NYSDOH Issues Proposed Regulations on SHIN-NY Interoperability and Accessibility
Per the notice below, published in the New York State Register on February 14, 2024, the New York State Department of Health (NYSDOH) has issued proposed regulations designed to make the Statewide Health Information Network for New York (SHIN-NY) more interoperable and accessible to health care providers.
Department of Health
PROPOSED RULE MAKING
NO HEARING(S) SCHEDULED
Statewide Health Information Network for New York (SHIN-NY)
I.D. No. HLT-07-24-00015-P
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action: Amendment of Part 300 of Title 10 NYCRR.
Statutory authority: Public Health Law, sections 201, 206(1), (18-a), (d), 2803, 2816, 3612, 4010, 4403 and 4712
Subject: Statewide Health Information Network for New York (SHINNY).
Purpose: To establish the State Designated Entity and Enhancing SHIN-NY Efficiency and Flexibility.
Substance of proposed rule (Full text is posted at the following State website: https://regs.health.ny.gov/regulations/proposed-rule-making): Public Health Law sections 206(18-a)(d) and 2816 give the Department broad authority to promulgate regulations, consistent with federal law and policies, that govern the Statewide Health Information Network for New York (SHIN-NY).
These amendments support the development of the statewide data infrastructure, thereby increasing interoperability and providing the flexibility necessary for the SHIN-NY to adapt in a constantly evolving technological environment. The goal of these amendments is to ensure consistency across the SHIN-NY in how SHIN-NY participants connect and exchange data, to support public health during emergencies and to assist with Medicaid reporting in support of the Medicaid program’s Social Security Act Section 1115 waiver (see 42 USC § 1315).
In order to promote efficiency through the development of networkwide policies, processes, and solutions, these amendments create a process to develop the statewide data infrastructure that will facilitate the exchange of data among SHIN-NY participants. Relevant activities required of the Department or its contracted vendor under the amendments include enhancement of the data matching process for patient demographic information submitted by SHIN-NY participants, creation of a statewide provider directory to serve as a standardized resource for resolving provider and facility identities, development of a statewide patient consent management system, and the aggregation of data from SHIN-NY participants in a secure statewide repository.
In addition, under these regulations, the Department will create a statewide common participation agreement to be used by each qualified entity and which will allow SHIN-NY participants to connect to the statewide data infrastructure by agreeing to participate in the SHIN-NY and adhering to SHIN-NY policy guidance. This will allow patient data to be contributed to the statewide data infrastructure and used for statewide reporting and analytics for public health surveillance and Medicaid purposes, to the extent authorized by law.
This will further promote consistency and efficiency across the SHIN-NY by requiring the qualified entities to use and accept networkwide agreements and patient consent decisions. The statewide common participation agreement will eliminate the current variation in the terms and conditions applicable to participating in the SHIN-NY through one qualified entity versus another. The amendments also reduce ambiguity by requiring qualified entities to honor and implement patient consent decisions that authorize data access by treating providers across the network, regardless of which qualified entity such providers have contracted with, to participate in the SHIN-NY.
This amendment will further the Legislature’s intent under chapter 54 of the Laws of 2023, which appropriated an additional $2.5 million “for modernizing health reporting systems.” By clarifying the data reporting and aggregation responsibilities applicable to the qualified entities, the proposed amendments will transform the SHIN-NY into a functional resource for the analysis and reporting of statewide health information for authorized public health and health oversight purposes.
Text of proposed rule and any required statements and analyses may be obtained from: Katherine Ceroalo, DOH, Bureau of Program Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.ny.gov
Data, views or arguments may be submitted to: Same as above.
Public comment will be received until: 60 days after publication of this notice. This rule was not under consideration at the time this agency submitted its Regulatory Agenda for publication in the Register.
Regulatory Impact Statement
Statutory Authority: Public Health Law (PHL) § 206(18-a)(d) authorizes the Commissioner to make such rules and regulations as may be necessary to 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. In addition, PHL sections 201, 206(1), 2803, 2816, 3612, 4010, 4403, and 4712 authorize the Commissioner to make such rules and regulations as may be necessary to effectuate the provisions and purposes of PHL Articles 28 (hospitals), 36 (home care services), 40 (hospice), 44 (health maintenance organizations) and 47 (shared health facilities) and provide additional authority for the Commissioner to create and make use of the Statewide Health Information Network for New York (SHIN-NY).
