130250-130255
HEALTH AND SAFETY CODE
SECTION 130250-130255
130250. The Legislature finds and declares all of the following: (a) Health information technology provides tools that can improve the quality, safety, and value of health care services. However, the full benefit of health information technology cannot be realized until electronic health record systems supporting the secure exchange of individual health records are in place and used by health care providers, payers, patients, and other individuals throughout the state, and across state boundaries. (b) There is a need to promote secure electronic health data exchange among payers, health care providers, consumers of health care, researchers, and governmental agencies. (c) Health information exchange necessarily includes the sharing of private health records and information of individuals. Establishing the security of individual privacy rights and confidentiality of personal health and medical records is of paramount importance to creating public confidence in any broad-based electronic health records system. Ensuring transparent accountability, governance, and oversight are critical components to maintaining the public's trust. (d) The American Recovery and Reinvestment Act of 2009 (ARRA) (Public Law 111-5) includes within it the Health Information Technology for Economic and Clinical Health Act (the HITECH Act). The HITECH Act provides an unprecedented opportunity for California to develop a statewide health information technology infrastructure to improve California's health care system. It includes provisions and federal funding to encourage the adoption and meaningful use of health information technology and exchange. (e) Section 3013 of ARRA provides federal grant funds to facilitate and expand the electronic movement and use of health information among organizations according to nationally recognized standards. (f) Lack of a timely and available health information exchange jeopardizes the ability of the state and providers to access available federal Medicaid and Medicare incentive payments. 130250.1. (a) This division shall be known, and may be cited, as the California Health Information Technology Act. (b) Any duties under the act are subject to the availability of sufficient funding to carry out the duties. The provisions of this act shall only be implemented to the extent permitted by federal law. 130251. (a) The California Health and Human Services Agency or one of the departments under its jurisdiction may apply for federal funds made available through the federal American Recovery and Reinvestment Act of 2009 (Public Law 111-5) for health information technology and exchange. If the California Health and Human Services Agency or one of the departments under its jurisdiction submits an application pursuant to this subdivision, and later chooses to subgrant, in whole or in part, a portion of the federal grant to a qualified nonprofit entity for the purposes of establishing health information exchange, that entity shall be designated as the state governance entity. (b) In the event that the California Health and Human Services Agency or one of the departments under its jurisdiction elects not to submit an application described in subdivision (a), the Governor shall designate a qualified nonprofit entity to be the state-designated entity for the purposes of health information exchange, pursuant to the requirements set forth in the federal American Reinvestment and Recovery Act of 2009. (c) In addition to existing requirements applicable to nonprofit entities, the state governance entity may be held to additional requirements under federal and state law, and directives from the California Health and Human Services Agency. (d) The agency or state-designated entity shall execute tasks related to accessing federal stimulus funds made available through ARRA, and facilitate and expand the use and disclosure of health information electronically among organizations according to nationally recognized standards and implementation specifications while protecting, to the greatest extent possible, individual privacy and the confidentiality of electronic medical records. (e) The agency or state-designated entity shall develop strategic and operational plans to ensure that health information exchange capabilities are available, adopted, and utilized statewide so that patients do not experience disparities in access to the benefits of this technology by age, race, ethnicity, language, income, insurance status, geography, or otherwise. (f) The agency, state-designated entity, or state governance entity shall create a plan for a self-sustaining funding mechanism that does not include use of General Fund moneys that shall cover all reasonable costs of the administration of health information exchange when federal ARRA funds expire or are exhausted. A detailed business plan and sustainability model shall be submitted to the Governor and the Legislature by April 1, 2011. The plan may include a combination of approaches to create viable revenue streams, and shall take into account the needs of safety net institutions and providers. (g) The state-designated entity or state governance entity shall continually meet any conditions for being so designated as determined by the Secretary of California Health and Human Services. Failure to comply with this subdivision may result in the applicable entity losing its contract for state designation or subgrant agreement. (h) As a condition of receiving the contract for state designation or subgrant agreement, the state-designated entity or state governance entity shall comply with all of the following requirements: (1) It shall be subject to oversight by the California Health and Human Services Agency. (2) (A) It shall be governed by an initial board with a diverse composition from multiple types of organizations from multiple regions throughout the state. The initial governing board shall include all of the following: (i) The Secretary of California Health and Human Services or his or her designee. (ii) The Chair of the Senate Committee on Health or his or her designee. (iii) The Chair of the Assembly Committee on Health or his or her designee. (iv) One administrator from a state department under the jurisdiction of the California Health and Human Services Agency responsible for a statewide health program. (v) At least two consumer representatives, one of whom shall have expertise in privacy and security of health information. (vi) One licensed physician and surgeon, representing a solo or small group practice. (vii) One licensed physician and surgeon, representing a medical group or independent practice association. (viii) One representative from a safety net clinic. (ix) Two representatives of hospitals, one of whom shall represent a public hospital. (x) Two representatives of health plans or health insurers, one of whom shall represent a publicly run health plan or