Alexis Gilroy, a national leader in the digital health industry, advises on complex transactional and health regulatory issues with an emphasis on virtual health methods, such as telemedicine, telehealth, and mobile health. With more than two decades in digital health her experience supports various regulatory counseling and transactional needs for health AI, digital health product development, and life sciences organizations, including novel virtual clinical trial offerings. Alexis is co-leader of the Firm's Health Care & Life Sciences Practice.
Focused on transactions across the health care, life sciences, and digital health sectors on innovative technologies and methods, Alexis pairs practical experience with a keen understanding of often novel and still evolving federal and state regulatory requirements. Health systems and other health providers, virtual care companies, technology organizations, pharmacy and retail leaders, life sciences businesses, medical device organizations, and investors across the United States and abroad seek her legal counsel. She frequently structures and negotiates telehealth specific services and affiliation contracts and manages health regulatory matters for M&A and equity transactions with both investor/buy-side and company/target-side experience. She also advises on multijurisdictional digital health strategy and implementation, state-specific telehealth regulation, corporate practice of medicine, reimbursement, online prescribing, patient consent, credentialing by proxy, remote supervision, and fraud and abuse considerations.
Alexis speaks and writes extensively on matters involving digital health, including testimony before legislative and regulatory bodies. She was an appointee to the Maryland governor's Telemedicine Task Force, member of the Federation of State Medical Boards' workgroup on telehealth, leader of the American Bar Association's Science & Technology Practice Group, and leader of the American Health Lawyer Association's (AHLA) E-Health and Telemedicine Affinity Group.
经验
The following represents experience prior to joining Jones Day.
Developed national regulatory strategy and complete corporate structure as it relates to federal and state telemedicine and corporate practice rules, patient consent, and other regulatory matters for a leading national doctor to doctor telemedicine business (for teleneurology, telepsychiatry, and telecritical care) operating throughout the United States.
Designed documentation for strategic partnerships between multiple national telemedicine companies and academic medical centers (AMCs) and other hospital systems across the United States.
Developed national regulatory strategy and related documentation for a tele-ophthalmology business model to be deployed in multiple states and handled communications with state medical board to discuss unique legal aspects of telehealth business model.
Developed national regulatory strategy and related documentation for an international online health care information and second opinion service for consumers provided by leading specialists from across the nation.
Developed national regulatory strategy as it relates to state telemedicine and corporate practice rules and related documentation for a national online lab requisition and strategic pharma marketing and data company.
Designed hospital customer documentation for a national cloud storage company of health care data.
Developed corporate documentation and web site disclosures and terms and provided advice on business structure for various e-health start-ups, including a mobile physician portal, a photo image calibration service, a long-term care physician communications portal, and a remote physical therapy platform, among others.
其他出版物
- Forthcoming
Legal and Regulatory Issues with Telemedicine Practice in the ICU. In Telemedicine in the Intensive Care Unit. Springer - November 2018
Emergency Telemedicine: Achieving and Maintaining Compliance with the Emergency Medical Treatment and Labor Act. Telemed J E Health. 2018 Nov;24(11):934-937 - August 2015
