There is no question that connected healthcare is in our future. The technology is certainly there, as evidenced by the growing number of smartphones and tablets being used in hospitals and physician offices. Unfortunately, the hurdle for most developers has been the regulatory approval process—a tedious but necessary process to get mobile medical technology off the design table and into the market.
As the industry continues to innovate, one of the main challenges for developers has been waiting for the FDA to figure out how it will apply its regulatory authorities to select software applications intended for use on mobile platforms. Needless to say, this is slowing an already slow approval process.
The industry is making headway, however. Last week, GE Healthcare, www.gelifesciences.com, announced it received FDA clearance for a technology that allows radiologists to remotely review diagnostic CT (computed tomography) and MR (magnetic resonance) images using their iPads or iPhones.
The Centricity Radiology Mobile Access 2.0 received clearance for primary diagnosis that accesses images and reports from Centricity PACS, GE’s picture archive and communication system. According to GE, this new mode of access removes a sizable productivity barrier for an increasingly mobile field.
Because the application was originally designed for the Apple iOS and Android frameworks, Woodlock says the system requires little training and “provides a more productive user experience versus an emulated Windows application that was designed to be driven by a mouse.”
In addition to diagnostic CT and MR images, the platform provides users with access to past exams. Patient privacy is protected, however, as medical professionals are not allowed to download any personal data to the client device. There are other fine print items as well: Diagnostic clearance is limited to computed tomography and magnetic resonance exams on an iPad or iPhone when not in proximity to a PACS workstation.
The FDA approved the first diagnostic radiology application for mobile devices back in February. The solution, manufactured by Cleveland-based MIM Software Inc., www.mimsoftware.com, is similar to GE’s technology. Radiology images taken in the hospital or physician’s office are compressed for secure network transfer and then sent to the appropriate portable wireless device via software called Mobile MIM. Physicians can then user their iPad or iPhone to view images and make medical diagnoses based on CT, MRI, and nuclear medicine technology, such as PET (positron emission tomography).
However, the FDA was once again clear, stating the technology “is not intended to replace full workstations and is indicated for use only when there is no access to a workstation.”
As the medical community gets more mobile and the line between consumer and enterprise devices continues to blur, it will be interesting to see if these types of qualifiers will eventually be lifted—or if the approval process will need to be adjusted. Will we eventually have to choose between patient privacy and advancing medicine? Hopefully the FDA, not to mention the connected healthcare industry, can figure out how to have both.