Medical apps for smartphones: lack of evidence undermines quality and safety
TL;DR: This work proposes several strategies to enhance the development of evidence-based medical apps while retaining their open nature, and establishes appropriate regulatory procedures to enable this potential to be fulfilled, while at all times ensuring the safety of the patient.
Abstract: 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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TL;DR: The state of the art in mobile clinical and health-related apps is examined, as healthcare professionals and consumers continue to express concerns about the quality of many apps, calling for some form of app regulatory control or certification to be put in place.
Abstract: This paper examines the state of the art in mobile clinical and health-related apps. A 2012 estimate puts the number of health-related apps at no fewer than 40,000, as healthcare professionals and consumers continue to express concerns about the quality of many apps, calling for some form of app regulatory control or certification to be put in place. We describe the range of apps on offer as of 2013, and then present a brief survey of evaluation studies of medical and health-related apps that have been conducted to date, covering a range of clinical disciplines and topics. Our survey includes studies that highlighted risks, negative issues and worrying deficiencies in existing apps. We discuss the concept of ‘apps as a medical device’ and the relevant regulatory controls that apply in USA and Europe, offering examples of apps that have been formally approved using these mechanisms. We describe the online Health Apps Library run by the National Health Service in England and the calls for a vetted medical and health app store. We discuss the ingredients for successful apps beyond the rather narrow definition of ‘apps as a medical device’. These ingredients cover app content quality, usability, the need to match apps to consumers’ general and health literacy levels, device connectivity standards (for apps that connect to glucometers, blood pressure monitors, etc.), as well as app security and user privacy. ‘Happtique Health App Certification Program’ (HACP), a voluntary app certification scheme, successfully captures most of these desiderata, but is solely focused on apps targeting the US market. HACP, while very welcome, is in ways reminiscent of the early days of the Web, when many “similar” quality benchmarking tools and codes of conduct for information publishers were proposed to appraise and rate online medical and health information. It is probably impossible to rate and police every app on offer today, much like in those early days of the Web, when people quickly realised the same regarding informational Web pages. The best first line of defence was, is, and will always be to educate consumers regarding the potentially harmful content of (some) apps.
566 citations
Cites background from "Medical apps for smartphones: lack ..."
...We describe the online Health Apps Library run by the National Health Service in England and the calls for a vetted medical and health app store....
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...at the general public, and whether (and most importantly how) they should be assessed and controlled by the US Food and Drug Administration (FDA) and/or other relevant and corresponding entities in other countries such as the Medicines and Healthcare Products Regulatory Agency (MHRA) in England [88-91]....
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...Regulatory control and certification of medical and health apps Studies expressing concerns about existing apps for colorectal diseases, microbiology, dermatology, asthma, diabetes and opioid converters A number of recent articles and studies have investigated the potential dangers and safety of some clinical and health apps aimed at healthcare professionals (but available to all) or aimed at the general public, and whether (and most importantly how) they should be assessed and controlled by the US Food and Drug Administration (FDA) and/or other relevant and corresponding entities in other countries such as the Medicines and Healthcare Products Regulatory Agency (MHRA) in England [88-91]....
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...But many apps with dosage calculator functions currently marketed in the UK still do not carry the CE mark to show that they have been registered as class I medical devices with the MHRA in England or one of the corresponding regulatory bodies in other EU countries [109]....
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...NHS (England) online Health Apps Library: a full-fledged ‘vetted app store’ is still a far distance away The National Health Service (NHS) in England runs an online Health Apps Library [111], where it lists and recommends some carefully selected apps such as ‘iBreastCheck’ (Breakthrough Breast Cancer) [112] and the NHS’ own ‘Health Choices’ app [113] (not all of the listed apps can be considered as medical devices)....
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TL;DR: A range of different kinds of risks that medical apps can contribute to and important contextual variables that can modify these risks are identified and a simple generic risk framework is developed to assess the likely risks posed by a specific app in a specific context.
Abstract: The use of mobile medical apps by clinicians and others has grown considerably since the introduction of mobile phones. Medical apps offer clinicians the ability to access medical knowledge and patient data at the point of care, but several studies have highlighted apps that could compromise patient safety and are potentially dangerous. This article identifies a range of different kinds of risks that medical apps can contribute to and important contextual variables that can modify these risks. We have also developed a simple generic risk framework that app users, developers, and other stakeholders can use to assess the likely risks posed by a specific app in a specific context. This should help app commissioners, developers, and users to manage risks and improve patient safety.
224 citations
Cites background from "Medical apps for smartphones: lack ..."
...Such risks have led to recent calls for increased regulation before further use and adoption of some apps in clinical practice [15-17]....
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TL;DR: A comprehensive review of the state-of-the-art research and developments in smartphone-sensor based healthcare technologies is presented and a discussion on regulatory policies for medical devices and their implications in smartphones-based healthcare systems is presented.
Abstract: Over the past few decades, we have witnessed a dramatic rise in life expectancy owing to significant advances in medical science and technology, medicine as well as increased awareness about nutrition, education, and environmental and personal hygiene. Consequently, the elderly population in many countries are expected to rise rapidly in the coming years. A rapidly rising elderly demographics is expected to adversely affect the socioeconomic systems of many nations in terms of costs associated with their healthcare and wellbeing. In addition, diseases related to the cardiovascular system, eye, respiratory system, skin and mental health are widespread globally. However, most of these diseases can be avoided and/or properly managed through continuous monitoring. In order to enable continuous health monitoring as well as to serve growing healthcare needs; affordable, non-invasive and easy-to-use healthcare solutions are critical. The ever-increasing penetration of smartphones, coupled with embedded sensors and modern communication technologies, make it an attractive technology for enabling continuous and remote monitoring of an individual’s health and wellbeing with negligible additional costs. In this paper, we present a comprehensive review of the state-of-the-art research and developments in smartphone-sensor based healthcare technologies. A discussion on regulatory policies for medical devices and their implications in smartphone-based healthcare systems is presented. Finally, some future research perspectives and concerns regarding smartphone-based healthcare systems are described.
