Overview
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 know-how. 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), the Federal Trade Commission, the Centers for Medicare & Medicaid Services, and the Office of Inspector General 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.
Our Services
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 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.
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Insights
Insights
- BlogsOCR Withdraws Appeal of District Court Order Declaring Unlawful and Vacating the “Proscribed Combination” Portion of ...4 minute read
- Media Coverage
Bradley Merrill Thompson Featured in AHLA’s Speaking of Health Law Podcast, “AI in Health Care: Managing Algorithmic ...
2 minute read - Media CoverageMarylana Saadeh Helou Quoted in “FDA Offers Road Map for Remote Trials, but Questions Linger”2 minute read
- Media CoverageChristine Worthen Featured in “Beltway Moves”1 minute read
- Media CoverageEpstein Becker Green Adds Healthcare Attorney Christine Burke Worthen in Washington, DC2 minute read
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- Media CoverageDavid Shillcutt Quoted in “Proposed Digital Therapy Codes Good Idea with Barriers: Experts”2 minute read
- PublicationsMajor Updates to Substance Use Disorder Treatment Confidentiality Requirements Increase Alignment with HIPAA but Raise ...2 minute read
- Media CoverageAmy Lerman Quoted in “What the House Subcommittee Hearing Tells Us About Telehealth’s Future”2 minute read
- Firm AnnouncementsEpstein Becker Green Fuels West Coast Momentum with Six-Attorney Health Care Team6 minute read
- PublicationsHealth Care M&A Insights: Q4 2023 & Outlook for 2024 Deal Activity4 minute read
- Media CoverageAmy Lerman Featured on Podcast: “Navigating the Telehealth Landscape for 2024”1 minute read
- PublicationsTelemental Health Laws: 2023 Overview10 minute read
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- Media CoverageBonnie Odom Quoted in “Health Care’s AI Embrace Boosts Workforce Despite Privacy Risks”2 minute read
- Media CoverageAlaap Shah Quoted in "New Health App Rule Would Better Protect Users – and So Can You"2 minute read
- Media CoverageRobert Hearn Quoted in “Surveying Laboratory Tests from a Health IT Perspective”3 minute read
- Firm Announcements
Jessika Tuazon Named to the 2023 Southern California Rising Stars List
6 minute read - PublicationsFDA Issues Draft Recommendations for Implementing Decentralized Clinical Trials20 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Ready or Not, AI Chatbots Are Coming to Hospitals”3 minute read
- PublicationsWomen's Network—Health Apps for Women: Life Solutions v. Data Risks2 minute read
- PublicationsBradley Merrill Thompson Quoted in “FDA’s Human Factors Draft Draws Fire for Introduction of ‘Critical Task’ ...2 minute read
- Firm Announcements
Epstein Becker Green Recognized Among Top 10 Largest Health Care Law Firms by Modern Healthcare
2 minute read - Media CoverageBradley Merrill Thompson Quoted in “Trade Group Pushes Back on FDA’s Clinical Decision Support Guidance”3 minute read
- Publications
Abortion-Related Time Off After Dobbs: How the FMLA and Other Laws Might Apply
22 minute read - Media CoverageEpstein Becker Green’s Telemental Health Laws Survey Featured in “States Continue to Expand Regulations to Support ...3 minute read
- Firm Announcements2022 Telemental Health Regulations Unlock Access and Evolve Compliance Practices6 minute read
- PublicationsTelemental Health Laws: 2022 Overview8 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Software to Predict Risk of Sepsis, Stroke Should Be Regulated as a Medical Device ...4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Acknowledges Shortcomings of Pre-Cert Pilot in Report”6 minute read
- Firm Announcements
Epstein Becker Green’s Amy Dow Honored in Crain’s 2022 Notable Women in Law
2 minute read - Media CoverageAmy Lerman Quoted in “Don’t Let OIG Fraud Alert Disrupt Your Practice’s Telehealth Program”2 minute read
- Media CoverageAmy Lerman Quoted in “Telemedicine or Telescam? Heed the Warnings in the Latest Special Fraud Alert”2 minute read
- Media CoverageEpstein Becker Green’s Unpacking Averages Report “Casts Doubt on Value of US FDA’s Breakthrough Devices Program” ...2 minute read
- Media CoverageBradley Merrill Thompson Featured in “Meet the Top 8 Lawyers Helping Startups Patent Artificial Intelligence and Comply ...2 minute read
- Blogs
The Pendulum Swings Both Ways: State Responses to Protect Reproductive Health Data, Post-Roe
13 minute read - Media Coverage
Alaap Shah Featured in AHLA Connections Magazine: Member Spotlight
3 minute read - Media CoverageBradley Merrill Thompson Quoted in “Senate HELP Sends User Fee Reauthorization Bill to Floor Vote”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Should Step In to Help Spur AI/ML Standards”3 minute read
- Firm Announcements
Jessika Tuazon Named to the 2022 Southern California Rising Stars List
5 minute read - Firm AnnouncementsEpstein Becker Green Again Recognized as One of the Largest Health Care Law Firms2 minute read
- Media CoverageEpstein Becker Green Finds Success with Client-Facing Wage & Hour and Telemental Health Laws Apps3 minute read
- Media CoverageAlaap Shah Quoted in “HHS Guidance Addresses HIPAA and Emergency Protective Orders”3 minute read
- Media CoverageGary Herschman, Anjana Patel, Timothy McHale Quoted in “Health-Care Deals Stay Strong Amid Fears Over War in Ukraine” ...3 minute read
- PublicationsRecord Number of Health-Care Deals Close 2021 with a Bang4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Use This App and Call Me in the Morning: The Promise of Prescription Digital ...2 minute read
- PublicationsPrescription Digital Therapeutics Don't Need a Physician3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Top Med-Tech Trends of 2021: Regulatory Torpor Adding Drag to Advances in Artificial ...6 minute read
- Media CoverageEpstein Becker Green Reports Telemental Health’s Influence Grows Throughout COVID-19 Pandemic3 minute read
- Media CoverageEpstein Becker Green’s Telemental Health Laws Survey Featured in “Fraud Enforcement Followed Spike in Telemental ...5 minute read