Jessica Boubker headshot.

Jessa Boubker

Associate

Jessa Boubker

Associate

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

  • 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)
11 December 2023 Innovative Technology Insights

AI in Health Care: Powering Patient Outcomes

Welcome to AI in Health Care: Powering Patient Outcomes. In this eBook, our contributors examine this intersection through lenses including its impact on merger activity, antitrust enforcement, patent prosecution, and more.
06 December 2023 Health Care Law Today

Decentralized Clinical Trials: Diversity in Clinical Trials

The U.S. Food and Drug Administration (FDA) has demonstrated a commitment to expanding diversity in clinical trials.
10 October 2023 Health Care Law Today

FDA Laboratory Developed Test Oversight: What Stakeholders Need to Know About Proposed Overhaul

After years of enforcement discretion, the U.S. Food and Drug Administration (FDA) published a proposed rule on October 3, 2023 under which the agency articulated its intent to increase regulatory oversight of laboratory developed tests (LDTs).
15 September 2023 In the News

Foley Attorneys Author Article Exploring New CMS Proposal for Medicare Coverage of Breakthrough Devices

Foley & Lardner LLP Health Care Practice Group co-chairs and partners Kyle Faget and Judith Waltz and associate Jessa Boubker authored the article, “CMS Proposes New Medicare Coverage Pathway for Breakthrough Devices,” published in the American Health Law Association’s Health Law Weekly newsletter.
08 September 2023 Health Care Law Today

Clinical Trials: Consent Process Clarified in New FDA Final Guidance

The U.S. Food & Drug Administration (FDA) issued final guidance (Final Guidance) regarding informed consent titled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” on August 15, 2023.
18 July 2023 Deals and Wins

Foley Serves as Legal Adviser to Thirty Madison in Strategic Acquisition of The Pill Club Assets

Foley & Lardner LLP served as legal adviser to Thirty Madison, a leading chronic care management platform, in its strategic acquisition of assets from The Pill Club.