1. Mobile-health (mHealth) applications are regularly used by patients and providers because of convenience and low cost, but a recent report argues that mHealth applications can pose privacy, security, and safety risks to patients.
2. To solve the risks associated with mHealth applications, the report author suggests that regulatory standards must be created, verification by a regulatory agency must be established, certification must be indicated by the applications, and applications must be continuously tested for compliance.
Evidence Rating Level: 4 (Below Average) The source law report for this article is an expert opinion
Rundown: The boost in technological capabilities of cell phones and applications has facilitated patients and physicians’ use of mobile-health (mHealth) applications in medical care. Despite the potential convenience of these applications, mHealth applications are mostly unregulated and can be risky to the privacy, security, and safety of patients. Thus, the article suggested that better regulatory schemes should be applied to mHealth applications to ensure patients are sufficiently protected.
The United States has encouraged doctors to use technology (like the use of electronic health records) to improve coordination of care between different service providers and minimize medical error. The author of this report concluded that mHealth applications possess incredible potential to increase the access and affordability of health care, especially in rural areas where visits to a doctor’s office can be more difficult. The use of these applications has exploded in recent years, but storing patient data over unsecured networks on mobile devices poses multiple risks.
Even though HIPPA has established rules regulating security and privacy standards for electronically transmitted patient health information, the report determined that rules are largely inadequate given the evolving technological landscape of the health technology environment. For example, mHealth applications can present privacy concerns for patients. Providers may store patient data or electronic medical records on their mobile devices that are easily accessible by third parties if a physician’s phone is stolen, lost, or hacked into. The report also suggested that mHealth applications can also be unsafe if they provide false medical information or bad advice to patients who may rely on such applications to treat conditions. For instance, even if mHealth applications are helpful to patients with chronic conditions that need constant monitoring, if the applications are faulty and provide false measurements, patient safety issues arise.
Additionally, the article revealed that the FDA has authority to regulate medical devices, but the FDA has failed to consider potential unauthorized access to mHealth applications that could affect patients’ privacy and security. Furthermore, the cost of implementing safeguards is high in comparison to the relatively low cost of mobile applications in other, non-health related contexts. The author proposed that for regulation to be effective, there must be regulatory standards imposed for data storage, a form of verification from a regulatory authority (like the FDA or some other entity) is necessary to identify which mHealth applications meet the established standards, and some kind of certification is necessary to indicate the application’s compliance with the relevant requirements. Then, once an mHealth application is on the market, it must be continuously tested and monitored for compliance.
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