Us Congress 2025-2026 Regular Session

Us Congress House Bill HB661 Compare Versions

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

Old	New	Differences
1	1	I
2	2	119THCONGRESS
3	3	1
4	4	STSESSION H. R. 661
5	5	To require the Secretary of Health and Human Services, in consultation
6	6	with the Secretary of Commerce, the Council for Technology and Innova-
7	7	tion of the Centers for Medicare & Medicaid Services, and the Commis-
8	8	sioner of Food and Drugs, to carry out a program to facilitate and
9	9	coordinate efforts between the United States and Israel to expand and
10	10	enhance collaboration on the development and delivery of health care
11	11	products and services.
12	12	IN THE HOUSE OF REPRESENTATIVES
13	13	JANUARY23, 2025
14	14	Mr. B
15	15	UCHANAN(for himself, Mr. SOTO, and Mrs. MILLER-MEEKS) introduced
16	16	the following bill; which was referred to the Committee on Energy and
17	17	Commerce
18	18	A BILL
19	19	To require the Secretary of Health and Human Services,
20	20	in consultation with the Secretary of Commerce, the
21	21	Council for Technology and Innovation of the Centers
22	22	for Medicare & Medicaid Services, and the Commissioner
23	23	of Food and Drugs, to carry out a program to facilitate
24	24	and coordinate efforts between the United States and
25	25	Israel to expand and enhance collaboration on the devel-
26	26	opment and delivery of health care products and services.
27	27	Be it enacted by the Senate and House of Representa-1
28	28	tives of the United States of America in Congress assembled, 2
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31	31	•HR 661 IH
32	32	SECTION 1. SHORT TITLE. 1
33	33	This Act may be cited as the ‘‘Maximizing Israel-U.S. 2
34	34	Research Advancement and Collaborative Leadership in 3
35	35	Emerging Medical Technology Act of 2025’’ or the ‘‘MIR-4
36	36	ACLE Medical Technology Act of 2025’’. 5
37	37	SEC. 2. PROGRAM FOR FACILITATION AND COORDINATION 6
38	38	OF UNITED STATES-ISRAEL EFFORTS ON THE 7
39	39	DEVELOPMENT AND DELIVERY OF HEALTH 8
40	40	CARE PRODUCTS AND SERVICES. 9
41	41	(a) I
42	42	NGENERAL.—Subject to the availability of ap-10
43	43	propriations, the Secretary of Health and Human Serv-11
44	44	ices, in consultation with the Secretary of Commerce, the 12
45	45	Council for Technology and Innovation of the Centers for 13
46	46	Medicare & Medicaid Services, and the Commissioner of 14
47	47	Food and Drugs, shall carry out a program to facilitate 15
48	48	and coordinate efforts between the United States and 16
49	49	Israel to expand and enhance collaboration on— 17
50	50	(1) the development of health care products and 18
51	51	services; and 19
52	52	(2) the delivery of such products and services to 20
53	53	those in need. 21
54	54	(b) P
55	55	ROGRAMCOMPONENTS.—The program under 22
56	56	subsection (a) shall include facilitation and coordination 23
57	57	of efforts including each of the following: 24
58	58	(1) R
59	59	ESEARCH AND DEVELOPMENT .— 25
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62	62	•HR 661 IH
63	63	(A) Joint research projects between United 1
64	64	States and Israeli institutions and companies. 2
65	65	(B) Promoting collaboration in areas such 3
66	66	as medical device technology, pharmaceuticals 4
67	67	(including biological products, genomics, and in-5
68	68	novative digital health care solutions), and 6
69	69	health care systems management, including a 7
70	70	special focus on early-stage clinical trials. 8
71	71	(C) With respect to biological products, 9
72	72	supporting— 10
73	73	(i) innovation; 11
74	74	(ii) process optimization; and 12
75	75	(iii) the development of advanced 13
76	76	manufacturing techniques that can en-14
77	77	hance productivity, reduce costs, and im-15
78	78	prove product quality. 16
79	79	(D) Work toward developing a framework 17
80	80	for sharing health data for research purposes 18
81	81	with the Ministry of Health of Israel. 19
82	82	(2) I
83	83	NNOVATION AND START -UP ECOSYSTEM.— 20
84	84	(A) Fostering collaboration between United 21
85	85	States and Israeli start-up and other companies 22
86	86	in the health care sector. 23
87	87	(B) Facilitating innovative technology ac-24
88	88	ceptance by the marketplace. 25
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91	91	•HR 661 IH
92	92	(C) Facilitating mechanisms for technology 1
93	93	transfer and joint venture opportunities. 2
94	94	(D) Supporting innovation hubs to accel-3
95	95	erate the development and commercialization of 4
96	96	United States health care technologies in the 5
97	97	Israeli market, including by encouraging cyber-6
98	98	security standards for sharing data, promoting 7
