Today's Law As Amended


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SB-605 Medical Device Right to Repair Act.(2021-2022)



As Amends the Law Today


SECTION 1.

 Article 5.5 (commencing with Section 111611) is added to Chapter 6 of Part 5 of Division 104 of the Health and Safety Code, to read:

Article  5.5. The Medical Device Right to Repair Act
111611.
 This article shall be known, and may be cited, as the Medical Device Right to Repair Act.
111611.1.
 It is the intent of the Legislature to promote choice and competition for repair of medical devices by requiring manufacturers of powered medical equipment used in the treatment, monitoring, or diagnosis of a patient, to make available to a hospital and an independent repair provider engaged by the hospital for the purpose of providing medical equipment maintenance and repair, on fair and reasonable terms, the documentation, parts, and tools used to inspect, diagnose, maintain, and repair this equipment.
111611.2.
 For the purposes of this article, the following definitions apply:
(a) “Authorized repair provider” means an individual or business who is unaffiliated with an original equipment manufacturer and who has an arrangement with the original equipment manufacturer, for a definite or indefinite period, under which the original equipment manufacturer grants to the individual or business a license to use a trade name, service mark, or other proprietary identifier for the purposes of offering the services of inspection, diagnosis, maintenance, or repair of powered medical equipment under the name of the original equipment manufacturer, or other arrangement with the original equipment manufacturer to offer those services on behalf of the original equipment manufacturer. An original equipment manufacturer who offers the services of inspection, diagnosis, maintenance, or repair of its own powered medical equipment, and who does not have an arrangement described in this subdivision with an unaffiliated individual or business, shall be considered an authorized repair provider with respect to that equipment.
(b) “Powered medical equipment” or “equipment” means any powered device approved by the United States Food and Drug Administration that is used in the treatment, monitoring, or diagnosis of a patient, and includes assistive, adaptive, and rehabilitative devices.
(c) “Documentation” means any manual, diagram, reporting output, service code description, schematic, or other guidance or information used in effecting the services of inspection, diagnosis, maintenance, or repair of powered medical equipment.
(d) “Embedded software” means any programmable instructions provided on firmware delivered with powered medical equipment, or with a part for that equipment, for purposes of equipment operation, including all relevant patches and fixes made by the manufacturer of the equipment or part for these purposes.
(e) (1) “Fair and reasonable terms” for obtaining a part, tool, documentation, or training course and materials means at costs and terms that are equivalent to the most favorable costs and terms under which an original equipment manufacturer offers the part, tool, documentation, services access method, or training course and materials to an authorized repair provider, including all of the following requirements:
(A) Accounting for any discount, rebate, convenient means of delivery, means of enabling fully restored and updated functionality, rights of use, or other incentive or preference the original equipment manufacturer offers to an authorized repair provider, or any additional cost, burden, or impediment the original equipment manufacturer imposes on an independent repair provider.
(B) Not conditioned on, or imposing, a substantial obligation or restriction that is not reasonably necessary for enabling a hospital or independent repair provider to engage in the diagnosis, maintenance, or repair of powered medical equipment made by, or on behalf of, the original equipment manufacturer.
(C) Not conditioned on an arrangement described in subdivision (a).
(2) For documentation, including any relevant updates, “fair and reasonable terms” also means at no charge, except that, when the documentation is requested in physical printed form, a charge may be included for the reasonable actual costs of preparing and sending the copy.
(3) For software tools, “fair and reasonable terms” also means all of the following:
(A) Provided at no charge and without requiring authorization or internet access.
(B) Without imposing impediments to access or use, in the course of effecting the diagnosis, maintenance, or repair and without impairing the efficient and cost-effective performance of the diagnosis, maintenance, or repair.
(C) Enables full functionality.
(4) If an original equipment manufacturer does not utilize an authorized repair provider, “fair and reasonable terms” means an equitable price in consideration of the actual cost to the original equipment manufacturer to prepare and distribute the part, tool, service access method, or documentation, exclusive of any research and development costs incurred.
(f) “Firmware” means a software program or set of instructions programmed on powered medical equipment, or on a part for that equipment, to allow the equipment or part to communicate within itself or with other computer hardware.
(g) “Hospital” means a facility licensed pursuant to subdivision (a), (b), or (f) of Section 1250.
(h) “Independent repair provider” means an individual or business, other than the manufacturer or hospital, that is engaged in the services of inspection, diagnosis, maintenance, or repair of powered medical equipment for purposes of returning it to the safety and performance specifications established by the manufacturer and to meet its original intended use.
