Bill Text: CA AB1331 | 2023-2024 | Regular Session | Amended

California Assembly Bill 1331

NOTE: There are more recent revisions of this legislation. Read Latest Draft

Bill Title: California Health and Human Services Data Exchange Framework.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Engrossed) 2024-08-15 - In committee: Held under submission. [AB1331 Detail]

Download: California-2023-AB1331-Amended.html

Amended IN Senate June 27, 2023

Amended IN Assembly April 10, 2023

CALIFORNIA LEGISLATURE— 2023–2024 REGULAR SESSION

Assembly Bill

No. 1331

Introduced by Assembly Member Wood

February 16, 2023

An act to amend and renumber Section 130290 of of, and to add Section 130213 to, the Health and Safety Code, relating to the California Health and Human Services Data Exchange Framework.

LEGISLATIVE COUNSEL'S DIGEST

AB 1331, as amended, Wood. California Health and Human Services Data Exchange Framework.

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.

Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO

The people of the State of California do enact as follows:

SECTION 1.

Section 130290 of the Health and Safety Code is amended and renumbered to read:

130212.

(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.

(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 board’s 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 board’s 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 center’s 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 network’s service area.