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Classification Level Sort descending	Data Class	Data Class Description	Data Element	Data Element Description	Applicable Standards	Submitter Name	Submitter Organization	Submission Date
Level 0	Medical Devices	An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.	Medical Device Name	The name of the medical device.		Sandi Mitchell	J P Systems, Inc.	09/28/2023 - 14:42
Level 0	Medical Devices	An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.	Measured ventilator peak inspiratory pressure	Measured peak inspiratory pressure if the patient is receiving mechanical ventilation	Airway type LOINC LL5542-7 PEEP LOINC 20077-4 Pressure support LOINC 20079-0 Plateau Pressure LOINC 76259-1 Tidal Volume LOINC 76221-1 Respiratory Rate LOINC 33438-3	Ali Abbasi MD- on behalf of the I-SPY COVID investigators	I-SPY COVID Trial Investigators	09/21/2023 - 00:09
Level 0	Medical Devices	An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.	Ventilator measured plateau pressure	The measured plateau pressure on the ventilator if the patient is receiving mechanical ventilation	Airway type LOINC LL5542-7 PEEP LOINC 20077-4 Pressure support LOINC 20079-0 Plateau Pressure LOINC 76259-1 Tidal Volume LOINC 76221-1 Respiratory Rate LOINC 33438-3	Ali Abbasi MD- on behalf of the I-SPY COVID investigators	I-SPY COVID Trial Investigators	09/21/2023 - 00:09
Level 0	Medical Devices	An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.	Ventilator Mode	The mode of mechanical ventilation if the patient is receiving mechanical ventilation. Could refer to LOINV 20124-4 for options.	Airway type LOINC LL5542-7 PEEP LOINC 20077-4 Pressure support LOINC 20079-0 Plateau Pressure LOINC 76259-1 Tidal Volume LOINC 76221-1 Respiratory Rate LOINC 33438-3	Ali Abbasi MD- on behalf of the I-SPY COVID investigators	I-SPY COVID Trial Investigators	09/21/2023 - 00:09
Level 0	Special Alerts for Care Handoffs		Conditions with substantial risk of complications ICD 10, SNOMED	Serious chronic mental illness Transplants Substance Use Disorder Incontinence Healed pressure injury Active pressure injury	ICD 10, SNOMED, LOINC, RxNorm	Holly Miller, MD	MedAllies	09/22/2022 - 19:51
Level 0	Special Alerts for Care Handoffs		Infections ICD 10, SNOMED	Infection precautions (COVID 19, MPV, C diff, MRSA, MDRO, etc.) Vaccination status especially unvaccinated or contraindicated	ICD 10, SNOMED, LOINC, RxNorm	Holly Miller, MD	MedAllies	09/22/2022 - 19:51
Level 0	Special Alerts for Care Handoffs		External devices LOINC	Lines Tubes Drains Catheters Date/time prior urinary catheter removed	ICD 10, SNOMED, LOINC, RxNorm	Holly Miller, MD	MedAllies	09/22/2022 - 19:51
Level 0	Special Alerts for Care Handoffs		Internal devices LOINC	Stents Monitors Pumps Defibrillators	ICD 10, SNOMED, LOINC, RxNorm	Holly Miller, MD	MedAllies	09/22/2022 - 19:51
Level 0	Medications	Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.	Medication experience		FHIR Resource: HL7 FHIR R4 MedicationStatement, aka R5 MedicationUsage Data element: MedicationStatement.status; MedicationUsage.takenAsOrdered Values in http://hl7.org/fhir/CodeSystem/medication-statement-status: {active \| completed \| entered-in-error \| intended \| stopped \| on-hold \| unknown \| not-taken} These are defined in terms of taking; i.e., “active” in MedicationRequest means that the prescription can be filled, but in MedicationStatement, means that the patient is taking it. FHIR R5 target is to remove “status” and create “use,” with values { Taking \| Taking as directed \| Taking not as directed \| Not Taking \| Unknown (unable to obtain)} AVS/PVS system uses “I am taking this med {As written \| Differently \| Not taking \| Unsure}”	Maureen Layden, MD, MPH	United States Department of Veterans Affairs	10/02/2020 - 19:13
Level 0	Medical Devices	An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.	Ventilator set tidal volume	The tidal volume set on the ventilator if the patient is receiving mechanical ventilation.	Airway type LOINC LL5542-7 PEEP LOINC 20077-4 Pressure support LOINC 20079-0 Plateau Pressure LOINC 76259-1 Tidal Volume LOINC 76221-1 Respiratory Rate LOINC 33438-3	Ali Abbasi MD- on behalf of the I-SPY COVID investigators	I-SPY COVID Trial Investigators	09/21/2023 - 00:09
Level 0	Special Alerts for Care Handoffs		Special equipment needed LOINC	Oxygen Hoyer Special fit wheelchair Bariatric Extended length Wound care VAC Prosthetics, orthoses	ICD 10, SNOMED, LOINC, RxNorm	Holly Miller, MD	MedAllies	09/22/2022 - 19:51
Level 0	Special Alerts for Care Handoffs		Medications RxNorm, SNOMED	Important drug-drug interactions High risk medications e.g.: anticoagulants opiates sedatives electrolyte altering hypoglycemics antipsychotics Immunosuppressants Tricyclic antidepressants Complicated regimens e.g.: loading tapering sliding scale precise schedule Instructions for missed or late medications	ICD 10, SNOMED, LOINC, RxNorm	Holly Miller, MD	MedAllies	09/22/2022 - 19:51
Level 0	Special Alerts for Care Handoffs		Risk Scores	LACE - https://www.mdcalc.com/calc/3805/lace-index-readmission	ICD 10, SNOMED, LOINC, RxNorm	Holly Miller, MD	MedAllies	09/22/2022 - 19:51
