I 

118TH CONGRESS 

2D SESSION H. R. 10406 

To amend the Federal Food, Drug, and Cosmetic Act to authorize requiring 

the manufacturers of a covered device to disclose to a patient all patientspecific data that is recorded or transmitted by the device and accessible 

to the manufacturer, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 12, 2024 

Ms. SHERRILL introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

authorize requiring the manufacturers of a covered device 

to disclose to a patient all patient-specific data that 

is recorded or transmitted by the device and accessible 

to the manufacturer, and for other purposes. 

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 ‘‘Patient Device Data 

5 Access Act of 2024’’. 


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1 SEC. 2. SHARING OF PATIENT-SPECIFIC DATA BY DEVICE 

2 MANUFACTURERS. 

3 (a) IN GENERAL.—Subchapter A of chapter V of the 

4 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 

5 et seq.) is amended by adding at the end the following: 

6 ‘‘SEC. 524C. SHARING OF PATIENT-SPECIFIC DATA BY DE7 VICE MANUFACTURERS. 

8 ‘‘(a) REQUIREMENT AUTHORIZED.—The Secretary 

9 may require the manufacturer of a covered device, at the 

10 request of a patient who is using or has used such covered 

11 device, to disclose all patient-specific data that is— 

12 ‘‘(1) recorded or transmitted by such device; 

13 and 

14 ‘‘(2) accessible to the manufacturer. 

15 ‘‘(b) REGULATIONS.— 

16 ‘‘(1) ISSUANCE.—Any requirement imposed on 

17 manufacturers under subsection (a) shall be by regu18 lation. 

19 ‘‘(2) APPLICABILITY TO ALL MANUFACTURERS

20 OF COVERED DEVICES.—Any requirement imposed 

21 under subsection (a) shall be applicable with respect 

22 to all manufacturers of covered devices. 

23 ‘‘(3) CONSIDERATION.—In issuing any regula24 tion under paragraph (1), the Secretary shall take 

25 into consideration the guidance issued in October 

26 2017 by the Food and Drug Administration titled 


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1 ‘Manufacturers Sharing Patient-Specific Information 

2 from Medical Devices with Patients Upon Request’. 

3 ‘‘(4) CONTENTS.—If the Secretary issues regu4 lations under paragraph (1), the Secretary may in5 clude in such regulations provisions requiring the 

6 manufacturer of a covered device to do the following: 

7 ‘‘(A) Disclose patient-specific data referred 

8 to in subsection (a), where possible, in a format 

9 that is— 

10 ‘‘(i) understandable to the patient; 

11 and 

12 ‘‘(ii) at the request of the patient, to 

13 the extent practicable, in a preferred for14 mat, including an industry standard data 

15 format. 

16 ‘‘(B) Receive and consider patient requests 

17 to disclose patient-specific data in a preferred 

18 format described in subparagraph (A). 

19 ‘‘(C) Publish on the public website of the 

20 manufacturer of a covered device— 

21 ‘‘(i) an indication that such device is 

22 a covered device subject to regulation 

23 under this section; 

24 ‘‘(ii) what types of patient-specific 

25 data, if any, are— 


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1 ‘‘(I) being recorded or trans2 mitted by the covered device; and 

3 ‘‘(II) accessible to the manufac4 turer; 

5 ‘‘(iii) whether the covered device oper6 ates in a closed system or otherwise col7 lects patient-specific data that is inacces8 sible to the manufacturer; and 

9 ‘‘(iv) whether and how the manufac10 turer utilizes patient data. 

11 ‘‘(D) Make publicly available, by posting 

12 on the manufacturer’s website, the method by 

13 which patients who are using or have used the 

14 covered device may request their own patient15 specific data described in subsection (a). 

16 ‘‘(E) Notify, where possible, patients who 

17 are using or have used the covered device about 

18 how they can access patient-specific data de19 scribed in subsection (a). 

20 ‘‘(F) Notify patients if their covered device 

21 is subject to a recall, has a software update, or 

22 has generated an error message. 

23 ‘‘(c) EXCEPTIONS.—This section does not authorize 

24 the Secretary to require the manufacturer of a covered de25 vice— 


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1 ‘‘(1) to disclose data that is— 

2 ‘‘(A) recorded, transmitted, and retained in 

3 a closed system; and 

4 ‘‘(B) inaccessible to the manufacturer; 

5 ‘‘(2) to redesign the covered device to enable 

6 disclosure of patient-specific data; or 

7 ‘‘(3) to disclose patient-specific data that is in8 accessible to the manufacturer. 

9 ‘‘(d) DEFINITIONS.—In this section: 

10 ‘‘(1) The term ‘covered device’ means any elec11 tronic device that is— 

12 ‘‘(A) intended for use in the diagnosis, 

13 cure, mitigation, treatment, or prevention of 

14 disease; 

15 ‘‘(B) implanted into a patient’s body; 

16 ‘‘(C) used for the purposes of remote moni17 toring; and 

18 ‘‘(D) capable of recording or transmitting 

19 patient data. 

20 ‘‘(2) The term ‘patient-specific data’— 

21 ‘‘(A) means data unique to an individual 

22 patient or unique to the patient’s treatment or 

23 diagnosis that is recorded or transmitted by a 

24 covered device; 


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1 ‘‘(B) includes data described in subpara2 graph (A) irrespective of whether such data, ab3 sent regulation under this section, would other4 wise be required by law to be disclosed to the 

5 patient or their physician; and 

6 ‘‘(C) shall include— 

7 ‘‘(i) data a health care provider inputs 

8 into a covered device to record the status, 

9 and ongoing treatment, of a patient; 

10 ‘‘(ii) information recorded by a cov11 ered device regarding usage, alarms, or 

12 outputs; and 

13 ‘‘(iii) pulse oximetry data, heart elec14 trical activity data, and data on rhythms 

15 as monitored by a pace maker. 

16 ‘‘(3) The term ‘inaccessible to the manufac17 turer’ means data that is not reasonably acces18 sible.’’. 

19 (b) CIVIL PENALTIES.—Section 303(f)(1)(A) of the 

20 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

21 333(f)(1)(A)) is amended after ‘‘a requirement of this Act 

22 which relates to devices’’ by inserting ‘‘, including any 

23 such requirement under section 524C,’’. 

Æ 


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