Legislative Objectives: The explicit legislative objective of PHL § 206(18-a) is the promotion of widespread, non-duplicative interoperability among disparate health information systems and data types, 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. Such interoperability is intended to improve patient outcomes, minimize unnecessary service utilization, and reduce health care costs by fostering efficiency and supporting care coordination.
Existing regulations at 10 NYCRR Part 300 advanced these legislative objectives by establishing requirements for the regional health information organizations (RHIOs) that were created as health information exchanges in New York State. Under the provisions of Part 300, the RHIOs became the qualified entities (QEs) that facilitate the exchange of health information in the SHIN-NY. These regulatory amendments will further the legislative intent by making it easier for health care providers, health plans, and governmental agencies to become SHIN-NY participants and access the SHIN-NY through the use of a statewide common participation agreement, while ensuring patient privacy and data security.
Needs and Benefits: Pursuant to the current regulation, responsibility for the development and maintenance of SHIN-NY policies and technical infrastructure is divided between the QEs and the Department. In practice, this division of oversight and operational responsibilities has resulted in the deployment of disparate forms, processes, and technology solutions across the network. The proposed amendments are necessary to support the development of the statewide data infrastructure, thereby increasing interoperability and providing the flexibility necessary for the SHIN-NY to adapt in a constantly evolving technological environment. The goal of these amendments is to ensure consistency across the SHIN-NY in how SHIN-NY participants connect and exchange data, and to support the sharing of information for public health purposes, such as the Medicaid program’s Social Security Act Section 1115 waiver (see 42 USC § 1315).
In order to promote efficiency through the development of networkwide policies, processes, and solutions, these amendments create a process to develop the statewide data infrastructure that will facilitate the exchange of data among SHIN-NY participants by enhancing the matching of patient demographic information submitted by SHIN-NY participants, with a statewide provider directory, and statewide consent management system.
In addition, under these regulations, the Department will create a statewide common participation agreement to be used statewide by each qualified entity whether the participant connects through a qualified entity or directly through the statewide infrastructure. This will enable SHIN-NY participants to connect with the statewide data infrastructure and contribute patient data. Furthermore, the statewide common participation agreement will allow the use of such data for statewide reporting and analytics for public health surveillance and Medicaid purposes, in accordance with SHIN-NY policy guidance.
The regulations will further promote consistency and efficiency across the SHIN-NY by requiring the QEs to use and accept network-wide agreements and patient consent decisions. The statewide common participation agreement will eliminate the current variation in the terms and conditions applicable to participating in the network through one QE versus another. The regulatory amendments will also reduce ambiguity by requiring QEs to honor and implement patient consent decisions that authorize data access by treating providers across the network, regardless of which QE such providers have contracted with to participate in the SHIN-NY.
These amendments will also further the Legislature’s intent under chapter 54 of the Laws of 2023, which appropriated an additional $2.5 million “for modernizing health reporting systems.” As the COVID-19 and requirement to use the Hospital Emergency Reporting Data System (HERDS) for crucial public health reporting pandemic demonstrated, the current framework for SHIN-NY data collection and reporting is insufficient to enable timely analysis and decision making in situations involving an emergent public health concern. By providing for a statewide data infrastructure and explicitly requiring all SHIN-NY participants to submit data for aggregation, these amendments will ensure that facilities and the Department are not required to navigate and implement an ad-hoc or emergency data collection procedure during future public health scenarios of urgent concern. Additionally, it will enable more efficient reporting for healthcare facilities.
