3.0.0 1656 2023-01-11T13:37:01Z 2023-01-11T13:37:01Z Senate S 2017-07-27 115 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2017-07-27T20:29:40Z 2017-07-27 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2017-07-27 Introduced in Senate IntroReferral 10000 9 Library of Congress B001277 Sen. Blumenthal, Richard [D-CT] Richard Blumenthal D CT N Health Health 00 2017-07-27 Introduced in Senate 2017-12-29T21:15:07Z Medical Device Cybersecurity Act of 2017

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), in coordination with others, to create a cybersecurity report card for devices that have network or Internet connectivity, connect to an external drive or external media, or have any other cyber capability.

Report cards must contain specified information, including: (1) information pertaining to the essential elements described in the most recent version of the Manufacturer Disclosure Statement for Medical Device Security, (2) a cybersecurity risk assessment conducted by the manufacturer or third party, and (3) whether the device is capable of being accessed remotely.

A cyber device manufacturer must include a report card in any premarket notification or application for premarket approval. The FDA shall provide a copy of a device's report card if requested by a health care industry entity or an entity with a valid interest in the report card. 

The bill establishes procedures, including notifications to providers and patients, for manufacturers when cyber devices are remotely accessed or no longer going to be sold. Fixes and updates to cyber devices must be free of charge for specified time periods.

The bill expands the responsibilities of the Department of Homeland Security's Industrial Control Systems Cyber Emergency Response Team to include investigating cybersecurity vulnerabilities of cyber devices that may cause harm to human life or the significant misuse of personal health information, and coordinating device-specific responses.

]]> Medical Device Cybersecurity Act of 2017 Display Title Medical Device Cybersecurity Act of 2017 Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act to provide cybersecurity protections for medical devices. Introduced in Senate IS Short Titles as Introduced Medical Device Cybersecurity Act of 2017 Introduced in Senate 2017-07-27T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115s1656is/xml/BILLS-115s1656is.xml 2017-07-27 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.