California Initiative to Advance Precision Medicine

Section § 130300

Explanation

This section emphasizes that while the U.S. has made significant progress in biological research and medicine, our ability to collect data now exceeds our ability to analyze it meaningfully. The National Academy of Sciences highlights the need for a new knowledge network to enable precise medicine, which would personalize disease treatment and improve healthcare outcomes. Precision medicine, especially for infectious diseases, could greatly improve responses to pandemics through better diagnostics. California, with its robust scientific and technological capabilities, aims to spearhead advancements in precision medicine through a state initiative. This initiative will bring together various stakeholders in science and medicine to push forward new technologies and therapies for better health care.

The Legislature finds and declares all of the following:
(a)CA Health & Safety Code § 130300(a) Over the past three decades, the United States has been a leader in biological research and medicine that describes fundamental biological structures and processes in unprecedented detail and that has led to breakthroughs in therapies and treatments. Advances in information technology and computing have also furthered our ability to gather important data to better understand disease functions. However, we are now at a point where our capacity to collect information has outpaced our capacity to integrate and analyze it and to convert data to new knowledge.
(b)CA Health & Safety Code § 130300(b) According to a 2011 report from the National Academy of Sciences, entitled “Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease,” the aggregation, integration, and analysis of data from research, clinical, personal, and population health settings are critical to creating a new knowledge network that will enable us to deliver more precise medicine, whether by targeting existing therapies more safely and effectively to patients, or by developing new therapies based on new insights into disease. Precision medicine, which embodies efforts to create this new knowledge network through data infrastructure, technology tools, and diagnostics, holds promise to transform health, health care, and biomedical research.
(c)CA Health & Safety Code § 130300(c) Precision medicine, particularly in the form of better diagnostic tools for infectious disease, has the potential to alleviate the burdens of pandemics through early detection, faster response, and better countermeasures.
(d)CA Health & Safety Code § 130300(d) California, with its vast scientific, medical, and technological resources, is positioned to lead advances in the field of precision medicine, which is gaining both national and international prominence. By establishing a California Initiative to Advance Precision Medicine, the state can help coordinate public, private, and nonprofit partners to advance this important intersection between science, research, and medicine, and to foster the creation of new technologies and therapies that can improve the health of Californians. A California Initiative to Advance Precision Medicine will bring together state precision medicine leaders as well as complete projects that demonstrate the power and application of precision medicine to the people of the State of California.
biological research precision medicine data integration ...

Section § 130301

Explanation

This section defines the term 'California Initiative to Advance Precision Medicine' as the initiative that is laid out in Section 130302.

As used in this division, “California Initiative to Advance Precision Medicine” or “initiative” means the California Initiative to Advance Precision Medicine established in Section 130302.
California Initiative to Advance Precision Medicine precision medicine initiative definition ...

Section § 130302

Explanation

This law establishes the California Initiative to Advance Precision Medicine under the California Health and Human Services Agency. It outlines how the agency will develop, implement, and assess precision medicine projects, collaborating with public, nonprofit, and private partners. The agency must create projects that could quickly benefit patients and fight pandemics. They also need to set clear goals, monitor progress, and report back to the Legislature.

The agency must maintain an inventory of precision medicine resources and post funding guidelines online. They can partner with public and nonprofit bodies to manage these programs and must involve stakeholders in developing additional guidelines. They can also integrate nonstate funds, provided certain conditions are met. Up to 30% of their funding is contingent on matching funds, and up to 10% can be used for administrative costs.

Additionally, a selection committee is formed to choose projects based on specific skills. The committee must adhere to open meeting laws and document its decision-making processes online. The agency is granted the flexibility to implement these directives without going through the standard rulemaking process.

