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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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... Despite their ubiquity, numerous concerns regarding the usage and indeed increasing reliance of pharmacists on MMA exist. The lack of evidence and professional medical involvement in the design and development of some MMA raised concerns regarding the reliability and accuracy of their medical content, and the potential adverse consequences to patient safety [6]. This complexity was heighten by the difficulties faced in adjudicating the accuracy and reliability of available MMA, as they are all created by independent developers without oversight by any regulatory bodies [7]. ...
... The frequency of access was higher compared to a similar study conducted in Malaysia in 2013, suggesting an increased reliance on MMA, to the point that it can be considered an indispensable tool [3]. Respondents also have high trust on the accuracy of the information, despite the various concerns regarding credibility raised in the literature [6,7,17]. This may be because that most of the MMA they were using were established apps being universally used by most pharmacists and pharmacy students [3,9,10]. ...
... This may be because that most of the MMA they were using were established apps being universally used by most pharmacists and pharmacy students [3,9,10]. Nevertheless, better regulation on MMA, including mandating external peer review and periodic assessment should be pursued to safeguard the integrity of the information, increasing the confidence of healthcare professionals to use them [6,19]. The national formulary was the most downloaded app, demonstrating the importance of having a localized formulary app to facilitate drug information decision making. ...
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Introduction: Pharmacists are frequent users of mobile medical apps (MMA) for drug information (DI) and clinical decision-making purposes. However, the wide range of available MMA may be of variable credibility and results in heterogeneous recommendations. The need for subscription may also influence choice of apps. Objective: The objective of this study was to determine the usage pattern of MMA among hospital pharmacists, including their perceptions and factors affecting their choice of apps. Methods: This cross-sectional study required respondents to fill in an online questionnaire. The questionnaire included sections on respondents' demographic data, MMA usage pattern, perceived usefulness and opinion on subscription fees. Items were adapted from available literature and validated locally. It was made accessible for 6 weeks starting November 2019 for all pharmacists working in the 23 public hospitals in Sarawak to response (universal sampling). Collected data were analysed using descriptive and inferential statistics. Results: A response rate of 37.2% was achieved (n = 162). Respondents were heavily reliant on MMA, with 78.4% accessing them multiple times daily. The majority also agreed that MMA contain correct and up-to-date information. A median of 5 apps were downloaded, suggesting an ultimate app catering for all DI needs was lacking. The Malaysian Drug Formulary was the most downloaded app (88.3%), whereas Lexicomp® was the most "well-rounded" in terms of functionality. Clinical pharmacists were significantly more likely to purchase MMA, in particular UpToDate® (p < 0.01) due to their need to access clinical updates. Respondents highly recommended institutional access for either UpToDate® or Lexicomp® be made available. Pre-registration pharmacists should be guided on judicious MMA usage, as they downloaded significantly more apps and were more likely to indicate not knowing which DI recommendation to follow (both p < 0.01). Conclusion: MMA has become an indispensable tool for hospital pharmacists, however there was a tendency to download multiple apps for DI needs. Institutional access can be considered for credible apps identified to ensure accuracy and uniformity of DI recommendations, with purchase decision made after surveying the needs and preferences of end users.
