Legal Archives - AdvaMed https://www.advamed.org/topics/legal/ Advanced Medical Technology Association Mon, 10 Feb 2025 18:32:23 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.1 https://www.advamed.org/wp-content/uploads/2021/05/cropped-AdvaMed_A_color-32x32.png Legal Archives - AdvaMed https://www.advamed.org/topics/legal/ 32 32 AdvaMed Medical Device Mass Tort TV Ad Trend – Q4 2024 https://www.advamed.org/member-center/resource-library/advamed-medical-device-mass-tort-tv-ad-trend-q4-2024/ Mon, 10 Feb 2025 15:32:02 +0000 https://www.advamed.org/?post_type=resource&p=13100 The post AdvaMed Medical Device Mass Tort TV Ad Trend – Q4 2024 appeared first on AdvaMed.

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Legal

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AdvaMed Recommendations to CMS Regarding Sunshine Reporting Audits https://www.advamed.org/member-center/resource-library/advamed-recommendations-to-cms-regarding-sunshine-reporting-audits/ Sat, 21 Dec 2024 00:00:00 +0000 https://www.advamed.org/?post_type=resource&p=12784 AdvaMed, the world’s leading medtech trade association, communicated to Centers for Medicaid & Medicare Services (CMS) recommendations regarding administration of the Open Payments program.

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AdvaMed, the world’s leading medtech trade association, communicated to Centers for Medicaid & Medicare Services (CMS) recommendations regarding administration of the Open Payments program.

Access the full letter here.

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AdvaMed Asks U.S. Court of Appeals to Support a Fair and Balanced Approach to Patent Damages https://www.advamed.org/industry-updates/news/advamed-asks-u-s-court-of-appeals-to-support-a-fair-and-balanced-approach-to-patent-damages/ Wed, 27 Nov 2024 15:06:01 +0000 https://www.advamed.org/?post_type=news&p=12457 AdvaMed, the Medtech Association, asked the United States Court of Appeals to support a fair and balanced approach to patent damages.

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Legal

Washington, D.C., Nov. 27, 2024 – AdvaMed, the Medtech Association, asked the United States Court of Appeals to support a fair and balanced approach to patent damages.

This case presents the Court with a critical opportunity, sitting en banc, to clarify and rationalize the law of reliable expert testimony for the benefit of all future patent litigation in this country. While the dispute before the Court involves two parties in the “high-tech” industry, the Court’s decision will reach every aspect of district-court patent litigation in cases involving parties in every technological sector.

AdvaMed, representing the world’s largest medical-device manufacturers, which are both plaintiff and defendant in patent-infringement litigation with some regularity, offered their perspective to aid the Court in reaching a conclusion that is sound and workable, consistent with Supreme Court precedent and the Federal Rules of Evidence, and most likely to carry out the Court’s congressionally mandated charge to spur the growth of technology and innovation.

Daubert’s screening — or gatekeeping — obligations require district courts to police whether experts’ conclusions are reliable, including determining that the expert’s opinion reflects a reliable application of the principles and methods to the facts of the case,” said Pat Fogarty, Deputy General Counsel & Senior VP of Legal at AdvaMed. “Given the great financial incentive parties have to exploit the inherent imprecision in patent valuation, this gatekeeping duty is of particular importance in the context of expert testimony on patent damages.”

Read a copy of the AdvaMed amicus brief.  Gregory A. Castanias of Jones Day served as Counsel of Record on behalf of AdvaMed.

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The End of Chevron Deference: What it Means for Medtech https://www.advamed.org/member-center/resource-library/the-end-of-chevron-deference-what-it-means-for-medtech/ Tue, 16 Jul 2024 13:03:44 +0000 https://www.advamed.org/?post_type=resource&p=11403 The AdvaMed Code of Ethics on Interactions with Health Care Professionals in China – the “AdvaMed China Code” or “Code” – serves as a foundational charter for medical technology companies’ compliance programs and encourages the companies to adopt best practices in the ethics unique to their industry.  

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Legal

We hope you found our recent webinar on the Supreme Court’s decision in Relentless v. Department of Commerce and Loper Bright Enterprises v. Raimondo both informative and insightful. This landmark ruling, which overrules the doctrine of “Chevron deference,” will undoubtedly have a significant impact on the medtech industry and all regulated sectors for years to come.

