Internet of Medical Things Resilience Partnership Act of 2017

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

HR 3010 - Promoting Good Cyber Hygiene Act of 2017 - All Provisions; S. 1691, The Internet of Things (IoT) Cybersecurity Act of 2017 - all provisions; H.R. 3985, The Internet of Medical Things Resilience Partnership Act - all provisions; FY 2019 National Defense Authorization Act.

Client expense: $170,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Natl Telecommunications & Information Administration (NTIA), SENATE, White House Office

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.

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

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.

HR 3010 - Promoting Good Cyber Hygiene Act of 2017 - All Provisions; S. 1691, The Internet of Things (IoT) Cybersecurity Act of 2017 - all provisions; H.R. 3985, The Internet of Medical Things Resilience Partnership Act - all provisions; FY 2019 National Defense Authorization Act.

Client expense: $180,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Natl Telecommunications & Information Administration (NTIA), SENATE, White House Office

HR 2810 - National Defense Authorization Act for Fiscal Year 2018; HR 3010 - Promoting Good Cyber Hygiene Act of 2017 - All Provisions; HR 2227 - Modernizing Government Technology Act - All Provisions; S. 1691, The Internet of Things (IoT) Cybersecurity Act of 2017 - all provisions; H.R. 3985, The Internet of Medical Things Resilience Partnership Act - all provisions; FY 2019 National Defense Authorization Act.

Client expense: $220,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Natl Telecommunications & Information Administration (NTIA), SENATE, White House Office

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

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

HR 2810 - National Defense Authorization Act for Fiscal Year 2018; HR 3010 - Promoting Good Cyber Hygiene Act of 2017 - All Provisions; HR 2227 - Modernizing Government Technology Act - All Provisions; S. 1691, The Internet of Things (IoT) Cybersecurity Act of 2017 - all provisions; H.R. 3985, The Internet of Medical Things Resilience Partnership Act - all provisions; FY 2019 National Defense Authorization Act.

Client expense: $190,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Natl Telecommunications & Information Administration (NTIA), SENATE, White House Office

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

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

HR 2810 - National Defense Authorization Act for Fiscal Year 2018; HR 3010 - Promoting Good Cyber Hygiene Act of 2017 - All Provisions; HR 2227 - Modernizing Government Technology Act - All Provisions; S. 1691, The Internet of Things (IoT) Cybersecurity Act of 2017 - all provisions; H.R. 3985, The Internet of Medical Things Resilience Partnership Act - all provisions.

Client expense: $210,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Natl Telecommunications & Information Administration (NTIA), SENATE, White House Office

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

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

HR 2810 - National Defense Authorization Act for Fiscal Year 2018; HR 3010 - Promoting Good Cyber Hygiene Act of 2017 - All Provisions; HR 2227 - Modernizing Government Technology Act - All Provisions; S. 1691, The Internet of Things (IoT) Cybersecurity Act of 2017 - all provisions; H.R. 3985, The Internet of Medical Things Resilience Partnership Act - all provisions.

Client expense: $220,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Natl Telecommunications & Information Administration (NTIA), SENATE, White House Office

HR 2810 - National Defense Authorization Act for Fiscal Year 2018; HR 3010 - Promoting Good Cyber Hygiene Act of 2017 - All Provisions; HR 2227 - Modernizing Government Technology Act - All Provisions; S. 1691, The Internet of Things (IoT) Cybersecurity Act of 2017 - all provisions; H.R. 3985, The Internet of Medical Things Resilience Partnership Act - all provisions.

Client expense: $220,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Natl Telecommunications & Information Administration (NTIA), SENATE, White House Office

Issues related to implementation of PL 112-144, the Food and Drug Administration Safety and Innovation Act Issues related to implementation of the 21st Century Cures Act Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. H.R. 2164 related to medical device preemption protection H.R. 2163 related to medical device reporting H.R. 2118 related to third party servicing of medical devices H.R. 1703 related to medical product communications H.R. 2026 related to medical product communications H.R. 878 the Right to Try Act of 2017 Issues related to diagnostics regulation Issues related to diagnostics payment reform Issues related to cybersecurity for medical technology S. 1691 Internet of Things (IoT) Cybersecurity Improvement Act of 2017 H.R. 3985 Internet of Medical Things Resilience Partnership Act of 2017 H.R. 4163 and S. 2020 Cyber Shield Act of 2017 H.R. 4191 HHS Cybersecurity Modernization Act Issues related to procurement and acquisition policies of the VA health system for medical technology and supplies Issues related to the regulation of, reimbursement for, and access to cancer diagnostics, imaging, and radiation therapies

Client expense: $1,010,000 · Firm income: Not reported

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)

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

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

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