FDA's Digital Health Policies Support 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. This page is intended to outline the FDA’s current policies that may support innovation in COVID-19 related digital health technologies and the response to COVID-19.

The FDA does not consider most apps and software systems for public health surveillance and communication to be devices regulated by the FDA. These are mobile apps or solutions that are intended for use by public health officials at the Centers for Disease Control and Prevention (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 solely to track locations or contacts associated with public health surveillance because these products generally do not meet the definition of a device in the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA also generally 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 the following guidances, including those that have been implemented during the COVID-19 public health emergency:

• Policy for Device Software Functions and Mobile Medical Applications (MMA);
• Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PD-COV);
• Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (NIRM-COV);
• Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (IS-COV); and 
• General Wellness: Policy for Low Risk Devices (GW). 

While there are other guidances that describe the FDA’s risk-based policies during the ongoing public health emergency, this page is focused on digital health policies that were in effect prior to the public health emergency and discusses how they may apply to certain COVID-19 specific digital health products.

In the MMA guidance, the FDA has identified many software functions that are not devices within the meaning of the FD&C Act, including some that may be useful in the response to COVID-19:

• Software that provides health care providers with educational information about COVID-19  is not a 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.” (MMA p.16, #2)
• Software that provides patients with commonly used reference information related to COVID-19 is not a 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 professionals assessment of a specific patient, replace the judgment of a health professional, or perform any clinical assessment).” (MMA p.17, #3)
• Software that provides patients or individuals who are self-quarantining with information about their health conditions or treatments is not a device: “Software functions that provide easy access to information related to patients’ health conditions or treatments.” (MMA p.19, #9)
• Software for videoconferencing, even when intended for use in telemedicine, is not a device: “Software that serves as a videoconferencing portal specifically intended for medical use and to enhance communications between patients, health care providers, and caregivers.” (MMA p.19, #11)

Software functions that are intended for maintaining or encouraging a healthy lifestyle and are unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition, pursuant to section 520(o)(1)(B) of the FD&C Act, are not devices. Some types of general wellness software functions that are not devices that may be useful in the response to COVID-19 include:

• “General Wellness software functions unrelated to a specific disease or condition, such as (PD-COV p.10, #1):
  • promoting relaxation, mindfulness, meditation; and
  • reducing stress, fatigue, or feelings of isolation due to the COVID-19 public health emergency.”
• “General Wellness software functions related to sleep, such as [(PD-COV p.11, #2)]: 
  • Promoting good sleep;
  • Improving your sleep experience;
  • Having more relaxing or restful sleep;
  • Sleeping through the night or sleeping all night.”
• “Software functions that provide reminders, at opportune times, to keep safe physical (or ‘social’) distancing practices during the current public health emergency.” (PD-COV p.11, #4)

The following are examples of software functions that are not devices pursuant to section 520(o) of the FD&C Act: 

• “Software that uses a patient’s diagnosis (or presumptive diagnosis) to provide a health care provider with current practice treatment guidelines based on any imaging findings of COVID-19 or co-existing conditions, and provides the source of the guidelines.” (IS-COV p.16)
• “Software that provides health care providers with recommendations on the appropriate use of imaging and recommended protocols for a patient with confirmed or suspected COVID-19 that are consistent with the FDA-required labeling or that are described in other sources from professional medical imaging societies. The practice guidelines are described as the basis for the recommendation and provided for the health care professional to review, such that the health care provider does not rely primarily on the software’s recommendation.” (IS-COV p.16)
• “Software that compares imaging findings with available practice guidelines (institutions-based or academic/clinical society-based) to recommend condition-specific diagnostic tests, investigations, monitoring, or therapy, or triaging patient care. The practice guidelines are described as the basis for the recommendation and provided for the health care professional to review, such that the healthcare provider does not rely primarily on the software’s recommendation.” (IS-COV p.16)
• “A software function that is intended to analyze medical information about a patient diagnosed with COVID-19, such as temperature and heart rate, to provide recommendations to the health care professional for opportunities for additional monitoring or care, and the basis for the recommendation, such as CDC guidelines, is provided so that the health care professional does not rely primarily on the recommendation.” (NIRM-COV p.12)

In addition to the many non-device software functions that may support the response to COVID-19, the FDA has said that it does not intend to enforce the requirements under the FD&C Act at this time for certain lower-risk software functions that may be 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.” (MMA 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.” (MMA 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.” (MMA 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.” (MMA p.23, #9)
• “Software functions that enable a patient or caregiver to create and send an alert or general emergency notification to first responders.” (MMA p.23, #10)
• General Wellness software functions to promote, track, and/or encourage choices, which, as part of a healthy lifestyle, may help living well with or reduce the risk of certain chronic psychiatric diseases or conditions where the link between living well and reducing the risk or impact of a chronic psychiatric disease or medical condition is well understood. Chronic psychiatric conditions may include (but are not limited to): Depression, Anxiety, Obsessive Compulsive Disorder, Autism, Attention Deficit Hyperactive Disorder (PD-COV, p.11). Such General Wellness software functions could include claims as follows: “Software Product V tracks and records your sleep, work, and exercise routine which, as part of a healthy lifestyle, may help living well with anxiety.” (GW, p.4-5)

Finally, for the subset of device higher-risk digital health technologies that are outside the scope of the FDA’s digital health and COVID-19 enforcement policies, 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.

Examples of circumstances where the FDA currently believes devices do not represent low risk general wellness or low risk digital health products for psychiatric conditions include:

• “Software functions for the treatment of a specific psychiatric condition (e.g., intended to increase abstinence from a patient’s substances of abuse during treatment).” (PD-COV p.12, #1)
• “Treatment claims for specific psychiatric conditions where the underlying psychiatric condition may require an urgent or immediate clinical intervention and the delay of the intervention may pose significant harm to the patient, such as treatment of suicidality.” (PD-COV p.12, #2)
• “Treatment claims for specific psychiatric conditions where the device is intended to replace face-to-face or telehealth treatment sessions.” (PD-COV p.12, #3)