Moreover, interoperability and analytics based on data from the SHIN-NY will be a key component of the Department’s mandatory reporting in relation to its Medicaid Section 1115 demonstration project and associated waiver. Whereas the current regulation merely authorizes the QEs to disclose patient information without written consent to a public health authority or health oversight agency, the proposed amendments will require the QEs and SHIN-NY participants to submit data using the statewide data infrastructure, both on a regular basis and in response to ad hoc requests from the Department or its designated contractor. By clarifying the data reporting and aggregation responsibilities applicable to the QEs and the permissible uses of such data by the Department or its designated contractor, the proposed amendments will transform the SHIN-NY into a functional resource for the analysis and reporting of statewide health information for authorized public health and health oversight purposes.
Beyond supporting interoperability and consistency across the network for QEs and SHIN-NY participants and clarifying the data reporting obligations of both, these regulations also address the need to allow for providers to connect directly to the statewide data infrastructure and participate in SHIN-NY data exchange and data reporting without a qualified entity acting as intermediary. To that end, the definition of “qualified entity participant” has been changed to refer to “SHIN-NY participants,” which will account for the possibility that provider organizations may participate in the SHIN-NY without contracting with one of the qualified entities. In such circumstances, the provider organization would enter into the statewide common participation agreement with the Department or its designated contractor, under which the organization would agree to adhere to applicable SHIN-NY policies and provide data to other SHIN-NY participants and the Department for data reporting and aggregation. To further support such direct connection to the statewide data infrastructure, subdivision 300.6(c)(4) is amended to exempt a health care facility that demonstrates “the technical capacity for private and secure bi-directional access, executes a statewide common participation agreement, and connects to the SHIN-NY using the statewide data infrastructure” from the requirement to enter into a participation agreement with a qualified entity. These changes reflect the fact that health information technology has rapidly advanced since the inception of the SHIN-NY, to the point where most larger health systems now possess the technical capacity to connect to and retrieve data from a statewide network without the assistance of a dedicated health information exchange partner or may exchange through electronic health record networks established at the national level.
These regulations account for the possibility that the Department, its designated contractor, and/or other types of health care organizations or other national networks might provide data and/or services through the SHIN-NY in the future. Data and services may be provided through the SHIN-NY by the Department, by its designated contractor, or by other SHIN-NY participants that meet the minimum technical, security, privacy, organizational and other requirements set forth by the Department. Along with the provisions that authorize providers to connect directly to the SHIN-NY, this change will support the shift to an ecosystem model for New York’s health information system in favor of the current system under which participation is restricted to those organizations that contract and follow the policies of the certified QEs.
Finally, these amendments will promote the development of a statewide provider directory and consent management system, both of which have been longstanding goals for the Department and will contribute substantially to the modernization of New York’s health reporting system once implemented.
Costs:
Costs to Private Regulated Parties: The private parties subject to the proposed amendments are the QEs and SHIN-NY participants. To the extent that any expenditures are necessary by QEs in order to comply with these amendments, such expenditures are expected to continue to be reimbursed using money appropriated to the Department’s designated contractor. It is not anticipated that SHIN-NY participants will incur any costs as a result of these amendments. Most regulated facilities are currently connected to the SHIN-NY via a qualified entity. The amendments are also intended to allow the alignment of SHIN-NY interoperability requirements with interoperability requirements from the federal Department of Health and Human Services. By aligning with federal interoperability requirements, this should create more efficiency by leveraging interoperability standards currently built into electronic health records.
Costs to Local Government: This proposal will not impact local governments unless they operate a health care facility, in which case the impact would be the same as outlined above for private parties.
Costs to the Department of Health: While there will be costs to build the statewide data infrastructure initially, those costs have already been budgeted. It is anticipated there will be greater efficiency in how technology is deployed in the SHIN-NY. Initial outlays will be funded through a $2.5 million increase in the budget appropriation that occurred in the SFY 2023-2024 budget.
Costs to Other State Agencies: The proposed regulatory changes will not result in any additional costs to other State agencies.
Local Government Mandates: Health facilities operated by local governments will be required to comply with these amendments in the same manner as other facilities. The regulation is not anticipated to impose any direct costs on SHIN-NY participants, including local health departments.
Paperwork: No new paperwork requirements would be imposed under the proposed amendments. Any consent forms that are developed will replace current consent forms and deployed can be done electronically. Additionally, there will be less variation in consent forms because of a consistent consent form developed by the Department.
