I 

118TH CONGRESS 

1ST SESSION H. R. 1557 

To require the Secretary of Health and Human Services to submit a report 

on the interoperability of medical devices. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 10, 2023 

Mrs. MILLER-MEEKS (for herself, Ms. CRAIG, Mr. MURPHY, and Ms. 

SCHRIER) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To require the Secretary of Health and Human Services 

to submit a report on the interoperability of medical devices. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Better Interoperability 

5 for Devices Act of 2023’’ or the ‘‘BID Act of 2023’’. 

6 SEC. 2. REPORT ON THE INTEROPERABILITY OF MEDICAL 

7 DEVICES. 

8 (a) IN GENERAL.—Not later than 1 year after the 

9 date of the enactment of this Act, the Secretary of Health 

10 and Human Services (in this section referred to as the 


kjohnson on DSK79L0C42PROD with BILLS
2 

•HR 1557 IH

1 ‘‘Secretary’’), acting through the Commissioner of Food 

2 and Drugs and in consultation with the National Coordi3 nator for Health Information Technology, shall prepare 

4 and submit to the Committee on Energy and Commerce 

5 of the House of Representatives and the Committee on 

6 Health, Education, Labor, and Pensions of the Senate, 

7 and make publicly available (including through posting on 

8 the website of the Food and Drug Administration), a re9 port on the state of interoperability of medical devices and 

10 the implications of such state for the safety and effective11 ness of such medical devices. 

12 (b) CONTENTS.—The report described in subsection 

13 (a) shall include— 

14 (1) a review of existing medical device inter15 operability standards and the extent to which such 

16 standards have been adopted, including— 

17 (A) whether medical device interoperability 

18 standards included in the Recognized Con19 sensus Standards Database of the Food and 

20 Drug Administration were widely adopted by 

21 the medical device industry upon inclusion in 

22 the Database; 

23 (B) a discussion of how adoption of inter24 operability standards for medical devices sup25 port patient access to data, home-based care, 


kjohnson on DSK79L0C42PROD with BILLS
3 

•HR 1557 IH

1 telemedicine, and data sharing among devices 

2 used in the clinical setting; 

3 (C) a comparison of the standards used for 

4 device interoperability with the standards used 

5 for other aspects of clinical care, such as stand6 ards to ensure the security of health informa7 tion and standards to support interoperability 

8 among electronic health record systems; 

9 (D) an assessment of the ability of patients 

10 to obtain standard data from the devices they 

11 use, and the associated standards used to facili12 tate access to such data; and 

13 (E) an analysis of the cost burden on 

14 health care providers, the medical device indus15 try, and other entities associated with the adop16 tion of medical device interoperability stand17 ards; 

18 (2) recommendations to improve adoption of de19 vice interoperability standards, including any needed 

20 guidance, regulatory or statutory changes, or incen21 tives for such adoption; and 

22 (3) a summary of recommendations or informa23 tion submitted to the Secretary by stakeholders 

24 under subsection (c). 


kjohnson on DSK79L0C42PROD with BILLS
4 

•HR 1557 IH

1 (c) STAKEHOLDER COMMENT.—Not later than 180 

2 days prior to the submission of the report under sub3 section (a), the Secretary, acting through the Commis4 sioner of Food and Drugs, shall consult with representa5 tives of regulated industry groups, patient groups, aca6 demia, and other interested parties to obtain recommenda7 tions or information relevant to the report. 

Æ 


kjohnson on DSK79L0C42PROD with BILLS