AB 1331: California Health and Human Services Data Exchange Framework.
- Session Year: 2023-2024
- House: Assembly
- Latest Version Date: 2023-07-13
Current Status:
Failed
(2024-08-15: In committee: Held under submission.)
Introduced
In Committee
First Chamber
In Committee
Second Chamber
Enacted
What does this bill do?
The bill moves responsibility for creating and running California’s Health and Human Services Data Exchange Framework to the Center for Data Insights and Innovation and creates a CalHHS Data Exchange Board to review and approve the framework’s data‑sharing rules and oversee compliance. It also requires the center to set up a process to designate “qualified health information organizations” — nonprofit regional data networks that connect to electronic health records, clean and link clinical and social‑service records, are not EHR vendors, and welcome any provider, plan, or public health participant — to act as intermediaries for sharing data.
The summary is provided by generative AI which can make mistakes. For original language, please view the details in the table below.
Existing law establishes the Center for Data Insights and Innovation within the California Health and Human Services Agency to ensure the enforcement of state law mandating the confidentiality of medical information. Existing law, subject to an appropriation in the annual Budget Act, requires the California Health and Human Services Agency to establish the California Health and Human Services Data Exchange Framework on or before July 1, 2022, to govern and require the exchange of health information among health care entities and government agencies.
This bill would require the Center for Data Insights and Innovation to take over establishment, implementation, and all the functions related to the California Health and Human Services Data Exchange Framework on or before July 1, 2023, January 1, 2024, subject to an appropriation in the annual Budget Act. The bill would require the center to establish the CalHHS Data Exchange Board, with specified membership, to develop recommendations and to review, modify, and approve any modifications to the Data Exchange Framework data sharing agreement, among other things. The bill would require the center to submit an annual report to the Legislature that includes required signatory compliance with the data sharing agreement, assessment of consumer experiences with health information exchange, and evaluation of technical assistance and other grant programs. The bill would require the center, by July 1, 2024, to establish a process to designate qualified health information organizations according to specified criteria.
Existing law establishes the Center for Data Insights and Innovation within the California Health and Human Services Agency to ensure the enforcement of state law mandating the confidentiality of medical information. Existing law, subject to an appropriation in the annual Budget Act, requires the California Health and Human Services Agency to establish the California Health and Human Services Data Exchange Framework on or before July 1, 2022, to govern and require the exchange of health information among health care entities and government agencies.
This bill would require the Center for Data Insights and Innovation to take over establishment, implementation, and all the functions related to the California Health and Human Services Data Exchange Framework on or before July 1, 2023, subject to an appropriation in the annual Budget Act. The bill would require the center to establish the CalHHS Data Exchange Board, with specified membership, to develop recommendations and to approve any modifications to the Data Exchange Framework data sharing agreement, among other things. The bill would require the center to submit an annual report to the Legislature that includes required signatory compliance with the data sharing agreement, assessment of consumer experiences with health information exchange, and evaluation of technical assistance and other grant programs. The bill would require the center, by July 1, 2024, to establish a process to designate qualified health information organizations according to specified criteria.
Existing law establishes the Center for Data Insights and Innovation within the California Health and Human Services Agency to ensure the enforcement of state law mandating the confidentiality of medical information. Existing law, subject to an appropriation in the annual Budget Act, requires the California Health and Human Services Agency to establish the California Health and Human Services Data Exchange Framework on or before July 1, 2022, to govern and require the exchange of health information among health care entities and government agencies.
This bill would require the Center for Data Insights and Innovation to take over establishment, implementation, and all the functions related to the California Health and Human Services Data Exchange Framework on or before July 1, 2023, subject to an appropriation in the annual Budget Act. The bill would require the center to establish the CalHHS Data Exchange Board, with specified membership, to develop recommendations and to approve any modifications to the Data Exchange Framework data sharing agreement, among other things.
Existing law establishes the California Health and Human Services Agency (CHHSA), which includes departments charged with administration of health, social, and human services. Existing law establishes the California Health and Human Services Data Exchange Framework that includes a single data sharing agreement and common set of policies and procedures that govern and require the exchange of health information among health care entities and government agencies in California. Existing law requires specified entities to execute the framework data sharing agreement on or before January 31, 2023. This bill would establish the Data Exchange Framework governing board and require the board to approve any modifications to that data sharing agreement and its policies and procedures. The bill would require the governing board to consist of 5 members, appointed as specified.Existing law establishes the California Health and Human Services Agency (CHHSA), which includes departments charged with administration of health, social, and human services. Existing law establishes the California Health and Human Services Data Exchange Framework that includes a single data sharing agreement and common set of policies and procedures that govern and require the exchange of health information among health care entities and government agencies in California. Existing law requires specified entities to execute the framework data sharing agreement on or before January 31, 2023.
This bill would establish the Data Exchange Framework governing board and require the board to approve any modifications to that data sharing agreement and its policies and procedures. The bill would require the governing board to consist of 5 members, appointed as specified.
(a)On or before July 1, 2022, and subject to an appropriation in the annual Budget Act, the California Health and Human Services Agency, along with its departments and offices and in consultation with stakeholders and local partners, shall establish the California Health and Human Services Data Exchange Framework that shall include a single data sharing agreement and common set of policies and procedures that will leverage and advance national standards for information exchange and data content, and that will govern and require the exchange of health information among health care entities and government agencies in California. On or before July 1, 2023, January 1, 2024, and subject to an appropriation in the annual Budget Act, the Center for Data Insights and Innovation shall take over establishment, implementation, and all the functions related to the California Health and Human Services Data Exchange Framework, including the data sharing agreement and policies and procedures, from the California Health and Human Services Agency.
(1)The California Health and Human Services Data Exchange Framework is not intended to be an information technology system or single repository of data, rather it is technology agnostic and is a collection of organizations that are required to share health information using national standards and a common set of policies in order to improve the health outcomes of the individuals they serve.
(2)The California Health and Human Services Data Exchange Framework will be designed to enable and require real-time access to, or exchange of, health information among health care providers and payers through any health information exchange network, qualified health information organization, or technology that adheres to specified standards and policies.
(3)The California Health and Human Services Data Exchange Framework shall align with state and federal data requirements, including the federal Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191), the Confidentiality of Medical Information Act of 1996 (Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code), and other applicable state and federal privacy laws related to the sharing of data among and between providers, payers, and the government, while also streamlining and reducing reporting burden.
(4)For the purposes of this section, health information means:
(A)For hospitals, clinics, and physician practices, at a minimum, the United States Core Data for Interoperability Version 1, until October 6, 2022. After that date, it shall include all electronic health information as defined under federal regulation in Section 171.102 of Title 45 of the Code of Federal Regulations and held by the entity.
(B)For health insurers and health care service plans, at a minimum, the data required to be shared under the Centers for Medicare and Medicaid Services Interoperability and Patient Access regulations for public programs as contained in United States Department of Health and Human Services final rule CMS-9115-F, 85 FR 25510.
(b)(1)On or before January 31, 2024, the entities listed in subdivision (f), except those identified in paragraph (2), shall exchange health information or provide access to health information to and from every other entity in subdivision (f) in real time as specified by the center pursuant to the California Health and Human Services Data Exchange Framework data sharing agreement for treatment, payment, or health care operations.
(2)The requirement in paragraph (1) shall not apply to physician practices of fewer than 25 physicians, rehabilitation hospitals, long-term acute care hospitals, acute psychiatric hospitals, critical access hospitals, rural general acute care hospitals with fewer than 100 acute care beds, state-run acute psychiatric hospitals, and any nonprofit clinic with fewer than 10 health care providers until January 31, 2026.
(c)The California Health and Human Services Agency shall convene a stakeholder advisory group no later than September 1, 2021, to advise on the development and implementation of the California Health and Human Services Data Exchange Framework.
(1)The members of the stakeholder advisory group shall be appointed by the Secretary of California Health and Human Services and shall not have a financial interest, individually or through a family member, related to issues the stakeholder advisory group will advise on.
(2)The stakeholder advisory group shall be composed of health care stakeholders and experts, including representatives of all the following:
(A)The State Department of Health Care Services.
(B)The State Department of Social Services.
(C)The Department of Managed Health Care.
(D)The Department of Health Care Access and Information.
(E)The State Department of Public Health.
(F)The Department of Insurance.
(G)The Public Employees Retirement System.
(H)The California Health Benefit Exchange.
(I)Health care service plans and health insurers.
(J)Physicians, including those with small practices as determined by the Office of Health Care Affordability. practices.
(K)Hospitals, including public, private, rural, and critical access hospitals.
(L)Clinics, long-term care facilities, behavioral health facilities, or substance use disorder facilities.
(M)Consumers.
(N)Organized labor.
(O)Privacy and security professionals.
(P)Health information technology professionals.
(Q)Community health information organizations.
(R)County health, social services, and public health.
(S)Community-based organizations providing social services.
(T)The State Department of State Hospitals.
(U)The State Department of Developmental Services.
(V)The Emergency Medical Services Authority.
(W)The Department of Corrections and Rehabilitation.
(3)The stakeholder advisory group shall provide information and advice to the California Health and Human Services Agency on health information technology issues, including all of the following:
(A)Identify which data beyond health information as defined in paragraph (4) of subdivision (a), at minimum, should be shared for specified purposes between the entities outlined in this subdivision and subdivision (f).
(B)Identify gaps, and propose solutions to gaps, in the life cycle of health information, including gaps in any of the following:
(i)Health information creation, including the use of national standards in clinical documentation, health plan records, and social services data.
(ii)Translation, mapping, controlled vocabularies, coding, and data classification.
(iii)Storage, maintenance, and management of health information.
(iv)Linking, sharing, exchanging, and providing access to health information.
(C)Identify ways to incorporate data related to social determinants of health, such as housing and food insecurity, into shared health information.
(D)Identify ways to incorporate data related to underserved or underrepresented populations, including, but not limited to, data regarding sexual orientation and gender identity and racial and ethnic minorities.
(E)Identify ways to incorporate relevant data on behavioral health, developmental disabilities, and substance use disorder conditions.
(F)Address the privacy, security, and equity risks of expanding care coordination, health information exchange, access, and telehealth in a dynamic technological, and entrepreneurial environment, where data and network security are under constant threat of attack.
(G)Develop policies and procedures consistent with national standards and federally adopted standards in the exchange of health and social services information, including matters of consent, privacy, confidentiality, and security, and ensure that health and social services information sharing broadly implements national frameworks and agreements consistent with federal rules and programs.
(H)Develop definitions of complete clinical, administrative, and claims data consistent with federal policies and national standards.
(I)Identify how all payers will be required to provide enrollees with electronic access to their health information, consistent with rules applicable to federal payer programs.
(J)Assess governance structures to help guide policy decisions and general oversight.
(K)Identify federal, state, private, or philanthropic sources of funding that could support data access and exchange.
(4)The stakeholder advisory group shall hold public meetings with stakeholders, solicit input, and set its own meeting agendas. Meetings of the stakeholder advisory group are subject to the Bagley-Keene Open Meeting Act (Article 9 (commencing with Section 11120) of Chapter 1 of Part 1 of Division 3 of Title 2 of the Government Code).
(5)The members of the stakeholder advisory group shall serve without compensation, but shall be reimbursed for any actual and necessary expenses incurred in connection with their duties as members of the group.
(d)No later than April 1, 2022, the California Health and Human Services Agency shall submit an update, including written recommendations, to the Legislature based on input from the stakeholder advisory group on the issues identified in paragraph (3) of subdivision (c).
(e)On or before January 31, 2023, the center shall work with the California State Association of Counties to encourage the inclusion of county health, public health, and social services, to the extent possible, as part of the California Health and Human Services Data Exchange Framework in order to assist both public and private entities to connect through uniform standards and policies. It is the intent of the Legislature that all state and local public health agencies will exchange electronic health information in real time with participating health care entities to protect and improve the health and well-being of Californians.
(f)On or before January 31, 2023, and in alignment with existing federal standards and policies, the following health care organizations shall execute the California Health and Human Services Data Exchange Framework data sharing agreement pursuant to subdivision (a):
(1)General acute care hospitals, as defined by Section 1250.
(2)Physician Provider and physician organizations and medical groups. as defined by Section 127500.2.
(3)Skilled nursing facilities, as defined by Section 1250, that currently maintain electronic records.
(4)Health care service plans and disability insurers that provide hospital, medical, or surgical coverage that are regulated by the Department of Managed Health Care or the Department of Insurance. This section shall also apply to a Medi-Cal managed care plan under a comprehensive risk contract with the State Department of Health Care Services pursuant to Chapter 7 (commencing with Section 14000) or Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the Welfare and Institutions Code that is not regulated by the Department of Managed Health Care or the Department of Insurance.
(5)Clinical laboratories, as that term is used in Section 1265 of the Business and Professions Code, and that are regulated by the State Department of Public Health.
(6)Acute psychiatric hospitals, as defined by Section 1250.
(7)Emergency medical services, as defined by Section 1797.72.
(g)Compliance with subdivision (f) shall be required as a condition of contracting with the State Department of Health Care Services, the Public Employees Retirement System, and the California Health Benefit Exchange.
(h)The center shall have the authority to determine other categories of entities that shall sign the California Health and Human Services Data Exchange Framework data sharing agreement.
(i)The center shall work with experienced nonprofit organizations and entities represented in the stakeholder advisory group in subdivision (c) to provide technical assistance to the entities outlined in subdivisions (e) and (f).
(j)On or before July 31, 2022, the California Health and Human Services Agency shall develop in consultation with the stakeholder advisory group in subdivision (c) a strategy for unique, secure digital identities capable of supporting master patient indices to be implemented by both private and public organizations in California.
(k)For purposes of implementing this section, including, but not limited to, hiring staff and consultants, facilitating and conducting meetings, conducting research and analysis, and developing the required reports, the center may enter into exclusive or nonexclusive contracts on a bid or negotiated basis. Contracts entered into or amended pursuant to this section shall be exempt from Chapter 6 (commencing with Section 14825) of Part 5.5 of Division 3 of Title 2 of the Government Code, Section 19130 of the Government Code, and Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code, and shall be exempt from the review or approval of any division of the Department of General Services. A person hired or otherwise retained pursuant to this subdivision shall not be permitted to have any financial interest in the California Health and Human Services Data Exchange Framework or shall not be, or be affiliated with, any health care organization required to participate in the California Health and Human Services Data Exchange Framework pursuant to subdivisions (b) and (f). The term person, as used in this subdivision, means any individual, partnership, joint venture, association, corporation, or any other organization or any combination thereof.
