Digital Health

Primary contacts

Michele L. Buenafe, Timothy L. Bransford, Steven M. Cohen, John J. Concannon III, John L. Hemmer, W. Reece Hirsch, Brett A. Lovejoy, Ph.D., Catherine Wang

Driven by increasing consumer demand, the emergence of innovative technologies, and a shift to value-based care, digital health products and services are disrupting the global healthcare landscape at a rapid pace.

Morgan Lewis advises clients involved in the digital health sector on the full spectrum of novel and evolving legal, business, privacy, regulatory, and policy challenges they confront. Our clients include startups, venture capital and private equity firms, healthcare providers, health insurers, trade associations, consumer electronics, medical devices, pharmaceuticals, biotech, telecommunications, and technology companies.

What We Do

Our lawyers help navigate clients through US Food and Drug Administration (FDA) regulation, privacy and cybersecurity concerns, reimbursement matters, Federal Communications Commission (FCC) and telecommunications regulation, state regulations, intellectual property matters, and transactions related to government contracts, venture capital, financing, mergers and acquisitions, and initial public offerings (IPOs), among other matters.

Our team, which includes more than 200 lawyers with experience in the healthcare, technology and life sciences sectors, advises clients across the digital health landscape, including companies focusing on the following areas:

  • Artificial intelligence
  • Big data and analytics
  • Bioinformatics, genomics and sequencing
  • Care coordination
  • Consumer health information portals
  • Cloud computing and cloud storage
  • Electronic medical records (EMR)
  • Internet of Things (IoT)
  • Medical devices
  • Online pharmacies
  • Wearables and remote patient monitoring
  • ePayment and online scheduling
  • Patient engagement
  • Population health management
  • Telemedicine and mHealth
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Who We Serve

  • Startups seeking to market their first digital health products
  • Providers of telemedicine and remote patient monitoring devices and services
  • Venture capital and private equity firms investing or looking to invest in digital health 
  • Technology and telecommunications providers expanding into the digital health space
  • Consumer electronics companies focusing on or expanding into the digital health sector
  • Healthcare providers and health insurers developing in-house health computer networks and software products
  • Traditional drug, biotech, and medical device companies looking to partner strategically with developers of digital health products and services
  • Industry and professional groups representing digital health stakeholders

Select Matters Handled by Our Lawyers

  • Advised a web and mobile social media company delivering content to the health plan community in its Series D-2 financing
  • Represented a digital health company in its IPO
  • Represented a telecommunications company in its response to an inquiry from FDA medical device compliance officials on the marketing and regulatory status of its mobile technology products
  • Represented a technology company in its acquisition of a healthcare predictive analytics company
  • Assisted digital health companies in preparing premarket submissions to FDA for remote monitoring systems
  • Advised a technology company on regulatory issues related to the development of a new wearable product
  • Counseled a software startup on regulatory pathway issues and provided assistance in preparing for a presubmission meeting with FDA
  • Advised a pharmaceutical company in evaluating potential partnerships with companies that market mobile medical apps designed to monitor and track patient symptoms

Regulatory & Compliance

  • Regulatory jurisdiction issues (FDA, Federal Trade Commission, US Consumer Product Safety Commission)
  • Clinical study requirements (FDA and FCC), pre-submission meetings, and FDA marketing applications
  • Complaint handling, adverse event and recall reporting, quality system regulation (QSR) compliance
  • Inspection and enforcement issues
  • Labeling and promotional compliance

Privacy & Cybersecurity

  • Privacy policies and procedures
  • Audits of Health Insurance Portability and Accountability Act (HIPAA) compliance and training workforce members
  • Use and disclosure of protected health information under US federal and state healthcare privacy laws
  • Compliance management
  • Transactional issues
  • Data breach response and litigation

Corporate Transactions

  • Public/private mergers and acquisitions, including joint ventures, spin-offs, and strategic alliances
  • All aspects of real estate
  • Sponsorships and promotional agreements, including licensing
  • Vendor relations, bidding process, and procurement

Finance

  • Equity and debt financings
  • Senior secured credit facilities
  • Acquisition financings
  • Refinancings
  • Institutional investments
  • Bankruptcy and restructuring
  • Private note placements
  • Multicurrency and cross-border financing

Intellectual Property

  • Trademark protection and licensing
  • IP licensing and joint development agreements
  • Patent litigation
  • Patent prosecution and counseling
  • Trade secret litigation
  • Trademark litigation
  • US Patent and Trademark Office (USPTO) proceedings before the Patent Trial and Appeal Board, including inter partes reexaminations, and the Trademark Trial and Appeal Board, including oppositions

Tax

  • Nonprofit tax planning
  • Transfer pricing
  • Tax controversy and tax litigation
  • Cross-border and domestic tax structuring and planning
  • Payroll taxes, fringe benefits, and withholding advice
  • State and local tax issues
  • Tax exposure withholdings

Technology, Outsourcing & Commercial Transactions

  • Technology transfer and licensing
  • Collaborations
  • Outsourcing and managed services
  • Commercial transactions

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