author provides recommendations for fixing certain conditions in the explanatory note of a medical worker.

Current Knowledge and Future Possibilities of Medical Digital Technologies based on Mobile Health

Medical digital technologies have the potential to improve public access to healthcare by enhancing its flexibility. The availability of complementary details about health, ailments, complications, and the most recent advancements in biomedical research are all included. Diagnostic and medical services are now becoming more available and accessible, especially in low-income countries. Regarding digital health technology, there are still a lot of challenges that need to be overcome, such as dependability, safety, testing, and ethical concerns. We propose that mobile technology should enhance rather than replace the psychiatrist-patient connection in the existing environment of inadequate regulatory oversight and scientific research to lessen possible clinical and moral harm to patients at risk. We identify potential areas of moral conflict between consumer-driven mobile businesses and healthcare practice and create a decision tree model for putting ethical safeguards in place. Informed consent, confidentiality, and shared treatment expectations are the main areas of attention for this paradigm when it comes to risk management in the therapeutic partnership. To comprehend the utility, capacity, and limitations, this study covers recent breakthroughs in mobile technologies, their applications, and a comparative analysis of their performance metrics. Understanding the weaknesses of current technologies can facilitate the creation of new frameworks with increased performance capabilities and superior service quality.

Основополагающие принципы стандартизации и систематизации информации о наборах данных для машинного обучения в медицинской диагностике

Backgraund: Active implementation of artificial intelligence technologies in the healthcare in recent years promotes increasing amount of medical data for the development of machine learning models, including radiology and instrumental diagnostics data. To solve various problems of digital medical technologies, new datasets are being created through machine learning algorithms, therefore, the problems of their systematization and standardization, storage, access, rational and safe use become actual. A i m : development of an approach to systematization and standardization of information about datasets to represent, store, apply and optimize the use of datasets and ensure the safety and transparency of the development and testing of medical devices using artificial intelligence. M a t e r i a l s a n d m e t h o d s : analysis of own and international experience in the creation and use of medical datasets, medical reference books searching and analysis, registry structure development and justification, scientific publications search with the keywords “datasets”, “registry of medical data”, placed in the databases of the RSCI, Scopus, Web of Science. R e s u l t s . The register of medical instrumental diagnostics datasets structure has been developed in accordance with stages of datasets lifecycle: 7 parameters at the initiation stage, 8 – at the planning stage, 70 – dataset card, 1 – version change, 14 – at the use stage, total – 100 parameters. We propose datasets classification according to the purpose of their creation, a classification of data verification methods, as well as the principles of forming names for standardization and datasets presentation clarity. In addition, the main features of the organization of maintaining this registry are highlighted: management, data quality, confidentiality and security. C o n c l u s i o n s . For the first time, an original technology of medical datasets for instrumental diagnostics structuring and systematization is proposed. It is based on the developed terminology and principles of information classification. This makes it possible to standardize the structure of information about datasets for machine learning, and ensures the storage centralization. It also allows to get quick access to all information about the dataset, and ensure transparency, reliability and reproducibility of artificial intelligence developments. Creating a registry makes it possible to quickly form visual data libraries. This allows a wide range of researchers, developers and companies to choose data sets for their tasks. This approach ensures their widespread use, resource optimization and contributes to the rapid development and implementation of artificial intelligence.

P39: Generational Status as a Factor in Medical Device Information and Data Exchange

