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Medical Device Cybersecurity Act of 2017
Legislative Progress
Momentum (last 30 days)
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0 actions · 0 new cosponsors · 0 votes
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vs 3,805 other S bills in the 115th — cohort avg 41d
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.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (5)
2018 · fourth_quarter · Science/Technology
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Healthcare cybersecurity, medical device cybersecurity, patient safety, NIST Cybersecurity Framework, Patient Identification/Patient Data Matching, electronic health records, healthcare data standards, interoperability, S. 770 - MAIN STREET Cybersecurity Act, S. 1656- Medical Device Cybersecurity Act, H.R. 4191 - HHS Cybersecurity Modernization Act, Stark Exemption for Cybersecurity Donation
Client expense: $15,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
2018 · fourth_quarter · Homeland Security
Healthcare Cybersecurity, medical device cybersecurity, cybersecurity threat information sharing, Ransomware/Malware, Breach notification, NIST Cybersecurity Framework, S. 770 - MAIN STREET Cybersecurity Act, S.1656 - Medical Device Cybersecurity Act, H.R. 4191 - HHS Cybersecurity Modernization Act, H.R. 6378 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018
Client expense: $15,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
2018 · fourth_quarter · Homeland Security
S. 1656, Medical Device Cybersecurity Act, provisions related to cybersecurity and medical technology. S. 1691, Internet of Things (IoT) Cybersecurity Improvement Act, provisions related to cybersecurity and medical technology. S. 2020, The Cyber Shield Act, provisions related to cybersecurity and medical technology. H.R. 3985, Internet of Things Resilience Partnership Act, provisions related to medical technology. H.R. 4191, the HHS Cybersecurity Modernization Act, provisions related to cybersecurity and medical technology.
Client expense: $800,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of the Vice President of the United States, SENATE
2018 · fourth_quarter · Health Issues
Public Law 115-52 FDA Reauthorization Act of 2017- specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule HR5997 - Ensuring Patient Access to Critical Breakthrough Products Act FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S1656- Cyber Security for Medical Devices S1691- Internet of Things Cyber Security Improvement Act of 2017-Specifically regarding Medical Devices HR3985- Recommended voluntary frameworks and guidelines to increase security of Internet of Things Medical Devices Working draft of Comprehensive Addiction & Recovery Act 2.0 (CARA 2.0) to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain House & Senate Opioid Legislation: HELP Bills, E&C Bills, W&M bills, Senate Finance Bills aimed at addressing the national opioid epidemic; specifically the role of FDA approved alternative treatments for Chronic pain and opioid abuse. Public Law 115-271 SUPPORT for Patients and Communities Act - Specifically, advocacy for FDA approved alternative treatments for Chronic Pain, and medical device's role in the opioid epidemic.
Client expense: $450,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Homeland Security
S. 1656, Medical Device Cybersecurity Act, provisions related to cybersecurity and medical technology. S. 1691, Internet of Things (IoT) Cybersecurity Improvement Act, provisions related to cybersecurity and medical technology. S. 2020, The Cyber Shield Act, provisions related to cybersecurity and medical technology. H.R. 3985, Internet of Things Resilience Partnership Act, provisions related to medical technology. H.R. 4191, the HHS Cybersecurity Modernization Act, provisions related to cybersecurity and medical technology.
Client expense: $1,550,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of the Vice President of the United States, SENATE
2018 · third_quarter · Health Issues
Public Law 115-52 FDA Reauthorization Act of 2017- specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule HR5997 - Ensuring Patient Access to Critical Breakthrough Products Act FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S1656- Cyber Security for Medical Devices S1691- Internet of Things Cyber Security Improvement Act of 2017-Specifically regarding Medical Devices HR3985- Recommended voluntary frameworks and guidelines to increase security of Internet of Things Medical Devices Working draft of Comprehensive Addiction & Recovery Act 2.0 (CARA 2.0) to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain House & Senate Opioid Legislation: HELP Bills, E&C Bills, W&M bills, Senate Finance Bills aimed at addressing the national opioid epidemic; specifically the role of FDA approved alternative treatments for Chronic pain and opioid abuse. HR6 -Substance Use-Disorder Prevention that Promises Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act - Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S2680 - Opioid Crisis Response Act (OCRA) - Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S3120 - Helping to End Addiction & Lessen Substance Abuse Disorders Act (HEAL Act) - Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S2891 - Fighting the Opioid Epidemic with Sunshine Act of 2018(Sunshine Expansion Act) - Specifically, transparency and medical device's role in the opioid epidemic.
