Designing and Using Mobile Health Applications (Medical and Health Apps): Practical Guidelines Are Needed

Background The number of Mobile Medical applications or “mobile medical apps” has been growing exponentially in the last few months and they are expected to grow even more in the next future. The use of health apps promises to be a means for improving patient care and making easier professional activity. However, some cases of malfunction or inaccurate diagnosis and treatment recommendations have been reported. Regulations are necessary tools to safeguard users (general public and professionals) and support the product development. In this work we present a preliminary analysis of the current recommendations related to medical apps, and based on the previous experience acquired, in the accreditation activities of health related content websites of the Medical Association of Barcelona during ten years, we put forward the development of a specific health apps certification program in Spain. Objective To determine the existence of practical recommendations for the design and use of medical and health apps and, by analyzing them, to establish the basis for setting up a health apps certification program. Methods Based on the combination of several keywords in Google, Bing and Yahoo!, the first 50 links, displayed in the page results of these search engines in the 20th February 2013, were reviewed in order to find recommendations and practical guidelines related to medical and health apps. The search strategy used was the following: ("mobile medical application" OR "health apps" OR "medical apps") AND (regulation OR guidance OR ((certification OR accreditation) program OR standards) OR "practical guide"). Results There are several institutions around the world promoting recommendations and practical guidelines for the design, implementation and use of medical and health apps, such as the Food and Drug Administration, Happtique, Devices 4 Limited or mHIMSS. Other institutions such as the European Commission, the National Library of Medicine or the National Health Service (UK) are promoting a repository website (something like an app store) where some apps are included after been submitted to some kind of screening process. The CE Mark for medical devices (European Commission) could be applied in some kinds of apps used in clinical environments. The main recommendations include standards related to accessibility, privacy and confidentiality, technical aspects, security and scientific accuracy. Conclusions The use of medical apps, above all those that are used in a clinical environment, should follow certain regulatory requirements and a clear protocol in the process of designing them to guarantee that, as much the health information as the clinical advice (diagnosis or treatment) they are providing, are accurate and avoid the potential risks to public health and patients. As a first step it seems critical to establish whether an app is a medical or not. Based on the analysis of international practical guidelines, the process model of the experienced quality program of health-related content websites, and the application of the specific features and use of medical apps, the most important standards and process of a certification program have been defined (target and general information, technical aspects, security, privacy and scientific content). []