Us Congress 2023-2024 Regular Session

Us Congress House Bill HB1557 Compare Versions

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

Old	New	Differences
1	1	I
2	2	118THCONGRESS
3	3	1
4	4	STSESSION H. R. 1557
5	5	To require the Secretary of Health and Human Services to submit a report
6	6	on the interoperability of medical devices.
7	7	IN THE HOUSE OF REPRESENTATIVES
8	8	MARCH10, 2023
9	9	Mrs. M
10	10	ILLER-MEEKS(for herself, Ms. CRAIG, Mr. MURPHY, and Ms.
11	11	S
12	12	CHRIER) introduced the following bill; which was referred to the Com-
13	13	mittee on Energy and Commerce
14	14	A BILL
15	15	To require the Secretary of Health and Human Services
16	16	to submit a report on the interoperability of medical devices.
17	17	Be it enacted by the Senate and House of Representa-1
18	18	tives of the United States of America in Congress assembled, 2
19	19	SECTION 1. SHORT TITLE. 3
20	20	This Act may be cited as the ‘‘Better Interoperability 4
21	21	for Devices Act of 2023’’ or the ‘‘BID Act of 2023’’. 5
22	22	SEC. 2. REPORT ON THE INTEROPERABILITY OF MEDICAL 6
23	23	DEVICES. 7
24	24	(a) I
25	25	NGENERAL.—Not later than 1 year after the 8
26	26	date of the enactment of this Act, the Secretary of Health 9
27	27	and Human Services (in this section referred to as the 10
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30	30	•HR 1557 IH
31	31	‘‘Secretary’’), acting through the Commissioner of Food 1
32	32	and Drugs and in consultation with the National Coordi-2
33	33	nator for Health Information Technology, shall prepare 3
34	34	and submit to the Committee on Energy and Commerce 4
35	35	of the House of Representatives and the Committee on 5
36	36	Health, Education, Labor, and Pensions of the Senate, 6
37	37	and make publicly available (including through posting on 7
38	38	the website of the Food and Drug Administration), a re-8
39	39	port on the state of interoperability of medical devices and 9
40	40	the implications of such state for the safety and effective-10
41	41	ness of such medical devices. 11
42	42	(b) C
43	43	ONTENTS.—The report described in subsection 12
44	44	(a) shall include— 13
45	45	(1) a review of existing medical device inter-14
46	46	operability standards and the extent to which such 15
47	47	standards have been adopted, including— 16
48	48	(A) whether medical device interoperability 17
49	49	standards included in the Recognized Con-18
50	50	sensus Standards Database of the Food and 19
51	51	Drug Administration were widely adopted by 20
52	52	the medical device industry upon inclusion in 21
53	53	the Database; 22
54	54	(B) a discussion of how adoption of inter-23
55	55	operability standards for medical devices sup-24
56	56	port patient access to data, home-based care, 25
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60	60	telemedicine, and data sharing among devices 1
61	61	used in the clinical setting; 2
62	62	(C) a comparison of the standards used for 3
63	63	device interoperability with the standards used 4
64	64	for other aspects of clinical care, such as stand-5
65	65	ards to ensure the security of health informa-6
66	66	tion and standards to support interoperability 7
67	67	among electronic health record systems; 8
68	68	(D) an assessment of the ability of patients 9
69	69	to obtain standard data from the devices they 10
70	70	use, and the associated standards used to facili-11
71	71	tate access to such data; and 12
72	72	(E) an analysis of the cost burden on 13
73	73	health care providers, the medical device indus-14
74	74	try, and other entities associated with the adop-15
75	75	tion of medical device interoperability stand-16
76	76	ards; 17
77	77	(2) recommendations to improve adoption of de-18
78	78	vice interoperability standards, including any needed 19
79	79	guidance, regulatory or statutory changes, or incen-20
80	80	tives for such adoption; and 21
81	81	(3) a summary of recommendations or informa-22
82	82	tion submitted to the Secretary by stakeholders 23
83	83	under subsection (c). 24
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87	87	(c) STAKEHOLDER COMMENT.—Not later than 180 1
88	88	days prior to the submission of the report under sub-2
89	89	section (a), the Secretary, acting through the Commis-3
90	90	sioner of Food and Drugs, shall consult with representa-4
91	91	tives of regulated industry groups, patient groups, aca-5
92	92	demia, and other interested parties to obtain recommenda-6
93	93	tions or information relevant to the report. 7
94	94	Æ
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