For those who couldn’t attend live or wish to revisit the discussion, you can access the webinar recording and slide deck below.

Webinar Recording

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Circuit Court Sides with Patient Safety and Medtech Innovators in Concluding that DMCA Exemptions are Subject to Judicial Review https://www.advamed.org/2024/06/25/circuit-court-sides-with-patient-safety-and-medtech-innovators-in-concluding-that-dmca-exemptions-are-subject-to-judicial-review/ Tue, 25 Jun 2024 17:30:30 +0000 https://www.advamed.org/?p=11294 In a decisive victory for medtech innovation, the D.C. Circuit Court of Appeals earlier this month held that the Digital Millennium Copyright Act (DMCA) regulations are judicially reviewable. Under this ruling, the Library of Congress must rein in rulemaking that inadvertently could jeopardize patient safety and give away intellectual property by helping unregulated, third-party repair companies hack into highly complex, lifesaving medical devices. Instead, this decision ensures that exemptions to the DMCA anticircumvention provision are subject to the bedrock principle of judicial review. 

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Legal

In a decisive victory for medtech innovation, the D.C. Circuit Court of Appeals earlier this month held that the Digital Millennium Copyright Act (DMCA) regulations are judicially reviewable. Under this ruling, the Library of Congress must rein in rulemaking that inadvertently could jeopardize patient safety and give away intellectual property by helping unregulated, third-party repair companies hack into highly complex, lifesaving medical devices. Instead, this decision ensures that exemptions to the DMCA anticircumvention provision are subject to the bedrock principle of judicial review. 

Two years ago, AdvaMed challenged the DMCA exemption that allows hacking into medical devices. We argued in part that the exemption was arbitrary and capricious, in violation of the Administrative Procedures Act (APA), because, under the text of the DMCA, exemptions are permitted only for non-infringing uses of copyrighted work. Here, there is no doubt that the third-party repair companies seeking to avail themselves of the DMCA exemption are engaging in commercial, non-transformative, infringing uses, so the Library’s finding to the contrary was not in accordance with the law. Without reaching the merits of our arguments, the trial court found that the Library, as an extension of the legislative branch, was not subject to the APA, which typically applies only to executive agencies. 

We appealed the trial court’s erroneous decision.  The D.C. Circuit found in our favor, concluding that even if the Library is not an agency, its enactment of the DMCA exemption is still reviewable under the APA because the Copyright Act specifies that regulations promulgated thereunder, like the DMCA exemption, are subject to the APA.  In its opinion, the D.C. Circuit recognized that the DMCA exemption affects “valuable property rights, such as a copyright holder’s ability to limit access to a digital creation and to prevent intellectual property theft.” Given these important interests, including the implications for patient safety, the D.C. Circuit emphasized that judicial review of the DMCA exemption aligns with “fundamental principles regarding the protection of individual rights against unlawful government action.”  

This ruling marks a significant shift in the legal landscape for medtech innovation. Medtech manufacturers may now challenge in court the exemptions to the DMCA that permit hacking at the expense of the substantial investment those manufacturers made in their intellectual property. More importantly, patients now have added assurance that regulations affecting the integrity of the complex medical devices they depend on are subject to judicial oversight. Next, the trial court will take up the merits of our argument. We look forward to arguing for an outcome that will have lasting impact for patients.  

Special thanks to AdvaMed’s Terry Chang, JD, MD, and the team of medtech lawyers who worked with counsel on the legal argument and strategy. 

For more information on why only authorized parties should repair complex medical devices, click here

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AdvaMed Applauds D.C. Circuit Decision Restoring Judicial Oversight to Rulemaking that Impacts Patient Care https://www.advamed.org/industry-updates/news/advamed-applauds-d-c-circuit-decision-restoring-judicial-oversight-to-rulemaking-that-impacts-patient-care/ Fri, 07 Jun 2024 17:42:26 +0000 https://www.advamed.org/?post_type=news&p=11231 Today, The Advanced Medical Technology Association (AdvaMed) commended the U.S. Court of Appeals for the District of Columbia Circuit’s decision in the case Medical Imaging & Technology Alliance and Advanced Medical Technology Association v. Library of Congress and Carla Hayden (Case No. 23-5067), which ruled favorably in AdvaMed’s lawsuit to prevent unauthorized and unregulated repair companies from hacking into life-saving medical devices.

