§171.102. Definitions. — Inbound Citations

(2) Makes this determination using objective, verifiable criteria that are applied fairly and consistently across all apps and developers through which parties seek to access electronic health information, as defined in 45 CFR 171.102, including but not limited to, criteria that rely on automated monitoring and risk mitigation tools.

(2) Makes this determination using objective, verifiable criteria that are applied fairly and consistently across all apps and developers through which parties seek to access electronic health information, as defined in 45 CFR 171.102, including but not limited to criteria that rely on automated monitoring and risk mitigation tools.

(2) Makes this determination using objective, verifiable criteria that are applied fairly and consistently across all apps and developers through which parties seek to access electronic health information, as defined in 45 CFR 171.102, including but not limited to criteria that rely on automated monitoring and risk mitigation tools.

(a) For this subpart, violation means a practice, as defined in 45 CFR 171.102, that constitutes information blocking, as set forth in 45 CFR part 171.

(2) Makes this determination using objective, verifiable criteria that are applied fairly and consistently across all apps and developers through which parties seek to access electronic health information, as defined in 45 CFR 171.102, including but not limited to criteria that rely on automated monitoring and risk mitigation tools.

(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—

(2) A Merit-based Incentive Payment System (MIPS) eligible clinician as defined in 42 CFR 414.1305, who is also a health care provider as defined in § 171.102, is not a meaningful EHR user for MIPS as defined in 42 CFR 414.1305.

(a) This part applies to health care providers, health IT developers of certified health IT, health information exchanges, and health information networks, as those terms are defined in § 171.102.

(iii) The practice, as the term is defined in § 171.102 and referenced in § 171.103, found to have been information blocking, including when the practice occurred;

(1) Section 164.524(a)(3)(iii) of this title where the practice is likely to, or in fact does, interfere with access, exchange, or use (as these terms are defined in § 171.102) of the patient's electronic health information by their legal representative (including but not limited to personal representatives recognized pursuant to 45 CFR 164.502) and the practice is implemented pursuant to an individualized determination of risk of harm consistent with paragraph (c)(1) of this section;

(2) If an actor fulfills a request for electronic health information in any manner requested:

(i) Any fees charged by the actor in relation to fulfilling the request are not required to satisfy the exception in § 171.302; and

(ii) Any license of interoperability elements granted by the actor in relation to fulfilling the request is not required to satisfy the exception in § 171.303.

(5) Must be disclosed under operation of law, provided that, to the extent permitted by Applicable Law, the recipient gives the discloser reasonable notice to allow the discloser to object to such redisclosure, and such redisclosure is made to the minimum extent necessary to comply with Applicable Law.

Connectivity Services. The technical services provided by a QHIN, Participant, or Subparticipant to its Participants and Subparticipants that facilitate TEFCA Exchange and are consistent with the technical requirements of the TEFCA framework.

Covered Entity. Has the meaning assigned to such term at 45 CFR 160.103.

Designated Network. The health information network that a QHIN uses to offer and provide Designated Network Services.

Designated Network Services. The Connectivity Services and/or Governance Services.

Designation (including its correlative meanings “Designate,” “Designated,” and “Designating”). The written determination that an Applicant QHIN has satisfied all requirements and is now a QHIN.

Disclosure (including its correlative meanings “Disclose,” “Disclosed,” and “Disclosing”). The release, transfer, provision of access to, or divulging in any manner of TEFCA Information (TI) outside the entity holding the information.

Electronic Protected Health Information (ePHI). Has the meaning assigned to such term at 45 CFR 160.103.

Exchange Purpose(s) or XP(s). The reason, as authorized by a Framework Agreement, including the applicable standard operating procedure(s) (SOP(s)), for a transmission, Query, Use, Disclosure, or Response transacted through TEFCA Exchange.

Exchange Purpose Code or XP Code. A code that identifies the Exchange Purpose being used for TEFCA Exchange.

Foreign Control. A non-U.S. Person(s) or non-U.S. Entity(ies) having the direct or indirect power, whether or not exercised, to direct or decide matters materially affecting the Applicant's ability to function as a QHIN in a manner that presents a national security risk.

Framework Agreement(s). With respect to QHINs, the Common Agreement; and with respect to a Participant or Subparticipant, the Participant/Subparticipant Terms of Participation (ToP).

Governance Services. The governance functions described in applicable SOP(s), which are performed by a QHIN's Designated Network Governance Body for its Participants and Subparticipants to facilitate TEFCA Exchange in compliance with the then-applicable requirements of the Framework Agreements.

