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Medical apps for smartphones: Lack of evidence undermines quality and safety
Abstract and Figures
Increasing numbers of healthcare professionals are using smartphones and their associated applications (apps) in daily clinical care. While these medical apps hold great potential for improving clinical practice, little is known about the possible dangers associated with their use. Breaches of patient confidentiality, conflicts of interests and malfunctioning clinical decision-making apps could all negatively impact on patient care. We propose several strategies to enhance the development of evidence-based medical apps while retaining their open nature. The increasing use of medical apps calls for broader discussion across medicine's organising and accrediting bodies. The field of medical apps is currently one of the most dynamic in medicine, with real potential to change the way evidence-based healthcare is delivered in the future. Establishing appropriate regulatory procedures will enable this potential to be fulfilled, while at all times ensuring the safety of the patient.
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... [5][6][7][8][9][10] Even though randomized trials reported improvements in lifestyle and risk factor control, the effects of mHealth apps on disease prevention and outcomes remain controversial. [11][12][13][14][15] One of the reasons for the inconsistency in reported results might be the varying quality of mHealth apps. A recent consensus statement on the prevention of noncommunicable diseases pointed out the importance of human-centered design processes to develop effective and innovative interventions. ...
... 18 Another reason for the varying results might be the lack of evidence-based content in mHealth apps. 14 Two recent studies reviewing apps in the fields of dermatology and microbiology found that only a minority of the apps had medical professional involvement. 19,20 Finally, a possible lack of usability evaluation could also explain the varying results of mHealth apps. ...
... 30 Referring to recent reports criticizing the lack of evidence-based content in mHealth apps, HerzFit´s content was created on the basis of national and international recommendations on healthy lifestyles and CVD prevention. 1,14,31,45 The great variety of high-quality information and the guideline-based CVD risk calculator were particularly appreciated by our test users. ...
Background
Mobile health (mHealth) apps can be used for cardiovascular disease (CVD) prevention. User-centered design, evidence-based content and user testing can be applied to ensure a high level of usability and adequate app access.
Objective
To develop and evaluate an mHealth app (HerzFit) for CVD prevention.
Methods
HerzFit´s development included a user-centered design approach and guideline-based content creation based on the identified requirements of the target group. Beta testing and a preliminary usability evaluation of the HerzFit prototype were performed. For evaluation, German versions of the System Usability Scale (SUS) and the mHealth App Usability Questionnaire (GER-MAUQ) as well as free text feedback were applied.
Results
User-centered design thinking led to the definition of four personas. Based on their requirements, HerzFit enables users to individually assess, monitor, and optimize their cardiovascular risk profile. Users are also provided with a variety of evidence-based information on CVD and their risk factors. The user interface and system design followed the identified functional requirements. Beta-testers provided feedback on the structure and functionality and rated the usability of HerzFit´s prototype as slightly above average both in SUS and GER-MAUQ rating. Participants positively noted the variety of functions and information presented in HerzFit, while negative feedback mostly concerned wearable synchronization.
Conclusions
The present study demonstrates the user-centered development of a guideline-based mHealth app for CVD prevention. Beta-testing and a preliminary usability study were used to further improve the HerzFit app until its official release.
... Mobile health (mHealth) apps hold promise for bridging gaps in health care. However, a lack of evidence exists for the effectiveness of available mHealth apps [2], and highquality trials are needed to examine their effects [3]. So far, only reviews of the use of mHealth apps without systematic searches and evaluations have been performed [4]. ...
Background
The prevalence of chronic wounds is predicted to increase within the aging populations in industrialized countries. Patients experience significant distress due to pain, wound secretions, and the resulting immobilization. As the number of wounds continues to rise, their adequate care becomes increasingly costly in terms of health care resources worldwide. eHealth support systems are being increasingly integrated into patient care. However, to date, no systematic analysis of such apps for chronic wounds has been published.
Objective
The aims of this study were to systematically identify and subjectively assess publicly available German- or English-language mobile apps for patients with chronic wounds, with quality assessments performed by both patients and physicians.
Methods
Two reviewers independently conducted a systematic search and assessment of German- or English-language mobile apps for patients with chronic wounds that were available in the Google Play Store and Apple App Store from April 2022 to May 2022. In total, 3 apps met the inclusion and exclusion criteria and were reviewed independently by 10 physicians using the German Mobile App Rating Scale (MARS) and the System Usability Scale (SUS). The app with the highest mean MARS score was subsequently reviewed by 11 patients with chronic wounds using the German user version of the MARS (uMARS) and the SUS. Additionally, Affinity for Technology Interaction (ATI) scale scores were collected from both patients and physicians.