Duplication: This regulation will not conflict with any state or federal rules.
Alternatives: An alternative to the proposed regulation would be not to make any amendments to 10 NYCRR Part 300 regulations. However, these amendments are necessary to fulfill the legislature’s objective of creating an efficient statewide health information network that serves as a resource for patients, providers, and public health officials across the State. These regulations are essential to improve the long-term efficacy of the SHIN NY and therefore the alternative of not making any amendments to the regulation was not considered viable.
Federal Standards: The proposed amendments do not duplicate or conflict with any federal regulations. These amendments will complement the Office of the National Coordinator for Health Information Technology (ONC) Final Rule implementing certain provisions of the 21st Century Cures Act (85 Fed. Reg. 25642, May 1, 2020), which requires patient information to be accessible under application programming interface (API) requirements and prohibits actions that constitute information blocking. See 42 USC § 300jj–11 et seq.
Compliance Schedule: The amendments will be effective upon publication of a Notice of Adoption in the New York State Register.
Regulatory Flexibility Analysis
No regulatory flexibility analysis is required pursuant to section 202- (b)(3)(a) of the State Administrative Procedure Act. The proposed amendment does not impose an adverse economic impact on small businesses or local governments, and it does not impose reporting, record keeping or other compliance requirements on small businesses or local governments. By having a standard participation agreement across the state, SHIN-NY participants will have a consistent participation agreements that will not vary by region. This should result lower costs compared to current variation across the state.
Rural Area Flexibility Analysis
A Rural Area Flexibility Analysis for this amendment is not being submitted because the amendment will not impose any adverse impact or significant reporting, record keeping or other compliance requirements on public or private entities in rural areas. By having a standard participation agreement across the state, SHIN-NY participants will have a consistent participation agreements that will not vary by region. This should result lower costs compared to current variation across the state. There are no professional services, capital, or other compliance costs imposed on public or private entities in rural areas as a result of the proposed amendments.
Job Impact Statement
A Job Impact Statement for the proposed regulatory amendments is not being submitted because it is apparent from the nature and purposes of the amendment that it will not have a substantial adverse impact on jobs and/or employment opportunities.
Department of Health
PROPOSED RULE MAKING
NO HEARING(S) SCHEDULED
Statewide Health Information Network for New York (SHIN-NY)
I.D. No. HLT-07-24-00015-P
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action: Amendment of Part 300 of Title 10 NYCRR.
Statutory authority: Public Health Law, sections 201, 206(1), (18-a), (d), 2803, 2816, 3612, 4010, 4403 and 4712
Subject: Statewide Health Information Network for New York (SHINNY).
Purpose: To establish the State Designated Entity and Enhancing SHIN-NY Efficiency and Flexibility.
Substance of proposed rule (Full text is posted at the following State website: https://regs.health.ny.gov/regulations/proposed-rule-making): Public Health Law sections 206(18-a)(d) and 2816 give the Department broad authority to promulgate regulations, consistent with federal law and policies, that govern the Statewide Health Information Network for New York (SHIN-NY).
These amendments support the development of the statewide data infrastructure, thereby increasing interoperability and providing the flexibility necessary for the SHIN-NY to adapt in a constantly evolving technological environment. The goal of these amendments is to ensure consistency across the SHIN-NY in how SHIN-NY participants connect and exchange data, to support public health during emergencies and to assist with Medicaid reporting in support of the Medicaid program’s Social Security Act Section 1115 waiver (see 42 USC § 1315).
In order to promote efficiency through the development of networkwide policies, processes, and solutions, these amendments create a process to develop the statewide data infrastructure that will facilitate the exchange of data among SHIN-NY participants. Relevant activities required of the Department or its contracted vendor under the amendments include enhancement of the data matching process for patient demographic information submitted by SHIN-NY participants, creation of a statewide provider directory to serve as a standardized resource for resolving provider and facility identities, development of a statewide patient consent management system, and the aggregation of data from SHIN-NY participants in a secure statewide repository.
