Digital Health

Bringing your digital health strategies to life.

Digital Health

Bringing your digital health strategies to life.

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Health care is among the most heavily regulated sectors in the United States and across the globe. Digital health is now integral and indispensable to efficient and effective care delivery and continues to challenge the boundaries between tech innovation and regulation.

The Dentons Digital Health team combines deep legal expertise with practical experience: our attorneys have been thought leaders and have represented digital health companies, as well as the federal healthcare agencies, academic institutions, and large payors and health systems critical to their success. We help our clients navigate the broad range of legal, regulatory, policy, operational, competitive, compliance and financial considerations underpinning the industry.

We have teams that specialize in all company stages of growth and funding—from pre-seed through exit. Every client works with a partner that serves, like an outside general counsel, as their go-to contact to deliver timely, coordinated and expert advice within budget expectations.

Digital Health Wheel of Services

Typical areas of focus for our clients:

Corporate and Transactional
- Company formation, venture capital, private equity and growth financing
- M&A, IPOs and securities and tax law matters
- Strategic partnerships, joint ventures and deal diligence
- Commercial and technology transactions
- Capitalization and restructuring
Healthcare Regulatory and Policy
- Regulatory, including product and reimbursement strategy
- Anti-kickback, Stark Law, and Fraud, Waste & Abuse counseling
- Provider networks and contracting, including ACOs, value-based care and risk arrangements
- Friendly PC Models
- State managed care, insurance and provider licensure o Commercial (fully-insured and self-funded/ERISA) and Government Programs (Medicare/Medicaid managed care)
- Internal and government investigations, compliance program design, implementation and training; regulatory gap analyses
- FDA Medical Device and Software as Medical Device (SaMD)
- Risk management and litigation; FCA and FCPA defense
- Public policy and counseling
Emerging Technology
- Payment processing and transactions; revenue cycle management
- Telehealth platforms
- Blockchain and Cryptocurrency
- Artificial Intelligence (AI), Generative AI (GenAI), Retrieval-Augmented Generation (RAG), Machine Learning (ML) and Large Language Models (LLM)
- Intellectual Property (IP) commercialization, strategy, protection and enforcement
Data Security and Privacy
- Data privacy (HIPAA, GDPR, medical records, electronic health records and state law) and offshoring
- Cybersecurity (HITRUST, SOC2 Type 2)

Experience

BenevolentAI: Assisting an AI-based digital health company with patent policy, patent drafting and global filing strategies.
BIOS Health: Advising BIOS Health, a med tech company unlocking the potential of the nervous system in treating chronic disease by using AI-powered neural interfaces that can automatically read and write neural signals, on intellectual property policy, strategy, training of key employees and exploitation, as well as related drafting commercial agreements related to intellectual property.
Congenica: Advising a leading digital health company leveraging its proprietary AI in its world leading clinical decision support platform, enabling the rapid analysis and interpretation of human genomic data, on technology protection, patent risk management, freedom to operate, patent strategy, patent drafting and portfolio management.
Digital health company: Advising company on alternative data use strategies, monetization of digital health data and comparative legal requirements for deidentification under HIPAA, the Common Rule, and the GDPR; advising company on customer and supplier contracting strategies with respect to alternative data use rights, intellectual property rights, confidentiality, privacy, cybersecurity and data.
Digital health company: Advised company on alternative data use strategies, monetization of digital health data, and comparative legal requirements for deidentification under HIPAA, the Common Rule, California Consumer Privacy Act (“CCPA”)/California Privacy Rights Act (“CPRA”), and General Data Protection Regulation (“GDPR”). Advised the company on customer and supplier contracting strategies with respect to alternative data use rights, intellectual property rights, confidentiality, privacy, cybersecurity, and data protection, including in the context of research.
Emerging AI voice translation provider: Providing expansive healthcare regulatory, privacy, and cybersecurity advice to emerging AI-powered healthcare translation service provider.
Global digital health company: Advising on the building of a sophisticated AI platform used in drug discovery and finding new use for existing drugs, including invention harvesting and global management of IP derived from the initial patent filings.
Health care technology company: Advised a health care technology company with respect to transactional, privacy, and cybersecurity matters in connection with its collaborative research and development project with a Fortune 500 business partner. Worked with the client to develop and negotiate the terms of the collaboration and draft, negotiate, and finalize the arrangement with a series of key transactional and corporate documents (e.g., collaboration and service agreements and corresponding business associate agreements).
Leading healthcare technology company: Representation of a leading healthcare technology company during various start-up and mature company phases. This included development of regulatory, producer, and provider frameworks and contracts.
Leading US healthcare technology service provider: Advising a leading US healthcare technology service provider on building a responsible AI governance framework, external AI statements, and contract provisions.
Online health community: Serving as exclusive privacy and data security counsel to this data-driven, direct-to-consumer advertising, custom patient research and clinical services online health community. Dentons assists in developing a holistic, enterprise-wide privacy framework, including privacy governance documents, a vendor management and onboarding program, data transfer and sharing documents and an information security program for new business initiatives. In addition, we have played a key role in ensuring client is compliant with new and proposed data privacy legislation.