Without clinician input and validation, healthcare apps could be a liability
Orrin I. Franko, MD
The use of mobile technology to assist physicians and patients, recently dubbed “mHealth,” has firmly established its presence in hospitals and training programs nationwide. One of the most visible aspects of mHealth includes the use of mobile smartphones and tablets that run applications (apps) that can function as clinical examination tools, reference databases, technique guides, or medical calculators.
The use of mobile apps for the treatment of disease is not without concern. Although apps are heavily scrutinized and must meet specific criteria before acceptance for publication online, the review process only validates an app’s compliance with developer guidelines, not the accuracy of its data. As a result, physicians of various specialties have identified reliance on such data as a potential area of risk and have proposed suggestions for future regulation.
Orthopaedic surgery is at the forefront of app development and adoption in the clinical arena—with more than 225 orthopaedic apps currently available. Orthopaedic providers should be aware of the risks inherent in using apps and should take precautions to increase patient safety and reduce error.
The first step in developing an app, writing the software, is generally performed by a developer without medical training. Because medical apps are not required to be reviewed by physicians or medical organizations, the involvement of professional oversight is purely voluntary.
After the app is finalized, it can be submitted to app stores such as Apple’s App Store, Google’s Android Marketplace, and Microsoft’s Windows Store for approval and publication. The approval process generally requires that the app meet each company’s guidelines and pertain to content matter, but the process does not validate the data contained within the program for medical accuracy or functionality before making the app available for public use. The result is an easily accessible library of mobile health applications without validation or peer review that can be downloaded by patients, students, and providers alike.
Although some apps include a legal statement, they are not required to disclose their limitations or information sources. As a result, a legitimate concern regarding the development of harmful apps exists. Studies have already identified apps that poorly recognize the carcinogenic skin moles they aim to prevent, poorly adhere to smoking-cessation guidelines, and even directly promote smoking.
Attempts at regulation
In the United States, medical devices are scrutinized and approved by the Food and Drug Administration (FDA). The increasing use of mobile apps within the health arena prompted the FDA to issue draft guidelines in July 2011. These draft guidelines, however, are not legally enforceable and reflect “current thinking on a topic and should be viewed only as recommendations.”
The FDA has specifically outlined which mobile apps are covered by the draft guidelines. These include apps that are used as an accessory to a regulated medical device or transform a mobile communication device (smartphone) into a regulated medical device. The FDA also outlines apps that are explicitly not covered by the guidelines, which include the following:
- “copies” of reference materials such as textbooks or teaching aids
- apps focused on tracking or making recommendations about general health and wellness
- apps that assist with office functions such as billing, appointments, or insurance transactions
- apps that function as “generic aids” but are not specifically advertised for a medical purpose
This last category would likely apply to the plethora of “range of motion” apps that transform the internal accelerometer of smartphones into digital goniometers. It is clear from the draft guidelines that, although mobile apps have the potential to pose risks to public health, the FDA recognizes it is not properly positioned to validate the content of mobile medical applications.
Need for validation
These limitations have prompted both medical providers and app developers to validate apps, presumably to ensure patient safety and increase sales, respectively. Orthopaedic surgery currently claims the greatest number of validated apps, most of which are directly related to goniometric calculations. For example, peer-review publications have demonstrated the validity of apps that measure scoliosis and radiographic Cobb angles, assess range of motion, and confirm appropriate device implantation and anatomy.
Despite this positive effort, hundreds of apps in use provide point-of-care data, treatment advice and demonstrations, and physical examination education without validation or peer approval. Faced with this dilemma, how can we as orthopaedic surgeons protect our patients from harm and protect ourselves from liability?
The number of orthopaedic apps developed with proper orthopaedic involvement is unknown. Based on apps in other areas of medicine, most orthopaedic apps were probably developed without input from a practicing orthopaedic surgeon. For example, among both colorectal apps and microbiology apps, only about one third included named professional involvement, according to two separate studies. An examination of pain management apps also identified a low level of healthcare professional involvement.
As alluded to above, orthopaedic surgeons appear to have taken a different route by demonstrating clinical efficacy and validity for apps on an individual basis. Unfortunately, this approach is impractical for all apps based on the exponential growth of software and the time course required for peer-review.
Another approach has been the creation of sites that test and review apps from the perspective of a clinician, while a third approach has been the proposal to establish a medical app certification program that addresses operability, security, and content issues. It has also been suggested that individual institutions should play a larger role and that hospitals should encourage and support the use of apps among their providers.
Although no permanent solution has yet been established to address the validity and peer-review of mobile health apps, existing efforts by individuals and organizations are encouraging. Clearly, greater involvement of true healthcare professionals in the creation, development, and review of apps is a crucial step toward ensuring the safety of patients and reducing the risks of providers.
Some authors have advocated for regulatory guidance, while others believe that individual developers and companies will lead the way. Regardless of which route is ultimately successful, the basic tenets remain the same. Physicians, and orthopaedic surgeons in particular, must be acutely aware of the inherent limitations of mobile apps and must personally take precautions to ensure that safe medicine is delivered. Surgeons who use smartphones and tablets in their practices should remain abreast of new developments in the realm of app validation and peer review.
Apps should be frequently updated to ensure that all data is current, and surgeons should ensure that any apps they recommend to patients are carefully vetted for content. In the end, it is the surgeon’s responsibility to ensure the safety of his or her patients.
Orrin I. Franko, MD, is an orthopaedic resident at the University of California, San Diego department of orthopaedics and founder of the website, www.toporthoapps.com
Disclosure information: Dr. Franko reports ties to the following: www.TopOrthoApps.com; Lineage Medical, LLC.; OrthoMind, LLC.; CARE, LLC.; Visible Health, LLC; Journal of Mobile Technology in Medicine.
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