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Visuell präsentierte Belege werden in der Wissenschaftskommunikation nicht nur zur Veranschaulichung von wissenschaftlichen Zusammenhängen genutzt, sondern sie stehen mitunter auch stellvertretend für die Evidenz demonstrierter Sachverhalte und suggerieren Objektivität. Verschiedene (visuelle) Evidenzpraktiken können unterschieden werden, welche allerdings auch instrumentalisiert wurden und werden, um politische Strategien oder Ideologien zu legitimieren. Der Beitrag zeigt anhand unterschiedlicher visueller Evidenzen und Evidenzpraktiken in Gesundheitsausstellungen, wie diese in verschiedenen historischen Kontexten zur Wissenschaftskommunikation und politischen Instrumentalisierung eingesetzt wurden. Unsere explorative, historische Analyse zeigt, dass visuelle Evidenzen und Evidenzpraktiken gezielt für politische Propaganda unterschiedlicher politischer Systeme in Gesundheitsausstellungen des Deutschen Hygienemuseums Dresden eingesetzt wurden. Diese politische Instrumentalisierung visueller Evidenzen zeigt sich auch ganz aktuell in der Verbreitung von Falschinformationen zum Thema Impfen und COVID-19
... Solche Feststellungen decken sich mit anderen Untersuchungen [39,40,41,42]. Insgesamt gibt es eine Reihe von Arbeiten, die belegen, dass digitale Anwendungen zu einer signifikanten Senkung des HbA1c-Werts, einer konsequenten Glukosekontrolle sowie einer Verbesserung des Wohlbefindens sowie Einhaltung eines gesünderen Lebensstils beitragen können [16,17,18,19,20,21,22,25,43,44,45,46,47,48,49,50,51,52]. Ebenso konnte durch das Selbstmonitoring ein Rückgang der kardiovas- kulären Mortalität sowie eine Steigerung der Aufmerksamkeit gegenüber Symptomen festgestellt werden [43]. ...
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Hintergrund: Mit Blick auf Diabetes mellitus Typ 2 als lebensstilinduzierte Erkrankung wird ein großer potenzieller Nutzen in Gesundheits-Apps gesehen, die gesundheitsunterstützend bei Prävention und Monitoring oder auch der Therapie helfen sollen. Das Ziel der Studie ist es, den Anwendungshorizont, die Akzeptanz und Einstellungen sowie Erfahrungen von Ärzt*innen aus diabetologischen Schwerpunktpraxen hinsichtlich des Nutzungspotenzials von Gesundheits-Apps für Diagnostik, Therapie und Prävention bei Diabetes mellitus Typ 2 explorativ zu beleuchten. Methodik: Aufbauend auf mehreren Vorstudien wurden mittels schriftlicher Befragung zwischen März und Mai 2021 insgesamt 291 Ärzt*innen diabetologischer Schwerpunktpraxen in Rheinland-Pfalz, Hessen, Thüringen und dem Saarland anonymisiert befragt. Die Rücklaufquote beträgt 30% (N=88). Neben der deskriptiven Analyse wurde ein t-Test bei unabhängigen Stichproben durchgeführt. Ergebnisse: Die Befragten verbinden mit dem Einsatz von Apps eine wirksame Stärkung von Empowerment, Motivation und Compliance, aber auch durch Erinnerungs- und lebensstilunterstützenden Funktionen eine mögliche Effektivierung der Prävention und des Erkrankungsmanagements von Typ-2-Diabetes-Patient*innen. Gerade jüngere Ärzt*innen in städtischen Praxisumgebungen begegnen Gesundheits-Apps mit positiver Einstellung und greifen im Praxisalltag auf solche Tools zurück. Skepsis besteht auf Seiten der Befragten u.a. in Bezug auf die Anwendungsfreundlichkeit und Datensicherheit bestehender Apps sowie hinsichtlich rechtlicher Fragestellungen. Eine Mehrheit räumt ein, keinen ausreichenden Überblick über diabetologische Apps zu besitzen und traut sich eine Beratung von Patient*innen nur bedingt zu. Diejenigen Ärzt*innen, bei denen Apps schon in der Versorgung Einzug fanden, beobachten in großer Mehrzahl positive Effekte bei der Steigerung der Compliance, im schnelleren Aufdecken bzw. Verringern von Komplikationen, bei der Gewichtsreduktion sowie bei der Abnahme des HbA1c-Werts. Diskussion: Trotz der positiver Effekte, die Gesundheits-Apps für Prävention und Therapie haben können, bestehen bei vielen diabetologischen Ärzt*innen Vorbehalte hinsichtlich der Überschaubarkeit, Transparenz und Sicherheit von Apps. Diese Bedenken sollten verstärkt adressiert werden, um die richtigen Voraussetzungen für eine erfolgreiche Integration von Gesundheits-Apps in die diabetologische Versorgung zu schaffen (u.a. verbindliche Datenschutz- und Qualitätsstandards, klare Rechtslage in Bezug auf die Anwendung von Apps, Schulungen, Tools zur Übersicht und Einordnung). https://www.thieme-connect.com/products/ejournals/abstract/10.1055/a-1859-6400 Background: With a view to type 2 diabetes mellitus as a lifestyle-induced disease, a great potential benefit is seen in health apps that are