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Allison Smith Newsome

Allison Smith Newsome

Senior Associate

1100 Superior Avenue
Suite 2000
Cleveland, OH 44114
T 919.329.3884
allison.smithnewsome@nelsonmullins.com
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Allison focuses her practice on advising healthcare and life science organizations and partners as they navigate complex regulatory landscapes, operational challenges, and expansion. With extensive experience in government oversight, compliance, and healthcare business practices, she provides strategic counsel that helps clients manage risk while advancing their organizational goals.

Allison brings a deep understanding of the ethical...

Allison focuses her practice on advising healthcare and life science organizations and partners as they navigate complex regulatory landscapes, operational challenges, and expansion. With extensive experience in government oversight, compliance, and healthcare business practices, she provides strategic counsel that helps clients manage risk while advancing their organizational goals.

Allison brings a deep understanding of the ethical implications shaping today’s rapidly evolving healthcare environment. She is particularly adept at guiding clients through issues involving healthcare technology governance, data use, and emerging innovations, offering clarity on some of the field’s most difficult ethical dilemmas.

Allison Smith Newsome

implications shaping today’s rapidly evolving healthcare environment. She is particularly adept at guiding clients through issues involving healthcare technology governance, data use, and emerging innovations, offering clarity on some of the field’s most difficult ethical dilemmas.

Experience

The following is a selected sampling of matters and is provided for informational purposes only. Past success does not indicate the likelihood of success in any future matter.

Previous Professional Experience

  • Harvard Law School Center for Health Law and Policy Innovation, Student Counsel (Jan. 2025-May 2025)
  • Full service law firm, Associate (2019-2024); Summer Associate (2017, 2018)
  • Case Western Reserve University School of Law, Adjunct Professor (2021-2024)

Representative Matters

  • Advised durable medical equipment manufacturers, sellers, and lessors on FDA compliant products and marketing.
  • Drafted human subjects research sponsorship agreements, government-agency settlements, CMS participation agreements, work-for hire employee development agreements, and institutional as well as patient-facing HIPAA policies. 
  • Secured state and federal drug distribution sampling and compounding registrations and licenses for multi-facility vascular and weight management practice.
  • Counseled non-physician providers and their unlicensed business partners on applicability of corporate practice of medicine (CPOM) statutes in states where they intended to open clinics, spas, and other medical and wellness businesses. Drafted entity formation documents (e.g., HIPAA consents and waivers, employment agreements, shareholder agreements, operating agreement) necessary for operation, and registered businesses with applicable Secretaries of State and IRS. 
  • Assisted in due diligence review of private equity fund purchase of group of chiropractic practices in 8-figure deal, assessing practices’ regulatory compliance with state and federal law, such as compensation arrangements limited to fair market value and meeting exception or safe harbor for referral-based compensation, as well as HIPAA compliant patient consents. Advised client post-review of potential risks and penalties, made recommendations to limit liability, and proposed protocols to ensure compliance moving forward.
  • Represented a physician in creation, maintenance, compliance, and governance of tri-state telehealth practice providing weight loss and hormone replacement therapy treatment. 
  • Negotiated settlements on behalf of national counseling and behavioral therapy business across six states with government and private payors following multi-million-dollar acquisition and subsequent claims diligence audit.
  • Advised billion-dollar global beauty brand on ethical and regulatory permissibility of using diagnostic medical devices for purely non-medical, market research purposes. 
  • Represented multi-pharmacy owner and licensed pharmacist in 7-figure Medicaid criminal trial in Federal Court defending charges of fraud and conspiracy.

Publications

  • “Humanizing pulmonary care in the era of acoustic artificial intelligence: toward global health equity,” Frontiers in Medicine (October 13, 2025)
  • “Dr. Watson, A.I.: The Current Approach to Artificial Intelligence Training in the Medical Field and Legal Considerations for AI Diagnosis Dependence,” American Health Law Association (July 6, 2023)
  • “Don’t Take A Shot In The Dark: Legal Implications & Considerations of A Mandatory Employee COVID-19 Vaccination Policy,” Cleveland Metropolitan Bar Association Bar Journal (March, 2021)
  • Note, “Preserving the Possibility of a Future Biological Family: The Call for State-Mandated Insurance Coverage of Fertility Preservation in Youth Patients Where Primary Treatment Causes Sterility,” 18 Dukeminier Awards Journal of Sexual Orientation and Gender Identity Law Journal, UCLA and the Williams Institute (2019)
The following is a selected sampling of matters and is provided for informational purposes only. Past success does not indicate the likelihood of success in any future matter.

