1 | 2 | 4 | 5 | 7 | A | B | C | D | E | F | G | H | I | J | L | M | N | O | P | Q | R | S | T | U | V | W

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.

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

The HIPAA Privacy Rule regulates the use and disclosure of Protected Health Information (PHI) held by "covered entities" (generally, employer sponsored health plans, health insurers, and medical service providers that engage in certain transactions). By regulation, the DHHS extended the HIPAA privacy rule to independent contractors of covered entities who fit within the definition of "business associates". PHI is any information held by a covered entity which concerns health status, provision of health care, or payment for health care that can be linked to an individual. This is interpreted rather broadly and includes any part of an individual's medical record or payment history. They also must disclose PHI when required to do so by law, such as reporting suspected child abuse to state child welfare agencies.

 

HHS

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

HIPAA

Health Insurance Portability and Accountability Act of 1996, as amended, and privacy regulations promulgated pursuant to the Act

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 affect fewer than 4000 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.