intended to help with prevention and monitoring or therapy. The aim of the study is to exploratively illuminate the application horizon, the acceptance and attitudes as well as the experiences of doctors from practices specializing in diabetes with regard to the potential use of health apps for diagnosis, therapy and prevention of type 2 diabetes mellitus. Methods: Based on several preliminary studies, a total of 291 doctors from specialist diabetology practices in Rhineland-Palatinate, Hesse, Thuringia and Saarland were interviewed anonymously by means of a written survey between March and May 2021. The response rate is 30% (N=88). In addition to the descriptive analysis, a t-test was performed with independent samples. Results: Respondents associate the use of apps with an effective strengthening of empowerment, motivation and compliance, but also with reminder and lifestyle-supporting functions so that prevention and disease management of type 2 diabetes patients can be made more effective. In particular, younger doctors in urban practice environments have a positive attitude towards health apps and use such tools in everyday practice. The respondents are skeptical about the user-friendliness and data security of existing apps, as well as with regard to legal issues. A majority admits that they do not have a sufficient overview of diabetological apps and only have limited confidence in advising patients. The vast majority of those doctors who have already used apps in care observe positive effects in terms of increasing compliance, detecting or reducing complications more quickly, reducing weight and reducing the HbA1c value. Discussion: Despite the positive effects that health apps can have on prevention and therapy, many doctors from specialist diabetology practices have reservations regarding the manageability, transparency and security of apps. These concerns should be addressed in order to create the prerequisites for the successful integration of health apps into diabetological care (such as data protection and quality standards, clear legal situation with regard to the use of apps by physicians, further education, tools for overview and classification).
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In China, online medical consultation is regarded as part of the “Internet + medical treatment” and has gradually become an accepted way for people to seek medical advice. However, many factors can affect users’ security information behavior during the consultation process. In order to explore and evaluate the factors influencing the security information behavior of online medical consultation users, this paper firstly adopted semistructured interviews to collect data concerning the influencing factors originating from users themselves, other personnel, and the environment. Secondly, the Delphi method was used to determine the evaluation index system of the factors influencing the security information behavior of online medical consultation users based on the interview data. In this system, there are three first-level indexes, nine second-level indexes, and twenty-three third-level indexes. Finally, the weight of each evaluation index was calculated by the analytic hierarchy process (AHP) in the index system. This study improves and deepens the theoretical system of influencing factor evaluation of security information behavior. In addition, it also provides theoretical guidance and support for the more rational development of online medical consultation information services.
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There has been a rapid increase in the interest of various mHealth technologies for both monitoring and treatment within mental health. We aimed to provide a systematic review and quality assessment of published randomized trials (RCTs) investigating the use of smartphones for treatment in psychiatry. MEDLINE, PsycINFO and Embase was search for published trials. A total of 29 RCTs including a total of 2891 patients with psychiatric disorders were included for evaluation. Overall, a total of seven RCTs included patients with psychotic disorders, 12 RCTs included patients with affective disorders, and ten included patients with other psychiatric disorders (e.g. anxiety disorders and alcoholism). The trials investigated different smartphone-based systems including symptom monitoring, CBT elements, and behavioral activation. All trials were assessed to be at high risk of bias or reasons to be concerned. Overall, there is a lack of RCTs with large sample sizes using rigorous study methodology and long follow-up periods.
