Jessa Boubker

Associé

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Jessa Boubker

Associé

[email protected]

Boston 617.342.4039

Secteurs

Domaines d'activité

L'éducation

Boston University School of Law (J.D., 2021)
Boston University School of Public Health (M.P.H., 2021)
Smith College (B.A., 2015)

Admissions

Massachusetts

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.

Réglementation de la FDA

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.

Expérience des représentants

Représentation de Sports Medicine North Orthopedic Surgery, Inc. et de son centre de chirurgie ambulatoire affilié dans le cadre de leur acquisition par Spire Orthopedic Partners, société de services de gestion des soins orthopédiques et de la colonne vertébrale basée dans le Connecticut, une société de portefeuille de Kohlberg & Co.
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.

Affiliations

Membre de l'association du barreau de Boston
Member, American Health Law Association (AHLA)
Member, American Telemedicine Association (ATA)

Présentations et publications

Co-auteur, "GLP-1 Receptor Agonists : Clinical Trial Considerations", Health Care Law Today (22 juillet 2025)
Co-auteur, "Texas Court Vacates FDA's Laboratory Developed Test (LDT) Final Rule", Health Care Law Today (2 avril 2025)
Co-auteur, "GLP-1 Drugs : Brand Companies Push FDA to Limit Compounding", Health Care Law Today (2 décembre 2024)
Co-auteur, "Cancer Drugs : Clinical Trial Issues for Antibody Drug Conjugates (ADCs)/Antibody Therapeutics," Health Care Law Today (5 novembre 2024)
Co-auteur, "Medicare Coverage : CMS Finalizes New Pathway for Breakthrough Devices," Health Care Law Today (14 octobre 2024)
Co-auteur, "LDTs : FDA Rolls Out a Phased Implementation for New Regulatory Requirements", Health Care Law Today (20 mai 2024)
Co-auteur, "Clinical Trials : FDA Issues Finalized Charging Guidance for Investigational Drug Use," Health Care Law Today (13 mars 2024)
Co-auteur, "OIG Opines on Subsidizing Medicare Cost-Sharing for Clinical Trials", Health Care Law Today (26 février 2024)
Conférencier, "Équilibrer l'innovation et la sécurité : AI in Health Care," Northwest Regional Telehealth Resource Center Telehealth Conference (30 avril 2024)
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)