Sensor-based tools and assessment apps that “pre-screen” or screen for signs of disease risk and refer to care.

Apps and devices in this category may ask patients to conduct performance testing or may interpret signals or measurements made by sensors on smartphones (e.g. gyroscopes, microphones, images) to detect signs of disease risk, such as a patient’s score or value falling outside normal range. Many are for at-home use by patients but some are used in clinics or created by providers or their institutions as gated applications for patients. Devices in this category may be approved for “pre-screening,” to be confirmed by other screening methods while those that are not approved medical devices are not intended to guide decisions.

Clinical decision support (CDS) tools that assess patient health data to help inform providers as they diagnose disease.

Apps and platforms used by providers at the point of care that serve as evidence-based adjuncts to assessment and diagnosis. They analyze patient-specific information (e.g. symptoms, lab results, medical history, SDOH data from EMR) in the context of the latest medical research and clinical guidelines, and then may offer tailored information, alerts, recommendations to improve care. They may assess patient-specific risk, suggest diagnostic tests or potential diagnoses, or identify unique patient needs but are not intended to be the primary factor in diagnostic decision making. They must give providers the ability to independently review the basis for any recommendation and independently determine next steps. Most are exempt from FDA approval.

Validated software devices intended to guide clinical decisions made by providers by detecting or characterizing diseases and conditions.

These SAMD and SIMD devices detect or characterize disease presence or status, response, progression, or recurrence by interpreting the clinical relevance of inputted biometrics, health data signals, patterns, or medical images. Inputs from which anomalous patterns are detected may include wearable sensors, in vitro diagnostics or other signal acquisition systems. They require FDA approval and their accuracy (sensitivity/ specificity) must be validated. Though some are intended as standalone devices delivering automated diagnosis, others are intended for use as diagnosis aids.

Digital measurement tools intended to monitor patient symptoms and biometric data to inform care decisions.

Used in both clinical and research settings, these tools track health data to inform caregivers, providers and investigators whether a patient’s disease is well controlled (i.e., therapy is effective) or is improving or worsening and sometimes notifies of exacerbations. RPM provider software platforms may receive data from patient-facing apps that collect functional assessments or ePROs, and/or patient-facing biometric sensors such as wearables that continuously or episodically track physiologic or behavioral data. They are especially valuable for monitoring health of patients with chronic and high-risk conditions and are intended to inform care revisions and enable personalized care.

Digital tools intended to predict a patient’s future course of disease by analyzing biometric and symptom data.

These digital solutions may monitor disease progression and therapy response like RPM tools but additionally provide insight into a patient’s future course of disease, such as response to a specific type of therapy, or risk of disease flare or recurrence. Through their predictive models they may help to prevent adverse events and notify providers. Like digital diagnostics these are validated SAMD or SIMD and like RPM tools, they are Intended to inform HCP decision-making around medical Intervention.