(l)(1)The center shall administer, manage, oversee, and enforce the California Health and Human Services Data Exchange Framework and its data sharing agreement, including its related policies and procedures, governance, and all other materials or initiatives related to the California Health and Human Services Data Exchange Framework.
(2)The center shall have the authority to develop a framework for investigating potential violations of the data sharing agreement and its policies and procedures.
(3)The center shall report violations to state licensing entities or other entities authorized to ensure compliance with execution of the data sharing agreement or with the data sharing agreement and its policies and procedures.
(4)The center shall be responsible for oversight of the dispute resolution and grievance processes for the California Health and Human Services Data Exchange Framework.
(5)The center shall submit an annual report to the Legislature that includes required signatory compliance with the data sharing agreement, assessment of consumer experiences with health information exchange, and evaluation of technical assistance and other grant programs. The report shall be submitted in compliance with Section 9795 of the Government Code.
(m)(1)The center shall establish and administer the CalHHS Data Exchange Board. The board shall be separate and distinct from the stakeholder advisory group.
(2)(A)The board shall be composed of five voting members and seven nonvoting members.
(B)The voting members shall be as follows:
(i)The Secretary of California Health and Human Services, or their designee, shall serve as the chair and as an ex officio member of the board.
(ii)Two individuals appointed by the Governor, and at least one of whom shall be a consumer representative.
(iii)One individual appointed by the Speaker of the Assembly.
(iv)One individual appointed by the Senate Committee on Rules.
(C)The nonvoting members shall be comprised of one representative from each of the following, who shall be ex officio members of the board:
(i)The Public Employees Retirement System.
(ii)The California Health Benefit Exchange.
(iii)The State Department of Health Care Services.
(iv)The State Department of Developmental Services.
(v)The Emergency Medical Services Authority.
(vi)The State Department of State Hospitals.
(vii)The Department of Corrections and Rehabilitation.
(3)Each individual appointed to the board shall have demonstrated and acknowledged expertise, as needed, in health information exchange, health data privacy, and administration of public and private health care or social service delivery systems. The appointing authorities shall consider the expertise of the other board members and attempt to make appointments so that the boards composition reflects a diversity of expertise and perspectives. The appointing authorities shall take into consideration the cultural, ethnic, and geographical diversity of the state so that the boards composition reflects the communities of California.
(4)Board members, other than ex officio members, shall serve up to two terms of four years per term, except that the initial appointment by the Speaker of the Assembly shall be for a term of five years, and the initial appointment by the Senate Committee on Rules shall be for a term of five years. Appointed board members shall be eligible for reappointment at the end of their first term. A board member may continue to serve until the appointment and qualification of their successor. Vacancies shall be filled by appointment for an unexpired term.
(5)Board members shall be subject to strict conflict-of-interest policies. The board shall be subject to Article 3 (commencing with Section 87300) of Chapter 7 of Title 9 of the Government Code and the regulations promulgated thereunder.
(6)Except for those who are board members pursuant to subparagraph (C) of paragraph (2), a board member shall not be employed by, a member of the board of directors of, affiliated with, a vendor to, or otherwise a representative of signatories of, the California Health and Human Services Data Exchange Framework data sharing agreement while serving as a board member.
(7)Board members shall not have a conflict of interest and shall disclose all financial interests, investments, and positions in business entities or any signatories to the California Health and Human Services Data Exchange Framework data sharing agreement using the form as specified by the centers conflict of interest conflict-of-interest code.
(8)Board members shall serve without compensation, but shall be reimbursed for any actual and necessary expenses incurred in connection with their duties as board members.
(n)(1)The board shall review, modify, and approve modifications to the California Health and Human Services Data Exchange Framework data sharing agreement and its policies and procedures and any new policies and procedures developed by the center.
(2)The board shall review, modify, and approve new data sharing requirements for signatories to the California Health and Human Services Data Exchange Framework data sharing agreement developed by the center.
(3)The board may advance recommendations on criteria and procedures on health information exchange technical assistance, onboarding, and other grant programs established by the center.
(4)The board shall develop recommendations to the Legislature and the Governor on statutory amendments to align state law with federal law to advance health information exchange.
(5)The board shall review, modify, and approve changes to the California Health and Human Services Data Exchange Framework priorities and principles as developed by the center and shall advise the center on the advancement of those priorities and principles.
(6)Subject to appropriation by the Legislature and in partnership with the center, the board shall develop a consumer outreach and education program that informs individuals of their rights, as well as the benefits of health data exchange, and provides a forum for members of the public to provide ongoing input related to health information exchange.
(7)On or before January 1, 2025, the board shall convene stakeholders, including data exchange signatories, consumer advocates, and racial equity experts, to develop recommendations for statutory changes, training and technical assistance, and best practices to require the entities listed in subdivision (f) to collect individual level demographic and health-related social needs data about Californians served, using the demographic and social needs data categories in the latest version of the United States Core Data for Interoperability adopted through the federal Office of the National Coordinator for Health IT Standards Version Advancement Process.
(8)On or before July 1, 2025, the center shall publish a policy proposal to adopt or modify the recommendations developed pursuant to paragraph (7).
(9)The board shall review the annual report submitted to the Legislature by the center pursuant to paragraph (5) of subdivision (l).
(o)(1)All actions to implement the California Health and Human Services Data Exchange Framework, including the adoption or development of any data sharing agreement, requirements, policies and procedures, guidelines, subgrantee contract provisions, or reporting requirements, shall be exempt from the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code). The center shall release program notices that detail the requirements of the California Health and Human Services Data Exchange Framework.
(2)The center may, but is not obligated to, enact recommendations advanced by the board in accordance with the law and its rulemaking authority.
(3)The center may adopt reasonable rules and regulations to implement, administer, and oversee its duties under this section in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.
(4)The center may adopt emergency regulations to consolidate, clarify, or make consistent regulations, including emergency regulations adopted to implement this section.
(5)A rule rule, action, or regulation adopted pursuant to this section shall be discussed by the board during at least one properly noticed board meeting before the office center adopts the rule or regulation.
(6)The board may call emergency meetings with at least five business days notice for the purpose of discussing regulations. regulation changes for purposes of federal regulatory compliance. Once the board is established, the center shall bring each proposed regulation to the board to be discussed at least once at one board meeting before adoption.
(7)The center may readopt any emergency regulation authorized by this section that is the same as, or substantially equivalent to, an emergency regulation previously adopted as authorized by this section. A readoption shall be limited to one time for each regulation.
(8)An emergency regulation adopted pursuant to this section after the establishment of the board shall be repealed by operation of law unless the adoption, amendment, or repeal of the regulation is promulgated by the center within five years of the initial adoption of the emergency regulation.
(9)Notwithstanding any other law, the adoption of emergency regulations and the readoption of emergency regulations authorized by this section, if done on or before December 31, 2025, shall be deemed an emergency and necessary for the immediate preservation of the public peace, health, safety, or general welfare. The emergency regulations and the readopted emergency regulations authorized by this section shall each be submitted to the Office of Administrative Law for filing with the Secretary of State and shall remain in effect for no more than 180 days, by which time final regulations may be adopted.
(p)For purposes of this section:
(1)Board means the CalHHS Data Exchange Board established pursuant to subdivision (m).
(2)Center means the Center for Data Insights and Innovation.
(3)Qualified health information organization means an entity that has applied for, and satisfied, the process and criteria described in Section 130213.
SEC. 2.Section 130213 is added to the Health and Safety Code, to read:130213.(a)No later than July 1, 2024, the center shall establish a process to designate qualified health information organizations as data-sharing intermediaries that have demonstrated their ability to meet requirements of the California Health and Human Services Data Exchange Framework. Health and human service organization organizations may comply with the data exchange framework by participating in and sharing information with a qualified health information organization.
(b)The criteria for qualification shall include, but not be limited to, being a nonprofit California regional or multiregional data network that meets all of the following organizational, functional, and operational requirements:
(1)Connects to electronic health record (EHR) systems of participating health care providers.
(2)Cleans, matches, securely stores, aggregates, and unifies clinical health and social service records to support care coordination, population health management, and analytic quality improvement and reporting.
(3)Is unaffiliated with a health care organization or EHR provider. Is not an EHR vendor, a subsidiary of an EHR vendor, or an enterprise network that is exclusively available to organizations contractually partnered with a distinct health care organization such as a hospital or fully integrated delivery system.
(4)Welcomes the participation of any health care provider, health plan, social services provider, or public health organization in the networks service area.
(a)On or before July 1, 2022, and subject to an appropriation in the annual Budget Act, the California Health and Human Services Agency, along with its departments and offices and in consultation with stakeholders and local partners, shall establish the California Health and Human Services Data Exchange Framework that shall include a single data sharing agreement and common set of policies and procedures that will leverage and advance national standards for information exchange and data content, and that will govern and require the exchange of health information among health care entities and government agencies in California. On or before July 1, 2023, and subject to an appropriation in the annual Budget Act, the Center for Data Insights and Innovation shall take over establishment, implementation, and all the functions related to the California Health and Human Services Data Exchange Framework, including the data sharing agreement and policies and procedures, from the California Health and Human Services Agency.
(1)The California Health and Human Services Data Exchange Framework is not intended to be an information technology system or single repository of data, rather it is technology agnostic and is a collection of organizations that are required to share health information using national standards and a common set of policies in order to improve the health outcomes of the individuals they serve.
(2)The California Health and Human Services Data Exchange Framework will be designed to enable and require real-time access to, or exchange of, health information among health care providers and payers through any health information exchange network, qualified health information organization, or technology that adheres to specified standards and policies.
(3)The California Health and Human Services Data Exchange Framework shall align with state and federal data requirements, including the federal Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191), the Confidentiality of Medical Information Act of 1996 (Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code), and other applicable state and federal privacy laws related to the sharing of data among and between providers, payers, and the government, while also streamlining and reducing reporting burden.
(4)For the purposes of this section, health information means:
(A)For hospitals, clinics, and physician practices, at a minimum, the United States Core Data for Interoperability Version 1, until October 6, 2022. After that date, it shall include all electronic health information as defined under federal regulation in Section 171.102 of Title 45 of the Code of Federal Regulations and held by the entity.
(B)For health insurers and health care service plans, at a minimum, the data required to be shared under the Centers for Medicare and Medicaid Services Interoperability and Patient Access regulations for public programs as contained in United States Department of Health and Human Services final rule CMS-9115-F, 85 FR 25510.
(b)(1)On or before January 31, 2024, the entities listed in subdivision (f), except those identified in paragraph (2), shall exchange health information or provide access to health information to and from every other entity in subdivision (f) in real time as specified by the center pursuant to the California Health and Human Services Data Exchange Framework data sharing agreement for treatment, payment, or health care operations.
(2)The requirement in paragraph (1) shall not apply to physician practices of fewer than 25 physicians, rehabilitation hospitals, long-term acute care hospitals, acute psychiatric hospitals, critical access hospitals, rural general acute care hospitals with fewer than 100 acute care beds, state-run acute psychiatric hospitals, and any nonprofit clinic with fewer than 10 health care providers until January 31, 2026.
(c)The California Health and Human Services Agency shall convene a stakeholder advisory group no later than September 1, 2021, to advise on the development and implementation of the California Health and Human Services Data Exchange Framework.
(1)The members of the stakeholder advisory group shall be appointed by the Secretary of California Health and Human Services and shall not have a financial interest, individually or through a family member, related to issues the stakeholder advisory group will advise on.
(2)The stakeholder advisory group shall be composed of health care stakeholders and experts, including representatives of all the following:
(A)The State Department of Health Care Services.
(B)The State Department of Social Services.
(C)The Department of Managed Health Care.
(D)The Department of Health Care Access and Information.
(E)The State Department of Public Health.
(F)The Department of Insurance.
(G)The Public Employees Retirement System.
(H)The California Health Benefit Exchange.
(I)Health care service plans and health insurers.
(J)Physicians, including those with small practices. practices as determined by the Office of Health Care Affordability.
(K)Hospitals, including public, private, rural, and critical access hospitals.
(L)Clinics, long-term care facilities, behavioral health facilities, or substance use disorder facilities.
(M)Consumers.
(N)Organized labor.
(O)Privacy and security professionals.
(P)Health information technology professionals.
(Q)Community health information organizations.
(R)County health, social services, and public health.
(S)Community-based organizations providing social services.
(T)The State Department of State Hospitals.
(U)The State Department of Developmental Services.
(V)The Emergency Medical Services Authority.
(W)The Department of Corrections and Rehabilitation.
(3)The stakeholder advisory group shall provide information and advice to the California Health and Human Services Agency on health information technology issues, including all of the following:
(A)Identify which data beyond health information as defined in paragraph (4) of subdivision (a), at minimum, should be shared for specified purposes between the entities outlined in this subdivision and subdivision (f).
(B)Identify gaps, and propose solutions to gaps, in the life cycle of health information, including gaps in any of the following:
(i)Health information creation, including the use of national standards in clinical documentation, health plan records, and social services data.
(ii)Translation, mapping, controlled vocabularies, coding, and data classification.
(iii)Storage, maintenance, and management of health information.
(iv)Linking, sharing, exchanging, and providing access to health information.
(C)Identify ways to incorporate data related to social determinants of health, such as housing and food insecurity, into shared health information.
(D)Identify ways to incorporate data related to underserved or underrepresented populations, including, but not limited to, data regarding sexual orientation and gender identity and racial and ethnic minorities.
(E)Identify ways to incorporate relevant data on behavioral health, developmental disabilities, and substance use disorder conditions.
(F)Address the privacy, security, and equity risks of expanding care coordination, health information exchange, access, and telehealth in a dynamic technological, and entrepreneurial environment, where data and network security are under constant threat of attack.
(G)Develop policies and procedures consistent with national standards and federally adopted standards in the exchange of health and social services information, including matters of consent, and ensure that health and social services information sharing broadly implements national frameworks and agreements consistent with federal rules and programs.
(H)Develop definitions of complete clinical, administrative, and claims data consistent with federal policies and national standards.
(I)Identify how all payers will be required to provide enrollees with electronic access to their health information, consistent with rules applicable to federal payer programs.
(J)Assess governance structures to help guide policy decisions and general oversight.
(K)Identify federal, state, private, or philanthropic sources of funding that could support data access and exchange.
