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North Carolina House Bill H460

North Carolina 2025-2026 Regular Session

North Carolina House Bill H460 Compare Versions

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11 GENERAL ASSEMBLY OF NORTH CAROLINA
22 SESSION 2025
3-H 1
4-HOUSE BILL 460
3+H D
4+HOUSE BILL DRH30139-NH-53
5+
56
67
78 Short Title: Medical Equipment Right to Repair Act. (Public)
8-Sponsors: Representatives Belk, Carney, Cunningham, and Buansi (Primary Sponsors).
9-For a complete list of sponsors, refer to the North Carolina General Assembly web site.
10-Referred to: Rules, Calendar, and Operations of the House
11-March 20, 2025
12-*H460 -v-1*
9+Sponsors: Representative Belk.
10+Referred to:
11+
12+*DRH30139 -NH-53*
1313 A BILL TO BE ENTITLED 1
1414 AN ACT TO REQUIRE ORIGINAL EQUIPMENT MANUFACTURERS OF MEDICAL 2
1515 IMAGING EQUIPMENT AND MEDICAL RADIATION THERAPY EQUIPMENT TO 3
1616 PROVIDE EQUIPMENT OWNERS AND REPAIR PROVIDERS ACCESS TO THE 4
1717 SUPPORT DOCUMENTS, TOOLS, AND PARTS NECESSARY TO PERFORM 5
1818 DIAGNOSTIC, MAINTENANCE, AND REPAIR SERVICES ON THE EQUIPMENT. 6
1919 The General Assembly of North Carolina enacts: 7
2020 SECTION 1. Chapter 66 of the General Statutes is amended by adding a new Article 8
2121 to read: 9
2222 "Article 52. 10
2323 "Medical Equipment Right to Repair Act. 11
2424 "§ 66-503. Citation and definitions. 12
2525 (a) This Article may be cited as the "Medical Equipment Right to Repair Act." 13
2626 (b) As used in this Article, the following definitions apply unless context otherwise 14
2727 requires: 15
2828 (1) Authorized repair provider. – An individual or entity that has contracted with 16
2929 an original equipment manufacturer to offer or perform diagnostic, 17
3030 maintenance, or repair services of the manufacturer's medical imaging or 18
3131 radiation therapy equipment whether operating under (i) a license to use the 19
3232 manufacturer's trade name, service mark, or other proprietary identifier or (ii) 20
3333 an alternative arrangement under which a provider offers to or provides 21
3434 services on behalf of the manufacturer. For purposes of this Article, an 22
3535 original equipment manufacturer that offers or performs diagnostic, 23
3636 maintenance, or repair services of its own medical imaging or radiation 24
3737 therapy equipment is also an authorized repair provider. 25
3838 (2) Independent repair provider. – An individual or business that offers or 26
3939 performs diagnostic, maintenance, or repair services of medical imaging or 27
4040 radiation therapy equipment without contracting with the original equipment 28
4141 manufacturer. 29
4242 (3) Medical imaging equipment. – Any device used to view the human body to 30
4343 diagnose, monitor, or treat medical conditions, including products for 31
4444 ultrasound imaging, magnetic resonance imaging, medical X ray, 32
4545 radiography, computed tomography, fluoroscopy, and mammography. 33
4646 (4) Medical radiation therapy equipment. – Any device that produces high 34
47-energy-charged particles to provide radiation therapy and related support 35 General Assembly Of North Carolina Session 2025
48-Page 2 House Bill 460-First Edition
49-devices, including signal analysis and display equipment; patient and 1
50-equipment supports; treatment planning software; and component parts and 2
51-accessories. 3
52-(5) Original equipment manufacturer (OEM). – An individual or entity that is 4
53-engaged in the business of manufacturing and selling, leasing, or otherwise 5
54-supplying medical imaging and radiation therapy equipment to others. 6
55-(6) Owner. – An individual or entity that owns or leases medical imaging or 7
56-radiation therapy equipment. 8
57-(7) Part. – Any part made available by the original equipment manufacturer, 9
58-whether new or used, that is necessary for the maintenance or repair of medical 10
59-imaging or radiation therapy equipment. 11
60-(8) Support documentation. – Any manual, diagram, reporting output, service 12
61-code description, schematic diagram, security codes, passwords, or other 13
62-guidance or information necessary to perform diagnostic, maintenance, or 14
63-repair services on medical imaging and radiation therapy equipment. 15
64-(9) Tool. – Any software, hardware, or other apparatus necessary to perform 16
65-diagnostic, maintenance, or repair services on medical imaging and radiation 17
66-therapy equipment, including items needed to program or pair new parts, 18
67-calibrate functionality, conduct software updates, or perform any other 19
