Traditional Medical Devices Research Articles

Discussion on the Application of Supercritical Carbon Dioxide Technology for Sterilization of Medical Devices

Traditional medical device sterilization processes are mature, but there are constraints when using on medical devices by new materials. With increasing environmental concerns, using of ethylene oxide sterilization has been limited by global environmental protection administrations. Exploring new sterilization methods for medical devices is urgently needed. This paper reviews the supercritical carbon dioxide sterilization technology by arranging the exploratory work of industry researchers. In the paper, we introduce the theory of supercritical carbon dioxide sterilization technology, microbial inactivation ability, material influence research and sterilization equipment. Then we discuss the concerns and possibilities of the technology applied to the medical device industry basing on the good manufacturing practices.

An Innovative Risk Assessment Methodology for Medical Information Systems

Modern Medical Information Systems very often comprise Medical Devices and governed by regulations which require stringent Risk Management activities to be implemented to minimize the occurrence of safety risks. Currently, the reference standard adopted by manufacturers for Risk Management is ISO 14971, which, however, was devised for traditional (mostly hardware) Medical Devices and does not either take into account the peculiarities of modern Medical Information Systems, or define a formal methodology to conduct Risk Assessment. Moreover, the approaches currently implemented by manufacturers typically aims at obtaining qualitative Risk Assessment results. Within the so-delineated application scenario, this paper proposes a methodology for the Dynamic Probabilistic Risk Assessment of Medical Information Systems, by specifically looking at medical devices that are intended as one of the most relevant components in such systems. The methodology complies with ISO 14971 and improves current practices because it allows the analyst to conduct a quantitative analysis, also taking into account the temporal dimension. It relies on a Probabilistic Risk Model, defined as a set of Markov Models, which is model-checked to obtain quantitative information about the risks. The proposed methodology is also adopted to improve definitively the Medical Device post-market surveillance, which is currently implemented as a wait for an incident activity.

Effect of educational intervention on awareness of pharmacovigilance among medical undergraduates in a tertiary care teaching hospital

Aim:(1) To assess the knowledge and attitude of undergraduates about adverse drug reaction (ADR) reporting at a tertiary care teaching hospital. (2) To assess the effect of educational intervention among medical undergraduates on knowledge and attitude about pharmacovigilance (PV).Materials and Methods:Cross-sectional, questionnaire-based survey conducted at a tertiary care teaching hospital. Respondents were 192 undergraduate students (2nd year). The study instrument was a self-developed, prevalidated semi-structured questionnaire. Participants were given 1 h to complete the questionnaire. After this, a 2 h lecture about PV was taken. Participants were asked to fill the same questionnaire after the educational intervention. Pre- and post-test questionnaire were compared.Results:There was an overall improvement in all three aspects, i.e., awareness, knowledge, and attitude. Most of the students had knowledge of the meaning of PV and reporting of ADR by doctors. However, there was a significant improvement in the knowledge regarding reporting of ADR by dentist, nurses, and pharmacist. Similarly, students were aware of the fact that ADR with allopathic medicines should be reported, but postintervention, there was improvement in percentage regarding reporting of ADR in the case of herbal and traditional medicine, blood products, and biological and medical device. There was a significant improvement in percentage regarding awareness about process of reporting ADR after exposure to lecture.Conclusion:There is a need of increasing awareness among the medical students to improve the reporting of ADRs. Adequate consideration needs to be given to the subject of ADRs in the clinical pharmacology and therapeutics curricula in undergraduate medical education.

Design and Implementation of Remote Firmware Update System Based on IAP Technology

This paper introduces a network remote firmware update system based on IAP technology, which aims to solve the problems of low efficiency and high cost in the traditional upgraded medical device firmware (lower computer program) mode, and to improve the portability of the lower computer program upgrade maintenance. In order to better cope with market changes, customer needs, and solve software failures in medical devices, it is necessary to update and upgrade medical device software in a timely manner. Through the IAP technology and Internet communication technology of STM32 platform, this solution can complete the update of all instrument firmware in a short time, which not only saves a lot of travel expenses, mailing costs and labor costs, but also greatly shortens the update time.