In addition, under these regulations, the Department will create a statewide common participation agreement to be used by each qualified entity and which will allow SHIN-NY participants to connect to the statewide data infrastructure by agreeing to participate in the SHIN-NY and adhering to SHIN-NY policy guidance. This will allow patient data to be contributed to the statewide data infrastructure and used for statewide reporting and analytics for public health surveillance and Medicaid purposes, to the extent authorized by law.
This will further promote consistency and efficiency across the SHIN-NY by requiring the qualified entities to use and accept networkwide agreements and patient consent decisions. The statewide common participation agreement will eliminate the current variation in the terms and conditions applicable to participating in the SHIN-NY through one qualified entity versus another. The amendments also reduce ambiguity by requiring qualified entities to honor and implement patient consent decisions that authorize data access by treating providers across the network, regardless of which qualified entity such providers have contracted with, to participate in the SHIN-NY.
This amendment will further the Legislature’s intent under chapter 54 of the Laws of 2023, which appropriated an additional $2.5 million “for modernizing health reporting systems.” By clarifying the data reporting and aggregation responsibilities applicable to the qualified entities, the proposed amendments will transform the SHIN-NY into a functional resource for the analysis and reporting of statewide health information for authorized public health and health oversight purposes.
Text of proposed rule and any required statements and analyses may be obtained from: Katherine Ceroalo, DOH, Bureau of Program Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.ny.gov
Data, views or arguments may be submitted to: Same as above.
Public comment will be received until: 60 days after publication of this notice. This rule was not under consideration at the time this agency submitted its Regulatory Agenda for publication in the Register.
Regulatory Impact Statement
Statutory Authority: Public Health Law (PHL) § 206(18-a)(d) authorizes the Commissioner to make such rules and regulations as may be necessary to 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. In addition, PHL sections 201, 206(1), 2803, 2816, 3612, 4010, 4403, and 4712 authorize the Commissioner to make such rules and regulations as may be necessary to effectuate the provisions and purposes of PHL Articles 28 (hospitals), 36 (home care services), 40 (hospice), 44 (health maintenance organizations) and 47 (shared health facilities) and provide additional authority for the Commissioner to create and make use of the Statewide Health Information Network for New York (SHIN-NY).
Legislative Objectives: The explicit legislative objective of PHL § 206(18-a) is the promotion of widespread, non-duplicative interoperability among disparate health information systems and data types, 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. Such interoperability is intended to improve patient outcomes, minimize unnecessary service utilization, and reduce health care costs by fostering efficiency and supporting care coordination.
Existing regulations at 10 NYCRR Part 300 advanced these legislative objectives by establishing requirements for the regional health information organizations (RHIOs) that were created as health information exchanges in New York State. Under the provisions of Part 300, the RHIOs became the qualified entities (QEs) that facilitate the exchange of health information in the SHIN-NY. These regulatory amendments will further the legislative intent by making it easier for health care providers, health plans, and governmental agencies to become SHIN-NY participants and access the SHIN-NY through the use of a statewide common participation agreement, while ensuring patient privacy and data security.
Needs and Benefits: Pursuant to the current regulation, responsibility for the development and maintenance of SHIN-NY policies and technical infrastructure is divided between the QEs and the Department. In practice, this division of oversight and operational responsibilities has resulted in the deployment of disparate forms, processes, and technology solutions across the network. The proposed amendments are necessary to support the development of the statewide data infrastructure, thereby increasing interoperability and providing the flexibility necessary for the SHIN-NY to adapt in a constantly evolving technological environment. The goal of these amendments is to ensure consistency across the SHIN-NY in how SHIN-NY participants connect and exchange data, and to support the sharing of information for public health purposes, such as the Medicaid program’s Social Security Act Section 1115 waiver (see 42 USC § 1315).
In order to promote efficiency through the development of networkwide policies, processes, and solutions, these amendments create a process to develop the statewide data infrastructure that will facilitate the exchange of data among SHIN-NY participants by enhancing the matching of patient demographic information submitted by SHIN-NY participants, with a statewide provider directory, and statewide consent management system.
