Medical Equipment Right to Repair Act

GENERAL ASSEMBLY OF NORTH CAROLINA SESSION 2025 H D HOUSE BILL DRH30139-NH-53 Short Title: Medical Equipment Right to Repair Act. (Public) Sponsors: Representative Belk. Referred to: *DRH30139-NH-53* A BILL TO BE ENTITLED 1 AN ACT TO REQUIRE ORIGINAL EQUIPMENT MANUFACTURERS OF MEDICAL 2 IMAGING EQUIPMENT AND MEDICAL RADIATION THERAPY EQUIPMENT TO 3 PROVIDE EQUIPMENT OWNERS AND REPAIR PROVIDERS ACCESS TO THE 4 SUPPORT DOCUMENTS, TOOLS, AND PARTS NECESSARY TO PERFORM 5 DIAGNOSTIC, MAINTENANCE, AND REPAIR SERVICES ON THE EQUIPMENT. 6 The General Assembly of North Carolina enacts: 7 SECTION 1. Chapter 66 of the General Statutes is amended by adding a new Article 8 to read: 9 "Article 52. 10 "Medical Equipment Right to Repair Act. 11 "§ 66-503. Citation and definitions. 12 (a) This Article may be cited as the "Medical Equipment Right to Repair Act." 13 (b) As used in this Article, the following definitions apply unless context otherwise 14 requires: 15 (1) Authorized repair provider. – An individual or entity that has contracted with 16 an original equipment manufacture r to offer or perform diagnostic, 17 maintenance, or repair services of the ma nufacturer's medical imaging or 18 radiation therapy equipment whether operating under (i) a license to use the 19 manufacturer's trade name, service mark, or other proprietary identifier or (ii) 20 an alternative arrangement under which a provider offers to or provides 21 services on behalf of the manufacturer. For purposes of this Article, an 22 original equipment manufacturer that offers or performs diagnostic, 23 maintenance, or repair services of its own medical imaging or radiation 24 therapy equipment is also an authorized repair provider. 25 (2) Independent repair provider . – An individual or business that offers or 26 performs diagnostic, maintenance, or repair services of medical imaging or 27 radiation therapy equipment without contracting with the original equipment 28 manufacturer. 29 (3) Medical imaging equipment. – Any device used to view the human body to 30 diagnose, monitor, or treat medical conditions, including products for 31 ultrasound imaging, magnetic resonance imaging, medical X ray, 32 radiography, computed tomography, fluoroscopy, and mammography. 33 (4) Medical radiation therapy equipment. – Any device that produces high 34 energy-charged particles to provide radiation therapy and related support 35 devices, including signal analysis and display equipment; patient and 36 H.B. 460 Mar 19, 2025 HOUSE PRINCIPAL CLERK General Assembly Of North Carolina Session 2025 Page 2 DRH30139-NH-53 equipment supports; treatment planning software; and component parts and 1 accessories. 2 (5) Original equipment manufacturer (OEM). – An individual or entity that is 3 engaged in the business of manufacturing and selling, leasing, or otherwise 4 supplying medical imaging and radiation therapy equipment to others. 5 (6) Owner. – An individual or entity that owns or leases medical imaging or 6 radiation therapy equipment. 7 (7) Part. – Any part made available by the original equipment manufacturer, 8 whether new or used, that is necessary for the maintenance or repair of medical 9 imaging or radiation therapy equipment. 10 (8) Support documentation. – Any manual, diagram, reporting output, service 11 code description, schematic diagram, security codes, passwords, or other 12 guidance or information necessary to perform diagnostic, maintenance, or 13 repair services on medical imaging and radiation therapy equipment. 14 (9) Tool. – Any software, hardware, or other apparatus necessary to perform 15 diagnostic, maintenance, or repair services on medical imaging and radiation 16 therapy equipment, including items needed to program or pair new parts, 17 calibrate functionality, conduct software updates, or perform any other 18 function required to bring the product back to fully functional condition. 19 "§ 66-503.1. Duties of original equipment manufacturer. 20 Any OEM that manufactur es medical imaging equipment or medical radiation therapy 21 equipment that is used in this State is required to do the following: 22 (1) Make available to any hospital or independent repair provider any support 23 documentation, parts, or tools necessary to perform diagnostic, maintenance, 24 or repair services of the manufacturer's medical imaging or radiation therapy 25 equipment subject to the following terms: 26 a. Anytime the OEM updates the support documentation for its 27 equipment, the OEM shall automatically send notice of the updated 28 information to all known equipment owners and independent repair 29 providers. 30 b. An OEM shall provide acce ss to support documentation at no charge 31 to an owner or independent repair provider, however , if the owner or 32 independent repair provider requests a printed copy of a support 33 document, the OEM may charge the owner or independent repair 34 provider the actual costs of printing and shipping the print copy. 35 c. An OEM shall provide access to tools without requiring authorization, 36 registration, or other such impediment to access or use necessary tools, 37 including impairing the ability to use the tools in an efficient and 38 cost-effective manner. The OEM shall make tools available at no cost 39 to an owner or independent repair provider , however, the OEM may 40 charge an owner or independent repair provider the actual costs o f 41 preparing and shipping a tool. 42 d. An OEM shall provide access to any support documentation or tools 43 needed to access or reset any electronic security lock or any other 44 security-related function. 45 e. Both OEM and authorized repair providers shall provide access to 46 parts at the same costs and under the same terms as the most favorable 47 agreement between the OEM and any authorized repair provider. 48 (2) An OEM shall be in compliance with this section if the OEM dele gates the 49 requirements of this section to an authorized repair provider and the 50 authorized repair provider satisfies the requirements on behalf of the OEM. 51 General Assembly Of North Carolina Session 2025 DRH30139-NH-53 Page 3 (3) If an OEM offers training courses o r training materials on how to properly 1 operate, inspect, diagnose, maintain, or repair its equipment to authorized 2 repair providers, the OEM must offer the same courses or materials to owners 3 and independent repair providers. 4 "§ 66-503.2. Limitations and enforcement. 5 (a) Any violation of this Article is an unfair or deceptive trade practice for purposes of 6 Chapter 75 of the General Statutes, and the violating party is subject to suit thereunder by injured 7 parties and the Attorney General. 8 (b) Nothing in this Article shall be construed to require an OEM to divulge any trade 9 secret, as defined in G.S. 66-152, to an owner or independent repair provider. 10 (c) Any provision of an agreement between an OEM and an authorized repair provider 11 that purports to waive, avoid, restrict, or limit an OEM's obligation to comply with this Article is 12 void and unenforceable. 13 (d) No OEM or authorized repair provider shall be liable for any damage caused to 14 medical imaging or radiation therapy equipment or injury caused to an owner or independent 15 repair provider which occurs during repair, diagnosis, or maintenance of the equipment." 16 SECTION 2. This act becomes effective July 1, 202 5, and applies to equipment in 17 use on or after that date. 18