Sectors

Digital Health

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

blogs

Health Law Scan

Legal Insights and Perspectives for the Healthcare Industry

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