Digital Health

Telehealth has become a transformative force in digital health, increasing access to health care through virtual consultations and digital health platforms, to remote monitoring solutions that provide real-time data and diagnoses. The possibilities are endless, and with the rapid emergence of new technologies, so too are the regulatory schema guiding the ethical collection and use of digital health solutions. Our team understands, through experience, the legal and regulatory challenges unique to telehealth. For clients entering this space or those with established telehealth operations, we provide tailored guidance and support that enables them to deliver accessible, compliant, and cost-effective virtual care. Our clients cut across the telehealth spectrum, including providers or developers of:

• Telemedicine
• Digital platforms (web-based and mobile applications, patient portals, back-office support, etc.)
• Remote patient monitoring (RPM)
• Remote therapeutic monitoring (RTM)
• Wearable devices, sensors and implantables used in clinical settings and/or direct to consumer variety

Capabilities

• Regulatory compliance, including HIPAA and the Telemedicine Practice Act
• Data security and privacy, including state-level privacy laws and those governing international data transfers
• Data governance
• Federal and state licensing and regulations
• Fraud, waste and abuse, including Anti-Kickback laws, Stark Law and False Claims Act
• Payment arrangements
• Reimbursement and billing issues (Medicare, private insurers, etc.)
• Informed consent, disclosure and notifications
• Business formation, tax planning and IRC 1202 qualification and exit strategies
• Venture capital, fundraising and financing issues
• Contractual structures
• Intellectual property, including patent applications, prosecution and litigation
• Product commercialization and “as a service” agreements
• Litigation, including business disputes, product liability, tort and antitrust

Experience

• Structured RPM arrangements for clients, complying with regulations while also allowing physician groups to explore
  new technologies with their patient base.
• Counseled senior living providers developing remote patient monitoring programs utilizing new equipment and
  technologies focused on measuring vital signs of residents.
• Assisted telehealth client in obtaining and managing necessary licensing.
• Assisted telehealth client with navigating regulatory and reimbursement requirements related to the provider/payor
  dynamic.
• Handled IP aspects for a multinational biopharma and diagnostics manufacturer in a number of acquisitions, including
  companies that provide telecare and passive monitoring systems, manufacture microcalorimetry systems and software,
  as well as nuclear and medical imaging developers and manufacturers.
• Advised RTM company through formation and development to operations.
• Counseled RPM company on service offers for value-based arrangements.
• Assisted health system with development of telehealth program for neurology service line.
• Advised RTM company on FDA medical device compliance.
• Advised telehealth client on corporate restructuring for corporate practice compliance.
• Assisted health system with development of telehealth program for neurology service line.

At the core of digital health solutions is the collection, access, usage, and storage of data. And while interoperability has the ability to create a seamless health care experience for consumers, patients, providers, and payors alike, it’s wrought with complexities. Our team regularly counsels on health data exchanges, electronic health records (EHRs), electronic medical records (EMRs), document management systems, and other related industry-wide software and systems. We not only understand applied health law and legal considerations, but we also bring working knowledge of the technical systems themselves. We’re able to apply our in-depth knowledge concerning the computer science of data flow—and how systems transmit data and “talk” to one another—to help clients implement interoperable solutions that promote seamless, secure, and patient-centered care across platforms.

Capabilities

• Regulatory compliance, including HIPAA
• Information blocking
• Data security and privacy, including state-level privacy laws
• Data governance
• Incident response planning and mitigation
• Informed consent, disclosure and notifications
• Vendor agreements, licensing and contractual structures

Experience

• Counseled clients as to privacy and security implications of social media and internet applications providing a medical
  records interface and repository.
• Assisted medical research software manufacturer with obtaining DOC EU-U.S. Safe Harbor Certification.
• Counseled health care exchanges and health systems with respect to data use and exchange.
• Represented a regional nonprofit health and health care improvement organization in Cincinnati that supports the
  delivery of high-quality care, promotes efficiency, reduces costs and drives collaboration across its members in the
  health care community.
• Advised multiple health care providers with information blocking rules.