Clarifying Remanufacturing to Protect Patient Safety Act of 2022

3rd Party Service regulation Cybersecurity Artificial Intelligence issues relating to medical devices Population Health and Connected Care Issues FDA guidance and legislation on re-manufacturing FDA device approval- 510(k) and PMA processes Connected care and remote patient monitoring Supply chain legislative proposals S.4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022 (Title II, Rosen cybersecurity amendment adopted in Committee) H.R.7667 - Food and Drug Amendments of 2022 (Title II, Title VIII - Sec. 808) H.R.959 Momnibus Act of 2021, all provisions S.801 Connected MOM Act, all provisions H.R.6637 - Health Equity Accountability Act Digital Millennium Copyright Act, Section 1201 rulemaking by Librarian of Congress H.R.5640 /S.3252 - Data Mapping to Save Moms Lives Act, in whole HR 5376. Build Back Better Act - maternal health and tax provisions Right to Repair of medical devices H.R.7253 - Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions H.R.7084 - Protecting and Transforming Cyber Health Care (PATCH) Act, all provisions S.3983 - PATCH Act (whole) H.R.8152, the American Data Privacy and Protection Act (whole)

Client expense: $870,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor legislative and administrative action related to copay assistance. Monitor legislative and administrative action related to cosmetics reform legislation. Monitor legislative and administrative action related to drug take back and pseudoephedrine regulation. Monitor legislative and administrative action related to COVID-19, including drug supply chain issues. Monitor legislative and administrative action related to the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to the Rare Pediatric Disease Priority Review Voucher Program. Monitor legislative and administrative action related to implementation of P.L. 116-136, Coronavirus Aid, Relief, and Economic Security Act (CARES Act), including monograph reform and HSA/FSA provisions. Monitor legislative and administrative action related to telehealth expansion. Monitor legislative and administrative action related to a WTO IP waiver. S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022. H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act. H.R. 2617, Consolidated Appropriations Act, 2023 (P.L. 117-328), including FDA provisions. H.R. 5376, Inflation Reduction Act of 2022. H.R. 7253, Clarifying Remanufacturing to Protect Patient Safety Act of 2022. H.R. 7667, Food and Drug Amendments of 2022.

Medical Device User Fee Agreement; Remanufacturing Medical Devices (HR 7253;"Clarifying Remanufacturing to Protect Patient Safety Act of 2022") Right to Repair; Artificial Intelligence for imaging devices; Cybersecurity for legacy imaging equipment(including Protecting and Transforming Cyber Health Act);S.3648/HR 748 CARES Act; HR 925 Heroes Act.

Client expense: $120,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Medical Device User Fee Agreement; Remanufacturing Medical Devices (HR 7253;"Clarifying Remanufacturing to Protect Patient Safety Act of 2022") Right to Repair; Artificial Intelligence for imaging devices; Cybersecurity for legacy imaging equipment(including Protecting and Transforming Cyber Health Act); S.3648/HR 748 CARES Act; HR 925 Heroes Act.

Client expense: $400,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Issues related to Health Care Trade and Supply Chain Security. Issues related to AI in Health Care. Issues related to Department of Health and Human Services Appropriations. Issues related to research and development tax policy. HR 1846, To amend the Public Health Service Act with respect to hospital infrastructure, all provisions. HR 4479 / S 2609, Facilitating Innovative Nuclear Diagnostics Act of 2021, all provisions. S 2107, Facilitating American-Built Semiconductors Act, all provisions. HR 7253, Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions. HR 5585, Advanced Research Projects Agency - Health Act, all provisions. S 3983 / HR 7084, PATCH Act of 2022, all provisions. HR 7667, Food and Drug Amendments of 2022, all provisions. HR 4521 / S 1260, United States Innovation and Competition Act of 2021, all provisions. S 2533 / HR 4794, Making Advances in Mammography and Medical Options for Veterans Act, all provisions. S 2102, Dr. Kate Hendricks Thomas SERVICE Act, all provisions. HR 4571, Supporting Expanded Review for Veterans In Combat Environments Act of 2021, all provisions. HR 2617, Consolidated Appropriations Act, 2023, provisions pertaining to health care cyber security, medical contrast and diagnostic radiopharmaceutical regulation, and HHS ASPR Hospital Preparedness Program appropriations. S 3799, PREVENT Pandemics Act, provisions pertaining medical device shortage reporting.

