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      Transparency of Health-Apps for Trust and Decision Making

      , Dr med, MPH , 1

      (Reviewer)

      Journal of Medical Internet Research

      JMIR Publications Inc.

      smartphone, technology, education, medicine, app, health care, Android, iPhone, BlackBerry, Windows Phone, mobile phone, standards

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          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Smart devices such as smartphones and tablet PCs have become an integral part of everyday life as well as for professional applications. This is also true for medicine [1]. To enhance patient safety for medical apps or health apps that are to be used successfully in today’s medical settings, a good information policy should always be part of the marketing strategy. Patients and doctors that are well informed about the benefits, limits, and risks of an app are in a better position to give more reasoning to their decisions whether they want to use it in a medical context or not. To address the current shortcomings concerning the way information about apps is provided to potential users of apps, Lewis, in a recent letter to JMIR, proposed a set of standard criteria [2] analogous to those published by the Health on the Net foundation [3] to be used for assessing the utility of medical apps based on a systematic self-certification model. He suggested using a central platform for this purpose, for example, the United Kingdom National Health Service App Store, to allow registered developers of mobile medical apps to highlight the fact that they conform to these criteria. This would probably also give developers and distributors of such apps an advantage over their competitors. While this certainly is a promising approach, I would like to add a few points. For one, in an international setting with users coming from various (and in many cases non-professional) backgrounds, it may be difficult to lead them to a separate platform that is not the standard app distribution platform that users are accustomed to. This is especially the case for casual users who probably tend to use information that is readily available on the app stores or to simply read what other users have to say about an app. In my opinion, the users themselves should not be disregarded in the overall process since they play an important role by applying the information they have at hand to the product they are interested in and evaluating whether it meets their needs. In contrast to other medical products (eg, for clinical use), where many professional users are confronted with already chosen products that have been labeled as appropriate by experts, many professionals or laypersons have to decide on the appropriateness of the medical app themselves. Therefore, especially for apps, ensuring patient safety also has to include the identification of the right product, in this case an app, that matches the desired setting and indication. Every piece of information covering the necessary aspects helps decision makers and/or end users in professional settings as well as for private use to determine whether an app can be trusted and safe. Thus, to ensure high impact, it would probably make sense to provide users with the appropriate information at places where they expect it (ie, directly in an app’s description on the respective app store and/or on the manufacturer’s homepage and/or marketing material). This should be done following a standardized structure that includes criteria with a clear rationale (Table 1), for example, in the form of a clearly structured app synopsis (Table 2) [4]. A basis for this was proposed in [5], which also included the aspects mentioned in [2] with more detail. There are already a number of existing initiatives and projects that use almost identical criteria to those suggested by Lewis, for example, the “Apps Peer-Review” by the Journal of Medical Internet Research (JMIR) launched in 2013 [6]. The JMIR mHealth disclosure form [7] also covers many of the concerns mentioned in the proposed app synopsis. Mostly, these projects reach this goal by installing certification and/or (third party) review processes and publishing the corresponding evaluation results using specific channels (eg, their own webpage or scientific journals). The app synopsis could be seen as a “first level” approach according to criteria already specified by previous projects dealing with quality assurance for Web-based information sources [8], though its focus is slightly different. At first, it could serve to provide all interested parties with sufficient information that, in addition to providing customers with basic information about an app, can then also be used as a starting point for building tests (eg, to identify the appropriate reviewers and testing methods, independent of the business model or revenue strategy that is employed by each respective initiative). The current market players come from different backgrounds and thus also have different interests in mind. In Germany, for example, there are some initiatives focusing mainly on a single disease while others target health apps in general. Also, their funding strategies differ significantly, ranging from privately funded initiatives or publicly financed institutions to companies that are being paid on a case-by-case basis. If manufacturers were to publish the necessary information following this app synopsis, both they as well as the users would clearly benefit. Users would receive a complete and easily comprehensible set of information that would support them in their decision making process while manufacturers would be able to follow the simple structure of the synopsis to compile the necessary information without expending too much effort since they only have to compile information that should already be available to them. Although this is not equivalent to an officially sanctioned certification process, information published according to the synopsis could nevertheless serve as a reference if there are any disputes between both sides.   