The FDA limited the guidelines only to certain defined mobile medical apps that are able to do the following:
• Displaying, storing or transmitting patient-specific medical device data in its original format.
• Controlling the intended use, function, modes or energy source of the connected medical device.
• Transforming or making the mobile platform into a regulated medical device.
• Creating alarms, recommendations or creating new information (data) by analyzing or interpreting medical device data.
A Reuters report indicated that apps that allow physicians to view X-rays or MRIs on a smartphone or tablet are examples of the above that could fall to regulation.
However, the FDA clarified that regulations are not final and are only recommendations at this stage. Comments and suggestions regarding the draft can be submitted within 90 days.
Related Articles on Mobile Medical Apps:
Diabetes Management App to Connect Patients with Resources
New Health IT Ideas Aim to Solve Communication Problems
Patients Able to View Insurance Plans With Smartphone Apps
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.