Previous Professional Experience

  • Harvard Law School Center for Health Law and Policy Innovation, Student Counsel (Jan. 2025-May 2025)
  • Full service law firm, Associate (2019-2024); Summer Associate (2017, 2018)
  • Case Western Reserve University School of Law, Adjunct Professor (2021-2024)

Representative Matters

  • Advised durable medical equipment manufacturers, sellers, and lessors on FDA compliant products and marketing.
  • Drafted human subjects research sponsorship agreements, government-agency settlements, CMS participation agreements, work-for hire employee development agreements, and institutional as well as patient-facing HIPAA policies. 
  • Secured state and federal drug distribution sampling and compounding registrations and licenses for multi-facility vascular and weight management practice.
  • Counseled non-physician providers and their unlicensed business partners on applicability of corporate practice of medicine (CPOM) statutes in states where they intended to open clinics, spas, and other medical and wellness businesses. Drafted entity formation documents (e.g., HIPAA consents and waivers, employment agreements, shareholder agreements, operating agreement) necessary for operation, and registered businesses with applicable Secretaries of State and IRS. 
  • Assisted in due diligence review of private equity fund purchase of group of chiropractic practices in 8-figure deal, assessing practices’ regulatory compliance with state and federal law, such as compensation arrangements limited to fair market value and meeting exception or safe harbor for referral-based compensation, as well as HIPAA compliant patient consents. Advised client post-review of potential risks and penalties, made recommendations to limit liability, and proposed protocols to ensure compliance moving forward.
  • Represented a physician in creation, maintenance, compliance, and governance of tri-state telehealth practice providing weight loss and hormone replacement therapy treatment. 
  • Negotiated settlements on behalf of national counseling and behavioral therapy business across six states with government and private payors following multi-million-dollar acquisition and subsequent claims diligence audit.
  • Advised billion-dollar global beauty brand on ethical and regulatory permissibility of using diagnostic medical devices for purely non-medical, market research purposes. 
  • Represented multi-pharmacy owner and licensed pharmacist in 7-figure Medicaid criminal trial in Federal Court defending charges of fraud and conspiracy.

Publications

  • “Humanizing pulmonary care in the era of acoustic artificial intelligence: toward global health equity,” Frontiers in Medicine (October 13, 2025)
  • “Dr. Watson, A.I.: The Current Approach to Artificial Intelligence Training in the Medical Field and Legal Considerations for AI Diagnosis Dependence,” American Health Law Association (July 6, 2023)
  • “Don’t Take A Shot In The Dark: Legal Implications & Considerations of A Mandatory Employee COVID-19 Vaccination Policy,” Cleveland Metropolitan Bar Association Bar Journal (March, 2021)
  • Note, “Preserving the Possibility of a Future Biological Family: The Call for State-Mandated Insurance Coverage of Fertility Preservation in Youth Patients Where Primary Treatment Causes Sterility,” 18 Dukeminier Awards Journal of Sexual Orientation and Gender Identity Law Journal, UCLA and the Williams Institute (2019)

Media

Visit Insights

Recognitions

The bar rules of some states require that the standards for an attorney's inclusion in certain public accolades or recognitions be provided. When such accolades or recognitions are listed, a hyperlink is provided that leads to a description of the respective selection methodology.

  • Best Lawyers: Ones to Watch in America, Corporate Governance and Compliance Law (2025)
  • Ohio Rising Star, Super Lawyers (2025)
  • Notable Women in Law, Crain’s Cleveland (2024)
  • Ohio Rising Star, Super Lawyers (2024) 

Professional Activities

  • OhioGuidestone Board, Director, (October 2022-Present); Associate Board, Director (2020-2022)
  • American Health Law Association, Fraud & Abuse, Vice Chair (2024-Present); Academic Medical Centers and Teaching Hospitals Publications, Vice Chair (2021-2023); Leadership Development Program (2020-2021)
  • Greater Cleveland Film Commission Board, Director (2021-Present)
  • Cleveland Metropolitan Bar Association Board, Director (2020-2023)
  • Leadership Council on Legal Diversity, Pathfinder (2021)

Community

  • Rocky River Juvenile Court Diversion Program, Magistrate (2020-Present)
  • Salvation Army Echelon Board, Director, Communications Chair (Present), Service and Events Chair (2021-2024) 

Allison focuses her practice on advising healthcare and life science organizations and partners as they navigate complex regulatory landscapes, operational challenges, and expansion. With extensive experience in government oversight, compliance, and healthcare business practices, she provides strategic counsel that helps clients manage risk while advancing their organizational goals.

Allison brings a deep understanding of the ethical... implications shaping today’s rapidly evolving healthcare environment. She is particularly adept at guiding clients through issues involving healthcare technology governance, data use, and emerging innovations, offering clarity on some of the field’s most difficult ethical dilemmas.

Experience

The following is a selected sampling of matters and is provided for informational purposes only. Past success does not indicate the likelihood of success in any future matter.