Results
This study assessed mobile apps for patients with chronic wounds that were selected from a pool of 118 identified apps. Of the 73 apps available in both app stores, 10 were patient oriented. After excluding apps with advertisements or costs, 3 apps were evaluated by 10 physicians. Mean MARS scores ranged from 2.64 (SD 0.65) to 3.88 (SD 0.65) out of 5, and mean SUS scores ranged from 50.75 (SD 27) to 80.5 (SD 17.7) out of 100. WUND APP received the highest mean MARS score (mean 3.88, SD 0.65 out of 5) among physicians. Hence, it was subsequently assessed by 11 patients and achieved a similar rating (uMARS score: mean 3.89, SD 0.4 out of 5). Technical affinity, as measured with the ATI scale, was slightly lower in patients (score: mean 3.62, SD 1.35 out of 6) compared to physicians (score: mean 3.88, SD 1.03 out 6).
Conclusions
The quality ratings from physicians and patients were comparable and indicated mediocre app quality. Technical affinity, as assessed by using the ATI scale, was slightly lower for patients. Adequate apps for patients with chronic wounds remain limited, emphasizing the need for improved app development to meet patient needs. The ATI scale proved valuable for assessing technical affinity among different user groups.
... (18) Un estudio publicado en Evidence-based medicine en 2013 concluyó que las aplicaciones móviles de salud pueden tener un impacto positivo en los resultados de salud de los pacientes y mejorar la calidad de la atención. (19) La creciente adopción de aplicaciones móviles y dispositivos portátiles presenta una oportunidad única para mejorar la telemedicina y la educación médica en áreas rurales. (20) Estas tecnologías pueden proporcionar a los profesionales de la salud en áreas remotas un acceso más fácil a la información médica actualizada, a las herramientas de diagnóstico y a las oportunidades de formación continua. ...
Introducción: La educación médica ha experimentado una notable transformación impulsada por los avances tecnológicos en las últimas décadas. La integración progresiva de herramientas digitales y tecnologías innovadoras ha enriquecido significativamente el acceso a recursos educativos y mejorado la práctica clínica.Objetivo: Este análisis tiene como objetivo evaluar el impacto de diversas tecnologías emergentes en la educación médica y su influencia en la práctica clínica, destacando las mejoras en las habilidades y la precisión diagnóstica, así como la personalización del aprendizaje.Métodos: Se realizó un análisis integral de estudios piloto y revisiones sistemáticas que evaluaron el impacto de diversas tecnologías en la educación médica. Se examinaron los datos recopilados de instituciones líderes y se utilizaron técnicas estadísticas para evaluar la efectividad de estas intervenciones tecnológicas.Resultados: Los estudios piloto demostraron mejoras significativas en las habilidades quirúrgicas y la precisión diagnóstica de los estudiantes de medicina que se beneficiaron de la realidad virtual y los simuladores clínicos. La aplicación de la inteligencia artificial y el aprendizaje automático también ha mejorado la interpretación de datos médicos y el diagnóstico precoz de enfermedades.Conclusiones: La integración continua de tecnologías emergentes en la educación médica muestra un potencial prometedor para personalizar el aprendizaje y mejorar la atención al paciente. Sin embargo, se deben abordar desafíos como la seguridad de los datos y la capacitación adecuada para garantizar una implementación exitosa y un impacto duradero en la práctica clínica y la educación médica.
... To develop an EHR that can meet these requirements, computer scientists and doctors who are familiar with the development and requirements of such an application must work together to prevent regulations, especially those that may be rather detrimental to patient welfare and beneficial to other parties [68]. With the constant progress of scientific knowledge, the contents of an EHR must also be regularly re-evaluated and improved. ...
Depressive disorders have one of the highest disability-adjusted life years (DALYs) of all medical conditions, which led the European Psychiatric Association to propose a policy paper, pinpointing their unmet health care and research needs. The first part focuses on what can be currently done to improve the care of patients with depression, and then discuss future trends for research and healthcare. Through the narration of clinical cases, the different points are illustrated. The necessary political framework is formulated, to implement such changes to fundamentally improve psychiatric care. The group of European Psychiatrist Association (EPA) experts insist on the need for (1) increased awareness of mental illness in primary care settings, (2) the development of novel (biological) markers, (3) the rapid implementation of machine learning (supporting diagnostics, prognostics, and therapeutics), (4) the generalized use of electronic devices and apps into everyday treatment, (5) the development of the new generation of treatment options, such as plasticity-promoting agents, and (6) the importance of comprehensive recovery approach. At a political level, the group also proposed four priorities, the need to (1) increase the use of open science, (2) implement reasonable data protection laws, (3) establish ethical electronic health records, and (4) enable better healthcare research and saving resources.