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Legal

Court’s Ruling Enhances Patient Safety by Ensuring Regulatory Oversight and Accountability in Medical Device Rulemaking

WASHINGTON – Today, AdvaMed, the Medtech Association, commended the U.S. Court of Appeals for the District of Columbia Circuit’s decision in the case Medical Imaging & Technology Alliance and Advanced Medical Technology Association v. Library of Congress and Carla Hayden (Case No. 23-5067), which ruled favorably in AdvaMed’s lawsuit to prevent unauthorized and unregulated repair companies from hacking into life-saving medical devices.

The court’s decision restores accountability to rulemaking under the Digital Millennium Copyright Act (DMCA) and affirms that the Library of Congress is subject to the Administrative Procedure Act (APA) when engaged in rulemaking under the DMCA. This ruling recognizes that the ability of federal courts to review federal rules is a fundamental component of the checks and balances system established by the Constitution.

“This decision is a significant victory for the medical technology industry and the principles of good governance,” said Christopher White, chief policy officer and general counsel of AdvaMed. “The ruling ensures that regulatory actions affecting our industry are subject to judicial review, thereby protecting the innovation and safety standards that are critical to our mission of advancing medical technology for better patient outcomes.”

AdvaMed brought this suit to challenge a DMCA rule that allows unregulated repair companies to hack into life-saving medical devices. In March of 2023, the D.C. District Court held that our claims were barred by sovereign immunity because the APA does not authorize lawsuits against Congress, and the Librarian of Congress is a part of Congress. AdvaMed argued that the Library of Congress, while conducting executive rulemaking functions, must be considered an agency subject to the APA. The D.C. Circuit’s decision validates this argument, ensuring that the Library’s rulemakings are not exempt from the procedural safeguards and judicial oversight established by the APA.

AdvaMed looks forward to a decision on remand that vacates the rule to resolve this important public health matter and protect the integrity of complex FDA-regulated medical devices.

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What Chevron’s Demise Could Mean for Medtech https://www.advamed.org/2024/06/03/what-chevrons-demise-could-mean-for-medtech/ Mon, 03 Jun 2024 16:58:27 +0000 https://www.advamed.org/?p=11204 The Supreme Court will soon address the fate of agency deference—an issue presented in Relentless v. Department of Commerce and Loper Bright Enterprises v. Raimondo—in a ruling expected to have far-reaching effects on how federal agencies regulate medtech and many other industries and how the industries interact with lawmakers, agencies, and the courts.

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Legal

The Supreme Court will soon address the fate of agency deference—an issue presented in Relentless v. Department of Commerce and Loper Bright Enterprises v. Raimondo—in a ruling expected to have far-reaching effects on how federal agencies regulate medtech and many other industries and how the industries interact with lawmakers, agencies, and the courts.

At the core of the Supreme Court’s review is the doctrine in Chevron v. Natural Resources Defense Council, under which courts defer to an agency’s construction of an ambiguous statute, so long as it was reasonable. The Supreme Court has been asked to overturn or limit this deference and direct courts to instead ask: Was the agency’s interpretation the best reading of the statute?

If the Court does away with Chevron deference, that decision would have far-reaching consequences across regulated industries and would have a profound impact on medtech. 

Overall—and what I’m watching most closely—is what the Court’s final opinion means for regulatory certainty by expert agencies that know the fragile medtech innovation ecosystem and science best. Medtech innovation thrives best in a predictable legal environment. 

  • On one hand (without Chevron deference), where long-standing and balanced regulatory agency decisions may be easily litigated and thereby change or reverse standards, the ability to bring the latest innovations to patients can be compromised. 
  • On the other (with Chevron deference), where agency decisions key to innovation and patient access change from one administration to the next, innovation and patient access can be compromised.  

Patients need a finely tuned outcome in this case. More stability and continuity could be more conducive to unleashing the bold innovations patients need.

