Jessa Boubker is a health care lawyer 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, including hospitals, health systems, provider practice groups, long-term care facilities, and medical device companies.
Jessa has assisted in the development and maintenance of clinical trial compliance programs, and has drafted and reviewed clinical trial agreements and corporate policies on behalf of institutions, contract research organizations, and pharmaceutical and medical device clients. She has worked with a number of digital health companies to launch and scale their direct-to-consumer telehealth platforms and operations throughout the United States, and has helped advise clients on regulatory compliance considerations when developing software as a medical device, including devices employing artificial intelligence. Jessa is a member of the American Telemedicine Association, serving on the ATA’s Therapeutic Lifecycle, Healthy Aging, and Digital Transformation special interest groups.
Prior to joining Foley, Jessa was the Editor-in-Chief of the American Journal of Law & Medicine, the country’s leading health law journal. During her time as Editor-in-Chief, she published four issues of the journal and oversaw the 2021 Annual Symposium: Legal Innovations in Response to Public Health Crises. She also developed and published a special issue of the journal: Diversity and Inclusion in the American Legal Profession: Discrimination and Bias Reported by Lawyers with Disabilities and Lawyers Who Identify as LGBTQ+.
While in law school, Jessa served as a judicial intern for Magistrate Judge Donald L. Cabell of the U.S. District Court for the District of Massachusetts. She was also a member of the Legislative Policy & Drafting Clinic and drafted long-term care legislation on behalf of a Massachusetts State Senator. Jessa began her career as a summer associate at Foley, where she assisted on a range of regulatory and transactional matters.
Representative Experience
- Represented Sports Medicine North Orthopedic Surgery, Inc., and its affiliated ambulatory surgery center in their acquisition by Connecticut-based orthopedic and spine care management services organization Spire Orthopedic Partners, a portfolio company of 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
American Telemedicine Association Special Interest Group (SIG) Member
Therapeutic Lifecycle SIG: The Therapeutic Lifecycle SIG focuses holistically on the full lifecycle of therapeutic development, from clinical trials to in-market use. Initial work focuses on clinical research, regulatory submission, in-market pharmaceuticals, and connecting research technology solutions to in-market technology solutions.
Healthy Aging SIG: The purpose of this SIG is to engage our membership in collaborating and engaging together to bring policy guidance, innovative technology, and ideas, as well as informative data for lasting change to make an impact on daily life for our aging population.
Digital Transformation SIG: The mission of the Digital Transformation SIG is to engage members on topics of emerging care models, business processes, data management, institutional governance, continuity of care, care transformation, and population health management.
Presentations and Publications
- Co-author, “Cancer Drugs: Clinical Trial Issues for Antibody Drug Conjugates (ADCs)/Antibody Therapeutics,” Health Care Law Today (November 5, 2024)
- Co-author, “Medicare Coverage: CMS Finalizes New Pathway for Breakthrough Devices,” Health Care Law Today (October 14, 2024)
- Co-author, “LDTs: FDA Rolls Out a Phased Implementation for New Regulatory Requirements,” Health Care Law Today (May 20, 2024)
- Co-author, “Clinical Trials: FDA Issues Finalized Charging Guidance for Investigational Drug Use,” Health Care Law Today (March 13, 2024)
- Co-author, “OIG Opines on Subsidizing Medicare Cost-Sharing for Clinical Trials,” Health Care Law Today (February 26, 2024)
- Speaker, “Balancing Innovation and Safety: AI in Health Care,“ Northwest Regional Telehealth Resource Center Telehealth Conference (April 30, 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)
Cancer Drugs: Clinical Trial Issues for Antibody Drug Conjugates (ADCs)/Antibody Therapeutics
Medicare Coverage: CMS Finalizes New Pathway for Breakthrough Devices
LDTs: FDA Rolls Out a Phased Implementation for New Regulatory Requirements
2024 Health Care & Life Sciences Top Trends
Clinical Trials: FDA Issues Finalized Charging Guidance for Investigational Drug Use