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規制
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.
代表的な経験
- コネティカット州を拠点とする整形外科・脊椎治療管理サービス会社Spire Orthopedic Partners社（Kohlberg & Co.のポートフォリオ会社）によるSports Medicine North Orthopedic Surgery, Inc.およびその関連外来手術センターの買収を代理。
- 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.
所属
- ボストン弁護士会会員
- Member, American Health Law Association (AHLA)
- Member, American Telemedicine Association (ATA)
プレゼンテーションと出版物
- 共著「GLP-1受容体作動薬：臨床試験に関する考察」（Health Care Law Today、2025年7月22日号）
- 共著者「テキサス州裁判所がFDAの臨床検査（LDT）最終規則を取り消す」（Health Care Law Today, April 2, 2025）
- 共著者「GLP-1薬：ブランド企業がFDAに配合制限を求める」（Health Care Law Today、2024年12月2日号）
- 共著「がん治療薬：抗体薬物複合体(ADC)/抗体治療薬の臨床試験における問題点」ヘルスケア・ロー・トゥデイ(2024年11月5日)
- 共著「メディケアの適用範囲：CMS Finalizes New Pathway for Breakthrough Devices」（Health Care Law Today、2024年10月14日号）
- 共著「LDTs：FDA Rolls Out a Phased Implementation for New Regulatory Requirements」ヘルスケア・ロー・トゥデイ（2024年5月20日号）
- 共著「臨床試験：FDA Issues Finalized Charging Guidance for Investigational Drug Use（FDAが治験薬使用の課金ガイダンスを最終決定）」Health Care Law Today（2024年3月13日号
- 共著者「OIG Opines on Subsidizing Medicare Cost-Sharing for Clinical Trials」Health Care Law Today（2024年2月26日号）
- スピーカー、「イノベーションと安全性のバランス：ヘルスケアにおけるAI」Northwest Regional Telehealth Resource Center Telehealth Conference（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)
フォーリー弁理士が米国医療法協会の更新されたテレヘルス法ハンドブックに寄稿
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FDAの攻勢！強制措置の波で製薬会社の医薬品広告を狙う
GLP-1受容体作動薬：臨床試験に関する考察
テキサス州裁判所、FDAの検査室開発検査（LDT）最終規則を無効とする
フォーリー、2025年度JD Supraリーダーズ・チョイス・アワードを受賞
