Alexis S. Gilroy | Abogados

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.

Experiencia

Cardinal Health acquires the Bendcare CPO-GPO entity and makes a minority investment in the Bendcare MSOJones Day advised Cardinal Health, Inc. in the acquisition of the Bendcare group purchasing organization (CPO-GPO) entity and a minority investment in the Bendcare management services organization (MSO).

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.

Maven Clinic receives historic Series D investment fundingJones Day advised Maven Clinic as health regulatory counsel in its $110 million Series D investment round, co-led by Dragoneer Investment Group and Lux Capital.

MDLIVE sells company to Cigna's EvernorthJones Day advised MDLIVE in its sale to Cigna's health services subsidiary Evernorth.

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.

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.

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.

PWNHealth receives significant growth investment by Spectrum EquityJones Day advised PWNHealth LLC as health regulatory counsel in the significant growth investment led by Spectrum Equity, a leading growth equity firm focused on internet-enabled software and information services companies, with participation by the Blue Venture Fund (BVF), a unique collaboration between Blue Cross and Blue Shield (BCBS) companies, Blue Cross Blue Shield Association (BCBSA), and Sandbox to which thirty-six BCBS companies have committed over $800 million across four funds.

Several digital health companies successfully close state regulatory board investigationsJones Day successfully represented several digital health companies and their affiliated physicians in responding to state medical board investigations regarding the provision of clinical services including certain laboratory tests and prescription drug orders.

Telehealth provider obtains dismissal of complaint before state regulatory boardJones Day represented a telehealth provider in responding to a complaint filed with a state regulatory board.

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.

Academic medical center considers multi-state second opinion servicesJones Day provided strategic health regulatory guidance to a preeminent academic medical center in connection with their multi-state second opinion and telehealth programs.

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.

Large critical infrastructure employer develops and implements protocol for international relocation of essential workers during COVID-19 pandemicJones Day represented a large critical infrastructure employer during the COVID-19 crisis to develop appropriate protocols and policies for the international relocation of several employees in accordance with CDC guidelines.

Emerging specialty service launches telehealth platformJones Day advised an emerging direct to consumer telehealth organization focusing on teledermatology with terms of service, privacy policy, and telehealth consent for launching operations in several states across the U.S.

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.

November 2024 Alert

Publicaciones adicionales

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 S.Gilroy

Practice Leader Health Care & Life Sciences

Contacto:

Experiencia

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

New York Imposes Stringent Cybersecurity and Cyber Incident Reporting Obligations on Hospitals

U.S. District Court Invalidates HHS Guidance Overreading HIPAA's Application to Online Technologies

Vital Signs: Digital Health Law Update | Spring 2024

FTC's Final Health Breach Notification Rule: Expanded Scope, New Obligations, and Modified Reporting Requirements

FDA Proposes Updated Guidance Concerning Cybersecurity of Medical Devices

New State Health Privacy Laws—Moving Beyond HIPAA and Recasting Consumer Health Data Rights?

Vital Signs: Digital Health Law Update | Winter 2024

Federal Agencies Launch Joint Inquiry Into Private Investment in Health Care

HHS Releases Cybersecurity Performance Goals to Enhance Cybersecurity for Health Care and Public Health Sectors

Publicaciones adicionales

Alexis S.Gilroy

Practice Leader Health Care & Life Sciences

Contacto:

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Experiencia

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

New York Imposes Stringent Cybersecurity and Cyber Incident Reporting Obligations on Hospitals

U.S. District Court Invalidates HHS Guidance Overreading HIPAA's Application to Online Technologies

Vital Signs: Digital Health Law Update | Spring 2024

FTC's Final Health Breach Notification Rule: Expanded Scope, New Obligations, and Modified Reporting Requirements

FDA Proposes Updated Guidance Concerning Cybersecurity of Medical Devices

New State Health Privacy Laws—Moving Beyond HIPAA and Recasting Consumer Health Data Rights?

Vital Signs: Digital Health Law Update | Winter 2024

Federal Agencies Launch Joint Inquiry Into Private Investment in Health Care

HHS Releases Cybersecurity Performance Goals to Enhance Cybersecurity for Health Care and Public Health Sectors

Publicaciones adicionales

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