; and (2) by inserting after paragraph (5) the following new paragraph: (6) The Secretary shall establish and operate an electronic reporting system to facilitate compliance with this subsection by covered device users who choose to use such system to submit reports pursuant to this subsection. . (b) Commencement Not later than 3 years after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall commence operation of the electronic reporting system required by section 519(b)(6) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a). 4. Public availability of reports Section 519 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360i ) is amended by adding at the end the following new subsection: (j) Public availability of reports (1) In general Notwithstanding any exemption for withholding information under section 552 of title 5, United States Code, but subject to paragraph (2), the Secretary shall make reports submitted under this section publicly available on the website of the Department of Health and Human Services. (2) Individually identifiable patient information Paragraph (1) does not require the Secretary to make publicly available any individually identifiable patient information. .