(4)The stakeholder advisory group shall hold public meetings with stakeholders, solicit input, and set its own meeting agendas. Meetings of the stakeholder advisory group are subject to the Bagley-Keene Open Meeting Act (Article 9 (commencing with Section 11120) of Chapter 1 of Part 1 of Division 3 of Title 2 of the Government Code).
(5)The members of the stakeholder advisory group shall serve without compensation, but shall be reimbursed for any actual and necessary expenses incurred in connection with their duties as members of the group.
(d)No later than April 1, 2022, the California Health and Human Services Agency shall submit an update, including written recommendations, to the Legislature based on input from the stakeholder advisory group on the issues identified in paragraph (3) of subdivision (c).
(e)On or before January 31, 2023, the center shall work with the California State Association of Counties to encourage the inclusion of county health, public health, and social services, to the extent possible, as part of the California Health and Human Services Data Exchange Framework in order to assist both public and private entities to connect through uniform standards and policies. It is the intent of the Legislature that all state and local public health agencies will exchange electronic health information in real time with participating health care entities to protect and improve the health and well-being of Californians.
(f)On or before January 31, 2023, and in alignment with existing federal standards and policies, the following health care organizations shall execute the California Health and Human Services Data Exchange Framework data sharing agreement pursuant to subdivision (a):
(1)General acute care hospitals, as defined by Section 1250.
(2)Physician organizations and medical groups.
(3)Skilled nursing facilities, as defined by Section 1250, that currently maintain electronic records.
(4)Health care service plans and disability insurers that provide hospital, medical, or surgical coverage that are regulated by the Department of Managed Health Care or the Department of Insurance. This section shall also apply to a Medi-Cal managed care plan under a comprehensive risk contract with the State Department of Health Care Services pursuant to Chapter 7 (commencing with Section 14000) or Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the Welfare and Institutions Code that is not regulated by the Department of Managed Health Care or the Department of Insurance.
(5)Clinical laboratories, as that term is used in Section 1265 of the Business and Professions Code, and that are regulated by the State Department of Public Health.
(6)Acute psychiatric hospitals, as defined by Section 1250.
(7)Emergency medical services, as defined by Section 1797.72.
(g)Compliance with subdivision (f) shall be required as a condition of contracting with the State Department of Health Care Services, the Public Employees Retirement System, and the California Health Benefit Exchange.
(h)The center shall have the authority to determine other categories of entities that shall sign the California Health and Human Services Data Exchange Framework data sharing agreement.
(g)(i)The center shall work with experienced nonprofit organizations and entities represented in the stakeholder advisory group in subdivision (c) to provide technical assistance to the entities outlined in subdivisions (e) and (f).
(h)(j)On or before July 31, 2022, the California Health and Human Services Agency shall develop in consultation with the stakeholder advisory group in subdivision (c) a strategy for unique, secure digital identities capable of supporting master patient indices to be implemented by both private and public organizations in California.
(i)(k)For purposes of implementing this section, including, but not limited to, hiring staff and consultants, facilitating and conducting meetings, conducting research and analysis, and developing the required reports, the center may enter into exclusive or nonexclusive contracts on a bid or negotiated basis. Contracts entered into or amended pursuant to this section shall be exempt from Chapter 6 (commencing with Section 14825) of Part 5.5 of Division 3 of Title 2 of the Government Code, Section 19130 of the Government Code, and Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code, and shall be exempt from the review or approval of any division of the Department of General Services. A person hired or otherwise retained pursuant to this subdivision shall not be permitted to have any financial interest in the California Health and Human Services Data Exchange Framework or shall not be, or be affiliated with, any health care organization required to participate in the California Health and Human Services Data Exchange Framework pursuant to subdivisions (b) and (f). The term person, as used in this subdivision, means any individual, partnership, joint venture, association, corporation, or any other organization or any combination thereof.
(j)(l)(1)The center shall administer, manage, and oversee oversee, and enforce the California Health and Human Services Data Exchange Framework and its data sharing agreement, including its related policies and procedures, governance, and all other materials or initiatives related to the California Health and Human Services Data Exchange Framework.
(2)The center shall have the authority to develop a framework for investigating potential violations of the data sharing agreement and its policies and procedures.
(3)The center shall report violations to state licensing entities to ensure compliance with execution of the data sharing agreement or with the data sharing agreement and its policies and procedures.
(2)(4)The center shall be responsible for oversight of the dispute resolution and grievance processes for the California Health and Human Services Data Exchange Framework.
(5)The center shall submit an annual report to the Legislature that includes required signatory compliance with the data sharing agreement, assessment of consumer experiences with health information exchange, and evaluation of technical assistance and other grant programs. The report shall be submitted in compliance with Section 9795 of the Government Code.
(k)(m)(1)The center shall establish and administer the CalHHS Data Exchange Board. The board shall be separate and distinct from the stakeholder advisory group.
(2)(A)The board shall be composed of 12 voting members, including all of the following: five voting members and seven nonvoting members.
(B)The voting members shall be as follows:
(A)(i)The Secretary of California Health and Human Services, or their designee, shall serve as the chair and as an ex officio member of the board.
(B)(ii)Two individuals appointed by the Governor, and at least one of whom shall be a consumer representative.
(C)(iii)One individual appointed by the Speaker of the Assembly.
(D)(iv)One individual appointed by the Senate Committee on Rules.
(E)One(C)The nonvoting members shall be comprised of one representative from each of the following, who shall be ex officio members of the board:
(i)The Public Employees Retirement System.
(ii)The California Health Benefit Exchange.
(iii)The State Department of Health Care Services.
(iv)The State Department of Developmental Services.
(v)The Emergency Medical Services Authority.
(vi)The State Department of State Hospitals.
(vii)The Department of Corrections and Rehabilitation.
(3)Each individual appointed to the board shall have demonstrated and acknowledged expertise, as needed, in health information exchange, health data privacy, and administration of public and private health care or social service delivery systems. The appointing authorities shall consider the expertise of the other board members and attempt to make appointments so that the boards composition reflects a diversity of expertise and perspectives. The appointing authorities shall take into consideration the cultural, ethnic, and geographical diversity of the state so that the boards composition reflects the communities of California.
(4)Board members, other than ex officio members, shall serve up to two terms of four years per term, except that the initial appointment by the Speaker of the Assembly shall be for a term of five years, and the initial appointment by the Senate Committee on Rules shall be for a term of five years. Appointed board members shall be eligible for reappointment at the end of their first term. A board member may continue to serve until the appointment and qualification of their successor. Vacancies shall be filled by appointment for an unexpired term.
(5)Board members shall be subject to strict conflict-of-interest policies.
(6)Except for those who are board members pursuant to subparagraph (E) (C) of paragraph (2), a board member shall not be employed by, a member of the board of directors of, affiliated with, a vendor to, or otherwise a representative of signatories of, the California Health and Human Services Data Exchange Framework data sharing agreement while serving as a board member.
(7)Board members shall not have a conflict of interest and shall disclose all financial interests, investments, and positions in business entities or any signatories to the California Health and Human Services Data Exchange Framework data sharing agreement using the form as specified by the centers conflict of interest code.
(8)Board members shall serve without compensation, but shall be reimbursed for any actual and necessary expenses incurred in connection with their duties as board members.
(l)(n)(1)The board shall approve modifications to the California Health and Human Services Data Exchange Framework data sharing agreement and its policies and procedures and any new policies and procedures developed by the center.
(2)The board may establish new data sharing requirements for signatories to the Data Exchange Framework data sharing agreement with approval from the Secretary of California Health and Human Services and the center.(2)The board shall review, modify, and approve new data sharing requirements for signatories to the California Health and Human Services Data Exchange Framework data sharing agreement developed by the center.
(3)The board may advance recommendations on criteria and procedures on health information exchange technical assistance, onboarding, and other grant programs established by the center.
(4)The board shall develop recommendations to the Legislature and the Governor on statutory amendments to align state law with federal law to advance health information exchange.
(5)The board shall advise the center on the advancement and refinement of the California Health and Human Services Data Exchange Framework priorities and principles.(5)The board shall review, modify, and approve changes to the California Health and Human Services Data Exchange Framework priorities and principles as developed by the center and shall advise the center on the advancement of those priorities and principles.
(6)Subject to appropriation by the Legislature and in partnership with the center, the board shall develop a consumer outreach and education program that informs individuals of their rights, as well as the benefits of health data exchange, and provides a forum for members of the public to provide ongoing input related to health information exchange.
(7)On or before January 1, 2025, the board shall convene stakeholders, including data exchange signatories, consumer advocates, and racial equity experts, to develop recommendations for statutory changes, training and technical assistance, and best practices to require the entities listed in subdivision (f) to collect individual level demographic and health-related social needs data about Californians served, using the demographic and social needs data categories in the latest version of the United States Core Data for Interoperability adopted through the federal Office of the National Coordinator for Health IT Standards Version Advancement Process.
(8)On or before July 1, 2025, the center shall publish a policy proposal to adopt or modify the recommendations developed pursuant to paragraph (7).
(9)The board shall review the annual report submitted to the Legislature by the center pursuant to paragraph (5) of subdivision (l).
(m)(o)(1)All actions to implement the California Health and Human Services Data Exchange Framework, including the adoption or development of any data sharing agreement, requirements, policies and procedures, guidelines, subgrantee contract provisions, or reporting requirements, shall be exempt from the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code). The center shall release program notices that detail the requirements of the California Health and Human Services Data Exchange Framework.
(2)The center may, but is not obligated to, enact recommendations advanced by the board in accordance with the law and its rulemaking authority.
(3)The center may adopt reasonable rules and regulations to implement, administer, and oversee its duties under this section in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.
(4)The center may adopt emergency regulations to consolidate, clarify, or make consistent regulations, including emergency regulations adopted to implement this section.
(5)A rule or regulation adopted pursuant to this section shall be discussed by the board during at least one properly noticed board meeting before the office adopts the rule or regulation.
(6)The board may call emergency meetings for the purpose of discussing regulations. Once the board is established, the center shall bring each proposed regulation to the board to be discussed at least once before adoption.
(5)(7)The center may readopt any emergency regulation authorized by this section that is the same as, or substantially equivalent to, an emergency regulation previously adopted as authorized by this section. A readoption shall be limited to one time for each regulation.
(8)An emergency regulation adopted pursuant to this section after the establishment of the board shall be repealed by operation of law unless the adoption, amendment, or repeal of the regulation is promulgated by the center within five years of the initial adoption of the emergency regulation.
(6)(9)Notwithstanding any other law, the adoption of emergency regulations and the readoption of emergency regulations authorized by this section, if done on or before December 31, 2025, shall be deemed an emergency and necessary for the immediate preservation of the public peace, health, safety, or general welfare. The emergency regulations and the readopted emergency regulations authorized by this section shall each be submitted to the Office of Administrative Law for filing with the Secretary of State and shall remain in effect for no more than 180 days, by which time final regulations may be adopted.
(n)(p)For purposes of this section:
(1)Board means the CalHHS Data Exchange Board established pursuant to subdivision (k). (m).
(2)Center means the Center for Data Insights and Innovation.
(3)Qualified health information organization means an entity that has applied for, and satisfied, the process and criteria described in Section 130213.
SEC. 2.Section 130213 is added to the Health and Safety Code, to read:130213.(a)No later than July 1, 2024, the center shall establish a process to designate qualified health information organizations as data-sharing intermediaries that have demonstrated their ability to meet requirements of the California Health and Human Services Data Exchange Framework. Health and human service organization may comply with the data exchange framework by participating in and sharing information with a qualified health information organization.
(b)The criteria for qualification shall include, but not be limited to, being a nonprofit California regional or multiregional data network that meets all of the following organizational, functional, and operational requirements:
(1)Connects to electronic health record (EHR) systems of participating health care providers.
(2)Cleans, matches, securely stores, aggregates, and unifies clinical health and social service records to support care coordination, population health management, and analytic quality improvement and reporting.
(3)Is unaffiliated with a health care organization or EHR provider.
(4)Welcomes the participation of any health care provider, health plan, social services provider, or public health organization in the networks service area.
(a)On or before July 1, 2022, and subject to an appropriation in the annual Budget Act, the California Health and Human Services Agency, along with its departments and offices and in consultation with stakeholders and local partners, shall establish the California Health and Human Services Data Exchange Framework that shall include a single data sharing agreement and common set of policies and procedures that will leverage and advance national standards for information exchange and data content, and that will govern and require the exchange of health information among health care entities and government agencies in California. On or before July 1, 2023, and subject to an appropriation in the annual Budget Act, the Center for Data Insights and Innovation shall take over establishment, implementation, and all the functions related to the California Health and Human Services Data Exchange Framework, including the data sharing agreement and policies and procedures, from the California Health and Human Services Agency.
(1)The California Health and Human Services Data Exchange Framework is not intended to be an information technology system or single repository of data, rather it is technology agnostic and is a collection of organizations that are required to share health information using national standards and a common set of policies in order to improve the health outcomes of the individuals they serve.
(2)The California Health and Human Services Data Exchange Framework will be designed to enable and require real-time access to, or exchange of, health information among health care providers and payers through any health information exchange network, health information organization, or technology that adheres to specified standards and policies.
(3)The California Health and Human Services Data Exchange Framework shall align with state and federal data requirements, including the federal Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191), the Confidentiality of Medical Information Act of 1996 (Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code), and other applicable state and federal privacy laws related to the sharing of data among and between providers, payers, and the government, while also streamlining and reducing reporting burden.
(4)For the purposes of this section, health information means:
(A)For hospitals, clinics, and physician practices, at a minimum, the United States Core Data for Interoperability Version 1, until October 6, 2022. After that date, it shall include all electronic health information as defined under federal regulation in Section 171.102 of Title 45 of the Code of Federal Regulations and held by the entity.
(B)For health insurers and health care service plans, at a minimum, the data required to be shared under the Centers for Medicare and Medicaid Services Interoperability and Patient Access regulations for public programs as contained in United States Department of Health and Human Services final rule CMS-9115-F, 85 FR 25510.
(b)(1)On or before January 31, 2024, the entities listed in subdivision (f), except those identified in paragraph (2), shall exchange health information or provide access to health information to and from every other entity in subdivision (f) in real time as specified by the California Health and Human Services Agency center pursuant to the California Health and Human Services Data Exchange Framework data sharing agreement for treatment, payment, or health care operations.