Potential Pros for Medtech of Overturning Chevron include:

  • Opportunities for legal challenges to overzealous rulemakings: Overturning Chevron could create opportunities for medtech to challenge in court regulations that restrain medtech innovation and have adverse consequences for patient access. This could be particularly important where agencies promulgate broad-based policies without understanding the innovation, research, manufacturing, supply chain or FDA approval implications on medical technology and patient access.
  • Opportunities to support lawmakers and agencies: As Congress will have greater responsibility for drafting technical and precise legislation, this will provide more opportunity and value in receiving expert input from industry stakeholders like medtech. This can be especially valuable for medtech, as America leads the world in medtech innovation and manufacturing.

Potential Cons for Medtech of Overturning Chevron include:

  • Risks to patient access and favorable agency action: Patients rely on one centralized decision maker to ensure the safety and effectiveness of medical technology. Where FDA product clearances are subject to re-review by self-interested parties like the trial bar, that can have adverse effects on patient access in general (and create differential patient access premised on court jurisdiction), chill investment in innovation, and drive other uncertainties in the industry. 
  • Less flexibility for agencies in changing times: Some agencies essential to facilitating patient access to the latest medical technologies are hampered by old statutes that restrain innovation and benefit from the flexibility to reinterpret existing laws that Congress has not updated to account for evolving technology. Medical technology evolves at a rapid rate, and in some cases, Congress’ enacted legislation is anchored in the 1970s—where the law is outdated or silent, we can’t limit patients to the state of medical care at that time.

We look forward to providing updates on the Supreme Court’s decision—and its impact on medtech—which we expect the Supreme Court to issue this summer.

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Dark Money: Undisclosed Third Party Litigation Funding and Its Impact on Medical Technology https://www.advamed.org/member-center/resource-library/dark-money-undisclosed-third-party-litigation-funding-and-its-impact-on-medical-technology/ Wed, 17 Jan 2024 19:13:55 +0000 https://www.advamed.org/?post_type=resource&p=9868 Third party litigation funding has become widespread in the civil justice system. The growing use of TPLF to generate mass tort litigation, particularly against manufacturers of medical technology, misuses the civil justice system, adversely affects public health, chills innovation, and harms patients.

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Legal

Third party litigation funding has become widespread in the civil justice system. The growing use of TPLF to generate mass tort litigation, particularly against manufacturers of medical technology, misuses the civil justice system, adversely affects public health, chills innovation, and harms patients.

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The Trial Bar’s Most Wanted: Breaking Down Litigation Trends and Themes Affecting Key Industries https://www.advamed.org/member-center/resource-library/the-trial-bars-most-wanted-breaking-down-litigation-trends-and-themes-affecting-key-industries/ Wed, 17 Jan 2024 17:03:57 +0000 https://www.advamed.org/?post_type=resource&p=9860 Although the individual claims may differ, a review of recent products liability claims levied against industries targeted by the plaintiffs trial bar reveals common threads. For example, the drivers of litigation are the same regardless of the industry, such as, government action, studies (whether legitimate or not) implicating products, and areas of advanced innovation with new regulatory safeguards.

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Legal

Although the individual claims may differ, a review of recent products liability claims levied against industries targeted by the plaintiffs trial bar reveals common threads. For example, the drivers of litigation are the same regardless of the industry, such as, government action, studies (whether legitimate or not) implicating products, and areas of advanced innovation with new regulatory safeguards.

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MedTech Compliance Bootcamp https://www.advamed.org/events/2024-compliance-bootcamp/ Fri, 12 Jan 2024 22:47:35 +0000 https://www.advamed.org/?post_type=event&p=9838 This carefully curated program will provide you with a comprehensive understanding of the current medtech compliance framework.

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Events

AdvaMed Medical Device Mass Tort TV Ad Trend – Q4 2024

AdvaMed Medical Device Mass Tort TV Ad Trend – Q4 2024

  1. Overview
  2. Agenda
  3. Speakers

AdvaMed Medical Device Mass Tort TV Ad Trend – Q4 2024

Our 2024 Compliance Bootcamp has officially concluded but join our mailing list to receive updates on the 2025 program.

This event is perfect for those who have recently taken on compliance responsibilities, are currently revamping an existing program, or just want a quick refresher. The carefully curated program will provide you with a comprehensive understanding of the current compliance framework; practical, hands-on approaches for addressing challenges and hurdles; and methods for effectively managing compliance within a medical technology company. Ensure your team is up to speed on compliance issues and secure your spot for this event!