Table 1 Criteria for assessing health apps and medical apps. Criteria Content Rationale Imprint Information about the manufacturer/distributor and associates To get in touch, to identify conflicts of interest (influence) of the sponsor and all associated parties   Metadata of the app To get basic information about the actuality of the app Rationale Description of the app’s intended purpose(s), targeted user(s), the dedicated setting of the app, its categorization as a medical / non-medical app To understand the idea behind the app, its categorization on a professional level and its ideal deployment setting and field of application Functionality Description on the functionalities and features of the app and the restrictions and limits To understand the underlying functions to achieve the app's purpose(s) and its limits and risks to estimate whether the app is safe for usage   Details about what measures have been taken to assure good usability of the app To be informed about methods that were employed during the development cycle regarding the app’s usability for specific target groups Validity and reliability Description and reliability of information sources the app is based on To assess whether the content and its authors are reliable and whether the functionality base on reliable and valid information sources   Description of quality assurance methods To estimate the level of quality in the production process of the app Data requisitioning & management Description of the amount and types of data that are being collected and processed To be able to determine whether the app’s data collection & processing are  adequate to fulfil the stated purpose Data protection & privacy Information about the manufacturer’s adherence to data protection and privacy laws and regulations and the involved jurisdictions To find out whether the manufacturer provides a privacy statement and data protection policy that is well adapted to the app’s purpose Data transmission & storage Description of all measures taken to protect data entrusted to the app To assess whether data transmission & storage is protected adequately Table 2 Detailed description of items of the App-Synopsis for health apps and medical apps. Item Category Checklist Item Sub Items 1. Imprint 1.1 Meta Data 1. Operating system     2. Version number     3. Web link (project pages and link to the app store)     4. Category: Commercial project, non-commercial project, other     5. Category: public access via an app store, only available to a restricted number of users/experts (in-house), other (please specify)   1.2 Developer/Distributor 1. Information about the manufacturer/developer     1.1 Name, address, webpage, contact person(s), email address, phone and fax number     2. Information about the distributor     2.1 Name, address, webpage, contact person(s), email address, phone and fax number   1.3 Sponsoring/Advertising 1. Information about the funding used for developing the app     1.1 Category: sponsoring, advertisements, other 2. Rationale 2.1 Category 1. Category: medical product or not, if yes: which class; has the app been certified voluntarily (by whom?), uncertified app   2.2 User group For each user group:     1. Specific disease/condition (or as an alternative/addition: which health care professions are targeted, etc)     2. Gender, age (range), other descriptive items   2.3 Setting 1. Clinical, outpatient setting, at home, other     2. Short description of a typical “use case”   2.4 Purpose 1. Short description of the purpose of the app     2. Category: information, reference work, educational resources, documentation, diagnostics, therapy, prevention, research, other     3. Basic description of what the app is to be used for including specific information for the user group(s) 3. Functionality 3.1 Functions and Features For each available function/feature:     1. Function (designation)     1.1 Example     1.2 Source(s)     1.3 Category: scientifically accepted, up-to-date content and reflects the current state of science and technology, evidence level if applicable   3.2 Restrictions and Limits 1. Restrictions and limits of the app     1.1 Specific description of the app’s restrictions and limits     1.2 Description of potential or existing risks for the user group(s)     1.3 Measures that have been implemented to avoid risks for the user group(s)     2. Already known undesirable effects     2.1 Detailed description of undesirable effects, if any   3.3 Usability 1. Methods that were employed during the development cycle     1.1 Results of usability testing 4. Validity and reliability 4.1 Content 1. Information about the expert(s) responsible for the app’s content     1.1 Name of the author(s)     1.2 Description of the qualification of the expert(s)     1.3 Description of potential or actual conflict of interest     2. Information about source(s)/reference(s) for all content and algorithms integrated into the app     2.1 Specific information about the source(s)     2.2 Evidence level of the source(s)     3. Studies that have been performed concerning the app     3.1 Type of the study, references/literature, other evidence     4. Additional material about the app (test reports, etc)     4.1 Type of additional material, reference links, ...   4.2 Quality assurance 1. Information about quality assurance measures that were used  during development 5. Data requisitioning & management 5.1 Data handling 1. Data processing   1.1 Information about data collection mechanisms integrated into the app     2. Data protection & privacy     2.1 Voluntariness of participating in any data collection     3. Data transmission & storage     3.1 Purpose of the data collection     3.2 Who profits from the collected data     3.3 What kind of and how much data are being collected, at what times (including time intervals where applicable)? In which country is the data being stored? This is especially important considering the differences between data privacy laws and regulations in different countries.     3.4 Which methods are being used for storing and evaluating the data?     3.5 Specifics about user’s rights to obtain information about any data that are stored about him; in addition, there must be means to revoke an already given permission to store data. For this purpose, a contact address must be specified.     3.6 It must also be possible to delete data that have already been stored and the user must be informed about the timespan that is needed until the data are really deleted.     3.7 Encryption methods and level used for protecting the user’s data during transmission, storage and evaluation. It should also be specified whether it is possible to connect a specific user to the stored data or whether the data are being stored anonymously or pseudonymized.     3.8 An indication about whether it is possible to prevent data collection and/or transmission and if yes, how this is possible.

