Instrument, apparatus, machine, equipment, implant, software, hardware, or related component or accessory intended to diagnose, treat, cure, mitigate, or prevent disease, or to affect the structure or function of the body.

Data Element
Medical Device Use
Submitted By: Sandi Mitchell / J P Systems, Inc.
Data Element Information
Data Element Description The use of the medical device.
Use Case Description(s)
Use Case Description In order to best treat the patient, the clinician and receiving system must understand the medical device name and use.
Estimate the breadth of applicability of the use case(s) for this data element Level 0
ONC Priority
  • None of the above
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s) N/A
Additional Specifications N/A
Current Use (Level 0) Captured, stored, or accessed in limited settings such as a pilot or proof of concept demonstration
Extent of exchange N/A
Potential Challenges
Restrictions on Standardization (e.g. proprietary code) None
Restrictions on Use (e.g. licensing, user fees) None
Privacy and Security Concerns Standard HIPAA concerns.
Estimate of Overall Burden This data element impacts patient safety to ensure clinicians understand the medical name and use.
Other Implementation Challenges N/A
ASTP Evaluation Details
Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1
Maturity - Current Standards		 Level 0 - Data element is not represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2
Maturity - Current Use 		Level 0 - Data element is captured, stored, or accessed in limited settings such as a pilot or proof of concept demonstration.
Criterion #3
Maturity - Current Exchange		 Level 0 - Data element is electronically exchanged in limited environments, such as connectathons or pilots.
Criterion #4
Use Case(s) - Breadth of Applicability		 Level 0 - Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements.

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Data Class and Data Element

Fig 1 The "Data Class" and "Data Element" dropdown menus allow users to specify the exact content they wish to comment on.

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  3. In the ONDEC system, follow the provided instructions to submit your proposal for a new data class or element.
  4. Once your proposal is submitted through ONDEC, it will be reviewed separately from the commenting process.
Propose New Data Class or Element

Fig 2 The "Propose a New Data Class or Data Element" button redirects users to the ONDEC Submission System for proposing new data elements not currently available in the system.

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Fig 3 The "Comment on another data element" link enables users to create multiple comments addressing different elements within a single submission.

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Upload Supporting Files

Fig 4 The "File Upload" section permits users to attach supporting documentation that supplements their written comments.

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Fig 5 A red triangle with exclamation mark indicator appears next to the “Return to saved Comment” button when draft comments are saved in the system.

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Review and Submit

Fig 6 The review screen allows users to verify comment content and make any necessary modifications before final submission.

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