Data Protection Challenges for Telemedicine in the EU and US - August 2015
eHealth Law & Policy Data protection challenges for telemedicine in the EU and US, eHealth Law & Policy - August 2015
Data protection challenges for telemedicine in the EU and US, eHealth law&policy - September 22, 2014
American Telemedicine Association Releases Reports Grading States on Telehealth Policy, AHLA HIT PG - September 2014
Medicare Compliance & Reimbursement, Eli Healthcare - July 13, 2014
More Signs Of Telemedicine Moving Into The Mainstream, Law360 - June 20, 2014
AMA Adopts New Recommendations on Telemedicine, Signaling Further Comfort with Telehealth - May 2014
E-Patient: The Doctor May "See" You Now -- A Look at Various Regulatory Considerations Impacting Digital Health and Telehealth, coauthor - May 15, 2014
Telemedicine and the Standard of Care: Review of Current State Practices and the New Federation of State Medical Boards Policy - 2013
Unique Considerations for Health Care Mergers and Acquisitions, Navigating Healthcare M&A Transactions, Inside the Minds, Aspatore - November 2012
Telemedicine Legal Hurdles - An Overview of Lesser Known Challenges, HIT News
- November 6-8, 2019
Specialists on Call: Telemed IQ Summit 2019: Telehealth Reimbursement Beyond Policy and Theory - October 6-8, 2019
Texas Health Law Conference: Direct-to-Consumer Virtual Care: When Regulation, Patient Preference, and Innovation Collide - October 2-4, 2019
TS19 Conference: Key Legal Considerations for International Telehealth - July 31-August 1, 2019
11th Annual mHealth and TeleHealth World Summit― Direct-to-Consumer Telemedicine: Lessons Learned and Strategies for Advancing Policy - July 15-17, 2019
InTouch Health Annual Innovation Forum: A View From the Hill - May 29-31, 2019
Boston Bar Association Health Care Conference - Digital Health - April 15, 2019
ATA19: The Ethics and Regulations of Al - April 14, 2019
ATA19: Global Telehealth Trailblazers - Experiences, Lessons & Key Considerations - April 4, 2019
CCI Inc. Healthcare Chief Legal Officer Roundtable - TeleHealth - October 8-9, 2018
SPS: Telemedicine & TeleHealth Service Provider Summit: Changes in CMS Rules and Federal Law and How They Affect You - October 8-9, 2018
SPS: Telemedicine & Telehealth Service Provider Summit: Why Do Industry Leaders Join Forces? - October 2018
McGee Event: BridgingGAPs (Global Access to Providers) A Look at New Models and Technology Enabling Remote Specialty Healthcare Services: Legal, Regulatory, and Policy Considerations - September 27, 2018
ATA EDGE - Using Al and Other Tools to Cut Through Marketing Clutter - September 20, 2018
Boston Bar Association Life Sciences Conference - Big Data & Artificial Intelligence - May 2018
The Future of Healthcare, HLTH - April 2018
Jones Day 2018 Health Care and Life Science Forum "Digital Health and Investors: Changing Delivery of Health Care, One Device at a Time" - February 2018
Physicians/Hospitals Conference, AHLA - November 15, 2017
Telemedicine Accreditation: Why One Size Doesn't Fit All - November 7, 2017
"Digital Health and Telemedicine" - Emerging Tech Breakfast Series, JD Dallas - October 2017
Telemedicine & Telehealth Service Provider Showcase - Advancing Telehealth Partnerships, SPS - October 2017
Telemedicine Services at Hospitals and Nursing Facilities, Webinar, AHLA - May 2017
Medical Informatics World Event - Impact & Opportunity-Evolution of Laws and Policy in the Business of Telehealth, Cambridge Healthtech Institute - May 2017
Annual Meeting - Telemedicine, American Urological Association - April 6, 2017
"Key Legal Considerations in Physician and Hospital Relationships" - Texas Medical Center Innovation Institute - February 2017
HIMSS 17: Opportunity in Telehealth - Strategies for Understanding & Managing Multi-Jurisdictional Laws to Achieve Scale - November 17, 2016
2016 Health Care Labor & Employment Symposium - Post Election Conference: What's Next? - November 2, 2016
Bar Association of Baltimore City: Development in Telemedicine - September 1, 2016
Telemedicine Series 2016: Supervision and Non-Physician Practitioner Issues, Webinar - September 1, 2016