Bibliometric analyses of software applications in plastic surgery are relatively limited. This study aims to address this gap by summarizing current research trends and providing insights that may guide future developments in this field.
Data were retrieved from the Web of Science Core Collection. Visualized results, including publication characteristics, disciplines, journals, documents, countries/regions, institutions, authors, and research focuses, were analyzed and optimized using CiteSpace and the “Results Analysis” and “Citation Reports” functions in WoSCC.
A total of 339 publications were identified through manual screening, indicating a general upward trend in annual publications and citations. Key research areas in this field include computer-aided design, modeling, virtual reality, augmented reality, artificial intelligence, social media software, telemedicine, and mobile health. However, challenges such as the high costs of advanced tools, the need for specialized training, and concerns regarding data security and patient privacy are significant barriers. Addressing these issues could be crucial for broader adoption. Despite these obstacles, the potential benefits offered by these technologies suggest their increasing relevance in plastic surgery.
Plastic surgery appears to be evolving toward a more standardized, digitalized, and intelligent future. Software has the potential to transform traditional workflows in both research and practice, contributing to improvements in efficiency and precision in the field.
This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.
A cetoacidose diabética é caracterizada por um quadro de hiperglicemia associada a um aumento na produção de corpos cetônicos. É uma emergência pediátrica muito relevante, causa mais comum de hospitalização e morte em crianças diabéticas. O diagnóstico tardio pode levar a complicações graves. O desenvolvimento de um aplicativo pode contribuir para o melhor atendimento dos pacientes diabéticos, evitando complicações, tempo de internação e custos, sendo o objetivo do trabalho Assim, foi desenvolvido um aplicativo nas duas principais plataformas móveis existentes: Android e iOS. O aplicativo foi disponibilizado na língua portuguesa. Seus vários módulos são apresentados em uma formato prático, facilitando o diagnóstico, o tratamento e as complicações da doença. É composto por vários parâmetros que podem ser utilizados, levando a diferentes passos sequenciais, conduzindo assim a um raciocínio clínico, desde fluxogramas, tabelas, definição, fisiopatologia, diagnóstico clínico e laboratorial, classificações, tratamento e sua cronologia, prevenção, orientações das complicações após resolução da cetoacidose e orientações gerais, como os tipos de insulina, os insumos necessários e horários específicos para realização da glicemia capilar. A importância do trabalho reside no método de diagnóstico protocolado que oriente as primeiras medidas terapêuticas a serem tomadas, de forma a instituí-las o mais precoce possível, minimizando as possíveis complicações. O aplicativo está pronto para teste, podendo possibilitar ao profissional uma melhor condução de pacientes pediátricos com suspeita de cetoacidose diabética.
Background: There are more than 350,000 health apps available in public app stores. The extolled benefits of health apps are numerous and well documented. However, there are also concerns that poor-quality apps, marketed directly to consumers, threaten the tenets of evidence-based medicine and expose individuals to the risk of harm. This study addresses this issue by assessing the overall quality of evidence publicly available to support the effectiveness claims of health apps marketed directly to consumers.
Methodology To assess the quality of evidence available to the public to support the effectiveness claims of health apps marketed directly to consumers, an audit was conducted of a purposive sample of apps available on the Apple App Store.
Results We find the quality of evidence available to support the effectiveness claims of health apps marketed directly to consumers to be poor. Less than half of the 220 apps (44%) we audited state that they have evidence to support their claims of effectiveness and, of these allegedly evidence-based apps, more than 70% rely on either very low or low-quality evidence. For the minority of app developers that do publish studies, significant methodological limitations are commonplace. Finally, there is a pronounced tendency for apps-particularly mental health and diagnostic apps-to either borrow evidence generated in other (typically offline) contexts or to rely exclusively on unsubstantiated, unpublished user metrics as evidence to support their effectiveness claims.
Conclusions Health apps represent a significant opportunity for individual consumers and healthcare systems. Nevertheless, this opportunity will be missed if the health apps market continues to be flooded by poor quality, poorly evidenced, and potentially unsafe apps. It must be accepted that a continuing lag in generating high-quality evidence of app effectiveness and safety is not inevitable: it is a choice. Just because it will be challenging to raise the quality of the evidence base available to support the claims of health apps, this does not mean that the bar for evidence quality should be lowered. Innovation for innovation's sake must not be prioritized over public health and safety.