In addition, under these regulations, the Department will create a statewide common participation agreement to be used statewide by each qualified entity whether the participant connects through a qualified entity or directly through the statewide infrastructure. This will enable SHIN-NY participants to connect with the statewide data infrastructure and contribute patient data. Furthermore, the statewide common participation agreement will allow the use of such data for statewide reporting and analytics for public health surveillance and Medicaid purposes, in accordance with SHIN-NY policy guidance.
The regulations will further promote consistency and efficiency across the SHIN-NY by requiring the QEs to use and accept network-wide agreements and patient consent decisions. The statewide common participation agreement will eliminate the current variation in the terms and conditions applicable to participating in the network through one QE versus another. The regulatory amendments will also reduce ambiguity by requiring QEs to honor and implement patient consent decisions that authorize data access by treating providers across the network, regardless of which QE such providers have contracted with to participate in the SHIN-NY.
These amendments will also further the Legislature’s intent under chapter 54 of the Laws of 2023, which appropriated an additional $2.5 million “for modernizing health reporting systems.” As the COVID-19 and requirement to use the Hospital Emergency Reporting Data System (HERDS) for crucial public health reporting pandemic demonstrated, the current framework for SHIN-NY data collection and reporting is insufficient to enable timely analysis and decision making in situations involving an emergent public health concern. By providing for a statewide data infrastructure and explicitly requiring all SHIN-NY participants to submit data for aggregation, these amendments will ensure that facilities and the Department are not required to navigate and implement an ad-hoc or emergency data collection procedure during future public health scenarios of urgent concern. Additionally, it will enable more efficient reporting for healthcare facilities.
Moreover, interoperability and analytics based on data from the SHIN-NY will be a key component of the Department’s mandatory reporting in relation to its Medicaid Section 1115 demonstration project and associated waiver. Whereas the current regulation merely authorizes the QEs to disclose patient information without written consent to a public health authority or health oversight agency, the proposed amendments will require the QEs and SHIN-NY participants to submit data using the statewide data infrastructure, both on a regular basis and in response to ad hoc requests from the Department or its designated contractor. By clarifying the data reporting and aggregation responsibilities applicable to the QEs and the permissible uses of such data by the Department or its designated contractor, the proposed amendments will transform the SHIN-NY into a functional resource for the analysis and reporting of statewide health information for authorized public health and health oversight purposes.
Beyond supporting interoperability and consistency across the network for QEs and SHIN-NY participants and clarifying the data reporting obligations of both, these regulations also address the need to allow for providers to connect directly to the statewide data infrastructure and participate in SHIN-NY data exchange and data reporting without a qualified entity acting as intermediary. To that end, the definition of “qualified entity participant” has been changed to refer to “SHIN-NY participants,” which will account for the possibility that provider organizations may participate in the SHIN-NY without contracting with one of the qualified entities. In such circumstances, the provider organization would enter into the statewide common participation agreement with the Department or its designated contractor, under which the organization would agree to adhere to applicable SHIN-NY policies and provide data to other SHIN-NY participants and the Department for data reporting and aggregation. To further support such direct connection to the statewide data infrastructure, subdivision 300.6(c)(4) is amended to exempt a health care facility that demonstrates “the technical capacity for private and secure bi-directional access, executes a statewide common participation agreement, and connects to the SHIN-NY using the statewide data infrastructure” from the requirement to enter into a participation agreement with a qualified entity. These changes reflect the fact that health information technology has rapidly advanced since the inception of the SHIN-NY, to the point where most larger health systems now possess the technical capacity to connect to and retrieve data from a statewide network without the assistance of a dedicated health information exchange partner or may exchange through electronic health record networks established at the national level.
These regulations account for the possibility that the Department, its designated contractor, and/or other types of health care organizations or other national networks might provide data and/or services through the SHIN-NY in the future. Data and services may be provided through the SHIN-NY by the Department, by its designated contractor, or by other SHIN-NY participants that meet the minimum technical, security, privacy, organizational and other requirements set forth by the Department. Along with the provisions that authorize providers to connect directly to the SHIN-NY, this change will support the shift to an ecosystem model for New York’s health information system in favor of the current system under which participation is restricted to those organizations that contract and follow the policies of the certified QEs.
