§801.3. Definitions. — Inbound Citations

(2) Purchases, arranges for or negotiates the purchase of a covered drug, device, biological, or medical supply for a group of individuals or entities, but not solely for use by the entity itself.

Applicable manufacturer means an entity that is operating in the United States and that falls within one of the following categories:

(20) In accordance with the “Health Concerns Section” of the standard specified in § 170.205(a)(4).

Day or Days means a calendar day or calendar days.

Device identifier is defined as it is in 21 CFR 801.3.

Disclosure is defined as it is in 45 CFR 160.103.

Electronic health information (EHI) is defined as it is in § 171.102.

Fee is defined as it is in § 171.102 of this subchapter.

Global Unique Device Identification Database (GUDID) is defined as it is in 21 CFR 801.3.

Health information technology means hardware, software, integrated technologies or related licenses, IP, upgrades, or packaged solutions sold as services that are designed for or support the use by health care entities or patients for the electronic creation, maintenance, access, or exchange of health information.

Health IT Module means any service, component, or combination thereof that can meet the requirements of at least one certification criterion adopted by the Secretary.

Human readable format means a format that enables a human to read and easily comprehend the information presented to him or her regardless of the method of presentation.

Implantable device is defined as it is in 21 CFR 801.3.

Implementation specification means specific requirements or instructions for implementing a standard.

Interoperability is, with respect to health information technology, such health information technology that—