Level 0	Care Team Members	Information about a person who participates or is expected to participate in the care of a patient.	Caregiver of disabled person	Person serving as a primary caregiver for a disabled person.	American Community Survey disability value set	Charles Mayo	University of Michigan, American Association of Physicists in Medicine	04/27/2022 - 15:25
Level 0	Clinical Notes	Narrative patient data relevant to the context identified by note types. Usage note: Clinical Notes data elements are content exchange standard agnostic. They should not be interpreted or associated with the structured document templates that may share the same name.	Tumor Board Notes	This may be a interdisciplinary note or a specific note for tumor boards.	https://loinc.org/85231-9/	Leslie Kelly Hall	Engaging Patient Strategy	06/29/2021 - 15:54
Level 0	Medical Devices	An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.	Ventilator set positive end expiratory pressure	The set positive end expiratory pressure (PEEP) if the patient is receiving mechanical ventilation or a biphasic positive airway pressure.	Airway type LOINC LL5542-7 PEEP LOINC 20077-4 Pressure support LOINC 20079-0 Plateau Pressure LOINC 76259-1 Tidal Volume LOINC 76221-1 Respiratory Rate LOINC 33438-3	Ali Abbasi MD- on behalf of the I-SPY COVID investigators	I-SPY COVID Trial Investigators	09/21/2023 - 00:09
Level 0	Medical Devices	An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.	Ventilator set respiratory rate	The set respiratory rate if the patient is receiving mechanical ventilation	Airway type LOINC LL5542-7 PEEP LOINC 20077-4 Pressure support LOINC 20079-0 Plateau Pressure LOINC 76259-1 Tidal Volume LOINC 76221-1 Respiratory Rate LOINC 33438-3	Ali Abbasi MD- on behalf of the I-SPY COVID investigators	I-SPY COVID Trial Investigators	09/21/2023 - 00:09
Level 0	Medical Devices	An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.	Ventilator pressure support	The pressure support above PEEP if the patient is receiving mechanical ventilation	Airway type LOINC LL5542-7 PEEP LOINC 20077-4 Pressure support LOINC 20079-0 Plateau Pressure LOINC 76259-1 Tidal Volume LOINC 76221-1 Respiratory Rate LOINC 33438-3	Ali Abbasi MD- on behalf of the I-SPY COVID investigators	I-SPY COVID Trial Investigators	09/21/2023 - 00:09
Level 0	Medical Devices	An instrument, machine, appliance, implant, software or other article intended to be used for a medical purpose.	Medical Device Category	AMIA recommends a more thorough breakdown of the Medical Devices Data Class. For medical devices, there should be a distinguishment between permanent versus temporary data classes. Temporary devices for example PICC line, indwelling foley and suprapubic catheters, and wound vacs. Medical applications should also be included as they are considered medical digital devices, such as digital therapeutics, standard languages, payor exchanges, what is included and excluded in this category.	FDA Unique Device Identification (UDI) System	Tayler Williams	American Medical Informatics Association (AMIA)	09/20/2023 - 17:11
Level 0	Clinical Notes	Narrative patient data relevant to the context identified by note types. Usage note: Clinical Notes data elements are content exchange standard agnostic. They should not be interpreted or associated with the structured document templates that may share the same name.	Postpartum Summary Note	The postpartum summary note supports the inclusion of any interval medical history since delivery, physical and pelvic examination information, review of newborn status, discussion of birth control options, depression and intimate partner violence screenings, immunization review, counseling regarding any future pregnancies, and any interventional education, screenings, tests and results including laboratory. The postpartum summary note includes information such as structured evaluation of risk (e.g., PRAPARE, homelessness, AHC-HRSN screening tool, etc.) for any maternal health SDOH data related to conditions in which people live, learn, work, and play and their effects on health risks and outcomes; plan of care including social support interventions including but not limited to access to care; education; income; food stability; housing; neighborhood characteristics; safety; transportation security; violence/abuse preventions, ETOH, Smoking, Substance use disorder assessment and treatment drug abuse prevention and treatment; living arrangement; Social support involvement baby father involvement; etc.	SNOMED CT 55410009 Maternal postpartum 86569001 Postpartum state LOINC: 57076-2 Postpartum hospitalization treatment Narrative https://loinc.org/57076-2/ 57083-8 Labor and Delivery record panel https://loinc.org/57083-8/ 92576-8 Maternal discharge summary - recommended IHE set https://loinc.org/92576-8/ ICD9 CM Complications of Pregnancy, Childbirth and the Puerperium http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113883.3.464.1003.111.11.1021 ICD10CM, SNOMED CT Complications of Pregnancy, Childbirth and the Puerperium http://cts.nlm.nih.gov/fhir/ValueSet/2.16.840.1.113883.3.464.1003.111.12.1012 Pregnancy https://vsac.nlm.nih.gov/valueset/2.16.840.1.113883.3.526.3.378/expansion	Andrea Fourquet	IHE USA	04/30/2022 - 00:30