Client expense: $410,000 · Firm income: Not reported
2018 · third_quarter · Homeland Security
Healthcare Cybersecurity, medical device cybersecurity, cybersecurity threat information sharing, Ransomware/Malware, Breach notification, NIST Cybersecurity Framework, S. 770 - MAIN STREET Cybersecurity Act, S.1656 - Medical Device Cybersecurity Act, H.R. 4191 - HHS Cybersecurity Modernization Act, H.R. 6378 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018
Client expense: $15,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
2018 · third_quarter · Science/Technology
Healthcare cybersecurity, medical device cybersecurity, patient safety, NIST Cybersecurity Framework, Patient Identification/Patient Data Matching, electronic health records, healthcare data standards, interoperability, S. 770 - MAIN STREET Cybersecurity Act, S. 1656- Medical Device Cybersecurity Act, H.R. 4191 - HHS Cybersecurity Modernization Act, Stark Exemption for Cybersecurity Donation
Client expense: $15,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
2018 · second_quarter · Homeland Security
Healthcare Cybersecurity, medical device cybersecurity, cybersecurity threat information sharing, Ransomware/Malware, Breach notification, NIST Cybersecurity Framework, S. 770 - MAIN STREET Cybersecurity Act, S.1656 - Medical Device Cybersecurity Act, H.R. 4191 - HHS Cybersecurity Modernization Act, H.R. 6378 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018
Client expense: $20,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE, White House Office
2018 · second_quarter · Science/Technology
Healthcare cybersecurity, medical device cybersecurity, patient safety, NIST Cybersecurity Framework, Patient Identification/Patient Data Matching, electronic health records, healthcare data standards, interoperability, S. 770 - MAIN STREET Cybersecurity Act, S. 1656- Medical Device Cybersecurity Act, H.R. 4191 - HHS Cybersecurity Modernization Act, Stark Exemption for Cybersecurity Donation
Client expense: $20,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE, White House Office
2018 · second_quarter · Homeland Security
S. 1656, Medical Device Cybersecurity Act, provisions related to cybersecurity and medical technology. S. 1691, Internet of Things (IoT) Cybersecurity Improvement Act, provisions related to cybersecurity and medical technology. S. 2020, The Cyber Shield Act, provisions related to cybersecurity and medical technology. H.R. 3985, Internet of Things Resilience Partnership Act, provisions related to medical technology. H.R. 4191, the HHS Cybersecurity Modernization Act, provisions related to cybersecurity and medical technology.
Client expense: $1,040,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Office of the Vice President of the United States, SENATE
2018 · second_quarter · Health Issues
Public Law 115-52 FDA Reauthorization Act of 2017- specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule HR5997 - Ensuring Patient Access to Critical Breakthrough Products Act FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S1656- Cyber Security for Medical Devices S1691- Internet of Things Cyber Security Improvement Act of 2017-Specifically regarding Medical Devices HR3985- Recommended voluntary frameworks and guidelines to increase security of Internet of Things Medical Devices Working draft of Comprehensive Addiction & Recovery Act 2.0 (CARA 2.0) to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain House & Senate Opioid Legislation: OCRA and other HELP Bills, E&C Bills, W&M bills, Senate Finance Bills aimed at addressing the national opioid epidemic; specifically the role of FDA approved alternative treatments for Chronic pain and opioid abuse. HR6 -Substance Use-Disorder Prevention that Promises Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act - Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S2680 - Opioid Crisis Response Act (OCRA) - Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S3120 - Helping to End Addiction & Lessen Substance Abuse Disorders Act (HEAL Act) - Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S2891 - Fighting the Opioid Epidemic with Sunshine Act of 2018(Sunshine Expansion Act) - Specifically, transparency and medical device's role in the opioid epidemic.