68-function required to bring the product back to fully functional condition. 20
69-"§ 66-503.1. Duties of original equipment manufacturer. 21
70-Any OEM that manufactures medical imaging equipment or medical radiation therapy 22
71-equipment that is used in this State is required to do the following: 23
72-(1) Make available to any hospital or independent repair provider any support 24
73-documentation, parts, or tools necessary to perform diagnostic, maintenance, 25
74-or repair services of the manufacturer's medical imaging or radiation therapy 26
75-equipment subject to the following terms: 27
76-a. Anytime the OEM updates the support documentation for its 28
77-equipment, the OEM shall automatically send notice of the updated 29
78-information to all known equipment owners and independent repair 30
79-providers. 31
80-b. An OEM shall provide access to support documentation at no charge 32
81-to an owner or independent repair provider, however, if the owner or 33
82-independent repair provider requests a printed copy of a support 34
83-document, the OEM may charge the owner or independent repair 35
84-provider the actual costs of printing and shipping the print copy. 36
85-c. An OEM shall provide access to tools without requiring authorization, 37
86-registration, or other such impediment to access or use necessary tools, 38
87-including impairing the ability to use the tools in an efficient and 39
88-cost-effective manner. The OEM shall make tools available at no cost 40
89-to an owner or independent repair provider, however, the OEM may 41
90-charge an owner or independent repair provider the actual costs of 42
91-preparing and shipping a tool. 43
92-d. An OEM shall provide access to any support documentation or tools 44
93-needed to access or reset any electronic security lock or any other 45
94-security-related function. 46
95-e. Both OEM and authorized repair providers shall provide access to 47
96-parts at the same costs and under the same terms as the most favorable 48
97-agreement between the OEM and any authorized repair provider. 49 General Assembly Of North Carolina Session 2025
98-House Bill 460-First Edition Page 3
99-(2) An OEM shall be in compliance with this section if the OEM delegates the 1
100-requirements of this section to an authorized repair provider and the 2
101-authorized repair provider satisfies the requirements on behalf of the OEM. 3
102-(3) If an OEM offers training courses or training materials on how to properly 4
103-operate, inspect, diagnose, maintain, or repair its equipment to authorized 5
104-repair providers, the OEM must offer the same courses or materials to owners 6
105-and independent repair providers. 7
106-"§ 66-503.2. Limitations and enforcement. 8
107-(a) Any violation of this Article is an unfair or deceptive trade practice for purposes of 9
108-Chapter 75 of the General Statutes, and the violating party is subject to suit thereunder by injured 10
109-parties and the Attorney General. 11
110-(b) Nothing in this Article shall be construed to require an OEM to divulge any trade 12
111-secret, as defined in G.S. 66-152, to an owner or independent repair provider. 13
112-(c) Any provision of an agreement between an OEM and an authorized repair provider 14
113-that purports to waive, avoid, restrict, or limit an OEM's obligation to comply with this Article is 15
114-void and unenforceable. 16
115-(d) No OEM or authorized repair provider shall be liable for any damage caused to 17
116-medical imaging or radiation therapy equipment or injury caused to an owner or independent 18
117-repair provider which occurs during repair, diagnosis, or maintenance of the equipment." 19
118-SECTION 2. This act becomes effective July 1, 2025, and applies to equipment in 20
119-use on or after that date. 21
47+energy-charged particles to provide radiation therapy and related support 35
48+devices, including signal analysis and display equipment; patient and 36
49+H.B. 460
50+Mar 19, 2025
51+HOUSE PRINCIPAL CLERK General Assembly Of North Carolina Session 2025
52+Page 2 DRH30139-NH-53
53+equipment supports; treatment planning software; and component parts and 1
54+accessories. 2
55+(5) Original equipment manufacturer (OEM). – An individual or entity that is 3
56+engaged in the business of manufacturing and selling, leasing, or otherwise 4
57+supplying medical imaging and radiation therapy equipment to others. 5
58+(6) Owner. – An individual or entity that owns or leases medical imaging or 6
59+radiation therapy equipment. 7
60+(7) Part. – Any part made available by the original equipment manufacturer, 8