While chronic disease afflicts a large Indian population, the technologies used to manage chronic diseases have largely been informed by studies conducted in other sociocultural contexts. To address this gap, we conducted qualitative interviews with 21 patients clinically diagnosed with abnormal blood pressure (BP) living in low-resourced communities of Haryana, Uttarakhand and Uttar Pradesh in India. We found that patients’ trust in the BP ecosystem and social ties plays a significant role in shaping their perceptions of technology and chronic care. Trust in one actor of the ecosystem fosters trust in another, e.g., trust in BP reading depended on the type of device and the person measuring the BP. We also observed nuanced sharing and intermediation of BP devices. Based on our findings, we recommend designs to boost patients’ trust, familiarity, and access to technologies used in BP management and improve their experience of care in low-resource settings in India.
Information and its handling and transmission form an essential part of health care and are reflected in professional standards. Automated information systems in health care—health informatics services—will improve these functions and bring new opportunities through the harnessing of modern information and communications technologies. Thus, computer support is now essential in many parts of medicine, the US Institute of Medicine has long espoused the value of computerised patient records,1 and many countries have developed strategies on this topic, and there are countless health related internet sites.However, as new information and communication technologies in health bring new opportunities, they also bring new risks. Emphasis has rightly been placed on ensuring appropriate levels of confidentiality in electronic information systems—to the point that the highly exacting requirements being demanded by independent commentators and professional bodies2 are difficult to satisfy without jeopardising the functioning of core services 3 4 or the interests of the most vulnerable groups.5 In contrast, much less thought has been given so far to ensuring the appropriateness of the design and integrity of functioning of health informatics services.
Summary points
Like drugs 40 years ago, products in health informatics are unregulated with regard to safety and efficacy
A European project has now recommended ways of accrediting healthcare related software, telemedicine, and internet sites
A scheme like CE marking of electrical goods is recommended for software, national regulatory bodies should be identified for telemedicine, and a European certification of integrity scheme developed for websites
Importance of quality assurance of health informatics systems
If informatics systems are increasingly essential in the delivery of health care then their integrity and quality must be of equal importance, but this has been scarcely recognised to date. In 1963 the then UK secretary of state for health stated to the House of Commons: “The House and the public suddenly woke up to the fact that any … manufacturer could market any product, however inadequately t sted, however dangerous, without having to satisfy any independent body as to its efficacy and safety and the public was almost uniquely unprotected in this respect.”6 That statement related to drugs, being triggered by the thalidomide disaster, and the situation was changed rapidly. However, the same situation applies today with regard to electronic health informatics products and services, which are now the most important unregulated healthcare resource—in sharp contrast to drugs, medical devices, and licensed health professionals.
When errors and failures have occurred it has generally been in the interests of suppliers, provider organisations, and clinicians to quietly rectify or remove the flawed systems rather than draw attention to them. This, however, allows for unidentified and thus unquantified errors to be dispersed, with potential risk to patient health. Box 1 gives published examples of such health threatening errors in computer software. In a modern consumerist environment, however, this situation is unacceptable, as shown by the public furore over the software that miscalculated the risk of Down's syndrome in pregnancies.10
Box 1: Examples of health-threatening software errors
Errors in updated embedded clinical coding software giving false plain language representation of diagnoses, United Kingdom7Errors in reference database calculation of Down's syndrome screening, giving false negatives8Age cohort of women omitted from call up for cervical screening, Grampian Region, Scotland9Error in software calculating risk of Down's syndrome led to falsely low calculation of risk for 150 women, Sheffield10
The TEAC-Health project
Recently, a European project—towards European accreditation and certification of telematics services in health (TEAC-Health)—was conducted to investigate the issues, and we report its core findings here. The findings outlined in the project report11 have recently been formally accepted by the European Commission, which intends to examine in detail the steps required for their implementation (Jean-Claude Healy, head of health applications unit, Information Society Directorate-General, personal communication, 2000).
The project arose from an expert conference at Turku University in 1997 organised by JF, which resulted in several published articles.12–14 The work of the project was undertaken by representatives of five European countries; details of the membership and working reports can be found on the Multimedica website.15
Classification of health informatics services
For the project, we classified health informatics services into three categories—software and related services, telemedicine, and internet sites. Although many services combine more than one of these elements, the quality assurance and regulatory components for each need to be considered separately as the issues are quite distinct. We also felt it inappropriate to consider processes of quality assurance and verification solely in the health sector and therefore looked at commercial approaches such as regulation in the financial sector and at other areas of public risk such as air traffic control and food safety.
