Representative Experience

Epstein Becker Green provides counsel to national and international clients on digital health and connected health issues, including eHealth, information and communication technologies for health, and health and well-being. Our attorneys have advised clients on regulatory compliance, reimbursement, coverage, and policy issues related to, among other things, the use of telehealth, mobile health, and related information technology platforms. Our professionals have served clients on various matters, including the following:

Regulatory

Reimbursement

Privacy & Security

Mergers, Acquisitions & Divestitures

Marketing & Advertising

Clinical Trials

Other


Regulatory

  • Assisted clients with regard to FDA strategy and execution associated with getting new products cleared by FDA
  • Assisted a manufacturer and provider of medical technologies in responding to an FDA warning letter that raised both quality system issues and advertising and promotional concerns, helped the company develop submissions to FDA designed to define the contours of products that are exempt from FDA premarket notification, counseled the company on data privacy and compliance with European regulatory requirements, and helped the company prepare for the possible implementation of the medical device tax
  • Provided the following services to an integrated care delivery network (with six hospitals, an extended care facility, and a school of nursing) regarding a nutritional mobile application to support cancer patients receiving radiation treatments:
    • evaluated the regulatory category of the mobile health app
    • reviewed the FDA exceptions for physician-developed medical apps and identified regulatory pathway issues
    • offered strategic advice on the reimbursement implications of using the app, clinical delivery, and investigation issues associated with using the app with patients and in developing appropriate quality control documentation to meet regulatory requirements
    • evaluated the informed consent and privacy/security issues associated with the use of this app within the provider’s network
  • Advised multiple clients that provide video consults via smartphone/tablet apps between a network of available physicians and patients all across the United States (one client involved a network of U.S. licensed physicians that is affiliated with independent physician-owned medical practices throughout the United States), and provided continuing counsel and advice on a number of regulatory matters, including scope of practice, licensure, prescribing, privacy and security, corporate practice of medicine, and fraud and abuse
  • Counseled one of the largest providers of telehealth medical consultations in the United States (the company provides access to U.S. board-certified doctors and pediatricians via phone or online video consultations) on health care regulatory matters, and advised on an Employee Retirement Income Security Act of 1974 (ERISA) issue and a number of state policy and advocacy matters
  • Advised a clinic in Washington, D.C., that provides primary care services to Latino residents of the District (the clinic won a half-million-dollar grant from a large insurer to implement a regional telepsychiatry program) on a number of regulatory issues regarding the implementation of a telepsychiatry program
  • Provided regulatory counsel to a large insurer regarding various telehealth initiatives that the company is launching around the country
  • Counseled a client that has initiated a national genetic counseling testing program provided via a telehealth platform, and supplied advice on a number of state regulatory matters
  • Represented a client that provides personalized second opinions to primary care and attending physicians from specialists at some of the most respected hospitals in the country, and offered continuing counseling on a range of regulatory issues impacting the company’s business model, marketing, and physician arrangements
  • Represented a biotech startup on a successful appeal to the Center for Drug Education and Research (CDER) regarding a non-approval decision for a new molecular entity drug used in medical imaging (as a result, the product was approved based on a reanalysis of existing data as opposed to the two new clinical trials requested by CDER’s Office of New Drugs (OND) Director)
  • Assisted a leading in vitro diagnostics (IVD) trade association in preparing comments on guidance regarding research use only (RUO) and investigational use only (IUO) products and other important regulatory issues

Reimbursement

  • Advised a legal and regulatory telehealth organization that provides vital support to the community on such topics as physician and nurse licensure, credentialing and privileging, Medicare and Medicaid reimbursement, and private insurance payment policies, and supplied regulatory and reimbursement counseling
  • Provided counsel to a specialty laboratory seeking Medicare coverage of a personalized oncology assay, and represented the laboratory in multiple administrative hearings and appeals
  • Provided coverage, coding, and reimbursement counsel to a molecular diagnostics company
  • Led a coalition of anatomic pathology labs to combat wide-scale payment reductions for surgical pathology services reimbursed under the Medicare Physician Fee Schedule
  • Developed, for a pharmaceutical and diagnostic manufacturer, a policy agenda designed to educate policymakers in Congress and federal agencies on the value of biomarker-based genetic tools for cancer screening
  • Advised clients on compliance with state and federal laws affecting telehealth and e-health, including issues related to the practice of medicine/scope of practice, licensure, prescribing, reimbursement and coverage, privacy, and risk management
  • Defended health care insurers and providers in a confidential data breach case, which was brought as a class action and implicated novel privacy and remediation issues related to the Health Insurance Portability and Accountability Act (HIPAA)