(2)The requirement in paragraph (1) shall not apply to physician practices of fewer than 25 physicians, rehabilitation hospitals, long-term acute care hospitals, acute psychiatric hospitals, critical access hospitals, and rural general acute care hospitals with fewer than 100 acute care beds, state-run acute psychiatric hospitals, and any nonprofit clinic with fewer than 10 health care providers until January 31, 2026.
(c)The California Health and Human Services Agency shall convene a stakeholder advisory group no later than September 1, 2021, to advise on the development and implementation of the California Health and Human Services Data Exchange Framework.
(1)The members of the stakeholder advisory group shall be appointed by the Secretary of California Health and Human Services and shall not have a financial interest, individually or through a family member, related to issues the stakeholder advisory group will advise on.
(2)The stakeholder advisory group shall be composed of health care stakeholders and experts, including representatives of all the following:
(A)The State Department of Health Care Services.
(B)The State Department of Social Services.
(C)The Department of Managed Health Care.
(D)The Department of Health Care Access and Information.
(E)The State Department of Public Health.
(F)The Department of Insurance.
(G)The Public Employees Retirement System.
(H)The California Health Benefit Exchange.
(I)Health care service plans and health insurers.
(J)Physicians, including those with small practices.
(K)Hospitals, including public, private, rural, and critical access hospitals.
(L)Clinics, long-term care facilities, behavioral health facilities, or substance use disorder facilities.
(M)Consumers.
(N)Organized labor.
(O)Privacy and security professionals.
(P)Health information technology professionals.
(Q)Community health information organizations.
(R)County health, social services, and public health.
(S)Community-based organizations providing social services.
(T)The State Department of State Hospitals.
(U)The State Department of Developmental Services.
(V)The Emergency Medical Services Authority.
(W)The Department of Corrections and Rehabilitation.
(3)The stakeholder advisory group shall provide information and advice to the California Health and Human Services Agency on health information technology issues, including all of the following:
(A)Identify which data beyond health information as defined in paragraph (4) of subdivision (a), at minimum, should be shared for specified purposes between the entities outlined in this subdivision and subdivision (f).
(B)Identify gaps, and propose solutions to gaps, in the life cycle of health information, including gaps in any of the following:
(i)Health information creation, including the use of national standards in clinical documentation, health plan records, and social services data.
(ii)Translation, mapping, controlled vocabularies, coding, and data classification.
(iii)Storage, maintenance, and management of health information.
(iv)Linking, sharing, exchanging, and providing access to health information.
(C)Identify ways to incorporate data related to social determinants of health, such as housing and food insecurity, into shared health information.
(D)Identify ways to incorporate data related to underserved or underrepresented populations, including, but not limited to, data regarding sexual orientation and gender identity and racial and ethnic minorities.
(E)Identify ways to incorporate relevant data on behavioral health health, developmental disabilities, and substance use disorder conditions.
(F)Address the privacy, security, and equity risks of expanding care coordination, health information exchange, access, and telehealth in a dynamic technological, and entrepreneurial environment, where data and network security are under constant threat of attack.
(G)Develop policies and procedures consistent with national standards and federally adopted standards in the exchange of health information and social services information, including matters of consent, and ensure that health and social services information sharing broadly implements national frameworks and agreements consistent with federal rules and programs.
(H)Develop definitions of complete clinical, administrative, and claims data consistent with federal policies and national standards.
(I)Identify how all payers will be required to provide enrollees with electronic access to their health information, consistent with rules applicable to federal payer programs.
(J)Assess governance structures to help guide policy decisions and general oversight.
(K)Identify federal, state, private, or philanthropic sources of funding that could support data access and exchange.
(4)The stakeholder advisory group shall hold public meetings with stakeholders, solicit input, and set its own meeting agendas. Meetings of the stakeholder advisory group are subject to the Bagley-Keene Open Meeting Act (Article 9 (commencing with Section 11120) of Chapter 1 of Part 1 of Division 3 of Title 2 of the Government Code).
(5)The members of the stakeholder advisory group shall serve without compensation, but shall be reimbursed for any actual and necessary expenses incurred in connection with their duties as members of the group.
(d)No later than April 1, 2022, the California Health and Human Services Agency shall submit an update, including written recommendations, to the Legislature based on input from the stakeholder advisory group on the issues identified in paragraph (3) of subdivision (c).
(e)On or before January 31, 2023, the California Health and Human Services Agency center shall work with the California State Association of Counties to encourage the inclusion of county health, public health, and social services, to the extent possible, as part of the California Health and Human Services Data Exchange Framework in order to assist both public and private entities to connect through uniform standards and policies. It is the intent of the Legislature that all state and local public health agencies will exchange electronic health information in real time with participating health care entities to protect and improve the health and well-being of Californians.
(f)On or before January 31, 2023, and in alignment with existing federal standards and policies, the following health care organizations shall execute the California Health and Human Services Data Exchange Framework data sharing agreement pursuant to subdivision (a):
(1)General acute care hospitals, as defined by Section 1250.
(2)Physician organizations and medical groups.
(3)Skilled nursing facilities, as defined by Section 1250, that currently maintain electronic records.
(4)Health care service plans and disability insurers that provide hospital, medical, or surgical coverage that are regulated by the Department of Managed Health Care or the Department of Insurance. This section shall also apply to a Medi-Cal managed care plan under a comprehensive risk contract with the State Department of Health Care Services pursuant to Chapter 7 (commencing with Section 14000) or Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the Welfare and Institutions Code that is not regulated by the Department of Managed Health Care or the Department of Insurance.
(5)Clinical laboratories, as that term is used in Section 1265 of the Business and Professions Code, and that are regulated by the State Department of Public Health.
(6)Acute psychiatric hospitals, as defined by Section 1250.
(7)Emergency medical services, as defined by Section 1797.72.
(g)The California Health and Human Services Agency center shall work with experienced nonprofit organizations and entities represented in the stakeholder advisory group in subdivision (c) to provide technical assistance to the entities outlined in subdivisions (e) and (f).
(h)On or before July 31, 2022, the California Health and Human Services Agency shall develop in consultation with the stakeholder advisory group in subdivision (c) a strategy for unique, secure digital identities capable of supporting master patient indices to be implemented by both private and public organizations in California.
(i)For purposes of implementing this section, including, but not limited to, hiring staff and consultants, facilitating and conducting meetings, conducting research and analysis, and developing the required reports, the California Health and Human Services Agency center may enter into exclusive or nonexclusive contracts on a bid or negotiated basis. Contracts entered into or amended pursuant to this section shall be exempt from Chapter 6 (commencing with Section 14825) of Part 5.5 of Division 3 of Title 2 of the Government Code, Section 19130 of the Government Code, and Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code, and shall be exempt from the review or approval of any division of the Department of General Services. No A person hired or otherwise retained pursuant to this subdivision shall not be permitted to have any financial interest in the California Health and Human Services Data Exchange Framework or shall not be, or be affiliated with, any health care organization required to participate in the California Health and Human Services Data Exchange Framework pursuant to subdivisions (b) and (f). The term person, as used in this subdivision, means any individual, partnership, joint venture, association, corporation, or any other organization or any combination thereof.
(j)(1)The center shall administer, manage, and oversee the California Health and Human Services Data Exchange Framework and its data sharing agreement, including its related policies and procedures, governance, and all other materials or initiatives related to the California Health and Human Services Data Exchange Framework.
(2)The center shall be responsible for oversight of the dispute resolution and grievance processes for the California Health and Human Services Data Exchange Framework.
(k)(1)The center shall establish and administer the CalHHS Data Exchange Board. The board shall be separate and distinct from the stakeholder advisory group.
(2)The board shall be composed of 12 voting members, including all of the following:
(A)The Secretary of California Health and Human Services, or their designee, shall serve as the chair and as an ex officio member of the board.
(B)Two individuals appointed by the Governor, and at least one of whom shall be a consumer representative.
(C)One individual appointed by the Speaker of the Assembly.
(D)One individual appointed by the Senate Committee on Rules.
(E)One representative from each of the following, who shall be ex officio members of the board:
(i)The Public Employees Retirement System.
(ii)The California Health Benefit Exchange.
(iii)The State Department of Health Care Services.
(iv)The State Department of Developmental Services.
(v)The Emergency Medical Services Authority.
(vi)The State Department of State Hospitals.
(vii)The Department of Corrections and Rehabilitation.
(3)Each individual appointed to the board shall have demonstrated and acknowledged expertise, as needed, in health information exchange, health data privacy, and administration of public and private health care or social service delivery systems. The appointing authorities shall consider the expertise of the other board members and attempt to make appointments so that the boards composition reflects a diversity of expertise and perspectives. The appointing authorities shall take into consideration the cultural, ethnic, and geographical diversity of the state so that the boards composition reflects the communities of California.
(4)Board members, other than ex officio members, shall serve up to two terms of four years per term, except that the initial appointment by the Speaker of the Assembly shall be for a term of five years, and the initial appointment by the Senate Committee on Rules shall be for a term of five years. Appointed board members shall be eligible for reappointment at the end of their first term. A board member may continue to serve until the appointment and qualification of their successor. Vacancies shall be filled by appointment for an unexpired term.
(5)Board members shall be subject to strict conflict-of-interest policies.
(6)Except for those who are board members pursuant to subparagraph (E) of paragraph (2), a board member shall not be employed by, a member of the board of directors of, affiliated with, a vendor to, or otherwise a representative of signatories of, the California Health and Human Services Data Exchange Framework data sharing agreement while serving as a board member.
(7)Board members shall not have a conflict of interest and shall disclose all financial interests, investments, and positions in business entities or any signatories to the Data Exchange Framework data sharing agreement using the form as specified by the centers conflict of interest code.
(8)Board members shall serve without compensation, but shall be reimbursed for any actual and necessary expenses incurred in connection with their duties as board members.
(l)(1)The board shall approve modifications to the Data Exchange Framework data sharing agreement and its policies and procedures and any new policies and procedures developed by the center.
(2)The board may establish new data sharing requirements for signatories to the Data Exchange Framework data sharing agreement with approval from the Secretary of California Health and Human Services and the center.
(3)The board may advance recommendations on criteria and procedures on health information exchange technical assistance, onboarding, and other grant programs established by the center.
(4)The board shall develop recommendations to the Legislature and the Governor on statutory amendments to align state law with federal law to advance health information exchange.
(5)The board shall advise the center on the advancement and refinement of the California Health and Human Services Data Exchange Framework priorities and principles.
(j)(m)(1)All actions to implement the California Health and Human Services Data Exchange Framework, including the adoption or development of any data sharing agreement, requirements, policies and procedures, guidelines, subgrantee contract provisions, or reporting requirements, shall be exempt from the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code). The California Health and Human Services Agency, or a designee department or office under its jurisdiction, center shall release program notices that detail the requirements of the California Health and Human Services Data Exchange Framework.
(2)The center may, but is not obligated to, enact recommendations advanced by the board in accordance with the law and its rulemaking authority.
(3)The center may adopt reasonable rules and regulations to implement, administer, and oversee its duties under this section in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.
(4)The center may adopt emergency regulations to consolidate, clarify, or make consistent regulations, including emergency regulations adopted to implement this section.
(5)The center may readopt any emergency regulation authorized by this section that is the same as, or substantially equivalent to, an emergency regulation previously adopted as authorized by this section. A readoption shall be limited to one time for each regulation.
(6)Notwithstanding any other law, the adoption of emergency regulations and the readoption of emergency regulations authorized by this section, if done on or before December 31, 2025, shall be deemed an emergency and necessary for the immediate preservation of the public peace, health, safety, or general welfare. The emergency regulations and the readopted emergency regulations authorized by this section shall each be submitted to the Office of Administrative Law for filing with the Secretary of State and shall remain in effect for no more than 180 days, by which time final regulations may be adopted.
(n)For purposes of this section:
(1)Board means the CalHHS Data Exchange Board established pursuant to subdivision (k).
(2)Center means the Center for Data Insights and Innovation.
SECTION 1.Section 130290.1 is added to the Health and Safety Code, immediately following Section 130290, to read:130290.1.(a)(1)There is hereby established in the California Health and Human Services Agency the Data Exchange Framework governing board (governing board).(2)The governing board established pursuant to paragraph (1) shall approve any modifications to the data-sharing agreement established pursuant to Section 130290 and its policies and procedures.(b)(1)The governing board shall consist of the following five members that are residents of California and be appointed pursuant to the criteria of subdivision (c):(A)Two members that shall be appointed by the Governor.(B)One member that shall be appointed by the Senate Committee on Rules.(C)One member that shall be appointed by the Speaker of the Assembly.(D)The Secretary of California Health and Human Services or the secretarys designee, who shall serve as a voting, ex officio member of the governing board.(2)Members of the governing board, other than an ex officio member, shall be appointed for a term of four years, except that the initial appointment by the Senate Committee on Rules shall be for a term of five years, and the initial appointment by the Speaker of the Assembly shall be for a term of two years. A member of the governing board may continue to serve until the appointment and qualification of the members successor. A vacancy shall be filled by appointment for the unexpired term.(3)Appointments by the Governor shall be subject to confirmation by the Senate.(4)The governing board shall elect a chairperson on an annual basis.(c)(1)Each individual appointed to the governing board shall have demonstrated and acknowledged expertise in health information exchange and administration of public and private health care or social service delivery systems or both necessary to meet Californias health care access, equity, affordability, public health, and quality goals. (2)Appointing authorities pursuant to subdivision (b) shall consider both of the following:(A)The expertise of the other governing board members and attempt to make appointments so that the governing boards composition reflects a diversity of expertise and perspectives. (B)The cultural, ethnic, and geographical diversity of the state so that the governing boards composition reflects the communities of California.(a)(1)There is hereby established in the California Health and Human Services Agency the Data Exchange Framework governing board (governing board).
(2)The governing board established pursuant to paragraph (1) shall approve any modifications to the data-sharing agreement established pursuant to Section 130290 and its policies and procedures.
(b)(1)The governing board shall consist of the following five members that are residents of California and be appointed pursuant to the criteria of subdivision (c):
(A)Two members that shall be appointed by the Governor.
(B)One member that shall be appointed by the Senate Committee on Rules.
(C)One member that shall be appointed by the Speaker of the Assembly.
(D)The Secretary of California Health and Human Services or the secretarys designee, who shall serve as a voting, ex officio member of the governing board.
