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HC (Hospital Component)

Money to Hospital for space, equipment, supplies, staff etc. (CDM/EAP)

Health Information Technology for Economic & Clinical Health (HITECH)

The HITECH Act was signed into law on February 17, 2009, to promote the adoption and meaningful use of health information technology. Subtitle D of the HITECH Act addresses the privacy and security concerns associated with the electronic transmission of health information, in part, through several provisions that strengthen the civil and criminal enforcement of the HIPAA rules.

HHS

 the U.S. Health and Human Services; see also DHHS

HIPAA

Health Insurance Portability and Accountability Act of 1996 imposes requirements for how a covered entity protects the privacy and security of Protected Health Information. Some HIPAA provisions apply to research involving human participants. See Research A-Z HIPAA topic, especially the pages HIPAA and Protected Health Information.

Related Terms: Protected Health Information (PHI), Covered Entity, Individually Identifiable Health Information

HIPAA identifiers

HIPAA Protected Health Information is considered identifiable if any of the following identifiers are included:

  1. Name
  2. Geographic subdivisions smaller than a state.
  3. All elements of dates (except year) for dates that are directly related to an individual; and all ages over 89 and all elements of dates (including year) indicative of such age
  4. Telephone numbers
  5. Fax numbers
  6. Email addresses
  7. Social security numbers
  8. Medical record numbers
  9. Health plan numbers
  10. Account numbers
  11. Certificate or license numbers
  12. Vehicle identification/serial numbers, including license plate numbers
  13. Device identification/serial numbers
  14. Universal Resource Locators (URLs)
  15. Internet protocol (IP) addresses
  16. Biometric identifiers, including finger and voice prints
  17. Full face photographs and comparable images
  18. Any other unique identifying number, characteristic, or code

For details and exceptions, see Research A-Z webpage Protected Health Information, heading "HIPAA identifiers."

Related Terms: Protected Health Information (PHI), HIPAA, Limited Data Set (LDS), De-identified , Individually Identifiable Health Information

HITECH

Health Information Technology for Economic & Clinical Health

 

Hospital Account No.

When initial IRBMED approval is obtained,OnCore Support sends the RPE to RCRB who creates the RMRN. For studies in OnCore, a RMRN request form does not have to be completed and submitted.

hPSCRO

Human Pluripotent Stem Cell Research Oversight Committee

HRPP

University of Michigan’s Human Research Protection Program

HUM Number

The number assigned to project applications through eResearch.  Through the life of a study, each project will only ever have one HUM Number, though for Amendments and AE/ORIO submissions will be given a second identifying number. For example: HUM0001234, ADV0004567.

Human Pluripotent Stem Cell Research Oversight Committee (hPSCRO)

The hPSCRO provides local oversight of ethical issues related to derivation and research use of human embryonic stem (hES) cells and induced pluripotent stem (iPS) cells. The HPSCRO also provides local oversight of research with human pluripotent stem cells in experiments designed or expected to yield gametes (oocytes or sperm) or with the intent or potential to integrate these cells into the central nervous system of animals.

Human Subject

Human Subject means:

  • OHRP: “A living individual about whom an investigation conducting research obtains (1) Data through intervention or interaction with the individual or (2) identifiable private information.” 45 CFR 46.102 (f)
  • FDA: “An individual who is or becomes a participant in research, either as a recipient of the test article or as a control.  A subject may be either a healthy human or a patient.”   21 CFR 50.3 (g) and 21 CFR 56.102 (e)

Humanitarian Device Exemption (HDE)

An application that permits the marketing of a humanitarian use device.

Humanitarian Use Device (HUD)

An FDA regulated medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the US per year, but not yet approved for unrestricted use. The use of a HUD is subject to IRB oversight. Contact IRMBED Office for guidance.