Telehealth: What you Need to Know Before you Get Involved, Association of Otolaryngology Administrators Annual Meeting - September 1, 2016
General Counsel Roundtable - Critical Legal Considerations in Telemedicine, The Healthcare Roundtable - September 1, 2016
Special Panel "Outsiders at the Gate - What Will Disrupt Healthcare and What Should You Do About It?", ATA Fall Forum - June 2016
2016 Telemedicine & Telehealth Service Provider Showcase, University of Arizona - June 2016
Hot Topics in Telemedicine 2016: Payment Policy, Prescribing, and Practice Standards AHLA Annual Meeting - May 2016
Introduction to Telemedicine Legal & Regulatory Issues; How to Build an Online Primary and Urgent Care Service; Teledermatology Panel Discussion; Material Transactions in the Telemedicine Industry; ATA Practice Guidelines: How Can They Be Used Effectively? American Telemedicine Association - March 2016
Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions: Telemedicine Programs, AHLA - February 2016
Telemedicine - Michigan Chapter, American College of Healthcare Executives - November 2015
CISO Executive Network: Digital Health--Trends & Opportunities - October 2015
ATA: TeleDerm & Unique Legal Issues - October 2015
Lessons on Telemedicine - Opportunities and Unique Diligence and Payment Considerations, AHLA Health Plan Counsel Institute - August 2015
Cambridge Healthtech Institute: Next General Dx Summit - Impact & Opportunity-Evolution of Laws and Policy in the Business of Telehealth - July 2015
MATTER Workshop: Digital Health Law - An Overview and Practical Perspectives - June 2015
The Foundry Cup: Digital Health Law - June 2015
University of Maryland: CHIDS-Maryland Health Leaders Network Program - Telehealth Regulatory Update - June 2015
Telemedicine Transactions-Highlights and Updates of Applicable Health Regulatory Topics with Experienced Insights on Appropriate Diligence and Transactional Documentation, AHLA In-House Counsel Program at Annual Meeting - May 4, 2015
ATA Telemedicine Investor and Strategic Summit - May 4, 2015
Telehealth Partnering in US and Abroad: A Look at Viable Strategies and Legal Considerations, American Telemedicine Association Annual Meeting - May 2015
Legal Issues in Teleneurology Practice, American Academy of Neurology Teleneurology and Technologies Program - May 2015
Telemedicine, Telediagnostics and Mobile Health, PLI Health Care IT Conference - May 2015
ATA Annual Meeting: Direct to Consumer Legal and Regulatory Course - April 2015
ATA: The Business of Telemedicine - Part IV: Show Me the Money - Information on the Increasing Reimbursement and Payment Options Available for Telemedicine - March 2015
Opportunity in a Fragmented Regulatory Environment - An Overview of Notable Telehealth Regulations and Requirements, Colorado Health Law Symposium - January 16, 2015
Legal Perspectives Essential to Reimbursement, American Telemedicine Association - December 10, 2014
mHealth Summit 2014 - November 23, 2014
Legal issues related to connected health, Memorial Sloan Kettering Telehealth Conference - November 13, 2014
Envisioning The Future Of Dermatology Through The Lens Of Medical Informatics: Navigating the Regulations - An Overview of Notable Federal and State Regulations Impacting Digital Health, Memorial Sloan Kettering Cancer Center - November 13, 2014
Patient Privacy in the Mobile and Cloud Computing Era - October 6-7, 2014
Policy, Legal and Regulatory Issues; and Finding a Best-of-breed Telehealth Service Provider: A Practical Guide to Doing Due Diligence, Telemedicine Service Provider Conference - September 24, 2014
Legal issues related to connected health, Mt. Sinai Connected Health Day - September 7-8, 2014
Building a Chronic Care Management Program - Perspectives on State-Specific Legal Considerations, American Telemedicine Association Fall Forum Conference - June 16-17, 2014
Exploring Legal Challenges to Fulfilling the Potential of mHealth in a Safe and Responsible Environment - May 18, 2014
ATA Telemedicine Venture Summit 2014 - May 6, 2014