Background: Medical devices (MD), either implantable, such as mechanical circulatory support systems, or wearable, i.e. motion/physiologic sensors, are increasingly utilized for diagnostic/therapeutic purposes. For maximal use efficacy and efficiency, MDs require individual compliance and adherence to operating instructions and data exchange. In today’s world we have increasingly shifted from paper-based information transfer (data sheets, directions for use, etc.) to periodic downloads, and web- and social media-based wireless communication. With growth of MD use it has become evident that a disconnect exists in the tactics employed by device designers and manufacturers compared with patient end-users. This disconnect relates to the form and means of communication utilized to convey and extract information versus patient facility with computer, smartphone and social media information exchange. As a starting point in examining this problem, we studied this disconnect as it relates to individual “generational” status. We conducted an anonymous survey, to examine “generational ” familiarity, acceptance and use; focusing on wearable technology and web-based information sources. Methods: An anonymous survey was developed and distributed to individuals ranging in age from 19 to 78, equally split as to gender. Generations examined included: Silent (age 74-91); Boomers (age 55-73), Gen X (age 39-54), Millennials (age 23-38), and Gen Z (age 7-22). Participants were queried via 10 multiple-choice questions related to digital health, wearable technologies and telemedicine. Results: Eighty-seven individuals participated in the survey. As to generational breakdown, this included 4 Silent (5% of group), 12 Boomers (14% of group), 9 Gen X (10% of group), 38 Millennials (43% of group) and 24 Gen Z (28% of group). Overall younger individuals tended to utilize and believed in the greater accuracy of wearable technologies compared to older individuals. Up to 90% of individuals under the age of 40 believed in the accuracy of wearable technology. Out of the 87 individuals surveyed, 95% reported they were comfortable with their personal health data (labs, imaging, medications, etc.) being shared electronically, but not a single individual believed that digital health/telemedicine improved their quality of care when compared to in-person medical care. Conclusions: Our results reveal that although all individuals are willing to utilize wearable medical technology and web-based information sources, younger generational cohorts are significantly more comfortable with the technology and more inclined to use it. Our hope is that this data may help guide future device development to incorporate means of addressing these generational disparities. Incorporating means of enhancing familiarity, adoption and facility of digital medical devices technologies and web-based information sources, will continue to improve use and value of these devices driving precision medicine.

A robust NIfTI image authentication framework to ensure reliable and safe diagnosis.

Advancements in digital medical imaging technologies have significantly impacted the healthcare system. It enables the diagnosis of various diseases through the interpretation of medical images. In addition, telemedicine, including teleradiology, has been a crucial impact on remote medical consultation, especially during the COVID-19 pandemic. However, with the increasing reliance on digital medical images comes the risk of digital media attacks that can compromise the authenticity and ownership of these images. Therefore, it is crucial to develop reliable and secure methods to authenticate these images that are in NIfTI image format. The proposed method in this research involves meticulously integrating a watermark into the slice of the NIfTI image. The Slantlet transform allows modification during insertion, while the Hessenberg matrix decomposition is applied to the LL subband, which retains the most energy of the image. The Affine transform scrambles the watermark before embedding it in the slice. The hybrid combination of these functions has outperformed previous methods, with good trade-offs between security, imperceptibility, and robustness. The performance measures used, such as NC, PSNR, SNR, and SSIM, indicate good results, with PSNR ranging from 60 to 61 dB, image quality index, and NC all close to one. Furthermore, the simulation results have been tested against image processing threats, demonstrating the effectiveness of this method in ensuring the authenticity and ownership of NIfTI images. Thus, the proposed method in this research provides a reliable and secure solution for the authentication of NIfTI images, which can have significant implications in the healthcare industry.

Application of breast milk smears in umbilical care of full-term newborn

ABSTRACT With the continuous innovation of digital technology in my country at this stage and the design of medical imaging technology systems, the depth and breadth of the development of digital medical imaging technology have been greatly expanded. This paper focus on application of medical images in breast milk smearing of the umbilical nursing for full-term newborns. Objective: To explore the effect of breast milk application in umbilical nursing of full-term newborns. Methods: 596 full-term newborns were divided into three groups: Experimental Group, Control Group A and Control Group B, Experimental Group A treated with breast milk, control group a treated with 75% alcohol, and control group B treated with 37 ~ 42°C warm boiled water, the time of umbilical cord abscission, infection and other complications were compared among the three groups. The process was recorded by images. Results: According to the images, compared with the Control Group A and B, the experimental group significantly shortened the time of umbilical cord shedding, the difference was statistically significant (p < 0.001). Conclusion: The application of breast milk in umbilical region of full-term neonates can reduce the time of umbilical cord abscission without increasing the incidence of Omphalitis.

Digitalization of Education in the Medical University: Transformation Factors

The COVID-19 pandemic provoked a sudden transition to distance learning and intensive development of the digital environment of universities in Ukraine, which, in fact, continues to this day. Considering the wide and sustainable implementation of digital technologies in the national health care system, there is a need to investigate the digitalization of education in institutions of higher medical education, and to assess how successful the process of forming the innovative infrastructure of a modern university and the range of possible consequences of the rapid implementation of digital education. The article examines the experience of organizing distance learning, which is regulated by regulatory documents, the conditions for the formation of electronic and digital infrastructure components in a modern university; study of the spectrum of possible consequences of the use of digital education in institutions of higher medical education. The concepts of «digital education» and «digital competence», «digital medical technologies» were analyzed. The educational process is considered, namely online courses and distance educational technologies, educational resources, virtual digital library. The implementation of educational disciplines in medicine using virtual simulators and augmented reality is analyzed. Considered the issues of organizational and management sphere in the medical university. Some applications were analyzed, namely, a digital campus, an electronic student card, a digital diploma, a digital footprint of a higher education applicant, a teacher's digital portfolio, etc. The image positioning of the medical university is considered, namely, the website of university, digital transformation of career guidance and employment processes; creation of a competence center at the university as a basis for improving the qualifications of professors and teaching staff based on the concept of continuous education. The positive and negative social effects of the use of digital technologies in the educational environment are analyzed.