(a)CA Health & Safety Code § 130302(a) The California Initiative to Advance Precision Medicine is hereby established in the California Health and Human Services Agency. In establishing the initiative, the California Health and Human Services Agency shall incorporate agreements and partnerships regarding precision medicine entered into prior to January 1, 2016.
(b)Copy CA Health & Safety Code § 130302(b)
(1)Copy CA Health & Safety Code § 130302(b)(1) The California Health and Human Services Agency shall develop, implement, and evaluate demonstration or nondemonstration projects on precision medicine in collaboration with public, nonprofit, and private entities. A demonstration project may focus on one or more disease areas or a subset of a population, and an award of funds under any appropriation of funds to the office for precision medicine may be based on criteria that include, but are not limited to, the following:
(A)CA Health & Safety Code § 130302(b)(1)(A) The potential for tangible benefit to patients within two to five years, including the likelihood that the study will have an immediate impact on patients.
(B)CA Health & Safety Code § 130302(b)(1)(B) The prospects of preventing or alleviating the impact of a pandemic through pathways including, but not limited to, tracking of emerging pathogens, early infectious disease outbreak detection, rapid outbreak response, and transmission reduction.
(C)CA Health & Safety Code § 130302(b)(1)(C) The depth and breadth of data available in the disease focus areas across institutions.
(D)CA Health & Safety Code § 130302(b)(1)(D) The prospects for efficient and effective data integration and analysis.
(E)CA Health & Safety Code § 130302(b)(1)(E) The expertise of potential team members.
(F)CA Health & Safety Code § 130302(b)(1)(F) The resources available for the project outside of the initiative, including the potential for leveraging nonstate funding.
(G)CA Health & Safety Code § 130302(b)(1)(G) The clinical and commercial potential of the project.
(H)CA Health & Safety Code § 130302(b)(1)(H) The potential to reduce health disparities.
(I)CA Health & Safety Code § 130302(b)(1)(I) The potential to scale and leverage multiple electronic health records systems.
(J)CA Health & Safety Code § 130302(b)(1)(J) The potential to develop the use of tools, measurements, and data, including publicly generated and available data.
(2)CA Health & Safety Code § 130302(b)(2) A demonstration project that is selected by the California Health and Human Services Agency shall advance greater understanding in at least one of the following areas, or in another area that is determined by the California Health and Human Services Agency to be necessary to advance precision medicine:
(A)CA Health & Safety Code § 130302(b)(2)(A) The application of precision medicine to specific disease areas.
(B)CA Health & Safety Code § 130302(b)(2)(B) The feasibility of the technology in preventing, mitigating, or monitoring pandemics or other large-scale disease outbreaks.
(C)CA Health & Safety Code § 130302(b)(2)(C) The challenges of system interoperability.
(D)CA Health & Safety Code § 130302(b)(2)(D) Economic analysis.
(E)CA Health & Safety Code § 130302(b)(2)(E) Standards for sharing data or protocols across institutions.
(F)CA Health & Safety Code § 130302(b)(2)(F) The federal and state regulatory environment.
(G)CA Health & Safety Code § 130302(b)(2)(G) The clinical environment.
(H)CA Health & Safety Code § 130302(b)(2)(H) Challenges relating to data, tools, and infrastructure.
(I)CA Health & Safety Code § 130302(b)(2)(I) The protection of privacy and personal health information.
(J)CA Health & Safety Code § 130302(b)(2)(J) The potential for reducing health disparities.
(K)CA Health & Safety Code § 130302(b)(2)(K) Methods and protocols for patient engagement.
(3)CA Health & Safety Code § 130302(b)(3) The California Health and Human Services Agency shall develop concrete metrics and goals for demonstration projects, monitor their progress, and comprehensively evaluate projects upon completion.
(4)Copy CA Health & Safety Code § 130302(b)(4)
(A)Copy CA Health & Safety Code § 130302(b)(4)(A) The California Health and Human Services Agency shall annually submit a report to the Legislature that provides an update of the demonstration projects selected. Upon completion of a demonstration project, the California Health and Human Services Agency shall submit an evaluation of the demonstration project to the Legislature. A demonstration project is deemed complete when it has completed the agreed upon tasks and deliverables, and the project funding has been completed.
(B)CA Health & Safety Code § 130302(b)(4)(A)(B) A written report made pursuant to subparagraph (A) shall be made in compliance with Section 9795 of the Government Code.
(c)CA Health & Safety Code § 130302(c) The California Health and Human Services Agency shall develop an inventory of precision medicine assets, including projects, data sets, and experts. In developing the inventory, the California Health and Human Services Agency shall assemble knowledge across broad disease areas. The California Health and Human Services Agency shall use the inventory to inform strategic areas for the future development of precision medicine-related projects.
(d)CA Health & Safety Code § 130302(d) The California Health and Human Services Agency may enter into agreements with public entities, or with nonprofit or not-for-profit organizations for the purpose of jointly administering the programs established under the initiative or to administer any provision of this section.
(e)CA Health & Safety Code § 130302(e) The California Health and Human Services Agency shall create and post on a publicly available internet website guidelines for an award of funds made under any appropriation of funds to the California Health and Human Services Agency for precision medicine. The guidelines shall include, but are not limited to, the following:
