Laura E.Koman

Associate

Washington + 1.202.879.3601

Collegati

Condividi

Laura Koman represents health care and life sciences companies on complex regulatory and compliance matters in emerging areas. Laura advises large health systems and national provider organizations on unique legal, regulatory, and reimbursement structures impacting remote delivery of health care services and multijurisdictional digital health strategy. Laura also represents global life sciences organizations on the contractual, regulatory, and ethical issues associated with clinical research.

Laura has advised clients on e-health topics impacted by complex and rapidly evolving federal and state regulatory regimes, such as direct-to-consumer telemedicine and telehealth, provider-to-provider consults, e-prescribing and controlled substance prescribing, licensure, remote supervision, reimbursement and billing and coding, patient consent, corporate structure and corporate practice of medicine, and COVID-19 PHE (Public Health Emergency) waiver issues. Laura also counsels clients on health care fraud and abuse issues under the federal Anti-Kickback Statue and the Stark Law, including in the context of novel digital health arrangements and value-based care models, and structures health care transactions and other arrangements for the provision of professional, practice management, or administrative services.

Laura represents life sciences companies conducting global clinical trials and research collaborations on emerging topics such as clinical trial diversity, the design and implementation of decentralized clinical trials and site networks, and expanded patient recruitment programs. Laura negotiates clinical trial agreements and other regulatory documents and provides support to clients engaged in life sciences M&A and other transactions.

Laura is a member of the American Health Law Association.

Esperienze

  • Riverside acquires CRIO, Inc.Jones Day advised The Riverside Company in the acquisition of CRIO, Inc., a leading provider of eSource and other eClinical software for clinical trial sites, CROs and the pharmaceutical/biotech market.
  • KKR acquires IVI-RMA GlobalJones Day acted as U.S. counsel in the €3 billion acquisition of IVI-RMA, a group specialized in assisted reproduction techniques.
  • Riverside portfolio company acquires Jupiter Life Science Consulting (Jupiter)Jones Day advised The Riverside Company in connection with the acquisition and financing by portfolio company Red Nucleus of Jupiter Life Science Consulting (Jupiter), a leading provider of commercial and market access strategies for global pharma, biotech, and medical device companies with its primary focus in rare disease, hematology/oncology, metabolic, and neurology therapeutic areas.
  • Riverside portfolio company acquires RockpointeJones Day represented The Riverside Company in connection with the acquisition by portfolio company Clinical Education Alliance (CEA) of Rockpointe, Inc., a premier healthcare education company providing accredited continuing education activities and related training for healthcare professionals.
  • Nurx merges with Thirty MadisonJones Day provided healthcare and data privacy counsel to Nurx in connection with its merger with Thirty Madison, a leading digital healthcare company operating across the U.S.
  • Riverside portfolio company acquires Medical Marketing Solutions GroupJones Day represented The Riverside Company in connection with the acquisition and financing by portfolio company Medical Marketing Solutions Group (MMSG), a leading medical education company that provides strategic services, scientific and medical communications, and operational and event management services to global biopharmaceutical companies.
  • City of Hope acquires Cancer Treatment Centers of AmericaJones Day advised City of Hope, a world-renowned, National Cancer Institute (NCI)-designated comprehensive cancer research and treatment organization, in connection with its acquisition of Cancer Treatment Centers of America, a network of oncology hospitals and outpatient care centers across the United States.
  • Misonix merges with BioventusJones Day represented Misonix, Inc. (Nasdaq: MSON) in its acquisition by Bioventus Inc. (Nasdaq: BVS).
  • PWNHealth and Home Access Health Corporation sold to Everlywell, forming Everly HealthJones Day advised PWNHealth LLC and Home Access Health Corporation in its sale to Everlywell, a leading digital health company, and forming Everly Health.
  • Sumitovant Biopharma acquires remaining stake in Urovant SciencesJones Day advised Sumitovant Biopharma in its acquisition of all of the outstanding shares of Urovant Sciences Ltd. not already owned by Sumitovant at a price of $16.25 per share in cash.
  • Riverside portfolio company acquires iTakeControlJones Day represented The Riverside Company in connection with the acquisition by portfolio company Red Nucleus, a premier provider of learning, performance, and process solutions for the life sciences industry, of iTakeControl, a leading provider of clinical operations and medical affairs technology and services focused on rare disease and specialty pharma.
  • Smith & Nephew acquires Extremity Orthopedics business of Integra LifeSciences Holdings Corporation for $240 millionJones Day advised Smith & Nephew plc, the global medical technology company, in its acquisition of the Extremity Orthopedics business of Integra LifeSciences Holdings Corporation (NASDAQ: IART) for $240 million on a cash and debt-free basis.
  • SOC Telemed merges with Healthcare Merger Corp.Jones Day provided healthcare and general corporate counsel to SOC Telemed, Inc. in its $720 million merger with Healthcare Merger Corp.
  • Olive Tree Ventures participates in $33 million investment in Lemonaid HealthJones Day represented Olive Tree Ventures as health regulatory and privacy counsel in connection with its investment in Lemonaid Health, a convenient, affordable, on-demand platform for accessing healthcare online.
  • UPMC subsidiary Curavi Health combined with CarePointe and U.S. Health Systems to form Arkos HealthJones Day advised University of Pittsburgh Medical Center (UPMC) in the business combination of its subsidiary Curavi Health, Inc. with CarePointe and U.S. Health Systems to form Arkos Health, a company that will provide virtual care solutions and health insights to vulnerable populations across the United States.
  • Riverside sells ActivStyleJones Day advised The Riverside Company in its sale of ActivStyle, a distributor of consumable medical supplies with an emphasis on incontinence products.
  • Digital health company expands telehealth programming in response to the COVID-19 public health crisisJones Day represented a digital health company in the expansion of their telehealth programming in response to the COVID-19 public health crisis.
  • National diagnostic clinician network expands telehealth programming in response to COVID-19 public health crisisJones Day represented a national diagnostic clinician network in their expansion of telehealth programming in response to the COVID-19 public health crisis.
  • Telehealth company expands programming in response to COVID-19 public health crisisJones Day represented a telehealth company in the expansion of their telehealth programming in response to the COVID-19 public health crisis and related health regulatory and contracting matters.
  • Telemedicine provider expands telehealth programming in response to COVID-19 public health crisisJones Day represented a telemedicine provider in their expansion of telehealth programming in response to the COVID-19 public health crisis.
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    November 2024 Alert