Learning Objectives

  • How to build and maintain an effective compliance program, as well as implement best practices.
  • Group breakout sessions and interactive discussions of relevant hypothetical case studies.
  • An in-depth look at major risk areas and compliance challenges and the ways to mitigate those risks.
  • A holistic breakdown of the fundamentals of compliance.

This event is in partnership with:

Porzio Logo

2024 Agenda

The full Compliance Bootcamp agenda is below. You can also download a copy of it here.

DAY ONE – Tuesday, September 10th
Start TimeTopic/Details
All Sessions Will Be Interactive Throughout
8:00 amBreakfast
8:30 amIntroduction
Faculty Bios
Program Overview
Attendees’ Goals for This Program/Polling
AdvaMed Intro
9:00 amThe Amorphous Power of Culture
Impact of Culture on Compliance
Pressure Points that Can Affect (and Change?) Culture
9:45 amThe Foundation of Your Compliance Program
Relevant Laws, Rules and Guidance
Converting the Required Elements of an Effective Compliance Program into a Structure
The Tools and Environment to Manage Risk
Motivating Senior Management and Educating the Board
10:45 amBreak
11:00 amWhat Interests The Government These Days
Recent Government Enforcement Actions & Areas of Focus
Lessons Learned and Their Relevance to Your Business
New Developments
12:00 pmLunch
1:00 pmCompliance Deep Dive: Identifying and Mitigating Ongoing and Emerging Risk Areas Inside and Outside the United States
Identifying High Risk Areas
Addressing and Mitigating Risks Locally and Globally   Considerations related to Interactions with HCPs and Other Health Care Entities;
Managing Third-Party Distributors;
Data Privacy; Other Compliance Challenges
3:00 pmBreak
3:15 pmInteractive Break Out Session
Present hypothetical scenarios and consider application of the AdvaMed Code and other compliance considerations
Conducting a compliance risk assessment
5:15 pmReview of Day One/Plan for Day Two
5:30 pmAdjourn Day One
5:30 pmProgram Reception – AdvaMed Rooftop
1301 Pennsylvania Avenue NW Suite 400, Washington, DC 20004
DAY TWO – Wednesday, September 11th
Start TimeTopic/Details
All Sessions Will Be Interactive Throughout
8:00 amBreakfast
8:30 amRecap of Day 1 and Interactive Q&A
9:00 amManaging Promotional, Medical, Corporate & Investor Communications (including Social Media): What You Can/Should/Shouldn’t Say to Whom
Regulatory Requirements for Promotion
Recent Developments:
FDA and FTC Enforcement
Key Considerations for Scientific Exchange
Disease Awareness and Corporate Communications
Social Media and Considerations with Use of “Influencers”
10:00 amIndustry Panel – Healthcare Compliance and All Its Glory in the Medical Device Business
This session will involve current in-house Compliance Officers and AdvaMed compliance leaders who will discuss the multifaceted considerations associated with managing and mitigating health care compliance risks in today’s medical device industry.
11:30 amAdvaMed Update
Patrick Fogarty, Deputy General Counsel and Senior Vice President, Legal, AdvaMed
Ida Nassar, Vice President, Assistant General Counsel, Compliance & Ethics, Legal, AdvaMed
12:15 pmLunch Break
12:45 pmHot Topics
1:45 pmClosing Discussion, Q&A and Wrap-up
Any Remaining (Burning) Questions
So What Are You Going to Do When You Get Back to Work?
2:00 pmAdjourn Day Two

2024 Speakers

Michelle Axelrod Headshot

Michelle D. Axelrod, J.D. Managing Principal of Porzio, Bromberg & Newman.

Michelle D. Axelrod is the Managing Principal of Porzio, Bromberg & Newman’s New England office. Michelle has over 25 years of experience addressing legal and compliance issues impacting companies in the life sciences industry; 15 years as in-house counsel. Michelle primarily counsels pharmaceutical, medical device, and biotech clients on legal and compliance issues related to product commercialization and related sales, marketing, and reimbursement activities. Michelle reviews promotional
content and medical communications, advises on fraud and abuse matters and related issues, provides direction regarding field and account management, and supports clients’ compliance initiatives, including the development of policies/SOPs, training, and monitoring and auditing programs. Michelle also negotiates, drafts and reviews commercial and government contracts, including discount and rebate agreements with health plans/PBMs, retail/specialty pharmacies, GPOs, wholesalers, and other healthcare entities. In addition, she handles distribution agreements and other fee-for-service consulting and service arrangements common in the life sciences industry.

