Overview
Attorney Andy Rusczek provides regulatory and compliance advice to a broad range of clients in the health care and life sciences industries, including hospitals, academic medical centers, and related providers as well as pharmaceutical, medical device, and biotechnology companies. His practice encompasses many legal areas within the health care and life sciences space.
Andy has particular experience with respect to the following types of matters, among others:
- Hospital and health plan transactions and affiliations, including negotiations of definitive agreements, revisions to governance documents, regulatory approvals, and diligence matters
- Regulatory and compliance issues for pharmaceutical and device companies
- Formation and operation of accountable care organizations, physician-hospital organizations, independent practice associations, and related multi-provider networks
- Compliance with the federal anti-kickback statute, the Stark law, and other fraud and abuse laws, such as in the context of product discount arrangements, relationships with physicians, and health care transactions
- Development of comprehensive privacy and security policies and related guidance documents in accordance with the European Union General Data Protection Regulation (GDPR) and HIPAA, HITECH, and state privacy laws
- Human subjects research and related issues, both domestically and internationally
Additionally, Andy has gained a strong understanding of the operational aspects and business of pharmaceutical and device companies through prior on-site placements at three different companies. In these positions, he advised clients on various legal issues, including fraud and abuse laws, clinical trials and related issues (such as privacy, subject recruitment, site contracting, informed consent forms, and FDA requirements for INDs), market research, promotional review activities, patient assistance programs, group purchasing organization and customer contracts, discount and pricing arrangements, sales representative contracts, and state manufacturer conduct and disclosure laws as well as FDA regulations and other legal requirements related to operating a start-up or commercial company.
Before joining Epstein Becker Green, Andy was a partner at a Boston law firm and served as chair of its Health Care & Life Sciences Group. He also served as a community member of the Brigham and Women’s Hospital Institutional Review Board (2010-2015).
While attending the University of Pennsylvania Law School, Andy earned a Master of Bioethics from the University of Pennsylvania School of Medicine to better assist future clients with ethical issues involved with human subjects research.
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Focus Areas
Services
- Academic and Clinical Research
- Corporate Compliance Program Development, Implementation, and Effectiveness
- Cross-Border Data Transfers
- Drug and Medical Device Distribution
- FDA Inspections and Enforcement
- Fraud and Abuse Compliance Counseling and Defense
- Government and Commercial Coding, Coverage, and Payment
- Health Care
- Industry Research and Clinical Trials
- Life Sciences
- Privacy Compliance Strategies
- Privacy, Cybersecurity & Data Asset Management
- Product Marketing and Compliance
- Ransomware
- Regulatory Strategy, Product Development, and Product Approvals
- Stark and Self-Referral Laws
- Value-Based Purchasing and Accountable Care
Experience
Recognition
- The Best Lawyers in America: Health Care Law (2017 to 2025)
- Chambers USA, America’s Leading Lawyers for Business: Massachusetts—Healthcare, "Leader in Their Field" (2019 to 2024)
- New England Rising Stars: Health Care (2013 to 2019)
Credentials
Education
- University of Pennsylvania Law School (J.D., cum laude, 2008)
- University of Pennsylvania School of Medicine (M.BE., 2008)
- Bowdoin College (A.B., magna cum laude, 2002)
- Phi Beta Kappa
Bar Admissions
- Massachusetts
Professional & Community Involvement
- American Health Lawyers Association
- Boston Bar Association
Events
Past Events
- April 13, 2022
- February 2, 2022
- University of Maine School of Law: Innovative Big Health Data Research2020
- Information Privacy in Practice Conference: Using Data Ethically and Legally
Insights
Insights
- Firm Announcements
Epstein Becker Green Attorneys Honored for Excellence in the Legal Profession by Best Lawyers 2025
14 minute read - Firm Announcements
Epstein Becker Green Honored for Exceptional Performance in Key Practice Areas by Chambers USA 2024
5 minute read - BlogsFDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors4 minute read
- Firm Announcements
Epstein Becker Green Attorneys Recognized by 2024 Best Lawyers for Excellence in the Legal Profession
12 minute read - PublicationsEuropean Commission Adopts an Adequacy Decision for a New EU-U.S. Data Privacy Framework6 minute read
- PublicationsFDA Issues Draft Recommendations for Implementing Decentralized Clinical Trials20 minute read
- Firm Announcements
Epstein Becker Green Recognized for Focused Excellence Across Core Practice Areas in Chambers USA 2023
5 minute read - Firm Announcements
Epstein Becker Green Attorneys Recognized by 2023 Best Lawyers for Excellence in the Legal Profession
11 minute read - Firm AnnouncementsChambers USA 2022 Recognizes Epstein Becker Green's Focused Excellence in Core Practice Areas: Distinguished in ...4 minute read
- Firm AnnouncementsFifty-Eight Epstein Becker Green Attorneys Recognized for Professional Excellence–Three Attorneys Distinguished as ...7 minute read
- PublicationsRansomware: A Guide to Practical, Regulatory, and Reputational Risk Management16 minute read
- Firm Announcements
Epstein Becker Green’s Focused Excellence Lauded by Chambers USA in 2021 Edition of Leading Law Firms and Attorneys ...
3 minute read - Media Coverage
Epstein Becker Green’s Latest Health Hires in Boston Featured in Law360
2 minute read - PublicationsEpstein Becker Green’s Boston Health Care and Life Sciences Practice Featured in “Hire Up: This Week’s Lateral ...2 minute read
- Firm AnnouncementsEpstein Becker Green Adds Group of Health Care & Life Sciences Attorneys in Boston6 minute read