2018 · first_quarter · Health Issues
Public Law 115-52 FDA Reauthorization Act of 2017- specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S1656- Cyber Security for Medical Devices S1691- Internet of Things Cyber Security Improvement Act of 2017-Specifically regarding Medical Devices HR3985- Recommended voluntary frameworks and guidelines to increase security of Internet of Things Medical Devices Working draft of Comprehensive Addiction & Recovery Act 2.0 (CARA 2.0) to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain House & Senate Draft Opioid Legislation: OCRA and other HELP Draft Bills, E&C Draft Bills, W&M Draft bills, Senate Finance Draft Bills aimed at addressing the national opioid epidemic; specifically the role of FDA approved alternative treatments for Chronic pain and opioid abuse.
Client expense: $410,000 · Firm income: Not reported
2018 · first_quarter · Homeland Security
Healthcare Cybersecurity, medical device cybersecurity, cybersecurity threat information sharing, Ransomware/Malware, Breach notification, NIST Cybersecurity Framework, S. 770 - MAIN STREET Cybersecurity Act, S.1656 - Medical Device Cybersecurity Act, H.R. 4191 - HHS Cybersecurity Modernization Act
Client expense: Not reported · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE, White House Office
2018 · first_quarter · Science/Technology
Healthcare cybersecurity, medical device cybersecurity, patient safety, NIST Cybersecurity Framework, Patient Identification/Patient Data Matching, electronic health records, healthcare data standards, interoperability, S. 770 - MAIN STREET Cybersecurity Act, S. 1656- Medical Device Cybersecurity Act, H.R. 4191 - HHS Cybersecurity Modernization Act, Stark Exemption for Cybersecurity Donation
Client expense: Not reported · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE, White House Office
2018 · first_quarter · Homeland Security
S. 1656, Medical Device Cybersecurity Act, provisions related to cybersecurity and medical technology. S. 1691, Internet of Things (IoT) Cybersecurity Improvement Act, provisions related to cybersecurity and medical technology. S. 2020, The Cyber Shield Act, provisions related to cybersecurity and medical technology. H.R. 3985, Internet of Things Resilience Partnership Act, provisions related to medical technology. H.R. 4191, the HHS Cybersecurity Modernization Act, provisions related to cybersecurity and medical technology.
Client expense: $1,390,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Office of the Vice President of the United States, SENATE
2018 · first_quarter · Health Issues
Public Law 115-52 FDA Reauthorization Act of 2017- specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain S1656- Cyber Security for Medical Devices S1691- Internet of Things Cyber Security Improvement Act of 2017-Specifically regarding Medical Devices HR3985- Recommended voluntary frameworks and guidelines to increase security of Internet of Things Medical Devices Working draft of Comprehensive Addiction & Recovery Act 2.0 (CARA 2.0) to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain House & Senate Draft Opioid Legislation: OCRA and other HELP Draft Bills, E&C Draft Bills, W&M Draft bills, Senate Finance Draft Bills aimed at addressing the national opioid epidemic; specifically the role of FDA approved alternative treatments for Chronic pain and opioid abuse.
Client expense: $410,000 · Firm income: Not reported
2018 · first_quarter · Consumer Issues/Safety/Products
Has been investigating cybersecurity for medical devices that connect to the Internet and met with several Congressional offices on introduced legislation, specifically H.R. 3985, S. 1691, and S.1656. Our interest in this matter specifically pertains to hearing aids.
Client expense: $30,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2018 · first_quarter · Taxation/Internal Revenue Code
Tax reform; cash accounting; Section 199; tax treatment of S corps; R&D tax credit; funding for the Highway Trust Fund; tax incentives for water projects; tax treatment of municipal bonds; bonus depreciation; Production Tax Credits for renewable energy; Section 179D; PABs for public buildings (HR 960/S 326); MLP Parity Act (S 1656/HR 2883); estate tax repeal; tax extenders; Section 199A implementation.
