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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1557 Introduced in House (IH)]

<DOC>

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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Better Interoperability for Devices 
Act of 2023'' or the ``BID Act of 2023''.

SEC. 2. REPORT ON THE INTEROPERABILITY OF MEDICAL DEVICES.

    (a) In General.--Not later than 1 year after the date of the 
enactment of this Act, the Secretary of Health and Human Services (in 
this section referred to as the ``Secretary''), acting through the 
Commissioner of Food and Drugs and in consultation with the National 
Coordinator for Health Information Technology, shall prepare and submit 
to the Committee on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate, and make publicly available (including through posting on the 
website of the Food and Drug Administration), a report on the state of 
interoperability of medical devices and the implications of such state 
for the safety and effectiveness of such medical devices.
    (b) Contents.--The report described in subsection (a) shall 
include--
            (1) a review of existing medical device interoperability 
        standards and the extent to which such standards have been 
        adopted, including--
                    (A) whether medical device interoperability 
                standards included in the Recognized Consensus 
                Standards Database of the Food and Drug Administration 
                were widely adopted by the medical device industry upon 
                inclusion in the Database;
                    (B) a discussion of how adoption of 
                interoperability standards for medical devices support 
                patient access to data, home-based care, telemedicine, 
                and data sharing among devices used in the clinical 
                setting;
                    (C) a comparison of the standards used for device 
                interoperability with the standards used for other 
                aspects of clinical care, such as standards to ensure 
                the security of health information and standards to 
                support interoperability among electronic health record 
                systems;
                    (D) an assessment of the ability of patients to 
                obtain standard data from the devices they use, and the 
                associated standards used to facilitate access to such 
                data; and
                    (E) an analysis of the cost burden on health care 
                providers, the medical device industry, and other 
                entities associated with the adoption of medical device 
                interoperability standards;
            (2) recommendations to improve adoption of device 
        interoperability standards, including any needed guidance, 
        regulatory or statutory changes, or incentives for such 
        adoption; and
            (3) a summary of recommendations or information submitted 
        to the Secretary by stakeholders under subsection (c).
    (c) Stakeholder Comment.--Not later than 180 days prior to the 
submission of the report under subsection (a), the Secretary, acting 
through the Commissioner of Food and Drugs, shall consult with 
representatives of regulated industry groups, patient groups, academia, 
and other interested parties to obtain recommendations or information 
relevant to the report.
                                 <all>
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