Executive Roundtable Series: New Frontiers in Health Care and Life Sciences; A Look at the Legal Implication - May 6, 2014
Telehealth & Lesser Known Challenges, American Health Lawyers Association Practice Group - April 29, 2014
Telemedicine and the Law: Keys to Avoiding Legal Liability - April 1, 2014
2014 Annual Summit: Adding Value through Sustainable Telehealth - April 1, 2014
Developing a Sustainable ROI Using Reimbursement & Cash Pay Options - Show Me the Money, American Health Lawyers Association Practice Group - February 23, 2014
HIMSS 2014 Annual Conference, SciTech Law Track - February 20, 2014
Legal and Policy Considerations in Implementation of Digital Health - February 20, 2014
The Digital Health Revolution: How Law is Shaping the Next Frontier in Health Care Delivery, Health Law and Justice Society - December 10, 2013
Telehealth Bootcamp Series: A Look at Legal and Regulatory Matters Specific to Telehealth, Telemedicine, and mHealth: Area II, Part I, American Health Lawyers Association - December 10, 2013
Practice of Medicine in a Virtual World: Rethinking Health Regulatory Basics, American Health Lawyers Association Practice Group - December 8-11, 2013
2013 mHealth Summit - October 26, 2013
Digital Health Winners: Which Companies will Best Serve Customers and Investors?, 2013 Wharton Alumni Conference, University of Pennsylvania - October 8, 2013
Where We've Been in Telehealth: Has the Industry's Time Arrived? American Health Lawyers Association Practice Group - May 5, 2013
An Overview of Key Legal Topics lmpacting Telehealth Programs & Businesses - Fundamentals of Credentialing 'By-Proxy', AHLA & ATA Pre-Meeting Short Course - May 5, 2013
Getting Your Documentation in Order - Legal and Regulatory Considerations for your Telehealth Startup, Business and Finance SIG Pre-Meeting Short Course - May 1, 2013
Getting Your Documentation in Order - Legal and Regulatory Considerations for your mHealtb Enterprise, American Conference Institute's Legal and Business Guide to mHealth and Wireless Medical Technology Post-Conference Working Group - February 6, 2013
Telehealth & Telemedicine State of Industry & Opportunities, HIMSS - January 16-17, 2013
State Medical Licensure and Discipline: Advocacy and Opportunities in 2013 and Beyond - November 16, 2012
Technologies to Improve Health & Wellness, 2nd Annual Healthcare Conference - September 21, 2012
TeleHealth: Update on Market Activities & Legal Matters, HealthTech Net - August 4, 2012
Telemedicine: An Overview of the Legal Hurdles, 2012 ABA Annual Meeting - June 27, 2012
Telemedicine & Corporate Practice of Medicine, Business & Finance SIG Meeting - April 30, 2012
Telemedicine & Corporate Practice of Medicine, 2012 ATA Annual Meeting - August 8, 2011
New Opportunities & Hurdles: A Review of the New CMS Rule on Telemedicine Credentialing and Privileging, ATA Business & Finance - June 7, 2011
New CMS Rule on Telemedicine Credentialing and Privileging, American Health Lawyers Association - August 3, 2010
Show Me the Money...Show Us the Jobs, SAE - Southeastern Bioenergy Conference - April 28, 2010
Telemedicine Opportunities & Hurdles, ASG (May 26, 2010) and Health IT Conference - September 2015
New York Telemedicine Parity Laws, Mt. Sinai Connected Health Symposium
"Alexis is the most innovative and creative attorney that I know. She is amazing across the board."BTI Annual Client Survey of Top Legal Decision Makers
- American University (J.D. 2002); University of North Carolina at Chapel Hill (B.A. in Political Science with honors and distinction 1998; Morehead Scholar; Dean's Fellow)
- District of Columbia and Georgia
BTI Client Service All-Star (2023)
Law360 MVP in Health Care (2020) & Rising Star in Health Law (2014)
"Healthcare Trailblazers" (inaugural list) — The National Law Journal (2019)
Chambers USA (ranked every year since 2017)
The Legal 500 United States (Health Care Leading Lawyer)
Served on the board of directors and as vice president of the American Telemedicine Association (ATA) and is a member of the ATA College of Fellows
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