Privacy & Security

  • Represented two related health plans in Philadelphia, obtaining a significant ruling from a state court judge denying class certification in a case involving a protected health information (PHI) data breach (in addition to demonstrating our command of the issues surrounding health data confidentiality and its limits, we were able to convince the court to follow recent U.S. Supreme Court precedents, agree to consider merits-based facts at the certification phase of the case, and reject the presumption of certification, a rare result in a case where numerosity was not an issue)
  • Advised leading financial and health institutions, as well as innovative startup companies, on identifying, evaluating, and improving the security posture and mission critical processes of their organizations
  • Assisted Fortune 500 clients with their security and risk analysis obligations under U.S., Canadian, and European Union (EU) law
  • Conducted risk assessments and IT audits for health care and financial services companies following HIPAA, FDIC, Federal Reserve Bank, the Office of Thrift Supervision, the Office of the Comptroller of the Currency’s Information Security Guidelines, the Gramm-Leach-Bliley Act (GLBA), and other best practices
  • Designed and implemented cost-effective strategies for managing electronic documents, including collecting, preserving, reviewing, analyzing, and producing electronic data
  • Advised clients regarding privacy and security legislation: HIPAA Privacy and Security Regulations, the GLBA, the EU Commission’s Directive on Data Protection (95/46) and the U.S.-EU Safe Harbor, the Personal Information Protection and Electronic Documents Act (Canada), the U.S. Patriot Act, the Sarbanes-Oxley Act of 2002, state-based security breach notification legislation (both acquisition- and risk-based variations), OIG Corporate Integrity Agreements and the Medicare and Medicaid Patient Protection Act of 1987 (the “Anti-Kickback Statute”), and National Institute of Standards and Technology (NIST) and Information Services Office (ISO) privacy and security standards
  • Managed computer security incidents for various clients in both the health care and financial sectors, including performing and creating procedures for system security audits, penetration tests, and vulnerability assessments to define real metrics by which an organization can evaluate and demonstrate its privacy and security due diligence
  • Conducted health care regulatory due diligence for transactions involving health care technology or medical device companies
  • Supported a medical device manufacturer’s acquisition of multiple mobile technology platforms, including providing analyses of the regulatory classification of the products and the implications for product marketing and sales, advice and counseling regarding user testing activities and documentation, and advice regarding purchase agreement provisions

Mergers, Acquisitions & Divestitures

  • Counseled one of Montana’s largest comprehensive hospitals (which serves the health care needs of more than 400,000 people in a four-state area and is focused on being a technology leader in the health care industry), advised on transactional matters, and prepared a number of agreements between the health system and the participating telehealth sites
  • Executed transactional work with an insurance exchange platform developer

Marketing & Advertising

  • Provided advice on scope of practice, licensure, terms of use, and marketing issues to a service provider that connects treating physicians facing challenging cases with medical experts and enables patients to seek second opinions through their services platform (the expert review and report can be provided peer to peer or directly to the patient)
  • Counseled pharmaceutical, device, and diagnostic clients regularly on various promotional matters, including RUO/IUO products, off-label issues associated with selling instruments, analyte specific reagents, and the use of disease-branded websites and other social media tools
  • Provided a medical device manufacturer with training on regulatory and advertising and promotion considerations associated with a proposed digital health initiative

Clinical Trials

  • Regularly counsel sponsors on clinical trial issues involving novel technologies and wearable devices
  • Analyzed regulatory requirements and assisted in the development of a clinical study conducted in a remote environment exclusively using a cloud-based technology platform
  • Negotiated agreements and provided regulatory guidance with respect to the use of various clinical trial and remote technologies, including eCFRs, electronic diaries/ePRO tools, and ECG equipment/training/reading vendors

Other

  • Served as Counsel for Continua Health Alliance, as counsel to AdvaMed for payment issues, and as General Counsel to the Combination Products Coalition, the mHealth Regulatory Coalition, and the CDS Coalition (focusing on clinical decision support software)
  • Managed antitrust matters, the development of accountable care organization capability, and IT security risk management issues, including electronic medical record “meaningful use” certification, and established and participate in the Quality Oversight and Community Benefit Committee of a large health system’s board of directors (the committee oversees system-wide health care quality and community benefit initiatives, quality reporting, and transparency)