Client expense: $1,440,000 · Firm income: Not reported

Issues related to the FDA oversight of medical device servicing and remanufacturing; Clarifying Remanufacturing to Protect Patient Safety Act of 2022 (H.R. 7253)

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

3rd Party Service regulation Cybersecurity Artificial Intelligence issues relating to medical devices Population Health and Connected Care Issues FDA guidance and legislation on re-manufacturing Connected care and remote patient monitoring Supply chain legislative proposals Right to Repair of medical devices H.R.7253 - Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions H.R.7084 - Protecting and Transforming Cyber Health Care (PATCH) Act, all provisions S.3983 - PATCH Act (whole) H.R.8152, the American Data Privacy and Protection Act (whole)

Client expense: $490,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

General issues related to medical device cybersecurity, including S.3983/H.R. 7084, PATCH Act, Artificial Intelligence, and the healthcare supply chain. Issues related to coverage for certain medical devices. Issues related to the thirty-party servicing of medical devices and remanufacturing of medical devices, including H.R. 7253, the Clarifying Remanufacturing to Protect Patient Safety Act of 2022. Issues related to S.2609/H.R. 4479, Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2023.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 7253 - Clarifying Remanufacturing to Protect Patient Safety Act of 2022; Issues related to FDA and Medicare reimbursement, Consolidated Appropriations Act, 2023 (PL 117-328); Issues related to cancer care.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE

Medical Device User Fee Agreement; Remanufacturing Medical Devices (HR 7253;"Clarifying Remanufacturing to Protect Patient Safety Act of 2022") Right to Repair; Artificial Intelligence for imaging devices; Cybersecurity for legacy imaging equipment(including Protecting and Transforming Cyber Health Act); Copyright 1201 exemption impacting medical devices;

Client expense: $360,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

General issues related to medical device cybersecurity, including S.3983/H.R. 7084, PATCH Act, Artificial Intelligence, and the healthcare supply chain. Issues related to coverage for certain medical devices. Discussions related to medical device user fees in the user fees reauthorization legislation. Issues related to the thirty-party servicing of medical devices and remanufacturing of medical devices, including H.R. 7253, the Clarifying Remanufacturing to Protect Patient Safety Act of 2022.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medical Device User Fee Agreement; Remanufacturing Medical Devices (HR 7253;"Clarifying Remanufacturing to Protect Patient Safety Act of 2022") Right to Repair; Artificial Intelligence for imaging devices; Cybersecurity for legacy imaging equipment(including Protecting and Transforming Cyber Health Act); Copyright 1201 exemption impacting medical devices; S.3648/HR 748 CARES Act; HR 925 Heroes Act.

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

3rd Party Service regulation Cybersecurity Artificial Intelligence issues relating to medical devices Population Health and Connected Care Issues FDA guidance and legislation on re-manufacturing Connected care and remote patient monitoring Supply chain legislative proposals S.4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022 (Title II, Rosen cybersecurity amendment adopted in Committee) H.R.7667 - Food and Drug Amendments of 2022 (Title II, Title VIII - Sec. 808) Digital Millennium Copyright Act, Section 1201 rulemaking by Librarian of Congress HR 5376. Build Back Better Act - maternal health and tax provisions Right to Repair of medical devices H.R.7253 - Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions H.R.7084 - Protecting and Transforming Cyber Health Care (PATCH) Act, all provisions S.3983 - PATCH Act (whole) H.R.8152, the American Data Privacy and Protection Act (whole)

Client expense: $620,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor legislative and administrative action related to copay assistance. Monitor legislative and administrative action related to cosmetics reform legislation. Monitor legislative and administrative action related to drug take back and pseudoephedrine regulation. Monitor legislative and administrative action related to COVID-19, including drug supply chain issues. Monitor legislative and administrative action related to the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to the Rare Pediatric Disease Priority Review Voucher Program. Monitor legislative and administrative action related to implementation of P.L. 116-136, Coronavirus Aid, Relief, and Economic Security Act (CARES Act), including monograph reform and HSA/FSA provisions. Monitor legislative and administrative action related to telehealth expansion. Monitor legislative and administrative action related to a WTO IP waiver. S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022. H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act. H.R. 5376, Inflation Reduction Act of 2022. H.R. 7253, Clarifying Remanufacturing to Protect Patient Safety Act of 2022. H.R. 7667, Food and Drug Amendments of 2022.