In the health sector, precedents have been set in the regulation of drugs and medical devices, but neither of these is directly applicable to health informatics services. Safety control of new drugs now depends largely on controlled trials, which are neither feasible nor affordable as a mandatory control for clinical software or internet sites. Regulation of medical devices has several similarities, but key differences are the much wider range of user proficiency and circumstances of use of informatics systems compared with medical devices and the difficulties of ensuring structured user training and education.
A taxonomy of risk assessment
We next considered how best to categorise risk in health informatics services, as it is only by identifying risk that appropriate control methods can be identified. For medical devices, the regulations are clear and helpful: they require that a device's manufacturer or supplier identifies the risk level as determined by the type of product and how life critical are the circumstances of its use.16 We concluded that risk in health informatics services depends on a combination of type of user, circumstances of use, type of use, and nature of the system. For example, a failure in an automated appointments system can have serious consequences by passing undetected, whereas an experienced clinician may filter out spurious results from a diagnostic support tool used merely as an aide memoire. The table shows the different levels of risk associated with different health informatics services.
View this table:View PopupView InlineLevels of risk in the use of health telematic systems
Quantification of the problem
We sought to identify and quantify the risks attributable to informatics services, and the degree of concern they produced. A comprehensive literature search and a small targeted survey of European opinion leaders from health and consumer domains showed that the problem was, if anything, greater than anticipated.15
Clinical software
Many of the problems identified when using clinical software are resolved between supplier and user on condition that there is no publicity, while the problems that are not identified cannot, by definition, be reported. Thus the literature will substantially underestimate these problems, but some errors have been reported (see box 1), as has the adverse outcome of software upgrades producing erroneous printed interpretations of previously recorded diagnostic data.17
Telemedicine
Less has been published about the risks of telemedicine services because of their comparative newness. However, we identified concerns about authenticity and risks in telemedicine services, including email consultations, other than those within a single provider organisation or on a closed, point to point basis.15 There are indications that a quarter of those offering telemedicine consultations directly to the general public do not hold the qualifications they claim (S Schanz, personal communication, 2000), and others may be offering advice beyond their qualifications. Studies have shown there is wide variation in the quality of advice provided, and, although guidance may generally be sound, the occurrence of so many outliers is an unacceptable and avoidable risk. 18 19
Internet sites
Services on the world wide web are the most obvious risk, as anyone can publish any information they like. Much of this information is valuable and the internet allows freedom of expression for patient support groups and leaders in alternative therapies, but studies have shown that both misleading and life threatening advice is readily available. 20 21 A figure of 1400 “suspicious” websites was reported by the coordinator of a study for the G8 group of countries, with a 21% increase in that number annually,22 and a recent US study found errors and contradictions even within sites.23 Yet, by its very nature, the internet cannot be controlled or censored.
Project survey
Our survey of opinion leaders, for which we used a “snowball sample” method, yielded 54 respondents, of whom 36 (67%) indicated that they had experienced one or more problems with health telematics services. Of the 74 problems reported, 10 adversely affected patient safety, four adversely affected optimum treatment of a patient, and 31 adversely affected the health professional's duty of care to a patient. Of all the respondents, 19 were “very concerned” about the current lack of quality assurance of telematics services and a further 22 had some concerns, giving a total of 41 (76%) “concerned.”
TEAC-Health recommendations for clinical software
In view of the need to avoid identified risks to the public, and the professional opinion in favour of some form of regulation, we concluded that specially crafted regulation was needed based on existing European experience with product control and monitoring health risks. The components suggested are as follows.
CE marking
Applying this publicly understood and reliable mark on approved goods is a well established process in Europe based on clear regulation24 and with variants for medical devices.16 However, further research is needed on the specific criteria to accommodate clinical software. This will require a “notified body” to have overall responsibility and to identify and monitor essential requirements for these products and services. As concurrent verification of design and quality is far more effective than retrospective testing, the necessary identification of control measures for production and quality assurance will itself yield invaluable standards for clinical software developers.
Labelling
A legally underpinned requirement for accurate and detailed labelling is a key element of our proposed solution, as this will enable purchasing organisations and clinical users to know much more about the software product. Identification of named responsible individuals will also substantially increase the commitment to ensure quality of design and manufacture. The exact requirements will need further discussion and definition, but box 2 shows a suggested list.