Application of three-dimensional reconstruction in stomatology

Three-dimensional reconstruction (3D) in computer vision, is the process of three-dimensional view information from single or multiple views. In medicine, 3D reconstruction techniques are mainly based on MSCT, magnetic resonance imagin and other output medical digital image communication protocol (DICOM) format files. As a new digital medical technology, 3D reconstruction technology has been widely used in the field of stomatology, using 3D software, we can freely rotate, segment and view the CT scan results from many different angles, so that we can get more clear skull contrast and more information, data in CT scan results can also be processed so that reference markers can be clearly displayed for better diagnosis and treatment [1]. It has the unique preoperation design advantage, reduces the operation time, enhances the operation accuracy.

The Role of Interactive Technologies in Optimizing the Process of Patient Treatment: Prospects and Challenges for Health Care

The introduction of medical digital technologies can provide better access and flexibility of healthcare for the population. It includes the availability of open information about health, treatment, complications, and recent progress in biomedical research. Nowadays, even in low-income countries, diagnostic and medical services are becoming more accessible. However, many issues related to digital health technologies remain unresolved, including reliability, security, testing, and ethical issues.The penetration of AI currently affects almost all areas of work of medical organizations and government and supervision bodies in the field of healthcare, as well as all major nosological groups. The leading areas of AI application are: medical diagnostics and image analysis, predictive clinical and managerial analytics, medical decision support systems, data analysis of wearable devices, telemedicine, monitoring of patients with chronic non-communicable diseases, virtual assistants, including robot-assisted surgery, decision assistance mental health problems, etc.This article explores the role of interactive technologies in optimizing the patient care process and discusses the prospects and challenges they present for healthcare. In recent years, interactive technologies such as mobile applications, virtual reality, remote medical consultations and electronic health monitoring systems have become increasingly common in medical practice. Digital platforms can help optimize patient diagnosis, counselling and treatment. However, due to the lack of official regulations and recommendations, stakeholders, including private and public organizations, face the problem of adequate verification and testing of new digital health technologies. In this regard, proper scientific research is needed before a digital product is deployed for the health sector.The authors emphasize that interactive technologies have a significant potential for optimizing the process of treating patients in healthcare. They can improve the availability and quality of medical care, as well as increase patient satisfaction.

HTA216 Assessment of Key Drivers of Economic Evaluations for Digital Health and Medical Technologies: Insights and Lessons From Review of NICE Medical Technology Assessment Reports (2010-2022)

HTA216 Assessment of Key Drivers of Economic Evaluations for Digital Health and Medical Technologies: Insights and Lessons From Review of NICE Medical Technology Assessment Reports (2010-2022)

Multi-modal image fusion using contourlet and wavelet transforms: a multi-resolution approach

In recent years, vast improvement and progress has been observed in the field of medical research, especially in digital medical imaging technology. Medical image fusion has been widely used in clinical diagnosis to get valuable information from different modalities of medical images to enhance its quality by fusing images like computed tomography (CT), and magnetic resonance imaging (MRI). MRI gives clear information on delicate tissue while CT gives details about denser tissues. A multi-resolution approach is proposed in this work for fusing medical images using non-sub-sampled contourlet transform (NSCT) and discrete wavelet transform (DWT). In this approach, initially the input images are decomposed using DWT at 4 levels and NSCT at 2 levels which helps to protect the vital data from the source images. This work shows significant enhancement in pixel clarity and preserves the information at the corners and edges of the fused image without any data loss. The proposed methodology with an improved entropy and mutual information helps the doctors in better clinical diagnosis of brain diseases.

Applications of Medical Digital Technologies for Noncommunicable Diseases for Follow-Up during the COVID-19 Pandemic.