(2)Members of the governing board, other than an ex officio member, shall be appointed for a term of four years, except that the initial appointment by the Senate Committee on Rules shall be for a term of five years, and the initial appointment by the Speaker of the Assembly shall be for a term of two years. A member of the governing board may continue to serve until the appointment and qualification of the members successor. A vacancy shall be filled by appointment for the unexpired term.
(3)Appointments by the Governor shall be subject to confirmation by the Senate.
(4)The governing board shall elect a chairperson on an annual basis.
(c)(1)Each individual appointed to the governing board shall have demonstrated and acknowledged expertise in health information exchange and administration of public and private health care or social service delivery systems or both necessary to meet Californias health care access, equity, affordability, public health, and quality goals.
(2)Appointing authorities pursuant to subdivision (b) shall consider both of the following:
(A)The expertise of the other governing board members and attempt to make appointments so that the governing boards composition reflects a diversity of expertise and perspectives.
(B)The cultural, ethnic, and geographical diversity of the state so that the governing boards composition reflects the communities of California.
|
Date
|
Status
|
|---|---|
| Aug 15, 2024 | In committee: Held under submission. |
| Sep 1, 2023 | In committee: Held under submission. |
| Aug 14, 2023 | In committee: Referred to APPR suspense file. |
| Jul 13, 2023 | Read second time and amended. Re-referred to Com. on APPR. |
| Jul 13, 2023 | From committee: Amend, and do pass as amended and re-refer to Com. on APPR. (Ayes 10. Noes 0.) (July 12). |
| Jul 3, 2023 | In committee: Hearing postponed by committee. |
| Jun 27, 2023 | From committee chair, with author's amendments: Amend, and re-refer to committee. Read second time, amended, and re-referred to Com. on HEALTH. |
| May 31, 2023 | Referred to Com. on HEALTH. |
| May 18, 2023 | In Senate. Read first time. To Com. on RLS. for assignment. |
| May 18, 2023 | Read third time. Passed. Ordered to the Senate. (Ayes 74. Noes 0. Page 1597.) |
| May 11, 2023 | Read second time. Ordered to Consent Calendar. |
| May 10, 2023 | From committee: Do pass. To Consent Calendar. (Ayes 14. Noes 0.) (May 10). |
| Apr 26, 2023 | From committee: Do pass and re-refer to Com. on APPR. (Ayes 15. Noes 0.) (April 25). Re-referred to Com. on APPR. |
| Apr 13, 2023 | In committee: Set, first hearing. Hearing canceled at the request of author. |
| Apr 11, 2023 | Re-referred to Com. on HEALTH. |
| Apr 10, 2023 | From committee chair, with author's amendments: Amend, and re-refer to Com. on HEALTH. Read second time and amended. |
| Mar 2, 2023 | Referred to Com. on HEALTH. |
| Feb 17, 2023 | From printer. May be heard in committee March 20. |
| Feb 16, 2023 | Read first time. To print. |
|
Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Aug 14, 2023 | Placed on suspense file | Senate Standing Committee on Appropriations |
Passed |
|
| Jul 12, 2023 | Do pass as amended, but first amend, and re-refer to the Committee on [Appropriations] | Senate Standing Committee on Health |
Passed |
|
| May 18, 2023 | AB 1331 Wood Consent Calendar Second Day Regular Session | Assembly Floor |
Passed |
|
| May 10, 2023 | Do pass. To Consent Calendar. | Assembly Standing Committee on Appropriations |
Passed |
|
| Apr 25, 2023 | Do pass and be re-referred to the Committee on [Appropriations] | Assembly Standing Committee on Health |
Passed |
This list shows positions taken on this bill by organizations on the date displayed, which is linked to the original source.
Positions by individuals are not included.
|
Organization
|
Position
|
Date
|
|---|---|---|
| America'S Physician Groups | ** Support | |
| Anthem, Inc. | ** Support | |
| Blue Shield Of California | * Support | Jul 12, 2023 |
| California Association of Health Information Exchanges | ** Support | |
| California Association of Public Hospitals | * Against Unless Amend | Jul 12, 2023 |
| California Black Health Network | ** Support | |
| California Hospital Association | * Against Unless Amend | Jul 12, 2023 |
| California Medical Association | * For If Amend | Jul 12, 2023 |
| California Pan-Ethnic Health Network | ** Support | |
| Children Now | ** Support | |
| Connecting for Better Health Coalition | * Support | Aug 14, 2023 |
| El Sol Neighborhood Educational Center | ** Support | |
| Empowering Pacific Islander Communities | ** Support | |
| Health Access California | * Support | Jul 12, 2023 |
| Health Information Exchange in California | * Support | Jul 12, 2023 |
| Inland Empire Foundation for Medical Care | ** Support | |
| Inland Empire Health Information Organization | ** Support | |
| Inland Empire Health Plan | ** Support | |
| Invitae | ** Support | |
| Justice in Aging | ** Support | |
| Kaiser Permanante | * For If Amend | Jul 12, 2023 |
| Korean Community Center of the East Bay | ** Support | |
| Latino Coalition for a Healthy California | ** Support | |
| LevelUP NorCal | ** Support | |
| Los Angeles Network for Enhanced Services | ** Support | |
| Manifest Medex | ** Support | |
| Michigan Health Information Network Shared Services | ** Support | |
| Point Click Care | * Against Unless Amend | Jul 12, 2023 |
| Riverside County Medical Association | ** Support | |
| SacValley Medshare | ** Support | |
| San Diego Health Connect | ** Support | |
| Savage & Savage, LLC. | ** Support | |
| Serving Communities Health Information Organization | ** Support | |
| South Asian Network | ** Support | |
| Synclarity Consulting | ** Support | |
| The Childrens Partnership | ** Support | |
| Velatura Public Benefit Corporation | ** Support | |
| Western Center for Law and Poverty | * Support | Jul 12, 2023 |
| Zen Healthcare It | ** Support |
SENATE COMMITTEE ON APPROPRIATIONS
Senator Anthony Portantino, Chair
2023 - 2024 Regular Session
AB 1331 (Wood) - California Health and Human Services Data Exchange Framework
Version: July 13, 2023 | Policy Vote: HEALTH 10 - 0 |
Urgency: No | Mandate: No |
Hearing Date: August 14, 2023 | Consultant: Agnes Lee |
Bill Summary:
AB 1331 would move the responsibility of the California Health and Human Services Data Exchange Framework to the Center for Data Insights and Innovation (CDII) and make other changes to the data exchange framework.
Fiscal Impact:
The California Health and Human Services Agency (CHHS) estimates ongoing General Fund costs of $3.5 million for the CDII. This includes $1 million for staff resources and $2.5 million for contract costs.
Background:
Current law requires the CHHS, along with its departments and offices and in consultation with stakeholders and local partners, to establish the CHHS Data Exchange Framework to include a single data sharing agreement and common set of policies and procedures that will leverage and advance national standards for information exchange and data content, and that will govern and require the exchange of health information among health care entities and government agencies in California. Current law requires CHHS to convene a stakeholder advisory group to advise on the development and implementation of the data exchange framework.
The following health care organizations are required to execute the data exchange framework data sharing agreement:
- General acute care hospitals;
- Physician organizations and medical groups;
- Skilled nursing facilities that currently maintain electronic records;
- Health plans and disability insurers that provide hospital, medical, or surgical coverage that are regulated by the Department of Managed Health Care (DMHC) or the Department of Insurance (CDI); including a Medi-Cal managed care plan under a comprehensive risk contract with the State Department of Health Care Services that is not regulated by DMHC or CDI;
- Clinical laboratories, as specified, and that are regulated by the State Department of Public Health; and,
- Acute psychiatric hospitals.
Current law requires, on or before January 31, 2024, the entities listed above, to exchange health information or provide access to health information to and from every other entity listed above in real time as specified by CHHS pursuant to the data exchange framework data sharing agreement for treatment, payment, or health care operations. The following entities are exempt until January 31, 2026: physician practices of fewer than 25 physicians, rehabilitation hospitals, long-term acute care hospitals, acute psychiatric hospitals, critical access hospitals, and rural general acute care hospitals with fewer than 100 acute care beds, state-run acute psychiatric hospitals, and any nonprofit clinic with fewer than 10 health care providers.
The CDII was established through the merger of four entities within CHHS: the Committee for the Protection of Human Subjects, Office of Health Information Integrity, Office of Innovation, and the Office of the Patient Advocate. Each entity possesses key data-sharing and governance-related operational units whose capabilities and experience are aligned with the CDII strategic priorities.
Proposed Law:
Specific provisions of the bill would:
- Require, on or before January 1, 2024, and subject to an appropriation in the annual Budget Act, the CDII to take over establishment, implementation, and all the functions related to the data exchange framework, including the data sharing agreement and policies and procedures, from CHHS.
- Make changes to the existing stakeholder advisory group, as specified.
- Add emergency medical services to the entities that must execute the data sharing agreement; and provide CDII the authority to determine other categories of entities that must sign the data sharing agreement.
- Require compliance with executing the data sharing agreement as a condition of contracting with the Department of Health Care Services, CalPERS, and Covered California.
- Add duties for the CDII, including but not limited to:
- Submit an annual report to the Legislature that includes required signatory compliance with the data sharing agreement, assessment of consumer experiences with health information exchange, and evaluation of technical assistance and other grant programs.
- Report violations to state licensing entities or other entities authorized to ensure compliance with execution of the data sharing agreement or with the data sharing agreement and its policies and procedures.
- Establish and administer a CalHHS Data Exchange Board, separate and distinct from the existing stakeholder advisory group.
- Establish a process to designate “qualified health information organizations” as data-sharing intermediaries that have demonstrated their ability to meet requirements of the data exchange framework, as specified.
Related Legislation:
The Governor’s budget included proposed trailer bill language which contained some similar provisions that are now included in AB 1331. The trailer bill language was not adopted as part of the Budget Act of 2023-24.
-- END --
SENATE COMMITTEE ON APPROPRIATIONS
Senator Anthony Portantino, Chair
2023 - 2024 Regular Session
AB 1331 (Wood) - California Health and Human Services Data Exchange Framework
Version: July 13, 2023 | Policy Vote: HEALTH 10 - 0 |
Urgency: No | Mandate: No |
Hearing Date: August 14, 2023 | Consultant: Agnes Lee |
Bill Summary:
AB 1331 would move the responsibility of the California Health and Human Services Data Exchange Framework to the Center for Data Insights and Innovation (CDII) and make other changes to the data exchange framework.
Fiscal Impact:
The California Health and Human Services Agency (CHHS) estimates ongoing General Fund costs of $3.5 million for the CDII. This includes $1 million for staff resources and $2.5 million for contract costs.
Background:
Current law requires the CHHS, along with its departments and offices and in consultation with stakeholders and local partners, to establish the CHHS Data Exchange Framework to include a single data sharing agreement and common set of policies and procedures that will leverage and advance national standards for information exchange and data content, and that will govern and require the exchange of health information among health care entities and government agencies in California. Current law requires CHHS to convene a stakeholder advisory group to advise on the development and implementation of the data exchange framework.
The following health care organizations are required to execute the data exchange framework data sharing agreement:
- General acute care hospitals;
- Physician organizations and medical groups;
- Skilled nursing facilities that currently maintain electronic records;
- Health plans and disability insurers that provide hospital, medical, or surgical coverage that are regulated by the Department of Managed Health Care (DMHC) or the Department of Insurance (CDI); including a Medi-Cal managed care plan under a comprehensive risk contract with the State Department of Health Care Services that is not regulated by DMHC or CDI;
- Clinical laboratories, as specified, and that are regulated by the State Department of Public Health; and,
- Acute psychiatric hospitals.
Current law requires, on or before January 31, 2024, the entities listed above, to exchange health information or provide access to health information to and from every other entity listed above in real time as specified by CHHS pursuant to the data exchange framework data sharing agreement for treatment, payment, or health care operations. The following entities are exempt until January 31, 2026: physician practices of fewer than 25 physicians, rehabilitation hospitals, long-term acute care hospitals, acute psychiatric hospitals, critical access hospitals, and rural general acute care hospitals with fewer than 100 acute care beds, state-run acute psychiatric hospitals, and any nonprofit clinic with fewer than 10 health care providers.
The CDII was established through the merger of four entities within CHHS: the Committee for the Protection of Human Subjects, Office of Health Information Integrity, Office of Innovation, and the Office of the Patient Advocate. Each entity possesses key data-sharing and governance-related operational units whose capabilities and experience are aligned with the CDII strategic priorities.
Proposed Law:
Specific provisions of the bill would:
- Require, on or before January 1, 2024, and subject to an appropriation in the annual Budget Act, the CDII to take over establishment, implementation, and all the functions related to the data exchange framework, including the data sharing agreement and policies and procedures, from CHHS.
- Make changes to the existing stakeholder advisory group, as specified.
- Add emergency medical services to the entities that must execute the data sharing agreement; and provide CDII the authority to determine other categories of entities that must sign the data sharing agreement.
- Require compliance with executing the data sharing agreement as a condition of contracting with the Department of Health Care Services, CalPERS, and Covered California.
- Add duties for the CDII, including but not limited to:
- Submit an annual report to the Legislature that includes required signatory compliance with the data sharing agreement, assessment of consumer experiences with health information exchange, and evaluation of technical assistance and other grant programs.
- Report violations to state licensing entities or other entities authorized to ensure compliance with execution of the data sharing agreement or with the data sharing agreement and its policies and procedures.
- Establish and administer a CalHHS Data Exchange Board, separate and distinct from the existing stakeholder advisory group.
- Establish a process to designate “qualified health information organizations” as data-sharing intermediaries that have demonstrated their ability to meet requirements of the data exchange framework, as specified.
Related Legislation:
The Governor’s budget included proposed trailer bill language which contained some similar provisions that are now included in AB 1331. The trailer bill language was not adopted as part of the Budget Act of 2023-24.
-- END --
SENATE COMMITTEE ON HEALTH
Senator Dr. Susan Talamantes Eggman, Chair
BILL NO: AB 1331
AUTHOR: | Wood | ||
VERSION: | June 27, 2023 | ||
HEARING DATE: | July 12, 2023 | ||
CONSULTANT: | Teri Boughton | ||
SUBJECT: California Health and Human Services Data Exchange Framework
SUMMARY:
Moves the responsibility of the California Health and Human Services Data Exchange Framework to the Center for Data Insights and Innovation (CDII); requires emergency medical services to sign the data sharing agreement; makes signing the data sharing agreement a required condition for contracting with specified state agencies; authorizes CDII to develop a framework for investigating violations of the data sharing agreement; requires CDII to report violations to state licensing entities and oversee disputes and grievances; establishes a board to review, modify, and approve data sharing requirements for signatories; requires CDII to establish a process to designate Qualified Health Information Organizations (QHIO) and establish criteria to be a QHIO, such as being a nonprofit and unaffiliated to health care organization; and, provides emergency regulation authority to CDII.
