FDA's Digital Health Policies Allow Innovators to Create COVID-19 Related Public Health Solutions

The FDA recognizes that digital health technologies can provide powerful tools for public health officials and the public in the management of the COVID-19 response by helping public health officials reach and communicate with a vast number of people more quickly, efficiently, and effectively.

The FDA does not consider most apps and software systems for public health surveillance and communication to be medical devices regulated by the FDA. These are mobile apps or solutions that are intended for use by public health officials at the CDC and at state and local health departments to improve communication between public health officials and members of the public, including by people who may have been exposed to a disease of interest to public health officials, such as COVID-19. These solutions may help people document the presence or absence of commonly understood symptoms such as fever and shortness of breath in themselves or in others with whom they have had close contact. These solutions may also help people support public health officials' efforts to retrace locations visited and people with whom they have had close contact.

The FDA generally does not regulate products that are intended to track locations or contacts associated with public health surveillance because these products generally do not meet the definition of a medical device in the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA also does not regulate general purpose location tracking, contact tracking, journaling, scheduling, or related functions.

The FDA has clarified its risk-based approach to regulating digital health products through Guidance on Device Software Functions and Mobile Medical Applications. In this policy, the FDA has identified many software functions that are not regulated as medical devices, including some that may be useful in the response to COVID-19:

• The FDA does not regulate software that provides health care providers with educational information about COVID-19 because this software is not a medical device: "Software functions that are intended for health care providers to use as educational tools for medical training or to reinforce training previously received – These may have more functionality than providing an electronic copy of text (e.g., videos, interactive diagrams), but are not devices because they are intended generally for user education and are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease by facilitating a health professional's assessment of a specific patient, replacing the judgment of clinical personnel, or performing any clinical assessment." (p. 16, #2)
• The FDA does not regulate software that provides patients with commonly used reference information related to COVID-19 because this software is not a medical device: "Software functions that are intended for general patient education and facilitate patient access to commonly used reference information – This software can be patient-specific (i.e., filters information to patient-specific characteristics), but is intended for increased patient awareness, education, and empowerment, and ultimately supports patient-centered health care. These functions are not devices because they are intended generally for patient education, and are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease by aiding clinical decision-making (i.e., to facilitate a health professional's assessment of a specific patient, replace the judgment of a health professional, or perform any clinical assessment)." (p. 17, #3)
• The FDA does not regulate software that provides patients or individuals who are self-quarantining with information about their health conditions or treatments because this software is not a medical device: "Software functions that provide easy access to information related to patients' health conditions or treatments" (p. 19, #9)
• The FDA does not regulate software for videoconferencing, even when intended for use in telemedicine, because this software is not a medical device: "Software that serves as a videoconferencing portal specifically intended for medical use and to enhance communications between patients, health care providers, and caregivers." (p. 19, #11)

In addition to the many non-medical device software functions that may support the response to COVID-19, the FDA has said that it does not intend to enforce requirements under the FD&C Act at this time for certain lower risk device software functions. These include:

• "Software functions that use patient characteristics such as age, sex, and behavioral risk factors to provide patient-specific screening, counseling, and preventive recommendations from well-known and established authorities" (p. 22, #6)
• "Software functions that use a checklist of common signs and symptoms to provide a list of possible medical conditions and advice on when to consult a health care provider" (p. 22, #7)
• "Software functions that guide a user through a questionnaire of signs and symptoms to provide a recommendation for the type of health care facility most appropriate to their needs" (p. 23, #8)
• "Software functions that are intended to allow a user to initiate a pre-specified nurse call or emergency call using broadband or cellular phone technology" (p. 23, #9)
• "Software functions that enable a patient or caregiver to create and send an alert or general emergency notification to first responders" (p. 23, #10)

Finally, for the subset of higher-risk digital health devices that are outside of the FDA's COVID-19 policy, the FDA is interested in engaging with manufacturers through the Emergency Use Authorization process to help expand access to critical medical products for use during the COVID-19 pandemic. More information about the FDA's EUA process can be found in the Emergency Use Authorization of Medical Products and Related Authorities guidance.