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What role should the FDA have in regulating ophthalmic digital health smartphone applications?
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FDA path has flexibility
The FDA has chosen a path of determining what the smartphone application is intended to do. Broadly speaking, consumers can use medical apps to monitor their health status and communicate with their health care team, whereas medical professionals can deploy medical apps to monitor, but also to improve and extend care to larger populations. The FDA has appropriately decided to regulate apps that conform to the regulatory definitions of a medical device and meet one of these other criteria:
- Serve as an accessory to a regulated device; or
- Turn the smartphone into a medical device by virtue of the app’s functions.
However, the FDA has made the correct decision to exempt from premarket approval (but not enforcement) apps that pose minimal risks to consumers, including the following:
- Self-management tools absent specific recommendations;
- Organizational tools;
- Educational tools;
- Documentation/communication tools; and
- Automation tools.
This path the FDA has chosen appears to give maximum flexibility to mobile app development while still recognizing that apps can transform mobile devices into medical devices by designation. In fact, the FDA has come up with a new classification system, Software as a Medical Device (SAMD) to complement the traditional Software in a Medical Device (SIMD), to acknowledge the blurring of lines between traditional hardware-based medical devices and the growing importance and proliferation of algorithm-based medical devices. I think the FDA has made a decision that advances both the needs of consumers while also providing leeway for developers to create apps that will having varying degrees of regulatory burden depending on their intended activity.
- References:
- www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf.
- www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM524904.pdf.
Darius M. Moshfeghi, MD, is chief of the Retina Division for Byers Eye Institute, Stanford University of School of Medicine. Disclosure: Moshfeghi reports no relevant financial disclosures.
The future is here
Digital health was once a thought of the future, but it is here. Our lives are so intertwined in technology, and the natural bridge has been to leverage technology to help us take better care of patients. As with most things digital, there are important implications to taking on digital data responsibility. Specifically in ophthalmology, we now have several digital devices and tools that can be used to do things such as monitor visual acuity changes at home, track IOP and collect images that can be remotely sent from patients to clinicians.
Important issues as they relate to ophthalmic digital health applications include patient privacy and protection of health information, accuracy and precision of these tools, and probably the largest issue is management of data gathered from these tools. The FDA serves an important role in our society to protect patients and clinicians by ensuring that drugs and devices have undergone rigorous testing and study so that we can provide the highest-quality care and safety for our patients.
Unlike in the drug and device arena, digital health applications, in my opinion, should not be formally regulated by the FDA, but rather it should fall on the clinician or another entity to monitor and manage the generated data so that patients are not lost in the data. The FDA has the utmost experience with assessing new technology, so perhaps the initial role of the FDA would be best served by producing a guideline of best practices and ethics to help shape this uncharted territory.
The number of ophthalmic digital health devices and applications is only going to increase in the years to come, and as a group we should demand that there are the highest standards in data collection and monitoring of that data in a secure and safe way. I feel fortunate to be part of a specialty that changes so rapidly and is so welcoming of new technology. We as a group should set the standards to regulate ourselves in this arena so that all future technologies are required to uphold a standard of safety and excellence.
Preeya K. Gupta, MD, is an OSN Cornea/External Disease Board Member. Disclosure: Gupta reports no relevant financial disclosures.