(1)CA Health & Safety Code § 130302(e)(1) Eligibility requirements.
(2)CA Health & Safety Code § 130302(e)(2) A competitive, merit-based application process that allows public and private academic and nonprofit institutions to submit proposals as principal investigators.
(3)CA Health & Safety Code § 130302(e)(3) A comprehensive peer-reviewed selection process.
(4)CA Health & Safety Code § 130302(e)(4) Requirements regarding the use of awarded funds.
(5)CA Health & Safety Code § 130302(e)(5) Requirements regarding the use and sharing of research data and findings.
(6)CA Health & Safety Code § 130302(e)(6) Requirements for the protection of privacy and personal health information.
(f)CA Health & Safety Code § 130302(f) The California Health and Human Services Agency shall solicit public, nonprofit, and private sector input for any additional guidelines for an award of funds made pursuant to this section.
(g)CA Health & Safety Code § 130302(g) The California Health and Human Services Agency shall establish standards that require a grant to be subject to an intellectual property agreement that balances the opportunity of the state to benefit from the patents, royalties, and licenses that result from basic research, therapy development, and clinical trials against the need to ensure that the agreement does not unreasonably hinder essential medical research.
(h)Copy CA Health & Safety Code § 130302(h)
(1)Copy CA Health & Safety Code § 130302(h)(1) The California Health and Human Services Agency may receive nonstate funds in furtherance of the initiative. “In furtherance of the initiative” means that funds may be used to award additional demonstration projects under the same terms and conditions as state funds in the initiative, held in reserve for follow-on funding of any awardees, or used to fund other nondemonstration project activities in a proportion no greater than 20 percent of the total of nonstate funds received over the term of the commitment.
(2)CA Health & Safety Code § 130302(h)(2) The California Health and Human Services Agency may work with external stakeholders to receive nonstate funds that enable the initiative to develop new demonstration projects that look to prevent or mitigate future infectious disease outbreaks and pandemics.
(i)CA Health & Safety Code § 130302(i) Up to 30 percent of any amount appropriated for precision medicine may be held by the California Health and Human Services Agency until an equivalent amount of nonstate matching funds is identified and received. Amounts subject to nonstate match may be released in increments as determined by the California Health and Human Services Agency.
(j)CA Health & Safety Code § 130302(j) Up to 10 percent of any amount appropriated to the California Health and Human Services Agency for precision medicine for demonstration projects may be used by the California Health and Human Services Agency for administrative costs.
(k)CA Health & Safety Code § 130302(k) The California Health and Human Services Agency shall recruit a precision medicine expert selection committee to represent various precision medicine-related skills, such as bioinformatics, statistics, health economics, patient engagement, and genomics. The Legislature may make nominations for the selection committee to the California Health and Human Services Agency for consideration.
(l)CA Health & Safety Code § 130302(l) Members of the selection committee shall be deemed to not be interested in any contract, including any award of funds by the committee, pursuant to this section.
(m)CA Health & Safety Code § 130302(m) Prior to the selection committee’s deliberative process, the California Health and Human Services Agency shall notify the Legislature of the selection of the committee members.
(n)CA Health & Safety Code § 130302(n) The selection committee established in subdivision (k) shall comply with 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), except during the deliberative process as it relates to reviewing and ranking proposals and making final selections.
(o)CA Health & Safety Code § 130302(o) The selection committee shall report on the justification for selecting the demonstration projects that are awarded funding and provide a list of the demonstration projects that were not selected. This report shall be posted on the internet website created in subdivision (e).
(p)CA Health & Safety Code § 130302(p) Notwithstanding the rulemaking provisions of 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 may implement or interpret this division without taking any regulatory action.
precision medicine projects California Health and Human Services Agency demonstration projects ...

Section § 130303

Explanation

This law explains that the Legislature wants certain awards to go specifically to demonstration projects within California. These awards should prioritize public and private nonprofit organizations. They should also include public institutions throughout both northern and southern California.

It is the intent of the Legislature that the office make awards in compliance with the following:
(a)CA Health & Safety Code § 130303(a) The awards are made to demonstration projects in California.
(b)CA Health & Safety Code § 130303(b) The awards are prioritized for public and private nonprofit entities.
(c)CA Health & Safety Code § 130303(c) The awards include, but are not limited to, awards to public institutions in both northern and southern California.
demonstration projects nonprofit entities public institutions ...

Section § 130304

Explanation

This law is set to expire on June 30, 2029, meaning it will no longer be effective after that date.

This division shall remain in effect only until June 30, 2029, and as of that date is repealed.
expiration date repeal June 30 ...