Client expense: $706,876 · Firm income: Not reported
Government targets: Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Aviation Administration (FAA), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Highway Administration (FHA), Federal Transit Administration (FTA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2017 · third_quarter · Health Issues
Public Law 115-52 FDA Reauthorization Act of 2017- specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain H.R. 2430 - FDA Re-authorization Act - Legislation to extend and revise the user-fee programs for Medical Devices S. 934 - FDA Re-authorization Act - Legislation to extend and revise the user-fee programs for Medical Devices S1656- Cyber Security for Medical Devices S1691- Internet of Things Cyber Security Improvement Act of 2017-Specifically regarding Medical Devices HR3985- Recommended voluntary frameworks and guidelines to increase security of Internet of Things Medical Devices
Client expense: $410,000 · Firm income: Not reported
2017 · fourth_quarter · Health Issues
Public Law 115-52 FDA Reauthorization Act of 2017- specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain H.R. 2430 - FDA Re-authorization Act - Legislation to extend and revise the user-fee programs for Medical Devices S. 934 - FDA Re-authorization Act - Legislation to extend and revise the user-fee programs for Medical Devices S1656- Cyber Security for Medical Devices S1691- Internet of Things Cyber Security Improvement Act of 2017-Specifically regarding Medical Devices HR3985- Recommended voluntary frameworks and guidelines to increase security of Internet of Things Medical Devices
Client expense: $410,000 · Firm income: Not reported
2017 · fourth_quarter · Taxation/Internal Revenue Code
Tax reform; cash accounting; Section 199; tax treatment of S corps; R&D tax credit; funding for the Highway Trust Fund; tax incentives for water projects; tax treatment of municipal bonds; bonus depreciation; Production Tax Credits for renewable energy; Section 179D; PABs for public buildings (HR 960/S 326); MLP Parity Act (S 1656/HR 2883); estate tax repeal.
Client expense: $706,877 · Firm income: Not reported
Government targets: Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Aviation Administration (FAA), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Highway Administration (FHA), Federal Transit Administration (FTA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2017 · fourth_quarter · Homeland Security
S. 1656, Medical Device Cybersecurity Act, provisions related to cybersecurity and medical technology. S. 1691, Internet of Things (IoT) Cybersecurity Improvement Act, provisions related to cybersecurity and medical technology. S. 2020, The Cyber Shield Act, provisions related to cybersecurity and medical technology. H.R. 3985, Internet of Things Resilience Partnership Act, provisions related to medical technology. H.R. 4191, the HHS Cybersecurity Modernization Act, provisions related to cybersecurity and medical technology.
Client expense: $800,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA)
2017 · fourth_quarter · Consumer Issues/Safety/Products
Began investigating cybersecurity for medical devices that connect to the Internet and met with several Congressional offices on introduced legislation, specifically H.R. 3985, S. 1691, and S.1656. Our interest in this matter specifically pertains to hearing aids.
Client expense: $25,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2017 · fourth_quarter · Health Issues
Public Law 115-52 FDA Reauthorization Act of 2017- specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain H.R. 2430 - FDA Re-authorization Act - Legislation to extend and revise the user-fee programs for Medical Devices S. 934 - FDA Re-authorization Act - Legislation to extend and revise the user-fee programs for Medical Devices S1656- Cyber Security for Medical Devices S1691- Internet of Things Cyber Security Improvement Act of 2017-Specifically regarding Medical Devices HR3985- Recommended voluntary frameworks and guidelines to increase security of Internet of Things Medical Devices
Client expense: $410,000 · Firm income: Not reported
2017 · fourth_quarter · Homeland Security
Healthcare Cybersecurity, medical device cybersecurity, cybersecurity threat information sharing, Ransomware/Malware, Breach notification, NIST Cybersecurity Framework, S. 770 - MAIN STREET Cybersecurity Act, S.1656 - Medical Device Cybersecurity Act, H.R. 4191 - HHS Cybersecurity Modernization Act
Client expense: $15,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE
2017 · fourth_quarter · Science/Technology
Healthcare cybersecurity, medical device cybersecurity, patient safety, NIST Cybersecurity Framework, Patient Identification/Patient Data Matching, electronic health records, healthcare data standards, interoperability, S. 770 - MAIN STREET Cybersecurity Act, S. 1656- Medical Device Cybersecurity Act, H.R. 4191 - HHS Cybersecurity Modernization Act, Stark Exemption for Cybersecurity Donation
Client expense: $15,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE
2017 · third_quarter · Taxation/Internal Revenue Code
Tax reform; cash accounting; Section 199; tax treatment of S corps; R&D tax credit; funding for the Highway Trust Fund; tax incentives for water projects; tax treatment of municipal bonds; bonus depreciation; Production Tax Credits for renewable energy; Section 179D; PABs for public buildings (HR 960/S 326); MLP Parity Act (S 1656/HR 2883); estate tax repeal.