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          Most cited references 8

          • Record: found
          • Abstract: found
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          Is Open Access

          The Smartphone in Medicine: A Review of Current and Potential Use Among Physicians and Students

          Background Advancements in technology have always had major impacts in medicine. The smartphone is one of the most ubiquitous and dynamic trends in communication, in which one’s mobile phone can also be used for communicating via email, performing Internet searches, and using specific applications. The smartphone is one of the fastest growing sectors in the technology industry, and its impact in medicine has already been significant. Objective To provide a comprehensive and up-to-date summary of the role of the smartphone in medicine by highlighting the ways in which it can enhance continuing medical education, patient care, and communication. We also examine the evidence base for this technology. Methods We conducted a review of all published uses of the smartphone that could be applicable to the field of medicine and medical education with the exclusion of only surgical-related uses. Results In the 60 studies that were identified, we found many uses for the smartphone in medicine; however, we also found that very few high-quality studies exist to help us understand how best to use this technology. Conclusions While the smartphone’s role in medicine and education appears promising and exciting, more high-quality studies are needed to better understand the role it will have in this field. We recommend popular smartphone applications for physicians that are lacking in evidence and discuss future studies to support their use.
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            A Systematic Self-Certification Model for Mobile Medical Apps

            Errol Ozdalga and colleagues recently highlighted the impressive range of roles and uses of smartphones in the medical setting [1]. An important point highlighted and worth developing from this paper is the difficulties associated with accurately comparing and assessing different medical apps for smartphones. This is mainly due to the fact that medical apps are often designed with one particular focus and inherently different interfaces which often make a direct comparison between apps unfeasible. Furthermore, even apps that purport to complete the same task often include extra functionality or features that make direct evaluation impossible. One solution offered by Ozdalga et al is to survey doctors on the perceived impact of specific apps available. However I believe that this is unfeasible given the rate at which the medical app ecosystem is evolving in terms of number, range, and type of app. With thousands of medical apps available, it is highly improbable that a clinician has a working knowledge of the complete range available. As such, any surveys will be subjective depending on the target audience and consequently offer limited utility for physicians and medical students alike. Moreover, surveys regarding specific apps are usually out of date by the time they are published. What is more important, is establishing a systematic method by which medical apps can be compared and their utility for health care professionals validated.   One proposed method to solve this is to develop a set of standard criteria that can be used to systematically assess the utility of a medical app for a health care professional. I believe that the most efficient and effective method should be based on a self-certification system with key criteria that have been adapted from the Health on the Net foundation (HON, [2]). Table 1 shows potential self-certification criteria which medical apps could be reasonably expected to achieve in order to establish the validity of the information contained within the app. The Health on the Net Foundation Code of Conduct (HONcode) for medical and health websites addresses one of Internet's main health care issues: the reliability and credibility of information. It is therefore highly applicable to medical apps that are subject to the same issues.   Using this system, it would then possible to set up a self-certification process where registered developers could highlight the fact that their app conforms to these basic criteria. At the moment, no such organization exists although there is clearly scope for such an entity. With the impending launch of the United Kingdom National Health Service App Store, it appears that there has never been a better time to develop a self-certification model for medical apps. Table 1 A list of potential criteria based on the HONcode to be used as the basis of a self-certification model for medical apps. Certification criteria Detailed description Information must be authoritative All medical information presented in a medical app must be attributed to an author and his/her training in the field must be mentioned. Purpose of the website A statement clearly declaring that