The Food & Drug Administration released their final guidance on Medical Mobile Applications back in September. Now that doctor’s are becoming familiar with the FDA’s guidelines we’re set to see more mobile apps for healthcare.
Healthcare Finance News citing a survey from Digitas Health, reported that as high as 90% of people with a chronic condition would accept a mobile app prescription. They also reported that patients are expecting doctors to be more tech savvy.
But until recently doctors have been leery of using mobile apps with their practice. Doctors feared that a misdiagnosis resulting from a medical app that was not approved or sanctioned by the FDA would spell a recipe for malpractice. That far outweighs the benefit of being more productive and modern in their practice.
The FDA’s guidance takes a tailored approach. The FDA will not put mobile medical apps that pose minimal risk to the patient through a review process. Their focus is on apps that:
- are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
- transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
“We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Dr. Jeffrey Shuren, Director of the FDA’s Center For Devices and Radiological Health. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”
It’s the kind of apps that the FDA will regulate that had doctors concerned. For example if a doctor were to use an app that transformed an iPhone into a mobile EKG and then missed a diagnosis, they would be liable. The FDA has approved 100 apps that meet the approval requiring criteria with 40 approved in the last year.
Apps that require FDA approval will be assessed using the same regulatory standards and risk based approach that the agency applies to other medical devices. The 510(k) process will also be available to medical app companies.
What this means for consumers is that we can expect more and more doctor’s offices to turn to mobile applications to make streamline their workflow and ultimately help make patient care easier for the patient.
See the entire FDA guidance here.