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SB-441 Electronic health records: vendors.(2019-2020)

Current Version: 03/25/19 - Amended Senate Compare Versions information image


Amended  IN  Senate  March 25, 2019


Senate Bill
No. 441

Introduced by Senator Galgiani

February 21, 2019

An act to add Division 109.7 (commencing with Section 130290) to the Health and Safety Code, relating to electronic health records.


SB 441, as amended, Galgiani. Electronic health records: vendors.
Existing law establishes within the California Health and Human Services Agency the Office of Health Information Integrity to ensure the enforcement of state law mandating the confidentiality of medical information. Existing law establishes the California Health Information Technology and Exchange Fund for purposes related to health information technology and exchange. Existing federal regulations provide a regulatory framework for health information technology standards, implementation specifications, certification criteria, and certification programs for health information technology.
This bill would enact the California Interoperability Enforcement Act, which would establish the Office of Interoperability Enforcement Act to regulate electronic health record vendors operating in California. The bill would require the office to review federal law and policy for opportunities to regulate electronic health record vendors and to establish an interoperability enforcement structure. The bill would require the office to promulgate regulations for this purpose. The bill would establish a Complaint and Technical Assistance Division within the office and the Office of Interoperability Enforcement Fund, which would be available, upon appropriation, to fund the administration of these provisions.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: YES   Local Program: NO  

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


 Division 109.7 (commencing with Section 130290) is added to the Health and Safety Code, to read:

DIVISION 109.7. California Interoperability Enforcement Act

 This act shall be known, and may be cited, as the California Interoperability Enforcement Act of 2020.

 For purposes of this division, “office” means the Office of Health Information Integrity within the California Health and Human Services Agency.


 The Legislature finds and declares all of the following:
(a) Lack of health care interoperability enforcement at the federal level has resulted in exploitive business practices by electronic health record (EHR) vendors that limit a health care provider’s ability to appropriately and efficiently exchange, access, and interpret health data across different health care settings.
(b) Lack of health care interoperability hampers industry-wide efforts related to quality improvement, care coordination, patient access to personal health information, and reduction of health care costs.
(c) The West Health Institute estimates that widespread medical device interoperability could eliminate at least $36 billion of waste in inpatient settings across the United States alone. It found that functional interoperability leads to increased efficiency, lower costs, and better quality by reducing redundant testing and clinician time spent manually entering information, in addition to shortening length of stay through more timely transmission of critical information such as lab results.
(d) Although technology to enable interoperability exists, vendors still view the adoption of open interfaces as detrimental to their competitive advantage, and vendors sell bundled solutions or a system of devices with closed, proprietary interfaces.
(e) EHR vendors charge costs above and beyond the initial expense of implementing EHR systems and participate in information blocking and opportunistic pricing, taking advantage of the high cost of switching technologies, the lack of clarity on necessary future upgrades, and the costs to maintain the systems.
(f) Almost half of California’s hospitals are still unable to electronically share patient information with other health care providers in the community.
(g) While federal law establishes a framework for the certification of EHR technology (CEHRT) that includes compliance with certain interoperability standards, there is not adequate enforcement or penalties under federal law to ensure that EHR systems are meeting these standards.
(h) When CEHRT vendors do not meet standards, the providers are left facing disruptions in service and payment penalties.
(i) It is important that existing and ongoing efforts to increase CEHRT standardization be properly enforced to enable the secure transfer of health data and achieve meaningful interoperability between disparate systems.
(j) The State of California should become a national leader and model for proper interoperability enforcement, and be recognized for its ability to improve access and affordability of quality health care.


 (a) The Office of Interoperability Enforcement is hereby established in state government to office shall regulate, to the extent authorized under federal law, electronic health record vendors operating in California.
(b) (1) The office shall review federal law and policy, including including, but not limited to, Part 170 of Title 42 45 of the Code of Federal Regulations, to identify opportunities to regulate electronic health record vendors and to establish an interoperability enforcement structure.
(2) Following the review, the office, in consultation with health care providers, office shall promulgate regulations, pursuant to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, concerning an interoperability enforcement structure.


 The Complaint and Technical Assistance Division shall be established within the office, and shall serve as the point of contact for health care providers who report dealings with electronic health vendors.


 The Office of Interoperability Enforcement Fund, Fund is hereby established in the State Treasury. Moneys in the fund shall be expended, upon appropriation by the Legislature, to the office for administration of this division.