The rapidly moving fields of medical technology and IT have found unique ways to work together, combining mobile communications with health-related applications. With tremendous potential health benefits, the need for mobile medical apps is clear. However, as this new industry takes off, it is necessary that a regulatory framework be developed to ensure the highest safety standards for these devices.
Canadian innovations have put Canada on the map in the mobile-health game, otherwise known as mHealth (think “eHealth”). So, perhaps it is not surprising that Canada is keeping a close eye on the recently released U.S. Food and Drug Administration (FDA) draft guidelines, proposed to regulate medical apps for personal mobile devices. Regulatory oversight could be very helpful to both industry and consumers, provided the guidelines are drafted properly.
Regulations in the U.S. are likely to set the tone for similar oversight in Canada. This prediction is based on both Canada’s desire to access the U.S. market and the tendency for Health Canada to be mindful of FDA guidelines. Thus far, the process appears to be on the right track, a good sign when one accounts for the immense potential these technologies hold.
In general, mHealth technologies focus on improving point-of-care capabilities for primary care, emergency care, and long-term monitoring of chronic health conditions. The idea behind mHealth is to make medical technologies convenient and accessible to the physician or patient, thus providing faster results for immediate clinical management decisions.
Many of these exciting new technologies are being developed here in Canada. For instance, our group is developing a medical device for rapid evaluation of brain status called the Halifax Consciousness Scanner (HCS). The HCS uses sensors to record brain waves on a personal mobile device. It is intended to be a push-button technology that takes less than five minutes to automatically extract indicators about an individual’s brain status. The HCS is being designed to evaluate major brain trauma (e.g., strokes and brain injuries), minor brain injuries (e.g., concussions), and brain diseases (e.g., Alzheimer’s disease). If successful, we hope to deploy the technology in ambulances, hospitals, health centres, sports arenas, and long-term care homes worldwide.
Here’s how the technology will work:
In cases of major brain trauma, the first critical questions health professionals ask typically relate to a person’s level of conscious awareness. Indeed, standard first-aid training teaches responders to pinch the victim and ask loudly, “Can you hear me?” Unfortunately, the current clinical approach is not that much more sophisticated – and it’s error-prone almost half the time. The HCS mobile medical app will evaluate whether key brain-wave indicators of conscious awareness are present. If they are, it will provide an objective physiological measurement of alterations in the individual’s brain status.
Similarly, controversy around concussions is driving the search for better approaches to detecting subtle changes that result from head injury. Here, HCS may be used to detect any deviations from a person’s prior brain status and, more importantly, the point at which their brain status returns to normal. For concussed athletes, the technology can help provide a better indication of whether it is safe to return to the game.
Perhaps even more promising, these monitoring capabilities can be further extended to track changes in degenerative conditions causing dementia. In this regard, the HCS mobile medical app can measure a person’s fluctuations in awareness from day-to-day to better help with long-term care.
The U.S. FDA draft guidelines focus mainly on the regulation of mobile medical devices that would pose an inherent risk if they failed to work as intended. A stethoscope mobile app, for example, must function like a traditional stethoscope, such that the risks of device malfunctions are regulated. In particular, the immediate subsets of mobile medical apps that the FDA draft guidelines target include: 1) accessories to medical devices that are currently regulated by the FDA (such as mobile medical apps that interpret images from MRIs); and 2) attachments that transform mobile devices into actual medical devices (such as those that monitor EKG signals).
While the need for mobile medical apps like the HCS is relatively clear and easily demonstrated, the pathway through regulatory approvals is less clear. In this regard, the FDA draft guidelines may represent much-needed structure for Canadian device developers and regulators. Standard procedures to establish reliability and validity, measure diagnostic accuracy, and safeguard privacy and confidentiality are critical. However, it is important that regulations for mobile applications clearly identify the risks related to “going mobile.”
Many of the emerging mobile medical apps are grounded in pre-existing technologies, such as electro-encephalography, or EEG (as is the case with the HCS). We know much more about the foundation technologies that evolved in controlled hospital environments than we do about the challenges that will invariably arise when these technologies move into the everyday world. In this respect, oversight guidelines are bound to be better than the absence of direction, as they will guide development and ensure that mobile medical technologies do more to help than hinder.
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Autor(en)/Author(s): Ryan D'Arcy
Quelle/Source: The Mark, 26.09.2011
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