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PurposeInformation technology (IT)-based interventions, especially mobile health (mHealth), possess a great potential for promoting self-management in patients with chronic diseases, including diabetes type II. The present study was aimed to design and develop a smartphone-based application (app) for nutrition management in patients with type II diabetes and evaluation of its usability.Methods In this study, a three-phase research approach was followed; (1) To determine the information content and functionalities of the app, a five-point Likert scale checklist including six parts was developed based on reviews of clinical practice guidelines and specialized databases. The checklist was then given to ten experts in endocrinology and metabolism, internal medicine, and nutrition, and those items with a mean score higher than 3.75 were approved. (2) In Android Studio, the app was designed and developed using Java language. (3) The Questionnaire for User Interaction Satisfaction (QUIS) was used to assess the app’s usability by 21 patients with type II diabetes, ten IT experts, and seven endocrinologists, internal medicine practitioners, and nutritionists over one month. Mean scores were divided into three levels: weak (0–3), average (3–6), and good (6–9).ResultsAccording to experts’ view, 17 out of 22 educational content and 17 out of 27 functionalities were approved. The app’s most important educational content was the timing of meals for insulin patients and the definition of diabetes and its complications. The designed app had the following functionalities: providing educational information, recording information, performing calculations, representing data graphically, setting reminders, and communicating with physicians. The most important features of the app were the insulin dose calculation, reminders for doctors’ appointments, setting times for tests and blood glucose measurements, and also tracking weight, blood glucose levels, and blood pressure. In terms of usability evaluation, the app was rated “good” level by diabetic patients (7.83 ± 0.74), IT experts (8.1 ± 0.66), and physicians (8.03 ± 0.95).Conclusion Given the desirable evaluation of the app by patients, physicians, and IT experts, it can be concluded that the developed app has the required functionalities for nutrition management of patients with type II diabetes. Smartphone-based apps appear to be able to improve self-management, the quality of care and health in patients with diabetes, and reduce many of their unnecessary visits to healthcare centers, and costs.
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Nutzungsraten von Smartphones, Tablets und Wearables steigen quer durch alle Bevölkerungsschichten und „mobile Gesundheit“ (mHealth) liegt im Trend. Ob als Schrittzähler, zum Erfassen von Blutdruckdaten oder als Berater bei Ernährungsfragen: in den App Stores tummeln sich unter den inzwischen hunderttausenden Apps auch geeignete für die Prävention und Gesundheitsförderung. Diverse Stakeholder aus Industrie, Politik, Gesundheitsbranche und Verbraucher schreiben der Technologie große Potenziale zu. Das vorliegende Kapitel setzt sich mit den wichtigsten Fragen zu den Kerncharakteristika von mHealth-basierten Lösungen auseinander und skizziert Chancen und Potenziale ebenso wie mögliche Hürden und Grenzen für die Technologie mit Fokus auf den Einsatz im Präventionsbereich. Ferner werden Qualitätsanforderungen an Apps adressiert und Hilfestellungen zum praktischen Erkennen von qualitativ adäquaten Apps gegeben.
Article
Background The quality of the patient experience has become one of the key pillars of service in the healthcare industry. Positive word-of-mouth, higher retention, and loyalty to healthcare providers are all influenced by a good and positive patient experience. This study was proposed to examine the relationship between service quality of medical apps, patient sensitivity, and patient experience. Methods Data were gathered from a sample of 387 respondents utilising medical applications to access various services. A few standardised questionnaires, including SERVQUAL, were used to collect the data. Python programming was used to perform the collected data's structural equation modelling (SEM) analysis. Results The findings show that there is a significant impact of service quality of medical apps on patient sensitivity and patient experience and also patient experience has a strong and positive relationship with patient sensitivity. Conclusion The research results indicate that patients prioritised service quality factors like reliability, tangibility, empathy, responsiveness and assurance when selecting services from medical applications.