99	99	patient privacy, and encouraging research. 8
100	100	(3) R
101	101	EGULATORY HARMONIZATION AND INTEL -9
102	102	LECTUAL PROPERTY PROTECTION .—Establishing 10
103	103	joint efforts— 11
104	104	(A) to ensure intellectual property protec-12
105	105	tion; 13
106	106	(B) to increase regulatory harmonization, 14
107	107	including with respect to regulatory data pro-15
108	108	tection for biological products; 16
109	109	(C) to formulate plans for a commer-17
110	110	cialization framework for medical device tech-18
111	111	nologies; 19
112	112	(D) to encourage a potential mutual rec-20
113	113	ognition agreement for pharmaceutical good 21
114	114	manufacturing Practices between the Food and 22
115	115	Drug Administration and Israeli regulators; 23
116	116	(E) to strengthen and reaffirm the con-24
117	117	fidentiality commitment with the Food and 25
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120	120	•HR 661 IH
121	121	Drug Administration and the Pharmaceutical 1
122	122	Division, the Medical Devices Department, and 2
123	123	the National Food Services and Nutrition Divi-3
124	124	sion of the Ministry of Health of Israel; 4
125	125	(F) to encourage Israel’s participation in 5
126	126	regulatory harmonization and cooperation orga-6
127	127	nizations; and 7
128	128	(G) to expand international collaboration 8
129	129	under Project Orbis for concurrent submission 9
130	130	and review of oncology products. 10
131	131	(4) H
132	132	EALTH CARE SYSTEM STRENGTHENING .— 11
133	133	Facilitating the sharing of best practices, knowledge, 12
134	134	and skills in areas such as clinical care and health 13
135	135	care management. 14
136	136	(5) T
137	137	ELEMEDICINE AND DIGITAL HEALTH CO -15
138	138	OPERATION.—Establishing initiatives— 16
139	139	(A) to enhance telemedicine infrastructure; 17
140	140	(B) to promote interoperability between 18
141	141	United States and Israeli health care systems; 19
142	142	and 20
143	143	(C) to facilitate collaboration on digital 21
144	144	health technologies, data analytics, and cyberse-22
145	145	curity. 23
146	146	(6) D
147	147	ISEASE PREVENTION INITIATIVES .—Col-24
148	148	laborating in disease prevention, including joint ef-25
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151	151	•HR 661 IH
152	152	forts to combat infectious diseases, develop vaccines, 1
153	153	and share epidemiological data. 2
154	154	(7) B
155	155	IOLOGICAL PRODUCT MANUFACTURING .— 3
156	156	(A) Promoting biological product manufac-4
157	157	turing. 5
158	158	(B) Establishing joint manufacturing fa-6
159	159	cilities for biological products in facilities in the 7
160	160	United States that leverage the strengths and 8
161	161	expertise of both countries. 9
162	162	(C) Pursuing accelerated development of 10
163	163	life-saving treatments and new sources of nutri-11
164	164	tion that are both healthier and more available 12
165	165	at an affordable cost. 13
166	166	(D) Workforce training and skill develop-14
167	167	ment, including promoting exchange programs 15
168	168	and training initiatives to develop a skilled 16
169	169	workforce in biological product manufacturing. 17
170	170	(E) Supply chain resilience through stra-18
171	171	tegic collaboration to identify and develop con-19
172	172	tingency plans to mitigate biological product 20
173	173	supply disruptions. 21
174	174	(F) Facilitating public-private partnerships 22
175	175	to support the development and scale-up of bio-23
176	176	logical product manufacturing capabilities. 24
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179	179	•HR 661 IH
180	180	(c) UNITEDSTATES-ISRAELHEALTHCARECOL-1
181	181	LABORATIONCENTER.—In carrying out the program 2
182	182	under subsection (a), the Secretary of Health and Human 3
183	183	Services may establish a joint United States-Israel Health 4
184	184	Care Collaboration Center in the United States leveraging 5
185	185	the experience, knowledge, and expertise of institutions of 6
186	186	higher education, national laboratories, entities in the pri-7
187	187	vate sector, and others in the development and delivery 8
188	188	of health care products and services. 9
189	189	(d) C
190	190	OMMENCEMENT OF IMPLEMENTATION.—Not 10
191	191	later than 6 months after the date of enactment of this 11
192	192	Act, the Secretary of Health and Human Services shall 12
193	193	commence implementation of the program under this sec-13
194	194	tion. 14
195	195	(e) A
196	196	UTHORIZATION OFAPPROPRIATIONS.—To carry 15
197	197	out this Act, there is authorized to be appropriated 16
198	198	$8,000,000 for each of fiscal years 2026 through 2030. 17
199	199	Æ
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