Evaluating the Accuracy of the VitalWellness Device

Background Wellness devices for health tracking have gained popularity in recent years. Additionally, portable and readily accessible wellness devices have several advantages when compared to traditional medical devices found in clinical environments The VitalWellness device is a portable wellness device that can potentially aide vital sign measuring for those interested in tracking their health. Objective In this diagnostic accuracy study, we evaluated the performance of the VitalWellness device, a wireless, compact, non-invasive device that measures four vital signs (blood pressure (BP), heart rate (HR), respiratory rate (RR), and body temperature using the index finger and forehead. Methods Volunteers age ≥18 years were enrolled to provide blood pressure (BP), heart rate (HR), respiratory rate (RR), and body temperature. We recruited participants with vital signs that fell within and outside of the normal physiological range. A sub-group of eligible participants were asked to undergo an exercise test, aerobic step test and/or a paced breathing test to analyze the VitalWellness device’s performance on vital signs outside of the normal physiological ranges for HR and RR. Vital signs measurements were collected with the VitalWellness device and FDA-approved reference devices. Mean, standard deviation, mean difference, standard deviation of difference, standard error of mean difference, and correlation coefficients were calculated for measurements collected; these measurements were plotted on a scatter plot and a Bland-Altman plot. Sensitivity analyses were performed to evaluate the performance of the VitalWellness device by gender, skin color, finger size, and in the presence of artifacts. Results 265 volunteers enrolled in the study and 2 withdrew before study completion. Majority of the volunteers were female (62%), predominately white (63%), graduated from college or post college (67%), and employed (59%). There was a moderately strong linear relationship between VitalWellness BP and reference BP (r=0.7, P<.05) and VitalWellness RR and reference RR measurements (r=0.7, P<.05). The VitalWellness HR readings were significantly in line with the reference HR readings (r=0.9, P<.05). There was a weaker linear relationship between VitalWellness temperature and reference temperature (r=0.3, P<.05). There were no differences in performance of the VitalWellness device by gender, skin color or in the presence of artifacts. Finger size was associated with differential performance for RR. Conclusions Overall, the VitalWellness device performed well in taking BP, HR, and RR when compared to FDA-approved reference devices and has potential serve as a wellness device. To test adaptability and acceptability, future research may evaluate user’s interactions and experiences with the VitalWellness device at home. In addition, the next phase of the study will evaluate transmitting vital sign information from the VitalWellness device to an online secured database where information can be shared with HCPs within seconds of measurement.

Evaluating the Accuracy of an Integrated Vital Sign Measurement Wellness Device

Background Wellness devices for health tracking have gained popularity in recent years. Additionally, portable and readily accessible wellness devices have several advantages when compared to traditional medical devices found in clinical environments. Building tools for patients to manage their health independently may benefit their health in the long run by improving health care providers’ (HCPs) awareness of their patients’ health information outside of the clinic. Increased access to portable wellness devices that track vital signs may increase how patients and HCPs track and monitor chronic conditions which can improve health outcomes. The VitalWellness is a portable wellness device that can potentially aid vital sign measuring for those interested in tracking their health. Objective In this diagnostic accuracy study, we evaluated the clinical performance of the VitalWellness, a wireless, compact, non-invasive device that measures four vital signs using the index finger and forehead against reference vital signs devices used in the hospital setting. Methods Volunteers age ≥18 years were enrolled to provide blood pressure (BP), heart rate (HR), respiratory rate (RR), and body temperature. We recruited volunteers with vital signs that fell within and outside of the normal physiological range, depending on the measurements they consented to undergo. A subgroup of eligible volunteers were asked to undergo an exercise test, aerobic step test and/or a paced breathing test to analyze the VitalWellness device's performance on vital signs outside of the normal physiological ranges for HR and RR. Vital signs measurements were collected with the VitalWellness device and FDA-approved reference devices. Mean, standard deviation, mean difference, standard deviation of difference, standard error of mean difference, and correlation coefficients were calculated for measurements collected; these measurements were plotted on a scatter plot and a Bland-Altman plot. Sensitivity analyses were performed to evaluate the performance of the VitalWellness device by gender, skin color, finger size, and in the presence of artifacts. Results We enrolled 265 volunteers in the study and 2 withdrew before study completion. The majority of volunteers were female (62%), predominately white (63%), graduated from college or post college (67%), and employed (59%). There was a moderately strong linear relationship between VitalWellness BP and reference BP (r=0.7, P<.05) and bewteen VitalWellness RR and reference RR measurements (r=0.7, P<.05). The VitalWellness HR readings were significantly in line with the reference HR readings (r=0.9, P<.05). There was a weaker linear relationship between VitalWellness temperature and reference temperature (r=0.3, P<.05). There were no differences in performance of the VitalWellness device by gender, skin color or in the presence of artifacts. Finger size was associated with differential performance for RR. Conclusions Overall, the VitalWellness device performed well in taking BP, HR and RR when compared to FDA-approved reference devices and has potential serve as a wellness device. To test adaptability and acceptability, future research may evaluate user’s interactions and experiences with the VitalWellness device at home. In addition, the next phase of the study will evaluate transmitting vital sign information from the VitalWellness device to an online secured database where information can be shared with HCPs within seconds of measurement.

