Given the need to implement monitoring tools to ensure remote patient care, new home monitoring technologies were developed, which unfortunately present risks in terms of patient safety and privacy.
The development of this technology includes the implementation of contact tracing and warning applications in several countries. Similarly, they have applications to monitor food consumption, among others.
The risk lies in the fact that such monitoring tools collect data related to health, which means that their storage and treatment imply sufficient security to guarantee autonomy and trust, since if this does not exist, patients will not want to continue using such tools, despite their benefits.
It is known that the US privacy regulation is not exactly the most rigorous in this matter, therefore, the companies that have developed this technology are not completely prohibited from sharing the data they collect with third parties, he said. HealthITSecurity. According to Harvard researchers, they could use this information as a commercial object.
According to the researchers, the problem has to do with the fact that the FDA (“Food and Drug Administration”) treats some of these monitoring tools as medical devices, and others, as simple home control tools. . Being that only those that have the first classification are subject to examination. According to the FDA “products that are intended to track contacts or locations associated with public health surveillance (…) do not meet the definition of a medical device.
On the other hand, given the current context, both the United States Department of Health and Human Services and the FDA have issued Emergency Use Authorization Declarations (hereinafter, “DAUE”) for various medical devices, including, possibly, home monitoring devices.
The problem? The criteria for granting such AEDs have to do with the reasonable belief that they are useful to treat, diagnose or prevent Covid 19. In this way, the analysis does not go through verifying that these devices are safe or have the necessary measures to protect privacy of patients who use them. It is vital to note that these devices collect information in the home of their patients, that is, in their most intimate sphere of privacy.