I probably should have titled this section Who Ensures that Digital Health Tools are Safe?. The Food and Drug Administration (FDA) is largely tasked with ensuring the safety and oversight of "traditional" medical devices. Consumer oriented technologies and many of the digital health tools available today present a more unique challenge for federal regulators. For example, software which reads digital mammograms is clearly a medical device intended to diagnose cancer. However, a mobile application which a user/consumer/patient leverages to track daily blood glucose levels is a very different approach. The mobile application is not making a diagnosis. There is limited risk of harm or change in medical management resulting from use. To address many of these nuances the FDA has created a resource page. The FDA often issues regulatory guidance documents in the event there is a question surrounding the legal authority provide oversight on a specific tool, device, or software component of a device.
FDA Approach to Risk
The FDA continues to evaluate technologies in the context of risk and classifies technologies in one of three tiers. It is important to note that any mobile app; regardless of if FDA approval is needed or not; may be submitted to the FDA for review. At times a vendor will submit to the FDA for review to increase the marketability of service or solution. The device itself is not required to be evaluated but the vendor chooses to do so anyway. The classes fall into one of the three following categories:
Class I - Low-risk where general reporting of adverse events occurs
Class II - Medium-risk where the FDA must provide review and clearance before marketing of the solution occurs. Review period takes between 60 to 90 days.
Class III - High risk where clearance before marketing must be obtained and the clearance must involve clinical studies showing that the product is safe and effective.
Mobile Medical Applications
The FDA has done a good job of clarifying the types of mobile apps that will not, will, and may be regulated by providing guidance documents. The FDA calls this document The aim of the guidance document is to clarify where the agency intends to enforce oversight and where the agency will continue to monitor developments. While the guidance document and website is extensive, there are a few key items worth mentioning. 1. The FDA defines what mobile medical applications ARE. They can be Apps or accessory devices which meet the definition of a medical device (somewhat abridged and abbreviated for simplicity)- recognized by the National Formulary (ie Pharmaceuticals), intended for the use in the diagnosis of disease, cure, mitigation, treatment, or prevention of disease; or affect the structure or function of the body of man or other animals. 2. Consumers can use both medical apps and mobile apps to manage their own health and wellness. 3. Apps which can help health care professionals improve and facilitate care. In general the FDA does not intend to actively monitor or review health and wellness apps identified in the glucose tracking app example mentioned earlier.
The Grey Zone of Regulation
To an extent there is a "grey" area. The FDA calls this area enforcement discretion. There are many apps which meet the definition of a medical device and the FDA will not expect manufactures to submit pre-market review or register the product or service on the FDAs website. These include apps which may "prompt" a change in an individuals behavior. might support PTSD or other mental health encounters, or use social information to provide screening.
Why is this Important?
I personally think this information is important for a few key reasons. First, a company may receive FDA clearance and not really need it. They might include the approval in marketing material to give a sense of legitimacy to the product (think of HR monitors for cycling or running like Garmin or the Apple Watch). Remember, many mobile medical applications are low risk and DO NOT need to be reviewed. Second, the guidance was important for developers and companies to move forward with deploying many of the services they could provide. Companies like Apple and Samsung might not have released products. I think it is also important to note that the average mobile application requires close to $50,000 to get off the ground. Many investors required some clarity so that they could invest in higher risk/reward technologies (Think of WellDoc and Propeller Health in our last module).
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