Client expense: $759,761 · Firm income: Not reported
Government targets: Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Aviation Administration (FAA), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Highway Administration (FHA), Federal Transit Administration (FTA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2017 · third_quarter · Science/Technology
Healthcare cybersecurity, medical device cybersecurity, patient safety, NIST Cybersecurity Framework, Patient Identification/Patient Data Matching, electronic health records, healthcare data standards, interoperability, S. 770 - MAIN STREET Cybersecurity Act, S. 1656- Medical Device Cybersecurity Act
Client expense: $15,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE
2017 · third_quarter · Homeland Security
Healthcare Cybersecurity, medical device cybersecurity, cybersecurity threat information sharing, Ransomware/Malware, Breach notification, NIST Cybersecurity Framework, S. 770 - MAIN STREET Cybersecurity Act, S.1656 - Medical Device Cybersecurity Act
Client expense: $15,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Bureau of Investigation (FBI), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institute of Standards & Technology (NIST), SENATE
2017 · third_quarter · Homeland Security
Issues related to cybersecurity for medical technology; S. 1656, Medical Device Cybersecurity Act of 2017 and S. 1691, Internet of Things (IoT) Cybersecurity Improvement Act of 2017.
Client expense: $1,040,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2017 · third_quarter · Health Issues
Public Law 115-52 FDA Reauthorization Act of 2017- specifically pertaining to user fees used to train FDA staff and streamline approval process Unique Device Identifiers (UDI) - Implementation of UDI rule FDA/CMS Breakthrough Pathway - Legislation to harmonize CMS Reimbursement with FDA Approval to speed products' market introduction House/Senate Implementation of Comprehensive Addiction & Recovery Act (CARA) Law to address the National Opioid epidemic. Specifically, Advocacy for FDA approved alternative treatments for Chronic Pain H.R. 2430 - FDA Re-authorization Act - Legislation to extend and revise the user-fee programs for Medical Devices S. 934 - FDA Re-authorization Act - Legislation to extend and revise the user-fee programs for Medical Devices S1656- Cyber Security for Medical Devices S1691- Internet of Things Cyber Security Improvement Act of 2017-Specifically regarding Medical Devices HR3985- Recommended voluntary frameworks and guidelines to increase security of Internet of Things Medical Devices
Client expense: $410,000 · Firm income: Not reported
2017 · second_quarter · Taxation/Internal Revenue Code
Tax reform; cash accounting; Section 199; tax treatment of S corps; R&D tax credit; funding for the Highway Trust Fund; tax incentives for water projects; tax treatment of municipal bonds; bonus depreciation; Production Tax Credits for renewable energy; Section 179D; PABs for public buildings (HR 960/S 326); MLP Parity Act (S 1656/HR 2883); estate tax repeal.
Client expense: $1,102,557 · Firm income: Not reported
Government targets: Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Aviation Administration (FAA), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Highway Administration (FHA), Federal Transit Administration (FTA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
2017 · first_quarter · Taxation/Internal Revenue Code
Tax reform; cash accounting; Section 199; tax treatment of S corps; R&D tax credit; funding for the Highway Trust Fund; tax incentives for water projects; tax treatment of municipal bonds; bonus depreciation; Production Tax Credits for renewable energy; Section 179D; PABs for public buildings (HR 960/S 326); MLP Parity Act (S 1656/HR 2883); estate tax repeal.
Client expense: $866,951 · Firm income: Not reported
Government targets: Army, Dept of (Corps of Engineers), Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Aviation Administration (FAA), Federal Emergency Management Agency (FEMA), Federal Energy Regulatory Commission (FERC), Federal Highway Administration (FHA), Federal Transit Administration (FTA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $410,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE