Jessa Boubker is a health care and life sciences associate with Foley & Lardner LLP and a member of the firm’s Health Care Practice Group. Jessa’s practice focuses on a broad range of federal and state regulatory compliance, transactional, and business matters for health industry clients.
FDA 监管
Jessa helps advise clients on U.S. Food and Drug Administration (FDA) regulatory compliance and transactional matters related to the research, development, and commercialization of pharmaceuticals, medical devices (including software as a medical device), cosmetics, dietary supplements, and general wellness products.
Clinical Research and Life Sciences
Jessa assists in the development and maintenance of clinical trial compliance programs, including drafting and reviewing corporate policies and agreements on behalf of institutions, site management organizations, contract research organizations, and pharmaceutical and medical device sponsors. She has drafted and negotiated an array of agreements necessary for the research, development, and commercialization of pharmaceutical and medical device products.
Health Care Providers and Digital Health
Jessa works with both telemedicine and brick-and-mortar health care provider clients on regulatory compliance matters pertaining to corporate practice of medicine, reimbursement, licensure, prescribing, and scope of practice issues. She has worked with a number of multi-state and national digital health and telemedicine companies to launch and scale their direct-to-consumer telehealth platforms and operations throughout the United States.
Jessa began her career as a summer associate at Foley, where she assisted on a range of regulatory and transactional matters. While in law school, Jessa was the Editor-in-Chief of the American Journal of Law & Medicine, the country’s leading health law journal devoted exclusively to the analysis of issues at the nexus of law and medicine. Jessa also served as a judicial intern for Magistrate Judge Donald L. Cabell of the U.S. District Court for the District of Massachusetts and was a member of the Legislative Policy & Drafting Clinic at Boston University School of Law in which she drafted long-term care legislation on behalf of a Massachusetts State Senator.
代表经验
- 在康涅狄格州的骨科和脊柱护理管理服务机构 Spire Orthopedic Partners（科尔伯格公司的投资组合公司）收购 Sports Medicine North Orthopedic Surgery, Inc.
- Represented Medical Imaging Services, LLC, a company engaged in the distribution, sale, and service of diagnostic imaging equipment, supplies, and parts in its sale to 626 Imaging, a Peak Rock Capital portfolio company.
附属机构
- Member, Boston Bar Association
- Member, American Health Law Association (AHLA)
- Member, American Telemedicine Association (ATA)
演讲和出版物
- 合著，"GLP-1 受体激动剂：临床试验注意事项》，《今日医疗保健法》（2025 年 7 月 22 日）
- 与他人合著，"德克萨斯州法院撤销 FDA 的实验室开发测试 (LDT) 最终规则"，《今日医疗保健法》（2025 年 4 月 2 日）
- 合著，"GLP-1 Drugs：品牌公司推动 FDA 限制复方制剂》，《今日医疗保健法》（2024 年 12 月 2 日）
- 合著，"Cancer Drugs：抗体药物共轭物 (ADC) / 抗体疗法的临床试验问题》，《今日医疗保健法》（2024 年 11 月 5 日）
- 合著，"Medicare Coverage：CMS Finalizes New Pathway for Breakthrough Devices，"Health Care Law Today（2024 年 10 月 14 日）
- 合著，"LDTs：FDA 推出分阶段实施的新监管要求》，《今日医疗保健法》（2024 年 5 月 20 日）
- 合著，"Clinical Trials：美国食品和药物管理局发布最终确定的研究药物使用收费指南》，《今日医疗保健法》（2024 年 3 月 13 日）
- 合著，"OIG Opines on Subsidizing Medicare Cost-Sharing for Clinical Trials"，《今日医疗保健法》（2024 年 2 月 26 日）
- 西北地区远程医疗资源中心远程医疗会议（2024 年 4 月 30 日），演讲人，"平衡创新与安全：西北地区远程医疗资源中心远程医疗会议，"医疗保健中的人工智能"（2024 年 4 月 30 日）