Design of traceability system for medical devices based on blockchain

Aiming at the centralization problem of the traditional medical device traceability system. This paper proposes a medical device traceability system based on blockchain technology. By integrating the traditional tracing system with the blockchain technology, based on the decentralization and non-tamperability of the blockchain, the alliance chain and the smart contract construction system are adopted. Manufacturers, distributors, hospitals and consumers in the system can access product information and trace the entire circulation process of the product through RFID. In addition, consumers do not need to register an account number, but directly through the RFID query products related to the main information, such as the shelf life, production enterprises, production time, product price, etc. This system solves the problem that the traditional system is vulnerable to network attack due to centralization, which can improve the robustness of the system, enhance the reliability of data and realizes the traceability of the production, sales and use of medical devices. Therefore, it ensures that the source of medical devices can be traced, the flow can be tracked, the information can be inquired and the responsibility can be investigated to ensure the public consumption safety.

Ultrasoft, Adhesive and Millimeter Scale Epidermis Electronic Sensor for Real-Time Enduringly Monitoring Skin Strain.

Epidermal electronic sensors (EESs) possess great advantages in the real-time and enduring monitoring of human vital information compared to the traditional medical device for intimately making contact with human skin. Skin strain is a significant and effective routine to monitor motion, heart rate, wrist pulse, and skin growth in wound healing. In this paper, a novel skin sensor combined with a ternary conductive nanocomposite (Carbon black (CB)/Decamethylcyclopentasiloxane (D5)/Silbione) and a two-stage serpentine connector is designed and fabricated to monitor skin strain. The ultrasoft (~2 kPa) and adhesive properties of the ternary conductive nanocomposite ensure the capacity of the EES to intimately couple with human skin in order to improve accuracy with a relative error of 3.39% at strain 50% as well as a large strain range (0~50%) and gauge factor (GF ~2.5). The millimeter scale EES (~5 mm × 1 mm × 100 μm), based on the micro-nano fabrication technique, consisted of a two-stage serpentine connector and screen print of the ternary conductive nanocomposite. EESs with high comprehensive performance (electrical and mechanical properties) are fabricated to confirm the analytical results and monitor the motion of a human hand. The good agreement between experimental and analytical results paves the way for bettering monitoring of skin growth during wound healing in order to avoid necrosis and scarring. This EES in monitoring the motion of a human exhibit presents a promising application for assisting prosthetic movement.

Safety control of traditional medical device and manipulation

Safety control of traditional medical device and manipulation

OP144 mHealth App Evaluation Framework For Reimbursement Decision-making

IntroductionMobile health (mHealth) applications (app) are being integrated into healthcare by patients and practitioners in Australia. However, there are currently no policies or frameworks available that can be used to conduct a health technology assessment (HTA) on mHealth apps for reimbursement purposes. The aim of the study was to determine what policy changes and assessment criteria are needed to facilitate the development of a system that evaluates mobile medical apps for regulatory and reimbursement purposes in Australia.MethodsTo obtain the information to determine what policy changes are needed and create an evidence-based framework that can evaluate mHealth apps for reimbursement decision-making, four studies were conducted. This research included (i) a policy analysis on international mHealth app regulation; (ii) a case study on American and Australian app regulation; (iii) a methodological systematic review on the suitability of current mHealth evaluation frameworks for reimbursement purposes; and (iv) the identification of HTA pathways and impediments to app reimbursement through stakeholder interviews. An evaluation framework for apps was created by combining and synthesizing the results.ResultsSoftware changes, connectivity, and cybersecurity need to be considered when evaluating mHealth apps for reimbursement purposes. Additionally, the potential dangers of apps providing misinformation, and poor software reliability in current regulation must be considered. Stakeholders indicated that they trust how traditional medical devices are currently appraised for reimbursement in Australia. They expressed caution around the lack of clarity regarding who is responsible for app quality as well as concerns about the digital literacy of medical practitioners and their patients.ConclusionsSince stakeholder trust in the current HTA process for medical devices in Australia is high, the process was adapted to create an evaluation framework for mHealth apps. The adaptations included making provisions for cybersecurity, software updates, and compatibility issues. Provisions to address concerns around practitioner responsibility and misinformation were incorporated into the framework.