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor legislative and administrative action related to copay assistance. Monitor legislative and administrative action related to cosmetics reform legislation. Monitor legislative and administrative action related to drug take back and pseudoephedrine regulation. Monitor legislative and administrative action related to COVID-19, including drug supply chain issues. Monitor legislative and administrative action related to the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to the Rare Pediatric Disease Priority Review Voucher Program. Monitor legislative and administrative action related to implementation of P.L. 116-136, Coronavirus Aid, Relief, and Economic Security Act (CARES Act), including monograph reform and HSA/FSA provisions. Monitor legislative and administrative action related to telehealth expansion. Monitor legislative and administrative action related to a WTO IP waiver. S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022. H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act. H.R. 5376, Inflation Reduction Act of 2022. H.R. 7253, Clarifying Remanufacturing to Protect Patient Safety Act of 2022. H.R. 7667, Food and Drug Amendments of 2022.

Issues related to the FDA oversight of medical device servicing and remanufacturing; Clarifying Remanufacturing to Protect Patient Safety Act of 2022 (H.R. 7253)

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Health Care Trade and Supply Chain Security. Issues related to AI in Health Care. Issues related to Department of Health and Human Services Appropriations. Issues related to research and development tax policy. HR 1846, To amend the Public Health Service Act with respect to hospital infrastructure, all provisions. HR 4479 / S 2609, Facilitating Innovative Nuclear Diagnostics Act of 2021, all provisions. S 2107, Facilitating American-Built Semiconductors Act, all provisions. HR 7253, Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions. HR 5585, Advanced Research Projects Agency - Health Act, all provisions. S 3983 / HR 7084, PATCH Act of 2022, all provisions. HR 7667, Food and Drug Amendments of 2022, all provisions. HR 4521 / S 1260, United States Innovation and Competition Act of 2021, all provisions. S 2533 / HR 4794, Making Advances in Mammography and Medical Options for Veterans Act, all provisions. S 2102, Dr. Kate Hendricks Thomas SERVICE Act, all provisions. HR 4571, Supporting Expanded Review for Veterans In Combat Environments Act of 2021, all provisions.

Client expense: $820,000 · Firm income: Not reported

H.R. 7253 - Clarifying Remanufacturing to Protect Patient Safety Act of 2022; H.R. 7667 - Food and Drug Amendments of 2022; S. 4348 - FDA Safety and Landmark Advancements (FDASLA) Act. H.R. 6833 Affordable Insulin Now Act (Continuing Resolution Shell).

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

3rd Party Service regulation Cybersecurity Artificial Intelligence issues relating to medical devices Population Health and Connected Care Issues FDA guidance and legislation on re-manufacturing FDA device approval- 510(k) and PMA processes Connected care and remote patient monitoring Supply chain legislative proposals S.4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022 (Title II, Rosen cybersecurity amendment adopted in Committee) H.R.7667 - Food and Drug Amendments of 2022 (Title II, Title VIII - Sec. 808) H.R.959 Momnibus Act of 2021, all provisions S.801 Connected MOM Act, all provisions H.R.6637 - Health Equity Accountability Act Digital Millennium Copyright Act, Section 1201 rulemaking by Librarian of Congress H.R.5640 /S.3252 - Data Mapping to Save Moms Lives Act, in whole HR 5376. Build Back Better Act - maternal health and tax provisions Right to Repair of medical devices H.R.7253 - Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions H.R.7084 - Protecting and Transforming Cyber Health Care (PATCH) Act, all provisions S.3983 - PATCH Act (whole) H.R.8152, the American Data Privacy and Protection Act (whole)

Client expense: $740,000 · Firm income: Not reported

Implementation of the American Rescue Plan Act of 2021, Pub. L. No. 117-2; Covid-19 Testing: Policies associated with use of serology and antigen testing; S. 2209, Verifying Accurate Leading-Edge IVCT Development Act (VALID), A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of in vitro clinical tests, and for other purposes, HR 4128, A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of in vitro clinical tests, and for other purposes; Medical Device User Fee Agreement; Remanufacturing Medical Devices (HR 7253;"Clarifying Remanufacturing to Protect Patient Safety Act of 2022") Right to Repair; Artificial Intelligence for imaging devices; Cybersecurity for legacy imaging equipment(including Protecting and Transforming Cyber Health Act); Proposed amendments to the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Pub. L. No. 116-136.; Copyright 1201 exemption impacting medical devices; HR 925 Heroes Act.

