N.Y. Comp. Codes R. & Regs. tit. 10 § 300.1

Current through Register Vol. 46, No. 45, November 2, 2024

Section 300.1 - Definitions

For the purposes of this Part, these terms shall have the following meanings:

(a)"Statewide Health Information Network for New York" or "SHIN-NY" means the technical infrastructure and the supportive policies and agreements that:

(i) make possible the electronic exchange of clinical information among SHIN-NY participants for authorized purposes to improve the quality, coordination and efficiency of patient care, reduce medical errors and carry out public health and health oversight activities, while protecting patient privacy and ensuring data security; and

(ii) enable widespread, non-duplicative interoperability among disparate health information systems, including electronic health records, personal health records, health care claims, payment and other administrative data, and public health information systems, while protecting patient privacy and ensuring data security.

(b)"Qualified entity" means a not-for-profit regional health information organization or other entity that has been certified under section 300.4 of this Part.

(c)"SHIN-NY participant" means any health care provider, health plan, governmental agency or other type of entity or person that has executed a statewide common participation agreement with a qualified entity or with the entity that facilitates their connection to the SHIN-NY statewide data infrastructure, pursuant to which it has agreed to participate in the SHIN-NY.

(d)Health care provider means a health care provider as defined in paragraph (b) of subdivision one of section 18 of the Public Health Law entitled "Access to patient information."

(e)Statewide collaboration process means an open, transparent process within which multiple SHIN-NY stakeholders contribute to recommendations for SHIN-NY policy guidance.

(f)SHIN-NY policy guidance means the set of policies and procedures, including technical standards and SHIN-NY services and products that are approved by the New York State Department of Health.

(g)"Patient information" means health information that is created or received by a SHIN-NY participant and relates to the past, present, or future physical or mental health or condition of an individual or the provision of health care to an individual, and that identifies the individual or with respect to which there is a reasonable basis to believe the information can be used to identify the individual.

(h)Minor consent patient information means patient information relating to health care of a patient under 18 years of age for which the patient provided his or her own consent as permitted by law, without a parent's or guardian's permission.

(i)Health oversight agency means an agency or authority of the United States, or New York State, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is authorized by law to oversee the health care system (whether public or private) or government programs in which health information is necessary to determine eligibility or compliance, or to enforce civil rights laws for which health information is relevant.

(j)Public health authority means an agency or authority of the United States, the New York State Department of Health, a New York county health department or the New York City Department of Health and Mental Hygiene, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.

(k)Written authorization means a signed consent that complies with the requirements for written authorizations in this Part. A written authorization may be an electronic record with an electronic signature, as provided by State Technology Law article 3 (Electronic Signatures and Records Act).

(l)Law means a Federal, State or local constitution, statute, regulation, rule, common law, or other governmental action having the force and effect of law, including the charter, administrative code and rules of the City of New York. Required by law means a mandate contained in law that compels a person or entity to make a use or disclosure of patient information and that is enforceable in a court of law.

(m)"Statewide common participation agreement" means a common agreement, developed using a statewide collaboration process, consistent with any minimum standards set forth in the SHIN-NY policy guidance and approved by the New York State Department of Health, that is used statewide by each qualified entity or by SHIN-NY participants, allowing them to connect to the SHINY-NY statewide data infrastructure either directly or through a contractor, and pursuant to which SHIN-NY participants agree to participate in the SHIN-NY and adhere to SHIN-NY policy guidance, including but not limited to causing patient data to be contributed to the statewide data infrastructure and authorizing the use of patient data for statewide reporting and analytics for public health activities and Medicaid purposes, consistent with applicable law.

(n)"Statewide data infrastructure" means the information technology infrastructure provided by the New York State Department of Health, either directly or through contract, to support the aggregation of data provided by qualified entities and SHINNY participants, statewide reporting and analytics for public health activities and Medicaid purposes, consistent with applicable law.

(o)"Public health activities" means purposes for which a SHIN-NY participant is permitted to disclose protected health information to a public health authority without an authorization or opportunity to agree or object under federal standards for uses and disclosures for public health activities.

(p)"Medicaid purposes" means purposes related to the administration of the Medicaid program, including but not limited to reporting to support any Social Security Act section 1115 waiver approved by the Centers for Medicare and Medicaid Services.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 300.1

Adopted New York State Register March 9, 2016/Volume XXXVIII, Issue 10, eff. 3/9/2016

Amended New York State Register July 10, 2024/Volume XLVI, Issue 28, eff. 7/10/2024