insurer. (xi) One local public health officer. (xii) Two representatives of health information exchange organizations, one from northern California, and one from southern California. (xiii) One representative of the medical informatics industry or who has experience in medical informatics. (xiv) One representative of an employer who provides employees with health care coverage, or a group purchaser of health care coverage. (xv) One representative from labor. (xvi) The chief executive officer of the nonprofit entity. (xvii) Two at-large cochairs of the nonprofit entity. (B) The majority of the board shall be comprised of nongovernmental employees. (3) If the governing board convenes workgroups or subcommittees, the workgroups or subcommittees shall be comprised of representatives from multiple types of organizations from multiple regions throughout the state, and meetings of any workgroup or subcommittee shall be held in an open, public, and transparent way. (4) The state-designated entity or state governance entity shall have nondiscrimination and conflict-of-interest policies that demonstrate a commitment to open, fair, and nondiscriminatory participation by stakeholders. (i) The California Health and Human Services Agency, in consultation with the initial governing board, may modify the composition of the initial governing board. If a modification is made to the composition of the initial governing board pursuant to this subdivision, the agency shall inform the Legislature of, and the reason for, the change implemented. (j) Upon the completion of the initial one-year term of the two at-large cochairs of the state-designated entity or state governance entity, the board shall select a chair or two cochairs from its membership. 130251.15. (a) All deliverables, as defined in the scope of work originated or prepared by the state-designated entity or state governance entity pursuant to its applicable contract, including papers, reports, charts, and other documentation, but not including the applicable entity's administrative communications and records relating to the contract, shall, upon delivery and acceptance by the California Health and Human Services Agency, become the exclusive property of the state, and may be copyrighted by the state under the oversight of the agency. (b) If any material funded pursuant to the contract may be copyrighted, the agency reserves the right to copyright the material, and the entity agrees not to copyright the material without prior written approval from the Secretary of California Health and Human Services. The secretary shall consent to, or give a reason for the denial to, the entity in writing within 60 days of receipt of the request. (c) If the material is copyrighted with the consent of the agency, the agency reserves a royalty-free, nonexclusive, and irrevocable license to reproduce, prepare derivative works, publish, distribute, and use the materials, in whole or in part, and to authorize others to do so, provided written credit is given to the author. (d) All inventions, discoveries, or improvements of the techniques, programs, or materials developed pursuant to the contract shall be the property of the agency. The agency agrees to grant a royalty-free, nonexclusive license for any invention, discovery, or improvement to the entity and further agrees that the entity may sublicense additional persons on the same royalty-free basis subject to the approval of the agency. (e) Nothing in this section shall be construed to limit the intellectual property and copyright authority of the federal government. 130252. (a) Subject to available funding, the California Health and Human Services Agency shall be responsible for ensuring that all federal grant deliverables are met. The agency shall coordinate electronic health activities in the state and work with stakeholders, state departments, and the Legislature to support policy needs for health information technology and health information exchange in California. (b) In the event that a state governance entity is established, all of the following conditions shall be met: (1) The agency shall be responsible for ensuring that all deliverables established in the strategic and operational plans established pursuant to subdivision (e) of Section 130251, and as required by the federal grant, are met. (2) Any grant issued by the agency to the state governance entity for health information exchange shall be deliverables based. All deliverables shall be subject to approval and acceptance by the agency. (c) The agency, state-designated entity, or the state governance entity shall establish and begin providing health information exchange services by January 1, 2012. (d) The state-designated entity or state governance entity shall ensure that an effective model for health information exchange governance and accountability is in place. In order to avoid any real or apparent conflict of interest, the state-designated entity or state governance entity shall ensure organizational and functional separation exists between the governance functions of the entity and its operational functions, specifically between operating entities that are or may be involved in building and maintaining the health information exchange. The agency shall conduct periodic internal reviews at least once after an entity has received the designation, and periodically as necessary, to ensure this separation is maintained, and that the state-designated entity or state governance entity operates in a manner that ensures organizational integrity and accountability. (e) The state-designated entity or state governance entity shall provide a process for public comment and input, which may include integrating public workgroups convened by the agency during the operational planning process into its organizational structure. (f) The state-designated entity or state governance entity, in consultation with the Office of Health Information Integrity, shall develop detailed standards and policies to be included in all contracts with health care entities that are participants of the state-designated entity's or governance entity's health information exchange for health information exchange services provided by the applicable entity. The state-designated entity or state governance entity shall also work with the Office of Health Information Integrity to ensure standardization of privacy and security policies for health information exchange statewide. The state-designated entity or state governance entity shall develop operational policies based on privacy and security guidelines developed by the state, and create a uniform set of privacy and security rules to be used by other entities participating in health information exchanges established by the state-designated entity or state governance entity for health information exchange or a contract made by the applicable entity for health information exchange. (g) The agency shall develop a