Health information network or HIN. The meaning assigned to it in 45 CFR 171.102.

Individual has the meaning assigned to such term at 45 CFR 171.202(a)(2).

HIPAA. The Health Insurance Portability and Accountability Act of 1996.

HIPAA Privacy Rule. The regulations set forth in 45 CFR part 160 and subparts A and E of 45 CFR part 164.

HIPAA Rules. The regulations set forth at 45 CFR parts 160, 162, and 164.

HIPAA Security Rule. The regulations set forth in 45 CFR part 160 and subparts A and C of 45 CFR part 164.

Individual. Has the meaning assigned to such term at 45 CFR 171.202(a)(2).

Individual Access Services (IAS). The services provided to an Individual by a QHIN, Participant, or Subparticipant that has a direct contractual relationship with such Individual in which the QHIN, Participant or Subparticipant, as applicable, agrees to satisfy that Individual's ability to access, inspect, or obtain a copy of that Individual's Required Information using TEFCA Exchange.

Individually Identifiable Information. Refers to information that identifies an Individual or with respect to which there is a reasonable basis to believe that the information could be used to identify an Individual.

Node. A technical system that is controlled directly or indirectly by a QHIN, Participant, or Subparticipant and that is listed in the RCE Directory Service.

Non-U.S. Entity. Any entity that is not a U.S. Entity.

Non-U.S. Person. Any Individual who is not a U.S. Qualified Person.

Onboarding. The process a prospective QHIN must undergo to become a QHIN and become operational in the production environment.

Organized Health Care Arrangement. Has the meaning assigned to such term at 45 CFR 160.103.

Participant. A U.S. Entity that has entered into the Participant/Subparticipant Terms of Participation in a legally binding contract with a QHIN to use the QHIN's Designated Network Services to participate in TEFCA Exchange in compliance with the Participant/Subparticipant Terms of Participation.

Participant/Subparticipant Terms of Participation (ToP). The requirements to which QHINs must contractually obligate their Participants to agree; to which QHINs must contractually obligate their Participants to contractually obligate their Subparticipants and Subparticipants of the Subparticipants to agree, in order to participate in TEFCA Exchange including the QHIN Technical Framework (QTF), all applicable SOPs, and all other attachments, exhibits, and artifacts incorporated therein by reference.

Qualified Health Information Network® or QHIN TM. A Health Information Network that has been so Designated.

Query(s) (including its correlative uses/tenses “Queried” and “Querying”). The act of asking for information through TEFCA Exchange.

Recognized Coordinating Entity® (RCE®). The entity selected by ASTP/ONC that enters into the Common Agreement with QHINs in order to impose, at a minimum, the requirements of the Common Agreement, including the SOPs and the QTF, on the QHINs and administer such requirements on an ongoing basis. The RCE is a Party to the Common Agreement.

Required Information. The Electronic Health Information, as defined in 45 CFR 171.102, that is:

(2) Information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding.

Exchange means the ability for electronic health information to be transmitted between and among different technologies, systems, platforms, or networks.

Fee means any present or future obligation to pay money or provide any other thing of value.

Health care provider has the same meaning as “health care provider” in 42 U.S.C. 300jj.

Health information network or health information exchange means an individual or entity that determines, controls, or has the discretion to administer any requirement, policy, or agreement that permits, enables, or requires the use of any technology or services for access, exchange, or use of electronic health information:

(2) Information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding.

Exchange means the ability for electronic health information to be transmitted between and among different technologies, systems, platforms, or networks.

Fee means any present or future obligation to pay money or provide any other thing of value.

Health care provider has the same meaning as “health care provider” in 42 U.S.C. 300jj.

Health information network or health information exchange means an individual or entity that determines, controls, or has the discretion to administer any requirement, policy, or agreement that permits, enables, or requires the use of any technology or services for access, exchange, or use of electronic health information:

(2) Information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding.

Exchange means the ability for electronic health information to be transmitted between and among different technologies, systems, platforms, or networks.

Fee means any present or future obligation to pay money or provide any other thing of value.

Health care provider has the same meaning as “health care provider” in 42 U.S.C. 300jj.

Health information network or health information exchange means an individual or entity that determines, controls, or has the discretion to administer any requirement, policy, or agreement that permits, enables, or requires the use of any technology or services for access, exchange, or use of electronic health information: