Will your healthcare IT application be regulated by the Food and Drug Administration? A report just released as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) brought together the FDA, the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC) to propose a strategy on health information technology. The recommendations include mobile medical applications and are charged with promoting innovation, protecting patient safety and avoiding regulatory duplication.
One interesting aspect of the framework is the lack of standards usually associated with healthcare IT like HIPAA. Maybe it’s because the office that enforces HIPAA policy on patients’ privacy is part of the Department of Health & Human Services.
The FDASIA framework breaks healthcare IT into three categories:
- Administrative functionality – business processes like admissions, billing and claims, inventory — tasks with limited or no risk to patient safety
- Health Management functionality – health information data capture and sharing, patient identification (think HIPAA)
- Medical Device functionality – This is where the FDA comes into the picture, overseeing medical devices that use IT for data gathering and analysis and can present a greater risk to patient safety than the first two categories
Uplogix in Healthcare IT
Providing healthcare IT organizations with a solution that simplifies the management of the widely distributed and complex IT infrastructure of healthcare organizations, Uplogix reduces IT support costs, maintains high network availability and service levels, and constantly enforces security and compliance auditing requirements.
In the future, machine-to-machine applications might involve building Local Management into “smart” devices. As medical devices become more and more specialized, they often have their own internal networks and specialized components that can benefit from high resolution, local monitoring and intelligent automation.