Form 0920-0950 Hour Wearable Devices

Attachment 17

24 Hour Wearable Devices Pilot

Form Approved

OMB No. 0920-0950

Exp. Date XX/XX/20XX

Notice – CDC estimates the average public reporting burden for this collection of information as 25 hours per response, including the time for reviewing instructions, searching existing data/information sources, gathering and maintaining the data/information needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Information Collection Review Office, 1600 Clifton Road, MS D-74, Atlanta, GA 30333; ATTN: PRA (0920-0950).

Assurance of Confidentiality – We take your privacy very seriously.  All information that relates to or describes identifiable characteristics of individuals, a practice, or an establishment will be used only for statistical purposes.  NCHS staff, contractors, and agents will not disclose or release responses in identifiable form without the consent of the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 U.S.C. 242m) and the Confidential Information Protection and Statistical Efficiency Act (Title III of the Foundations for Evidence-Based Policymaking Act of 2018 (Pub. L. No. 115-435, 132 Stat. 5529 § 302)).  In accordance with CIPSEA, every NCHS employee, contractor, and agent has taken an oath and is subject to a jail term of up to five years, a fine of up to $250,000, or both if he or she willfully discloses ANY identifiable information about you.

Up to 1,000 additional persons might participate in tests of wearable devices, if budgeted, including devices worn for a 24-hour period. Including time for providing instructions or conducting end of project interviews etc. results in an average burden of 25 hours for these respondents.

Wearable or mobile health data collection devices are increasingly being used in clinical and research environments as well as in personal settings. This project would investigate the feasibility of incorporating wearable blood pressure monitors among NHANES respondents. Before full implementation on the NHANES, information would be needed in several operational areas such as: measurement validity, data access and transfer, data storage, data processing, and acceptability to respondents. The list of wearable health monitors that could be explored as potential data collection tools continues to grow. Possible measurements could include: balance, cardiac rhythms, cortisol, physical activity, posture, sedentary behavior, sleep, blood pressure and weight etc.

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