There is considerable potential for mHealth apps to have a positive impact on the care provided to patients, although they also carry a risk of violating patient privacy and even causing patients to come to harm. To better protect the privacy of patients and improve safety, the FDA and other government bodies will be stepping up their efforts to reduce the risk to patients, in particular by taking action to ensure mHealth apps are safe to use. Part of that process will involve diverting more resources to the assessment of high risk healthcare mobile apps.
Regulators will Concentrate Resources on High Risk Healthcare Mobile Apps
Regulation of the mobile health industry falls within the remit of the Food and Drug Administration (FDA), and the organization is already playing a vital role in ensuring that the privacy of Americans is appropriately protected and device safety is assured. At present the FDA has said that it is “performing strongly” in this regard, and is already regulating wearable devices, mobile apps and other monitoring devices and their associated software.
In a recent report entitled “FDA’s Role in Ensuring American Patients Have Access to Safe and Effective Medical Device Technology,” the FDA states that it has already “implemented a range of initiatives to promote access to safe and effective medical devices for American patients,” and that its activities over the past 5 years show a “pattern of markedly improved performance.”
The report explains that rather than stick to programs that were developed more than 40 years ago – and are therefore outdated – it has implemented a number of “programmatic improvements and innovative approaches,” as part of its role in overseeing the introduction of new healthcare devices.
In recent years, numerous mobile medical applications – those which record, store and transmit medical data – have been developed and are now being used by healthcare providers in the delivery of healthcare services; however those devices have considerable potential to violate the privacy of patients, or potentially cause them to come to harm.
As such, the FDA must divert a considerable amount of resources to ensuring that the devices are safe and can be used by patients with minimal risk. The volume of devices, and software applications, released in recent years has skyrocketed, and with the current pace of technological development, that is not only likely to continue, but the volume is expected to increase significantly.
Consequently, the FDA has taken the decision to allocate more resources to the oversight of mobile healthcare apps, and will be making greater efforts to identify high risk healthcare mobile apps to keep Americans safe. In its report, the FDA says “mobile medical apps used to diagnose or treat patients will receive the greatest FDA surveillance.”
Two years ago, the FDA announced it would be bringing its oversight towards mobile health applications, in particular, high risk healthcare mobile apps as they posed the greatest risk to patients and consumers. More discretion was given to healthcare apps that carried a relatively low risk to patients.
However, the FDA has pointed out the limits of its oversight of devices. “When these items are not marketed, promoted or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or do not otherwise meet the definition of medical device, FDA does not regulate them.” The report goes on to say that the FDA will oversee mobile healthcare apps “When they are marketed, promoted or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or otherwise meet the definition of medical device, FDA intends to exercise enforcement discretion.”
Mobile healthcare apps have potential to revolutionize the healthcare industry, improving productivity, efficiency in the delivery of healthcare services, and ultimately they have potential to drive down the cost of healthcare provision. With the FDA’s commitment to strong oversight of the mHealth industry, the organization believes it can help to ensure the devices and applications have a positive impact on patient care, while ensuring Americans are kept safe and are properly protected.
The full FDA report can be viewed here.