Client expense: $390,000 · Firm income: Not reported

Issues related to Health Care Trade and Supply Chain Security. Issues related to AI in Health Care. Issues related to Department of Health and Human Services Appropriations. Issues related to research and development tax policy. HR 1846, To amend the Public Health Service Act with respect to hospital infrastructure, all provisions. HR 4479 / S 2609, Facilitating Innovative Nuclear Diagnostics Act of 2021, all provisions. S 2107, Facilitating American-Built Semiconductors Act, all provisions. HR 7253, Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions. HR 5585, Advanced Research Projects Agency - Health Act, all provisions. S 3983 / HR 7084, PATCH Act of 2022, all provisions. HR 7667, Food and Drug Amendments of 2022, all provisions. HR 4521 / S 1260, United States Innovation and Competition Act of 2021, all provisions. S 2533 / HR 4794, Making Advances in Mammography and Medical Options for Veterans Act, all provisions. S 2102, Dr. Kate Hendricks Thomas SERVICE Act, all provisions. HR 4571, Supporting Expanded Review for Veterans In Combat Environments Act of 2021, all provisions.

Client expense: $850,000 · Firm income: Not reported

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor legislative and administrative action related to copay assistance. Monitor legislative and administrative action related to cosmetics reform legislation. Monitor legislative and administrative action related to drug take back and pseudoephedrine regulation. Monitor legislative and administrative action related to COVID-19, including drug supply chain issues. Monitor legislative and administrative action related to the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to the Rare Pediatric Disease Priority Review Voucher Program. Monitor legislative and administrative action related to implementation of P.L. 116-136, Coronavirus Aid, Relief, and Economic Security Act (CARES Act), including monograph reform and HSA/FSA provisions. Monitor legislative and administrative action related to telehealth expansion. Monitor legislative and administrative action related to a WTO IP waiver. S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022. H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act. Build Back Better proposals, including H.R. 5376, the Build Back Better Act. H.R. 7253, Clarifying Remanufacturing to Protect Patient Safety Act of 2022. H.R. 7667, Food and Drug Amendments of 2022.

Medical Device User Fee Agreement; Remanufacturing Medical Devices (HR 7253;"Clarifying Remanufacturing to Protect Patient Safety Act of 2022") Right to Repair; Artificial Intelligence for imaging devices; Cybersecurity for legacy imaging equipment(including Protecting and Transforming Cyber Health Act); Copyright 1201 exemption impacting medical devices; S.3648/HR 748 CARES Act; HR 925 Heroes Act.

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE

Issues related to the FDA oversight of medical device servicing and remanufacturing; Clarifying Remanufacturing to Protect Patient Safety Act of 2022 (H.R. 7253)

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobbied on H.R. 6566, H.R. 7253, H.R. 4006, S. 3830, S. 3549, CPSC regarding The Dangers of Gas Stoves Campaign. 10 May Joined group letter to Senate Commerce committee members in support of S. 4145, the Consumer Protection Remedies Act of 2022. This bill would restore the Federal Trade Commissions (FTC) Section 13(b) authority to stop misconduct in the marketplace, and critically, to provide timely refunds and equitable relief to victims of consumer fraud and deception. 29 April Joined group petition to FTC Requesting Rulemaking Concerning the Finality of a Car Purchase (Spot Delivery and Yo-Yo Financing). 26 April Joined group letter to Acting Assistant Secretary Ali Khawar of Labor Re: Compliance Assistance Release No. 2022-01 401(k) Plan Investments in Cryptocurrencies.

Client expense: $10,000 · Firm income: Not reported

Government targets: Consumer Product Safety Commission (CPSC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), SENATE

Advocacy on HR 4479/S2609, the Facilitating Innovative Nuclear Diagnostics (FIND) Act, to fix policy packaging for radiopharmaceuticals; Advocacy with CMS on Beta Amyloid PET Medicare Coverage; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and S. 4333, the CLEAR Act, to allow FDA to continue regulating all imaging agents as drugs. Advocacy with Congress and FDA on H.R. 7084/S.3983 PATCH Act to seek improvements related to cybersecurity requirements of installed base devices; Advocacy on H.R. 7253, Clarifying Remanufacturing to Protect Patient Safety Act, to clarify the definition of remanufacturing and have education and enforcement of remanufacturers; Advocacy on HR 7667, the Food and Drug Administration Safety and Landmark Advancements Act of 2022 and provisions related to remanufacturing of medical devices and medical device cybersecurity; Advocacy on H.R. 2007 The Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021, to promote research and use of noninvasive treatment alternatives for uterine fibroids; Advocacy on Digital Millennium Copyright Act (DMCA) Section 1201 and Right to Repair issues broadly; Advocacy on focused ultrasound technology; advocacy on medical device cybersecurity.