Previous Professional Experience

  • Harvard Law School Center for Health Law and Policy Innovation, Student Counsel (Jan. 2025-May 2025)
  • Full service law firm, Associate (2019-2024); Summer Associate (2017, 2018)
  • Case Western Reserve University School of Law, Adjunct Professor (2021-2024)

Representative Matters

  • Advised durable medical equipment manufacturers, sellers, and lessors on FDA compliant products and marketing.
  • Drafted human subjects research sponsorship agreements, government-agency settlements, CMS participation agreements, work-for hire employee development agreements, and institutional as well as patient-facing HIPAA policies. 
  • Secured state and federal drug distribution sampling and compounding registrations and licenses for multi-facility vascular and weight management practice.
  • Counseled non-physician providers and their unlicensed business partners on applicability of corporate practice of medicine (CPOM) statutes in states where they intended to open clinics, spas, and other medical and wellness businesses. Drafted entity formation documents (e.g., HIPAA consents and waivers, employment agreements, shareholder agreements, operating agreement) necessary for operation, and registered businesses with applicable Secretaries of State and IRS. 
  • Assisted in due diligence review of private equity fund purchase of group of chiropractic practices in 8-figure deal, assessing practices’ regulatory compliance with state and federal law, such as compensation arrangements limited to fair market value and meeting exception or safe harbor for referral-based compensation, as well as HIPAA compliant patient consents. Advised client post-review of potential risks and penalties, made recommendations to limit liability, and proposed protocols to ensure compliance moving forward.
  • Represented a physician in creation, maintenance, compliance, and governance of tri-state telehealth practice providing weight loss and hormone replacement therapy treatment. 
  • Negotiated settlements on behalf of national counseling and behavioral therapy business across six states with government and private payors following multi-million-dollar acquisition and subsequent claims diligence audit.
  • Advised billion-dollar global beauty brand on ethical and regulatory permissibility of using diagnostic medical devices for purely non-medical, market research purposes. 
  • Represented multi-pharmacy owner and licensed pharmacist in 7-figure Medicaid criminal trial in Federal Court defending charges of fraud and conspiracy.

Publications

  • “Humanizing pulmonary care in the era of acoustic artificial intelligence: toward global health equity,” Frontiers in Medicine (October 13, 2025)
  • “Dr. Watson, A.I.: The Current Approach to Artificial Intelligence Training in the Medical Field and Legal Considerations for AI Diagnosis Dependence,” American Health Law Association (July 6, 2023)
  • “Don’t Take A Shot In The Dark: Legal Implications & Considerations of A Mandatory Employee COVID-19 Vaccination Policy,” Cleveland Metropolitan Bar Association Bar Journal (March, 2021)
  • Note, “Preserving the Possibility of a Future Biological Family: The Call for State-Mandated Insurance Coverage of Fertility Preservation in Youth Patients Where Primary Treatment Causes Sterility,” 18 Dukeminier Awards Journal of Sexual Orientation and Gender Identity Law Journal, UCLA and the Williams Institute (2019)

Education

  • Harvard Medical School, MS, Bioethics (2025)
  • Case Western Reserve University School of Law, JD, Health Law Concentration (2019)
    • Dean’s Honors List 
    • Commencement Speaker
    • 2019 Student of the Year 
    • CALI Excellence for the Future Award 
    • Moot Court, Best Oralist, Top 10 Advocates
  • Vanderbilt University, BA, Medicine, Health, and Society; Concentration: Health Policy and Economics (2016)

Admissions

  • Ohio
  • Supreme Court of Ohio
  • U.S. District Court for the Northern District of Ohio

Clerkships

  • Law Clerk, Chief Judge Solomon Oliver, Jr., U.S. District Court for the Northern District of Ohio (2017)

Practice Areas

Industries

The bar rules of some states require that the standards for an attorney's inclusion in certain public accolades or recognitions be provided. When such accolades or recognitions are listed, a hyperlink is provided that leads to a description of the respective selection methodology.

  • Best Lawyers: Ones to Watch in America, Corporate Governance and Compliance Law (2025)
  • Ohio Rising Star, Super Lawyers (2025)
  • Notable Women in Law, Crain’s Cleveland (2024)
  • Ohio Rising Star, Super Lawyers (2024) 
  • OhioGuidestone Board, Director, (October 2022-Present); Associate Board, Director (2020-2022)
  • American Health Law Association, Fraud & Abuse, Vice Chair (2024-Present); Academic Medical Centers and Teaching Hospitals Publications, Vice Chair (2021-2023); Leadership Development Program (2020-2021)
  • Greater Cleveland Film Commission Board, Director (2021-Present)
  • Cleveland Metropolitan Bar Association Board, Director (2020-2023)
  • Leadership Council on Legal Diversity, Pathfinder (2021)
  • Rocky River Juvenile Court Diversion Program, Magistrate (2020-Present)
  • Salvation Army Echelon Board, Director, Communications Chair (Present), Service and Events Chair (2021-2024)