Ann T.Hollenbeck

Partner-in-Charge Detroit

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Ann Hollenbeck advises clients in the health care and life sciences industry on digital health, artificial intelligence, human subjects research, organ transplant, pharmacy/340B, and fraud and abuse matters. Ann also represents health care, life sciences, and technology companies, as well as ambulatory surgery centers and telemedicine providers, in such transactional matters as ancillary services and pharmacy arrangements, joint ventures, and physician-hospital relationships, including co-management arrangements. She regularly advises these entities with regard to the negotiation of clinical trial-related agreements, including virtual clinical trials, in addition to related regulatory matters, such as Medicare reimbursement and institutional review board responsibilities.

Ann's recent experience includes advising on international telehealth and in-person care in South America, Europe, and Africa. Ann has also recently assisted clients in self-disclosure matters with the Centers for Medicare & Medicaid Services (CMS), Department of Justice (DOJ), and the Drug Enforcement Administration (DEA) and worked closely with in-house counsel on complex pharmacy compliance issues.

Ann previously served as assistant general counsel at the University of Michigan. She is a member of the American Health Lawyers Association and of the State Bar of Michigan (former chair, Health Law Section). Ann is a member of the community board of Ele's Place in Ann Arbor and the board of directors of Gift of Life Michigan (organ procurement organization).

Ann has been quoted in publications, such as MedPage Today and Crain's Detroit Business, and has published on various health care topics, including digital health and pharmacy/controlled substances matters.

Ann is the Partner-in-Charge of the Detroit Office.

執業經驗

  • 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.
  • 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.
  • Large health care system secures rescission of statutorily unappealable CMS decisionJones Day advised a large hospital health system regarding a statutorily unappealable decision from the Centers for Medicare and Medicaid Services ("CMS") that the health system did not qualify for the "mid-build exception" to the payment policy established under the Bipartisan Budget Act of 2015.
  • Digital health companies, specialty hospitals, and health systems maintain compliance with multistate requirements through 50-state surveyJones Day is representing digital health companies, specialty hospitals, and health systems in maintaining compliance with multistate requirements through a regularly updated, extensive 50-state survey on state laws and regulations applicable to telehealth activities of physicians and other health care professionals including licensing, establishing patient relationships, provider-to-provider consulting, supervision and delegation among providers, and prescribing and treatment standards.
  • Hospital system reaches settlement after DEA investigationJones Day represented one of the largest hospital systems in Michigan in connection with a multi-year DEA diversion investigation concerning potential violations of the Controlled Substances Act across multiple locations within the system.
  • 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.
  • 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.
  • General medical hospital acquires positron emission tomography center and cyclotronJones Day represented a general medical and surgical hospital in connection with its acquisition of certain assets related to a positron emission tomography center and cyclotron.
  • Nonprofit health system acquires assets of vascular and endovascular physician practiceJones Day advised a nonprofit health system in its acquisition of the assets of a vascular and endovascular physician practice, the integration of those assets into the health system, and employment of the physicians.
  • Large health care system investigates and voluntarily discloses clinical trial compliance concerns to federal agencyJones Day represented a large health care system in internal investigation, self-disclosure, and revision of company policies related to allegations of clinical trial noncompliance.
  • Nonprofit health system collaborates with research enterpriseJones Day is representing a nonprofit health system in its clinical research collaboration and support agreement in conjunction with a specialty research enterprise.
  • Large digital health company grows operations across U.S.Jones Day advised a large digital health company in expanding operations throughout multiple states in the U.S. and in responding to several state regulator inquiries regarding its operations.
  • Emerging digital health company expands operations to new telehealth servicesJones Day advised an emerging digital health company in expanding its telehealth product offerings to patients across the United States and in responding to several state regulator inquiries regarding its operations.
  • Nonprofit hospital enters co-management agreement with physician group for oncology service lineJones Day represented a nonprofit health system in negotiating and drafting a co-management agreement with physician group for oncology services at one of its subsidiary hospital's inpatient facility and outpatient locations.
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    AUGUST 2024 Alert

    FDA Remote Regulatory Assessments Are Not So Remote Anymore

    July 2024 Newsletters

    Vital Signs: Digital Health Law Update | Spring 2024

    APRIL 2024 Alert

    U.S. Department of Energy Conditionally Commits Up to $1.5 Billion to Finance Nuclear Plant in Michigan