Box 2: Suggested labelling requirements for clinical software
Country of originIdentity of legal person or company responsibleIntended purpose (such as clinical advice, decision support, prescribing advice)Competence of intended end user (such as general practitioner, endocrinology specialist, triage nurse)Assumed knowledge of user (such as specific clinical qualification)Identity and registration body of health professional responsible for supervising the clinical element of the designKey sources of clinical logic or knowledge (such as citation of published material, authorship of in house clinical design)Extent of previous use or in house testing of this version“Hotline” telephone number for postmarketing surveillance
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“Hotline” for postmarketing surveillance
An essential part of CE marking is postmarketing surveillance, in particular the requirement that the supplier provides a “hotline” telephone number to which any problem or concern can be reported. It is also a statutory requirement of CE marking that all serious incidents are reported by the supplier to a “competent authority,” and this process is liable to unannounced audit on site.
National hotlines and monitoring organisations
Based broadly on existing models for drug products and medical devices, national hotlines and monitoring organisations are necessary for clinical software to ensure that problems such as adverse interactions between different products (see box 1) can be identified speedily. They are of proved benefit for other clinical products and already apply to health software in Sweden.
In house software and informatics services
Software and services developed by particular healthcare organisations for their own use cannot readily be subjected to compulsory CE marking as they are not marketed products. However, our proposed regulation would bring two safeguards. Firstly, the identification of professional standards would form a yardstick for identifying reasonable practice and duty of care should there be a formal complaint or litigation. Secondly, in house products could be submitted voluntarily to the verification process.
TEAC-Health recommendations for telemedicine
Telemedicine presents an entirely different situation because telecommunications based services that cross legislative boundaries are almost free of regulation. Thus, providers of healthcare services could escape regulation, particularly when moving to the internet. Since this leaves patients at risk, some control mechanisms are needed. In principle, legislation should be independent of the communication medium used—namely, the same ethical principles and liabilities should apply to telemedicine as to conventional patient care. Because telemedicine services can readily cross international boundaries, international coordination or coregulation is needed in Europe and beyond. Similarly, in countries such as the United States regulation is at the state level, leading to complex and unwieldy situations that hamper legitimate national providers and thus also patients.
Key elements of regulating telemedicine services should include international agreement as to whether such services are delivered under the law of the supplier or that of the consumer. The European Permanent Committee of Physicians (EPCP) now favours accepting European law that it is the supplier's legal system that applies (Ä Markku, chairman, EPCP, personal communication, 2000). Secondly, labelling (as above) with legal sanctions should be required, linked to a code of conduct, which needs to be developed. Box 3 shows proposed key elements.
Box 3 : Key elements of proposed labelling requirements and code of conduct for telemedicine
Healthcare professionals should state their full name and qualificationsThe professional body responsible for monitoring clinical practice must be identifiedRecords must be kept to an agreed standard, with the database maintained and protected according to European standards for data protectionTelemedicine traffic should be strongly encryptedTelemedicine service providers should be required to register with a national agency for the provision of the services, related to international standards and qualifications which need to be developedServices should be provided in accordance with stated technical standards (including those for equipment, telecommunication, and data interchange) together with stated practice standards (such as for image labelling and agreed terminology)
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Global regulation
A global regulatory framework is also important. There are clear and effective global conventions and supervisory organisations for both civil aviation and food standards, both of which operate on an evidence based principle, obtaining and interpreting emergent scientific evidence in order to formulate new standards that then become the basis for universally agreed international regulation. Delivery of telemedicine services internationally puts individual patients at risk of injury or death through incompetent or malicious unregulated providers, but, because the transactions are individual and confidential, adverse outcomes are not as conspicuous as in domains such as civil aviation. The same situation applied to pharmaceutical products until regulation.6 The global risk to personal health continues unabated in the absence of international agreement on regulation, liability, and control. We consider international telemedicine to deserve at least the same level of regulation as the civil aviation and food sectors. This could also aid the development of national frameworks, especially in countries with largely independent states or provinces.
TEAC-Health recommendations for internet sites
We believe that the cost of developing a system solely to verify the quality of health internet sites would be high and that it would be impractical. The Health on the Net Foundation (HON) has for some time been promoting a voluntary code of conduct, and there have been several overlapping initiatives in the United States (see box 4), but their main drawback is that there is no external verification and so the system is open to abuse and, indeed, offers false security.
Box 4: Voluntary initiatives for codes of conduct for health internet sites
Health on the Net Foundation (HON). www.hon.chSwiss based organisation, European focusInternet Health Coalition. www.ihealthcoalition.comUS based organisation, European inputAmerican Medical AssociationPrinciples governing AMA publications websites. pubs.ama-assn.org/ama_web.htmlJAMA special communication. Guidelines for medical and health information sites on the internet. jama.ama-assn.org/issues/v283n12/ffull/jsc00054.htmlHealth Internet Ethics. www.hiethics.comUS based organisationQuackwatch—Your Guide to Health Fraud, Quackery, and Intelligent Decisions. www.quackwatch.comUS based initiative
All sites accessed 20 June 2001
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However, the need for independently verified sites is common to many other internet activities, including retailing.25 As with CE marking and other recognised quality standards, the power of effective regulation depends on the universality of use leading to public recognition. We studied earlier attempts to identify high quality sites to the public, the best known being filtering mechanisms and rating systems.11 Both have drawbacks.
