Mobile applications (apps) are special purpose applications designed for smartphone software platforms like Apple’s iOS or Google’s Android. Because of their accessibility for both clinicians and patients, they are often used in healthcare. Clinicians may use them either in medical education, at the point of care, through direct interaction with patients, or as a clinical reference. To patients, apps provide more information on particular conditions or overall health, allow access to their health records, thus empowering them and enabling better compliance.
Despite widespread use, the content and the quality of information of most mobile health apps freely available on the market today are not subjected to regulatory oversight. Namely, Food and Drug Administration’s act on Mobile Medical Applications in the USA and the European Commission’s Guidance Document for Medical Devices only refer to those mobile health apps that are qualified as medical devices, i.e. that are used in medical diagnosis and treatment (1, 2). On the other hand, the assessment of quality in the context of an app store, if any, typically refers to the app’s user interface design and the performance and stability of the software program.
Laboratory medicine data are part of many mobile health apps, where they may be involved in different ways. However their use, as well as the quality of the related information are questionable. That is why the Working Group of the European Federation of Clinical Chemistry and Laboratory Medicine on Patient Focused Laboratory Medicine (WG-PFLM) decided to search the online stores market for Android (Google Play) and iPhone (iTunes), as the two of the mostly used smartphone platforms, for health apps that manage in any way laboratory medicine data, in order to review them and perform a quality evaluation (3).
We have identified seven categories of apps dealing with laboratory medicine data:
- apps that offer medical advice about symptoms and health queries with the possibility to upload laboratory test results, which can be seen, stored and shared;
- reference ranges of selected analyses with basic information about the causes of increase or decrease designed for patients;
- apps that serve as quick reference guide to laboratory tests, designed for medical students and doctors;
- apps for monitoring the state of user’s health through a wide range of health parameters, including glucose and/or cholesterol as laboratory data;
- apps that provide access to patients’ laboratory results to physicians;
- apps that enable patients to access their laboratory test results directly from the diagnostic center; and
- electronic health records apps that include laboratory test results.
The results of the extensive review and content analysis conducted using the Mobile App Rating Scale (MARS) (4) showed overall above average total quality of the evaluated apps. However, the analysis across the different app categories revealed that the apps with the poorest performance and quality were those providing patients reference ranges and basic information on the causes of increased or decreased results. There were also considerable issues concerning the security of personal information used by these apps and the affiliations of developers (mostly unknown or commercial), without stating references for the information cited.
What should we recommend to all the potential app users who are searching for the meaning of laboratory test results, especially their own? First of all, to be aware that the content of apps is out of the regulatory scope of government and academic institutions. A reliable app should have clearly stated and visible references for the information that it offers. Finally, one should not rely on ratings of the apps provided by the app store as an indicator of quality, since they were not correlated with the objective quality evaluation we performed.
- U.S. Food and Drug Administration (FDA). Mobile medical applications: Guidance for industry and food and drug administration staff. Silver Spring, MD: U.S. FDA:2015.
- European Commission. Medical devices: guidance document. Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices. Brussels, Belgium. EC MEDDEV 2.1/6 July 2016.
- Jovičić S, Siodmiak J, Watson ID. Quality evaluation of smartphone applications for laboratory medicine. Clin Chem Lab Med 2019;57(3):388–97.
- Stoyanov SR, Hides L, Kavanagh DJ, Zelenko O, Tjodronegoro D, Mani M. Mobile app rating scale: a new tool for assessing the quality of health mobile apps. JMIR mHealth Uhealth 2015;3(1):e27. http://dx.doi.org/10.2196/mhealth.3422.