Alfred R. Brunetti, Principal, Porzio, Bromberg & Newman.

Alfred R. Brunetti is a seasoned counselor who guides clients through the increasingly complex matrix of data privacy and
security laws, regulations and guidance impacting business across all industries. Fred combines his in-depth knowledge of
existing and emerging privacy laws and best practices with his extensive nationwide litigation and compliance experience to
regularly advise clients, both large and small, on all manner of data privacy issues relating to the collection, processing and
management of personal information throughout its life cycle.

He leads the firm’s Data Privacy Practice Group and is certified by the International Association of Privacy Professionals
(IAPP) as both a Certified Information Privacy Professional in the laws of the United States (CIPP/US), a designation
evidencing information privacy expertise with advanced concentration in domestic private sector laws, and a Certified
Information Privacy Manager (CIPM), a designation evidencing expertise in the creation and management of a
comprehensive privacy program.

Fred began his legal career as a law clerk for the Hon. Elaine L. Davis, P.J. Crim., in Hudson County, NJ, and then as an
assistant prosecutor in the Union County Prosecutor’s Office in Elizabeth, NJ. He is a graduate of Seton Hall University and
Seton Hall University School of Law, where he was an award-winning member of the Interscholastic Moot Court Board.

Pat Fogarty Headshot

Pat Fogarty, Esq., Deputy General Counsel, Senior Vice President of Legal, AdvaMed

Pat Fogarty is the Deputy General Counsel & Senior VP of Legal at the Advanced Medical Technology Association (AdvaMed). AdvaMed advocates globally for the highest ethical standards and patient access to safe, effective and innovative medical technologies that save and improve lives. In addition to providing in-house legal counsel to the organization, Pat leads AdvaMed’s litigation reform legal policy work and related stakeholder outreach, which are emerging priorities for medtech innovators and patients who rely on FDA’s safety determinations. He also manages the association’s amicus curiae program, including filing multiple briefs on a myriad of issues in U.S. federal and state courts. Pat holds a B.A. from Virginia Tech and a J.D. from the Syracuse University College of Law. He is admitted to the District of Columbia Bar.

Marsha Goodman-Khan Headshot

Masha Goodman-Khan, Senior Director of Compliance and Legal Operations, Vericel

Masha Goodman-Khan is the Senior Director of Compliance and Legal Operations at Vericel Corporation.  She possesses over a decade of experience guiding biopharmaceutical and medical technology organizations in the area of healthcare and regulatory compliance, as well as healthcare law and policy.  Masha holds a Bachelor of Science in Biological Sciences from Georgia State University and a Master of Science in Jurisprudence (M.S.J) in Pharmaceutical and Medical Device Law & Compliance and Hospital and Health Policy from Seton Hall University School of Law.

Ida Nassar Headshot

Ida Nassar, Esq., Vice President, Assistant General Counsel, Ethics & ComplianceAdvaMed

Ms. Nassar manages AdvaMed’s ethics and compliance policy working groups on the AdvaMed Code, federal and state anti-kickback statutes, the Physician Self-Referral (Stark) Law, Sunshine Implementation, False Claims Act, and other health care laws and regulations applicable to medical device innovators and manufacturers. Ms. Nassar also handles AdvaMed’s global legal policy working groups, which seek to establish common global standards for anti­ corruption and business integrity and secure procurement, regulatory, and enforcement incentives that reward compliance. Prior to AdvaMed, Ms. Nassar was a Senior Attorney within the Drug Enforcement Administration’s Office of Chief Counsel where she handled enforcement actions under the Controlled Substances Act as well as defensive litigation matters for the department. She also served as Trial Attorney for the U.S. Department of Justice, managing commercial and torts litigation (including vaccine litigation). Ida also practiced for several years with the Hollingsworth law firm managing life sciences products liability litigation.

