What This Bill Does
This bill requires the Secretary of Health and Human Services to prepare and submit a report about how well medical devices work together. The report must examine existing standards for device interoperability (the ability of devices to communicate and share information with each other) and discuss what safety and effectiveness problems might result from poor interoperability.
Who It Affects
The bill directly affects:
• The Secretary of Health and Human Services and the Food and Drug Administration (the federal agency responsible for approving medical devices)
• Medical device manufacturers and the regulated industry
• Patient advocacy groups
• Academic institutions
• Healthcare providers
• Congress, specifically the Committee on Energy and Commerce in the House and the Committee on Health, Education, Labor, and Pensions in the Senate
Key Provisions
• The Secretary must complete and publicly release the report no later than 1 year after the bill becomes law, posting it on the Food and Drug Administration website (Sec. 2(a))
• The report must review existing medical device interoperability standards and examine how widely the medical device industry has adopted them (Sec. 2(b)(1)(A))
• The report must analyze whether medical device interoperability standards help patients access their own data, use home-based care, access telemedicine services, and share information between devices in clinical settings (Sec. 2(b)(1)(B))
• The report must include recommendations for improving adoption of device interoperability standards, including any guidance, regulatory changes or statutory changes needed (Sec. 2(b)(2))
• The Secretary must consult with industry groups, patient groups, academic institutions and other interested parties at least 180 days before submitting the report (Sec. 2(c))
What Changes
If this bill becomes law, the federal government will be required to study and report on how well medical devices communicate with each other. Currently, no such comprehensive federal report exists. The report will be made available to the public.
Important Definitions
The bill does not explicitly define any terms.
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 Com-
mittee 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.
Be it enacted by the Senate and House of Representa-
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tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘Better Interoperability
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for Devices Act of 2023’’ or the ‘‘BID Act of 2023’’.
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SEC. 2. REPORT ON THE INTEROPERABILITY OF MEDICAL
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DEVICES.
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(a) IN GENERAL.—Not later than 1 year after the
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date of the enactment of this Act, the Secretary of Health
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and Human Services (in this section referred to as the
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•HR 1557 IH
‘‘Secretary’’), acting through the Commissioner of Food
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and Drugs and in consultation with the National Coordi-
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nator for Health Information Technology, shall prepare
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and submit to the Committee on Energy and Commerce
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of the House of Representatives and the Committee on
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Health, Education, Labor, and Pensions of the Senate,
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and make publicly available (including through posting on
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the website of the Food and Drug Administration), a re-
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port on the state of interoperability of medical devices and
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the implications of such state for the safety and effective-
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ness of such medical devices.
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(b) CONTENTS.—The report described in subsection
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(a) shall include—
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(1) a review of existing medical device inter-
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operability standards and the extent to which such
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standards have been adopted, including—
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(A) whether medical device interoperability
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standards included in the Recognized Con-
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sensus Standards Database of the Food and
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Drug Administration were widely adopted by
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the medical device industry upon inclusion in
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the Database;
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(B) a discussion of how adoption of inter-
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operability standards for medical devices sup-
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port patient access to data, home-based care,
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•HR 1557 IH
telemedicine, and data sharing among devices
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used in the clinical setting;
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(C) a comparison of the standards used for
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device interoperability with the standards used
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for other aspects of clinical care, such as stand-
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ards to ensure the security of health informa-
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tion and standards to support interoperability
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among electronic health record systems;
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(D) an assessment of the ability of patients
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to obtain standard data from the devices they
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use, and the associated standards used to facili-
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tate access to such data; and
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(E) an analysis of the cost burden on
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health care providers, the medical device indus-
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try, and other entities associated with the adop-
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tion of medical device interoperability stand-
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ards;
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(2) recommendations to improve adoption of de-
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vice interoperability standards, including any needed
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guidance, regulatory or statutory changes, or incen-
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tives for such adoption; and
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(3) a summary of recommendations or informa-
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tion submitted to the Secretary by stakeholders
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under subsection (c).
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(c) STAKEHOLDER COMMENT.—Not later than 180
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days prior to the submission of the report under sub-
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section (a), the Secretary, acting through the Commis-
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sioner of Food and Drugs, shall consult with representa-
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tives of regulated industry groups, patient groups, aca-
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demia, and other interested parties to obtain recommenda-
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tions or information relevant to the report.
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Æ
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