Digital Health

Why Cooley

Breakthroughs happen with Cooley. At Cooley, we don't just advise – we accelerate your achievements. Our collaborative approach draws upon unparalleled experience and our extensive industry network to drive strategic solutions and resolve challenges. With Cooley as your catalyst, you're not just part of the digital health industry – you're shaping it.

We’re an innovation partner to 700+ digital health companies redefining healthcare access and improving the quality and affordability of care. We combine pragmatic and client-focused advice, an unmatched network of active healthcare investors, an industry-leading commercial licensing team, and a full-service regulatory platform to act as a springboard for our digital health clients.

Our counsel and insights are informed by decades of experience guiding healthcare and life sciences companies, software, ecommerce and social media innovators, mobile service and payment providers, gaming companies, healthcare providers, and leaders in the medical technology sector.

Corporate

We advise digital health companies, investors and institutions on an eclectic range of corporate services, including financings, mergers and acquisitions, public offerings and company and fund formation. Our team also has extensive experience representing our digital health clients in commercial transactions with hospitals and clinics, service and other technology providers, data partners, and joint venture partners.

Areas of practice

• Commercial and distribution agreements
• Company formation
• Financings
• Mergers and acquisitions
• Public financings and private placements
• Sale and purchase of assets
• Strategic partnerships
• Tax

Litigation

Cooley litigators are called to defend our clients when litigation issues surface, often resulting from attempts by plaintiffs’ lawyers to apply established laws to emerging technologies. Our lawyers have particular experience in class action defense and complex commercial litigation, representing clients throughout the United States in trial and appellate courts and before administrative agencies.

Areas of practice

• Antitrust litigation
• Class action defense
• Commercial litigation
• Contract and license disputes
• Employment litigation
• Intellectual property litigation
• Privacy litigation
• Product liability
• Restructuring, bankruptcy and creditors’ rights
• Securities litigation
• Trade secret litigation
• Trademark, copyright and advertising

Regulatory

Our lawyers deploy a unique combination of deep industry experience and knowledge to support our digital health clients’ innovation, growth and success, providing holistic advice related to regulatory matters.

Cooley’s digital health regulatory capabilities are part of our CooleyREG offering, through which we combine an understanding of the impact of disruptive advancements – and the regulatory issues that impose risk and slow progress – to help our clients navigate an increasingly complex regulatory landscape.

Regulatory capabilities

• Corporate practice of medicine
• Friendly professional corporation (PC) model and structuring, including management services organization (MSO)
• Friendly PC model implementation, including payment pathways, information sharing, patient consents
• Telehealth licensing requirements
• Operational compliance, including consents, billing requirements and modality questions
• Population health management
• Centers for Medicare & Medicaid Services (CMS) guidance and compliance
• Fraud and abuse

Counseling and advice

• Transition from Depository Trust Company (DTC) to payer-sponsored payment
• Value-based care and risk-based payment models
• Accountable care organization (ACO) models
• CMS and Center for Medicare and Medicaid Innovation (CMMI) demonstration models
• Third-party administrator (TPA) and/or employee assistance program (EAP) structuring and compliance
• Risk-bearing entity structuring and compliance

Transactional support

• Structuring and drafting technology agreements
• Creating design, development and manufacturing agreements for devices, appliances and other hardware
• Offering professional licensing and corporate practice counseling
• Advising on spinouts, joint ventures and strategic M&A
• Developing payer coverage and reimbursement policies for telehealth
• Assisting with Big Data licensing and data use

Additional areas of practice

• Antitrust counseling
• Federal Communications Commission regulatory counseling
• Corporate governance
• Employment and benefits
• Export control and international trade regulations
• Privacy and data protection counseling and data breach response

Intellectual Property

Our fully integrated prosecution, counseling and litigation practice tailors the solutions and legal strategies to meet each client’s unique needs and stage of development. We provide comprehensive patent and trademark solutions with an eye toward mitigating current and future intellectual property risks and monetizing IP assets.

Areas of practice

• Copyright
• IP litigation
• Patent office litigation
• Technology transactions
• Antitrust and competition
• Trademark, copyright and advertising
• Artificial intelligence
• Patent counseling and prosecution
• Trade secret litigation and dispute counseling