Life Cycle Assessment and Costing Methods for Device Procurement: Comparing Reusable and Single-Use Disposable Laryngoscopes.

Traditional medical device procurement criteria include efficacy and safety, ease of use and handling, and procurement costs. However, little information is available about life cycle environmental impacts of the production, use, and disposal of medical devices, or about costs incurred after purchase. Reusable and disposable laryngoscopes are of current interest to anesthesiologists. Facing mounting pressure to quickly meet or exceed conflicting infection prevention guidelines and oversight body recommendations, many institutions may be electively switching to single-use disposable (SUD) rigid laryngoscopes or overcleaning reusables, potentially increasing both costs and waste generation. This study provides quantitative comparisons of environmental impacts and total cost of ownership among laryngoscope options, which can aid procurement decision making to benefit facilities and public health. We describe cradle-to-grave life cycle assessment (LCA) and life cycle costing (LCC) methods and apply these to reusable and SUD metal and plastic laryngoscope handles and tongue blade alternatives at Yale-New Haven Hospital (YNHH). The US Environmental Protection Agency's Tool for the Reduction and Assessment of Chemical and other environmental Impacts (TRACI) life cycle impact assessment method was used to model environmental impacts of greenhouse gases and other pollutant emissions. The SUD plastic handle generates an estimated 16-18 times more life cycle carbon dioxide equivalents (CO2-eq) than traditional low-level disinfection of the reusable steel handle. The SUD plastic tongue blade generates an estimated 5-6 times more CO2-eq than the reusable steel blade treated with high-level disinfection. SUD metal components generated much higher emissions than all alternatives. Both the SUD handle and SUD blade increased life cycle costs compared to the various reusable cleaning scenarios at YNHH. When extrapolated over 1 year (60,000 intubations), estimated costs increased between $495,000 and $604,000 for SUD handles and between $180,000 and $265,000 for SUD blades, compared to reusables, depending on cleaning scenario and assuming 4000 (rated) uses. Considering device attrition, reusable handles would be more economical than SUDs if they last through 4-5 uses, and reusable blades 5-7 uses, before loss. LCA and LCC are feasible methods to ease interpretation of environmental impacts and facility costs when weighing device procurement options. While management practices vary between institutions, all standard methods of cleaning were evaluated and sensitivity analyses performed so that results are widely applicable. For YNHH, the reusable options presented a considerable cost advantage, in addition to offering a better option environmentally. Avoiding overcleaning reusable laryngoscope handles and blades is desirable from an environmental perspective. Costs may vary between facilities, and LCC methodology demonstrates the importance of time-motion labor analysis when comparing reusable and disposable device options.

Four Food and Drug Administration draft guidance documents and the REGROW Act: A litmus test for future changes in human cell- and tissue-based products regulatory policy in the United States?

Modern regenerative medicine research has expanded well past the development of traditional drugs and medical devices with many promising new therapies encompassing an increasingly diverse range of substances, notably cell‐based therapies. These substantial recent developments and the progress in the health care and therapeutics fields necessitate a new regulatory framework agile enough to accommodate these unique therapies and acknowledge their differences with traditional pharmaceuticals. In the United States, recent proposed changes in the regulatory framework for autologous human cells, tissues, and cellular and tissue‐based products (HCT/Ps) and their perceived risk–benefit analysis for patients remain controversial in the scientific field. To provide perspective on of the current status of the most recent attempts to redefine and conceptualize these changes in the United States, we will examine 4 draft guidance documents implemented by the Food and Drug Administration in interpreting relevant concepts and terminology pertaining to HCT/Ps: the Bipartisan Policy Center think tank report, “Advancing Regenerative Cellular Therapy: Medical Innovation for Healthier Americans,” the proposed REGROW Act for HCT/Ps, and the current 24 Food and Drug Administration‐approved HCT/Ps and related products in the United States.

