Introduction  1

1 Background  3

1.1 The role of wearables in clinical decision-making  3

1.2 Federal role for the use of wearables in clinical decision-making  5

2 Current Capabilities of Wearables for Use in Clinical Decision-Making  9

2.1 Current wearables rely on sensors  9

2.2 Wearables' capabilities depend on their accuracy and reliability  11

2.3 AI augmentation of wearables could increase autonomous decision-making  12

3 Potential Benefits of Wearables in Clinical Decision-Making  14

3.1 Wearables may provide benefits to individual health  14

3.2 Wearables could provide benefits to underserved populations  16

4 Challenges Limiting the Use of Wearables in Clinical Decision-Making  18

4.1 Challenges of ensuring patient health benefits  18

4.2 Challenges of integrating wearables into clinical workflows  20

4.3 Challenges of navigating the health technology market  22

5 Policy Options Related to Wearables in Clinical Decision-Making  24

5.1 Continue the status quo  24

5.2 Improve integration of wearables into clinical workflows  26

5.3 Incentivize improvements to wearables performance in clinical decision-making  27

6 Agency Comments  30