Client expense: $570,000 · Firm income: Not reported

General issues related to medical device cybersecurity, including S.3983/H.R. 7084, PATCH Act, Artificial Intelligence, and the healthcare supply chain. Issues related to coverage for certain medical devices, including in H.R. 6000, Cures 2.0 Act. Discussions related to the medical device user fee reauthorization in H.R.7667, Food and Drug Amendments Act of 2022, as amended. Issues related to the thirty-party servicing of medical devices and remanufacturing of medical devices, including H.R. 7253, the Clarifying Remanufacturing to Protect Patient Safety Act of 2022, and H.R. 6566, Freedom to Repair Act of 2022.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 7253 - Clarifying Remanufacturing to Protect Patient Safety Act of 2022; H.R. 7667 - Food and Drug Amendments of 2022; S. 4348 - FDA Safety and Landmark Advancements (FDASLA) Act.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

3rd Party Service regulation Cybersecurity Artificial Intelligence issues relating to medical devices Population Health and Connected Care Issues FDA guidance and legislation on re-manufacturing FDA device approval- 510(k) and PMA processes Connected care and remote patient monitoring Healthcare Data Privacy Supply chain legislative proposals Issues related to upcoming MDUFA V legislation H.R.959 Momnibus Act of 2021, all provisions S.801 Connected MOM Act, all provisions H.R.6637 - Health Equity Accountability Act Digital Millennium Copyright Act, Section 1201 rulemaking by Librarian of Congress HR 5640 /S. 3252. Data Mapping to Save Moms Lives Act, in whole HR 5376. Build Back Better Act - maternal health and tax provisions Right to Repair of medical devices H.R 7253, the Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions H.R. 7084, the Protecting and Transforming Cyber Health Care (PATCH) Act, all provisions

Client expense: $580,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

3rd Party Service regulation Cybersecurity Artificial Intelligence issues relating to medical devices Population Health and Connected Care Issues FDA guidance and legislation on re-manufacturing FDA device approval- 510(k) and PMA processes Connected care and remote patient monitoring Healthcare Data Privacy Supply chain legislative proposals Issues related to upcoming MDUFA V legislation H.R.959 Momnibus Act of 2021, all provisions S.801 Connected MOM Act, all provisions H.R.6637 - Health Equity Accountability Act Digital Millennium Copyright Act, Section 1201 rulemaking by Librarian of Congress HR 5640 /S. 3252. Data Mapping to Save Moms Lives Act, in whole HR 5376. Build Back Better Act - maternal health and tax provisions Right to Repair of medical devices H.R 7253, the Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions H.R. 7084, the Protecting and Transforming Cyber Health Care (PATCH) Act, all provisions

Client expense: $590,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Monitor legislative and administrative action related to health care policy. Monitor legislative and administrative action related to drug importation, drug shortages, authorized genetics, and prescription drug advertising. Monitor legislative and administrative action related to womens health issues. Monitor legislative and administrative action related to over-the-counter consumer care products. Monitor legislative and administrative action related to dietary supplements. Monitor legislative and administrative action related to servicing of medical device equipment. Monitor legislative and administrative action related to FDA monograph reform and user fees. Monitor legislative and administrative action related to the switch of prescription medications to over-the-counter medications. Monitor legislative and administrative action related to drug pricing, including rulemakings at HHS. Monitor legislative and administrative action related to copay assistance. Monitor legislative and administrative action related to cosmetics reform legislation. Monitor legislative and administrative action related to drug take back and pseudoephedrine regulation. Monitor legislative and administrative action related to COVID-19, including drug supply chain issues. Monitor legislative and administrative action related to the Supplemental Nutrition Assistance Program (SNAP). Monitor legislative and administrative action related to the Rare Pediatric Disease Priority Review Voucher Program. Monitor legislative and administrative action related to implementation of P.L. 116-136, Coronavirus Aid, Relief, and Economic Security Act (CARES Act), including monograph reform and HSA/FSA provisions. Monitor legislative and administrative action related to telehealth expansion. Monitor legislative and administrative action related to a WTO IP waiver. H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act. Build Back Better proposals, including H.R. 5376, the Build Back Better Act. H.R. 7253, Clarifying Remanufacturing to Protect Patient Safety Act of 2022.