(i) “Original equipment manufacturer” means a business engaged in the business of selling, leasing, or otherwise supplying new powered medical equipment manufactured by, or on behalf of, itself, to any individual or business.
(j) “Part” means any replacement part, either new or used, made available by an original equipment manufacturer for purposes of effecting the services of inspection, diagnosis, maintenance, or repair of powered medical equipment manufactured by, or on behalf of, sold, or otherwise supplied by the original equipment manufacturer.
(k) “Tools” means any software program, hardware implement, or other apparatus used in inspection, diagnosis, maintenance, or repair of powered medical equipment, including software or other mechanisms that provision, program, or pair a new part, calibrate functionality, or perform any other function required to bring the product back to fully functional condition.
(l) “Service access method” means any password, key, code, software, or token that allows access to medical equipment diagnostics, error logs, or configuration settings that is necessary to facilitate installation or restoration of medical equipment to normal operation.
(m) “Trade secret” means information, including a formula, pattern, compilation, program, device, method, technique, or process, that meets both of the following:
(1) Derives independent economic value, actual or potential, from not being generally known to the public or to other persons who can obtain economic value from its disclosure or use.
(2) Is the subject of efforts that are reasonable under the circumstances to maintain its secrecy.
111611.3.
 (a) For powered medical equipment, and parts for powered equipment, sold or used in this state, an original equipment manufacturer shall make available to a hospital and an independent repair provider engaged by the hospital for the purpose of providing medical equipment maintenance and repair, on fair and reasonable terms, any documentation, parts, service access methods, and tools, including any updates to information or embedded software, needed for purposes of inspection, diagnosis, maintenance, or repair of the equipment. This section does not require an original equipment manufacturer to make available a part if the part is no longer available to the original equipment manufacturer.
(b) For powered medical equipment, and parts for powered medical equipment, sold or used in this state, an original equipment manufacturer shall make available to a hospital and an independent repair provider engaged by the hospital for the purpose of providing medical equipment maintenance and repair, on fair and reasonable terms, training courses and materials on the operation, inspection, diagnosis, maintenance, and repair of the equipment. This section does not require an original equipment manufacturer to make available a training course or material if the original equipment manufacturer does not provide a training course or material to an authorized repair provider.
111611.4.
 (a) An original equipment manufacturer who knowingly violates any provision of this article, or who reasonably should have known that they violated any provision of this article, shall be liable for a civil penalty not to exceed ten thousand dollars ($10,000) per piece of equipment for the first violation, twenty thousand dollars ($20,000) per piece of equipment for the second violation, and fifty thousand dollars ($50,000) per piece of equipment for the third and any subsequent violations, which shall be assessed and recovered in a civil action brought in the name of the people of the State of California by the Attorney General or by any district attorney, county counsel, or city attorney in any court of competent jurisdiction.
(b) If the action is brought by the Attorney General, one-half of the penalty collected shall be paid to the treasurer of the county in which the judgment was entered, and one-half to the State Treasurer. If brought by a district attorney or county counsel, the entire amount of penalty collected shall be paid to the treasurer of the county in which the judgment was entered. If brought by a city attorney or city prosecutor, one-half of the penalty shall be paid to the treasurer of the county and one-half to the city.
(c) The penalties collected pursuant to this section by the Attorney General may be expended by the Attorney General, upon appropriation by the Legislature, to enforce this article.
(d) Section 111825 is not applicable to violations of this article.
111611.5.
 (a) This article does not require an original equipment manufacturer to divulge a trade secret to a hospital or an independent repair provider engaged by the hospital for the purpose of providing medical equipment maintenance and repair, except as necessary to provide documentation, parts, tools, service access methods, and training courses and materials on fair and reasonable terms.
(b) No provision in this article shall be construed to alter the terms of any arrangement described in subdivision (a) of Section 111611.2 in force between an authorized repair provider and an original equipment manufacturer, including, but not limited to, the performance or provision of warranty or recall repair work by an authorized repair provider on behalf of an original equipment manufacturer pursuant to an arrangement described in subdivision (a) of Section 111611.2, except that any provision that purports to waive, avoid, restrict, or limit the original equipment manufacturer’s obligations to comply with this article shall be void and unenforceable.
111611.6.
 This article applies with respect to equipment sold or in use on or after January 1, 2022.