A real-world perspective: Building and executing an integrated customer engagement roadmap that bridges the gaps in traditional medical device development processes

Today, up to 88% of medical technology companies fail to deliver significant return to their investors. Clearly, the traditional stage-gate process employed in new product development is not dynami...

Porous Polylactide Film Plus Atorvastatin-Loaded Thermogel as an Efficient Device for Peritoneal Adhesion Prevention.

Peritoneal adhesion is a common postoperative complication that causes many kinds of organ dysfunctions. It can be minimized by the integration of physical isolation and pharmaceutical treatment. However, the gas permeability of traditional medical devices for adhesion prevention is not satisfactory, which increases the risk of infection and inflammation, thus facilitating the formation of peritoneal adhesion. In this study, a device of porous polylactide (PLA) film plus atorvastatin (ATV)-loaded thermogel was developed for peritoneal adhesion prevention. PLA film acted as a physical barrier to prevent the connection of fibrin bridges between the injured tissues and nearby normal organs. Simultaneously, ATV was released to achieve the antifibrin deposition and anti-inflammatory effect. The porous properties of PLA film and thermogel increased the gas permeability and further inhibited the inflammatory responses. The in vivo study demonstrated that the porous PLA film with ATV-loaded thermogel possessed excellent anti-inflammation ability and satisfactory antiadhesion capacity, indicating its great potential for clinical application.

Spot and continuous monitoring of heart rate by combining time and frequency domain analysis of photoplethysmographic signals at rest conditions

Heart rate (HR) is one of the vital signs in healthcare monitoring systems. The traditional medical devices are very expensive and the accessibility of these devices is limited. So the objective is to propose an efficient framework to monitor the HR at on-demand and continuous modes during rest conditions, which are a typical use case. The proposed framework is based on combining the time-domain (TD) and frequency-domain (FD) analysis. This hybrid approach would handle the different signal conditions to improve the results. The proposed method is compared with the standard ECG device and the real-time results show that the HR is calculated accurately with an average pass percentage of 97.85, mean absolute percentage error of 1.99%, mean absolute error of 1.51 BPM and reference closeness factor of 0.977. The reliable on-demand HR output from the proposed method comes in 6th second, which is the minimum possible time. The results show that the proposed method is efficient in estimating the HR and the results are comparable with other methods. So the proposed method can be targeted to wearable devices to accurately monitor the HR at rest conditions.

Can machine learning complement traditional medical device surveillance? A case study of dual-chamber implantable cardioverter-defibrillators.

BackgroundMachine learning methods may complement traditional analytic methods for medical device surveillance.Methods and resultsUsing data from the National Cardiovascular Data Registry for implantable cardioverter–defibrillators (ICDs) linked to Medicare administrative claims for longitudinal follow-up, we applied three statistical approaches to safety-signal detection for commonly used dual-chamber ICDs that used two propensity score (PS) models: one specified by subject-matter experts (PS-SME), and the other one by machine learning-based selection (PS-ML). The first approach used PS-SME and cumulative incidence (time-to-event), the second approach used PS-SME and cumulative risk (Data Extraction and Longitudinal Trend Analysis [DELTA]), and the third approach used PS-ML and cumulative risk (embedded feature selection). Safety-signal surveillance was conducted for eleven dual-chamber ICD models implanted at least 2,000 times over 3 years. Between 2006 and 2010, there were 71,948 Medicare fee-for-service beneficiaries who received dual-chamber ICDs. Cumulative device-specific unadjusted 3-year event rates varied for three surveyed safety signals: death from any cause, 12.8%–20.9%; nonfatal ICD-related adverse events, 19.3%–26.3%; and death from any cause or nonfatal ICD-related adverse event, 27.1%–37.6%. Agreement among safety signals detected/not detected between the time-to-event and DELTA approaches was 90.9% (360 of 396, k=0.068), between the time-to-event and embedded feature-selection approaches was 91.7% (363 of 396, k=−0.028), and between the DELTA and embedded feature selection approaches was 88.1% (349 of 396, k=−0.042).ConclusionThree statistical approaches, including one machine learning method, identified important safety signals, but without exact agreement. Ensemble methods may be needed to detect all safety signals for further evaluation during medical device surveillance.