Advocacy on PDUFA and GDUFA user fee legislation/regulation seeking to maintain certain exemptions for positron emission tomography imaging drugs Advocacy on H.R. 7253, the Clarifying Remanufacturing to Protect Patient Safety Act, seeking clarification the definition of remanufacturing, education and inspections; advocacy on cybersecurity vulnerabilities of legacy medical imaging devices; advocacy on artificial intelligence and need for reimbursement pathway; advocacy on focused ultrasound and need for improved coverage pathways and research funding; advocacy on medical device user fees

Client expense: $565,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Issues related to COVID-19 response. Issues related to Health Care Trade and Supply Chain Security. Issues related to Health Care Cybersecurity. Issues related to Medical Device Servicing and Remanufacturing. Issues related to AI in Health Care. Issues related to the Authorization and Appropriation for Advanced Research Project Agency for Health (ARPA-H). Issues related to Department of Health and Human Services Appropriations. HR 831, Health STATISTICS Act of 2021, all provisions. HR 1846, To amend the Public Health Service Act with respect to hospital infrastructure, all provisions. HR 4479 / S 2609, Facilitating Innovative Nuclear Diagnostics Act of 2021, all provisions. S 2107, Facilitating American-Built Semiconductors Act, all provisions. HR 7253, Clarifying Remanufacturing to Protect Patient Safety Act of 2022, all provisions.

Client expense: $1,090,000 · Firm income: Not reported

Issues related to the FDA oversight of medical device servicing and remanufacturing; Clarifying Remanufacturing to Protect Patient Safety Act of 2022 (H.R. 7253)

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1319; American Rescue Plan Act of 2021; Covid-19 Testing: Policies associated with use of serology and antigen testing; S. 2209, Verifying Accurate Leading-Edge IVCT Development Act (VALID), A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of in vitro clinical tests, and for other purposes, HR 4128, A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of in vitro clinical tests, and for other purposes; Medical Device User Fee Agreement; Remanufacturing Medical Devices (HR 7253;"Clarifying Remanufacturing to Protect Patient Safety Act of 2022") Right to Repair; Artificial Intelligence for imaging devices; Cybersecurity for legacy imaging equipment(including Protecting and Transforming Cyber Health Act); Copyright 1201 exemption impacting medical devices; S.3648/HR 748 CARES Act; HR 925 Heroes Act.

Client expense: $250,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE

HR 1319; American Rescue Plan Act of 2021; Covid-19 Testing: Policies associated with use of serology and antigen testing; S. 2209, Verifying Accurate Leading-Edge IVCT Development Act (VALID), A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of in vitro clinical tests, and for other purposes, HR 4128, A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of in vitro clinical tests, and for other purposes; Medical Device User Fee Agreement; Remanufacturing Medical Devices (HR 7253;"Clarifying Remanufacturing to Protect Patient Safety Act of 2022") Right to Repair; Artificial Intelligence for imaging devices; Cybersecurity for legacy imaging equipment(including Protecting and Transforming Cyber Health Act); Copyright 1201 exemption impacting medical devices; S.3648/HR 748 CARES Act; HR 925 Heroes Act.

Client expense: $570,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

HR 1319; American Rescue Plan Act of 2021; Covid-19 Testing: Policies associated with use of serology and antigen testing; S. 2209, Verifying Accurate Leading-Edge IVCT Development Act (VALID), A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of in vitro clinical tests, and for other purposes, HR 4128, A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the regulation of in vitro clinical tests, and for other purposes; Medical Device User Fee Agreement; Remanufacturing Medical Devices (HR 7253;"Clarifying Remanufacturing to Protect Patient Safety Act of 2022") Right to Repair; Artificial Intelligence for imaging devices; Cybersecurity for legacy imaging equipment(including Protecting and Transforming Cyber Health Act); Copyright 1201 exemption impacting medical devices; S.3648/HR 748 CARES Act; HR 925 Heroes Act.

Client expense: $570,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

General issues related to medical device cybersecurity, Artificial Intelligence, and the healthcare supply chain. Issues related to coverage for certain medical devices, including in H.R. 6000, Cures 2.0 Act. Discussions related to the medical device user fee reauthorization. Issues related to the thirty-party servicing of medical devices and remanufacturing of medical devices, including H.R. 7253, the Clarifying Remanufacturing to Protect Patient Safety Act of 2022.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 7253 - Clarifying Remanufacturing to Protect Patient Safety Act of 2022.

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE