Table 1.
Commonly used sleep device/app technology terms.
| Wearable | Devices that are worn to provide physical data or feedback |
| Nearable | Nearby contactless devices that provide physiologic or environmental data or feedback |
| Sensor | A device that measures a physical input and converts it into understandable data |
| Photoplethysmography (PPG) | PPG sensors use a light source and a photodetector to measure blood flow changes, which provide signals that may use AI/ML/DL algorithms to deliver data outputs such as sleep stages |
| Sleep score or quality | Often a product specific computation of “sleep quality” derived from questionnaires and/or sensor data |
| Sleep stages | Device/app reporting of sleep stages such as “light sleep” or “deep sleep” that may vary in type of data acquisition, derivations, and definitions between devices/apps; staging may be derived from proprietary AI/ML/DL algorithms such as using PPG heart rate variability (HRV) rather than standard polysomnographic EEG scoring rules |
| Patient generated health data (PGHD) | Health care related data that are generated by patients and collected for the purpose to address a health concern or issue |
| Mhealth (mobile health) | The use of mobile phones or other wireless technologies to monitor and exchange health information |
| Software as a medical device (SaMD) | Software intended for medical uses that does so without being part of a hardware medical device |
| Mobile medical app (MMA) | A mobile app whose functionality meets the definition of a medical device |
| Clinical decision support (CDS) software | SaMD software risk categorization established by the International Medical Device Regulators Forum to determine if a software treats, diagnoses, or drives or informs clinical management |
| Artificial intelligence/machine learning (AI/ML) as an SaMD | SaMD that may have “locked” AI/ML algorithms or “adaptive learning” algorithms that may be assessed using an FDA Precert total Lifecycle product approach |
| Remote data monitoring | Monitoring of data remotely |
| Remote patient monitoring | A subset of remote data monitoring that is used clinically |
| Application programming interface (API) | A software interface that allows two or more applications to exchange information such as with an electronic health record |
| Algorithm | A sequence of statistical processing steps to solve a problem or compete a task |
| Artificial intelligence (AI) | The broad use of computer algorithms to simulate human tasks and thinking |
| Machine learning (ML) | A subset of AI that uses data training sets to make predictions and decisions without explicit programming |
| Deep learning (DL) | A subset of ML that enhances a deeper dive into smaller patterns of artificial neural networks |