Most filtering excludes inappropriate items but also excludes many relevant sites, as it is difficult to develop a 100% specific yet sensitive filter that does not filter out required material. For example, a filter designed to protect against pornography will exclude sites with the word “breast,” but it will also filter out important medical sites. Such “heuristic” filtering depends on finding and interpreting key words. The alternative, “filtering in,” requires the site to undertake self rating honestly and accurately.
Rating systems depend on third parties such as informed users to provide a rating and score for each individual site, but this raises questions of ensuring objectivity, impartiality, and common clinical and cultural values to the extent that there are now proposals for rating the raters. Moreover, this leaves most sites unrated. Clearly, these methods are not feasible to aid general public users, nor indeed most health professional users unfamiliar with the intricacies of the internet. Box 5 summarises the issues.
Box 5: Impediments to voluntary quality assurance for websites
Voluntary codes
No closed industrial or commercial groupingVoluntary initiatives may reflect sponsors' interests or valuesEnforcement and sanctions are difficult to applyConsumer confusion with numerous initiatives
Filtering
UndiscriminatingMay exclude relevant sites
Rating
Requires major expert resourcesImposes values of ratersSlow to cover new sitesSites can change rapidly after rating
Monitoring or reporting apparently adverse sites
Cannot be comprehensiveBased on personal values
No action
Allows inaccurate (and malevolent) sites to remain unchallengedConsumers continue to be at risk
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The EuroSeal proposal
We have therefore proposed development of a new European system and standard, entitled the EuroSeal. 12 15 This would be a seal supplied to a website by an accredited agency (the approach fundamental to CE marking). Once attached to the site, its integrity would be verified by secure single socket layer or similar secure software, as currently happens with secure trading sites. The seal would be provided at two levels, the higher of which would require independent onsite verification (for a higher fee). The verification processes would be open and transparent—by clicking on the EuroSeal symbol, visitors to the site would see details of the site inspections, drawn in real time from the records of the accrediting body (as applies with current secure links for web commerce), as well as the code(s) of conduct to which the site adhered.
Codes of conduct
These are an important element of the EuroSeal approach, as they would form the basis on which the third party assessed a site provider's claims and decided whether to award the EuroSeal. Each health professional body would be able to devise its own codes of conduct and standards, and viewers would know against which code the EuroSeal had been applied. This approach would also allow special interest groups—such as ethnic groups, those with particular religious beliefs, and advocates of alternative medicine—to devise their own codes of conduct. Patient support groups could also devise codes of conduct, provided they met a prescribed framework and standard for codes.
Thus, the EuroSeal approach would not only provide a simple, clear, and universal public safeguard without seeking censorship but would also be socially progressive, enabling positive support and selection for special interest groups and minorities. As a mark of high integrity, it would be sought after by sites and looked for by search or filter by viewers.
Conclusions
Health informatics systems are invaluable to aid health care. Moreover, they bring intrinsic advantages, such as electronic records being more accessible than paper ones and, if properly protected and encrypted, being more secure from damage or prying. However, this is no excuse not to address current known and avoidable risks.
The TEAC-Health project has clearly shown that public safety and professional integrity are threatened by the lack of regulation of health informatics services. These risks will increase rapidly as health informatics services expand and as telecommunications and globalisation radically change attitudes to and delivery of health care. 26 27 Initiatives to date have been based on restricted research, lacked consideration of overall feasibility and other issues, or depend on the (usually unpublished) integrity and values of a secondary service provider. The strategic proposals we describe, which have now been welcomed by the European Commission, form an evidence based solution.
Footnotes
Competing interests JW has a small part of the equity of Medix, an internet service provider for doctors, and receives research and consultancy funding from various commercial sources.
