Vermont 2025-2026 Regular Session

Vermont House Bill H0160 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	BILL AS INTRODUCED H.160
2	2	2025 Page 1 of 7
3	3
4	4
5	5	VT LEG #380003 v.1
6	6	H.160 1
7	7	Introduced by Representatives Donahue of Northfield, Priestley of Bradford, 2
8	8	Marcotte of Coventry, and Tomlinson of Winooski 3
9	9	Referred to Committee on 4
10	10	Date: 5
11	11	Subject: Commerce and trade; consumer protection; right to repair 6
12	12	Statement of purpose of bill as introduced: This bill proposes to require 7
13	13	manufacturers of medical devices to make available to hospitals and 8
14	14	independent service organizations, on fair and reasonable terms, the 9
15	15	documentation, parts, and tools used to diagnose, maintain, and repair medical 10
16	16	devices. 11
17	17	An act relating to creating a right to repair for medical devices 12
18	18	It is hereby enacted by the General Assembly of the State of Vermont: 13
19	19	Sec. 1. 9 V.S.A. chapter 106 is added to read: 14
20	20	CHAPTER 106. RIGHT TO REPAIR 15
21	21	Subchapter 1. Medical Devices 16
22	22	§ 4049. DEFINITIONS 17
23	23	As used in this chapter: 18
24	24	(1)(A) “Authorized repair provider” means an individual or business 19
25	25	that has an arrangement with the original equipment manufacturer under which 20 BILL AS INTRODUCED H.160
26	26	2025 Page 2 of 7
27	27
28	28
29	29	VT LEG #380003 v.1
30	30	the original equipment manufacturer grants to the individual or business a 1
31	31	license to use a trade name, service mark, or other proprietary identifier for the 2
32	32	purposes of offering the services of diagnosis, maintenance, or repair of 3
33	33	medical equipment under the name of the original equipment manufacturer or 4
34	34	other arrangement with the original equipment manufacturer to offer such 5
35	35	services on behalf of the original equipment manufacturer. 6
36	36	(B) An original equipment manufacturer that offers the services of 7
37	37	diagnosis, maintenance, or repair of its own medical equipment shall be 8
38	38	considered an authorized repair provider with respect to such equipment. 9
39	39	(2) “Documentation” means any manual, diagram, reporting output, 10
40	40	service code description, schematic diagram, security code, password, or other 11
41	41	guidance or information, whether in an electronic or tangible format, used to 12
42	42	perform the services of diagnosis, maintenance, or repair of medical 13
43	43	equipment. 14
44	44	(3) “Fair and reasonable terms” means making available parts, tools, or 15
45	45	documentation as follows: 16
46	46	(A) with respect to documentation required for repair, that 17
47	47	documentation is provided by the OEM at no charge, except that, when the 18
48	48	documentation is requested in physical printed form, a charge may be included 19
49	49	for the reasonable actual costs of preparing and sending the copy; 20 BILL AS INTRODUCED H.160
50	50	2025 Page 3 of 7
51	51
52	52
53	53	VT LEG #380003 v.1
54	54	(B) with respect to tools, that tools are made available by the OEM at 1
55	55	no charge and without requiring authorization or internet access for use or 2
56	56	operation of the tool, or imposing impediments to access or use of the tool to 3
57	57	diagnose, maintain, or repair and enable full functionality of medical 4
58	58	equipment, except that when a tool is requested in physical form, a charge may 5
59	59	be included for the reasonable, actual costs of preparing and sending the tool; 6
60	60	and 7
61	61	(C) with respect to parts, that parts are made available by the OEM, 8
62	62	either directly or indirectly through an authorized repair provider, to 9
63	63	independent repair providers and health care facilities at reasonable costs and 10
64	64	terms that are equivalent to the most favorable costs and terms under which an 11
65	65	OEM offers the part to an authorized repair provider and that: 12
66	66	(i) account for any discount, rebate, convenient and timely means 13
67	67	of delivery, means of enabling fully restored and updated functionality, rights 14
68	68	of use, or other incentive or preference the OEM offers to an authorized repair 15
69	69	provider, or any additional cost, burden, or impediment the OEM imposes on 16
70	70	an independent repair provider or health care facility; 17
71	71	(ii) are not conditioned on or imposing a substantial obligation or 18
72	72	restriction that is not reasonably necessary for enabling the independent repair 19
73	73	provider or health care facility to engage in the diagnosis, maintenance, or 20
74	74	repair of medical equipment made by or on behalf of the OEM; and 21 BILL AS INTRODUCED H.160
75	75	2025 Page 4 of 7
76	76
77	77
78	78	VT LEG #380003 v.1
79	79	(iii) are not conditioned on an arrangement described in 1
80	80	subdivision (1)(A) of this section. 2
81	81	(4) “Health care facility” means all persons or institutions, including 3
82	82	mobile facilities, whether public or private, proprietary or not for profit, that 4
83	83	offer diagnosis, treatment, inpatient, or ambulatory care to two or more 5
84	84	unrelated persons, and the buildings in which those services are offered. The 6
85	85	term shall not apply to any facility operated by religious groups relying solely 7
86	86	on spiritual means through prayer or healing but includes all institutions 8