Existing law:
- Requires, on or before July 1, 2022, and subject to an appropriation in the annual Budget Act, the California Health and Human Services (CHHS) Agency, along with its departments and offices and in consultation with stakeholders and local partners, to establish the CHHS Data Exchange Framework (data exchange framework) to include a single data sharing agreement and common set of policies and procedures that will leverage and advance national standards for information exchange and data content, and that will govern and require the exchange of health information among health care entities and government agencies in California. [HSC §130290]
- Requires, on or before January 31, 2023 and in alignment with existing federal standards and policies, the following health care organizations to execute the data exchange framework data sharing agreement:
- General acute care hospitals;
- Physician organizations and medical groups;
- Skilled nursing facilities that currently maintain electronic records;
- Health plans and disability insurers that provide hospital, medical, or surgical coverage that are regulated by the Department of Managed Health Care (DMHC) or the Department of Insurance (CDI), including a Medi-Cal managed care plan under a comprehensive risk contract with the State Department of Health Care Services that is not regulated by DMHC or CDI;
- Clinical laboratories, as specified, that are regulated by the State Department of Public Health; and,
- Acute psychiatric hospitals. [HSC §130290]
- Requires the entities listed above, on or before January 31, 2024, to exchange health information or provide access to health information to and from every other entities listed above in real time as specified by CHHS pursuant to the data exchange framework data sharing agreement for treatment, payment, or health care operations. Exempts, until January 31, 2026, physician practices of fewer than 25 physicians, rehabilitation hospitals, long-term acute care hospitals, acute psychiatric hospitals, critical access hospitals, and rural general acute care hospitals with fewer than 100 beds, state-run acute psychiatric hospitals, and any nonprofit clinic with fewer than ten health care providers. [HSC §130290]
- Requires CHHS to convene a stakeholder advisory group, no later than September 1, 2021, to advise on the development and implementation of the data exchange framework, and requires the stakeholder advisory group to inform and advise the CHHS agency on HIT issues, including:
- Identifying additional data that should be shared;
- Identifying gaps, and propose solutions to gaps, in the life cycle of health information, including gaps in any of the following:
- Health information creation, including the use of national standards in clinical documentation, health plan records, and social services data;
- Translation, mapping, controlled vocabularies, coding, and data classification;
- Storage, maintenance, and management of health information; and,
- Linking, sharing, exchanging, and providing access to health information;
- Identifying ways to incorporate data related to social determinants of health, such as housing and food insecurity, into shared health information;
- Identifying ways to incorporate data related to underserved or underrepresented populations, including, but not limited to, data regarding sexual orientation and gender identity and racial and ethnic minorities;
- Identifying ways to incorporate relevant data on behavioral health and substance use disorder conditions;
- Addressing the privacy, security, and equity risks of expanding care coordination, health information exchange (HIE), access, and telehealth in a dynamic technological, and entrepreneurial environment, where data and network security are under constant threat of attack;
- Developing policies and procedures consistent with national standards and federally adopted standards in the exchange of health information and ensure that health information sharing broadly implements national frameworks and agreements consistent with federal rules and programs;
- Developing definitions of complete clinical, administrative, and claims data consistent with federal policies and national standards;
- Identifying how all payers will be required to provide enrollees with electronic access to their health information, consistent with rules applicable to federal payer programs;
- Assessing governance structures to help guide policy decisions and general oversight; and,
- Identifying federal, state, private, or philanthropic sources of funding that could support data access and exchange. [HSC §130290]
- Enacts the Information Practices Act (IPA), which limits government collection and disclosure of individuals’ personal information. [CIV §1798, et seq.]
This bill:
- Requires, on or before July 1, 2023, and subject to an appropriation in the annual Budget Act, the CDII to take over establishment, implementation, and all the functions related to the data exchange framework, including the data sharing agreement and policies and procedures, from CHHS.
- Adds the state Department of State Hospitals (DSH), Department of Developmental Services (DDS), the Emergency Medical Services Authority (EMSA), and the California Department of Corrections and Rehabilitation (CDCR) to the stakeholder advisory group.
- Requires the stakeholder advisory group to identify ways to incorporate relevant data on developmental disabilities, develop policies and procedures and standards on the exchange of social services information, including exchange of social services information, including matters of consent, and that it implements national frameworks and agreements consistent with federal policies and national standards.
- Adds emergency medical services, which are services utilized in responding to a medical emergency, to the entities that must sign the data sharing agreement by January 31, 2023.
- Requires compliance with signing the data sharing agreement by January 31, 2023 to be required as a condition of contracting with the DHCS, CalPERS, and Covered California.
- Requires CDII to do the following:
- Have the authority to determine other categories of entities that are required to sign the data sharing agreement;
- Administer, manage, oversee, and enforce the data exchange framework and its data sharing agreement, including its related policies and procedures, governance, and all other materials or initiatives related to the data exchange framework;
- Have the authority to develop a framework for investigating potential violations of the data sharing agreement and its policies and procedures;
- Report violations to state licensing entities to ensure compliance with execution of the data sharing agreement or with the data sharing agreement and its policies and procedures;
- Be responsible for oversight of the dispute resolution and grievance processes for the data exchange framework;
- Submit an annual report to the Legislature that includes required signatory compliance with the data sharing agreement, assessment of consumer experiences with HIE, and evaluation of technical assistance and other grant programs; and,
- Establish and administer the CalHHS Data Exchange Board (board), separate and distinct from the stakeholder advisory group.
- Requires the board to be composed of:
- Five voting members;
- Secretary of the CHHS, or their designee, who serves as Chair and an ex officio member of the board;
- Two individuals appointed by the Governor, and at least one is a consumer representative;
- One individual appointed by the Speaker of the Assembly;
- One individual appointed by the Senate Committee on Rules; and,
- Seven nonvoting, ex officio members are representatives from CalPERS, Covered California, DHCS, DDS, EMSA, DSH, and CDCR.
- Establishes that board members have demonstrated expertise, as needed, in HIE, health data privacy, and administration of public and private health care or social service delivery systems, and be subject to strict conflict-of interest policies, disclose financial interests, and serve without compensation.
- Five voting members;
- Requires the board to:
- Approve modifications to the data sharing agreement and its policies and procedures and any new policies and procedures developed by CDII;
- Review, modify, and approve new data sharing requirements for signatories to the data sharing agreement developed by CDII;
- Develop recommendations to the Legislature and the Governor on statutory amendments to align state law with federal law to advance HIE;
- Review, modify, and approve changes to the data exchange framework priorities and principles as developed by CDII and advise CDII on the advancement of those priorities and principles;
- Develop, upon appropriation, a consumer outreach and education program that informs individuals of their rights, as well as the benefits of health data exchange, and provides a forum for members of the public to provide ongoing input related to HIE;
- Convene, on or before January 1, 2025, stakeholders to develop recommendations for statutory changes, training and technical assistance, and best practices for collecting individual level demographic and health-related social needs data, as specified; and,
- Publish, on or before January 1, 2025, a policy proposal to adopt or modify the recommendations.
- Authorizes the board to advance recommendations on criteria and procedures on HIE technical assistance, onboarding, and other grant programs established by CDII.
- Authorizes CDII to:
- Enact recommendations advanced by the board;
- Adopt reasonable rules and regulations after discussion by the board at least one properly noticed board meeting in advance;
- Call emergency meetings to discuss regulation;
- Readopt once any emergency regulation that is the same as, or substantially equivalent to, and emergency regulation previously adopted; and,
- Have emergency regulation authority before December 31, 2025.
- Requires CDII, no later than July 1, 2024, to establish a process to designate QHIOs as data-sharing intermediaries that have demonstrated their ability to meet requirements of the data exchange framework. Defines a QHIO as an entity that has applied for, and satisfied, the process described in 13) below.
- Authorizes health and human service organization to comply with the data exchange framework by participating in and sharing information with a QHIO.
- Requires the QHIO criteria to include, but not be limited to, being a nonprofit California regional or multiregional data network that meets all of the following organizational, functional, and operational requirements:
- Connects to electronic health record (EHR) systems of participating health care providers;
- Cleans, matches, securely stores, aggregates, and unifies clinical health and social service records to support care coordination, population health management, and analytic quality improvement and reporting;
- Is unaffiliated with a health care organization or EHR provider; and,
- Welcomes the participation of any health care provider, health plan, social services provider, or public health organization in the network’s service area.
FISCAL EFFECT:
CHHSA, CDII reports minor and absorbable costs.
PRIOR VOTES:
Assembly Floor: | 74 - 0 |
Assembly Appropriations Committee: | 14 - 0 |
Assembly Health Committee: | 15 - 0 |
COMMENTS:
- Author’s statement. According to the author, this bill establishes that next step to ensure that the CHHS Data Exchange Framework is successful in achieving the exchange of information to ensure that California achieves its health care access, equity, affordability, public health, and quality of care goals.
- Data exchange framework. According to the CDII website, the data exchange framework is not a new technology or centralized data repository; instead, it is an agreement across health and human services systems and providers to share information safely. That means every health care provider can access the information they need to treat a patient quickly and safely; health care, behavioral health and social services agencies can connect to each other to deliver what Californians need to be healthy; and, the public health system can better assess how to address the needs of all communities. Hundreds of experts and members of the public have spent the last year shaping a framework that delivers on these principles. The data sharing agreement was finalized July 1, 2022 and was expected to be executed by health and human services organizations on January 31, 2023. Health care entities required to participate are: general acute care hospitals, physician organizations and medical groups, skilled nursing facilities, health plans and insurers, Medi-Cal managed care plans, clinical laboratories, and acute psychiatric hospitals. Most providers are required to begin data exchange by January 31, 2024 and the remaining providers are required to begin data exchange by January 31, 2026. Over $250 million over the next several years has been budgeted to support data exchange adoption. As of July 10, 2023 over 1,050 health care organizations have signed the data sharing agreement out of at least 37,826 organizations.
- Budget trailer bill. Budget trailer bill provisions proposed by the Newsom Administration in 2023 would have, by July 1, 2023 and subject to appropriation in the annual Budget Act, require CDII to take over establishment, implementation, and all the functions related to the data exchange framework, including the data sharing agreement and policies and procedures, from the CHHS agency. The trailer bill also would have added additional state departments to the stakeholder advisory group, and added social services and developmental disabilities data and information sharing to the work of the stakeholder advisory group. The trailer bill would have required CDII to establish a board of 12 voting members made mostly of Governor’s appointees (eight out of 12) and only two legislative appointees that would approve modifications to the data exchange framework data sharing agreement and its policy and procedures. The board would establish new data sharing requirements for signatories with approval from the Secretary of CHHS, would advance recommendations on technical assistance, onboarding, and grant programs, but would have been required to develop recommendations to the Legislature and Governor on statutory amendments to align state law with federal law, and advise the CDII on the advancement and refinement of the data exchange framework priorities and principles. The trailer bill provisions were not adopted, but many are contained in this bill.
- Related legislation. SB 582 (Becker) requires the data exchange framework stakeholder advisory group to consider whether standards for including EHR vendors in the data exchange framework would be appropriate, and, if determined appropriate develop those standards. SB 582 requires, if standards are developed, EHR vendors to execute the data exchange framework data sharing agreement no later than 12 months after the completion of the standards and in alignment with existing federal standards and policies. SB 582 requires any fees charged by an EHR vendor to enable compliance with the data exchange framework to be reasonable, consistent with federal regulations, as specified, and, permits CHHS to establish administrative oversight and enforcement authority, including the imposition of fines and penalties against an EHR vendor that is found not in compliance with federal standards, as specified. SB 582 passed out of the Assembly Health Committee with a vote of 15-0 on June 27, 2023.
- Prior legislation. AB 133 (Committee on Budget, Chapter 143, Statutes of 2021), among many other provisions, establishes a process for developing the CHHS agency data exchange framework, including the components and milestones related to the stakeholder advisory group, establishing the data exchange framework; health care organization adoption of the data exchange framework; and real-time HIE.
AB 1131 (Wood of 2021) would have established the statewide health information network governing board, an independent public entity not affiliated with an agency or department with specified membership, to provide the data infrastructure needed to meet California’s health care access, equity, affordability, public health, and quality goals, as specified. AB 1131 was held on the Assembly Appropriations Committee suspense file.
SB 371 (Caballero of 2021) would have required any federal funds CHHS receives for HIT and exchange to be deposited in the California Health Information Technology and Exchange Fund. Would have authorized CHHS to use the fund to provide grants to health care providers to implement or expand HIT and to contract for direct data exchange technical assistance for safety net providers. SB 371 would have required a health information organization to be connected to the California Trusted Exchange Network and to a qualified national network. SB 371 would have required a health care provider, health system, health care service plan, or health insurer that engages in HIE to comply with specified federal standards. SB 371 was not heard in the Assembly Health Committee.
SB 441 (Galgiani of 2019) would have enacted the California Interoperability Enforcement Act to regulate EHR vendors operating in California and require the office to review federal law and policy for opportunities to regulate EHR vendors and to establish an interoperability enforcement structure. SB 441 was not heard in the Senate Health Committee.
SB 853 (Committee on Budget, Chapter 717, Statutes of 2010) authorizes the state to contract with a qualified nonprofit entity to operate a federally-funded HIE. SB 853 establishes a process for a nonprofit entity to implement a statewide collaborative process for expanding capacity for electronic HIE, as well as, establishes the parameters and requirements of entering into a contract with a nonprofit entity.
SB 337 (Alquist, Chapter 180, Statutes of 2009) authorizes CHHS to apply for federal HIT and exchange funding and, if no application is made by a certain date, requires selection of a state-designated qualified nonprofit agency for the purposes of submitting an application for federal HIT and exchange funding.