    March 2024 Newsletters

    Vital Signs: Digital Health Law Update | Winter 2024

    January 2024 Alert

    FDA Final Rule: IRB Waiver of Informed Consent for Minimal-Risk Investigations

    November 2023 Commentary

    HHS-OIG Issues Long-Anticipated General Compliance Program Guidance for All Health Care Stakeholders

    November 2023 Newsletters

    Vital Signs: Digital Health Law Update | Fall 2023

    NOVEMBER 2023 Alert

    Michigan Senate Votes to Repeal Pharmaceutical Immunity From Product Liability Suits

    September 2023 Alert

    FDA Announces Delayed Enforcement of Looming Supply Chain Requirements for Drugs Until 2024

    September 2023 Newsletters

    Vital Signs Digital Health Law Update | Summer 2023
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    著作

    • May 2024
      Lawyering in the age of GenAI
    • May-June 2020
      Better a Step Ahead Than a Step Behind: The Benefits of Proactive Opioid Diversion and Loss Reporting to Regulators and Law Enforcement, Hollenbeck, Gabel, and Joseph, 22 No. 3 J. Health Care Compliance 45 (May-June, 2020).
    • May 6, 2019
      Legal and Regulatory Issues with Teledermatology, Current Dermatology Reports
    • March 5, 2019
      Health Care Compliance Legal Issues Manual, Co-Editor, American Health Lawyers Association
    • December 2018
      Institutional Review Boards, Co-author of Secondary Findings in Genomic Research, American Health Lawyers

    Publications Prior to Jones Day

    February 2017

    Advice for the Non-Healthcare Lawyer Representing Clients in Arrangements with Hospitals and Other Health Care Providers (February 2017) Michigan Bar Journal

    August 2016

    Representing Hospitals  and Health Systems Handbook (August 2016) Co-author American Health Lawyers Association (AHLA)

    April 2016

    Policy and Review:  The IRB's Imperative in Incidental Findings in Research (April 2016) Co-author American Health Lawyers Association (AHLA)

    2014

    Health Care Compliance Legal Issues Manual (2014) Co-author American Health Lawyers Association (AHLA)

    • May 25, 2023
      Healthcare Regulation & Reimbursement Summit, Plante Moran
    • April 20, 2023
      Michigan Health & Hospital Association, A Board Member's Guide to Legal Issues and Regulatory Challenges Faced by Hospitals
    • March 30, 2023
      Michigan Health & Hospital Association, The End of the COVID-19 Public Health Emergency and Preparing for the New Regulatory Environment
    • March 9, 2023
      Federal Regulatory Update, Institute of Continuing Legal Education/Health Law Institute
    • March 25, 2021
      Telemedicine 0-60 MPH: Building a Pandemic Telemedicine Program from the Ground Up, American Health Law Association
    • March 12, 2021
      Federal Regulatory Update, Health Law Institute, Institute of Continuing Legal Education/Michigan State Bar Association
    • August 6, 2020
      Healthcare on the Other Side: Deal Activity to Accelerate (BDO)
    • March 12, 2020
      Federal Regulatory Update, Health Law Institute, Institute of Continuing Legal Education/Michigan State Bar Association
    • December 3, 2019
      Artificial Intelligence, Machine Learning, and Big Data: What You and Your Organization Should Know
    • June 21, 2019
      Pharmaceutical Compliance & Legal Issues, Health Care Compliance Association Regional Conference
    • March 7, 2019
      Federal Regulatory Update, Health Law Institute, Institute of Continuing Legal Education/Michigan State Bar Association

    Speaking Engagements Prior to Jones Day

    March 2017

    Incidental Findings in Genomic Research: Ethics, Law and Practicality, Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions, AHLA co-sponsored with National Association of College and University Attorneys (NACUA) and Association of American Medical Colleges (AAMC),

    Baltimore, MD

    April 2016

    Hospital/Physician Relationships and the Law, Excellence in Governance Fellowship, Michigan Health and Hospital Association

    Grand Rapids, MI

    January 2015

    Clinical Research Update - How Will New Developments Impact Your Institution?, Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions, AHLA co-sponsored with National Association of College and University Attorneys (NACUA) and Association of American Medical Colleges (AAMC)

    Washington, D.C.

    October 2013

    Tax Issues in Clinical Research, Tax Issues for Health Care Organizations Conference, American Health Lawyers Association

    Washington, D.C.

    January 2013

    Research Collaborations between AMCs and Community Hospitals, Legal Issues Affecting Academic Health Centers and Other Teaching Institutions Conference, American Health Lawyers Association

    Washington, D.C.

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