Finally, these amendments will promote the development of a statewide provider directory and consent management system, both of which have been longstanding goals for the Department and will contribute substantially to the modernization of New York’s health reporting system once implemented.
Costs:
Costs to Private Regulated Parties: The private parties subject to the proposed amendments are the QEs and SHIN-NY participants. To the extent that any expenditures are necessary by QEs in order to comply with these amendments, such expenditures are expected to continue to be reimbursed using money appropriated to the Department’s designated contractor. It is not anticipated that SHIN-NY participants will incur any costs as a result of these amendments. Most regulated facilities are currently connected to the SHIN-NY via a qualified entity. The amendments are also intended to allow the alignment of SHIN-NY interoperability requirements with interoperability requirements from the federal Department of Health and Human Services. By aligning with federal interoperability requirements, this should create more efficiency by leveraging interoperability standards currently built into electronic health records.
Costs to Local Government: This proposal will not impact local governments unless they operate a health care facility, in which case the impact would be the same as outlined above for private parties.
Costs to the Department of Health: While there will be costs to build the statewide data infrastructure initially, those costs have already been budgeted. It is anticipated there will be greater efficiency in how technology is deployed in the SHIN-NY. Initial outlays will be funded through a $2.5 million increase in the budget appropriation that occurred in the SFY 2023-2024 budget.
Costs to Other State Agencies: The proposed regulatory changes will not result in any additional costs to other State agencies.
Local Government Mandates: Health facilities operated by local governments will be required to comply with these amendments in the same manner as other facilities. The regulation is not anticipated to impose any direct costs on SHIN-NY participants, including local health departments.
Paperwork: No new paperwork requirements would be imposed under the proposed amendments. Any consent forms that are developed will replace current consent forms and deployed can be done electronically. Additionally, there will be less variation in consent forms because of a consistent consent form developed by the Department.
Duplication: This regulation will not conflict with any state or federal rules.
Alternatives: An alternative to the proposed regulation would be not to make any amendments to 10 NYCRR Part 300 regulations. However, these amendments are necessary to fulfill the legislature’s objective of creating an efficient statewide health information network that serves as a resource for patients, providers, and public health officials across the State. These regulations are essential to improve the long-term efficacy of the SHIN NY and therefore the alternative of not making any amendments to the regulation was not considered viable.
Federal Standards: The proposed amendments do not duplicate or conflict with any federal regulations. These amendments will complement the Office of the National Coordinator for Health Information Technology (ONC) Final Rule implementing certain provisions of the 21st Century Cures Act (85 Fed. Reg. 25642, May 1, 2020), which requires patient information to be accessible under application programming interface (API) requirements and prohibits actions that constitute information blocking. See 42 USC § 300jj–11 et seq.
Compliance Schedule: The amendments will be effective upon publication of a Notice of Adoption in the New York State Register.
Regulatory Flexibility Analysis
No regulatory flexibility analysis is required pursuant to section 202- (b)(3)(a) of the State Administrative Procedure Act. The proposed amendment does not impose an adverse economic impact on small businesses or local governments, and it does not impose reporting, record keeping or other compliance requirements on small businesses or local governments. By having a standard participation agreement across the state, SHIN-NY participants will have a consistent participation agreements that will not vary by region. This should result lower costs compared to current variation across the state.
Rural Area Flexibility Analysis
A Rural Area Flexibility Analysis for this amendment is not being submitted because the amendment will not impose any adverse impact or significant reporting, record keeping or other compliance requirements on public or private entities in rural areas. By having a standard participation agreement across the state, SHIN-NY participants will have a consistent participation agreements that will not vary by region. This should result lower costs compared to current variation across the state. There are no professional services, capital, or other compliance costs imposed on public or private entities in rural areas as a result of the proposed amendments.
Job Impact Statement
A Job Impact Statement for the proposed regulatory amendments is not being submitted because it is apparent from the nature and purposes of the amendment that it will not have a substantial adverse impact on jobs and/or employment opportunities.
