From remote monitoring in the home to global telehealth services and on-the-go care via mobile health networks, digital health is essential to meeting the challenges of delivering quality health care while alleviating the unsustainable growth in costs through greater efficiency and better outcomes.
Epstein Becker Green’s Digital Health Team knows your environment and its pressures. We can help make your leadership more effective by increasing your confidence, options, and expertise. We provide practice experience focused on digital health, connected health, and telehealth to a wide range of players: startups, established companies, entrepreneurs, investors, and health care institutions. And members of our Digital Health Team are actively involved in policy development and maintain relationships at government agencies that affect the digital health space, including the U.S. Food and Drug Administration (FDA), Federal Trade Commission (FTC), Centers for Medicare & Medicaid Services (CMS), and Office of Inspector General (OIG) of the U.S. Department of Health and Human Services.
We regularly assist health IT companies, technology companies, telecommunications providers, software developers, biotech companies, network device and medical device manufacturers, health care providers, and venture capital and private equity firms in planning for the regulatory environment that they will encounter, so that they will be prepared to make sound decisions and maximize value at the critical time.
Services/Scope of Practice
Our digital health-related services cut across multiple legal and regulatory fields and include, but are not limited to:
- Developing regulatory strategies for innovative technologies, and assisting clients in executing those strategies to achieve regulatory and business goals
- Counseling on FDA regulations, submissions, approvals, and clearance and marketing issues
- Advising on privacy and security laws, and assisting clients with their security and risk analysis obligations under international, federal, and state laws and with data-breach response and mitigation
- Advising on licensure, credentialing and privileging, online prescribing, and corporate practice of medicine matters for telemedicine providers
- Providing guidance on Medicare and Medicaid reimbursement and innovative payment systems to drive technology adoption
- Drafting clinical trial agreements, and advising on risk management during clinical trials
- Counseling on compliance with the Stark Law, the Anti-Kickback Statute, and other federal and state fraud and abuse laws
- Drafting and reviewing contracts for digital health products and services
- Providing guidance on the formation, financing, and governance of digital health entities
- Providing digital health investors with venture capital and private equity transaction support
- Advising on strategic alliances and joint ventures, mergers and acquisitions, and divestitures
- Conducting health care regulatory due diligence in corporate transactions
To provide our clients with the best possible outcomes, we often take a multidisciplinary approach to complex problems, looking at not only the law but also clinical care pathways and health outcome goals. We work regularly with a team of engineers, scientists, and technology experts to bring clients comprehensive and sensible solutions. Whether we offer a specific recommendation or an array of options, our guidance focuses on practical ways to protect and increase value as well as lays the groundwork for the next logical step that you should take to maintain momentum.