218 citations
Cites background from "Medical apps for smartphones: lack ..."
...Concerns also remain among many researchers about whether and/or how a regulatory policy would be adopted and enforced by the government bodies such as the US Food and Drug Administration (FDA), and Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) [185,186]....
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TL;DR: Based on the available evidence, apps may be considered feasible health interventions, but more studies involving larger sample sizes, and with patient and health professional input at all stages, are needed to determine apps’ acceptability and effectiveness.
Abstract: Background: The prevalence of physical chronic or long-term conditions in adolescents aged 10-24 years is rising. Mobile phone and tablet mobile technologies featuring software program apps are widely used by these adolescents and their healthy peers for social networking or gaming. Apps are also used in health care to support personal condition management and they have considerable potential in this context. There is a growing body of literature on app use in health contexts, thereby making a systematic review of their effectiveness very timely. Objective: To systematically review the literature on the effectiveness of mobile apps designed to support adolescents’ management of their physical chronic or long-term conditions. Methods: We conducted a review of the English-language literature published since 2003 in five relevant bibliographical databases using key search terms. Two independent reviewers screened titles and abstracts using data extraction and quality assessment tools. Results: The search returned 1120 hits. Of the 19 eligible full-text papers, four met our review criteria, reporting one pilot randomized controlled trial and three pretest/post-test studies. Samples ranged from 4 to 18 participants, with a combined sample of 46 participants. The apps reported were targeted at type 1 diabetes, asthma, and cancer. Two papers provided data for calculating effect size. Heterogeneity in terms of study design, reported outcomes, follow-up times, participants’ ages, and health conditions prevented meta-analyses. There was variation in whether adolescents received guidance in using the app or were solely responsible for navigating the app. Three studies reported some level of patient involvement in app design, development, and/or evaluation. Health professional involvement in the modelling stages of apps was reported in all studies, although it was not always clear whether specific clinical (as opposed to academic) expertise in working with adolescents was represented. The dearth of studies
201 citations
Cites background from "Medical apps for smartphones: lack ..."
...The additional contextual challenge is that manufacturers are readily developing apps which are not based on empirical evidence [68]....
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TL;DR: This Review assesses the current literature and content of existing apps that target patients with CVD risk factors and that can facilitate behaviour change and evaluates how apps can be used throughout all age groups with different CVD prevention needs.
Abstract: Cardiovascular disease (CVD) is the leading cause of morbidity and mortality globally. Mobile technology might enable increased access to effective prevention of CVDs. Given the high penetration of smartphones into groups with low socioeconomic status, health-related mobile applications might provide an opportunity to overcome traditional barriers to cardiac rehabilitation access. The huge increase in low-cost health-related apps that are not regulated by health-care policy makers raises three important areas of interest. Are apps developed according to evidenced-based guidelines or on any evidence at all? Is there any evidence that apps are of benefit to people with CVD? What are the components of apps that are likely to facilitate changes in behaviour and enable individuals to adhere to medical advice? In this Review, we assess the current literature and content of existing apps that target patients with CVD risk factors and that can facilitate behaviour change. We present an overview of the current literature on mobile technology as it relates to prevention and management of CVD. We also evaluate how apps can be used throughout all age groups with different CVD prevention needs.
184 citations
References
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TL;DR: The clinical use of smartphones and apps will likely continue to increase, and the absence of high-quality and popular apps despite a strong desire among physicians and trainees is demonstrated.
Abstract: 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.
490 citations
TL;DR: 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, and there is considerable risk of individuals being misled.
Abstract: 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.
338 citations
"Medical apps for smartphones: lack ..." refers background in this paper
...Eighty-six percent of 111-reviewed pain-management apps were found to have no medical professional involvement.(12) Only 12% reported a physician as the app’s author....
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TL;DR: 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.
Abstract: Background
The use of smartphones and their associated applications (apps) provides new opportunities for physicians, and specifically orthopaedic surgeons, to integrate technology into clinical practice.
176 citations
TL;DR: In this case, IVIG therapy may be considered as a new therapeutic option in resistant forms of IGDA and the exact mechanism of action of IVIG remains unclear.
Abstract: antagonist production, activation of blockade of death receptor Fas (CD95), modulation of dendritic cell properties, increased expression and signalling through the inhibitory Fc receptor, Fc-c RIIB and enhanced steroid sensitivity. In our case, the exact mechanism of action of IVIG remains unclear. IVIG therapy may be considered as a new therapeutic option in resistant forms of IGDA. More case reports and trials are required to demonstrate the efficacy of this treatment in patients with IGDA.
124 citations
"Medical apps for smartphones: lack ..." refers background in this paper
...Two recent studies in the fields of dermatology and microbiology revealed that less than 35% of medical apps had medical expert involvement during their development.(3) Eighty-six percent of 111-reviewed pain-management apps were found to have no medical professional involvement....
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TL;DR: 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.
Abstract: 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
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 …
107 citations