- Support. Connecting for Better Health and other proponents write that this bill will make the needed changes to California law to grant CDII the authority needed to set a data exchange framework governing board and continue to refine the data sharing agreement and its policies and procedures, in particular those that would allow CDII to investigate potential violations of the data sharing agreement and report them to state licensing entities, and that require compliance with signing the data sharing agreement as a condition of contracting with the DHCS, CalPERS, and the Covered California. Doing so will ensure that CDII and other agencies advance the Legislature’s goal of ubiquitous data sharing across all required signatories in compliance with the data sharing agreement. Connecting for Better Health also support a definition of QHIOs that requires them to be willing to serve all health care providers, health plans, social service providers, and public health organizations to ensure all signatories are able to meet their data sharing needs with QHIOs. Finally, they support the changes to the composition of the Board and its functions. These welcome changes will help avoid potential conflicts of interest and ensure the Board is able to provide input on the data exchange framework, as it continues to evolve to meet stakeholders’ needs. Representatives of California’s health information organizations write to strongly support the QHIO language in this bill through statute or regulation, Arizona, Delaware, the District of Columbia, New York, and Wisconsin have codified nonprofit status as a condition of HIO designation/certification. At least 13 other states have exclusively designated nonprofit HIOs to provide statewide HIE, reflecting these organizations’ established trust with health care, social service, and consumer stakeholders in their public mission and stewardship of data privacy and security.
- Support if amended. The California Medical Association writes that the make-up of the governing board should include a balance of experts and signatories. The conflict of interest provisions are overly strict, and there should be limits on how much and how often the governing board can alter the policies and procedures. Barring nonparticipating entities from contracting with the state could destabilize already challenged provider networks. Kaiser Permanente writes participatory governance is critical to the data exchange framework success. Rather than improving governance and oversight, Kaiser fears this latest version could cause confusion due to the three bodies that will have some level of governance and oversight responsibilities over the data exchange framework. The new language in this bill places into statute soon to be finalized QHIO policies and procedures. This level of granular detail in the statute on this one narrow topic is puzzling and unnecessary, as this is all being done via the policies and procedures and the data sharing agreement, with the flexibility of modifying them into the future. The details about the criteria for qualifications is already included in the QHIO program policies and procedures. There is no need to codify this in law, which will make it harder to adjust them as necessary. HIE is a very fluid and dynamic area, and there must be flexibility to adapt the policies and procedures.
- Concerns. The California Hospital Association and the California Association of Public Hospitals and Health Systems write that until the foundational policies and procedures are finalized, so that hospitals and other entities have a clear understanding of what will be required of them to comply, they are not able to implement the data sharing agreement and therefore it is too soon to create new enforcement mechanisms. Enforcement should be discussed with the advisory committee and wait until the data sharing agreement is finalized. There should be parameters on how much and how often the proposed governing board can alter policies and procedures. The conflict of interest provisions may not be appropriate and the board should include a balance of experts.
- Opposition unless amended. Point Click Care writes limiting QHIO participation to non-profits located within California will significantly hinder the data exchange framework’s chance of long-term success due to stifling the innovation that it will require to succeed as HIT continues to develop at a rapid pace. Preventing the participation of for-profit entities to participate in public-private partnerships will jeopardize California’s ability to continue to be at the cutting edge of technology development and the protection of patient’s sensitive data. By only allowing a very limited number of applicants to become QHIO’s, California may create unintended consequences that lead to long-term viability of the program causing harm to those it is intended to help, and suggests removing language in Section 130213(b) limiting QHIO qualification to only California nonprofits.
- Opposition. The Electronic Frontier Foundation (EEF) writes that the data exchange framework needs far more reform if it is to protect Californians. First, the promotion of data sharing goes far beyond ordinary health data, including social determinants of health data and data related to underserved or underrepresented populations. When we move from health data to non-health data, and we begin to incorporate government agencies that are not subject to health privacy laws including HIPAA, it becomes much harder to assure the public that their data is being held confidentially. Indeed, under current state law, local government entities are not governed by the IPA. Yet the data exchange framework puts local agencies squarely into its data-sharing structure with uncertain privacy guardrails. EEF suggests requiring non-state agencies to comply with the IPA to assure local government can be trusted to hold sensitive health and other information, and provide local government with resources and training to handle sensitive health and other data. Second, California enacted the data exchange framework before the U.S. Supreme Court issued its decision in the case of Dobbs v. Jackson Women’s Health Organization, and before Texas adopted a law allowing residents to seek civil damages against anyone who aids an abortion after six weeks of pregnancy. These developments require California to think about data flows in a new way. It is doubtful that the 2021, pre-Dobbs vision of the data exchange framework is adequate in terms of privacy and security today. In this new Dobbs world, domestic violence and human trafficking survivors, for example, can be at risk from provider disclosures; some out-of-state public officials even regard gender-affirming care for transgender children to be child abuse.
- Policy comments. Some clarifications to the bill are necessary such as changing the date that CDII takes over responsibilities of the data sharing agreement to coincide with the effective date of this bill. Other amendments are described below.
- Amendments. The author has agreed to amendments to:
- Add privacy, confidentiality and security to the topics to be developed under the policies and procedures;
- Require CDII to report violations to any other entities authorized to ensure compliance with data sharing policies and procedures;
- Make the board subject to Article 3 (commencing with Section 87300) of Chapter 7 of Title 9 of the Government Code, and regulation promulgated thereunder, instead of subject to strict conflict of interest policies. This is the same as the Office of Health Care Affordability Board;
- Require the board to review, modify and approve new data sharing requirements;
- Authorize the board to call emergency meeting for the purpose of federal regulatory compliance with at least 5 business days’ notice and ensure that at least one board meeting occurs before adoption; and,
- Replace 130213(b)(3)
Is unaffiliated with a health care organization or EHR providerwith “Is not an EHR vendor, a subsidiary of an EHR vendor, or an enterprise network that is exclusively available to organizations contractually partnered with a distinct health care organization such as a hospital or fully integrated delivery system.”
SUPPORT AND OPPOSITION:
Support: America's Physician Groups
Anthem, INC.
Blue Shield of California
California Association of Health Information Exchanges
California Black Health Network
California Pan-Ethnic Health Network
Children Now
Connecting for Better Health
El Sol Neighborhood Educational Center
Empowering Pacific Islander Communities
Health Access California
Inland Empire Foundation for Medical Care
Inland Empire Health Information Organization
Inland Empire Health Plan
Invitae
Justice in Aging
Korean Community Center of the East Bay
Latino Coalition for a Healthy California
LevelUP NorCal
Los Angeles Network for Enhanced Services
Manifest Medex
Michigan Health Information Network Shared Services
Riverside County Medical Association
SacValley Medshare
San Diego Health Connect
Savage & Savage, LLC.
Serving Communities Health Information Organization
South Asian Network
Synclarity Consulting
The Children’s Partnership
Velatura Public Benefit Corporation
Western Center on Law & Poverty
Zen Healthcare IT
Oppose: Electronic Frontier Foundation (unless amended)
PointClickCare (unless amended)
-- END --
Date of Hearing: May 10, 2023
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Chris Holden, Chair
ABPCA Bill Id:AB 1331
Author:(Wood) – As Amended Ver:April 10, 2023
Policy Committee: | Health | Vote: | 15 - 0 |
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Urgency: No State Mandated Local Program: No Reimbursable: No
SUMMARY:
This bill requires the Center for Data Insights and Innovation (CDII) to take over the establishment, implementation, and all functions related to the California Health and Human Services Agency (CHHSA) Data Exchange Framework (Framework), subject to an appropriation in the state budget. This bill requires the Center to establish the CHHSA Data Exchange Board (Board), with specified membership, to develop recommendations and to approve any modifications to the Framework data sharing agreement (DSA).
FISCAL EFFECT:
CHHSA, CDII reports minor and absorbable costs.
COMMENTS:
- Purpose. According to the author, this bill establishes the next step to ensure the Framework is successful in achieving the exchange of information to ensure California achieves its health care access, equity, affordability, public health, and quality of care goals.
- Background. According to a 2021 California Health Care Foundation report, information must easily be exchanged among medical, behavioral, social services, and public health professionals to allow them to make informed decisions that impact the lives of every resident. Access to this kind of critical information is limited, with the exchange of health data confined to a subset of clinical patient information shared mostly among larger clinics and hospitals with federally certified electronic health record (EHR) technologies.
Every patient encounter with a health care provider generates health information. Until the last decade, most patient health information was paper-based. When patients saw multiple health care providers, their treating providers were often unaware of the patient’s treatment history. Over the last decade, the increased adoption and use of EHRs by health care providers and hospitals has enabled patient health information to be exchanged more easily. However, despite technological advances, California has a fragmented and decentralized health information exchange (HIE) network, with areas of the state with no HIE entity and limited participation by major types of providers. This fragmentation limits the ability of patients, health care providers and public health departments to use data to improve health care quality and care coordination, reduce duplicative imaging and laboratory tests, and monitor population health.
CDII. AB 172 (Committee on Budget), Chapter 696, Statutes of 2021, established CDII within CHHSA. Four offices and committees within CHHS merged to become CDII: the Committee for the Protection of Human Subjects, Office of Health Information Integrity, Office of Innovation, and the Office of the Patient Advocate. All four component offices continue to perform their existing statutory functions while expanding their scope to advance CDII’s projects and services. With CDII’s data and engineering division, Insights Lab, CDII is working to establish a standardized and reliable data-sharing infrastructure, provide CHHSA leadership with the tools to integrate CHHSA data sets, and foster data-driven decision-making.
2021 Budget Language. AB 133 (Committee on Budget), Chapter 143, Statutes of 2021, established the Framework and required CHHSA, in consultation with members of the Stakeholder Advisory Group, to finalize a DSA. The Framework defines the parties subject to new data exchange rules and sets forth a common set of terms, conditions, and obligations to support secure, real-time access to and exchange of health and social services information. Beginning January 2024, health care entities are required to participate. According to CDII, over 1,400 organizations signed the Framework’s DSA by the January 31, 2023 deadline. Many California health entities are required by law to sign the DSA effective immediately, but there appear to be a significant number of health care systems that have yet to execute the Framework.
According to CDII, every Californian, regardless of where they live, should be able to walk into a doctor’s office, a county social service agency, or an emergency room and be assured health and human services providers can access the information needed to provide safe, effective, whole person care, while keeping data private and secure. This is the goal of California’s Framework, a statewide DSA that will accelerate and expand HIE among health care entities, government agencies, and social service programs beginning in 2024.
State Budget Investments. The Governor and Legislature agreed in the 2022-23 budget to invest $250 million over the next several years to support data exchange adoption: $50 million for CDII to provide technical assistance to small or under-resourced providers, particularly small physician practices, rural hospitals, and community-based organizations; and $200 million for grants and technical assistance to allow small physician practices to upgrade their clinical infrastructure, such as EHR systems, data collection and reporting capabilities, implementation of care management systems, and other activities that will allow the adoption of value-based and other payment models that improve health care quality while reducing costs.
Analysis Prepared by: Allegra Kim / APPR. / (916) 319-2081
Date of Hearing: April 25, 2023
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
ABPCA Bill Id:AB 1331
Author:(Wood) – As Amended Ver:April 10, 2023
SUBJECT: California Health and Human Services Data Exchange Framework.
SUMMARY: Requires the Center for Data Insights and Innovation (Center) to take over the establishment, implementation, and all the functions related to the California Health and Human Services Agency (CHHSA) Data Exchange Framework (Framework) on or before July 1, 2023, subject to an appropriation in the annual Budget Act. Requires the Center to establish the CHHSA Data Exchange Board (Board), with specified membership, to develop recommendations and to approve any modifications to the Framework data sharing agreement (DSA). Specifically, this bill:
- Requires the Center to take over the establishment, implementation, and all the functions related to the Framework, including the DSA and policies and procedures, from the CHHSA.
- Adds the following to the existing list of Framework stakeholders: the Department of State Hospitals (DSH); the Department of Developmental Services (DDS); the Emergency Medical Services Authority (EMSA); and, the Department of Corrections and Rehabilitation (CDCR).
- Adds relevant data on developmental disabilities and policies and procedures in the exchange of social services information, and consent to the list of information and advice to the CHHSA.
- Adds Emergency Medical Services to the list of health care organizations required to execute the Framework.
- Requires the Center to administer, manage, and oversee the Framework and its DSA, including its related policies and procedures, governance, and all other materials or initiatives related to the Framework.
- Requires the Center to be responsible for oversight of the dispute resolution and grievance processes for the Framework.
- Requires the Center to establish and administer the Board. Requires the Board to be separate and distinct from the stakeholder advisory group.
- Requires the Board to be composed of 12 voting members, including all of the following:
- CHHSA Secretary, or their designee, to serve as the chair and as an ex officio member of the Board;
- Two individuals appointed by the Governor, and at least one of whom to be a consumer representative;
- One individual appointed by the Assembly Speaker;
- One individual appointed by the Senate Rules Committee; and,
- One representative from each of the following, to be ex officio members of the Board:
- The Public Employees’ Retirement System;
- The California Health Benefit Exchange;
- The Department of Health Care Services;
- DDS;
- EMSA;
- DSH; and,
- CDCR.
- Requires each individual appointed to the Board to have demonstrated and acknowledged expertise, as needed, in health information exchange (HIE), health data privacy, and administration of public and private health care or social service delivery systems. Requires the appointing authorities to consider the expertise of the other Board members and attempt to make appointments so that the Board’s composition reflects a diversity of expertise and perspectives. Requires the appointing authorities to take into consideration the cultural, ethnic, and geographical diversity of the state so that the Board’s composition reflects the communities of California.
- Requires Board members, other than ex officio members, to serve up to two terms of four years per term, except that the initial appointment by the Assembly Speaker and Senate Rules Committee to be a term of five years. Requires appointed Board members to be eligible for reappointment at the end of their first term. Allows a Board member to continue to serve until the appointment and qualification of their successor. Requires vacancies to be filled by appointment for an unexpired term.
- Subjects Board members to conflict-of-interest policies.
- Prohibits a Board member from being employed by, a member of the Board of directors of, affiliated with, a vendor to, or otherwise a representative of signatories of, the Framework DSA while serving as a Board member, except as specified.
- Prohibits Board members from having a conflict of interest and requires disclosures of all financial interests, investments, and positions in business entities or any signatories to the Framework DSA using the form as specified by the Center’s conflict of interest code.
- Requires Board members to serve without compensation, but to be reimbursed for any actual and necessary expenses incurred in connection with their duties as Board members.
- Requires the Board to approve modifications to the Framework DSA and its policies and procedures and any new policies and procedures developed by the Center.
- Authorizes the Board to establish new data sharing requirements for signatories to the Framework DSA with approval from the CHHSA Secretary and the Center.