A Conceptual Framework of Smart Home Context

Addressing the health problems of the 21st century will require individuals to use a new set of medical and public health resources that extend beyond historic and traditional medical devices and are built on current and smart information technologies. Much of these new medical tools was originally designed by device manufacturers to be used only in clinical settings and by trained healthcare professionals but recently are finding their way into the home nevertheless. Their migration to the home poses many challenges to both caregivers and care recipients. In order to facilitate their migration to the home, it is very important to first understand the domain boundary, its components and their interactions. Little research discusses the context of smart home healthcare and its surrounding entities to date. This paper aims to fill the knowledge gap by developing a framework of smart home healthcare context. To this end, the authors conducted semi-structured interviews with patients and health professionals served for or by home healthcare agencies on the east coast in the United States. They analyzed the content applying thematic approach. The findings revealed four major components of the framework including person, tasks, technologies, and environments. The findings also revealed to define the interactions between these components. The findings have significant implications for smart home designers and manufacturers, and service providers.

Cuffless and Continuous Blood Pressure Estimation from the Heart Sound Signals.

Cardiovascular disease, like hypertension, is one of the top killers of human life and early detection of cardiovascular disease is of great importance. However, traditional medical devices are often bulky and expensive, and unsuitable for home healthcare. In this paper, we proposed an easy and inexpensive technique to estimate continuous blood pressure from the heart sound signals acquired by the microphone of a smartphone. A cold-pressor experiment was performed in 32 healthy subjects, with a smartphone to acquire heart sound signals and with a commercial device to measure continuous blood pressure. The Fourier spectrum of the second heart sound and the blood pressure were regressed using a support vector machine, and the accuracy of the regression was evaluated using 10-fold cross-validation. Statistical analysis showed that the mean correlation coefficients between the predicted values from the regression model and the measured values from the commercial device were 0.707, 0.712, and 0.748 for systolic, diastolic, and mean blood pressure, respectively, and that the mean errors were less than 5 mmHg, with standard deviations less than 8 mmHg. These results suggest that this technique is of potential use for cuffless and continuous blood pressure monitoring and it has promising application in home healthcare services.

Can You Diagnose Me Now? A Proposal to Modify the FDA’s Regulation of Smartphone Mobile Health Applications with a Pre-Market Notification and Application Database Program

Advances in mobile technology continually create new possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA) has the authority to regulate a broad spectrum of products beyond traditional medical devices like stethoscopes or pacemakers. The regulatory question is not if the FDA has the statutory authority to regulate health-related software, but rather how it will exercise its regulatory authority. In September 2013, the FDA published Final Guidance on Mobile Medical Applications; in it, the Agency limited its oversight to a small subset of medical-related mobile applications, referred to as “mobile medical applications.” For the Final Guidance to be effective, the FDA must continue to work directly with all actors—including innovators, doctors, and patients as the market for mobile health applications continues to develop. This Note argues that the FDA should adopt a two-step plan—a pre-market notification program and a mobile medical application database—to aid in the successful implementation of its 2013 Final Guidance. By doing so, the FDA will ensure that this burgeoning market can reach its fullest potential.

Acquisition and analysis of cardiovascular signals on smartphones: potential, pitfalls and perspectives: by the Task Force of the e-Cardiology Working Group of European Society of Cardiology.

Smartphones, mobile applications ('apps'), social media, analytics, and the cloud are profoundly changing the practice of medicine and the way health decisions are made. With the constant progress of technology, the measurement of vital signals becomes easier, cheaper, and practically a standard approach in clinical practice. The interest in measuring vital signals goes beyond medical professionals to the general public, patients, informal caregivers, and healthy individuals, who frequently lack any formal medical training. On smartphone platforms such as iOS and Android, a proliferation of health or medical 'apps' acquire and analyse a variety of vital signs through embedded sensors, interconnected devices or peripherals utilising on occasion analytics and social media. Smartphone vendors compete with traditional medical device manufacturers in the grey area between health care, wellness, and fitness, as US and EU regulatory bodies are setting and revising rules for these new technologies. On the other hand, in the absence of robust validation results, clinicians are hesitant to trust measurements by apps or recommend specific apps to their patients, partly also due to lack of a cost reimbursement policy. This review focuses on the acquisition and analysis on smartphones of three important vital signs in the cardiovascular and respiratory field as well as in rehabilitation i.e. heart or pulse rate, blood pressure, and blood oxygenation. The potential, pitfalls, and perspectives on mobile devices and smartphone apps for health management by patients and healthy individuals are discussed.