    Inaugural Meeting for FDA's Digital Health Advisory Committee to Focus on GenAI-enabled Medical Devices

    June 2024 Alert

    FDA Launches the Center for Clinical Trial Innovation

    March 2022 Alert

    U.S. Federal Actions Support Continued Telehealth Services for Medicare Beneficiaries

    March 2022 Newsletters

    Vital Signs: Digital Health Law Update | Winter 2022

    August 2021 Newsletters

    Vital Signs: Digital Health Law Update | Summer 2021

    April 2021 Newsletters

    Vital Signs: Digital Health Law Update | Spring 2021

    January 2021 Newsletters

    Vital Signs: Digital Health Law Update | Winter 2021

    December 2020 Commentary

    OIG Issues Final Rule on New Exception for ESRD-Related Telehealth Technologies

    October 2020 Newsletters

    Vital Signs: Digital Health Law Update | Fall 2020

    July 2020 Newsletters

    Vital Signs: Digital Health Law Update | Summer 2020
    Vedi Insight

    Altre Pubblicazioni

    • May 3, 2019
      Legal and Regulatory Issues with Teledermatology (article co-author), Current Dermatology Reports, 2019
    • May 1, 2019
      Telehealth and Its Attendant Fraud and Abuse Risks (chapter co-author), Health Law Handbook, 2019
    • December 1, 2017
      Privilege Protection in Fraud and Abuse Matters (chapter co-author), AHLA Best Practices Handbook for Advising Clients on Fraud and Abuse Issues, 2017

    • August 1, 2019
      11th Annual mHealth and Telehealth World Summit―Addressing the Legal and Regulatory Barriers to Expand Telehealth Capabilities
    • April 14, 2019
      ATA19—Direct-to-Consumer Telemedicine – Lessons Learned and Strategies for Advancing Policy
    • March 22, 2019
      Institute on Medicare and Medicaid Payment Issues—2019 Changes to Medicare Reimbursement for Telehealth and Communication Technology Based Services
    • October 10, 2018
      AHLA Telemedicine Webinar Series—Part I: Fundamentals of Telemedicine Legal and Regulatory

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