Evan M. Hellman
Senior Counsel
Evan M. Hellman counsels high-growth companies and entrepreneurs in the health tech space, delivering practical, compliance, and transactional issues so that they can continue to move their businesses forward no matter what issues arise as their operations grow and evolve.
Evan advises on regulatory and transactional issues for a range of health care clients, including health-tech startups, major academic medical centers, community hospitals, nursing homes, physician groups, and other provider entities. His advice involves telemedicine and digital health operations, corporate practice of medicine compliance, scope of practice rules, licensing, permitting and change of ownership issues, fraud and abuse compliance, and HIPAA. Evan also advises clients on the development and operationalization of new business initiatives, governance, and transactional matters, including mergers, acquisitions, joint ventures, and other strategic affiliations.
Real Industry Experience
Evan knows the demands and strategic goals of venture-backed health care companies, as well as their investors. Prior to joining Foley, Evan spent three years as general counsel for Vault Health, Inc. Evan was with the company from the earliest stage. Beginning his role when the company was just a slide deck with three employees, helping it grow to over 250 people and offering services across the country. As the company’s chief legal advisor, he counseled the CEO and C-suite, the board of directors, and downstream departmental stakeholders across the company. He was integral in advising the business to launch its initial men’s health services and its expansion to nationwide COVID testing and clinical trial operations. Tackling the full spectrum of legal issues, including health care regulatory, venture financing, M&A, employment, real estate, government contracting, and strategic business development opportunities, Evan knows what drives health tech entrepreneurs to succeed and the issues they face when growing a business to scale.
Telemedicine, Telehealth, Virtual Care, Digital Health
“Foley is the premier firm for telehealth counsel.”
“A market leader in telemedicine issues.”
“This is the Dream Team.”
Chambers USA: America’s Leading Business Lawyers (2020 – 2021)
The Value Foley Brings to Telemedicine Companies
Representative Experience
- Direct-to-Consumer Cardiac Telemedicine. Advised a direct-to-consumer tele-cardiac health company in launching operations in multiple states throughout the country, enabling the company to offer cardiac-focused health services to patients remotely through the use of telemedicine. Counseled on regulatory and transactional issues, including entity creation and governance, cross-state business and professional licensure requirements, privacy and security, telemedicine prescribing, professional corporation affiliations, and corporate practice of medicine. Advised on the establishment of privacy and security policies and procedures payment acknowledgements, employment agreements, independent contractor agreements, and the multitude of operational documents associated with telehealth practices.
- Direct-to-Consumer Dermatology Hybrid Virtual and In-Person Office Model. Represented direct-to-consumer early stage health tech medical practice utilizing advanced practice registered nurses (APRNs) in national expansion plan. Advised on scope of practice, collaborative practice, prescribing, and telehealth practice standards as client expanded operations to additional states. Advice enabled company to efficiently determine which states its model would allow for compliant and effective operations as it sought to utilize more APRNs.
- Telemedicine Influencer Marketing Program. Advised client on regulatory and compliance considerations in connection with marketing products and services through social media influencers, including state law considerations and U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) rules and guidance associated with engaging influencers.
- Direct-to-Consumer Blood Pressure and Diabetes Remote Patient Monitoring. Counseled a direct-to-consumer remote patient monitoring company focused on care in the diabetes and hypertension space with expansion to multiple states in preparation for national growth. Advised on regulatory and transactional issues, including entity creation and governance, cross-state business and professional licensure requirements, privacy and security, and FDA rules in connection with use and marketing of prescription medical devices.
- Pediatric Chronic Care Telemedicine Provider. Represented a direct-to-consumer pediatric telemedicine company focused on behavioral health. Counseled on regulatory issues, including analysis of health care fraud and abuse compliance, professional licensure, controlled substance prescribing and general telemedicine prescribing, health care clinician labor and employment matters, corporate practice of medicine, and professional corporation affiliations.
- Wellness and Health Coaching Platform. Represented client on creation of wellness and coaching platform with data repository functions. Advised on professional licensure issues, including use of licensed and unlicensed personnel to deliver services, and privacy matters with collection of health data. Counseled on regulatory issues associated with provision of non-clinical services and marketing and e-commerce considerations in connection with consumer experience and platform engagement.
Awards and Recognition
- Chambers® USA: America’s Leading Business Lawyers (2020-2021)
- “Foley is the premier firm for telehealth counsel.”
- “A market leader in telemedicine issues. This is the Dream Team”
Affiliations
- Member of the American Telemedicine Association’s Home Testing Special Interest Group
- Member of the American Telemedicine Association
- Member of the American Health Lawyers Association
- Member of the New York Bar Association
Presentations and Publications
- Co-presenter, “Key Consideration for Interstate/Interjurisdictional and International Telehealth Practice,” 2023 Mid-Atlantic Telehealth Resource Center (MATRC) Summit, (March 17, 2023)
- Co-presenter, “Telehealth Legal, Regulatory, and Advocacy Considerations,” NYU Langone Health, CME Course, (April 8, 2022)
- Co-author, “Pharmaceutical and Medical Device Manufacturer and Telehealth Provider Partnerships: Compliance Issues for Consideration,” Journal of Health Care Compliance, Vol. 24, No. 6, (November-December 2022)
- Co-presenter, “How to Launch an At-Home Testing Service for Telemedicine Products,” 2023 American Telemedicine Association Annual Conference & Expo, (March 4, 2023)
- Co-presenter, “Telehealth Legal and Regulatory Updates After the COVID-19 Public Health Emergency,” NYU Langone Health, CME Course, (August 11, 2023)