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The past decade has witnessed the advent of the smartphone, a device armed with computing power, mobility and downloadable "apps," that has become commonplace within the medical field as both a personal and professional tool. The popularity of medically-related apps suggests that physicians use mobile technology to assist with clinical decision making, yet usage patterns have never been quantified. A digital survey examining smartphone and associated app usage was administered via email to all ACGME training programs. Data regarding respondent specialty, level of training, use of smartphones, use of smartphone apps, desired apps, and commonly used apps were collected and analyzed. Greater than 85% of respondents used a smartphone, of which the iPhone was the most popular (56%). Over half of the respondents reported using apps in their clinical practice; the most commonly used app types were drug guides (79%), medical calculators (18%), coding and billing apps (4%) and pregnancy wheels (4%). The most frequently requested app types were textbook/reference materials (average response: 55%), classification/treatment algorithms (46%) and general medical knowledge (43%). The clinical use of smartphones and apps will likely continue to increase, and we have demonstrated an absence of high-quality and popular apps despite a strong desire among physicians and trainees. This information should be used to guide the development of future healthcare delivery systems; expanded app functionality is almost certain but reliability and ease of use will likely remain major factors in determining the successful integration of apps into clinical practice.
The use of smartphones and their associated applications (apps) provides new opportunities for physicians, and specifically orthopaedic surgeons, to integrate technology into clinical practice.
The purpose of this study was twofold: to review all apps specifically created for orthopaedic surgeons and to survey orthopaedic residents and surgeons in the United States to characterize the need for novel apps.
The five most popular smartphone app stores were searched for orthopaedic-related apps: Blackberry, iPhone, Android, Palm, and Windows. An Internet survey was sent to ACGME-accredited orthopaedic surgery departments to assess the level of smartphone use, app use, and desire for orthopaedic-related apps.
The database search revealed that iPhone and Android platforms had apps specifically created for orthopaedic surgery with a total of 61 and 13 apps, respectively. Among the apps reviewed, only one had greater than 100 reviews (mean, 27), and the majority of apps had very few reviews, including AAOS Now and AO Surgery Reference, apps published by the American Academy of Orthopaedic Surgeons and AO Foundation, respectively. The national survey revealed that 84% of respondents (n = 476) have a smartphone, the majority (55%) have an iPhone, and that 53% of people with smartphones already use apps in clinical practice. Ninety-six percent of respondents who use apps reported they would like more orthopaedic apps and would pay an average of nearly $30 for useful apps. The four most requested categories of apps were textbook/reference, techniques/guides, OITE/board review, and billing/coding.
The use of smartphones and apps is prevalent among orthopaedic care providers in academic centers. However, few highly ranked apps specifically related to orthopaedic surgery are available, and the types of apps available do not appear to be the categories most desired by residents and surgeons.
we define 'apps' as discrete, independent pieces of software that run on mobile devices. The use of such software on mobile devices within a health environment is not a new phenomenon – there is academic research discussing the opportunities of this technology as early as 1996.
however, the proposition has only really become mainstream with the introduction of the Apple iPhone® and supporting App Store, backed by a hugely successful 'There's an app for that' advertising campaign. opening in July 2008 with a mere 500 applications available for
download, the App Store now stocks around 500,000 applications and recently surpassed a staggering milestone: 15 billion downloads. Latterly it has been joined by rival application markets from Blackberry®, Microsoft® and, most successfully, AndroidTM.
Clin Microbiol Infect 2012; 18: E218–E220
Increasing diversity of available medical applications (apps) has led to their widespread use in healthcare delivery. However, app involvement in diagnosis and patient management has raised concerns, specifically regarding accuracy and reliability of content. Here, we report on the contemporary range of microbiology-themed apps and prevalence of medical professional involvement in app development. Of 94 microbiology-themed apps identified, only 34% had stated medical professional involvement. The lack of such involvement in app design is concerning and undermines consumers’ ability to be informed regarding quality of content. We propose that increased regulatory measures are introduced to safeguard patient welfare.
Smartphone applications (or apps) are becoming increasingly popular. The lack of regulation or guidance for health-related apps means that the validity and reliability of their content is unknown. We have conducted a review of available apps relating to the generic condition of pain. The official application stores for five major smartphone platforms were searched: iPhone, Android, Blackberry, Nokia/Symbian and Windows Mobile. Apps were included if they reported a focus on pain education, management or relief, and were not solely aimed at health-care professionals (HCPs). A total of 111 apps met the inclusion criteria. The majority of apps reviewed claimed some information provision or electronic manual component. Diary tracking of pain variables was also a common feature. There was a low level of stated HCP involvement in app development and content. Despite an increasing number of apps being released, the frequency of HCP involvement is not increasing. Pain apps appear to be able to promise pain relief without any concern for the effectiveness of the product, or for possible adverse effects of product use. In a population often desperate for a solution to distressing and debilitating pain conditions, there is considerable risk of individuals being misled.
The popularity of smartphones now outstrips that of the personal computer, but is their use by doctors a desirable trend? Tom Nolan reports