Background: Noncommunicable chronic diseases (NCDs) are multifaceted, and the health implications of the COVID-19 pandemic are far-reaching, especially for NCDs. Physical distancing and quarantine can lead to the poor management of NCDs because the visual tracking of them has been replaced with medical digital technology, that is, smartphone apps. This study aimed to explore medical digital technology applications for NCDs for follow-up during the COVID-19 pandemic. Methods: The participants in this study were 400 adult patients with NCDs; they were selected by systematic random sampling. A descriptive cross-sectional design was used. The study was conducted in the outpatient department of Yanbu General Hospital and primary-care health centers in Yanbu Al-Baher, Al-Madinah Al-Munawwarah, in the Kingdom of Saudi Arabia. The tools used in this study were a structured questionnaire to collect the sociodemographic characteristics of the patients and their health history, an NCD questionnaire to assess follow-up of the patients during the COVID-19 pandemic, and a medical digital technologies questionnaire to explore the medical digital technology applications. Results: The mean age of the patients was 47.32 ± 14.362 years, and 62.8% of them were female and 372 were male. Of the patients, 69.2% and 57.5% had been diagnosed with diabetes mellitus and hypertension, respectively; 52.4% were followed up monthly, and 29.75% used medical digital technology applications such as Tabeby Online to monitor their health. Furthermore, 71.75% and 75.5% of the patients used the Sehhaty and Tawakkalna medical digital applications, respectively. Overall, 38.7% of the patients were satisfied with using medical digital technology applications used for follow-up during the COVID-19 pandemic. Conclusions: The study concluded that the services that use networks, smartphones, and medical digital technology applications on the Saudi Ministry of Health website and mobile applications to improve the quality of the health-care system, and that provide health services for noncommunicable or communicable diseases, are not effective. This is because the patients lack awareness of these services, with most of the chronic patients being elderly with lower levels of education and computer literacy.

Abstract P043: A Framework For The Evaluation Of Digital Tools

Digital health tools encompass a wide range of technologies that have been used in healthcare services including mobile applications, health information technology, smart wearable devices, remote monitoring and treatment, and health platforms. These tools walk a fine line between lifestyle consumer products and medical devices. Sleep applications can be used by consumers as a fun gadget to track sleep, but it may also be used as a medical tool to collect information concerning serious sleep disorders. The fast proliferation of these tools has put pressure on concerned stakeholders to make sense of this group of technologies. Various questions have been raised within this realm: What counts as medical as opposed to a lifestyle device? Which devices require regulation and under what standards? Which devices are allowed to be used in the medical context? And which are not? And under what conditions? Social scientists have highlighted the complexity of digital health tools that (include both medical and lifestyle characteristics and the difficulties accompanied with classifying these tools for regulatory purposes. In an attempt to do so, several regulatory bodies including the US Food and Drug Administration (FDA) have revised their existing standards to accommodate the regulation of digital health tools. As such, the FDA published a guidance document on Mobile Medical Applications; this led to various concerns questioning the boundaries between lifestyle and medical digital technologies that were defined by the FDA guidelines, which left a significant number of technologies that were considered to be low-risk, completely out of the FDA oversight and with no required compliance/quality control/effectiveness checks. This prompted many companies to develop hundreds of products that belong to the low-risk category, granting them the ability to ignore FDA regulations. Consequently, there remains considerable concern regarding the quality and safety of these digital health technologies that are being used within the medical context. Clear and well-defined regulation processes are needed to control the development and design of these tools, especially that many lack scientific evidence and data privacy. The framework ought to include a risk-based approach to classify devices for regulation in a way to ensure the safety and effectiveness of all digital health tools throughout their life cycle, even those classified as low-risk. The framework and regulatory process also need to take into consideration the rapid change in digital product development, as processes that extend for a long period of time may become obsolete in supporting decisions about these tools. As these digital health tools become more sophisticated, accessible, widespread, and cheaper, the need for classifying and regulating the sector becomes important, especially with the rapid evolution of these technologies.

Digital three-dimensional planning of orthodontic miniscrew anchorage: A literature review

Orthodontic miniscrews are used for skeletal orthodontic anchorage. An appropriate insertion technique is essential to avoid complications during miniscrew placement. The guides prepared using surface anatomy and 2D radiographs cannot correctly analyze bone volume. Advances in digital 3D medical technologies enabled orthodontists to use digital imaging, digital scanning, and 3D printing to accurately place miniscrews using a surgical guide developed with computer-aided design and manufacturing techniques. The objective of this article was to demonstrate the development of miniscrew placement techniques chronologically and provide brief information about the production, use, and efficiency of modern, digitally planned, and produced miniscrew insertion guides.