- Speaker, “Working with Experts: Understanding the Attorney-Client Privilege,” The New England Alliance Winter Conference & Annual Meeting (January 11-13, 2023)
- Co-Speaker, “Software as a Medical Device Legal Issues to Understand,” ACC Quick Hit (September 13, 2022)
- Guest Lecturer, “Hospital Finance,” Hospital Law Course, New England Law School (Feb. 15, 2022)
- Speaker, “Increased Oversight in Nursing Homes & Changes to COVID-19 Survey Activities,” The New England Alliance Winter Conference & Annual Meeting (January 12-14, 2022)
- Co-author, “FDA’s New Guidance Proposes Flexible Use of AI in Medical Devices,” Health Care Law Today (May 10, 2023)
- Co-author, “Framing FDA Regulatory Compliance and Patenting Strategy for Artificial Intelligence (AI)-Based Software as a Medical Device (SaMD),” Health Care & Life Sciences Top Trends for 2023 (2023)
- Co-author, “Legal Considerations,” Emerging Practices in Telehealth: Best Practices in a Rapidly Changing Field (2023)
- Co-author, “Migraine Company Fails to Avoid Own Headache: Jet Medical and Others to Pay $745,000 to Resolve Allegations that Medical Device was not Approved or Cleared before Commercialization,” Health Care Law Today (January 11, 2023)
- Author, “Biomedical Research,” Massachusetts Health & Hospital Law Manual (August 27, 2022)
- Co-author, “State and Federal Administrative Agencies Regulating Health-Care Providers and Payors,” Massachusetts Health & Hospital Law Manual (August 27, 2022)
- Co-author, “Emergency Medical Treatment and Labor Act,” Massachusetts Health & Hospital Law Manual (August 27, 2022)
- Author, When Medical Devices Have a Mind of their Own: The Challenges of Regulating Artificial Intelligence, 47 American Journal of Law and Medicine 427-454 (March 2022)
- Author, Legislating the New Normal: COVID-19 Waivers and Permanent Changes to Long-Term Care, New England Administrator, pg. 13-14 (March 2022)
- Co-author, “FDA Addresses the Role of Digital Health Technology in Clinical Trials,” Health Care Law Today (January 11, 2022)
- Co-author, “Medicare Telehealth and Substance Use Disorder Treatment: New CMS Reimbursement Requirements,” Health Care Law Today (January 10, 2022)
- Co-author, “FDA Drafts Public Health Emergency Transition Plan: What Device Manufacturers Need to Know,” Health Care Law Today (January 6, 2022)
- Co-author, “3D Printing Medical Devices at the Point of Care – FDA Invites Feedback”, 23 J. HEALTH CARE COMPLIANCE 19-20, 29 (Nov.-Dec. 2021)
- Co-Author, “3D Printing Medical Device at the Point of Care – FDA Invites Feedback,” Health Care Law Today (December 16, 2021)
- Co-Author, “CMS Changes Course by Repealing the Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary Rule Due to Insufficient Beneficiary Protections,” Health Care Law Today (November 21, 2021)
- Author, “Never Too Early to Save a Child’s Life: Eating Disorders Prevention in Schools Act of 2020,” DOME BLOG (Aug. 23, 2021)
- Author, “Preface,” 47 American Journal of Law and Medicine 7 (2021)
- Co-author, “HHS Provider Relief Funds and the Strings and Risks Attached: What Compliance Officers Need to be Thinking About Now,” 22 J. HEALTH CARE COMPLIANCE 5-10 (2020)
富理达律师为美国卫生法协会更新的《远程医疗法律手册》撰稿
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美国食品和药物管理局发起进攻！在一波执法行动中瞄准制药公司的药品广告
GLP-1受体激动剂：临床试验考量
德克萨斯州法院撤销美国食品药品监督管理局实验室开发检测（LDT）最终规则
Foley Recognized with 2025 JD Supra Readers' Choice Awards