detailed implementation plan that meets all requirements, deliverables, and goals specified in the strategic and operational plans established pursuant to subdivision (e) of Section 130251. The implementation plan shall be submitted to the Legislature by November 1, 2010. The implementation plan shall include, but need not be limited to, all of the following: (1) A detailed work plan and communications plan. (2) A model that defines the technical architecture for services recommended in the operational plan. (3) A description of specific core services enabled or provided by the health information exchange and timeframes for the rollout of those services. (4) A determination of how to most effectively engage stakeholders throughout the state. (5) A description of specific deliverables and timeframes to ensure that statewide health information exchange is achieved pursuant to the state strategic and operational plans. (6) Detailed information on internal infrastructure that ensures the state governance entity for health information exchange meets legal and regulatory criteria needed, including, but not limited to, a comprehensive staffing plan. (h) Any contract for state designation or subgrant agreement pursuant to this section shall be made through an open and competitive process as required by federal law. (i) The state designated entity or state governance entity shall comply with applicable provisions of the federal Health Information Technology for Economic and Clinical Health Act (HITECH Act; Public Law 111-5), the federal Public Health Service Act (42 U.S.C. Sec. 300x-26), and applicable federal policies, guidance, and requirements. These provisions shall include, but are not limited to, the requirement that funds be used to conduct activities to facilitate and expand the electronic movement and use of health information among organizations according to nationally recognized standards in effect on December 31, 2010. 130253. (a) To provide the public with transparency of the actions by the state-designated entity or state governance entity, the California Health and Human Services Agency shall require the state-designated entity or state governance entity to develop policies and procedures that include, but are not limited to, all of the following areas: (1) Conflicts of interest. The policies and procedures shall be consistent with federal law and modeled on the Political Reform Act of 1974 (Title 9 (commencing with Section 81000) of the Government Code). (2) Public access to meetings. (A) (i) The state-designated entity or state governance entity shall hold board and workgroup meetings open to the public, including the entity's annual meeting. (ii) The state-designated entity or state governance entity may hold additional meetings as it determines are necessary or appropriate. Subject to subparagraph (B), these meetings shall also be open to the public. (B) The state governance entity may conduct closed sessions when it meets to consider or discuss confidential matters, including, but not limited to, those concerning the appointment, employment, performance, compensation, or dismissal of the entity's officers and employees. (C) The state-designated entity shall award grants and contracts in public meetings consistent with federal requirements for an open and competitive process, and shall adopt all governance, technical, and policy standards in public meetings. (3) Contracts. (A) The Public Contract Code shall not apply to contracts issued by the state governance entity. This subparagraph shall not be construed to modify existing law regarding the application of the Public Contract Code. (B) For contracts entered into by the state governance entity, policies shall be governed by applicable federal regulations, policies specified by the Office of the National Coordinator for Health Information Technology, including, but not limited to, provisions required by the federal State Health Information Exchange Cooperative Agreement Program and any additional requirements as specified by the agency. (b) The policies and procedures developed pursuant to this section are 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). 130254. Notwithstanding Section 10231.5 of the Government Code, commencing October 1, 2010, the California Health and Human Services Agency shall report, by October 1 and April 1 of each year, to the Legislature regarding the expenditures made from the California Health Information Technology and Exchange Fund, and the status of health information technology and exchange activities funded through the fund. The report shall be in compliance with Section 9795 of the Government Code. This report shall include, at a minimum, all of the following: (a) The agency's evaluation of the extent to which the state governance entity for health information exchange has completed each deliverable outlined in grant agreements or contracts between the state and the entity, and the extent to which deliverables were completed within the timelines specified in the grant agreements or contracts. (b) A detailed update on hiring and expenditures on staff hired through this fund, including, but not limited to, staff hired by the state governance entity for health information exchange. (c) The status and amounts of grants and contracts awarded by the state governance entity for health information exchange, including, but not limited to, descriptions and deliverables. 130255. (a) In the event that the California Health and Human Services Agency applies for and receives federal funds made available through the federal American Recovery and Reinvestment Act of 2009 (Public Law 111-5) for health information technology and exchange, as outlined in subdivision (a) of Section 130251, the California Health Information Technology and Exchange Fund is hereby created in the State Treasury. (b) All moneys in the California Health Information Technology and Exchange Fund shall be available, upon appropriation by the Legislature, for purposes related to health information technology and exchange. (c) The California Health Information Technology and Exchange Fund shall consist of, but is not limited to, federal funds made available through ARRA for health information technology and exchange. Notwithstanding Section 16305.7 of the Government Code, any interest and dividends earned on deposits in the fund shall be retained in the fund for purposes of this division. (d) It is the intent of the Legislature that the activities associated with health information exchange be funded solely through the following: (1) Federal funds. (2) Private contributions identified by the state, the state-designated entity, or any relevant advisory panel convened by the California Health and Human Services Agency. (3) Funds generated by the self-sustaining funding mechanism to be established by the California Health and Human Services Agency or one of its departments, or the state-designated entity.