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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 RETURN TO TEXT “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) RETURN TO TEXT 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 RETURN TO TEXT 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 RETURN TO TEXT 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. References1.↵Dick RS, Steen EB eds.The computer-based patient record—an essential technology for health care.Washington DC: National Academy Press,1991.2.↵Anderson RJ.Security in clinical information systems.London: British Medical Association,1996.3.↵Anderson RRigby M.Keeping confidence in confidentiality: linking ethics, efficiency, and opportunity in health care computing—a case study. In: Anderson R ed.Personal medical information—security, engineering, and ethics; personal information workshop, Cambridge, UK, June 21–22, 1996 proceedings.Berlin: Springer-Verlag,1997:129–150.4.↵Anderson RRoberts R, Thomas J, Rigby M, Williams J.Practical protection of confidentiality in acute care. In: Anderson R ed.Personal medical information—security, engineering, and ethics; personal information workshop, Cambridge, UK, June 21–22, 1996 proceedings.Berlin: Springer-Verlag,1997:67–78.5.↵Cesnik B, McCray AT, Scherrer J-RRigby M, Hamilton R, Draper R.Towards an ethical protocol in mental health informatics. In: Cesnik B, McCray AT, Scherrer J-R eds.Medinfo 98 9th world congress in medical informatics, proceedings.Amsterdam: IOS Press,1998:1223–1227.6.↵House of Commons official report (Hansard). Session 1962–6., 1963 May 8.London: HMSO,1963.7.↵Hawking M.Code conversions, data stability, and the future—an agenda for discussion.J Inf Primary Care1995;June:3–5.8.↵Cavalli P.False-negative results in Down's syndrome screening.Lancet1996;347:965–966.OpenUrlMedlineWeb of Science9.↵Computer error leads to smear recalls failure.Health Serv J1998;106: 6.OpenUrl10.↵Wilkinson P.Down's test leaves 150 women in abortion fear.Times,2000 May31: 1, 3.11.↵Forsström J, Rigby M, Roberts R, Nilsson S, Wyatt J, Beier B, et al.Towards evaluation and certification of telematics services for health (TEAC-Health)—key recommendations.Turku: University of Turku,1999.12.↵Forsström J.Why certification of medical software would be useful?Int J Med Inf1997;47:143–152.OpenUrlMedline13.Wyatt J.Quantitative evaluation of clinical software, exemplified by decision support systems.Int J Med Inf1997;47:165–173.OpenUrlMedline14.↵Forsström J, Rigby M.Considerations on the quality of medical software and information services.Int J Med Inf1999;56: 1–3,169–76.15.↵Multimedica.Towards evaluation and certification of healthcare applications in Europe. (accessed 10 Aug 2001)16.↵EU Council.Directive 93/42/EEC concerning medical devices.Brussels: European Commission,1993.17.↵Anderson RHawking M.Organisation of general practice: implications of IM&T in the NHS. In: Anderson R ed.Personal medical information—security, engineering, and ethics; personal information workshop, Cambridge, UK, June 21–22, 1996 proceedings.Berlin: Springer-Verlag,1997:56–65.18.↵Eysenbach G, Diepgen TL.Responses to unsolicited patient e-mail requests for medical advice on the world wide web.JAMA1998;280: 15,1333–5.OpenUrl19.↵Sandvik H.Health information and interaction on the internet: a survey of female urinary incontinence.BMJ1999;319:29–32.OpenUrlFREE Full Text20.↵Impiccatore P, Pandolfini C, Casella N, Bonati M.Reliability of health information for the public on the world wide web: systemic survey of advice on managing fever in children at home.BMJ1997;314:1875–1879.OpenUrlFREE Full Text21.↵Weisbord SD, Soule JB, Kimmel PL.Poison on line—acute renal failure caused by oil of wormwood purchased through the internet.N Engl J Med1997;337:825–827.OpenUrlCrossRefMedlineWeb of Science22.↵Rogers R.A global information society for health—recommendations for international action.Br J Healthcare Computing Information Manage1999;16:28–30.OpenUrl23.↵Berland GK.Health information on the internet: accessibility, quality, and readability in English and Spanish.JAMA2001;285:2612–2621.OpenUrlFREE Full Text24.↵Council of the European Communities.Decision of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization directives.Brussels: European Commission,1993.25.↵Institute of Chartered Accountants in England and Wales.International chartered accountancy bodies launch webtrust—a worldwide web assurance service. (accessed 15 Aug 2001).26.↵Rigby M.The management and policy challenges of the globalisation effect of informatics and telemedicine.Health Policy1999;46:97–103OpenUrlCrossRefMedlineWeb of Science27.↵Rigby M, Roberts R, Thick MRigby M.And into the 21st century—telecommunications and the global clinic. In: Rigby M, Roberts R, Thick M eds.Taking health telematics into the 21st century.Oxford: Radcliffe Medical Press,2000
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