Jennifer Romanski Headshot

Jennifer Romanski, J.D., Principal, Porzio, Bromberg & Newman

Ms. Romanski, chair of the firm’s Life Sciences Legal, Regulatory, and Compliance Practice Group, has broad experience counseling pharmaceutical, biotech and medical device companies in regulatory and compliance matters, including preparation of corporate compliance programs, advertising and promotion activities, medical publication planning, interactions with healthcare practitioners, grants and continuing medical education programs, FDA enforcement activity, and sample accountability and PDMA requirements. She worked for many years in Porzio’s Key Client program where she served as part of the in-house legal team for various pharmaceutical companies several days a week. She has also served as acting compliance director at a large pharmaceutical company, where she was involved in over twenty compliance reviews and investigations.

Daniel Spicehandler Headshot

Daniel Spicehandler, VP, Compliance- Commercial Divisions, Stryker Corporation

Dan Spicehandler is currently the vice president for Compliance Commercial Divisions at Stryker, a leading international medical device and technology company. He is responsible for leading a team of compliance officers who support the commercial divisions at Stryker through a proactive, principles and risk-based program.

His career has involved multiple operational and leadership positions across the medtech, biotech, and pharmaceutical industries. Prior to Stryker, he served as the U.S. compliance officer for Sanofi Pasteur; led the monitoring, auditing, policy, and risk team at Novo Nordisk Inc.; and served as the director of compliance for Meda Pharmaceuticals (acquired by Mylan). His career has involved both compliance and legal positions, and he has also served as in-house counsel at both Novo Nordisk and Meda. Dan’s experience at both large multinational organizations under monitorships for Corporate Integrity Agreements and REMS programs and smaller U.S.-based companies have helped him to understand the importance of developing compliance programs designed to fit the needs of the business and adapt to the changing expectations of regulators.

Prior experience also includes work as a consultant in developing compliance programs with Polaris Management Partners (now IQVIA) and as a lawyer with the firm of Reed Smith LLP. He is a graduate of Fordham University School of Law, where he serves as an alumnus on its Advisory Board for Compliance Programs, and Union College in Schenectady, New York.

Alessandra Spina, VP and Deputy GC, Chief Compliance Officer – Healthcare Compliance –Terumo Americas

Alessandra  is a business oriented legal and compliance professional with over twenty years of diverse operational, transactional, and healthcare compliance experience in world-leading medical device and consumer electronics corporations. She has a proven record of success managing large-scale projects, global commercial transactions, and strategic development of anti-bribery/anti-corruption corporate compliance programs in the Americas, EMEA, and Asia Pacific.

Alessandra joined Terumo in 2016, serving the organization in legal and compliance roles of increasing responsibilities: as of 2019 Alessandra served as Terumo Americas Holding Deputy Chief Compliance Officer and the designated Chief Compliance Officer for MicroVention and Terumo Medical. In 2024 Alessandra was appointed as Chief Compliance Officer for Terumo Americas and continued to enhance the ABAC compliance program and bring alignment across all Terumo companies while fostering the company’s ethical culture.

Alessandra is an attorney admitted in New York State and in Italy (inactive). She holds an LL.M. in Corporate Compliance from Fordham University School of Law in New York City.

Prior to joining Terumo, she served as EMEA Legal Counsel for Zimmer Biomet based in Switzerland, and as Acting General Counsel Samsung Electronics based in Italy.

Chris White Headshot

Christopher L. White, General Counsel, Chief Policy Officer, and Secretary, AdvaMed

Mr. White serves as the Association’s Chief Legal Officer and AdvaMed’s Chief Policy Officer, leading the Association’s work to develop and promote policy positions enhancing patient access to medical technology worldwide. Mr. White also leads the Association’s strategic planning activities and investor relations matters. In March 2020, Mr. White was appointed the organization’s COVID-19 Action Team Leader, leading all COVID-19-related initiatives and policy. Additionally, he guided the organization to fully remote functioning upon the onset of the pandemic.

He testified before state and federal legislative committees on priority legal policy issues; led the drafting team revising the AdvaMed Code; and led the multinational negotiating team to draft the Kuala Lumpur Principles, harmonizing industry Codes of Ethics in Asia. He is a frequent speaker on health law and policy issues, and posts health policy blogs on his Linkedln page.

Prior to AdvaMed, Mr. White was a partner with the global law firm Morgan Lewis; and he began his health law legal career with the firm Drinker Biddle. Mr. White is a graduate of Wake Forest University, where he studied electron microscopy and cell biology, and Catholic University Law School.

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