- Allows the Board to advance recommendations on criteria and procedures on HIE technical assistance, onboarding, and other grant programs established by the Center.
- Requires the Board to develop recommendations to the Legislature and the Governor on statutory amendments to align state law with federal law to advance HIE.
- Requires the Board to advise the Center on the advancement and refinement of the Framework priorities and principles.
- Authorizes the Center to enact recommendations advanced by the Board in accordance with the law and its rulemaking authority and to adopt reasonable rules and regulations to implement, administer, and oversee its duties under this bill. Authorizes the Center to adopt emergency regulations to consolidate, clarify, or make consistent regulations, including emergency regulations adopted to implement this bill. Allows the Center to readopt any emergency regulation authorized by this bill that is the same as, or substantially equivalent to, an emergency regulation previously adopted as authorized by this bill. Requires a re-adoption to be limited to one time for each regulation.
- Deems the adoption of emergency regulations and the extension of emergency regulations authorized by this bill, if done on or before December 31, 2025, to be an emergency and necessary for the immediate preservation of the public peace, health, safety, or general welfare. Requires the emergency regulations and the readopted emergency regulations authorized by this bill to each be submitted to the Office of Administrative Law for filing with the Secretary of State and to remain in effect for no more than 180 days, by which time final regulations may be adopted.
EXISTING LAW:
- Establishes under federal law, the Health Information Portability and Accountability Act of 1996 (HIPAA), which sets standards for privacy of individually identifiable health information and security standards for the protection of electronic protected health information, including, through regulations, that a HIPAA covered entity cannot condition the provision of treatment, payment, enrollment in the health plan, or eligibility for benefits on the provision of an authorization, except under specified circumstances. Provides that if HIPAA’s provisions conflict with state law, the provision that is most protective of patient privacy prevails. [45 Code of Federal Regulations § 164.500, et. seq.]
- Prohibits, under the state Confidentiality of Medical Information Act (CMIA), a health care provider, a health care service plan, a contractor, a corporation and its subsidiaries and affiliates, or any business that offers software or hardware to consumers, including a mobile application or other related device, as defined, from intentionally sharing, selling, using for marketing, or otherwise using any medical information, as defined, for any purpose not necessary to provide health care services to a patient, except as expressly authorized by the patient, enrollee, or subscriber, as specified, or as otherwise required or authorized by law. States that a violation of these provisions that results in economic loss or personal injury to a patient is a crime. [Civil Code (CIV) § 56, et. seq.]
- Defines, for purposes of the CMIA, medical information to mean any individually identifiable information, in electronic or physical form, in possession of or derived from a provider of health care, health care service plan, pharmaceutical company, or contractor regarding a patient’s medical history, mental health app information, mental or physical condition, or treatment. [CIV § 56.05(i)]
- Prohibits health care providers, health care service plans, or contractors, as defined, from sharing medical information without the patient’s written authorization, subject to certain exceptions. [CIV § 56.10(a)]
- Deems any business organized for the purpose of maintaining medical information in order to make the information available to an individual or to a provider of health care at the request of the individual or the provider of health care, for purposes of allowing the individual to manage their information, or for the diagnosis and treatment of the individual, to be a health care provider subject to the requirements of the CMIA. [CIV § 56.06(a)]
- Deems any business that offers software or hardware to consumers, including a mobile application or other related device that is designed to maintain medical information in order to make the information available to an individual or a provider of health care at the request of the individual or a provider of health care, for purposes of allowing the individual to manage their information, or for the diagnosis, treatment, or management of a medical condition of the individual, to be deemed to be a health care provider subject to the requirements of the CMIA. [CIV § 56.06(b)]
- Requires, under the Patient Access to Health Records (PAHR) law, any adult patient of a health care provider, any minor patient authorized by law to consent to medical treatment, and any patient representative, to be entitled to inspect patient records upon presenting a health care provider with a written request for those records and upon payment of reasonable clerical costs incurred in locating and making the records available. Limits a patient who is a minor to inspect patient records pertaining only to health care of a type for which the minor is lawfully authorized to consent. [Health and Safety Code (HSC) § 123110]
- Requires the CHHSA, on or before July 1, 2022, to establish the Framework and include a single data-sharing agreement and common set of policies and procedures that will leverage and advance national standards for information exchange and data content, and that will govern and require HIE among health care entities and government agencies in California. [HSC § 130290]
FISCAL EFFECT: Unknown. This bill has not yet been analyzed by a fiscal committee.
COMMENTS:
- PURPOSE OF THIS BILL. According to the author, this bill establishes that next step to ensure that the Framework is successful in achieving the exchange of information to ensure that California achieves its health care access, equity, affordability, public health, and quality of care goals.
- BACKGROUND. According to a 2021 California Health Care Foundation report, entitled “Why California Needs Better Data Exchange: Challenges, Impacts, and Policy Options for a 21st Century Health System,” the efficient, effective, and equitable delivery of care is vital to the well-being of all Californians and is necessary for a strong and vibrant economy. Information must easily be exchanged among medical, behavioral, social services, and public health professionals to allow them to make informed decisions that impact the lives of every resident. Access to this kind of critical information is limited, with the exchange of health data confined to a subset of clinical patient information shared mostly among larger clinics and hospitals that have federally certified electronic health record (EHR) technologies.
Every patient encounter with a health care provider generates health information. Until the last decade, most patient health information was paper-based. When patients saw multiple health care providers, their treating providers were often unaware of the patient’s treatment history. Over the last decade, the increased adoption and use of EHRs by health care providers and hospitals has enabled patient health information to be exchanged more easily. However, despite the technological advances that make health information sharing faster and easier, California has a fragmented and decentralized HIE network with areas of the state with no HIE entity and limited participation by major types of providers which limits the ability of patients, health care providers and public health departments to use data to improve health care quality and care coordination, reduce duplicative imaging and laboratory tests, and monitor population health.
- CENTER. With the enactment of AB 172 (Committee on Budget), Chapter 696, Statutes of 2021, the Center was established within CHHSA. The Center was created through the merger of four component offices/committees within CHHS: The Committee for the Protection of Human Subjects, Office of Health Information Integrity, Office of Innovation, and the Office of the Patient Advocate. Each component office possesses key data-sharing and governance-related operational units whose capabilities and experience are aligned with the Center strategic priorities. All four component offices continue to perform their existing statutory functions while expanding their scope to advance the Center’s projects and services. Combined with the Center’s data and engineering division, Insights Lab, the Center is establishing a standardized and reliable data-sharing infrastructure, providing CHHSA leadership with the tools to integrate CHHS data sets, and fostering effective, equitable, and consistent data-driven decision-making.
- 2021 BUDGET LANGUAGE. AB 133 (Committee on Budget), Chapter 143, Statutes of 2021, established the Framework and required by July 1, 2022, in consultation with members of the Stakeholder Advisory Group, the CHHSA to finalize a DSA. The Framework defines the parties that will be subject to these new data exchange rules and sets forth a common set of terms, conditions, and obligations to support secure, real-time access to and exchange of health and social services information, in compliance with applicable federal, state, and local laws, regulations, and policies. Beginning January 2024, health care entities are required to participate. The Center notes that over 1,400 organizations signed the Framework’s DSA by the January 31, 2023 deadline. It should be noted that many California health entities are required by law to sign the DSA effective immediately but it appears that there are a significant number of health care systems that have yet to execute the Framework.
According to the Center, every Californian, no matter where they live, should be able to walk into a doctor’s office, a county social service agency, or an emergency room and be assured health and human services providers can access the information they need to provide safe, effective, whole person care—while keeping data private and secure. This is the goal of California’s Framework, a first-ever, statewide DSA that will accelerate and expand HIE among health care entities, government agencies, and social service programs beginning in 2024. The Framework is not a new technology or centralized data repository; instead, it is an agreement across health and human services systems and providers to share information safely. That means every health care provider can access the information they need to treat you quickly and safely; health care, behavioral health, and social services agencies can connect to each other to deliver what Californians need to be healthy; and, the public health system can better assess how to address the needs of all communities. The Center states that hundreds of experts and members of the public have spent the last year shaping the Framework that delivers on these principles.
- STATE BUDGET INVESTMENTS. The Governor and Legislature agreed in the 2022-23 budget to invest $250 million over the next several years to support data exchange adoption: $50 million for the Center to provide technical assistance to small or under-resourced providers, particularly small physician practices, rural hospitals, and community-based organizations; and, $200 million for grants and technical assistance to allow small physician practices to upgrade their clinical infrastructure, such as EHR systems, data collection and reporting capabilities, implementation of care management systems, and other activities that will allow the adoption of value-based and other payment models that improve health care quality while reducing costs.
- SUPPORT WITH RECOMMENDATIONS. Connecting for Better Health, a coalition representing diverse health care organizations and leaders including consumers, providers, and health plans is seeking the following amendments to clarify the required signatories to the Framework; grant the Center clear statutory authority to interpret state law and issue new rules and regulations; and require a formal mechanism for engaging state agencies and other entities like qualified health information organizations in advisory groups. The coalition believes that these changes strengthen this bill and provide a clearer path forward to encourage entities to sign the Framework, promote transparent state agency and stakeholder engagement, and allow additional changes to be made to the Framework and its policies and procedures.
- SUPPORT IF AMENDED. The California Pan Ethnic Health Network, Western Center on Law and Poverty, and Health Access California (consumer groups) are seeking amendments to ensure appropriate safeguards with the express goal of ensuring public health and safety and improving health outcomes for all Californians. The consumer groups recommend adding language to ensure those participating in the Framework must also begin to collect and be prepared to share demographic and health-related social needs data using categories in the latest version of the United States Core Data for Interoperability adopted through the federal Office of National Coordinator for Health IT Standards Version Advancement Process. Additionally, in order for consumers to put their trust into health data sharing, there must appropriate safeguards with the express goal of ensuring public health and safety and improving health outcomes for all Californians.
- CONCERNS. Collective Medical (CM) writes that as a care coordination platform, CM is fully supportive of a statewide infrastructure for the state of California and recommend that the state take an inclusive approach to its definition of HIE and other defined terms as part of the Framework’s implementation. In doing so, the state will honor its diverse communities that the existing care networks are tailor-made to support patients and the care they receive from providers. CM also recommends, where possible, to adopt federal definitions of key terms, such as HIE, and to not discriminate between for- or non-profit statuses. CMs believe any statewide approach to health information exchange should take advantage of, and preserve, existing provider and community chosen infrastructure and maintain the spirit of AB 133 by allowing the use of technology that best serves the patient population. In doing so, California will further advance its standing as a hub for technology innovation and driver of healthcare policy. CM concludes that it will also prevent unnecessary burden or the disruption of established workflows for care providers and hospitals.
- RELATED LEGISLATION.
- AB 815 (Wood) establishes within CHHSA a provider credentialing board and criteria for health care providers. AB 815 is pending in Assembly Health Committee.
- AB 236 (Gipson) requires a plan or insurer to annually audit and delete inaccurate listings from its provider directories, and would require a provider directory to be 60% accurate on January 1, 2024, with increasing required percentage accuracy benchmarks to be met each year until the directories are 95% accurate on or before January 1, 2027. AB 236 is pending in Assembly Appropriations Committee.
- AB 1697 (Schiavo) deletes the exemption from the CMIA of an authorization for the release of medical information by a health care provider, health care service plan, pharmaceutical company, or contractor and an authorization for the release of genetic test results by a health care service plan. Requires authorization for release of medical information to contain a specific end date or expiration event. AB 1697 is pending in Assembly Privacy and Consumer Protection Committee.
- SB 595 (Roth) requires a person or entity that receives personal information from Covered California to at all times take reasonable measures to safeguard the confidentiality of any personal information obtained from Covered California and prohibits a person or entity from using or disclosing that information for any purpose other than to market and publicize the availability of health care coverage through Covered California to individuals, as directed by Covered California. SB 595 is pending in Senate Appropriations Committee.
- PREVIOUS LEGISLATION.
- AB 133 requires CHHSA to establish a Data Exchange Framework by July 1, 2022.
- AB 1131 (Wood) of 2021 would have established the statewide health information network governing board, an independent public entity not affiliated with an agency or department with specified membership, to provide the data infrastructure needed to meet California’s health care access, equity, affordability, public health, and quality goals, as specified. AB 1131 was held in the Assembly Suspense Committee.
- SB 371 (Caballero) of 2021 would have required any federal funds CHHSA receives for health information technology (HIT) and exchange to be deposited in the California Health Information Technology and Exchange Fund. Would have authorized CHHSA to use the fund to provide grants to health care providers to implement or expand health information technology and to contract for direct data exchange technical assistance for safety net providers. Would have required a health information organization to be connected to the California Trusted Exchange Network and to a qualified national network. Would have required a health care provider, health system, health care service plan, or health insurer that engages in HIE to comply with specified federal standards. SB 371 was never heard in Assembly Health Committee.
- SB 441 (Galgiani) of 2019 would have enacted the California Interoperability Enforcement Act to regulate EHR vendors operating in California and require the office to review federal law and policy for opportunities to regulate EHR vendors and to establish an interoperability enforcement structure. SB 441 was scheduled but not heard in the Senate Health Committee.
- SB 853 (Committee on Budget), Chapter 717, Statutes of 2010, authorizes the state to contract with a qualified nonprofit entity to operate a federally-funded HIE. Establishes a process for a nonprofit entity to implement a statewide collaborative process for expanding capacity for electronic HIE, as well as, establishes the parameters and requirements of entering into a contract with a nonprofit entity.
- SB 337 (Alquist), Chapter 180, Statutes of 2009, authorizes CHHSA to apply for federal HIT and exchange funding and, if no application is made by a certain date, requires selection of a state-designated qualified nonprofit agency for the purposes of submitting an application for federal HIT and exchange funding.
REGISTERED SUPPORT / OPPOSITION:
Support
America's Physician Groups
Blue Shield of California
California Association of Health Information Exchanges
California Black Health Network
Connecting for Better Health
Invitae
Manifest Medex
Michigan Health Information Network Shared Services
Serving Communities Health Information Organization
Velatura Public Benefit Corporation
Zen Healthcare It
Opposition
None on file.
Analysis Prepared by: Kristene Mapile / HEALTH / (916) 319-2097
Discussed in Hearing
Senate Standing Committee on Appropriations
Senate Standing Committee on Health
Assembly Standing Committee on Health
Bill Author
Bill Co-Author(s):