26 Jun Consumer Sleep Technologies: How to Balance the Promises of New Technology with Evidence-Based Medicine and Clinical Guidelines
Consumer sleep technology (CST) has become a permanent part of the current and future medical landscape, and various colleges of Sleep Medicine worldwide are proactive in helping us understand and integrate these products into practice and research.
Many of these devices, even when they cannot be strictly considered medical devices, serve as an important entry point with patients and the public regarding their sleep concerns.
Within the sleep medicine community we generally support the increased public awareness of sleep disorders. Collectively we all have a responsibility to our patients and general membership to frame both the benefits and limitations of current CST advancements.
At present, there is inconsistent transparency regarding the algorithms, sensors, and data that drive many of these products. Although there are exceptions, the majority have not been validated. Some developers will not seek TGA or FDA clearance, although there is an implication that these are medical devices.
As clinicians and researchers, we recognize the potential consequences of false negative and false positive testing results for our patients. By challenging our colleagues in industry to provide robust data and produce reliable technology, we hope to expand the tools of sleep medicine in a responsible manner.
There is a lack of longitudinal, objective sleep recording in the home environment and this compromises the availablility of relevant information for the diagnosis and treatment of sleep disorders.
In order to be utilized in clinical practice, validation, standardized data measures, and practice guidelines are needed for clinicians. Due to the rapid evolution of CST types, there is a plan to communicate CST-related concerns to service providers, and provide a practical guide on how to assess the many different CSTs that are presented to clinicians by their patients.
We also support the TGA and FDA in the ongoing assessment of future value and potential applications of wearables and apps in medical care. In the context of retail product marketing to consumers, differences between entertainment and mobile medical devices often are unclear. Many current products utilize proprietary “black box” sensors, data collection methods, and/or data analytics including metric calculations, algorithms, and artificial intelligence [AI] models. Data reports and metrics may vary between products, thus making standardized practice guidelines and clinical use challenging.
In the USA the FDA has suggested a pathway for “software as medical devices” (SaMD) development, and established a Digital Health Program within its Center for Devices and Radiological Health, and provides weblinks for digital health technology models and policies.
The following are topics in the digital health field on which the FDA has been working on to provide clarity using practical approaches that balance benefits and risks:
- Wireless medical devices
- Mobile medical apps
- Health IT
- Medical device data systems
- Medical device interoperability
- Software as a Medical Device (SaMD)
- General Wellness
In Australia, the TGA regulates medical device software used for therapeutic purposes under the medical devices regulatory framework (if they meet the definition).
- Mobile apps would be considered within this framework
- Standalone Software would also be considered within this framework
- Regulation is risk based, and depends on the intended purpose
- Manufacturers of medical device software products (other than Class 1 – lowest risk) to obtain Conformity Assessment certification
- All medical devices are expected to meet the Essential Principles for safety and performance.
For further information, please refer to the Australian Regulatory Guidelines for Medical Devices (ARGMD).
In Australia for these regulations, a medical device has a measuring function if the device is intended by the manufacturer to measure:
(a) quantitatively a physiological or anatomical parameter; or
(b) a quantity, or a qualifiable characteristic, of energy or substances delivered to or removed from the human body.
The measurements given by a medical device that has a measuring function must:
- be displayed in Australian legal units of measurement or other units of measurement approved by the Secretary for the particular device; or
- be compared to at least one point of reference indicated in Australian legal units of measurement or other units of measurement approved by the Secretary for the particular device; and (b) must be accurate to enable the device to achieve its intended purpose
With SaMD development there is a need for peer review, transparency of algorithms and calculations, and validation of the data behind these variable technologies will limit patient risks (such as false positives and negatives), increase clinical confidence, and enhance the use of standardized metrics and practices for those CSTs that are intended to be utilized as medical devices.
With the current capabilities of data storage and sharing, manufacturers of CSTs have vast opportunities for validation of both the sensors used and algorithms applied to the derived data.
Overall there is cautious optimism there will be an inevitable successful integration of CST into practice and to provide true individual health benefits.