Mobile Medical Apps: Dangers and Potential Solutions

Mobile medical apps: dangers and potential solutions

Mobile medical applications (apps) are widely used on mobile phones, e-readers and tablet computers by health professionals in clinical practice. The apps enable information and tools such as textbooks and medical calculators to be accessed at the point of care. The medical app market has grown rapidly but with this certain dangers arise: how can health professionals know whether an app is reliable, evidence-based and free from bias? ¹ App-developers, such as individuals, insurance companies, non-profit organizations, and in particular pharmaceutical companies who are developing apps as part of their marketing strategies, need to be more transparent about their role in funding and developing apps. Health professionals need to be aware that some apps may contain unreliable or misleading information and choose carefully which apps they use in clinical care.

Increasing numbers of healthcare professionals are using smartphones and apps. ² There are thousands of medical apps available for smartphones and tablet computers. These include apps to view guidelines and medication databases, to perform calculations, remotely monitor patients’ vital signs and view radiology images. This can improve patient safety, clinical outcomes, communication and system efficiency. However, many medical apps are used to analyse patient specific data, or to transform a mobile phone into a medical device to output patient specific data after the entry of personal medical information. ³ One area that draws a lot of attention is confidentiality, where patient data is stored on the phone. ⁴ A more widespread but often overlooked danger concerns the clinical content of apps. In many cases, it is unclear whether clinical apps provide reliable, evidence-based information that is free from conflicts of interests and bias. Studies have reported a lack of involvement of clinical experts in the development of apps, and have found content containing a lack of academic references and misleading claims. ⁵ For example, a study reviewing available apps on the subject of pain, found that 86% of the 111 included apps reported no medical professional involvement. ⁶ Another study showed that of 61 apps relating to dermatology, authorship information was absent in 36%, and only 33% stated a named dermatologist, other physician or valid collaborative group involved in the creation of the app. ⁵ It should be noted however, that while it seems logical that medical professional involvement leads to better quality medical apps, this has not actually been proven.

With the popularity of apps growing amongst healthcare professionals, pharmaceutical and medical-device companies have started sponsoring, developing and merchandising medical apps. These companies develop apps for marketing purposes, with the ultimate goal of increasing the use of their products. They often make their apps free of charge, thus making their product more tempting to health professionals than those of rivals. In return, the company that owns the app obtains a new way to contact health professionals. When registering to use an app, health professionals are often required to provide personal information. This information can be used by the company to send personalised marketing messages, which may lead to conscious and unconscious bias in prescribing habits. A systematic review of studies of physicians who were exposed to information from pharmaceutical companies found that doctors exposed to drug company information prescribe more often, at a higher cost and with less quality. ⁷ However, all of the 58 studies reviewed had design limitations and most of them were observational rather than randomized. Another study demonstrated a strong association between authors’ published positions on the safety of drugs and their financial relationships with pharmaceutical manufacturers. ⁸ As well as possibly biasing their behaviour, the use of pharmaceutical company sponsored apps by healthcare professionals may affect patient and public perception of their impartiality.

It is often difficult for the medical professional to determine the origin of a medical app, and in particular whether it was funded or created by a private or a commercial entity. There are no official statistics for apps released by commercial or pharmaceutical companies. An online blog has been maintaining a list of apps released by the pharmaceutical industry. ⁹ It currently lists 106 apps from 26 different pharmaceutical companies. The real figure is likely to be far higher as this list depends on the input of users.

At present, there are few controls on the production and marketing of medical apps. To our knowledge there are no organizations systematically evaluating the safety, accuracy or reliability of medical apps. Furthermore, no protocols exist on how to recall a malfunctioning or dangerous medical app to stop it from being used. Regulatory guidance is needed, as well as ways of evaluating apps. However, different legal regulations apply for different countries, which makes it complicated to create guidelines that are internationally applicable.

In the largest and most well developed app market – the US – the Food and Drug Administration (FDA) have recently proposed draft guidelines for the regulation of mobile medical apps. ¹⁰ They have stated that “apps that are used as an accessory to a medical device or that transform a smartphone into a regulated medical device; apps that are an extension of a medical device or apps that allow users to input patient-specific information to output patient-specific result will face regulation in the future.” ¹⁰ Unfortunately, these regulations do not deal with problems related to pharmaceutical industry marketing through apps, or apps containing inaccurate or misleading clinical information.

So far, no official guidelines have been released regarding medical apps in any other country. In the UK, the Association of the British Pharmaceutical Industry, an industry-funded body, represents research-based biopharmaceutical companies. The latest version of their Code of Practices for the pharmaceutical industry gives clear guidelines for advertising, but does not address how these regulations apply to apps. ¹¹

In our opinion, there are some important challenges concerning pharmaceutical marketing in apps. We think that commercial sponsorship and expertise can be of great benefit in producing better quality medical apps. This should be encouraged, provided the companies’ role in the development is properly acknowledged and that they carry out this role in an ethical and responsible manner. For this to be accepted as legitimate, medical accrediting bodies and physicians’ organizations could provide guidelines. More transparency regarding the competing interests of those who fund and develop medical apps is needed. ¹² Financial and full authorship disclosure should be as explicit for apps as it is for authors in peer-reviewed journals. While the benefits of transparency will not on its own eliminate bias or misinformation in apps, it is a critical preventive measure. ¹³ Furthermore, regulatory rules should be published so that where a pharmaceutical company does not declare their funding of an app, or includes inaccurate or inappropriate content, there will be proportionate penalties. These rules must simultaneously minimize bureaucracy that might limit the potential benefits of medical apps.

An alternative system for quality assuring medical apps would be a “certification of approval” for apps that are developed for the health professional, including those that are classified as medical devices. Clear certification standards would serve as a guide for app-developers, and enable health professionals to easily identify those that have been quality-checked. Reviewing every medical app on the market would be a substantial undertaking, so an opt-in system might be developed, where developers could demonstrate to health professionals that their apps are reliable and have been developed according to best practice. Certified apps, which meet all required standards, would then enjoy a competitive advantage.

Policymakers face the decision of whether to defer medical app quality assurance and certification to self-regulation by the pharmaceutical industry and the medical profession, or to support government intervention. There needs to be further debate about the pros and cons of each approach. This debate should involve all stakeholders in the medical app market. In the absence of regulation or best practice guidelines, healthcare institutions and professionals need to be alert to the possibility of biased information in medical apps and the fact that users can be subject to personalized marketing. When using apps, health professionals should make substantial efforts to ensure that they are reliable, evidence-based, up-to-date and transparent.