the information on the app is not meant to replace the advice of a health professional has to be provided. A brief description of the app’s mission, purpose, and intended audience is necessary. Another brief description of the organization behind the app, its mission, and its purpose is also necessary. Confidentiality This principle is applicable to all apps, even if it does not host patient records or store any medical or personal data. The app must describe a privacy policy regarding how confidential, private or semi-private information such as email addresses and the content of emails received from or sent to users is treated. Users must be informed whether their data will be recorded in your own database, who can access this database (others, only you, nobody), if this information is used for your own statistics (anonymous or not), or if these statistics are used by third party or other companies. Even if one or more of these points are not relevant to your app, you must state how you handle the following information sent to you by your visitors: (email addresses or/and contact information, names, personal, or medical data). Information must be documented: referenced and dated All medical content (page or article) has to have a specific date of creation and a last modification date. All sources of the medical content must be clearly indicated the recognized, scientific, or official sources of health information quoted in the app. Ideally, a precise link to the source is provided whenever it is possible. Justification of claims All information about the benefits or performance of any treatment (medical and/or surgical), commercial product, or service is considered as claims. All claims have to be backed up with scientific evidence (medical journals, reports, or others). Contact details The app must be completely operational and the information must be accessible and clearly presented. There must be a way to contact the developer, such as a working email address or contact form, for users who would like to have more details or support. This contact must be easy to access from anywhere within the app. Financial disclosure Each app must include a statement declaring its sources of funding. This is required for all apps, including those with no external sources of funds, and apps funded by government agencies, pharmaceutical companies, or other commercial entities. All funding must be declared: government agency, private companies, donations, etc. Developers also have to declare all conflicts of interest. Advertising policy Conflicts of interest and external influences which could affect the objectivity of the editorial content must be clearly stated in a disclaimer. All apps displaying paying banners have to have an advertising policy. This policy must explain how the app distinguishes between editorial and advertising content and which advertisements are accepted. Any conflict of interest has to be explained.
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              App-synopsis - standard reporting for medical apps.

              The market for medical apps is rapidly expanding - both for professional use as well as for patient centered apps. There are numerous medical apps, but relevant information about their limitations and dangers is rarely available. In an exemplary evaluation of n=8 medical apps, deficits regarding data integrity, one half had security and privacy issues. Since standard users usually have neither the equipment, know-how nor time for such analyses before entrusting them with their data, ideally, manufacturers should provide information regarding the functionality and limits of their products. Mandatory information should cover data management, data protection and privacy issues. To increase transparency, a standardized reporting tool in the form of an app synopsis could be helpful for providing the necessary information.
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                Author and article information

                Contributors
                Journal
                J Med Internet Res
                JMIR
                Journal of Medical Internet Research
                JMIR Publications Inc. (Toronto, Canada )
                1439-4456
                1438-8871
                December 2013
                30 December 2013
                : 15
                : 12
                Affiliations
                1PL Reichertz Institute for Medical Informatics Hannover Medical School HannoverGermany
                Author notes
                Corresponding Author: Urs-Vito Albrecht albrecht.urs-vito@ 123456mh-hannover.de
                Article
                v15i12e277
                10.2196/jmir.2981
                3958693
                24449711
                ©Urs-Vito Albrecht. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 30.12.2013.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.

                Categories
                Original Paper
                Letter to the Editor

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