FDA Certification of Mobile Apps Lacks Clarity – FierceMobileHealthcare (Slabodkin, May 28) reported that the FDA expects to release final regulatory guidance mobile apps. The issue revolves around whether an app meets the definition of a medical device. For companies that produce mobile apps this may result in more costly and complex processes in order to receive approval for use, including the need to obtain a 510(k) clearance.
Medical Devices at Risk of Malware and Hacking – mHIMSS (Miliard, May 27). The complexity and interconnectedness of wireless medical devices is creating the potential for malware to cause device malfunctions and for the remote hacking of devices in order to produce unexpected behaviors. For example, imagine the havoc that could be caused by remotely modifying the dose dispensed by an insulin pumps or the rate of an implanted pacemaker.
Better Oversight Needed for Pain Management Apps – American Medical News (Dolan, May 13). Due to the rapid turnover of medical apps and a lack of oversight, including certification, it is very difficult to determine the quality of a pain app and whether any input was received during development from an MD or DO. In a study conducted by a team of researchers from Ohio State University led by Lorraine Wallace, PhD, it could not be determined whether input was provided by a healthcare professional in the development of a third of the pain apps while another third clearly had no healthcare professional input.