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General Resources
Shelter-in-Place / Stay-at-Home Orders
In response to the rapidly evolving shelter-in-place and business closure orders, AdvaMed is working with local, state and federal authorities to (1) clarify orders; and, (2) secure specific exemption text for essential medtech functions. We hope the following COVID-19 legal resources are helpful.
- State Actions on COVID-19 | Stateside report (updated several times a day)
- *April 10, 2020 | AdvaMed Defense Production Act Checklist / COVID-19 Trade Checklist | Status of COVID-19 Administration and AdvaMed Actions by Product Group | Access template
- April 9, 2020 | Norton Rose Fullbright – Legal Update | Cooperation amid COVID-19: Medical supply collaboration won’t face US antitrust scrutiny (Read the article)| US Department of Justice (DOJ) Business Review Letter – Healthcare Collaborations 20200404
- *April 8, 2020 | COVID-19 Risk Management, Exposure and Case Management Guidance | Access the model document
- March 23, 2020 | Reed Smith | A Resource Guide to the United States Quarantine and Isolation Laws by State
- *March 23, 2020 | AdvaMed Model Essential Employer Letter (template for use with essential company employees and suppliers) | Access the model document
- March 20, 2020 | DHS CISA guidance on essential critical infrastructure
- March 19, 2020 | “Dear Governor” Letter from 8 national health care products trade groups
- March 19, 2020 | Recommended language for states to use as a supplement to DHS CISA (federal consistency is preferred)
AdvaMed COVID-19 Legal Resources Staff Contacts: Chris White or Pat Fogarty
AdvaMed State Government Affairs Staff Contacts:
States west of the Mississippi River: Fielding Greaves
States east of the Mississippi River: Manthan Bhatt
COVID-19 Voluntary Front Line or Other Support Services Efforts
During the current COVID-19 health crisis there are several medically qualified employees providing voluntary front-line or other support services to aid the recovery process. AdvaMed has developed an example model policy document for consideration and voluntary use. This document includes a broad-based example covering multiple areas (e.g., general guidance; HR & Insurance awareness; legal implications; acknowledgment form), which can be customized to address unique circumstances and to include company-specific items.
- *April 3, 2020 | AdvaMed Model Volunteer Policy Letter (Template)
Code of Ethics Compliance
Medtech manufacturers affirm the importance of doing business with integrity and continuing to abide by the foundational principles of the AdvaMed Code of Ethics as they respond to the challenges of the COVID-19 pandemic. The guidance in the AdvaMed Code of Ethics is derived from various U.S. statutes and guidance, including the False Claims Act and Anti-Kickback Statute, which both very much still apply even during a state of emergency. The AdvaMed COVID-19 Compliance Guidance that follows below was drafted with the assistance of a robust group of member company compliance officers and is designed to support rapid decision-making in the context of the pandemic and mitigate compliance/corruption risks.
- AdvaMed COVID-19 Compliance Guidance
- AdvaMed 2020 Code of Ethics
- AdvaMed 2020 Code of Ethics Training Slides
AdvaMed Ethics Compliance Staff Contacts:
Nancy Travis
Ethan Gumpert
Archived Resources
- *June 17, 2020 | AdvaMed Post COVID-19 Policy Document
- June 9, 2020 | Re-entry Guidance for Health Care Facilities and Medical Device Representatives
- May 20, 2020 | Blog: Doing Good… While Doing Good
- April 27, 2020 | Coalition Statement on Reinforcing Business Ethics and Integrity amidst COVID-19
- *March 31, 2020 | Webinar | COVID-19: Product Liability and Potential Protections Under the PREP Act and Other Proposed Legislation | Access presentation materials
- Crowell & Moring – Coronavirus Resource Center
- Sidley – COVID-19 Resource Center
- Baker Tilly – Medical device and Pharmaceutical Coronavirus Resources