61+whether new or used, that is necessary for the maintenance or repair of medical 9
62+imaging or radiation therapy equipment. 10
63+(8) Support documentation. – Any manual, diagram, reporting output, service 11
64+code description, schematic diagram, security codes, passwords, or other 12
65+guidance or information necessary to perform diagnostic, maintenance, or 13
66+repair services on medical imaging and radiation therapy equipment. 14
67+(9) Tool. – Any software, hardware, or other apparatus necessary to perform 15
68+diagnostic, maintenance, or repair services on medical imaging and radiation 16
69+therapy equipment, including items needed to program or pair new parts, 17
70+calibrate functionality, conduct software updates, or perform any other 18
71+function required to bring the product back to fully functional condition. 19
72+"§ 66-503.1. Duties of original equipment manufacturer. 20
73+Any OEM that manufactures medical imaging equipment or medical radiation therapy 21
74+equipment that is used in this State is required to do the following: 22
75+(1) Make available to any hospital or independent repair provider any support 23
76+documentation, parts, or tools necessary to perform diagnostic, maintenance, 24
77+or repair services of the manufacturer's medical imaging or radiation therapy 25
78+equipment subject to the following terms: 26
79+a. Anytime the OEM updates the support documentation for its 27
80+equipment, the OEM shall automatically send notice of the updated 28
81+information to all known equipment owners and independent repair 29
82+providers. 30
83+b. An OEM shall provide access to support documentation at no charge 31
84+to an owner or independent repair provider, however, if the owner or 32
85+independent repair provider requests a printed copy of a support 33
86+document, the OEM may charge the owner or independent repair 34
87+provider the actual costs of printing and shipping the print copy. 35
88+c. An OEM shall provide access to tools without requiring authorization, 36
89+registration, or other such impediment to access or use necessary tools, 37
90+including impairing the ability to use the tools in an efficient and 38
91+cost-effective manner. The OEM shall make tools available at no cost 39
92+to an owner or independent repair provider, however, the OEM may 40
93+charge an owner or independent repair provider the actual costs of 41
94+preparing and shipping a tool. 42
95+d. An OEM shall provide access to any support documentation or tools 43
96+needed to access or reset any electronic security lock or any other 44
97+security-related function. 45
98+e. Both OEM and authorized repair providers shall provide access to 46
99+parts at the same costs and under the same terms as the most favorable 47
100+agreement between the OEM and any authorized repair provider. 48
101+(2) An OEM shall be in compliance with this section if the OEM delegates the 49
102+requirements of this section to an authorized repair provider and the 50
103+authorized repair provider satisfies the requirements on behalf of the OEM. 51 General Assembly Of North Carolina Session 2025
104+DRH30139-NH-53 Page 3
105+(3) If an OEM offers training courses or training materials on how to properly 1
106+operate, inspect, diagnose, maintain, or repair its equipment to authorized 2
107+repair providers, the OEM must offer the same courses or materials to owners 3
108+and independent repair providers. 4
109+"§ 66-503.2. Limitations and enforcement. 5
110+(a) Any violation of this Article is an unfair or deceptive trade practice for purposes of 6
111+Chapter 75 of the General Statutes, and the violating party is subject to suit thereunder by injured 7
112+parties and the Attorney General. 8
113+(b) Nothing in this Article shall be construed to require an OEM to divulge any trade 9
114+secret, as defined in G.S. 66-152, to an owner or independent repair provider. 10
115+(c) Any provision of an agreement between an OEM and an authorized repair provider 11
116+that purports to waive, avoid, restrict, or limit an OEM's obligation to comply with this Article is 12
117+void and unenforceable. 13
118+(d) No OEM or authorized repair provider shall be liable for any damage caused to 14
119+medical imaging or radiation therapy equipment or injury caused to an owner or independent 15
120+repair provider which occurs during repair, diagnosis, or maintenance of the equipment." 16
121+SECTION 2. This act becomes effective July 1, 2025, and applies to equipment in 17
122+use on or after that date. 18