87	87	included in 18 V.S.A. § 9432(8), except health maintenance organizations. 9
88	88	(5) “Independent repair provider” means a person operating in this State, 10
89	89	who does not have an arrangement with an OEM as described in subdivision 11
90	90	(1)(A) of this section, and who is engaged in the diagnosis, service, 12
91	91	maintenance, or repair of medical equipment. 13
92	92	(6) “Medical equipment” or “equipment” means any powered device 14
93	93	approved by the United States Food and Drug Administration that is used in 15
94	94	the treatment, monitoring, or diagnosis of a patient, and includes assistive, 16
95	95	adaptive, and rehabilitative devices. 17
96	96	(7) “Original equipment manufacturer” or “OEM” means a business 18
97	97	engaged in the business of selling, leasing, or otherwise supplying new medical 19
98	98	equipment manufactured by or on behalf of itself. 20 BILL AS INTRODUCED H.160
99	99	2025 Page 5 of 7
100	100
101	101
102	102	VT LEG #380003 v.1
103	103	(8) “Part” means any replacement part, either used or new, made 1
104	104	available by an OEM for purposes of effecting the services of maintenance or 2
105	105	repair of medical equipment manufactured by or on behalf of, sold or 3
106	106	otherwise supplied by, the OEM. 4
107	107	(9) “Tools” means any software program, service key, hardware 5
108	108	implement, or other apparatus used for diagnosis, maintenance, or repair of 6
109	109	medical equipment, including software or other mechanisms that provision, 7
110	110	program, or pair a new part; facilitate access to the equipment’s repair and 8
111	111	diagnostic functions; calibrate functionality; or perform any other function 9
112	112	required to bring the product back to fully functional condition, including any 10
113	113	updates. 11
114	114	(10) “Trade secret” has the same meaning as provided in 18 U.S.C. 12
115	115	§ 1839. 13
116	116	§ 4050. REQUIREMENTS 14
117	117	(a) General requirements. For medical equipment and parts sold and used 15
118	118	in this State, the OEM of the equipment or parts or an authorized repair 16
119	119	provider shall make available to independent repair providers and health care 17
120	120	facilities, on fair and reasonable terms, any: 18
121	121	(1) documentation, parts, and tools, required for the diagnosis, 19
122	122	maintenance, or repair of medical equipment and parts for medical equipment, 20
123	123	inclusive of any updates to information; and 21 BILL AS INTRODUCED H.160
124	124	2025 Page 6 of 7
125	125
126	126
127	127	VT LEG #380003 v.1
128	128	(2) training courses and materials on the operation, inspection, 1
129	129	diagnosis, maintenance, and repair of the equipment that the OEM similarly 2
130	130	provides to authorized repair providers. 3
131	131	(b) Security lock access. For medical equipment sold and used in this State 4
132	132	that contains an electronic security lock or other security-related function, the 5
133	133	OEM of the equipment or parts or an authorized repair provider shall make 6
134	134	available to independent repair providers and health care facilities, on fair and 7
135	135	reasonable terms, special documentation, tools, and parts required to access 8
136	136	and reset the lock or function when disabled in the course of diagnosis, 9
137	137	maintenance, or repair of such equipment. The documentation, tools, and parts 10
138	138	may be made available through appropriate secure release systems. 11
139	139	§ 4051. LIMITATIONS 12
140	140	(a) This subchapter does not require an OEM to divulge a trade secret to an 13
141	141	independent repair provider or health care facility. 14
142	142	(b) This subchapter does not alter the terms of any arrangement described 15
143	143	in subdivision 4049(1)(A) of this title in force between an authorized repair 16
144	144	provider and an OEM, including the performance or provision of warranty or 17
145	145	recall repair work by an authorized repair provider on behalf of an OEM 18
146	146	pursuant to such arrangement, except that any provision governing such an 19
147	147	arrangement that purports to waive, avoid, restrict, or limit the OEM’s 20
148	148	obligations to comply with this subchapter is void and unenforceable. 21 BILL AS INTRODUCED H.160
149	149	2025 Page 7 of 7
150	150
151	151
152	152	VT LEG #380003 v.1
153	153	(c) Original equipment manufacturers and authorized repair providers are 1
154	154	not liable for damage caused to any medical equipment by independent repair 2
155	155	providers or health care facilities that occurs during the course of repair, 3
156	156	diagnosis, or maintenance of the equipment. 4
157	157	§ 4052. ENFORCEMENT 5
158	158	(a) A person who violates a provision of this subchapter commits an unfair 6
159	159	and deceptive act in trade and commerce in violation of section 2453 of this 7
160	160	title. 8
161	161	(b) The Attorney General has the same authority to make rules, conduct 9
162	162	civil investigations, enter into assurances of discontinuance, and bring civil 10
163	163	actions as provided under chapter 63, subchapter 1 of this title. 11
164	164	Sec. 2. IMPLEMENTATION 12
165	165	This act applies to medical equipment and parts sold or in use in this State 13
166	166	on or after the effective date of this act. 14
167	167	Sec. 3. EFFECTIVE DATE 15
168	168	This act shall take effect on July 1, 2025. 16