Fig. 4. A framework for leveraging prior work to demonstrate a digital health technology (DHT) and digitally derived endpoint is fit-for-purpose—case study in remote monitoring sleep parameter in home setting.

Prior Work can and should be leveraged in all scenarios where available and appropriate, shading indicates when additional work may or likely will be needed. The light gray shading indicates no additional work is needed. The medium gray shading indicates additional work may be needed. The dark gray shading indicates additional work likely is needed.